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Polyrizon Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Polyrizon Ltd.
Response Received
1 company response(s)
High - file number match
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Polyrizon Ltd.
Response Received
1 company response(s)
High - file number match
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Polyrizon Ltd.
Response Received
22 company response(s)
High - file number match
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Company responded
2023-02-03
Polyrizon Ltd.
References: January 10, 2023
Summary
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Company responded
2023-02-27
Polyrizon Ltd.
References: February
3, 2023 | January 10, 2023
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Company responded
2024-09-03
Polyrizon Ltd.
References: February 27, 2023
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-09-20
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-09-13
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-08-30
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-06-14
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-02-21
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-02-16
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-01-23
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-12-23
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-10-21
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-06-02
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-05-17
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-04-19
Polyrizon Ltd.
Summary
Generating summary...
Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-03-10
Polyrizon Ltd.
Summary
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Polyrizon Ltd.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-02-07
Polyrizon Ltd.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-02 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2025-05-08 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2025-05-07 | SEC Comment Letter | Polyrizon Ltd. | Israel | 333-286849 | Read Filing View |
| 2025-01-13 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2025-01-06 | SEC Comment Letter | Polyrizon Ltd. | Israel | 333-284090 | Read Filing View |
| 2024-10-25 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-25 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-25 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-25 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-22 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-22 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-22 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-22 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-18 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-18 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-30 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-26 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-26 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-23 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-20 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2024-09-16 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-13 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2024-09-03 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-08-30 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2024-08-14 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-06-14 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2024-02-21 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2023-02-27 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2023-02-16 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2023-02-03 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2023-01-23 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2023-01-10 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2022-12-23 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-12-19 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2022-10-21 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-10-06 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2022-08-17 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-08-10 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2022-06-02 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-05-17 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-04-19 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-03-10 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-02-07 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-07 | SEC Comment Letter | Polyrizon Ltd. | Israel | 333-286849 | Read Filing View |
| 2025-01-06 | SEC Comment Letter | Polyrizon Ltd. | Israel | 333-284090 | Read Filing View |
| 2024-09-20 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2024-09-13 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2024-08-30 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2024-06-14 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2024-02-21 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2023-02-16 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2023-01-23 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-12-23 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-10-21 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-08-17 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-06-02 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-05-17 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-04-19 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-03-10 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| 2022-02-07 | SEC Comment Letter | Polyrizon Ltd. | Israel | 377-05914 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-02 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2025-05-08 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2025-01-13 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-25 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-25 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-25 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-25 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-22 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-22 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-22 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-22 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-18 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-10-18 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-30 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-26 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-26 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-23 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-16 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-09-03 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2024-08-14 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2023-02-27 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2023-02-03 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2023-01-10 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2022-12-19 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2022-10-06 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
| 2022-08-10 | Company Response | Polyrizon Ltd. | Israel | N/A | Read Filing View |
2025-12-02 - CORRESP - Polyrizon Ltd.
CORRESP 1 filename1.htm Polyrizon Ltd. 5 Ha-Tidhar Street Raanana, 4366507, Israel December 2, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: Polyrizon Ltd. (CIK 0001893645) Registration Statement No. 333-291368 on Form F-3 (the "Registration Statement") Ladies and Gentlemen: Polyrizon 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 3, 2025, at 9:00 a.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 David Huberman at 312.364.1633. The Company hereby authorizes Mr. Huberman to orally modify or withdraw this request for acceleration. Very truly yours, Polyrizon Ltd. By: /s/ Tomer Izraeli Name: Tomer Izraeli Title: Chief Executive Officer
2025-05-08 - CORRESP - Polyrizon Ltd.
CORRESP 1 filename1.htm Polyrizon Ltd. 5 Ha-Tidhar Street Raanana, 4366507, Israel May 8, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: Polyrizon Ltd. (CIK 0001893645) Registration Statement No. 333-286849 on Form F-1 (the "Registration Statement") Ladies and Gentlemen: Polyrizon 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 12, 2025 at 9:00 a.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 David Huberman at 312.364.1633. The Company hereby authorizes Mr. Huberman to orally modify or withdraw this request for acceleration. Very truly yours, Polyrizon Ltd. By: /s/ Tomer Izraeli Name: Title: Tomer Izraeli Chief Executive Officer
2025-05-07 - UPLOAD - Polyrizon Ltd. File: 333-286849
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 7, 2025 Tomer Izraeli Chief Executive Officer Polyrizon Ltd. 5 Ha-Tidhar Street Raanana, 4366507, Israel Re: Polyrizon Ltd. Registration Statement on Form F-1 Filed April 30, 2025 File No. 333-286849 Dear Tomer Izraeli: 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 Conlon Danberg at 202-551-4466 with any questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: David Huberman, Esq. </TEXT> </DOCUMENT>
2025-01-13 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
Polyrizon Ltd.
5 Ha-Tidhar Street
Raanana, 4366507, Israel
January 13, 2025
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Polyrizon Ltd. (CIK 0001893645)
Registration Statement No. 333-284090 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Polyrizon 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 15, 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 David Huberman at 312.364.1633. The Company hereby authorizes Mr. Huberman to orally modify or withdraw this request for acceleration.
Very truly yours,
Polyrizon LTD.
By:
/s/ Tomer Izraeli
Tomer Izraeli
Chief Executive Officer
2025-01-06 - UPLOAD - Polyrizon Ltd. File: 333-284090
January 6, 2025
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5 Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Registration Statement on Form F-1
Filed December 30, 2024
File No. 333-284090
Dear Tomer Izraeli:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:David A. Huberman
2024-10-25 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
Polyrizon Ltd.
Ha-Tidhar Street
Raanana, 4366507, Israel
October 25, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Polyrizon Ltd. (CIK 0001893645)
Registration Statement No. 333-266745 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Polyrizon 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 October 28, 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 David Huberman at (312) 364-1633. The Company hereby authorizes Mr. Huberman to orally modify or withdraw this request for
acceleration.
Very truly yours,
POLYRIZON LTD.
By:
/s/ Tomer Izraeli
Tomer Izraeli
Chief Executive Officer
2024-10-25 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
October 25, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, D.C. 20549
Re:
Polyrizon Ltd.
Registration Statement on Form F-1
File No. 333-266745
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence
via EDGAR on October 22, 2024, in which we requested the acceleration of the effective date of the above-referenced Registration Statement
for Thursday, October 24, 2024, at 5:00 p.m. Eastern Time or as soon as reasonably practicable thereafter, in accordance with Rule 461
under the Securities Act of 1933, as amended. 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.
Very truly yours,
Aegis Capital Corp.
/s/ Robert Eide
Robert Eide
Chief Executive Officer
2024-10-25 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
Polyrizon Ltd.
Ha-Tidhar Street
Raanana, 4366507, Israel
October 25, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Polyrizon Ltd. (CIK 0001893645)
Registration Statement No. 333-266745 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Reference is made to our letter,
filed as correspondence via EDGAR on October 22, 2024, in which we requested acceleration of the effective date of the above referenced
Registration Statement to 5:00 p.m., Eastern Time, on October 24, 2024, or as soon as possible thereafter, in accordance with Rule 461
under the Securities Act of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective at such
time and we hereby withdraw our request for acceleration of the effective date until further notice from the Company.
The Registrant respectfully
requests that it be notified of acceptance of this notice of withdrawal by a telephone call to David Huberman, Esq. of Greenberg Traurig,
P.A. at (312) 364-1633.
Very truly yours,
POLYRIZON LTD.
By:
/s/ Tomer Izraeli
Tomer Izraeli
Chief Executive Officer
2024-10-25 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
October 25, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F St., N.E.
Washington, D.C. 20549
Re:
Polyrizon Ltd.
Registration Statement on Form F-1
File No. 333-266745
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated
under the Securities Act of 1933, as amended (the “Securities Act”), Aegis Capital Corp., as representative of the underwriters,
hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at
5:00 p.m. Eastern Time on October 28, 2024 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, 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 confirms that
it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they
have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with
the above-referenced issue.
Very truly yours,
Aegis Capital Corp.
By:
/s/ Robert Eide
Name:
Robert Eide
Title:
Chief Executive Officer
2024-10-22 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
October 22, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street NE
Washington, D.C. 20549
Re:
Polyrizon Ltd.
Registration Statement on Form F-1
File No. 333-266745
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence
via EDGAR on October 18, 2024, in which we requested the acceleration of the effective date of the above-referenced Registration Statement
for Monday, October 21, 2024, at 5:00 p.m. Eastern Time or as soon as reasonably practicable thereafter, in accordance with Rule 461 under
the Securities Act of 1933, as amended. 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.
Very truly yours,
Aegis Capital Corp.
/s/ Robert Eide
Robert Eide
Chief Executive Officer
2024-10-22 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
October 22, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F St., N.E.
Washington, D.C. 20549
Re:
Polyrizon Ltd.
Registration Statement on Form F-1
File No. 333-266745
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated under the Securities
Act of 1933, as amended (the “Securities Act”), Aegis Capital Corp., as representative of the underwriters, hereby requests
acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00 p.m. Eastern
Time on October 24, 2024 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, 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 confirms that it has complied with
and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or
will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced
issue.
Very truly yours,
Aegis Capital Corp.
By:
/s/ Robert Eide
Name:
Robert Eide
Title:
Chief Executive Officer
2024-10-22 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
Polyrizon Ltd.
Ha-Tidhar Street
Raanana, 4366507, Israel
October 22, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Polyrizon Ltd. (CIK 0001893645)
Registration Statement No. 333-266745 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Reference is made to our letter,
filed as correspondence via EDGAR on October 18, 2024, in which we requested acceleration of the effective date of the above referenced
Registration Statement to 5:00 p.m., Eastern Time, on October 21, 2024, or as soon as possible thereafter, in accordance with Rule 461
under the Securities Act of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective at such
time and we hereby withdraw our request for acceleration of the effective date until further notice from the Company.
The Registrant respectfully
requests that it be notified of acceptance of this notice of withdrawal by a telephone call to David Huberman, Esq. of Greenberg Traurig,
P.A. at (312) 364-1633.
Very truly yours,
POLYRIZON LTD.
By:
/s/ Tomer Izraeli
Tomer Izraeli
Chief Executive Officer
2024-10-22 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
Polyrizon Ltd.
Ha-Tidhar Street
Raanana, 4366507, Israel
October 22, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Polyrizon Ltd. (CIK 0001893645)
Registration Statement No. 333-266745 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Polyrizon 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 October 24, 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 David Huberman at (312) 364-1633. The Company hereby authorizes Mr. Huberman to orally modify or withdraw this request for
acceleration.
Very truly yours,
POLYRIZON LTD.
By:
/s/ Tomer Izraeli
Tomer Izraeli
Chief Executive Officer
2024-10-18 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
October 18,
2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F St., N.E.
Washington, D.C. 20549
Re:
Polyrizon Ltd.
Registration Statement on Form F-1
File No. 333-266745
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated under the Securities
Act of 1933, as amended (the “Securities Act”), Aegis Capital Corp., as representative of the underwriters, hereby requests
acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00 p.m. Eastern
Time on October 21, 2024 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, 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 confirms that it has complied with
and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or
will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced
issue.
Very truly yours,
Aegis Capital Corp.
By:
/s/ Robert Eide
Name:
Robert Eide
Title:
Chief Executive Officer
2024-10-18 - CORRESP - Polyrizon Ltd.
CORRESP
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Polyrizon Ltd.
Ha-Tidhar Street
Raanana, 4366507, Israel
October 18, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Polyrizon Ltd. (CIK 0001893645)
Registration Statement No. 333-266745 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Polyrizon 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 October 21, 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 David Huberman at (312) 364-1633. The Company hereby authorizes Mr. Huberman to orally modify or withdraw this request for
acceleration.
Very truly yours,
POLYRIZON LTD.
By:
/s/
Tomer Izraeli
Tomer Izraeli
Chief Executive Officer
2024-09-30 - CORRESP - Polyrizon Ltd.
CORRESP
1
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Polyrizon Ltd.
Ha-Tidhar Street
Raanana, 4366507, Israel
September 30, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Polyrizon Ltd. (CIK 0001893645)
Registration Statement No. 333-266745 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Reference is made to our letter,
filed as correspondence via EDGAR on September 26, 2024, in which we requested acceleration of the effective date of the above referenced
Registration Statement to 5:00 p.m., Eastern Time, on September 30, 2024, or as soon as possible thereafter, in accordance with Rule 461
under the Securities Act of 1933, as amended. We are no longer requesting that such Registration Statement be declared effective at such
time and we hereby withdraw our request for acceleration of the effective date until further notice from the Company.
The Registrant respectfully requests
that it be notified of acceptance of this notice of withdrawal by a telephone call to David Huberman, Esq. of Greenberg Traurig, P.A.
at (312) 364-1633.
Very truly yours,
POLYRIZON LTD.
By:
/s/ Tomer Izraeli
Tomer Izraeli
Chief Executive Officer
2024-09-26 - CORRESP - Polyrizon Ltd.
CORRESP
1
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September 26,
2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F St., N.E.
Washington, D.C. 20549
Re:
Polyrizon Ltd.
Registration Statement on Form F-1
File No. 333-266745
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated under the Securities
Act of 1933, as amended (the “Securities Act”), Aegis Capital Corp., as representative of the underwriters, hereby requests
acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00 p.m. Eastern
Time on September 30, 2024 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, 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 confirms that it has complied with
and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or
will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced
issue.
Very truly yours,
Aegis Capital Corp.
By:
/s/ Robert Eide
Name:
Robert Eide
Title:
Chief Executive Officer
2024-09-26 - CORRESP - Polyrizon Ltd.
CORRESP
1
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Polyrizon Ltd.
Ha-Tidhar Street
Raanana, 4366507, Israel
September 26, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
Polyrizon Ltd. (CIK 0001893645)
Registration Statement No. 333-266745 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
Polyrizon 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 September 30, 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 David Huberman at (312) 364-1633. The Company hereby authorizes Mr. Huberman to orally modify or withdraw this request for
acceleration.
Very truly yours,
POLYRIZON LTD.
By:
/s/ Tomer Izraeli
Tomer Izraeli
Chief Executive Officer
2024-09-23 - CORRESP - Polyrizon Ltd.
CORRESP
1
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September 23, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Tracie Mariner
Kevin Vaughn
Benjamin Richie
Abby Adams
Re:
Polyrizon Ltd.
Amendment No. 9 to Registration Statement on Form F-1
Filed September 16, 2024
File No. 333-266745
Dear Sir or Madam:
On behalf of Polyrizon Ltd. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of Corporation
Finance of the Securities and Exchange Commission (the “Commission”) dated September 20, 2024, relating to the above referenced
Registration Statement on Form F-1 (File No. 333-266745) submitted by the Company on September 16, 2024 (the “Registration Statement”).
Concurrent with the submission of this letter,
the Company is filing via EDGAR Amendment No. 10 to the Registration Statement on Form F-1 (“Amendment No. 10”), which reflects
the Company’s responses to the comments received by the Staff and certain updated information. For your convenience, the Company
is also delivering via email a copy of this letter and the Registration Statement marked to indicate changes from the Registration Statement.
For ease of review, we have set forth below each
of the numbered comments of your letter in bold text, followed by the Company’s responses thereto. Capitalized terms used herein
but not defined herein have the meanings given to such terms in the Registration Statement.
Amendment No. 9 to Registration Statement on Form F-1
Exhibits
1. Please revise the fee table to calculate the filing fee for the resale shares based on the maximum offering price per share.
Response: In response to the Staff’s
comment, the Company has filed an updated Exhibit 107 to calculate the filing fee for the resale shares based on the maximum offering
price per share.
General
2. Please revise your selling shareholder disclosures on page 138 to identify more clearly which of the selling shareholders have
indicated an interest in purchasing units in the primary offering, and the percentage and amount the shareholders intend to purchase in
the primary offering, if known. Please make conforming changes to your filing, including your cover page, and revise the cover page to
disclose that the selling shareholders’ indications of interest equate to approximately 27% of the offering, as disclosed in the revised
risk factor on page 54.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 138 and throughout the prospectus, including the cover page, to identify more
clearly which of the selling shareholders have indicated an interest in purchasing units in the primary offering, and the percentage and
amount the shareholders intend to purchase in the primary offering, based on the number of Units offered by the Company and the midpoint
of the price range of the Units, each as set forth on the cover page of the prospectus.
In addition, the Company has revised the cover
page to disclose that the selling shareholders’ indications of interest equate to approximately 27% of the offering, as disclosed in the
risk factor on page 54.
Please contact me at +1 312.364.1633 if
you have any questions or require any additional information in connection with this letter or the Company’s submission of the Amendment
No. 10.
Sincerely,
/s/ David Huberman
cc: Tomer Izraeli, Chief Executive Officer
2024-09-20 - UPLOAD - Polyrizon Ltd. File: 377-05914
September 20, 2024
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5 Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 9 to Registration Statement on Form F-1
Filed September 16, 2024
File No. 333-266745
Dear Tomer Izraeli:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a 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. Unless we note otherwise,
any references to prior comments are to comments in our September 13, 2024 letter.
Amendment No. 9 to Registration Statement on Form F-1
Exhibits
1.Please revise the fee table to calculate the filing fee for the resale shares based on the
maximum offering price per share.
General
2.Please revise your selling shareholder disclosures on page 138 to identify more clearly
which of the selling shareholders have indicated an interest in purchasing units in the
primary offering, and the percentage and amount the shareholders intend to purchase in
the primary offering, if known. Please make conforming changes to your filing, including
your cover page, and revise the cover page to disclose that the selling shareholders'
indications of interest equate to approximately 27% of the offering, as disclosed in the
revised risk factor on page 54.
September 20, 2024
Page 2
Please contact Tracie Mariner at 202-551-3744 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Abby Adams at 202-551-6902 or Katherine Bagley at 202-551-2545 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:David Huberman, Esq.
2024-09-16 - CORRESP - Polyrizon Ltd.
CORRESP
1
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September 16, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Tracie Mariner
Kevin Vaughn
Benjamin Richie
Abby Adams
Re:
Polyrizon Ltd.
Amendment No. 8 to Registration Statement on Form F-1
Filed September 9, 2024
File No. 333-266745
Dear Sir or Madam:
On behalf of Polyrizon Ltd. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of Corporation
Finance of the Securities and Exchange Commission (the “Commission”) dated September 13, 2024, relating to the above referenced
Registration Statement on Form F-1 (File No. 333-266745) submitted by the Company on September 9, 2024 (the “Registration Statement”).
Concurrent with the submission of this letter,
the Company is filing via EDGAR Amendment No. 9 to the Registration Statement on Form F-1 (“Amendment No. 9”), which reflects
the Company’s responses to the comments received by the Staff and certain updated information. For your convenience, the Company
is also delivering via email a copy of this letter and the Registration Statement marked to indicate changes from the Registration Statement.
For ease of review, we have set forth below each
of the numbered comments of your letter in bold text, followed by the Company’s responses thereto. Capitalized terms used herein
but not defined herein have the meanings given to such terms in the Registration Statement.
Amendment No. 7 to Registration Statement on Form F-1
Plan of Distribution, page A-5
1.
We note your disclosure in the resale prospectus on page Alt-5 that your selling securityholders may sell their securities through various means, including purchases by a broker-dealer as principal and resale by the broker-dealer for its account. Please confirm your understanding that the retention by a selling securityholder of an underwriter would constitute a material change to your plan of distribution requiring a post-effective amendment. Refer to your undertaking provided pursuant to Item 512(a)(1)(iii) of Regulation S-K.
Response: In response to the Staff’s
comment, the Company confirms its understanding that the retention by a selling securityholder of an underwriter would constitute a material
change to the plan of distribution included in the Registration Statement requiring a post-effective amendment.
Exhibits
2.
Please revise the legal opinion(s) to address the resale shares.
Response: In response to the Staff’s
comment the Company has caused an updated Exhibit 5.1 and Exhibit 5.2 to be filed with Amendment No. 9 to refer to the resale of up to
2,801,330 ordinary shares held by selling securityholders, which is consistent with the Registration Statement.
General
3.
We note your response to prior comment 8. Please expand your responses to clarify whether any of the selling securityholders are in the business of underwriting securities. In addition, please provide further analysis regarding your basis for determining that XYLO is not an affiliate, in particular given the current share ownership, the position of its Chief Executive Officer on your Board, the recent timing of the transfers of stock and the history of transaction, and the statements in XYLO’s public filings of its affiliation with your company. In doing so, please address who exercises voting and dispositive power over the XYLO shares. Clarify whether any of the transferees of the XYLO shares are affiliates of XYLO or the company. Refer to Exchange Act Rules 12b-2 (“affiliate”), 13d- 3. In addition, to the extent you have not done so, please revise the beneficial ownership table to identify the natural person or persons who directly or indirectly exercise sole or shared voting and/or dispositive power with respect to the common stock held by the entities in the table. Refer to Item 403 of Regulation S-K.
Response: In response to the Staff’s
comment, the Company respectfully notes that, according to representations of all of the selling securityholders that the Company relied
upon in the course of the investments made by the selling securityholders, or the secondary transfers pursuant to which, each selling
securityholder acquired the Company’s ordinary shares for investment purposes and not with a view toward distribution or underwriting
of securities. Each selling securityholder made specific representations to the Company that such selling securityholders was acquiring
the Company’s ordinary shares in the ordinary course of business for such selling securityholder’s own account and not with
a view towards, or for resale in connection with, the public sale or distribution thereof. Accordingly, the Company does not believe that
any of the selling securityholders are in the business of underwriting securities.
In addition, while the Company does not believe that
Xylo Technologies Ltd. (“Xylo”) is currently an affiliate of the Company, in response to the Staff’s comment, the Company
respectfully notes that it has removed Xylo as a selling securityholder in Amendment No. 9. To the Company’s knowledge, none of
the transferees of the Xylo shares are affiliates of Xylo or the Company. The Company has also revised the beneficial ownership table
to identify the natural person or persons who directly or indirectly exercise sole or shared voting and/or dispositive power with respect
to the shares held by the entities in the table.
4.
We note the paragraph added to the prospectus cover page of the eighth amended registration statement, wherein you state the current securityholders, including those holding more than 5% of your securities, have expressed an interest in acquiring up to $1 million in ordinary shares in the initial public offering. As you are offering units of ordinary shares and warrants, please revise to provide this disclosure in terms of the volume of units. Please disclose whether any of the potential purchasers are selling securityholders or affiliates. In addition, please revise to disclose whether any of the potential purchasers are affiliates or securityholders who could hold greater than 5% beneficial ownership after the offering. To the extent these indications of interest could result in securityholders or affiliates acquiring more than 5% beneficial ownership of your securities or increasing holdings further above 5% beneficial ownership, please also revise the beneficial ownership disclosure accordingly. Finally, please provide risk factor disclosure regarding the effects of current securityholders or affiliates purchasing securities in the offering.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on the cover page and throughout the prospectus, including the sections titled “Principal
Shareholders” and “Selling Shareholders” to include additional information regarding the shareholders that have expressed
an interest in purchasing Units in the offering. The Company has revised its disclosure in the foregoing sections to disclose the resulting
beneficial ownership after the offering due to participation by the current securityholders in the offering.
2
In addition, the Company has revised its disclosure
on page 54 to include additional risk factor disclosure regarding the effects of current securityholders or affiliates purchasing securities
in the offering.
5.
Please revise the fee table to also include the resale offering.
Response: In response to the Staff’s
comment, the Company has filed an updated Exhibit 107 to include the resale offering.
Please contact me at +1 312.364.1633 if
you have any questions or require any additional information in connection with this letter or the Company’s submission of the Amendment
No. 7.
Sincerely,
/s/ David Huberman
cc: Tomer Izraeli, Chief Executive Officer
3
2024-09-13 - UPLOAD - Polyrizon Ltd. File: 377-05914
September 13, 2024
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5 Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 8 to Registration Statement on Form F-1
Filed September 9, 2024
File No. 333-266745
Dear Tomer Izraeli:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a 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. Unless we note otherwise,
any references to prior comments are to comments in our August 30, 2024 letter.
Amendment No. 7 to Registration Statement on Form F-1
Plan of Distribution, page A-5
1.We note your disclosure in the resale prospectus on page Alt-5 that your selling
securityholders may sell their securities through various means, including purchases by a
broker-dealer as principal and resale by the broker-dealer for its account. Please confirm
your understanding that the retention by a selling securityholder of an underwriter would
constitute a material change to your plan of distribution requiring a post-effective
amendment. Refer to your undertaking provided pursuant to Item 512(a)(1)(iii) of
Regulation S-K.
Exhibits
2.Please revise the legal opinion(s) to address the resale shares.
September 13, 2024
Page 2
General
3.We note your response to prior comment 8. Please expand your responses to clarify
whether any of the selling securityholders are in the business of underwriting securities. In
addition, please provide further analysis regarding your basis for determining that XYLO
is not an affiliate, in particular given the current share ownership, the position of its Chief
Executive Officer on your Board, the recent timing of the transfers of stock and the
history of transaction, and the statements in XYLO's public filings of its affiliation with
your company. In doing so, please address who exercises voting and dispositive power
over the XYLO shares. Clarify whether any of the transferees of the XYLO shares are
affiliates of XYLO or the company. Refer to Exchange Act Rules 12b-2 ("affiliate"), 13d-
3. In addition, to the extent you have not done so, please revise the beneficial ownership
table to identify the natural person or persons who directly or indirectly exercise sole or
shared voting and/or dispositive power with respect to the common stock held by the
entities in the table. Refer to Item 403 of Regulation S-K
4.We note the paragraph added to the prospectus cover page of the eighth amended
registration statement, wherein you state the current securityholders, including those
holding more than 5% of your securities, have expressed an interest in acquiring up to $1
million in ordinary shares in the initial public offering. As you are offering units of
ordinary shares and warrants, please revise to provide this disclosure in terms of the
volume of units. Please disclose whether any of the potential purchasers are selling
securityholders or affiliates. In addition, please revise to disclose whether any of the
potential purchasers are affiliates or securityholders who could hold greater than 5%
beneficial ownership after the offering. To the extent these indications of interest could
result in securityholders or affiliates acquiring more than 5% beneficial ownership of your
securities or increasing holdings further above 5% beneficial ownership, please also revise
the beneficial ownership disclosure accordingly. Finally, please provide risk factor
disclosure regarding the effects of current securityholders or affiliates purchasing
securities in the offering.
5.Please revise the fee table to also include the resale offering.
Please contact Tracie Mariner at 202-551-3744 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Benjamin Richie at 202-551-7857 or Abby Adams at 202-551-6902 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:David Huberman, Esq.
2024-09-03 - CORRESP - Polyrizon Ltd.
CORRESP
1
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September 3, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Tracie Mariner
Kevin Vaughn
Benjamin Richie
Abby Adams
Re:
Polyrizon Ltd.
Amendment No. 6 to Registration Statement on Form F-1
Filed August 14, 2024
File No. 333-266745
Dear Sir or Madam:
On behalf of Polyrizon Ltd.
(the “Company”), we are writing to submit the Company’s responses to the comments of the staff (the “Staff”)
of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated August 30, 2024,
relating to the above referenced Registration Statement on Form F-1 (File No. 333-266745) submitted by the Company on August 14, 2024
(the “Registration Statement”).
Concurrent with the submission
of this letter, the Company is filing via EDGAR Amendment No. 7 to the Registration Statement on Form F-1 (“Amendment No. 7”),
which reflects the Company’s responses to the comments received by the Staff and certain updated information. For your convenience,
the Company is also delivering via email a copy of this letter and the Registration Statement marked to indicate changes from the Registration
Statement.
For ease of review, we have
set forth below each of the numbered comments of your letter in bold text, followed by the Company’s responses thereto. Capitalized
terms used herein but not defined herein have the meanings given to such terms in the Registration Statement.
Amendment No. 6 to Registration Statement on Form F-1
Cover Page
1.
We note your revised disclosure in response to prior comment 1. Please revise your cover page and disclosure elsewhere, as appropriate, to specify the total number of shares being registered with respect to the units.
Response: In
response to the Staff’s comment, the Company has revised the cover page of Amendment No. 7 to specify the total number of
Ordinary shares being registered with respect to the units. Similar revisions were made in the Offering Box included in the Prospectus Summary on page 10, and also on the
back cover page of the prospectus.
2.
Please revise your cover page to state that the secondary offering will not commence until after the closing of your initial public offering and to discuss the duration of the secondary offering. Refer to Item 501(b)(3) of Regulation S-K.
Response: In response
to the Staff’s comment, the Company has revised the cover page of Amendment No. 7 to state that the secondary offering will not
commence until after the closing of its initial public offering and to indicate the duration of the secondary offering shall extend at
least until September 30, 2024.
Dilution, page 66
3.
We note that the table on page 67 reflects the number of Ordinary Shares purchased from you as part of the Units, as of December 31, 2023. Please update your disclosure to be representative as of a more recent date.
Response: In response
to the Staff’s comment, the Company respectfully notes that the Dilution section takes into account all Ordinary Shares issued subsequent
to December 31, 2023, on a pro forma basis. The company has revised its disclosure on page 67 to clarify that the table is recent as of
the date of the filing of Amendment No. 7.
Certain Relationships and Related Party Transactions,
page 126
4.
Please revise this section to clarify the relationship of each entity
to the company or its affiliates, and to provide all information required by Item 404 of Regulation S-K to the extent you have not done
so. For example, with respect to the August 2021 Share Purchase Agreement, identify the “certain investors, including certain of
[your] directors and officers” with whom you entered into this agreement, the amounts of each individual’s interests. Please refer
to Item 404(a) of Regulation S-K. Please clarify the terms of the June 2023 securities purchase agreement pursuant to which Xylo Technologies
was able to pay an equivalent of $60,000 by transfer of shares. In addition, please revise the Loans with Related Parties to clarify the
interest rates for each loan, when the interest is payable,
conversion features and all material terms of the agreements. Finally,
please revise to disclose all related parties. We note director Liron Carmel signed Exhibit 10.16 on behalf of lender Medigus Ltd. Please
revise or advise.
Response: In response
to the Staff’s comment, the Company has revised its disclosure to include the additional details regarding the related party transaction.
We further note that with respect to Exhibit 10.16, Medigus Ltd. has changed its name to Xylo Ltd. We have made note of the name change
in order to avoid any confusion.
Selling Shareholders, page 137
5.
Please clarify the amount of Ordinary Shares owned by each selling shareholder following the sale of the maximum number of shares included in this offering. We note the disclosure on page Alt-4 of the selling shareholder prospectus.
Response: In response
to the Staff’s comment, the Company has revised its disclosure to clarify the amount of Ordinary Shares owned by each selling shareholder
following the sale of the maximum number of shares included in this offering.
Polyrizon Ltd. Financial Statements
Report of Independent Registered Public Accounting
Firm, page F-3
6.
We note the limiting paragraph regarding the 1.1494 to one forward stock split and await the updated auditors’ report and consent.
Response: The
Company respectfully advises the Staff that the forward stock split is now effective and accordingly the limiting paragraph has been
removed from the Report of Independent Registered Public Accounting Firm. The limiting language has also been removed from the
Consent of Independent Registered Public Accounting Firm filed as Exhibit 23.1 to Amendment No. 7.
2
General
7.
We note your revised disclosure in response to prior comment 6. Please revise to provide the title and date of each study or article, and clarify whether any of the cited reports or studies were commissioned by the Company.
Response: In response
to the Staff’s comment, the Company has revised its disclosures throughout Amendment No. 7 to provide the title and date of each
study or article. In addition, the Company respectfully advises the Staff that none of the cited reports or studies were commissioned
by the Company.
8. We note the changes in selling shareholders, and their respective
shares, included in your resale prospectus. We note the resale prospectus has been including in this offering since your second amended
registration statement filed November 19, 2022. Please provide the following analysis:
· Why
you are able to register additional shares sold to selling security holders, in particular newly named selling security holders, after
the resale registration statement was filed. Refer to Securities Act Section 5 Compliance and Disclosure Interpretation (C&DI) 134.01.
· Whether
the added security holders are acting as underwriters selling on behalf of the company. Refer to Securities Act Rules C&DI 612.09.
· Why
shares that will not be issued to SciSparc Ltd. until the IPO, the number of which will depend on the IPO market price, are able to be
registered in the resale prospectus. Refer to Securities Act Section 5 C&DIs 139.11.
In providing your response, please include the date of sale of the
securities and circumstances surrounding the sale with respect to each selling security holder.
Response: In response
to the first bullet of the Staff’s comment, the Company respectfully notes that it added the following shareholders after it filed
Amendment No. 4 to Form F-1 Registration Statement on February 3, 2023 (the “February 2023 F-1”): Raul Srugo, Reuven Srugo
Construction Company (“Srugo Construction”), Xylo Technologies Ltd. (“Xylo”, f/k/a Medigus Ltd.), Capitallink
Ltd. (“Capitallink”), Gabi Gabzo, L.I.A. Pure Capital Ltd. (“Pure Capital”), Ronen Fatal, E. G. Europe Property
(“E.G. Europe”), Itamar David and SciSparc Ltd. (“SciSparc”).
With respect to Raul Srugo and Srugo Construction,
Raul Srugo received ordinary shares of the Company following the conversion of a SAFE in June 2023, as well as through securities purchase
agreements that Raul Srugo entered into with the Company in June 2023, December 2023 and May 2024. Srugo Construction received ordinary
shares of the Company following the conversion of a SAFE in June 2023 and the conversion of a convertible loan in May 2024. When the Company
filed the February 2023 F-1, Raul Srugo was listed as director of the Company under the Management section and the Company also included
disclosure that Raul Srugo was a partial owner of Srugo Construction. As a result, the Company treated both Raul Srugo and Srugo Construction
as affiliates of the Company and did not register the ordinary shares issued to or issuable upon the conversion of convertible securities
held by each of Raul Srugo and Srugo Construction. In the response letter sent by the Company to the Staff dated February 27, 2023, the
Company noted that it had removed from the selling shareholders all of the Company’s directors and officers. On August 16, 2024,
Raul Srugo notified the Company that he did not wish to remain on the Board of the Company following its initial public offering, and
accordingly the shareholders of the company voted to replace Raul Srugo with his adult son, Omer Srugo. Accordingly, when the Company
filed Amendment No. 6 to Form F-1 Registration Statement on August 14, 2024 (the “August 2024 F-1”), the Company removed Raul
Srugo as director of the Company under the Management section. As a result, the Company no longer treats Raul Srugo or Srugo Construction
as affiliates of the Company, and thus, the Company has included each of Raul Srugo and Srugo Construction as a selling shareholder in
the Registration Statement and registered their respective holdings in the Company.
3
With respect to Xylo, in the February 2023 F-1,
in the Principal Shareholders section, the Company included disclosure that Xylo owned 40.2% of the Company issued and outstanding ordinary
shares (calculated in accordance with Section 13(d) of the Securities Exchange Act, as amended (the “Exchange Act”)) prior
to the Company’s initial public offering and would have owned 20.1% of the Company issued and outstanding ordinary shares (calculated
in accordance with Section 13(d) of the Exchange Act) after the Company’s initial public offering, based on the assumed number of
ordinary shares to be issued or issuable upon the exercise of warrants in the February 2023 F-1. Thus, the Company treated Xylo as an
affiliate of the issuer at the time the Company filed the February 2023 F-1 due to Xylo’s beneficial holdings in the Company. Between
the time that the Company filed the February 2023 F-1 and the August 2024 F-1, the Company entered into a number of financing transactions
in June 2023, December 2023 and May 2024. In addition, Xylo notified the Company that it transferred 761,240 of its ordinary shares to
third parties. As a result, Xylo’s beneficial holdings in the Company (calculated in accordance with Section 13(d) of the Exchange
Act) was reduced to 9.8% of the Company issued and outstanding ordinary shares prior to the Company’s initial public offering. Thus,
the Company no longer treats Xylo as an affiliate of the Company, and accordingly, the Company has included Xylo as a selling shareholder
in the Registration Statement and registered its holdings in the Company.
With respect to Capitallink, Gabi Gabzo, Pure Capital,
Ronen Fatal, E. G. Europe and Itamar David, each of these investors received their ordinary shares of the Company via secondary transactions
from Xylo (as mentioned above) in July 2024 with beneficial holdings in the Company (calculated in accordance with Section 13(d) of the
Exchange Act) ranging from 1.44% to 9.0% on a pre-initial public offering basis. As a result, the Company does not treat any of these
investors as affiliates of the Company, and thus, the Company has included each investor as a selling shareholder in the Registration
Statement and registered their respective holdings in the Company.
With respect to SciSparc, in August 2024, the Company
and SciSparc entered into an exclusive patent license agreement pursuant to which the Company issued to SciSparc 320,000 ordinary shares
of the Company. In addition, upon the closing of the Company’s initial public offering, the Company has agreed to issue to SciSparc
pre-funded warrant and warrants (collectively, the “SciSparc Warrants”) to purchase ordinary shares of the Company. In Amendment
No. 7, the Company is only registering the 320,000 ordinary shares that have been issued to SciSparc prior to the date of Amendment No.
7 and will not register the ordinary shares issuable upon the exercise of the SciSparc Warrants, which have not yet been issued as of
the date of Amendment No. 7 and will be issued in connection with the closing of the Company’s initial public offering. SciSparc’s
beneficial holdings in the Company (calculated in accordance with Section 13(d) of the Exchange Act) is equal to 9.9% of the Company issued
and outstanding ordinary shares on a pre-initial public offering basis. Thus, the Company does not treat SciSparc as an affiliate of the
Company, and accordingly, the Company has included SciSparc as a selling shareholder in the Registration Statement and registered its
holdings in the Company.
In response to the second bullet of the Staff’s
comment, the Company acknowledges the Staff’s comment and respectfully submits that the proposed resale of shares of the Company’s
ordinary shares by the selling shareholders as contemplated by the Registration Statement is not an indirect primary offering and is properly
regarded as a secondary offering. As a result, the selling security holders are not acting as underwriters selling on behalf of the Company.
In an effort to assist registrants in determining
whether an offering by selling stockholders may be characterized as a secondary offering that is eligible to be made on a shelf basis
under Rule 415(a)(1)(i), the Staff issued Interpretation 612.09 in its Securities Act Compliance and Disclosure Interpretations (“C&DI
612.09”) . C&DI 612.09 provides that “[t]he question of whether an offering styled a secondary one is really on behalf
of the issuer is a difficult factual one, not merely a question of who receives proceeds” and that consideration be given to the
following factors:
●
how long the selling stockholders have held the shares;
●
the circumstances under which the selling stockholders have received the shares;
●
the relationship of the selling stockholders to the issuer;
●
the number of shares being sold;
●
whether the selling stockholders are in the business of underwriting securities; and
●
whether under all the circumstances it appears that the seller is acting as a conduit for the issuer.
4
For the reasons set forth below, the Company respectfully
submits that the registration and offering from time to time (the “Offering”) of up to 3,116,851 ordinary shares, no par value,
of the Company (the “Shares”) on behalf of the selling shareholders is not, and should not be considered, a primary offering
of the Shares to the public and none of the selling shareholders is, nor should be considered to be, acting as an underwriter within the
meaning of Section 2(a)(11) of the Securities Act of 1933, as amended (the “Securities Act”). We respectfully submit that
the Offering as proposed above should be considered a secondary offering under Rule 415(a)(1)(i) of the Securities Act and that no additional
disclosure be required.
How Long the Selling Shareholders Have Held the Shares
All
2024-08-30 - UPLOAD - Polyrizon Ltd. File: 377-05914
August 30, 2024
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5 Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 6 to Registration Statement on Form F-1
Filed August 14, 2024
File No. 333-266745
Dear Tomer Izraeli:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a 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. Unless we note otherwise,
any references to prior comments are to comments in our May 20, 2024 letter.
Amendment No. 6 to Registration Statement on Form F-1
Cover Page
1.We note your revised disclosure in response to prior comment 1. Please revise your cover
page and disclosure elsewhere, as appropriate, to specify the total number of shares being
registered with respect to the units.
2.Please revise your cover page to state that the secondary offering will not commence until
after the closing of your initial public offering and to discuss the duration of the secondary
offering. Refer to Item 501(b)(3) of Regulation S-K.
Dilution, page 66
3.We note that the table on page 67 reflects the number of Ordinary Shares purchased from
you as part of the Units, as of December 31, 2023. Please update your disclosure to be
representative as of a more recent date.
August 30, 2024
Page 2
Certain Relationships and Related Party Transactions, page 126
4.Please revise this section to clarify the relationship of each entity to the company or its
affiliates, and to provide all information required by Item 404 of Regulation S-K to the
extent you have not done so. For example, with respect to the August 2021 Share
Purchase Agreement, identify the "certain investors, including certain of [your] directors
and officers" with whom you entered into this agreement, the amounts of each individual's
interests. Please refer to Item 404(a) of Regulation S-K. Please clarify the terms of the
June 2023 securities purchase agreement pursuant to which Xylo Technologies was able
to pay an equivalent of $60,000 by transfer of shares. In addition, please revise the Loans
with Related Parties to clarify the interest rates for each loan, when the interest is payable,
conversion features and all material terms of the agreements. Finally, please revise to
disclose all related parties. We note director Liron Carmel signed Exhibit 10.16 on behalf
of lender Medigus Ltd. Please revise or advise.
Selling Shareholders, page 137
5.Please clarify the amount of Ordinary Shares owned by each selling shareholder following
the sale of the maximum number of shares included in this offering. We note the
disclosure on page Alt-4 of the selling shareholder prospectus.
Polyrizon Ltd. Financial Statements
Report of Independent Registered Public Accounting Firm, page F-3
6.We note the limiting paragraph regarding the 1.1494 to one forward stock split and await
the updated auditors' report and consent.
General
7.We note your revised disclosure in response to prior comment 6. Please revise to provide
the title and date of each study or article, and clarify whether any of the cited reports or
studies were commissioned by the Company.
8.We note the changes in selling shareholders, and their respective shares, included in your
resale prospectus. We note the resale prospectus has been including in this offering since
your second amended registration statement filed November 19, 2022. Please provide the
following analysis:
•Why you are able to register additional shares sold to selling security holders, in
particular newly named selling security holders, after the resale registration statement
was filed. Refer to Securities Act Section 5 Compliance and Disclosure
Interpretation (C&DI) 134.01.
•Whether the added security holders are acting as underwriters selling on behalf of the
company. Refer to Securities Act Rules C&DI 612.09.
•Why shares that will not be issued to SciSparc Ltd. until the IPO, the number of
which will depend on the IPO market price, are able to be registered in the resale
prospectus. Refer to Securities Act Section 5 C&DIs 139.11.
In providing your response, please include the date of sale of the securities and
circumstances surrounding the sale with respect to each selling security holder.
August 30, 2024
Page 3
Please contact Tracie Mariner at 202-551-3744 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Benjamin Richie at 202-551-7857 or Abby Adams at 202-551-6902 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:David Huberman, Esq.
2024-08-14 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
August 13, 2024
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Tracie Mariner
Kevin Vaughn
Benjamin Richie
Abby Adams
Re:
Polyrizon Ltd.
Amendment No. 5 to Registration Statement on Form F-1
Filed May 20, 2024
File No. 333-266745
Dear Sir or Madam:
On behalf of Polyrizon Ltd.
(the “Company”), we are writing to submit the Company’s responses to the comments of the staff (the “Staff”)
of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated June 14, 2024, relating
to the above referenced Registration Statement on Form F-1 (File No. 333-266745) submitted by the Company on May 20, 2024 (the “Registration
Statement”).
Concurrent with the submission
of this letter, the Company is filing via EDGAR Amendment No. 6 to the Registration Statement on Form F-1 (“Amendment No. 6”),
which reflects the Company’s responses to the comments received by the Staff and certain updated information. For your convenience,
the Company is also delivering via email a copy of this letter and the Registration Statement marked to indicate changes from the Registration
Statement.
For ease of review, we have
set forth below each of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein
but not defined herein have the meanings given to such terms in the Registration Statement.
Amendment No. 5 to Registration Statement on Form F-1
Cover Page
1.
Please revise the initial public offering
to include the volume of securities you intend to register.
Response: In response to the Staff’s
comment, the Company has revised its initial public offering on the cover page of the Amendment No. 6 to include the volume of securities
the Company intends to register.
Use of Proceeds, page 63
2.
Please revise the Use of Proceeds here and in the Summary to reflect any plans to repay debt from the proceeds of the offering, such as the April 2024 CLA Amount disclosed on page 4. Please also revise to provide more specific information regarding the amount of proceeds to be used for each potential product identified in the first bullet point, and identify the additional funds that will be needed to develop these products to commercialization, if you are able to obtain the required regulatory approvals.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 12 and 63 of the Amendment No. 6 to reflect the Company’s plans to repay
its debt from the proceeds of the offering, such as the April 2024 CLA Amount and the August 2024 CLA Amount, and provided more information
regarding the amount of proceeds to be used by the Company for each of its identified potential product. In addition, the Company has
revised its disclosure on page 80 of the Amendment No. 6 to identify the additional funds that will be needed to develop these products
to commercialization.
Business, page 75
3.
Please clarify the reasons for delays in your trials.
Response: The Company respectfully advises
the Staff that the delays in the Company’s trials are due to the need for proceeds from this offering to execute its development
plan. As a result of the postponement of the Company’s IPO by over a year, from 2023 to 2024, the Company had to adjust its development
timelines, including for its trials.
Intellectual Property, page 103
4. Please remove any patents that have expired or no longer material to the Company. Please explain the
status designation, “National Phase Entered.” Please also include patent numbers, when available.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 103 of the Amendment No. 6 to remove expired and non-material patents. The Company
has also included all available patent application numbers. In addition, the Company respectfully notes that the only patent application
number not available is for the Japanese national phase patent application and advises the Staff that the patent application number will
be available within a few months. Although the patent has been filed, obtaining the application number takes a few months due to the Japanese
patent filing procedure.
Exhibits
5. Please file the Company’s February 2023 and April 2024 convertible loan agreements as exhibits to the
registration statement.
Response: In response to the Staff’s
comment, the Company has filed the February 2023 and April 2024 convertible loan agreements as exhibits to the Amendment No. 6. In addition,
the Company has filed the August 2024 convertible loan agreement as an exhibit to the Amendment No. 6.
General
6. We note your references here and elsewhere throughout your disclosure to third party reports and studies
and revised market statistics. When referring to a statistic that is not common knowledge, study, or research article, please provide
a full citation to the source of the information, provide the date of the information, and, at first instance, provide a summary of the
material findings. Specifically, within your discussion within the Market Opportunities section, beginning on page 86, please provide
support for and cite your statements regarding market health and potential growth. In this regard, footnotes may be helpful.
Response: In response to the Staff’s
comment, the Company has revised its disclosures throughout the Amendment No. 6 to provide citations to the sources of the information
when referring to a statistic that is not common knowledge. This includes the disclosure on pages 86 to 90 of the Amendment No. 6, which
contains the Company’s statements regarding market health and potential growth.
* * *
2
Please contact me at +1 312.364.1633 if
you have any questions or require any additional information in connection with this letter or the Company’s submission of the Amendment
No. 6.
Sincerely,
/s/ David Huberman
cc: Tomer Izraeli, Chief Executive Officer
3
2024-06-14 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
June 14, 2024
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5 Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 5 to Registration Statement on Form F-1
Filed May 20, 2024
File No. 333-266745
Dear Tomer Izraeli:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a 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. Unless we note otherwise,
any references to prior comments are to comments in our February 16, 2023 letter.
Amendment No. 5 to Registration Statement on Form F-1
Cover Page
1.Please revise the initial public offering to include the volume of securities you intend to
register.
Use of Proceeds, page 63
2.Please revise the Use of Proceeds here and in the Summary to reflect any plans to repay
debt from the proceeds of the offering, such as the April 2024 CLA Amount disclosed on
page 4. Please also revise to provide more specific information regarding the amount of
proceeds to be used for each potential product identified in the first bullet point, and
identify the additional funds that will be needed to develop these products to
commercialization, if you are able to obtain the required regulatory approvals.
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
June 14, 2024 Page 2
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
June 14, 2024
Page 2
Business, page 75
3.Please clarify the reasons for delays in your trials.
Intellectual Property, page 103
4.Please remove any patents that have expired or no longer material to the Company. Please
explain the status designation, "National Phase Entered." Please also include patent
numbers, when available.
Exhibits
5.Please file the Company's February 2023 and April 2024 convertible loan agreements as
exhibits to the registration statement.
General
6.We note your references here and elsewhere throughout your disclosure to third party
reports and studies and revised market statistics. When referring to a statistic that is not
common knowledge, study, or research article, please provide a full citation to the source
of the information, provide the date of the information, and, at first instance, provide a
summary of the material findings. Specifically, within your discussion within the Market
Opportunities section, beginning on page 86, please provide support for and cite your
statements regarding market health and potential growth. In this regard, footnotes may be
helpful.
Please contact Tracie Mariner at 202-551-3744 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Benjamin Richie at 202-551-7857 or Abby Adams at 202-551-6902 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2024-02-21 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
February 21, 2024
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5 Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 4 to Registration Statement on Form F-1
Filed February 3, 2023
File No. 333-266745
Dear Tomer Izraeli:
It has been more than nine months since you last amended this registration statement and
it is now out of date. Within 30 days from the date of this letter, you should either:
•amend it to comply with the applicable requirements of the Securities Act of 1933, the rules
and regulations under the Act, and the requirements of the form; or
•file a request for withdrawal.
If you requested confidential treatment for portions of any exhibits to your registration
statement and you request withdrawal of that registration statement, please submit a concurrent
request for withdrawal of your application for confidential treatment.
If you do not amend the registration statement or file a request for withdrawal (or provide
us with a satisfactory explanation of why you have not done either) within 30 days, we may enter
an order declaring the registration statement abandoned under rule 479 of the Act.
Please contact Benjamin Richie at 202-551-7857 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
February 21, 2024 Page 2
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
February 21, 2024
Page 2
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
2023-02-27 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
February 27, 2023
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Abby Adams
Angela Connell
Celeste Murphy
Li Xiao
Re:
Polyrizon Ltd.
Amendment No. 4 to
Registration Statement on Form F-1
Filed February 3, 2023
File No. 333-266745
Ladies and Gentlemen
On behalf of Polyrizon Ltd. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of Corporation
Finance of the Securities and Exchange Commission (the “Commission”) dated February 16, 2023, relating to the above referenced
Registration Statement on Form F-1 (CIK No. 0001893645) filed by the Company on February 3, 2023 (the “Registration Statement”).
For ease of review, we have set forth below the
numbered comment of your letter and the Company’s response thereto.
Amendment No. 4 to Registration Statement on Form F-1
Cover Page
1.
We note your response to comment 1. Please clarify the statements in your response that appear to contradict. For example, at the bottom of page 4, you state, “The Company respectfully notes that it has removed from the selling shareholders all of the Company’s directors and officer.” At the top of page 6, you state, “No selling shareholder who is an officer or director of the Company and will be included in the Registration Statement is in the business of underwriting securities and none of such selling shareholders is a registered broker dealer or affiliated with a broker dealer.”
Response: In response to the Staff’s comment, the Company
acknowledges the inconsistency in its response to the Staff’s comment 1 from the letter sent by the Company to the Staff dated February
3, 2023 (the “Previous Response Letter”). The Company would like to amend and restate such response, by deleting the sentence
on page 6 that stated “No selling shareholder who is an officer or director of the Company and will be included in the Registration
Statement is in the business of underwriting securities and none of such selling shareholders is a registered broker dealer or affiliated
with a broker dealer.” The amended and restated response appears below. Except as restated herein, there are no other modifications
or revisions to the Previous Response Letter.
“Response: In response to the first bullet of the Staff’s
comment, the Company respectfully notes that it has consulted with Nasdaq about the Company’s initial listing plan in general, and
has specifically discussed with Nasdaq the issue of compliance with the “Market Value of Unrestricted Publicly Held Shares of at
least $15 million” under the Equity Standard of Nasdaq Listing Rule 5505(b)(1)1. The shares held by the Selling Shareholders
were considered “Restricted Securities” under Nasdaq Rule 5005(a)(38) upon issuance by the Company. However, following (i)
their registration by the Company under the Registration Statement and (ii) acceptance by the Company’s transfer agent of a blanket
opinion permitting the resale of those securities in the future, Nasdaq would no longer consider the shares to be “Restricted Securities,”
and such shares should be included as part of the Market Value of Unrestricted Publicly Held Shares (see Nasdaq FAQ Identification
Number 1710).
In response to the second bullet of the Staff’s
comment, the Company acknowledges the Staff’s comment and respectfully submits that the proposed resale of shares of the Company’s
ordinary shares by the selling shareholders as contemplated by the Registration Statement is not an indirect primary offering and is properly
regarded as a secondary offering.
In an effort to assist registrants in determining
whether an offering by selling stockholders may be characterized as a secondary offering that is eligible to be made on a shelf basis
under Rule 415(a)(1)(i), the Staff issued Interpretation 612.09 in its Securities Act Compliance and Disclosure Interpretations (“C&DI
612.09”) . C&DI 612.09 provides that “[t]he question of whether an offering styled a secondary one is really on behalf
of the issuer is a difficult factual one, not merely a question of who receives proceeds” and that consideration be given to the
following factors:
●
how long the selling stockholders have held the shares;
●
the circumstances under which the selling stockholders have received the shares;
●
the relationship of the selling stockholders to the issuer;
●
the number of shares being sold;
●
whether the selling stockholders are in the business of underwriting securities; and
●
whether under all the circumstances it appears that the seller is acting as a conduit for the issuer.
For the reasons set forth below, the Company respectfully
submits that the registration and offering from time to time (the “Offering”) of up to 1,858,803 ordinary shares, no par value,
of the Company (the “Shares”) on behalf of the selling shareholders is not, and should not be considered, a primary offering
of the Shares to the public and none of the selling shareholders is, nor should be considered to be, acting as an underwriter within the
meaning of Section 2(a)(11) of the Securities Act of 1933, as amended (the “Securities Act”). We respectfully submit that
the Offering as proposed above should be considered a secondary offering under Rule 415(a)(1)(i) of the Securities Act and that no additional
disclosure be required.
How Long the Selling Shareholders Have Held the Shares
All of the Shares being registered for resale under
the Registration Statement were issued and sold pursuant to a purchase agreement in which each selling shareholder made specific representations
to the Company that such selling shareholder was acquiring the Shares in the ordinary course of business for such selling shareholder’s
own account and not with a view towards, or for resale in connection with, the public sale or distribution thereof. There is no evidence
to suggest that those representations are false. The fact that the Shares are now being registered for resale is not evidence that the
selling shareholders desire to effect an immediate distribution.
1 The Company respectfully notes that in its response letter to
the Staff dated January 10, 2023, the Company incorrectly referenced Nasdaq Listing Rule 5550(b)(1), which covers Nasdaq’s continued
listing standards. In this letter, the Company has corrected the reference to Nasdaq Listing Rule 5505(b)(1), which covers Nasdaq’s
initial listing standards.
2
While the presumption is that the longer securities
are held, the less likely it is that a selling shareholder is acting as a conduit for a primary offering, such a factor is not determinative,
and the Commission has in fact specifically recognized that a short holding period does not by itself negate valid investment intent.
The Staff regularly permits issuers to register privately issued shares for resale promptly following, or even prior to, the closing of
a private placement transaction. For example, Securities Act Rules Compliance and Disclosure Interpretations Questions 116.19 (“CD&I
116.19”) and 131.11 (“CD&I 139.11”) both provide that:
In a PIPE transaction, a company will be permitted to register
the resale of securities prior to their issuance if the company has completed a Section 4(2)-exempt sale of the securities (or in the
case of convertible securities, of the convertible security itself) to the investor, and the investor is at market risk at the time of
filing of the resale registration statement. The investor must be irrevocably bound to purchase a set number of securities for a set purchase
price that is not based on market price or a fluctuating ratio, either at the time of effectiveness of the resale registration statement
or at any subsequent date.”
CD&I 116.19 and CD&I 139.11 contemplate
that a valid secondary offering could occur immediately following the closing of the private placement of securities (commonly known as
a “PIPE,” or private-investment of public-equity transaction) with no minimum holding period in the event the company has
completed the private transaction of all of the securities it is registering and the investor is at market risk at the time of filing
of the resale registration statement. Thus, there is no mandatory holding period that must be overcome for a PIPE transaction to be followed
by a valid secondary offering. This interpretation of CD&I 116.19 and CD&I 139.11 indicates that the existence of registration
rights and a short time between the issuance of the securities and the filing date of the Registration Statement do not preclude the offering
from being secondary in nature. This concept is completely consistent with custom and practice in the PIPE marketplace. In many PIPE
transactions (including this Offering) a registration statement is required to be filed shortly after closing or even as a condition to
the closing.
Each selling shareholder has borne for a considerable
time – in no event for a period less than approximately 18 months – and continues to bear the full economic and market risk
of its investment in the Company for the period prior to the date that the Registration Statement is ultimately declared effective and
the shares sold thereunder (or under any applicable exemption from registration) until the Registration Statement is declared effective,
which may not be for a considerable period of time. Each of the selling shareholders has already purchased and fully paid for or otherwise
given valuable consideration for the ordinary shares that the selling shareholders are proposing to resell. As a result, each of the selling
shareholders has been subject to not only market risk, but also the risk that the registration statement would not be declared effective
promptly or for a significant period of time. The Company believes selling shareholders’ purchase of the Shares is inconsistent
with the notion that such investors are acquiring such securities with a view towards, or for resale in connection with, the public sale
or distribution thereof, but rather consistent with a further long-term investment in the Company.
Lastly, none of the selling shareholders is acting
on the Company’s behalf with respect to the shares being registered for resale under the Registration Statement, and the Company
has no contractual relationship with the selling shareholders that would control the timing, nature and amount of resales of the shares
(or whether such shares are even resold at all) under the Registration Statement.
Accordingly, based on the foregoing, the Company
believes that the factors discussed above in the aggregate, support the conclusion that the offering pursuant to the Registration Statement
is a valid secondary offering.
Circumstances Under Which the Selling Shareholders Received Their
Shares
The selling shareholders acquired the Shares in
private placement transactions pursuant to an exemption from registration under Section 4(2) of the Securities Act and/or Rule 506 of
Regulation D promulgated under the Securities Act and, as noted above, have been at market risk for the Shares since their acquisition
of the Shares. As also noted above, each selling shareholder made specific representations to the Company that such selling shareholder
is acquiring the Shares in the ordinary course of business for such selling shareholder’s own account and not with a view towards,
or for resale in connection with, the public sale or distribution thereof, except pursuant to sales registered under the Securities Act
or under an exemption from such registration and in compliance with applicable federal and state securities laws, and such selling shareholder
does not have a present arrangement to effect any distribution of the Shares purchased from the Company. The Company is not aware of any
evidence that would indicate that these specific representations were false or of any evidence that any selling shareholder has any plan
to act in concert to effect a distribution of its Shares.
3
Furthermore, the Company is not aware of any evidence
that a distribution would occur if the Registration Statement is declared effective. Under the Commission’s rules, a “distribution”
requires special selling efforts. Rule 100(b) of Regulation M defines a “distribution” as “an offering of securities,
whether or not subject to registration under the Securities Act, that is distinguished from ordinary trading transactions by the magnitude
of the offering and the presence of special selling efforts and selling methods.” There is nothing to suggest that any special selling
efforts or selling methods by or on behalf of the selling shareholders have or would take place if the Registration Statement is declared
effective. The Company also is not aware of any facts to suggest that the selling shareholders have taken any actions to condition or
prime the market for the potential resale of the Shares. To do so would result in a breach of the respective representations made by the
selling shareholders to the Company.
The private placement agreements had the traditional
characteristics of a private investment and there is no indicia of the Offering being a “disguised underwriting” by the selling
shareholders. In a typical underwriting, the underwriter and the issuer agree on a price at which the securities will be sold to the public,
and the issuer sells the securities to the underwriter at a negotiated discount to the public offering price, with the “spread”
between the two prices representing the underwriter’s compensation for its selling efforts and for bearing market risk. The selling
shareholders purchased the securities in the Offering without any agreement or arrangement regarding the price at which they might later
resell the underlying shares to the public pursuant to the Registration Statement. As such, unlike an underwriter, the selling shareholders
have taken full investment risk with regard to the Shares they acquired, and there is no certainty that they will receive a premium on
the resale of any underlying shares.
None of the selling shareholders is acting on the
Company’s behalf with respect to the Shares registered for resale under the Registration Statement, and the Company has no contractual
relationship with the selling shareholders that would control the timing, nature and amount of resales of the Shares or whether such Shares
are even resold at all under the Registration Statement. In addition, as set forth in the Registration Statement, the Company will not
receive any proceeds from the sale of Shares under the Registration Statement. Instead the selling shareholders will receive all proceeds
received from resale of the Shares.
The Company believes that the facts surrounding
issuance of the Shares do not support a conclusion that the selling shareholders were acquiring such securities for the purposes of distributing
them on behalf of the Company.
The Selling Shareholders’ Relationship to the Company
The Company respectfully notes that it has removed
from the selling shareholders all of the Company’s directors and officer. Further, the Company does not have an underwriting relationship
with any of the selling shareholders. Each selling shareholder acquired the Shares in a negotiated transaction for the fair market value
on the date of issuance and represented to the Company that it was acquiring such shares for its own account and not with a view towards
distribution, and that it did not have any agreement or understanding, directly or indirectly, with any person to distribute the Shares
None of the selling shareholders had a prior relationship
with the Company before the consummation of each selling shareholders initial investment in the securities of the Company which are now
Shares.
Each of the selling shareholders is al
2023-02-16 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
February 16, 2023
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 4 to
Registration Statement on Form F-1
Filed February 3, 2023
File No. 333-266745
Dear Tomer Izraeli:
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. Unless we note
otherwise, our references to prior comments are to comments in our January 23, 2023 letter.
Amendment No. 4 to Registration Statement on Form F-4
Cover Page
1.We note your response to comment 1. Please clarify the statements in your response that
appear to contradict. For example, at the bottom of page 4, you state, "The Company
respectfully notes that it has removed from the selling shareholders all of the Company’s
directors and officer." At the top of page 6, you state, "No selling shareholder who is an
officer or director of the Company and will be included in the Registration Statement is in
the business of underwriting securities and none of such selling shareholders is a
registered broker dealer or affiliated with a broker dealer."
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
February 16, 2023 Page 2
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
February 16, 2023
Page 2
You may contact Li Xiao at (202) 551-4391 or Kevin Vaughn at (202) 551-3494 if you
have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2023-02-03 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
February 3, 2023
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Abby Adams
Angela Connell
Celeste Murphy
Li Xiao
Re:
Polyrizon Ltd.
Amendment No. 3 to
Registration Statement on Form F-1
Filed January 10, 2023
File No. 333-266745
Ladies and Gentlemen
On behalf of Polyrizon Ltd. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of Corporation
Finance of the Securities and Exchange Commission (the “Commission”) dated January 23, 2022, relating to the above referenced
Registration Statement on Form F-1 (CIK No. 0001893645) filed by the Company on January 10, 2023 (the “Registration Statement”).
Concurrent with the submission of this letter,
the Company is filing via EDGAR amendment number 4 to the Registration Statement (“Amendment No. 4”), which reflects the Company’s
responses to the comments received by the Staff and certain updated information. For your convenience, the Company is also delivering
via email a copy of this letter and Amendment No. 4 marked to indicate changes from the Registration Statement.
For ease of review, we have set forth below each
of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in Amendment No. 4.
Amendment No. 3 to Registration Statement on Form F-1
Cover Page
1.
We note your responses to Comments 1 and 6 regarding the purpose of the resale offering to meet the public float requirements of Nasdaq Listing Rule 5550(b)(1). Please provide the following additional information or revisions, as applicable:
●
In response to comment 1, you state, “Since the initial public offering is less than $15 million, the Company is registering the shares held by the Selling Shareholders in order to have a Public Float that complies with Nasdaq’s listing rules.” Tell us whether you have consulted with Nasdaq about this listing plan (specifically, regarding your plan for compliance with Nasdaq Listing Rule 5550(b)(1)).
●
Given the company’s involvement in the resale registration statement and the fact that the resales are necessary to create a market for the company’s listing, it appears the resale portion of the offering should be deemed an indirect primary being conducted by or on behalf of the issuer. Provide us with your analysis as to why they should not be deemed to be underwriters, or revise to include a statement that the selling shareholders are deemed underwriters and fix a price at which the resale shares will sell for the duration of the offering.
Response: In response to the first bullet of the Staff’s comment,
the Company respectfully notes that it has consulted with Nasdaq about the Company’s initial listing plan in general, and has specifically
discussed with Nasdaq the issue of compliance with the “Market Value of Unrestricted Publicly Held Shares of at least $15 million”
under the Equity Standard of Nasdaq Listing Rule 5505(b)(1)1. The shares held by the Selling Shareholders were considered “Restricted
Securities” under Nasdaq Rule 5005(a)(38) upon issuance by the Company. However, following (i) their registration by the Company
under the Registration Statement and (ii) acceptance by the Company’s transfer agent of a blanket opinion permitting the resale
of those securities in the future, Nasdaq would no longer consider the shares to be “Restricted Securities,” and such shares
should be included as part of the Market Value of Unrestricted Publicly Held Shares (see Nasdaq FAQ Identification Number 1710).
In response to the second
bullet of the Staff’s comment, the Company acknowledges the Staff’s comment and respectfully submits that the proposed resale
of shares of the Company’s ordinary shares by the selling shareholders as contemplated by the Registration Statement is not an indirect
primary offering and is properly regarded as a secondary offering.
In an effort to assist registrants
in determining whether an offering by selling stockholders may be characterized as a secondary offering that is eligible to be made on
a shelf basis under Rule 415(a)(1)(i), the Staff issued Interpretation 612.09 in its Securities Act Compliance and Disclosure Interpretations
(“C&DI 612.09”) . C&DI 612.09 provides that “[t]he question of whether an offering styled a secondary one is
really on behalf of the issuer is a difficult factual one, not merely a question of who receives proceeds” and that consideration
be given to the following factors:
● how long the selling stockholders have held the shares;
● the circumstances under which the selling stockholders have
received the shares;
● the relationship of the selling stockholders to the issuer;
● the number of shares being sold;
● whether the selling stockholders are in the business of underwriting
securities; and
● whether under all the circumstances it appears that the seller
is acting as a conduit for the issuer.
For the reasons set forth below, the Company respectfully
submits that the registration and offering from time to time (the “Offering”) of up to 1,858,803 ordinary shares, no par value,
of the Company (the “Shares”) on behalf of the selling shareholders is not, and should not be considered, a primary offering
of the Shares to the public and none of the selling shareholders is, nor should be considered to be, acting as an underwriter within the
meaning of Section 2(a)(11) of the Securities Act of 1933, as amended (the “Securities Act”). We respectfully submit that
the Offering as proposed above should be considered a secondary offering under Rule 415(a)(1)(i) of the Securities Act and that no additional
disclosure be required.
How Long the Selling Shareholders Have Held the Shares
All of the Shares being registered for resale under
the Registration Statement were issued and sold pursuant to a purchase agreement in which each selling shareholder made specific representations
to the Company that such selling shareholder was acquiring the Shares in the ordinary course of business for such selling shareholder’s
own account and not with a view towards, or for resale in connection with, the public sale or distribution thereof. There is no evidence
to suggest that those representations are false. The fact that the Shares are now being registered for resale is not evidence that the
selling shareholders desire to effect an immediate distribution.
1 The Company respectfully notes that in
its response letter to the Staff dated January 10, 2023, the Company incorrectly referenced Nasdaq Listing Rule 5550(b)(1), which covers
Nasdaq’s continued listing standards. In this letter, the Company has corrected the reference to Nasdaq Listing Rule 5505(b)(1),
which covers Nasdaq’s initial listing standards.
2
While the presumption is that the longer securities
are held, the less likely it is that a selling shareholder is acting as a conduit for a primary offering, such a factor is not determinative,
and the Commission has in fact specifically recognized that a short holding period does not by itself negate valid investment intent.
The Staff regularly permits issuers to register privately issued shares for resale promptly following, or even prior to, the closing of
a private placement transaction. For example, Securities Act Rules Compliance and Disclosure Interpretations Questions 116.19 (“CD&I
116.19”) and 131.11 (“CD&I 139.11”) both provide that:
In a PIPE transaction, a company will be permitted to
register the resale of securities prior to their issuance if the company has completed a Section 4(2)-exempt sale of the securities (or
in the case of convertible securities, of the convertible security itself) to the investor, and the investor is at market risk at the
time of filing of the resale registration statement. The investor must be irrevocably bound to purchase a set number of securities for
a set purchase price that is not based on market price or a fluctuating ratio, either at the time of effectiveness of the resale registration
statement or at any subsequent date.”
CD&I 116.19 and CD&I 139.11 contemplate
that a valid secondary offering could occur immediately following the closing of the private placement of securities (commonly known as
a “PIPE,” or private-investment of public-equity transaction) with no minimum holding period in the event the company has
completed the private transaction of all of the securities it is registering and the investor is at market risk at the time of filing
of the resale registration statement. Thus, there is no mandatory holding period that must be overcome for a PIPE transaction to be followed
by a valid secondary offering. This interpretation of CD&I 116.19 and CD&I 139.11 indicates that the existence of registration
rights and a short time between the issuance of the securities and the filing date of the Registration Statement do not preclude the offering
from being secondary in nature. This concept is completely consistent with custom and practice in the PIPE marketplace. In many PIPE
transactions (including this Offering) a registration statement is required to be filed shortly after closing or even as a condition to
the closing.
Each selling shareholder has borne for a considerable
time – in no event for a period less than approximately 18 months – and continues to bear the full economic and market risk
of its investment in the Company for the period prior to the date that the Registration Statement is ultimately declared effective and
the shares sold thereunder (or under any applicable exemption from registration) until the Registration Statement is declared effective,
which may not be for a considerable period of time. Each of the selling shareholders has already purchased and fully paid for or otherwise
given valuable consideration for the ordinary shares that the selling shareholders are proposing to resell. As a result, each of the selling
shareholders has been subject to not only market risk, but also the risk that the registration statement would not be declared effective
promptly or for a significant period of time. The Company believes selling shareholders’ purchase of the Shares is inconsistent
with the notion that such investors are acquiring such securities with a view towards, or for resale in connection with, the public sale
or distribution thereof, but rather consistent with a further long-term investment in the Company.
Lastly, none of the selling shareholders is acting
on the Company’s behalf with respect to the shares being registered for resale under the Registration Statement, and the Company
has no contractual relationship with the selling shareholders that would control the timing, nature and amount of resales of the shares
(or whether such shares are even resold at all) under the Registration Statement.
Accordingly, based on the foregoing, the Company
believes that the factors discussed above in the aggregate, support the conclusion that the offering pursuant to the Registration Statement
is a valid secondary offering.
3
The Circumstances Under Which the Selling Shareholders Received
Their Shares
The selling shareholders acquired the Shares in
private placement transactions pursuant to an exemption from registration under Section 4(2) of the Securities Act and/or Rule 506 of
Regulation D promulgated under the Securities Act and, as noted above, have been at market risk for the Shares since their acquisition
of the Shares. As also noted above, each selling shareholder made specific representations to the Company that such selling shareholder
is acquiring the Shares in the ordinary course of business for such selling shareholder’s own account and not with a view towards,
or for resale in connection with, the public sale or distribution thereof, except pursuant to sales registered under the Securities Act
or under an exemption from such registration and in compliance with applicable federal and state securities laws, and such selling shareholder
does not have a present arrangement to effect any distribution of the Shares purchased from the Company. The Company is not aware of any
evidence that would indicate that these specific representations were false or of any evidence that any selling shareholder has any plan
to act in concert to effect a distribution of its Shares.
Furthermore, the Company is not aware of any evidence
that a distribution would occur if the Registration Statement is declared effective. Under the Commission’s rules, a “distribution”
requires special selling efforts. Rule 100(b) of Regulation M defines a “distribution” as “an offering of securities,
whether or not subject to registration under the Securities Act, that is distinguished from ordinary trading transactions by the magnitude
of the offering and the presence of special selling efforts and selling methods.” There is nothing to suggest that any special selling
efforts or selling methods by or on behalf of the selling shareholders have or would take place if the Registration Statement is declared
effective. The Company also is not aware of any facts to suggest that the selling shareholders have taken any actions to condition or
prime the market for the potential resale of the Shares. To do so would result in a breach of the respective representations made by the
selling shareholders to the Company.
The private placement agreements had the traditional
characteristics of a private investment and there is no indicia of the Offering being a “disguised underwriting” by the selling
shareholders. In a typical underwriting, the underwriter and the issuer agree on a price at which the securities will be sold to the public,
and the issuer sells the securities to the underwriter at a negotiated discount to the public offering price, with the “spread”
between the two prices representing the underwriter’s compensation for its selling efforts and for bearing market risk. The selling
shareholders purchased the securities in the Offering without any agreement or arrangement regarding the price at which they might later
resell the underlying shares to the public pursuant to the Registration Statement. As such, unlike an underwriter, the selling shareholders
have taken full investment risk with regard to the Shares they acquired, and there is no certainty that they will receive a premium on
the resale of any underlying shares.
None of the selling shareholders is acting on the
Company’s behalf with respect to the Shares registered for resale under the Registration Statement, and the Company has no contractual
relationship with the selling shareholders that would control the timing, nature and amount of resales of the Shares or whether such Shares
are even resold at all under the Registration Statement. In addition, as set forth in the Registration Statement, the Company will not
receive any proceeds from the sale of Shares under the Registration Statement. Instead the selling shareholders will receive all proceeds
received from resale of the Shares.
The Company believes that the facts surrounding
issuance of the Shares do not support a conclusion that the selling shareholders were acquiring such securities for the purposes of distributing
them on behalf of the Company.
The Selling Shareholders’ Relationship to the Company
The Company respectfully notes that it has removed
from the selling shareholders all of the Company’s directors and officer. Further, the Company does not have an underwriting relationship
with any of the selling shareholders. Each selling shareholder acquired the Shares in a negotiated transaction for the fair market value
on the date of issuance and represented to the Company that it was acquiring such shares for its own account and not with a view towards
distribution, an
2023-01-23 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
January 23, 2023
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 3 to
Registration Statement on Form F-1
Filed January 10, 2023
File No. 333-266745
Dear Tomer Izraeli:
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.
Amendment No. 3 to Form F-3
Cover Page
1.We note your responses to Comments 1 and 6 regarding the purpose of the resale offering
to meet the the public float requirements of Nasdaq Listing Rule 5550(b)(1). Please
provide the following additional information or revisions, as applicable:
•In response to comment 1, you state, "Since the initial public offering is less than $15
million, the Company is registering the shares held by the Selling Shareholders in
order to have a Public Float that complies with Nasdaq’s listing rules.” Tell us
whether you have consulted with Nasdaq about this listing plan (specifically,
regarding your plan for compliance with Nasdaq Listing Rule 5550(b)(1)).
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
January 23, 2023 Page 2
FirstName LastNameTomer Izraeli
Polyrizon Ltd.
January 23, 2023
Page 2
•Given the company's involvement in the resale registration statement and the fact that
the resales are necessary to create a market for the company's listing, it appears the
resale portion of the offering should be deemed an indirect primary being conducted
by or on behalf of the issuer. Provide us with your analysis as to why they should not
be deemed to be underwriters, or revise to include a statement that the selling
shareholders are deemed underwriters and fix a price at which the resale shares will
sell for the duration of the offering.
Prospectus Summary, page 1
2.We note the revised disclosure in response to comment 3. Revise to clarify how the
anticipated timing of the pre-submission meeting an IDE filing added on pages 2 and 74
fits in the time frames for the trials disclosed in the paragraph that follows the new
disclosure. We note the added disclosure on page 94.
Risk Factors
Risks Related to this Offering and Ownership of Our Securities, page 52
3.We note the change to the risk factor on page 54. Here and on page 144, please revise to
disclose whether you expect to be a passive foreign investment company for 2022.
Exhibit Index, page II-5
4.We reissue Comment 5 from our December 23, 2022 letter and Comment 6 from our
October 21, 2022 letter. Please re-file the associated exhibits with the required legend
prominently featured on the cover page of each and the redactions marked, as required by
Item 601(b)(10)(iv).
General
5.We reissue comment 7. Revise to remove the SAFE shares from this registration
statement. Refer to Securities Act Section 5 C&DI 139.11.
6.Please revise the legal opinion to address the number of units in the offering and the
securities underlying the units, rather than the aggregate offering price. Also revise the
cover page to clarify that this is a firm commitment offering, by removing the language
that the offer is for "up to" 1.35 million units. Refer to Items 501(a)(2) and 601(a)(5) of
Regulation S-K.
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
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
January 23, 2023 Page 3
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
January 23, 2023
Page 3
statement.
You may contact Li Xiao at (202) 551-4391 or Kevin Vaughn at (202) 551-3494 if you
have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2023-01-10 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
January 10, 2023
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Abby Adams
Angela Connell
Celeste Murphy
Li Xiao
Re:
Polyrizon Ltd.
Amendment No. 2 to
Registration Statement on Form F-1
Filed December 19, 2022
File No. 333-266745
Ladies and Gentlemen
On behalf of Polyrizon Ltd. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of Corporation
Finance of the Securities and Exchange Commission (the “Commission”) dated December 23, 2022, relating to the above referenced
Registration Statement on Form F-1 (CIK No. 0001893645) filed by the Company on December 19, 2022 (the “Registration Statement”).
Concurrent with the submission of this letter,
the Company is filing via EDGAR amendment number 3 to the Registration Statement (“Amendment No. 3”), which reflects the Company’s
responses to the comments received by the Staff and certain updated information. For your convenience, the Company is also delivering
via email a copy of this letter and Amendment No. 3 marked to indicate changes from the Registration Statement.
For ease of review, we have set forth below each
of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in Amendment No. 3.
Amendment No. 2 to Registration Statement on Form F-1
Cover Page
1.
In
your Explanatory Note following the registration statement cover page, you list the differences between the two documents. We note
the following:
● Revise
the Resale Prospectus cover page to include the material information about the initial public
offering.
● Clarify
the statement on the Resale Prospectus cover page that “[t]he Selling Shareholder are
offering their securities in order to create a public trading market for our equity securities
in the United States.”
● You
state that the Resale Prospectus deletes the Principal Shareholder section and replaces it
with a Selling Shareholder section. Revise both the Public Offering Prospectus and the Resale
Prospectus to include both tables. Refer to Item 4.a. of Form F-1 and Items 7.A. and 9.D.
of Form 20F.
● We
note the deleted disclosure on page 134 regarding Eligibility of Restricted Shares for Sale
in the Public Market, and the following disclosure regarding lock up agreements and Rule
144. Revise to quantify the shares subject to lock up agreements, as you previously disclosed,
and provide similar disclosure in the selling shareholder prospectus.
Response: In response to the first bullet
of the Staff’s comment, the Company has revised its disclosure on the cover page of the Resale Prospectus to include the material
information about the initial public offering.
In response to the second bullet of the Staff’s
comment, the Company respectfully notes that it is registering the shares held by the Selling Shareholders in order in order to create
a public trading market for its equity securities, which is consistent with, and in order to comply with, the financial and liquidity
requirements of the Nasdaq Capital Market under the Equity Standard of Nasdaq Listing Rule 5550(b)(1) which, among others, requires a
market value of unrestricted publicly held shares (“Public Float”) of at least $15 million. Since the initial public offering
is less than $15 million, the Company is registering the shares held by the Selling Shareholders in order to have a Public Float that
complies with Nasdaq’s listing rules.
In response to the third bullet of the Staff’s
comment, the Company has revised its disclosure on (i) page 136 of the Public Offering Prospectus to include the Selling Shareholders
section from the Resale Prospectus and (ii) page Alt-1 of the Resale Prospectus to include the Principal Shareholders section from the
Public Offering Prospectus.
In response to the fourth bullet of the Staff’s
comment, the Company has revised its disclosure on (i) page 134 of the Public Offering Prospectus and (ii) page Alt-6 of the Resale Prospectus,
to clarify the shares subject to lock up agreements.
Prospectus Summary, page 1
2.
We note the revisions to the summary risk factors. Revise the summary risk factors to briefly summarize the risks associated with the statements made, such as the disclosure you eliminated in this amendment. For example, on page 5, briefly explain the risks associated with your dependence on your C&C product candidates, the fact that your C&C and T&T technologies are novel technologies, and that you are subject to U.S. federal and state healthcare laws.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 5 to 8 of Amendment No. 3 to reverse the revisions made to the summary risk factors,
including in order to briefly explain the risks associated with its dependence on its C&C product candidates, the fact that its C&C
and T&T technologies are novel technologies, and that it is are subject to U.S. federal and state healthcare laws.
3.
We note the revised disclosure regarding PL-15 and PL-16, which you plan to submit for approval pursuant to a De Novo classification request. You state preclinical safety trials are scheduled for the second quarter of 2023 for each. Clarify if you have or will need to submit an Investigational Device Exemption (IDE) in order to conduct the trial, and if so, your planned time frame for doing so.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 2 and 74 of Amendment No. 3 to include a discussion of the Company’s intention
to file an IDE in the future.
Certain Relationships and Related Party Transactions
Private Placements of our Securities, page
124
4.
We note the disclosure here regarding the private placements, including the SAFEs. Revise to disclose the exemption relied up for the transactions listed in this section. Revise the discussion of the SAFEs to summarize all material terms of the agreements.
Response: In response to the Staff’s
comment, the Company has revised its disclosures on page 125 of Amendment No. 3 to disclose the exemption relied upon for the transactions
listed in the “Private Placements of our Securities” section and to summarize all material terms of the SAFEs.
2
Exhibit Index, page II-5
5.
We reissue comment 6. We note the added footnote to the Exhibit Index that portions of the indicated exhibit have been omitted; however, no exhibits have the notation corresponding to that footnote. Also, file the revised exhibits, each with the required legend.
Response: In response to the Staff’s
comment, the Company has revised the Exhibit Index to indicate which exhibits have had portions omitted. In addition, the Company would
like to respectfully draw the Staff’s attention to Exhibit 10.5 and Exhibit 10.6, which were filed with the Company’s Amendment
No. 1 to Form F-1 on October 6, 2022, that each contain the legend required by Item 601(b)(10)(iv) of Regulation S-K.
General
6.
We note the addition of a selling shareholder prospectus in this amendment. Revise the cover page to disclose the offering price for the selling shareholder shares. Refer to Item 501(b)(3) of Regulation S-K. Tell us why you have included the selling shareholder prospectus where you state the selling shareholder offering will not commence until after the closing of the underwritten offering.
Response: In response to the Staff’s
comment, the Company respectfully notes that it has included the selling shareholder prospectus in order comply with the financial and
liquidity requirements of the Nasdaq Capital Market under the Equity Standard of Nasdaq Listing Rule 5550(b)(1).
In addition, the Company would like to respectfully
draw the Staff’s attention to the disclosure on the cover page of the Resale Prospectus that the Selling Shareholders are not selling
their shares in the initial public offering and may sell, only after the Ordinary Shares sold in the Company’s initial public offering
by the underwriter have been listed on the Nasdaq Capital Market, all or a portion of the Ordinary Shares from time to time in market
transactions through any market on which our Ordinary Shares are then traded, in negotiated transactions or otherwise, and at prices and
on terms that will be determined by the then prevailing market price or at negotiated prices directly or through a broker or brokers,
who may act as agent or as principal or by a combination of such methods of sale.
7.
As it appears the conversion of the SAFE investments pursuant to their terms will not occur until the consummation of the initial public offering, revise to remove the securities issued pursuant to the conversion of the SAFEs from this registration statement.
Response: In response to the Staff’s
comment, the Company respectfully notes that it believes that the SAFEs constitute a completed private placement under Section 4(a)(2)
of the Securities Act 1933 (the “Securities Act”) prior to its attempt to register the resale of the shares.
Securities Act Section Compliance and Disclosure Interpretations 134.01
and 139.06 provides, in relevant part:
At the time of filing the registration statement, the
purchasers in the private placement must be irrevocably bound to purchase the securities subject only to the filing or effectiveness of
the registration statement or other conditions outside their control, and the purchase price must be established at the time of the private
placement. The purchase price cannot be contingent on the market price at the time of effectiveness of the registration statement.
Pursuant to the SAFEs, the Company will be obligated to issue, and
the investors are irrevocably bound to accept, the SAFE shares in exchange for payment made in consideration of the SAFEs
at the time that the Company and the underwriters agree upon an initial offering price. The SAFE provides that, immediately prior to the closing of the initial public offering, the number of ordinary
shares issuable to each investor is equal to the purchase amount of the SAFE divided by the price per share determined by the Company
and the underwriter. The Company maintains that its initial offering price is distinct from “the market price at the time of effectiveness
of the registration statement” as contemplated by CD&I 134.01 and 139.06, since the Company actively determines the initial
offering price when it signs the underwriting agreement, rather than the price being determined by the market. In fact, the market price
for the Company’s shares will only result on the next trading day after the signing of the underwriting agreement, when the Company
begins to trade on the Nasdaq (which generally occurs more than 12 hours following the determination of the initial offering price).
8.
Revise the fee table and legal opinions to address the shares being registered for resale by the selling shareholders.
Response: In response to the Staff’s
comment, the Company has filed revised Exhibits 107, 5.1 and 23.2.
Sincerely,
/s/ David Huberman
cc:
Tomer Izraeli, Chief Executive Officer
3
2022-12-23 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
December 23, 2022
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 2 to
Registration Statement on Form F-1
Filed November 19, 2022
File No. 333-266745
Dear Tomer Izraeli:
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. Unless we note
otherwise, our references to prior comments are to comments in our October 21, 2022 letter.
Amendment No. 2 to Registration Statement on Form F-1
Cover Page
1.In your Explanatory Note following the registration statement cover page, you list the
differences between the two documents. We note the following:
•Revise the Resale Prospectus cover page to include the material information about
the initial public offering.
•Clarify the statement on the Resale Prospectus cover page that "[t]he Selling
Shareholder are offering their securities in order to create a public trading market for
our equity securities in the United States."
•You state that the Resale Prospectus deletes the Principal Shareholder section and
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
December 23, 2022 Page 2
FirstName LastNameTomer Izraeli
Polyrizon Ltd.
December 23, 2022
Page 2
replaces it with a Selling Shareholder section. Revise both the Public Offering
Prospectus and the Resale Prospectus to include both tables. Refer to Item 4.a. of
Form F-1 and Items 7.A. and 9.D. of Form 20F.
•We note the deleted disclosure on page 134 regarding Eligibility of Restricted Shares
for Sale in the Public Market, and the following disclosure regarding lock up
agreements and Rule 144. Revise to quantify the shares subject to lock up
agreements, as you previously disclosed, and provide similar disclosure in the selling
shareholder prospectus.
Prospectus Summary, page 1
2.We note the revisions to the summary risk factors. Revise the summary risk factors to
briefly summarize the risks associated with the statements made, such as the disclosure
you eliminated in this amendment. For example, on page 5, briefly explain the risks
associated with your dependence on your C&C product candidates, the fact that your
C&C and T&T technologies are novel technologies, and that you are subject to U.S.
federal and state healthcare laws.
3.We note the revised disclosure regarding PL-15 and PL-16, which you plan to submit for
approval pursuant to a De Novo classification request. You state preclinical safety trials
are scheduled for the second quarter of 2023 for each. Clarify if you have or will need to
submit an Investigational Device Exemption (IDE) in order to conduct the trial, and if so,
your planned time frame for doing so.
Certain Relationships and Related Party Transactions
Private Placements of our Securities, page 124
4.We note the disclosure here regarding the private placements, including the SAFEs.
Revise to disclose the exemption relied up for the transactions listed in this section.
Revise the discussion of the SAFEs to summarize all material terms of the agreements.
Exhibit Index, page II-5
5.We reissue comment 6. We note the added footnote to the Exhibit Index that portions of
the indicated exhibit have been omitted; however, no exhibits have the notation
corresponding to that footnote. Also, file the revised exhibits, each with the required
legend.
General
6.We note the addition of a selling shareholder prospectus in this amendment. Revise the
cover page to disclose the offering price for the selling shareholder shares. Refer to Item
501(b)(3) of Regulation S-K. Tell us why you have included the selling shareholder
prospectus where you state the selling shareholder offering will not commence until after
the closing of the underwritten offering.
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
December 23, 2022 Page 3
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
December 23, 2022
Page 3
7.As it appears the conversion of the SAFE investments pursuant to their terms will not
occur until the consummation of the initial public offering, revise to remove the securities
issued pursuant to the conversion of the SAFEs from this registration statement.
8.Revise the fee table and legal opinions to address the shares being registered for resale by
the selling shareholders.
You may contact Li Xiao at (202) 551-4391 or Angela Connell at (202) 551-3426 if you
have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-12-19 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
December 19, 2022
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Abby Adams
Celeste Murphy
Kevin Vaughn
Li Xiao
Re:
Polyrizon Ltd.
Registration Statement on Form F-1
Filed October 7, 2022
File No. 333-266745
Ladies and Gentlemen
On behalf of Polyrizon Ltd. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of Corporation
Finance of the Securities and Exchange Commission (the “Commission”) dated October 21, 2022, relating to the above referenced
Registration Statement on Form F-1 (CIK No. 0001893645) filed by the Company on October 7, 2022 (the “Registration Statement”).
Concurrent with the submission of this letter,
the Company is filing via EDGAR amendment number 2 to the Registration Statement (“Amendment No. 2”), which reflects the Company’s
responses to the comments received by the Staff and certain updated information. For your convenience, the Company is also delivering
via email a copy of this letter and Amendment No. 1 marked to indicate changes from the Registration Statement.
For ease of review, we have set forth below each
of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in Amendment No. 2.
Amendment No. 1 to Registration Statement on Form F-1 filed October
7, 2022 Prospectus Summary, page 1
1.
We note the revised
disclosure on pages 60, 64, 123 and elsewhere in the prospectus regarding the SAFE agreements. Revise the summary to highlight the
beneficial terms provided to the SAFE investors, including the option terms. Clarify at what point the SAFE Investors
ability to fulfil their purchase agreements and receive benefits as a result of the IPO will end.
Response:
In response to the Staff’s comment, the Company has revised its disclosure on page 4 of Amendment No. 2 to highlight the terms
of the SAFE Agreements. In addition, the Company has revised its disclosure on pages 4, 66 and 125 to clarify that the SAFE Investors
will have the right to receive warrants or other convertible instruments granted in an Equity Financing.
2.
Revise to clarify the purpose or purported benefit of the separate offering of pre-funded units to those who would otherwise beneficially own more than 4.99% of your Outstanding Shares immediately following consummation of this offering.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 10 of Amendment No. 2 to clarify the benefit of the separate offering of pre-funded
units to those who would otherwise beneficially own more than 4.99% (or, at the election of the purchaser, 9.99%) of such purchaser’s
Outstanding Shares immediately following the consummation of the offering.
U.S. Federal Income Tax Considerations, page
138
3.
We reissue comment 5 to the extent is it unclear why you have not been able to make a determination regarding your PFIC status for your fiscal year ended December 31, 2021, as of October 7, 2022, the date of this filing. Revise to state definitively whether you were a PFIC for 2021, and to eliminate the inappropriate disclaimers directing potential investors to consult their own tax advisors regarding your PFIC status. File a tax opinion regarding the PFIC status. For additional guidance, refer to Section III. of Staff Legal Bulletin No. 19.
Response: In response to the Staff’s comment, the Company
has revised its disclosure on pages 7, 54 and 142 to remove the discussion of PFIC status for the year ended December 31, 2021, and has
replaced it with a discussion on PFIC status for the year ended December 31, 2022. The revised disclosure clarifies that the Company does
not expect to be a PFIC for the year ended December 31, 2022. The Company believes a discussion of PFIC status for 2021 is no longer material,
due to the fact that we are now in the later months of 2022 and new investors in the IPO will not be affected by the Company’s PFIC
status for the year ended 2021.
With respect to the filing of a tax opinion regarding the Company’s
PFIC status for 2022, the Company cannot provide an opinion at this time as the taxable year has not ended.
4.
Revise the tax discussion of the pre-funded warrants to explain why counsel cannot provide an opinion that is free from doubt and explain the level of uncertainty. Refer to Section III.4 of Staff Legal Bulletin No. 19 for additional guidance. Provide a risk factor outlining the risks associated with this uncertainty. Eliminate the disclaimer directing investors to consult with their own tax advisors regarding these risks, as they are entitled to rely on the disclosure in your document.
Response:
In response to the Staff’s comment, the Company has revised its disclosure on page 140 of Amendment No. 2 to clarify that there
is no directly governing authority addressing the tax characterization of pre-funded warrants. In addition, the Company has added a risk
factor on page 53 of Amendment No. 2 to discuss the risks associated with this uncertainty. Finally, the Company has revised its disclosure
throughout Amendment No. 2 to eliminate disclaimers directing investors to consult with their own tax advisors regarding these risks.
2
Interim Financial Statement for the Six Months
Ended June 30, 2022 Note 6. Convertible Safe Notes, page F-32
5.
Your disclose here that the convertible safe notes were classified as a liability and are measured at fair value. Please revise to disclose the related fair value hierarchy required by ASC 820-10-50-2(b), and provide the disclosures for the valuation technique(s) and the inputs used in the fair value measurement required by ASC 820-10-50-2(bbb).
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page F-32.
Exhibit Index, page II-5
6.
Revise the Exhibit Index to provide the legend required by Item 601(b)(10)(iv) of Regulation S-K, and revise the individual exhibits accordingly.
Response: In response to the Staff’s
comment, the Company has revised the Exhibit Index to provide the legend required by Item 601(b)(10)(iv) of Regulation S-K. The Company
hereby confirms that the exhibits have been redacted accordingly.
7.
Revise Exhibit 5.2 to have counsel remove the assumption in paragraph (iv) on page 2, that there has been no change in law, which counters the substance of counsel's opinion.
Response: In response to the Staff’s
comment, we have revised Exhibit 5.2.
Please contact me at +1 312.364.1633 if you
have any questions or require any additional information in connection with this letter or the Company’s submission of the Registration
Statement.
Sincerely,
/s/ David Huberman
cc: Tomer Izraeli, Chief Executive Officer
3
2022-10-21 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
October 21, 2022
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 1 to
Registration Statement on Form F-1
Filed October 7, 2022
File No. 333-266745
Dear Tomer Izraeli:
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. Unless we note
otherwise, our references to prior comments are to comments in our August 17, 2022 letter.
Amendment No. 1 to Registration Statement on Form F-1 filed October 7, 2022
Prospectus Summary, page 1
1.We note the revised disclosure on pages 60, 64, 123 and elsewhere in the prospectus
regarding the SAFE agreements. Revise the summary to highlight the beneficial terms
provided to the SAFE investors, including the option terms. Clarify at what point the
SAFE Investors ability to fulfil their purchase agreements and receive benefits as a result
of the IPO will end.
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
October 21, 2022 Page 2
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
October 21, 2022
Page 2
2.Revise to clarify the purpose or purported benefit of the separate offering of pre-funded
units to those who would otherwise beneficially own more than 4.99% of your
Outstanding Shares immediately following consummation of this offering.
U.S. Federal Income Tax Considerations, page 138
3.We reissue comment 5 to the extent is it unclear why you have not been able to make a
determination regarding your PFIC status for your fiscal year ended December 31, 2021,
as of October 7, 2022, the date of this filing. Revise to state definitively whether you
were a PFIC for 2021, and to eliminate the inappropriate disclaimers directing potential
investors to consult their own tax advisors regarding your PFIC status. File a tax opinion
regarding the PFIC status. For additional guidance, refer to Section III. of Staff Legal
Bulletin No. 19.
4.Revise the tax discussion of the pre-funded warrants to explain why counsel cannot
provide an opinion that is free from doubt and explain the level of uncertainty. Refer to
Section III.4 of Staff Legal Bulletin No. 19 for additional guidance. Provide a risk factor
outlining the risks associated with this uncertainty. Eliminate the disclaimer directing
investors to consult with their own tax advisors regarding these risks, as they are entitled
to rely on the disclosure in your document.
Interim Financial Statement for the Six Months Ended June 30, 2022
Note 6. Convertible Safe Notes, page F-32
5. Your disclose here that the convertible safe notes were classified as a liability and are
measured at fair value. Please revise to disclose the related fair value hierarchy required
by ASC 820-10-50-2(b), and provide the disclosures for the valuation technique(s) and the
inputs used in the fair value measurement required by ASC 820-10-50-2(bbb).
Exhibit Index, page II-5
6.Revise the Exhibit Index to provide the legend required by Item 601(b)(10)(iv) of
Regulation S-K, and revise the individual exhibits accordingly.
7.Revise Exhibit 5.2 to have counsel remove the assumption in paragraph (iv) on page 2,
that there has been no change in law, which counters the substance of counsel's opinion.
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
October 21, 2022 Page 3
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
October 21, 2022
Page 3
You may contact Li Xiao at (202) 551-4391 or Kevin Vaughn at (202) 551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Abby Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-10-06 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
October 6, 2022
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Abby Adams
Celeste Murphy
Kevin Vaughn
Li Xiao
Re:
Polyrizon Ltd.
Registration Statement on Form F-1
Filed August 10, 2022
File No. 333-266745
Ladies and Gentlemen
On behalf of Polyrizon Ltd. (the “Company”),
we are writing to submit the Company’s responses to the comments of the staff (the “Staff”) of the Division of Corporation
Finance of the Securities and Exchange Commission (the “Commission”) dated August 17, 2022, relating to the above referenced
Registration Statement on Form F-1 (CIK No. 0001893645) filed by the Company on August 10, 2022 (the “Registration Statement”).
Concurrent with the submission of this letter,
the Company is filing via EDGAR amendment number 1 to the Registration Statement (“Amendment No. 1”), which reflects the Company’s
responses to the comments received by the Staff and certain updated information. For your convenience, the Company is also delivering
via email a copy of this letter and Amendment No. 1 marked to indicate changes from the Registration Statement.
For ease of review, we have set forth below each
of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein but not defined herein
have the meanings given to such terms in Amendment No. 1.
Registration Statement on Form F-1 filed August 10, 2022
Recent Developments
SciSparc Collaboration, page 3
1.
Please ensure that your discussion of
the SciSparc collaboration agreement includes a complete description of each parties' rights and obligations under the agreement.
Specifically, but without limitation, please revise the description to note:
● the duration of the agreement
and the royalty term;
● the termination provisions;
● the amount of any up-front
or executions payments received or paid; and
● the aggregate amounts paid
or received to date under the agreement.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 3 of Amendment No. 1 to include descriptions of the duration of the collaboration,
royalty terms and termination provisions for the SciSparc collaboration agreement. The Company hereby advises the Staff that to date,
that no payments have been made pursuant to the collaboration.
Recent Developments
NurExone Collaboration, page 3
2.
Please ensure that your discussion of
the NurExone collaboration agreement includes a complete description of each parties' rights and obligations under the agreement.
Specifically, but without limitation, please revise the description to note:
● the duration of the agreement
and the royalty term;
● the termination provisions;
● the amount of any up-front
or executions payments received or paid;
● the aggregate amounts paid
or received to date under the agreement; and
● the royalty rate or royalty
range.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 3 of Amendment No. 1 to include descriptions of the duration of the collaboration,
royalty terms, the amount of payments received to date and termination provisions for the NurExone collaboration agreement.
The Offering, page 9
3.
We note that you updated the terms of the warrants to be issued as part of the offering units, which now include a number of features such as reset price and additional warrants. Please tell us your planned accounting for these warrants and provide us with your analysis, including discussions under ASC 815-40, to support your planned accounting treatment. Please update the related presentation in your capitalization table if necessary.
Response: In response to the Staff’s comment, the Company
hereby advises the Staff that it has come to an agreement with the underwriters to revise the terms of the warrants to be issued as part
of the offering units to delete the provision providing for additional warrants. Considering the revised terms of the warrants, and given
that the reset price feature provides for an adjustment to the warrant settlement amount that is based on the Company's share price (i.e.
the adjustment is based on inputs to the fair value of a fixed-for-fixed forward or option on equity shares), the Company has determined,
in accordance with ASC 815-40-15-7D, that the reset price feature would not preclude equity classification and consequently the warrants
should be classified as equity. The Capitalization table on page 62 of Amendment No. 1 has been revised accordingly. The Company has also
revised the description of the warrants ”Description of Securities we are Offering” on page 130-131 of Amendment No. 1. In
addition, the Company has included the revised warrant as exhibit 4.1 to Amendment No. 1.
Use of Proceeds, page 60
2
4.
We note your statement here that you believe that your existing cash and cash equivalents will be sufficient to enable you to fund your operating expenses and capital expenditure requirements through June 2022. Please update this estimate.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 60 and 70 of Amendment No. 1 to clarify that its existing cash and cash equivalents
will be sufficient to fund its operating expenses and capital expenditure requirements through mid-December 2022, and that it expects to receive additional funding from the 2022 SAFEs, after which its cash and cash equivalents would
be sufficient to fund its projected cash needs until April 2023.
U.S. Federal Income Tax Considerations, page
138
5.
We note your revisions in response to previous comment 3 and re-issue the comment in part. Please revise your statement on page 52 to state, if true, that no definitive determination has been made with respect to PFIC status for the taxable year 2021. To the extent that you have not yet made a definitive determination with respect to PFIC status for taxable year 2021, please revise your disclosure to explain the uncertainties or complications regarding your income, valuation of assets and/or the market value of your Equity Securities that are causing a delay in reaching a definitive determination. Please also provide an estimate of when a definitive determination will be made or explain why you are unable to provide such an estimate. Given the potential for material adverse U.S. federal income tax consequences as a result of PFIC status, it is important that investors are able to understand your PFIC status and to evaluate the specific risks and uncertainties surrounding a PFIC determination.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 52 and 140 of Amendment No. 1 to clarify that following additional consideration
of the relevant factors, based on the projected composition of its income and valuation of its assets, the Company does not expect to
be a PFIC for 2021, and does not expect to become a PFIC in the future.
Please contact me at +1 312 372
2000 if you have any questions or require any additional information in connection with this letter or the Company’s
submission of the Registration Statement.
Sincerely,
/s/ David Huberman
cc: Tomer Izraeli, Chief Executive Officer
3
2022-08-17 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
August 17, 2022
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Registration Statement on Form F-1
Filed August 10, 2022
File No. 333-266745
Dear Mr. Izraeli:
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 F-1 filed August 10, 2022
Recent Developments
SciSparc Collaboration, page 3
1.Please ensure that your discussion of the SciSparc collaboration agreement includes a
complete description of each parties' rights and obligations under the agreement.
Specifically, but without limitation, please revise the description to note:
•the duration of the agreement and the royalty term;
•the termination provisions;
•the amount of any up-front or executions payments received or paid; and
•the aggregate amounts paid or received to date under the agreement.
Recent Developments
NurExone Collaboration, page 3
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
August 17, 2022 Page 2
FirstName LastNameTomer Izraeli
Polyrizon Ltd.
August 17, 2022
Page 2
2.Please ensure that your discussion of the NurExone collaboration agreement includes a
complete description of each parties' rights and obligations under the agreement.
Specifically, but without limitation, please revise the description to note:
•the duration of the agreement and the royalty term;
•the termination provisions;
•the amount of any up-front or executions payments received or paid;
•the aggregate amounts paid or received to date under the agreement; and
•the royalty rate or royalty range.
The Offering, page 9
3.We note that you updated the terms of the warrants to be issued as part of the offering
units, which now include a number of features such as reset price and additional warrants.
Please tell us your planned accounting for these warrants and provide us with your
analysis, including discussions under ASC 815-40, to support your planned accounting
treatment. Please update the related presentation in your capitalization table if necessary.
Use of Proceeds, page 60
4.We note your statement here that you believe that your existing cash and cash equivalents
will be sufficient to enable you to fund your operating expenses and capital expenditure
requirements through June 2022. Please update this estimate.
U.S. Federal Income Tax Considerations, page 138
5.We note your revisions in response to previous comment 3 and re-issue the comment in
part. Please revise your statement on page 52 to state, if true, that no definitive
determination has been made with respect to PFIC status for the taxable year 2021. To the
extent that you have not yet made a definitive determination with respect to PFIC status
for taxable year 2021, please revise your disclosure to explain the uncertainties or
complications regarding your income, valuation of assets and/or the market value of your
Equity Securities that are causing a delay in reaching a definitive determination. Please
also provide an estimate of when a definitive determination will be made or explain why
you are unable to provide such an estimate. Given the potential for material adverse U.S.
federal income tax consequences as a result of PFIC status, it is important that investors
are able to understand your PFIC status and to evaluate the specific risks and uncertainties
surrounding a PFIC determination.
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 LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
August 17, 2022 Page 3
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
August 17, 2022
Page 3
You may contact Li Xiao at 202-551-4391 or Kevin Vaughn at 202-551-3494 if you have
questions regarding comments on the financial statements and related matters. Please contact
Conlon Danberg at 202-551-4466 or Celeste Murphy at 202-551-3257 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-08-10 - CORRESP - Polyrizon Ltd.
CORRESP
1
filename1.htm
August 10, 2022
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention:
Abby Adams
Celeste Murphy
Kevin Vaughn
Li Xiao
Re:
Polyrizon Ltd.
Amendment No. 4 Draft Registration Statement on Form F-1
Submitted May 27, 2022
CIK No. 0001893645
Dear Ms. Adams:
On behalf of Polyrizon Ltd.
(the “Company”), we are writing to submit the Company’s responses to the comments of the staff (the “Staff”)
of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) dated June 2, 2022, relating
to the above referenced Draft Registration Statement on Form F-1 (CIK No. 0001893645) submitted by the Company on May 27, 2022 (the “Draft
Registration Statement”).
Concurrent with the
submission of this letter, the Company is publicly filing via EDGAR its Registration Statement (the “Registration
Statement”), which reflects the Company’s responses to the comments received by the Staff and certain updated
information. For your convenience, the Company is also delivering via email a copy of this letter and the Registration Statement
marked to indicate changes from the Draft Registration Statement.
For ease of review, we have
set forth below each of the numbered comments of your letter and the Company’s responses thereto. Capitalized terms used herein
but not defined herein have the meanings given to such terms in the Registration Statement.
August 10, 2022
Page 2
Amendment No. 3 to Draft Registration Statement
Prospectus Summary, Page 1
1.
We reissue comment 2. We note the added summary risk factor; however, it does not describe the risk that the FDA will reject your submission under the de novo pathway and require you to submit pursuant to a different pathway, which investors will not know prior to the offering. Revise to clarify.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 4 and 18 of the Registration Statement to clarify that in the event a de novo
pathway submission is rejected, the Company may be required to pursue a different pathway, such as a premarket approval pathway, which
can be a lengthier and more rigorous process.
Certain U.S. Federal Income Tax Considerations,
page 137
2.
We note the revisions to this section. Revise to eliminate the term “certain,” and the qualifiers that this is a "general summary" from the heading and the second full paragraph and throughout this section and revise the discussion to clarify that you have described the material U.S. federal tax consequences.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on page 138 of the Registration Statement to eliminate the term “certain,”
and the qualifiers that this disclosure is a “general summary” so the disclosure better clarifies that it describes
material U.S. federal tax consequences.
3.
Your revision in the introduction from "ordinary shares" to "equity securities" has been carried through to the summary risk factors on page 6 and the risk factor on page 51; however, it does not appear, from the disclosure in this section, that the summaries on pages 6 and 51 correctly describe the consequences to warrant holders, who are now part of "equity securities." Compare those sections to the disclosure on pages 139-140. Please revise the summary risk factor on page 6 and the risk factor on page 51, as well as any other applicable disclosure in the document affected by this change, or advise us why no revision is needed. Add a risk factor that addresses the separate risks posed by the warrants assuming you will be a PFIC for the most recent tax year and the different PFIC rules applying to the warrants. Highlight that risk in the summary risk factors. Finally, we note the disclosure, for example, on page 6, that the company believes it likely was a PFIC for federal tax purposes in 2021. It is now June 2022. Revise to clarify if that determination has been made.
Response: In response to the Staff’s
comment, the Company has revised its disclosure on pages 6 and 52 of the Registration Statement to clarify that the term “equity
securities” includes warrants, such that the disclosure makes clear that holders of warrants are subject to the risks described.
In addition, the Company revised its disclosure on pages 6 and 51 to include an additional risk factor that is unique to warrant holders
– that a QEF election and a mark-to-market election will be unavailable to holders if the Company is deemed to be a PFIC.
The Company respectfully advises the Staff that
it has not yet made a determination on PFIC status for federal tax purposes in 2021. The Company has revised its disclosure on pages 52
and 140 to clarify that although it likely believes it was a PFIC for 2021, no definitive determination has been made.
Please contact me at +1 312.372.2000 if
you have any questions or require any additional information in connection with this letter or the Company’s submission of the Registration
Statement.
Sincerely,
/s/ David Huberman
cc: Tomer Izraeli, Chief Executive Officer
2022-06-02 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
June 2, 2022
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 4 to Draft Registration Statement on Form F-1
Submitted May 27, 2022
CIK No. 0001893645
Dear Mr. Izraeli:
We have reviewed your amended draft offering 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 offering statement or publicly filing your offering 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 any amendment
to your draft offering statement or filed offering statement and the information you provide in
response to these comments, we may have additional comments.
Draft Registration Statement on Form F-1
Prospectus Summary, page 1
1.We reissue comment 2. We note the added summary risk factor; however, it does not
describe the risk that the FDA will reject your submission under the de novo pathway and
require you to submit pursuant to a different pathway, which investors will not know prior
to the offering. Revise to clarify.
Certain U.S. Federal Income Tax Considerations, page 137
2.We note the revisions to this section. Revise to eliminate the term “certain,” and the
qualifiers that this is a "general summary" from the heading and the second full paragraph
and throughout this section and revise the discussion to clarify that you have described the
material U.S. federal tax consequences.
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
June 2, 2022 Page 2
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
June 2, 2022
Page 2
3.Your revision in the introduction from "ordinary shares" to "equity securities" has been
carried through to the summary risk factors on page 6 and the risk factor on page 51;
however, it does not appear, from the disclosure in this section, that the summaries on
pages 6 and 51 correctly describe the consequences to warrant holders, who are now part
of "equity securities." Compare those sections to the disclosure on pages 139-140. Please
revise the summary risk factor on page 6 and the risk factor on page 51, as well as any
other applicable disclosure in the document affected by this change, or advise us why no
revision is needed. Add a risk factor that addresses the separate risks posed by the
warrants assuming you will be a PFIC for the most recent tax year and the different PFIC
rules applying to the warrants. Highlight that risk in the summary risk factors. Finally,
we note the disclosure, for example, on page 6, that the company believes it likely was a
PFIC for federal tax purposes in 2021. It is now June 2022. Revise to clarify if that
determination has been made.
You may contact Li Xiao at (202) 551-4391 or Kevin Vaughn at (202) 551-3494 if you
have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-05-17 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
May 17, 2022
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 3 to Draft Registration Statement on Form F-1
Submitted May 4, 2022
CIK No. 0001893645
Dear Mr. Izraeli:
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. 3 to Draft Registration Statement
Prospectus Summary, page 1
1.We note your revisions in the Prospectus Summary and throughout the document in
response to comment 1; however, the document still describes your industry as the
"pharmaceutical" industry with repeated references, and on page 32, you specifically
address "the pharmaceutical industry in which [you] operate." Please further revise the
document, including review of your risk factors and competition, to clarify. We note, for
example, risk factors that appear to address your product candidates more clearly as drugs
rather than medical devices, such as those on pages 14 (addressing dose escalation), 21
("clinical drug development is difficult to design..."), and 22-23, addressing issues arising
in pharmaceutical trials.
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
May 17, 2022 Page 2
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
May 17, 2022
Page 2
2.We note your response to comment 2. Revise the Risks Related to Discovery,
Development and Clinical Testing of Product Candidates in the Prospectus Summary to
highlight the risks associated with the fact that that you do not plan to conduct a pre-
submission meeting with the FDA’s Center for Devices and Radiological Health to
confirm the potential for the Class II medical device path under a de novo classification
request for its PL-15 and PL-16 products until after the completion of the initial public
offering.
3.We note your response to comment 3. Tell us the basis for your belief that the FDA
would not classify your PL-15 and PL-16 C&C product candidates as drugs, as opposed to
Class III medical devices, if the FDA does not agree with your marketing approval via De
Novo Classification.
You may contact Li Xiao at (202) 551-4391 or Kevin Vaughn at (202) 551-3494 if you
have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Celeste Murphy at (202) 55103257 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-04-19 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
April 19, 2022
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 2 to Draft Registration Statement on Form F-1
Submitted April 14, 2022
CIK No. 0001893645
Dear Mr. Izraeli:
We have reviewed your amended draft offering 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 offering statement or publicly filing your offering 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 any amendment
to your draft offering statement or filed offering statement and the information you provide in
response to these comments, we may have additional comments.
Amendment No. 2 to Draft Registration Statement on Form F-1 submitted April 14, 2022
Prospectus Summary, page 1
1.We reissue comment 1 in full. Further refine your disclosure to avoid terms that imply
your product is a drug. Your revised terms continue to imply or clearly state you will
mitigate or prevent disease. For example rather than focus on barrier or shield, you use
"reduce the risk of nasal infection" and describe "symptom alleviation" here and on page
92. Furthermore, you use terms such as "platform," which is typically used in the
pharmaceutical industry and does not provide insight as to the nature of your product.
Most importantly, the disclosure emphasizes in the first sentence of your document that
you "specialize in the development of innovative nasal gels to reduce the risk of nasal
infections caused by a wide range of biological assaults," and it is not until the third line of
the third paragraph of your prospectus that you use the term "medical device." To provide
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
April 19, 2022 Page 2
FirstName LastNameTomer Izraeli
Polyrizon Ltd.
April 19, 2022
Page 2
full disclosure, revise the first page to clarify that you are not developing drugs, why these
products are classified as medical devices and not drugs, and the risks associated if you
are wrong in your assessment of how they will be classified. Finally, to the extent you use
the term "biotech," tell us how your ingredients qualify for that nomenclature, i.e., identify
whether the ingredients in your nasal sprays are derived from living organisms or parts of
living organisms. Finally, to the extent that you do not have currently commercialized
products, revise the heading "our products" to a more appropriate title.
2.We note your response to comment 2. Revise the prospectus summary to separate the
candidates by type and clarify the differences between the types that dictate into which
FDA category you believe they will fall. Disclose when you plan to conduct the pre-
submission meeting with the FDA's Center for Devices and Radiological Health to
confirm the potential for the Class II medical device path under a de novo classification
request for PL-15 and PL-16.
3.Revise the added disclosure on page 1 regarding the experience of similar products to
clarify that there is no guarantee that your product candidates will advance in the FDA
process at the same rate, will advance at all, or will ever reach commercialization. Revise
to clarify what route your products must take if the FDA denies them approvals as medical
devices in your chosen categories or determines they must seek approval as
pharmaceuticals. Provide cross-references to appropriate risk factors.
Capitalization, page 64
4.Please revise to update the historical number of ordinary shares as of December 31, 2021
in the capitalization table here to be consistent with your balance sheet at page F-3.
Business
Overview, page 74
5.We note your response to comment 5. Revise the disclosure in the summary and business
section to prominently disclose that you have no predicate devices on which to determine
that you have identified the appropriate pathway for approval, that you have not
approached the FDA to determine the appropriate pathway, and that you do not plan to
approach the FDA about the appropriate pathway until after this offering is complete.
Also prominently disclose in both areas that there is no assurance the FDA will agree with
your choice of the appropriate pathway or your choice of the structure of the chosen
clinical trial or trials for any one of your potential medical devices or hybrid devices, or, if
they do, there is no assurance that any one of your devices will advance on the timelines
you anticipate, if at all, or that they will be successful in any trials, or if successful, will
obtain FDA clearance.
6.We reissue comment 6. Eliminate the graphic.
Principal Shareholders, page 125
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
April 19, 2022 Page 3
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
April 19, 2022
Page 3
7.Clarify the terms of the SAFE investments and whether the IPO will be a qualified equity
financing that will trigger a share issuance under the agreement. It appears from
the disclosure on page F-20 that the SAFE investment will be dilutive to IPO investors
and should be disclosed in the principal shareholders table, highlighted in the summary
and in the risk factors.
You may contact Li Xiao at (202) 551-4391 or Kevin Vaughn at (202) 551-3494 if you
have questions regarding our comment on the financial statements and related matters. Please
contact Abby Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-03-10 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
March 10, 2022
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Amendment No. 1 to Draft Registration Statement on Form F-1
Submitted February 22, 2022
CIK No. 0001893645
Dear Mr. Izraeli:
We have reviewed your amended draft offering 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 offering statement or publicly filing your offering 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 any amendment
to your draft offering statement or filed offering statement and the information you provide in
response to these comments, we may have additional comments.
Revised Draft Registration Statement on Form F-1 submitted February 22, 2022
Prospectus Summary
Overview, page 1
1.We note your response to comment 2. As you have identified your potential products
only as seeking approval as medical devices, revise the first sentence of the summary and
throughout your prospectus to clarify you are a medical device company, not a
"preclinical stage company" and avoid use of terms such as "preventative treatment,"
"treatment" and "prevention" that imply the gel is a drug, which the FDA defines as “a
substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease.” Use terms that convey your potential product, if true, as a physical barrier or
shield and is drug-free. For your T&T device, clarify that it is designed to deploy or
convey approved drugs developed by other companies. Provide examples of the types of
ingredients in your potential product that are generally recognized as safe ("GRAS").
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
March 10, 2022 Page 2
FirstName LastNameTomer Izraeli
Polyrizon Ltd.
March 10, 2022
Page 2
2.We note the revised disclosure in response to comment 3. To the extent you believe your
products are medical devices, please revise the prospectus to eliminate references to
"product candidates" and language implying you are developing what could be
commercialized in the future as a drug, and replace that language with "medical device,"
and otherwise revise your disclosure accordingly. Revise the summary to briefly describe
the medical device pathway to FDA approval. In doing so, when discussing your
timeline, quantifying any timeframes to the extent practicable.
Summary Risk Factors, page 2
3.Revise the summary risk factor disclosing the risk that you may be a passive foreign
investment company ("PFIC") to briefly describe the potential negative U.S. federal tax
consequences and provide a cross-reference to the more detailed risk factor and material
federal tax consequences disclosure. Also, clarify the risk to investors who purchase in
this offering. For example, disclose whether it is more likely than not that you will be a
PFIC this year. Finally, briefly disclose the implications for shareholders of being a
PFIC.
Risk Factors
Risks Related to this Offering and Ownership of Our Securities, page 12
4.We note your revised disclosure on page 131 in response to comment 16. We note that
your forum selection provision identifies the "competent courts of Tel Aviv, Israel" as the
sole and exclusive forum for certain litigation, including any “derivative action," and that
"unless you consent in writing to the selection of an alternative forum, the federal district
courts of the United States of America shall be the exclusive forum for the resolution of
any complaint asserting any cause of action under the Securities Act." You also state that
"[t]his provision would not apply to suits brought to enforce a duty or liability created by
the Exchange Act or to any other claim for which the U.S. federal courts have exclusive
jurisdiction." Please further clarify what will be the applicable jurisdiction for Exchange
Act claims, as it currently appears that Exchange Act claims would need to be enforced in
Israel. In that regard, we note that Section 27 of the Exchange Act creates exclusive U.S.
federal jurisdiction over all suits brought to enforce any duty or liability created by the
Exchange Act or the rules and regulations thereunder, and Section 22 of the Securities Act
creates concurrent jurisdiction for U.S. federal and U.S. state courts over all suits brought
to enforce any duty or liability created by the Securities Act or the rules and regulations
thereunder. Regarding the U.S. federal forum provision currently described in your
prospectus on page 131, please also revise the prospectus provide a risk factor that clearly
and prominently describes the provision, including the relevant forums for litigation and
any subject matter jurisdiction carve outs, that clearly describes any risks or other impacts
to investors, including increased costs to bring a claim, that the provisions may discourage
investors from bringing claims or limit investors' ability to bring a claim in a judicial
forum that they find favorable, that for claims brought in the U.S. under the federal forum
provision, there is uncertainty as to whether a court would enforce such provision and that
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
March 10, 2022 Page 3
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
March 10, 2022
Page 3
investors cannot waive compliance with the federal securities laws and the rules and
regulations thereunder.
Business
Overview, page 74
5.We reissue comment 10. We note the revised disclosure of your beliefs regarding the
510(c) and potential de novo pathway for your products through the FDA approval
process. Provide us support for your reasonable belief that these pathways, and your
timelines, are feasible. Tell us whether you have had any contact with the FDA to address
these proposed pathways.
6.We note your response to comment 11. To the extent your products are not seeking
approval to be marketed as drugs, eliminate the current graphic, which has the appearance
of a drug product candidate pipeline table.
7.We reissue comment 12, to the extent you have not identified the number of studies or the
p values for each of the charts provided. Also clarify if the charts represent one study or
an average of studies. Finally, revise to clarify how the focus on the reduction of
inflammation after treatment with your compound shows that the barrier/blocking purpose
of your potential product is working, as opposed to a chemical action within the cell. That
is, clarify how the study is designed to support the potential product as a medical device
rather than a drug product candidate.
8.We reissue comment 13 to the extent you have not removed the references to safety and
effectiveness from the prospectus. In the business section, you may present objective data
resulting from testing without drawing conclusions regarding safety and efficacy.
You may contact Li Xiao at (202) 551-4391 or Kevin Vaughn at (202) 551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Abby Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.
2022-02-07 - UPLOAD - Polyrizon Ltd. File: 377-05914
United States securities and exchange commission logo
February 7, 2022
Tomer Izraeli
Chief Executive Officer
Polyrizon Ltd.
5Ha-Tidhar Street
Raanana, 4366507, Israel
Re:Polyrizon Ltd.
Draft Registration Statement on Form F-1
Submitted January 10, 2022
CIK No. 0001893645
Dear Mr. Izraeli:
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 January 10, 2022
Market, Industry and Other Data, page ii
1.We note you commissioned Life Science Intelligence, Inc. to compile "market opportunity
data included in this prospectus." Please file their consent as an exhibit to your
registration statement. Refer to Securities Act Rule 436(b).
Summary, page 1
2.As it appears you have not begun clinical trials, revise the disclosure on page 1 and
throughout the document to clarify you are a preclinical stage company, not a "clinical
biotech company."
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
February 7, 2022 Page 2
FirstName LastNameTomer Izraeli
Polyrizon Ltd.
February 7, 2022
Page 2
3.Revise the summary to clarify the nature of your products as pharmaceuticals or medical
devices or combination products (as noted on page 93), clarify the current stage of
development for your products, the path to regulatory approval, the jurisdiction(s) in
which you intend to apply for regulatory approval and, if obtained, market the products,
and the time frame for your next regulatory submission(s). With respect to the required
regulatory approvals, where you address particular pathways, briefly describe them,
including the hybrid approval pathway in the European Union referenced at the top of
page 3. Please be certain to balance your disclosure with the risks that you may not obtain
regulatory approvals in the time frame(s) anticipated, if at all.
4.Where you discuss the experience of your leadership team, be more specific about the
type of life sciences experience they have, what you mean by their "strong financial
background," what comprises their "holistic know-how." Also, please provide additional
details regarding the "renowned academics" and explain or otherwise rephrase your use of
the term "thought leaders."
Implications of Being an "Emerging Growth Company" and a Foreign Private Issuer, page 7
5.Here and on page 55 and F-10 you state you have elected to take advantage of the
extended transition period for complying with new or revised accounting standards under
Section 107(b) of the JOBS Act. However, your Emerging Growth Company Status
disclosure on page 71 states that you will not be able to avail yourselves of this extended
transition period and, as a result, will adopt new or revised accounting standards on the
relevant dates on which adoption of such standards is required by the FASB. Please
correct the inconsistency. If you elect to opt out of these provisions, please indicate as
such on the cover page.
Risk Factors
Risks Related to Our Business Operations
"Our business and operations have been . . . adversely affected by the evolving and ongoing
COVID-19 global pandemic", page 43
6.Revise this risk factor to update it to the nature of pandemic currently. The risk factor
appears outdated where it speaks as though "a widespread pandemic" is a future
possibility but not a certainty. In addition, revise to more specifically address how the
pandemic has affected your company, to the extent it has, and how it may impact your
company in the future. We note the reference to the annual report on Form F-1.
Use of Proceeds, page 62
7.Please revise to clarify whether the proceeds to be disclosed are intended to complete a
particular phase of clinical development or to fully achieve marketing approval of the
FDA or another regulatory agency, and specify the agency or agencies. To the extent that
the proceeds are intended to complete only a particular phase of clinical development,
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
February 7, 2022 Page 3
FirstName LastNameTomer Izraeli
Polyrizon Ltd.
February 7, 2022
Page 3
please identify the relevant clinical phase and disclose the amount and source of other
funds needed for you to achieve commercialization. Refer to Instruction 3 to Item 3.C.1
of Form 20-F. Also, please clarify, based on your current plans, how far into the future
the proceeds from this offering, together with your existing cash and cash equivalents, will
fund your operations.
Capitalization, page 64
8.Please address the following comments related to your capitalization presentation:
•Please revise to only present long-term debt and equity items in the capitalization
table.
•If you choose to present cash balances, please double underline them so it is clear that
cash is not part of your total capitalization amount.
•Please revise to provide the number of shares outstanding historical, pro forma, as
well as pro forma as adjusted in your common stock caption.
•Please revise to disclose under the table and where necessary, all outstanding options
issued or contingently issuable as of date that are excluded from the capitalization
presentation, including the New Options and the CEO options as disclosed at F-26.
Dilution, page 65
9.Please revise to present your historical net tangible book value as of June 30, 2021 as
presented in the first paragraph of this section to be a deficit (i.e. negative balance).
Business
Overview, page 74
10.Revise to explain the basis on which you determine that this nasal liquid is a Class II
medical device rather than a drug, which the FDA defines as "a substance intended for use
in the diagnosis, cure, mitigation, treatment, or prevention of disease." Tell us the two
predicate devices you plan to reference in your Class II 510(k) submission for PL-14, as
disclosed on page 89.
Product Roadmap, page 77
11.Revise the pipeline table to include separate columns for Phases I, II and III of clinical
development (replacing the terms "Pilot" and "Pivotal"), or tell us on what basis you
expect to combine clinical phases (as depicted) for all of your candidates in all
jurisdictions. If the terms "Pilot" and "Pivotal" had meanings other than "Phase I" and
"Phase III," respectively, please provide further explanation. Clarify when you expect to
submit an IND to the FDA or other regulatory body for each product candidate, to the
extent known. Use an arrow to indicate the current status of each product candidate, and
in the last column, remove "FDA Approval" and replace it with a milestone column where
you list the date of your next anticipated milestone.
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
February 7, 2022 Page 4
FirstName LastNameTomer Izraeli
Polyrizon Ltd.
February 7, 2022
Page 4
Study Results, page 77
12.Revise this section to clarify who performed the studies you reference, the type of studies
performed, the number of subjects, type of subjects and the objective results, including p
values. Currently, you state that "over 10 pre-clinical studies were performed," but
address one, "a viral or allergen blocking assay" using "host cells treated with your
formula." As you revise this section, when reporting results of studies, present objective
data resulting from your trials without including conclusions related to efficacy, such as
"the formulation [was] found to be very effective for preventing the house dust mite
allergen . . ." on page 77.
Competition, page 87
13.Revise the graphic on page 87 to increase the size so that it is readable, including the
footnote, and to explain the graphic so investors understand what information you are
attempting to convey. Here and throughout your document, avoid describing your product
candidates as "safe" or effective, as safety and efficacy are determinations that are solely
within the authority of the U.S. Food and Drug Administration (FDA) or similar foreign
regulators, and they continue to be evaluated throughout all phases of clinical trials.
Intellectual Property, page 98
14.Here you state that you hold no patents, but expect to file patents in the future. In the risk
factor on page 38, you state that you have filed patent applications. Revise this section to
address the type of patent applications sought and to which product candidate family it
relates, or advise.
Management, page 102
15.To the extent you have not done so, provide the business experience for each officer and
director for the past five years, including Ms. Sidi and Mr. Zalman, as required by Item
401(e) of Regulation S-K.
Description of Share Capital, page 124
16.Please clarify the applicability of the exclusive forum provision described on page 128 in
light of the risks related to obtaining and/or enforcing judgments pursuant to the securities
laws in the risk factor on page 58 and the disclosure on page 146.
U.S. Federal Income Tax Considerations, page 137
17.Clarify the "current taxable year" for which you believe you will not be a passive foreign
investment company ("PFIC"), as disclosed on page 139. Provide a tax opinion for this
disclosure or tell us why one is not required. Refer to Item 601(b)(8) of Regulation S-K
and Staff Legal Bulletin No. 19, Section III.A.2. We note this disclosure is not consistent
with the risk factor on page 53, where you state you "may be classified as a PFIC for the
FirstName LastNameTomer Izraeli
Comapany NamePolyrizon Ltd.
February 7, 2022 Page 5
FirstName LastName
Tomer Izraeli
Polyrizon Ltd.
February 7, 2022
Page 5
taxable year ended December 31, 2020." Highlight the risk that you will be a passive
foreign investment company in the summary risk factors.
General
18.Please 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 Kevin Vaughn at (202) 551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Abby Adams at (202) 551-6902 or Celeste Murphy at (202) 551-3257 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Huberman, Esq.