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NewcelX Ltd.
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NewcelX Ltd.
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SEC wrote to company
2024-11-01
NewcelX Ltd.
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NewcelX Ltd.
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2024-05-31
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2023-01-18
NewcelX Ltd.
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2022-12-13
NewcelX Ltd.
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2022-06-16
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2022-02-08
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NewcelX Ltd.
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2022-01-04
NewcelX Ltd.
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NewcelX Ltd.
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2021-10-28
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NewcelX Ltd.
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2020-03-03
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2020-11-17
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2020-09-17
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-29 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-290516 | Read Filing View |
| 2025-09-29 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2024-11-25 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2024-11-18 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2024-11-01 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-282788 | Read Filing View |
| 2024-06-24 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2024-05-31 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-279806 | Read Filing View |
| 2023-01-18 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2023-01-18 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-12-13 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-12-13 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-06-17 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-06-16 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-02-10 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-02-08 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-01-04 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-01-04 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2021-11-01 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2021-10-28 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2021-01-25 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2021-01-25 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-11-19 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-11-17 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-10-19 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-09-17 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-08-31 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-03-03 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-01-15 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-29 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-290516 | Read Filing View |
| 2024-11-01 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-282788 | Read Filing View |
| 2024-05-31 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-279806 | Read Filing View |
| 2023-01-18 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-12-13 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-06-16 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-02-08 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-01-04 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2021-10-28 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-11-17 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-09-17 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-03-03 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-01-15 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-29 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2024-11-25 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2024-11-18 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2024-06-24 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2023-01-18 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-12-13 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-06-17 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-02-10 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-01-04 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2021-11-01 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2021-01-25 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2021-01-25 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-11-19 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-10-19 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2020-08-31 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
2025-09-29 - UPLOAD - NewcelX Ltd. File: 333-290516
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 29, 2025 Alexander Zwyer Chief Executive Officer NLS Pharmaceutics Ltd. The Circle 6 8058 Zurich, Switzerland Re: NLS Pharmaceutics Ltd. Registration Statement on Form F-1 Filed September 25, 2025 File No. 333-290516 Dear Alexander Zwyer: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Alan Campbell at 202-551-4224 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Ron Ben-Bassat, Esq. </TEXT> </DOCUMENT>
2025-09-29 - CORRESP - NewcelX Ltd.
CORRESP 1 filename1.htm NLS Pharmaceutics Ltd. The Circle 6 8058 Zurich, Switzerland September 29, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: NLS Pharmaceutics Ltd. (CIK 0001783036) Registration Statement No. 333-290516 on Form F-1 (the "Registration Statement") Ladies and Gentlemen: NLS Pharmaceutics 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, 2025, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant understands that the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement. Very truly yours, NLS PHARMACEUTICS LTD. By: /s/ Alexander Zwyer Alexander Zwyer Chief Executive Officer
2024-11-25 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
November 25, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: NLS Pharmaceutics Ltd. (CIK: 0001783036)
Registration Statement on Form F-3 (File No. 333-282788)
(the “Registration Statement”)
Request for Acceleration of Effective Date
Dear Sir or Madam:
Pursuant to Rule 461
under the Securities Act of 1933, as amended (the “Securities Act”), NLS Pharmaceutics Ltd. (the “Registrant”)
hereby requests that the effective date of the above-referenced Registration Statement be accelerated so that it will be declared effective
on November 26, 2024 at 4:30 p.m., Eastern Time, or as soon as practicable thereafter.
The Registrant understands
that the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed
public offering of the securities specified in the Registration Statement.
The Registrant respectfully
requests that it be notified of such effectiveness by a telephone call to Ron Ben-Bassat, Esq. of Sullivan & Worcester LLP at (212)
660-5003 and that such effectiveness also be confirmed in writing.
Very truly yours,
NLS PHARMACEUTICS LTD.
By:
/s/ Nicole Fernandez–McGovern
Nicole Fernandez–McGovern, Chief Financial Officer
2024-11-18 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics
Ltd.
The Circle 6
8058 Zurich, Switzerland
November 18, 2024
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Attention: Lauren Hamill and Joe McCann
Re:
NLS Pharmaceutics Ltd.
Registration Statement on Form F-3
Filed October 23, 2024
File No. 333-282788
Dear Ms. Hamill and Mr. McCann:
The purpose of this letter is to respond to the comments
of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission as set forth
in your letter of November 1, 2024, regarding the above referenced registration statement on Form F-3. For your convenience, your original
comments appear in bold, followed by our response. We are concurrently filing Amendment No. 1 to Form F-3 (“Amendment No. 1”).
General
1.
We note that on July 29, 2024 you entered into a binding term sheet with respect to a merger with Kadimastem Ltd (the “Transaction”), subject to, among other things, entry into a definitive agreement and approval by NLS and Kadimastem stockholders. We also note that your Report on Form 6-K filed on July 30, 2024 indicates that a definitive agreement was expected to be executed in September 2024 with an expected Transaction closing before December 31, 2024. Please tell us, and revise the registration statement to disclose, the current status of the Transaction. Also, please provide us an analysis of whether pro forma financial statements and financial statements of Kadimastem are required. Refer to Rule 11-01 and Rule 3-05 of Regulation S-X.
Response: In response to the Staff’s
comment, we have included an update on the status of the Transaction in Amendment No. 1. In addition, we have incorporated pro forma financial
statements and financial statements of Kadimastem, in compliance with Rule 11-01 and Rule 3-05 of Regulation S-X, as well as provided
appropriate disclosures relating to Kadimastem’s business.
* * *
Lauren Hamill and Joe McCann
Securities and Exchange Commission
November 18, 2024
Page 2
If you have any questions or require additional information,
please call our attorneys, Ron Ben-Bassat at (212) 660-5003 or Howard E. Berkenblit at (617) 338-2979.
Sincerely,
NLS PHARMACEUTICS LTD.
By:
/s/ Alexander Zwyer
Chief Executive Officer
cc:
Ron Ben-Bassat
Howard Berkenblit
2024-11-01 - UPLOAD - NewcelX Ltd. File: 333-282788
November 1, 2024
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Registration Statement on Form F-3
Filed October 23, 2024
File No. 333-282788
Dear Alexander Zwyer:
We have conducted a limited review of your registration statement and have the
following comment.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe 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.
Registration Statement on Form F-3 filed October 23, 2024
General
1.We note that on July 29, 2024 you entered into a binding term sheet with respect to a
merger with Kadimastem Ltd (the "Transaction"), subject to, among other things,
entry into a definitive agreement and approval by NLS and Kadimastem
stockholders. We also note that your Report on Form 6-K filed on July 30, 2024
indicates that a definitive agreement was expected to be executed in September 2024
with an expected Transaction closing before December 31, 2024. Please tell us, and
revise the registration statement to disclose, the current status of the Transaction.
Also, please provide us an analysis of whether pro forma financial statements and
financial statements of Kadimastem are required. Refer to Rule 11-01 and Rule 3-05
of Regulation S-X.
November 1, 2024
Page 2
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence
of action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Lauren Hamill at 303-844-1008 or Joe McCann at 202-551-6262 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ron Ben-Bassat
2024-06-24 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
June 24, 2024
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: NLS Pharmaceutics Ltd. (CIK: 0001783036)
Registration Statement on Form F-1 (File No. 333-
279806) (the “Registration Statement”)
Request for Acceleration of Effective Date
Dear Sir or Madam:
Pursuant to Rule 461 under
the Securities Act of 1933, as amended (the “Securities Act”), NLS Pharmaceutics Ltd. (the “Registrant”) hereby
requests that the effective date of the above-referenced Registration Statement be accelerated so that it will be declared effective on
June 25, 2024 at 4:15 p.m., Eastern Time, or as soon as practicable thereafter.
The Registrant understands that
the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed
public offering of the securities specified in the Registration Statement.
The Registrant respectfully requests
that it be notified of such effectiveness by a telephone call to Howard E. Berkenblit, Esq. of Sullivan & Worcester LLP at (617) 338-2979
and that such effectiveness also be confirmed in writing.
Very truly yours,
NLS PHARMACEUTICS LTD.
By:
/s/ Alexander C. Zwyer
Alexander C. Zwyer, Chief Executive Officer
2024-05-31 - UPLOAD - NewcelX Ltd. File: 333-279806
United States securities and exchange commission logo
May 31, 2024
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Registration Statement on Form F-1
Filed May 30, 2024
File No. 333-279806
Dear Alexander Zwyer:
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 Jessica Dickerson at 202-551-8013 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ron Ben-Bassat, Esq.
2023-01-18 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
January
18, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
NLS Pharmaceutics Ltd. (CIK 0001783036)
Registration Statement No. 333-269220 on Form F-3 (the “Registration Statement”)
Ladies and Gentlemen:
NLS Pharmaceutics 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 20, 2023, at 4:00 p.m.,
Eastern Time, or as soon thereafter as is practicable.
The Registrant understands that
the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange
Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement.
Very truly yours,
NLS PHARMACEUTICS LTD.
By:
/s/ Chad Hellmann
Chad Hellmann
Chief Financial Officer
2023-01-18 - UPLOAD - NewcelX Ltd.
United States securities and exchange commission logo
January 18, 2023
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Registration Statement on Form F-3
Filed January 13, 2023
File No. 333-269220
Dear Alexander Zwyer:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ron Ben-Bassat, Esq.
2022-12-13 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
December 13, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
NLS Pharmaceutics Ltd. (CIK 0001783036)
Registration Statement No. 333-268690 on Form F-3 (the “Registration Statement”)
Ladies and Gentlemen:
NLS Pharmaceutics 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 15, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The Registrant understands
that the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange
Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement.
Very truly yours,
NLS PHARMACEUTICS LTD.
By:
/s/
Alexander Zwyer
Alexander Zwyer
Chief Executive Officer
2022-12-13 - UPLOAD - NewcelX Ltd.
United States securities and exchange commission logo
December 13, 2022
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Registration Statement on Form F-3
Filed December 6, 2022
File No. 333-268690
Dear Alexander Zwyer:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Howard Berkenblit
2022-06-17 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich
Switzerland
June 17, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
NLS Pharmaceutics Ltd. (CIK: 0001783036)
Registration Statement No. 333-265529 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
NLS Pharmaceutics 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 June 21, 2022, at 4:00 p.m., Eastern
Time, or as soon thereafter as is practicable.
The Registrant understands that
the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement
as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange
Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement.
Very truly yours,
NLS PHARMACEUTICS LTD.
By:
/s/ Alexander Zwyer
Name: Alexander Zwyer
Title: Chief Executive Officer
2022-06-16 - UPLOAD - NewcelX Ltd.
United States securities and exchange commission logo
June 16, 2022
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Registration Statement on Form F-1
Filed June 10, 2022
File No. 333-265529
Dear Mr. Zwyer:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ron Ben-Bassat, Esq.
2022-02-10 - CORRESP - NewcelX Ltd.
CORRESP 1 filename1.htm NLS Pharmaceutics Ltd. The Circle 6 8058 Zurich Switzerland February 10, 2022 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: NLS Pharmaceutics Ltd. (CIK: 0001783036) Registration Statement No. 333-262489 on Form F-3 (the “Registration Statement”) Ladies and Gentlemen: NLS Pharmaceutics 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 February 11, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable. The Registrant understands that the Securities and Exchange Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement. Very truly yours, NLS PHARMACEUTICS LTD. By: /s/ Alexander Zwyer Alexander Zwyer, Chief Executive Officer
2022-02-08 - UPLOAD - NewcelX Ltd.
United States securities and exchange commission logo
February 8, 2022
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Registration Statement on Form F-3
Filed February 3, 2022
File No. 333-262489
Dear Mr. Zwyer:
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 Margaret Schwartz at 202-551-7153 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ron Ben-Bassat, Esq.
2022-01-04 - UPLOAD - NewcelX Ltd.
United States securities and exchange commission logo
January 4, 2022
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Registration Statement on Form F-1
Filed December 20, 2021
File No. 333-261766
Dear Mr. Zwyer:
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 Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Howard Berkenblit, Esq.
2022-01-04 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
January 4, 2022
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attention: Ada D. Sarmento
Re:
NLS Pharmaceutics Ltd.
Registration Statement on Form F-1
Filed December 20, 2021
File No. 333-261766
Dear Ada D. Sarmento:
Pursuant to Rule 461 under the
Securities Act of 1933, as amended, NLS Pharmaceutics Ltd. hereby requests acceleration of effectiveness of the above referenced Registration
Statement so that it will become effective at 4:00 p.m. EST on Thursday, January 6, 2022, or as soon as thereafter practicable.
Very truly yours,
/s/ Alexander Zwyer
Alexander Zwyer
Chief Executive Officer
cc:
Sullivan & Worcester LLP
2021-11-01 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics Ltd.
Alter Postplatz 2
CH-6370 Stans, Switzerland
November 1, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE: NLS
Pharmaceutics Ltd. (CIK: 0001783036)
Registration
Statement No. 333-260435 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
NLS Pharmaceutics Ltd. (the “Registrant”)
hereby requests acceleration of the effectiveness of the above-referenced Registration Statement pursuant to Rule 461 under the Securities
Act of 1933, as amended (the “Securities Act”), so that it may become effective on November 3, 2021 at 5:00 p.m., Eastern
Time, or as soon thereafter as is practicable.
The Registrant understands that
the Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the
fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed public offering of the
securities specified in the Registration Statement.
Very truly yours,
nls pharmaceutics LTD.
By:
/s/ Alexander Zwyer
Alexander Zwyer, Chief Executive Officer
2021-10-28 - UPLOAD - NewcelX Ltd.
United States securities and exchange commission logo
October 28, 2021
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
Alter Postplatz 2
6370 Stans, Switzerland
Re:NLS Pharmaceutics Ltd.
Registration Statement on Form F-1
Filed October 22, 2021
File No. 333-260435
Dear Mr. Zwyer:
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 Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ron Ben-Bassat
2021-01-25 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
January 25, 2021
Securities and Exchange Commission
100 F. Street, NE
Washington, D.C. 20549
Re:
NLS Pharmaceutics Ltd.
Registration Statement on Form F-1
File No. 333-236797
VIA EDGAR
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations of the
U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, Maxim Group LLC, 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., Washington D.C. time, on Thursday, January 28, 2021, or as soon thereafter as practicable.
The following is supplemental information supplied under Rule 418(a)(7)
and Rule 460 under the Securities Act of 1933:
(i)
Date of preliminary prospectus: January 19, 2021.
(ii)
Dates of distribution: January 19, 2021 through the date hereof.
(iii)
Number of prospective underwriters and selected dealers to whom the preliminary prospectus was furnished: 8.
(iv)
Number of prospectuses so distributed: 468.
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.
[Signature Page Follows]
MAXIM GROUP LLC
By:
/s/
Clifford A. Teller
Name:
Clifford A. Teller
Title:
Executive Managing Director
Head of Investment Banking
2021-01-25 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics Ltd.
Alter Postplatz 2
CH-6370 Stans, Switzerland
January 25, 2021
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
RE:
NLS Pharmaceutics Ltd. (CIK: 0001783036)
Registration Statement No. 333-236797 on Form F-1 (the “Registration Statement”)
Ladies and Gentlemen:
NLS Pharmaceutics 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 28, 2021 at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable. By separate letter, the underwriters
of the issuance of the securities being registered have joined in this request for acceleration.
The Registrant understands
that the Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation
of the fact that the Registrant is aware of its responsibilities under the Securities Act as they relate to the proposed public
offering of the securities specified in the Registration Statement.
Very truly yours,
nls pharmaceutics LTD.
By:
/s/ Alexander Zwyer
Alexander Zwyer, Chief Executive Officer
2020-11-19 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS
Pharmaceutics Ltd.
Alter Postplatz 2
CH-6370 Stans, Switzerland
November 19, 2020
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Attention: Laura Crotty and Mary Beth Breslin
Re:
NLS Pharmaceutics Ltd.
Amendment No. 3 to
Registration Statement on Form F-1
Filed November 13, 2020
File No. 333-236797
Dear Mss. Crotty and Breslin:
The purpose of this letter is to respond to
the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange
Commission as set forth in your letter of November 16, 2020, regarding the above referenced registration statement on Form F-1
(the “Registration Statement”). For your convenience, your original comments appear in bold, followed by our response.
Capitalized terms not otherwise defined herein shall have the meaning ascribed to them in the Registration Statement.
Exhibits
1.
We note assumption (e) in part II of
the legal opinion of Wenger & Vieli AG relating to the shareholder approval required to effect the increase in share
capital necessary to issue the Shares and such Common Shares for which Warrants and Underwriter Warrants are granted, and the
related required actions of the board of directors. We also note your statement on page 43 of the registration statement that
you expect to obtain authorization from your shareholders prior to the offering. Please advise us of the status of the
shareholder authorization and the related board of directors' actions. In addition, please confirm that an appropriately
unqualified legal opinion will be filed by post-effective amendment no later than the closing date of the offering to remove
assumption (e). See Section II.B.2.f. of Staff Legal Bulletin No. 19 for guidance.
Response: With respect to the shareholder authorization and
related board of directors’ actions we hereby advise you that as of the date hereof we have collected all necessary authorizations
of the current shareholders by way of proxies and the approval of the board of directors to effect the increase in share capital
necessary to validly issue the common shares included in the units to be offered pursuant to the Registration Statement as of the
closing date of the offering, and to create the authorized share capital (as basis for the issuance of the shares that the underwriters
may exercise pursuant to their over-allotment options) as well as the conditional share capital required to issue the Warrants
and Representative’s Warrants, including pursuant to the over-allotment option (each as defined in the Registration Statement)
(as basis for the issuance of the Common Shares for which the Warrants, including with respect to the over-allotment option, and
Representative’s Warrants are granted). As of the date of pricing (immediately thereafter pricing), based on the above mentioned
authorizations and approvals, the appropriate resolutions of the shareholders and the board of directors will be made, and as a
result thereof, they will become final and effective. Please note that until such time, each shareholder may revoke the authorization
and the board of directors may reverse the approval.
With respect to the legal opinion of Wenger
& Vieli AG, or WV, we hereby advise you that as of the date hereof WV has confirmed to us that it will provide us with an appropriately
unqualified legal opinion to remove assumption (e) for the purpose of filing by post-effective amendment by no later than the closing
date of the offering.
* * *
If you have any questions or require additional
information, please call our attorneys, Ron Ben-Bassat at (212) 660-5003, Howard E. Berkenblit at (617) 338-2979 or Oded Har-Even
at (212) 660-5002, of Sullivan & Worcester LLP.
Sincerely,
NLS PHARMACEUTICS LTD.
By:
/s/ Alexander Zwyer
Chief Executive Officer
cc:
Michael Fay
Jeanne Baker
2020-11-17 - UPLOAD - NewcelX Ltd.
United States securities and exchange commission logo
November 16, 2020
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
Alter Postplatz 2
CH-6370 Stans, Switzerland
Re:NLS Pharmaceutics Ltd.
Amendment No. 3 to
Registration Statement on Form F-1
Filed November 13, 2020
File No. 333-236797
Dear Mr. Zwyer:
We have reviewed your amended registration statement and have the following
comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Amendment 3 to Form F-1 filed November 13, 2020
Exhibits
1.We note assumption (e) in part II of the legal opinion of Wenger & Vieli AG relating to
the shareholder approval required to effect the increase in share capital necessary to issue
the Shares and such Common Shares for which Warrants and Underwriter Warrants are
granted, and the related required actions of the board of directors. We also note your
statement on page 43 of the registration statement that you expect to obtain authorization
from your shareholders prior to the offering. Please advise us of the status of the
shareholder authorization and the related board of directors' actions. In addition, please
confirm that an appropriately unqualified legal opinion will be filed by post-effective
amendment no later than the closing date of the offering to remove assumption (e). See
Section II.B.2.f. of Staff Legal Bulletin No. 19 for guidance.
FirstName LastNameAlexander Zwyer
Comapany NameNLS Pharmaceutics Ltd.
November 16, 2020 Page 2
FirstName LastName
Alexander Zwyer
NLS Pharmaceutics Ltd.
November 16, 2020
Page 2
You may contact Michael Fay at 202-551-3812 or Jeanne Baker at 202-551-3691 if you
have questions regarding comments on the financial statements and related matters. Please
contact Laura Crotty at 202-551-7614 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Howard Berkenblit, Esq.
2020-10-19 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS
Pharmaceutics Ltd.
Alter
Postplatz 2
CH-6370
Stans, Switzerland
October
19, 2020
Via
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
Office
of Life Sciences
100
F Street, NE
Washington,
DC 20549
Attention:
Laura Crotty and Mary Beth Breslin
Re:
NLS
Pharmaceutics Ltd.
Registration
Statement on Form F-1
Filed
August 31, 2020
File
No. 333-236797
Dear
Mss. Crotty and Breslin:
The
purpose of this letter is to respond to the comments of the staff of the Division of Corporation Finance (the “Staff”)
of the U.S. Securities and Exchange Commission as set forth in your letter of September 16, 2020, regarding the above referenced
registration statement on Form F-1. For your convenience, your original comments appear in bold, followed by our response. We
are concurrently filing Amendment No. 2 to Form F-1 (“Amendment No. 2”).
The
Offering, page 5
1.
We
have reviewed your response to prior comment 1 and note that you will account for the Transaction Fee as a reduction from
paid-in capital. Please tell us how you have considered SAB Topic 5.A, codified in ASC 340-10-S99-1, as part of the basis
for your accounting.
Response:
We have considered ASC 340-10-S99-1 in accounting for the offering expenses and as of the year ended December 31, 2019, the Company
has deferred $260,211 of specific costs attributable to the proposed offering. The costs deferred exclude any management and general
and administrative expenses, including the Transaction Fee (as defined in Amendment No. 2), and only include costs that are related
to the current offering contemplated by Amendment No. 2.
Financing
Activities, page 56
2.
We
note your statement on page 56 that you expect to formalize the terms of the 2020 Bridge Loan and file such agreement as an
exhibit to the registration statement. Please file the referenced agreement with the next amendment.
Response:
The 2020 Bridge Loan has been filed as an exhibit to Amendment No. 2.
Business
Pivotal
Study Development Strategy, page 67
3.
We
note your response to our prior comment 2 in which you have described the origin of the efficacy portion of the FDA's review of
product candidates; however, we do not see how the provided analysis supports your use of the term "pivotal" which is
most commonly associated with Phase III clinical trials. As previously requested, please tell us why it is appropriate to use
this term for both planned clinical trials, or revise the prospectus as appropriate.
Response:
We have revised our disclosures throughout Amendment No. 2 in response to the Staff’s comment and have elected to refrain
from referring to our clinical trials as pivotal trials in Amendment No. 2.
*
* *
Laura Crotty and Mary Beth Breslin
Securities and Exchange Commission
October 19, 2020
Page 2
If
you have any questions or require additional information, please call our attorneys, Ron Ben-Bassat at (212) 660-5003, Howard
E. Berkenblit at (617) 338-2979 or Oded Har-Even at (212) 660-5002, of Sullivan & Worcester LLP.
Sincerely,
NLS
PHARMACEUTICS LTD.
By:
/s/
Alexander Zwyer
Chief Executive Officer
cc:
Michael
Fay
Jeanne Baker
2020-09-17 - UPLOAD - NewcelX Ltd.
United States securities and exchange commission logo
September 16, 2020
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
Alter Postplatz 2
CH-6370 Stans, Switzerland
Re:NLS Pharmaceutics Ltd.
Amendment No. 1 to
Registration Statement on Form F-1
Filed August 31, 2020
File No. 333-236797
Dear Mr. Zwyer:
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 March 3, 2020 letter.
Registration Statement on Form F-1/A filed August 31, 2020
The Offering, page 5
1.We have reviewed your response to prior comment 1 and note that you will account for
the Transaction Fee as a reduction from paid-in capital. Please tell us how you have
considered SAB Topic 5.A, codified in ASC 340-10-S99-1, as part of the basis for your
accounting.
Financing Activities, page 56
2.We note your statement on page 56 that you expect to formalize the terms of the 2020
Bridge Loan and file such agreement as an exhibit to the registration statement. Please file
FirstName LastNameAlexander Zwyer
Comapany NameNLS Pharmaceutics Ltd.
September 16, 2020 Page 2
FirstName LastName
Alexander Zwyer
NLS Pharmaceutics Ltd.
September 16, 2020
Page 2
the referenced agreement with the next amendment.
Business
Pivotal Study Development Strategy, page 67
3.We note your response to our prior comment 2 in which you have described the origin of
the efficacy portion of the FDA's review of product candidates; however, we do not see
how the provided analysis supports your use of the term "pivotal" which is most
commonly associated with Phase III clinical trials. As previously requested, please tell us
why it is appropriate to use this term for both planned clinical trials, or revise the
prospectus as appropriate.
You may contact Michael Fay at 202-551-3812 or Jeanne Baker at 202-551-3691 if you
have questions regarding comments on the financial statements and related matters. Please
contact Laura Crotty at 202-551-7614 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Howard Berkenblit, Esq.
2020-08-31 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS
Pharmaceutics Ltd.
Alter Postplatz 2
CH-6370 Stans, Switzerland
August 31, 2020
Via EDGAR - Confidential
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Attention: Irene Paik and Mary Beth Breslin
Re:
NLS Pharmaceutics Ltd.
Registration Statement on Form F-1
Filed February 28, 2020
File No. 333-236797
Dear Mss. Paik and Breslin:
The purpose of this letter is to respond
to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange
Commission as set forth in your letter of March 3, 2020, regarding the above referenced registration statement on Form F-1. For
your convenience, your original comments appear in bold, followed by our response. We are concurrently filing Amendment No. 1
to Form F-1 (“Amendment No. 1”). Page references in our response are to Amendment No. 1.
The Offering, page 4
1.
Please
disclose how you will account for the Transaction Fee, including disclosure of an estimated dollar amount. Make conforming
changes throughout the filing.
Response: We have added disclosure on how we intend
to account for the Transaction Fee on page 46. We intend to account for the Transaction Fee as a reduction from paid-in capital
as this expense is part of the Company’s financing activities. We have also provided an estimated dollar amount for the
Transaction Fee on page 6 and elsewhere in the prospectus.
Business
Pivotal Study Development Strategy, page 64
2.
We
note that you label both clinical trials you are planning for Quilience as "pivotal" clinical trials. Please tell
us why it is appropriate to use this term for both clinical trials, or revise the prospectus as appropriate.
Response: We believe that it is
appropriate to describe both clinical trials (the “Trials”) that we are planning for Quilience, as disclosed in Amendment
No. 1, as “pivotal” because such Trials are intended to provide the ultimate evidence of safety and efficacy that
the U.S. Food and Drug Administration (the “FDA”) (and the European Medicines Agency) will use in deciding whether
or not to approve Quilience.
Such belief is based on the FDA’s
“Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products,” which
includes the following guidance:
“The effectiveness requirement
for drug approval was added to the Federal Food, Drug, and Cosmetic Act in 1962 (between the passage of the Act in 1938 and the
1962 amendments, drug manufacturers were required to show only that their drugs were safe). Since the 1962 Amendments added this
provision to the statute, discussions have ensued within the FDA regarding the quantity and quality of the evidence needed to
establish effectiveness. With regard to quantity, it has been FDA's position that Congress generally intended to require at least
two adequate and well-controlled studies, each convincing on its own, to establish effectiveness. (See e.g., Final Decision on
Benylin, 44 FR 51512, 518 (August 31, 1979); Warner-Lambert Co. V. Heckler, 787 F. 2d 147 (3d Cir. 1986)). The FDA’s position
is based on the language in the statute and the legislative history of the 1962 amendments. Language in a Senate report suggests
that the phrase "adequate and well-controlled investigations" was designed not only to describe the quality of the required
data but the "quantum" of required evidence. (S. Rep. No. 1744, Part 2, 87th Cong. 2d Sess. 6 (1962)).”
Irene Paik and Mary Beth Breslin
Office of Life Sciences
Securities and Exchange Commission
August 31, 2020
Page 2
Nolazol Clinical Trial Results
Phase 2 Pediatric Clinical Trial, page 74
3.
We
note your revisions in response to prior comment 11. Please further revise to avoid characterizing clinical trial results
in terms of safety or efficacy, such as where you describe the results from the phase 2 pediatric trial described on page
74.
Response: We have further revised the prospectus on
pages 77 an 78 to avoid characterizing clinical trial results in terms of safety or efficacy.
Note 1. Background, page F-6
4.
We
have reviewed the ownership interests in the three companies prior to the merger as set forth in your response to prior comment
14 and note your belief that in accordance with ASC 805-50-30-5 this was a common controlled transaction. However, we note
that no individual held more than 50% of the voting ownership interest of each entity. Please revise your disclosure to state,
if true, that due to the high degree of common ownership amount the three companies and because individual investor's ownership
are in substance the same after the transaction, that this was deemed to be a non-substantive merger, with no step up in basis
of the assets and liabilities in the merger.
Response: We have updated our disclosure
on page F-8 to state that due to the high degree of common ownership among the three companies and because individual investors’
ownership are, in substance, the same after the merger transaction, that this was deemed to be a non-substantive merger, with
no step up in basis of the assets and liabilities in the merger.
Note 8. License Revenues, page F-13
5. We
have reviewed your revised disclosures in response to prior comment 16 and have the following
additional comments:
● With
reference to ASC 606-10-25-19, please more fully explain how you determined that the
promises you have identified within the contract (i.e. the license, and promised services
with respect to (i) development and (ii) participation in a steering committee) are not
distinct. In this regard, specifically clarify why each good or service promised has
no value to Europharma on a stand-alone basis;
● Explain
your basis for bundling these promises into your License Performance Obligation. Also,
as required by ASC 606-10-25-31, please explain how the use of an input method as a measure
of progress towards completion of the License Performance Obligation using development
costs meets the overall objective of depicting your performance in satisfying this bundled
performance obligation. Specifically identify the patterns of performance of each nondistinct
promise and the judgement used in determining your stated measure of progress in the
combined performance;
Irene Paik and Mary Beth Breslin
Office of Life Sciences
Securities and Exchange Commission
August 31, 2020
Page 3
● Clarify
how you considered the guidance in ASC 606-10-55-50 through 55-53 in accounting for the
$2,500,000 upfront payment. In particular, explain how you assessed whether there was
a transfer of a promised good or service; and
● Provide
the disclosures required by ASC 606-10-50-17 and 50-18.
Response:
We have updated and expanded our disclosures beginning on page F-20 to address the comments and specific ASC Topic sections
as mentioned in the above comment.
*
* *
If
you have any questions or require additional information, please call our attorneys, Ron Ben-Bassat at (212) 660-5003, Howard
E. Berkenblit at (617) 338-2979 or Oded Har-Even at (212) 660-5002, of Sullivan & Worcester LLP.
Sincerely,
NLS
PHARMACEUTICS LTD.
By:
/s/
Alexander Zwyer
Chief
Executive Officer
cc:
Michael
Fay
Jeanne
Baker
2020-03-03 - UPLOAD - NewcelX Ltd.
March 3, 2020
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
Alter Postplatz 2
CH-6370 Stans, Switzerland
Re:NLS Pharmaceutics Ltd.
Registration Statement on Form F-1
Filed February 28, 2020
File No. 333-236797
Dear Mr. Zwyer:
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 14, 2020 letter.
Registration Statement on Form F-1 filed February 28, 2020
The Offering, page 4
1.Please disclose how you will account for the Transaction Fee, including disclosure of an
estimated dollar amount. Make conforming changes throughout the filing.
Business
Pivotal Study Development Strategy, page 64
2.We note that you label both clinical trials you are planning for Quilience as "pivotal"
clinical trials. Please tell us why it is appropriate to use this term for both clinical trials, or
revise the prospectus as appropriate.
FirstName LastNameAlexander Zwyer
Comapany NameNLS Pharmaceutics Ltd.
March 3, 2020 Page 2
FirstName LastNameAlexander Zwyer
NLS Pharmaceutics Ltd.
March 3, 2020
Page 2
Nolazol Clinical Trial Results
Phase 2 Pediatric Clinical Trial, page 74
3.We note your revisions in response to prior comment 11. Please further revise to avoid
characterizing clinical trial results in terms of safety or efficacy, such as where you
describe the results from the phase 2 pediatric trial described on page 74.
Interim Condensed Financial Statements
Notes to the Condensed Financial Statements
Note 1. Background, page F-6
4.We have reviewed the ownership interests in the three companies prior to the merger as
set forth in your response to prior comment 14 and note your belief that in accordance
with ASC 805-50-30-5 this was a common controlled transaction. However, we note
that no individual held more than 50% of the voting ownership interest of each entity.
Please revise your disclosure to state, if true, that due to the high degree of common
ownership amount the three companies and because individual investor's ownership are in
substance the same after the transaction, that this was deemed to be a nonsubstantive
merger, with no step up in basis of the assets and liabilities in the merger.
Note 8. License Revenues, page F-13
5.We have reviewed your revised disclosures in response to prior comment 16 and have the
following additional comments:
•With reference to ASC 606-10-25-19, please more fully explain how you determined
that the promises you have identified within the contract (i.e. the license, and
promised services with respect to (i) development and (ii) participation in a steering
committee) are not distinct. In this regard, specifically clarify why each good or
service promised has no value to Europharma on a stand-alone basis;
•Explain your basis for bundling these promises into your License Performance
Obligation. Also, as required by ASC 606-10-25-31, please explain how the use of
an input method as a measure of progress towards completion of the License
Performance Obligation using development costs meets the overall objective of
depicting your performance in satisfying this bundled performance obligation.
Specifically identify the patterns of performance of each nondistinct promise and the
judgement used in determining your stated measure of progress in the combined
performance;
•Clarify how you considered the guidance in ASC 606-10-55-50 through 55-53 in
accounting for the $2,500,000 upfront payment. In particular, explain how you
assessed whether there was a transfer of a promised good or service; and
•Provide the disclosures required by ASC 606-10-50-17 and 50-18.
FirstName LastNameAlexander Zwyer
Comapany NameNLS Pharmaceutics Ltd.
March 3, 2020 Page 3
FirstName LastName
Alexander Zwyer
NLS Pharmaceutics Ltd.
March 3, 2020
Page 3
You may contact Michael Fay at 202-551-3812 or Jeanne Baker at 202-551-3691 if
you have questions regarding comments on the financial statements and related matters.
Please contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Howard Berkenblit, Esq.
2020-01-15 - UPLOAD - NewcelX Ltd.
January 14, 2020
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
Alter Postplatz 2
CH-6370 Stans, Switzerland
Re:NLS Pharmaceutics Ltd.
Draft Registration Statement on Form F-1
Submitted December 18, 2019
CIK No. 0001783036
Dear Mr. Zwyer:
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 December 18, 2019
Prospectus Summary
Our Company, page 1
1.Please expand your disclosure regarding Quilience and Nolazol to briefly discuss your
stage of development of these product candidates and your plans for their development in
the future. Further, given your risk factor disclosure on page 10, please clarify whether
you are pursuing FDA approval of one or both of the lead product candidates for use in
children.
2.We note your statements throughout the prospectus that Quilience and Nolazol are
"novel" pharmaceutical products and agents, yet the active molecule in these product
candidates is a controlled release formulation of mazindol, which has been previously
FirstName LastNameAlexander Zwyer
Comapany NameNLS Pharmaceutics Ltd.
January 14, 2020 Page 2
FirstName LastNameAlexander Zwyer
NLS Pharmaceutics Ltd.
January 14, 2020
Page 2
approved in an immediate release form. Please revise the use of the term "novel"
throughout the prospectus as appropriate.
Risks Associated With Our Business, page 2
3.Please include a bullet point describing the risks related to the fact that over 70% of your
outstanding common stock is held by your chief executive officer and affiliates, and
discuss the extent to which they will continue to exert control over you after the offering.
Implications of Being an “Emerging Growth Company”, page 3
4.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Risk Factors
Obtaining approval of an NDA or a Marketing Authorization Application..., page 7
5.We note your disclosure that you have not received regulatory clearance to conduct the
additional clinical trials that are necessary to be able to submit an NDA to the FDA for
Nolazol. Please revise your disclosure to specify the regulatory clearance needed to
conduct additional trials and describe any additional steps involved in obtaining the
regulatory clearance.
Risks Related to Our Intellectual Property, page 25
6.Please add a risk factor, or revise in the appropriate risk factor, to address the limitations
of patents protecting the method of use as opposed to other types of patents, such as a
composition of matter patent.
Use of Proceeds, page 42
7.We note that the net proceeds will be used to further develop mazindol CR for use in
Quilience and Nolazol. Please revise your disclosure to specify how far in the clinical
development you expect to reach with the net proceeds for each of the identified product
candidates.
Business
Our Development Pipeline, page 57
8.We note that your pipeline table includes product candidates with regard to which you do
not provide any information (NLS 10, NLS-13 and NLS-14) or provide limited
information (NLS-2, NLS-3 and NLS-4). Please remove these product candidates from the
pipeline table or tell us why you believe these product candidates are material to your
business. To the extent you believe these product candidates are material, please provide
disclosure regarding these product candidates, including whether you own or license the
FirstName LastNameAlexander Zwyer
Comapany NameNLS Pharmaceutics Ltd.
January 14, 2020 Page 3
FirstName LastName
Alexander Zwyer
NLS Pharmaceutics Ltd.
January 14, 2020
Page 3
intellectual property underlying the product candidate, the mechanism of action, any trials
conducted to date and your plans for development.
Our Solution: Quilience for Narcolepsy - A Well-Suited Approach for the Disease Pathology ,
page 62
9.We note that in your pipeline table on page 57, it suggests that you have completed Phase
2 studies for Quilience. However, you do not provide a description of any studies
conducted to date with respect to Quilience and further disclose that you have not yet
submitted an IND application or CTA. Please revise your disclosure or the pipeline table
to reconcile this discrepancy. To the extent you have completed any clinical trials to date,
please provide a description of these trials.
10.We note your statement of belief that Quilience may qualify for the Breakthrough
program "based on positive real-world evidence using the same outcome measures
utilized in Phase 3 clinical trials." Please revise your disclosure to explain what this
means.
Our Solution: Nolazol - The Efficacy of a CII Stimulant with Improved Safety and Tolerability,
page 67
11.You make several assertions regarding the safety and efficacy of your product candidates.
For example, on page 67, you state that "Nolazol has the right balance of safety and
efficacy," that Nolazol demonstrated "evidence of efficacy and safety" in your Phase 2
clinical trial, and that Nolazol has "comparable efficacy, improved safety" compared to
CII treatments in use today and is "a more effective treatment than the available non-
stimulants." Safety and efficacy determinations are solely within the authority of the FDA
(or applicable foreign regulator). Please revise or remove statements/inferences
throughout your prospectus that your product candidates are safe and/or effective.
Manufacturing and Suppliers, page 74
12.We note that you rely on a single source for the production of your drug substance. Please
disclose the material terms of your agreement with this supplier and file the agreement as
an exhibit to the registration statement, or tell us why you do not believe this is
required. See Item 601(b)(10) of Regulation S-K.
Intellectual Property, page 75
13.Please expand your disclosure to clarify the type of patent protection your applications
covering mazindol CR for the treatment of ADHD and narcolepsy provide (e.g.,
composition of matter, method of use, etc.). Also revise to clarify the type of protection
covering NLS-2, NLS-3 and NLS-4 referenced in the last sentence of the second
paragraph.
FirstName LastNameAlexander Zwyer
Comapany NameNLS Pharmaceutics Ltd.
January 14, 2020 Page 4
FirstName LastName
Alexander Zwyer
NLS Pharmaceutics Ltd.
January 14, 2020
Page 4
Note 1: Background, page F-7
14.You disclose that as all of the companies were owned by the same shareholders, the
Merger was considered to be a common controlled transaction. Please tell us the
ownership interests of NLS-0 Pharma Ltd., NLS Pharma Ltd. and NLS-1 Pharma Ltd.
both before and after the Merger. If any of the ownership percentages changed, please
explain the appropriateness of accounting for the Merger at historical cost.
Note 2: Summary of Significant Accounting Policies
Revenue Recognition, page F-8
15.Although you indicate that you recognized revenue in accordance with ASC 606, your
disclosures herein and in Note 8 appear to refer to terminology and recognition principals
set forth in ASC 605. Please revise your disclosures to address your revenue recognition
policies and disclosure requirements under the guidance of ASC 606. Address this
comment as it relates to your Critical Accounting Policies regarding revenue recognition
on page 51. Also, see our specific comment below regarding your accounting for the EF
License Agreement.
Note 8: License Revenues, page F-12
16.Given the fact that you adopted the provisions of ASC 606 on January 1, 2019, please
revise your disclosures to identify the performance obligations included in your EF
License Agreement. Indicate the goods or services promised that are distinct and those
that are combined to form a bundled performance obligation. Refer to ASC 606-10-25-14
through 22 and provide the disclosures required by ASC 606-10-50-12 and 50-13. In
addition, with reference to ASC 606-10-32-28 through 35, please disclose how you
determined the transaction price and the amount allocated to each
performance obligation. In that regard, please address how you considered the guidance
in ASC 606-10-55-50 thorough ASC 606-10-55-53 in accounting for the $2.5 million
payment and how you considered the other milestone payments in determining your
transaction price and the extent to which such variable consideration was constrained.
Refer to ASC 606-10-50-20. Please address this comment as it relates to your disclosures
surrounding the accounting for your EF License Agreement on page 46.
FirstName LastNameAlexander Zwyer
Comapany NameNLS Pharmaceutics Ltd.
January 14, 2020 Page 5
FirstName LastName
Alexander Zwyer
NLS Pharmaceutics Ltd.
January 14, 2020
Page 5
You may contact Michael Fay at 202-551-3812 or Jeanne Baker at 202-551-3691 if you
have questions regarding comments on the financial statements and related matters. Please
contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Howard Berkenblit