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NewcelX Ltd.
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Company responded
2025-06-23
NewcelX Ltd.
References: June 9, 2025
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2025-03-20
NewcelX Ltd.
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-14 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2026-05-14 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-295770 | Read Filing View |
| 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 |
| 2025-09-08 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-09-03 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-08-28 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-08-15 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-08-06 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-07-29 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-07-23 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-06-23 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-06-18 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-06-09 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-06-09 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-04-15 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-03-31 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-03-20 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-02-28 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-01-27 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | 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 | SEC Comment Letter | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-12-13 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-06-17 | 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 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2022-01-04 | SEC Comment Letter | 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 |
|---|---|---|---|---|---|
| 2026-05-14 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-295770 | Read Filing View |
| 2025-09-29 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-290516 | Read Filing View |
| 2025-08-28 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-08-06 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-07-23 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-06-18 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-04-15 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-03-20 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | Read Filing View |
| 2025-01-27 | SEC Comment Letter | NewcelX Ltd. | Switzerland | 333-284075 | 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 |
|---|---|---|---|---|---|
| 2026-05-14 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-09-29 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-09-08 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-09-03 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-08-15 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-07-29 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-06-23 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-06-09 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-06-09 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-03-31 | Company Response | NewcelX Ltd. | Switzerland | N/A | Read Filing View |
| 2025-02-28 | 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 |
2026-05-14 - CORRESP - NewcelX Ltd.
CORRESP 1 filename1.htm NewcelX Ltd. Hohstrasse 1 8302 Kloten, Switzerland May 14, 2026 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: NewcelX Ltd. (CIK 0001783036) Registration Statement No. 333-295770 on Form F-3 (the "Registration Statement") Ladies and Gentlemen: NewcelX 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 15, 2026, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable. The undersigned respectfully requests that it be notified of the effectiveness of the Registration Statement by telephone call to our counsel, Greenberg Traurig, P.A., by calling Gary Emmanuel at 212.801.9200. The Company hereby authorizes Mr. Emmanuel to orally modify or withdraw this request for acceleration. Very truly yours, NEWCELX LTD. By: /s/ Ronen Twito Ronen Twito Chief Executive Officer
2026-05-14 - UPLOAD - NewcelX Ltd. File: 333-295770
May 14, 2026 Omri Hagai Chief Financial Officer NewcelX Ltd. Hohstrasse 1 8302 Kloten, Switzerland Re: NewcelX Ltd. Registration Statement on Form F-3 Filed May 11, 2026 File No. 333-295770 Dear Omri Hagai: 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 Jimmy McNamara at 202-551-7349 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Gary Emmanuel
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
2025-09-08 - CORRESP - NewcelX Ltd.
CORRESP 1 filename1.htm NLS Pharmaceutics Ltd. The Circle 6 8058 Zurich, Switzerland September 8, 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. 333-284075 on Form F-4 (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 9, 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
2025-09-03 - CORRESP - NewcelX Ltd.
CORRESP 1 filename1.htm NLS Pharmaceutics Ltd. The Circle 6 8058 Zurich, Switzerland September 3, 2025 Via EDGAR Angela Connell Eric Atallah Doris Stacey Gama Alan Campbell Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, DC 20549 Re: NLS Pharmaceutics Ltd. (the "Company," "we," "our" and similar terminology) Correspondence Submitted August 15, 2025 Amendment No. 6 to Registration Statement on Form F-4 File No. 333-284075 Ladies and Gentlemen: The purpose of this letter is to respond to the comment letter of August 28, 2025, received from the staff (the "Staff") of the U.S. Securities and Exchange Commission regarding the above-mentioned Correspondence Submitted August 15, 2025 regarding Amendment No. 6 to the Registration Statement on Form F-4. For your convenience, your original comments appear in bold text, followed by our response. We are concurrently filing Amendment No. 7 to the Registration Statement on Form F-4. Unless otherwise stated, any defined terms in Amendment No. 7 apply within this letter. Amendment No. 6 to Registration Statement on Form F-4 Record Date; Outstanding Shares; Shareholders Entitled to Vote, page 105 1. We note from your responses to prior comment 1 and 2 that your reference to "treasury shares" is under Swiss corporate law rather than U.S. GAAP. In instances where terms have different meanings under Swiss corporate law and U.S. GAAP, please clearly disclose that you are referring to Swiss corporate law. Briefly explain the requirements under the Swiss corporate law and clearly indicate that you are referring to amounts calculated in accordance with Swiss corporate law and that such amounts differ from amounts calculated under U.S. GAAP. Response: In response to the Staff's comment, and in reference to our prior responses in prior comments 1 and 2, under Swiss corporate law, shares held by the Company itself, even if never transferred to external parties, are considered issued and "warehoused" for future financings and are reflected as such in the Swiss share registry. Under Swiss corporate law, these holdings are referred to as "treasury shares." In response to the Staff's comment, we have revised the Registration Statement on Form F-4 to clarify that references to "treasury shares" are made in the context of Swiss corporate law, to briefly describe the relevant Swiss corporate law requirements, and to state that such amounts differ from those calculated under U.S. GAAP. NLS Pharmaceutics Ltd. and Subsidiaries Consolidated Balance Sheets, page F-4 2. We note your response to prior comment 6. We do not agree that the error in the preferred and common share line items on the face of your Consolidated Balance Sheet is immaterial. Accordingly, please revise your Registration Statement on Form F-4 to correct this error in your Consolidated Balance Sheet and remove the related pro forma adjustment. Response: In response to the Staff's comment, we have revised the Consolidated Balance Sheets on page F-4 of the Registration Statement on Form F-4 to correct the presentation of preferred and common shares. The related pro forma adjustment has been removed. If you have any questions or require additional information, please contact our attorneys Ron Ben-Bassat, Esq. at (212) 660-5003 or Oded Har-Even, Esq. at (212) 660-5002, each of Sullivan & Worcester LLP. Sincerely, NLS Pharmaceutics LTD. By: /s/ Alexander Zwyer Chief Executive Officer
2025-08-28 - UPLOAD - NewcelX Ltd. File: 333-284075
August 28, 2025
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Correspondence Submitted August 15, 2025
Amendment No. 6 to Registration Statement on Form F-4
File No. 333-284075
Dear Alexander Zwyer:
We have reviewed your August 15, 2025 response to our comment letter 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 6, 2025 letter.
Amendment No. 6 to Registration Statement on Form F-4
Record Date; Outstanding Shares; Shareholders Entitled to Vote, page 105
1.We note from your responses to prior comment 1 and 2 that your reference to
“treasury shares” is under Swiss corporate law rather than U.S. GAAP. In instances
where terms have different meanings under Swiss corporate law and U.S. GAAP,
please clearly disclose that you are referring to Swiss corporate law. Briefly explain
the requirements under the Swiss corporate law and clearly indicate that you are
referring to amounts calculated in accordance with Swiss corporate law and that such
amounts differ from amounts calculated under U.S. GAAP.
August 28, 2025
Page 2
NLS Pharmaceuticals Ltd. and Subsidiaries
Consolidated Balance Sheets, page F-4
2.We note your response to prior comment 6. We do not agree that the error in the
preferred and common share line items on the face of your Consolidated Balance
Sheet is immaterial. Accordingly, please revise your Registration Statement on Form
F-4 to correct this error in your Consolidated Balance Sheet and remove the related
pro forma adjustment.
Please contact Eric Atallah at 202-551-3663 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please contact Doris Stacey Gama at 202-551-3188 or Alan Campbell at 202-551-
4224 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ron Ben-Bassat, Esq.
2025-08-15 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
August 15, 2025
Via EDGAR
Angela Connell
Doris Stacey Gama
Alan Campbell
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re:
NLS Pharmaceutics Ltd. (the "Company," "we," "our" and similar terminology)
Amendment No. 6 to Registration Statement on Form F-4
Filed June 29, 2025
File No. 333-284075
Ladies and Gentlemen:
The purpose of this letter is to respond to the
comment letter of August 6, 2025, received from the staff (the "Staff") of the U.S. Securities and Exchange Commission regarding
the above-mentioned Amendment No. 6 to the Registration Statement on Form F-4. For your convenience, your original comments appear in
bold text, followed by our response. We intend to file Amendment No. 7 to the Registration Statement on Form F-4 ("Amendment No.
7") in the near future.
Unless otherwise stated, any defined terms in
Amendment No. 6 apply within this letter.
Amendment No. 6 to Registration Statement
on Form F-4
Record Date; Outstanding Shares; Shareholders
Entitled to Vote, page 105
1. In
prior comment one we requested a rollforward of each class of equity security that reconciles amounts reported on your December 31, 2024
balance sheet to the amounts disclosed on page 105. While the rollforward provided in Appendix 1 to your response reconciles to your
pro forma balance sheet on page 270, it does not reconcile to amounts disclosed on page 105. In this regard, your disclosure on page
105 states that as of the date of this prospectus, NLS outstanding share capital consisted of 4,908,034 Common Shares, 1,249,904 Preferred
Shares and 606,452 Preferred Participation Certificates. Accordingly, we reissue our comment in part as it relates to the requested reconciliation.
Response: Below are rollforwards
of each class of equity security that reconcile amounts reported on our December 31, 2024 balance sheet to the amounts disclosed on page
105 of the Form F-4:
Rollforward of Preferred Shares and PPCs (Including
Par Value Impact)
Outstanding Shares page105 Rollforward
(From December 31, 2024 through August 15, 2025
- in USD)
Adjustment
Description
Preferred Shares
Preferred Participation Certificates
Par Value Impact (USD)
Balance as of 12/31/2024
–
206,452
$ 2,740,958
(C)
Issuance of Preferred Shares and PPCs in March and June 2025 financing rounds
1,249,904
568,278
64,168
(F)
Conversion of PPCs to Common Shares
–
(551,532 )
(18,229 )
(G)
Issuance of PPCs
–
360,000
11,898
(K)
Adjustment for par value reduction (CHF 0.80 → CHF 0.03) **
–
–
(2,734,135 )
Ending Balance as of August 15, 2025 (Pro Forma) prior to Treasury Shares *
1,249,904
583,198
–
Shares held in treasury under Swiss Law
23,254
64,661
Ending Balance as of August 15, 2025 (Pro Forma) and Page 105 per Form-F-4
1,249,904
606,452
$ 64,661
* Total per pro forma reflected as Preferred Shares is 1,833,102
which consists of the 1,249,904 Preferred Shares and the 583,198 Preferred Participation Certificates.
** Reduction of Par Value was approved by the Company's shareholders'
on January 15, 2025
Common Shares Rollforward (Number of Shares and
Par Value Impact)
Outstanding Shares page105 Rollforward
(From December 31, 2024 through August 15, 2025-
in USD)
Adjustment
Description
Number of Shares
Par Value Impact (USD)
Beginning balance as of 12/31/2024, per the financial statements included in Form 20-F
3,159,535
$ 166,353
(B)
Exercise of warrants
76,847
2,540
(A)
Subsequent issuance under December 2024 securities purchase agreement
161,290
5,331
(F)
Conversion of 551,532 PPCs
754,384
24,933
(K)
Adjustment for par value reduction (CHF 0.80 → CHF 0.03) **
–
(61,927 )
Ending Balance as of August 15, 2025 (Pro Forma) prior to Kadimastem share issuance
*
4,152,056
–
_
Shares held in treasury for future financing, per Swiss Law
755,978
–
Ending Balance Total as of August 15, 2025 per Commercial Register of Zurich under Swiss Law and Page 105 per Form-F-4
4,908,034
$ 1,879,046
* The total number of shares outstanding on a pro forma basis,
including the Kadimastem transaction, is 50,184,342. Deducting the 46,032,286 shares to be issued to Kadimastem shareholders upon completion
of the merger results in 4,152,056 shares, which reconciles to the pro forma ending balance as of August 15, 2025 noted above.
** Reduction of the Par Value was approved by the Company's
shareholders on January 14, 2025.
We intend to update the disclosure on page 105
of the Form F-4, prospectively, to conform the number of shares outstanding to the figures recorded in the Commercial Register of the
Canton of Zurich under Swiss law, with separate disclosure for Common Shares, Preferred Participation Certificates, and treasury shares.
2
2. As
a related matter, please provide an additional rollforward of each class of equity security for each of the last three fiscal years.
For illustration purposes, please differentiate your preferred shares from your preferred participating certificates. Ensure that any
stock splits and/or par value changes are adequately reflected. Please also explain why amounts reported in your financial statements
as of December 31, 2024 differ from those disclosed in Exhibit 2.1 to your Form 20-F for the year ended December 31, 2024. In this regard,
your balance sheet on page F-4 discloses 3,159,535 common shares and 206,452 preferred shares (preferred participating certificates)
outstanding as of December 31, 2024. By contrast, Exhibit 2.1 states that as of December 31, 2024 you had outstanding common
shares of 2,901,228, registered preferred shares of 598,539 and participation capital in the form of preferred participating certificates
of 1,014,365.
Response: The following table presents
a comprehensive rollforward of each class of equity security, the Preferred Shares, Preferred Participation Certificates (PPCs), and Common
Shares, for the last three fiscal years, with distinctions between Preferred Shares and PPCs, and adjustments for stock splits and par
value changes.
Rollforward
of Preferred Shares, Preferred Participation Certificates, and Common Shares
Year
/ Transaction
Preferred Shares
Amount (USD)
PPCs (Shares)
Amount (USD)
Common Shares
Amount (USD)
Balance, Jan 1, 2022
–
–
–
–
405,585
314,948
Issuance – Registered Direct Offering (net)
–
–
–
–
75,384
60,308
Issuance – ATM financing
–
–
–
–
–
440
Exercise of pre-funded warrants
–
–
–
–
–
23,692
Issuance – Private Placement (net)
–
–
–
–
266,842
218,838
Conversion of convertible notes payable
–
–
–
–
62,911
50,329
Balance, Dec 31, 2022
–
–
–
–
810,722
668,555
Balance, Dec 31, 2023
–
–
–
–
810,722
668,555
Issuance – Private Placement (net)
–
–
–
–
1,063,396
922,391
Issuance of Preferred Shares – Debt Assumption
806,452
708,969
–
–
–
–
Exchange of Preferred Shares for PPCs
(806,752 )
806,752
Conversion of PPCs into Common Shares
(600,000 )
(542,616 )
600,000
542,616
Issuance–Debt Conversion
–
–
–
–
493,986
434,273
Exercise of pre-funded warrants
–
–
–
–
191,431
173,123
Balance, Dec 31, 2024
–
708,969
206,452
(542,616 )
3,159,535
2,740,958
The Company combined the Preferred Shares and
Preferred Participation Certificates into a single class of preferred equity for purposes of the Form 20-F financial statements because
the economic values of the Preferred Shares and Preferred Participation Certificates are the same. This presentation differs from the
share classes disclosed in Exhibit 2.1, which separately lists Preferred Shares and Preferred Participation Certificates in order to provide
a complete description of the Company's securities as required by that exhibit.
As of December 31, 2024, under Swiss statutory
reporting requirements, the Company had a share capital of CHF 2,799,813.60 divided into 2,901,228 registered Common Shares with a nominal
value of CHF 0.80 each and 598,539 registered Preferred Shares with a nominal value of CHF 0.80 each. The Company also had a participation
capital of CHF 811,492.00 divided into 1,014,365 Preferred Participation Certificates with a nominal value of CHF 0.80 each.
3
On November 13, 2024, as disclosed in our Form
6-K filed November 15, 2024, the Company filed Amended and Restated Articles of Association with the commercial registry of the Canton
of Zurich, Switzerland, to reflect the following:
● Capital
increase of CHF 29,887.20 through the issuance of 37,359 registered Common Shares with a
nominal value of CHF 0.80 each.
● Conversion
of 598,539 registered Common Shares into 598,539 registered Preferred Shares with a nominal
value of CHF 0.80 each.
● Exchange
of 207,913 registered Common Shares and 806,452 registered Preferred Shares into 1,014,365
non-voting registered PPCs with a nominal value of CHF 0.80 each.
Following this transaction, there were no Preferred
Shares outstanding for U.S. GAAP purposes as of December 31, 2024. The Preferred Participation Certificate balance outstanding as of December
31, 2024 for U.S. GAAP purposes was 206,452, which excludes warehoused but unissued statutory shares that are treated as issued under
Swiss law, but not outstanding under U.S. GAAP.
As of the date of our Annual Report on Form 20-F
for the year ended December 31, 2024 (which includes Exhibit 2.1), and subsequent to year-end on January 7, 2025, the Company underwent
further changes to its capital structure, including capital increases and changes to the nominal value of its registered Common Shares,
registered Preferred Shares, and Preferred Participation Certificates. Following these subsequent changes, the Company's registered
share capital consisted of CHF 178,738.14, divided into 4,708,034 registered Common Shares with a nominal value of CHF 0.03 each and 1,249,904
registered Preferred Shares with a nominal value of CHF 0.03 each. In addition, the Company had participation capital of CHF 18,193.56,
divided into 606,452 Preferred Participation Certificates with a nominal value of CHF 0.03 each.
As noted in Response No. 1, the share count reflects
4,908,034 registered Common Shares, which includes the conversion of 200,000 Preferred Participation Certificates into Common Shares which
was recorded subsequent to December 31, 2024 per the Commercial Register of Zurich under Swiss Law.
We intend to include revisions in Amendment No.
7 to include a comprehensive rollforward of each class of equity security (Preferred Shares, Preferred Participation Certificates, and
Common Shares) for each of the last three fiscal years. The rollforward will clearly differentiate Preferred Shares from Preferred Participation
Certificates and reflect all relevant transactions, including stock splits and par value change.
3. In
your response to prior comment one, you assert that your preferred participation certificates (PPCs) are identical to your preferred
shares with the exception of voting rights and that therefore you treat your PPCs and preferred shares as a single class of equity for
presentation and disclosure purposes. This assertion appears contradictory to your footnote disclosure on page F-22 which states that
preferred shares do not have voting rights. Please advise and/or revise accordingly.
Response: We acknowledge the Staff's
comment and provide the following clarification to our previous response.
Under the Company's Articles of Association,
the Board of Directors has discretion, as determined contractually between the parties, to specify whether any issuance of Preferred Shares
will carry voting rights. The disclosure on page F-22 describes the rights of the Preferred Shares issued in October 2024, which, consistent
with the related securities purchase agreement, did not include voting rights. .As of December 31, 2024, all outstanding Preferred Shares
were those issued in the Preferred Shares transaction that occurred in October 2024, which, consistent with the related securities purchase
agreement, did not include voting rights.
4
Accordingly, at that date, the Preferred Shares
and the PPCs were substantially identical in their economic rights, including dividend entitlements, liquidation preferences, conversion
features, and other contractual provisions, including voting rights. The only difference is that PPCs do not, and cannot under the Company's
Articles of Association, have voting rights, whereas Preferred Shares may or may not have voting rights depending on the contractual terms
of issuance. However, as of December 31, 2024, all outstanding Preferred Shares did not contain voting rights; therefore the Preferred
Shares and PPCs had substantially identical economic rights.
On a prospective basis, the Company intends to
revise its disclosures to provide additional information regarding the number of and economic rights of Preferred Shares and PPCs, including
contractual terms with respect to dividends, voting rights, liquidation preferences, and conversion features.
4. In
addition, Article 3 of your Articles of Association specifically distinguishes between share capital and participation capital and this
categorization is carried throughout your prospectus. As such, it would appear that separate presentation and disclosure of your PPCs
would provide meaningful information to investors. Currently, your financial statements and related footnotes make no mention of PPCs,
which can be confusing to investors considering the totality of disclosure in your prospectus. Accordingly, please revise your financial
statements to separately present your PPCs, or at a minimum, quantify the composition of your preferred shares and PPCs in your financial
statement footnotes. Please also revise to disclose the pertinent rights and privileges of your PPCs as required by ASC 505-10-50-3.
Response: We acknowledge the Staff's
comment and agree that our Articles of Association distinguish between share capital and participation capital, with the latter consisting
of Preferred Participation Certificates. Under our Articles of Association and consistent with our Form 6-K filed November 15, 2024, Preferred
Participation Certificates are non-voting registered participation certificates and carry no voting rights. Preferred Shares, by contrast,
may or may not have voting rights depending on the contractual terms established at the time of issuance. For example, the Preferred Shares
issued in the Preferred Shares transaction that occurred in October 2024 did not include voting rights pursuant to the applicable securities
purchase agreements. Therefore, as of December 31, 2024, the Preferred Shares and PPCs had substantially identical economic rights.
As noted in ASC 505-10-50-3, the Company is required
to disclose the pertinent rights and privileges of each class of capital stock. The rights and privileges of Preferred Participation Certificates
only differ from those of Preferred Shares in that Preferred Participation Certificates carry no voting rights. All other rights (including
dividend rate, liquidation preference, and conversion features) are determined by the contractual terms in effect for a specific issuance.
This is similar to the distinction between authorized but unissued shares, where the underlying rights exist, but may not be applicable
until issuance under agreed terms.
In future filings, beginning with our next periodic report, we will revise our financial statements, within the equity section, and footnotes
to:
1. Separate Presentation – Present Preferred Participation
Certificates as a distinct line item within the equity section of the balance sheet, separate from Preferred Shares.
2. Quantification – Disclose the number of Preferred Shares
and Preferred Participati
2025-08-06 - UPLOAD - NewcelX Ltd. File: 333-284075
August 6, 2025
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Amendment No. 6 to Registration Statement on Form F-4
Filed July 29, 2025
File No. 333-284075
Dear Alexander Zwyer:
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 July 23, 2025 letter.
Amendment No. 6 to Registration Statement on Form F-4
Record Date; Outstanding Shares; Shareholders Entitled to Vote, page 105
1.In prior comment one we requested a rollforward of each class of equity security that
reconciles amounts reported on your December 31, 2024 balance sheet to the amounts
disclosed on page 105. While the rollforward provided in Appendix 1 to your
response reconciles to your pro forma balance sheet on page 270, it does not reconcile
to amounts disclosed on page 105. In this regard, your disclosure on page 105 states
that as of the date of this prospectus, NLS outstanding share capital consisted of
4,908,034 Common Shares, 1,249,904 Preferred Shares and 606,452 Preferred
Participation Certificates. Accordingly, we reissue our comment in part as it relates to
the requested reconciliation.
August 6, 2025
Page 2
2.As a related matter, please provide an additional rollforward of each class of equity
security for each of the last three fiscal years. For illustration purposes, please
differentiate your preferred shares from your preferred participating certificates.
Ensure that any stock splits and/or par value changes are adequately reflected. Please
also explain why amounts reported in your financial statements as of December 31,
2024 differ from those disclosed in Exhibit 2.1 to your Form 20-F for the year ended
December 31, 2024. In this regard, your balance sheet on page F-4 discloses
3,159,535 common shares and 206,452 preferred shares (preferred participating
certificates) outstanding as of December 31, 2024. By contrast, Exhibit 2.1 states that
as of December 31, 2024 you had outstanding common shares of 2,901,228, registered
preferred shares of 598,539 and participation capital in the form of preferred
participating certificates of 1,014,365.
3.In your response to prior comment one, you assert that your preferred participation
certificates (PPCs) are identical to your preferred shares with the exception of voting
rights and that therefore you treat your PPCs and preferred shares as a single class of
equity for presentation and disclosure purposes. This assertion appears contradictory
to your footnote disclosure on page F-22 which states that preferred shares do not
have voting rights. Please advise and/or revise accordingly.
4.In addition, Article 3 of your Articles of Association specifically distinguishes
between share capital and participation capital and this categorization is carried
throughout your prospectus. As such, it would appear that separate presentation and
disclosure of your PPCs would provide meaningful information to investors.
Currently, your financial statements and related footnotes make no mention of PPCs,
which can be confusing to investors considering the totality of disclosure in your
prospectus. Accordingly, please revise your financial statements to separately present
your PPCs, or at a minimum, quantify the composition of your preferred shares and
PPCs in your financial statement footnotes. Please also revise to disclose the pertinent
rights and privileges of your PPCs as required by ASC 505-10-50-3.
5.Please address the following regarding your response to prior comment one as it
relates to treasury shares:
•You indicate that that while shares held by the company are considered issued and
outstanding as treasury shares under Swiss law, they are not considered treasury
shares under ASC 505-30 as they have not been transferred to external parties.
Please cite the authoritative guidance you relied upon in determining that shares
must first be transferred to external parties before being repurchased in order to
qualify as treasury stock under US GAAP.
•Please explain your consideration of ASC 505-30-25-2 as it relates to Swiss
corporate law and the related statutory accounting.
•Please explain why these shares were previously classified as treasury shares in
your Form 20-F for the year ended December 31, 2023 and prior periods and what
precipitated a change in classification during the current fiscal year. Clarify
whether the change was the result of an error in prior period financial statements
and if so, please revise to provide the disclosures required by ASC 250-10-50.
August 6, 2025
Page 3
NLS Pharmaceutics Ltd. and Subsidiaries
Consolidated Balance Sheets, page F-4
6.We note your response to prior comment seven. We could find no justification for
correcting this error via an adjustment to your pro forma financial statements rather
than by correcting the amounts presented in your historical financial statements. In
this regard, it is unclear how you concluded that this error was not material to the
preferred and common shares line items on your Balance Sheet. Further, the amounts
reported on your Balance Sheet differ from the corresponding amounts reported on
your Statement of Changes in Equity. Accordingly, please revise your historical
Balance Sheet to correct these line items.
7.Similarly, it is unclear to us why you have reflected the January 2025 reduction in par
value from $0.80 to $0.03 as a pro forma adjustment rather than giving retroactive
effect in your historical financial statements as required by SAB Topic 4.C. Please
advise or revise accordingly.
Notes to the Consolidated Financial Statements
Note 13 - Subsequent Events, page F-28
8.We note your response to prior comment eight and that you believe that further
updates to your Subsequent Event footnote are not required pursuant to ASC
855. Please confirm whether your auditors performed the subsequent event procedures
set forth in PCAOB Auditing Standards 4101 and 2801 when updating their consent
through July 29, 2025 and whether they concur with your conclusion that disclosure
of additional subsequent events is not warranted.
Please contact Eric Atallah at 202-551-3663 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please contact Doris Gama at 202-551-3188 or Alan Campbell at 202-551-4224 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ron Ben-Bassat, Esq.
2025-07-29 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
July 29, 2025
Via EDGAR
Angela Connell
Doris Stacey Gama
Alan Campbell
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re:
NLS Pharmaceutics Ltd. (the
“Company,” “we,” “our” and similar terminology)
Amendment No. 5 to Registration Statement on Form F-4
Filed June 9, 2025
File No. 333-284075
Ladies and Gentlemen:
The purpose of this letter is to respond to the
comment letter of July 23, 2025, received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission regarding
the above-mentioned Amendment No. 5 to the Registration Statement on Form F-3. For your convenience, your original comments appear in
bold text, followed by our response. We are concurrently filing Amendment No. 6 to the Registration Statement on Form F-4 (“Amendment
No. 6”).
Page references in our responses are to Amendment
No. 6. Unless otherwise stated, any defined terms in Amendment No. 6 apply within this letter.
Amendment No. 5 to Registration Statement
on Form F-4
Extraordinary Shareholder Meeting of NLS
Record Date; Outstanding Shares; Shareholders
Entitled to Vote, page 105
1. Please provide us with a rollforward
of each class of equity security that reconciles amounts reported herein to those reported
on your December 31, 2024 Consolidated Balance Sheet. Please also address the following:
● Your
disclosure indicates that you hold a certain amount of each equity class as Treasury shares.
However, you do not present Treasury shares on the face of your financial statements. Please
advise or revise accordingly.
●Your
disclosure indicates that you have issued 606,452 Preferred Participation Certificates (PPCs)
as of the date of this prospectus. Please describe the significant terms of these securities
and clarify when they were issued. To the extent that you had issued and outstanding PPCs
as of December 31, 2024, please revise your financial statements to disclose your accounting
policy for these
securities and clarify where they are presented in your financial statements.
●Ensure
that all equity issuances subsequent to December 31, 2024 are properly
reflected in both your pro forma financial statements and subsequent events
footnote.
Response: In response to the Staff’s
comment, we refer the Staff to Appendix 1 attached hereto for the requested rollforward schedules which reconcile the amounts reported
on the unaudited pro forma condensed combined balance sheet contained on page 269 of Amendment No. 6 to those reported on the
consolidated balance sheet of the Company as of December 31, 2024. We further provide the following in response to the Staff’s
comment:
●Under the Swiss company law, treasury shares are defined as shares
that have been issued and are held by the company itself, and thus are not considered outstanding. Although they may sometimes be informally
referred to as “reserve shares,” these are not merely authorized but unissued shares—they are legally existing shares
held by the company, as governed by Articles 659 to 659c of the Swiss Code of Obligations (the “CO”) Under Swiss statutory
accounting, treasury shares are presented as a separate line item within shareholders’ equity on the face of the balance sheet,
in accordance with Article 959a(2)(3)(e) CO, and must be disclosed for legal and corporate governance purposes, whether they are held
for cancellation, resale, or future financing activities. However, for U.S. GAAP purposes, these shares identified as “treasury
shares” under Swiss law and are not considered issued and outstanding, as they have not yet been transferred to external parties
such as investors or employees.
Therefore, we respectfully advise that
such shares are not required to be presented separately on the face of the balance sheet under ASC 505-30 (Treasury Stock), because these
shares are not held by the Company after having been issued. Instead, these shares are part of the authorized but unissued share capital
and are appropriately excluded from the share count and equity presentation under U.S. GAAP.
Accordingly, as the “treasury
shares” referred to in our disclosure are shares authorized under Swiss law but not yet issued for accounting purposes under U.S.
GAAP, they are not included in the NLS Common Shares issued and outstanding, nor presented separately on the face of the Company’s
financial statements.
●On November 8, 2024, the Company issued 1,014,365 Preferred Participation
Certificates (“PPCs”). That number was reduced on January 7, 2025 to 606,452 PPCs. The par value is CHF 0.03 per PPC.
The PPCs were created at the request of our lead investor in 2024 to
have holdings with economic rights that are identical to NLS Preferred Shares, including conversion terms, dividend rights, and liquidation
preferences, but without voting rights both from a Swiss corporate law perspective and contractually. In contrast to our NLS Preferred
Shares which bear voting rights unless contractually removed. Legally, PPCs are issued by the Company and constitute statutory equity
in accordance with Swiss Code of Obligations. However, the conversion feature is, as for the NLS Preferred Shares, contractually agreed.
For accounting purposes, under ASC 480 and ASC 505, PPCs and NLS Preferred Shares are treated as a single class of equity, given their
identical economics and conversion mechanics. We respectfully note that since PPCs and Preferred Shares have identical economic and accounting
characteristics, and since conversion into NLS Common Shares is treated identically under the terms of both NLS Preferred Shares and PPCs,
we believe the accounting presentation is appropriate.
●We acknowledge the Staff’s comment and confirm that the Company
has properly reflected its equity issuances subsequent to December 31, 2024 in all material respects in both the pro forma financial statements
and the subsequent events footnote in its financial statements for the year ended December 31, 2024, where applicable. Specifically,
two equity issuances occurred prior to the filing of the Company’s annual report on Form 20-F dated May 16, 2025 (the “Annual
Report”), and are disclosed in both the pro forma financial statements and the subsequent events footnote: (1) the issuance dated
January 8, 2025, pursuant to the Securities Purchase Agreement dated December 4, 2024, and (2) the issuance dated March 28, 2025, pursuant
to the first closing of the Securities Purchase Agreement dated March 27, 2025. A third issuance, completed on June 27, 2025, was included
in the pro forma financial statements but was not included in the subsequent events footnote, as it occurred after the filing of the Annual
Report. This treatment is consistent with the requirements of IAS 10 and ASC 855, which require subsequent event disclosure only for events
that occur before the financial statements are available for issuance. The Company believes, based on the relevant accounting guidance
and the facts available as of the date of the Annual Report, that the disclosure was appropriate in all material respects and no further
adjustments or changes are required.
2
Approval of Par Value Reduction, Reverse
Split, and Ordinary Share..., page 109
2. We note that your shareholders will
be asked to approve a reverse split of the issued and outstanding NLS Common Shares within
a range of two-for-one (2:1) to twenty-for-one (20:1) and that a table is provided on page
110 reflecting different reverse split assumptions. We also note your table includes a twenty-five-for-one
scenario (25:1). Given that twenty-five-for-one (25:1) is out of the range being voted on
please remove this assumption or otherwise advise.
Response: In response to the Staff’s
comment, we have revised the disclosure on page 110 of Amendment No. 6 to remove the twenty-five-for-one (25:1) assumption.
Unaudited Pro Forma Condensed Combined
Financial Statements
Notes to accompanying Financial Statements
Pro Forma Adjustments, page 272
3. Please
explain how the share amounts included in adjustment (C) were calculated. In this regard,
you disclose that you received net proceeds of $2,875,000 in connection
with the issuance of 1,249,904
preferred shares, 568,278 PPCs and warrants to purchase 1,181,818 common shares of NLS. It
is unclear how these amounts equate to the preferred shares par value adjustment of 64,168
presented on page 269.
Response: In response to the Staff’s
comment, adjustment (C) reflects the aggregate par value of equity instruments issued in two financing transactions pursuant to the first
and second closings of the Securities Purchase Agreement dated March 27, 2025 between the Company and certain investors (the “March
2025 SPA”). The financings under the first and second closings were completed on March 28, 2025 and June 26, 2025, respectively.
These instruments included NLS Preferred Shares and PPCs, each with a par value of CHF 0.03, and warrants to purchase NLS Common Shares
with an exercise price of $1.80 per share. The calculation of the par value for these transactions is as follows:
●On
March 28, 2025, the Company issued 1,212,121 NLS Preferred Shares, translated at the USD/CHF exchange rate of 1.134.
●On June 27, 2025, the Company issued a total of 606,061 equity instruments,
consisting of 37,783 NLS Preferred Shares, and 568,278 PPCs. This issuance was translated using the USD/CHF rate of 1.2613.
The
par value adjustment is calculated as follows:
(1,212,122×0.03×1.134)+(37,783×0.03×1.2613)+(568,278×0.03×1.2613)
= 64,169.
We also acknowledge that the original pro forma adjustment (C) did
not reflect the full breakdown between PPCs and NLS Preferred Shares issued in the March 2025 and June 2025 financings under the March
2025 SPA. In response to the Staff’s comment, we revised adjustment (C) of the pro forma adjustments on page 273 of Amendment No.
6 to provide a more detailed breakdown of the two financings under the March 2025 SPA.
4. As it relates to adjustments (F)
and (G), please revise to specify the dates of these transactions. As it relates specifically
to adjustment (F), you disclose that 551,532 PPCs were converted into 754,384 common shares,
which implies that such PPCs were reflected in your preferred share balance as of December
31, 2024. As previously requested, please revise your financial statements and relevant disclosures
throughout to disclose the significant terms of your PPCs, your accounting policy for such
securities and where they are classified in your financial statements. Please also tell us
your consideration of presenting PPCs separately from your preferred stock.
Response: In response to the Staff’s
comment, adjustment (F) reflects the conversion of 551,532 PPCs into 754,384 NLS Common Shares, which occurred on the following dates:
●January 28, 2025 – 50,000 NLS Common Shares were issued pursuant
to the conversion of 31,250 PPCs.
●January 31, 2025 – 150,000 NLS Common Shares were issued pursuant
to the conversion of 93,750 PPCs.
●May 20, 2025 – 200,000 NLS Common Shares were issued pursuant
to the conversion of 66,532 PPCs.
●June 23, 2025 – 354,384 NLS Common Shares were issued pursuant
to the conversion of 360,000 PPCs.
We confirm that the 551,532 PPCs converted into 754,384 NLS Common
Shares were reflected in the NLS Preferred Share balance as of December 31, 2024 – please refer to Appendix 1. As of December 31,
2024, the NLS Preferred Shares were contractually non-voting, therefore, we believe our financial statements, relevant disclosures throughout
and accounting policy for such securities are accurately reflected.
3
As previously disclosed, PPCs are economically
and contractually equivalent to NLS Preferred Shares, with the sole distinction being that PPCs are non-voting, a structural feature
specifically requested by the lead investor at the time of their creation in 2024. PPCs share the same liquidation preference, conversion
ratio, and other rights as NLS Preferred Shares, and they can be issued interchangeably depending on share availability in treasury or
as approved by shareholders.
Accordingly, we do not consider it necessary to present PPCs as a separate
class of equity or revise our accounting policy, as both PPCs and NLS Preferred Shares are treated identically for classification purposes
under ASC 505. However, in response to the Staff’s comment, we revised the disclosure on page 303 to provide additional clarity
on the significant terms of the PPCs.
5. As it relates to adjustment (K),
we note that this adjustment reflects the reduction in par value of your equity securities
from CHF 0.80 to CFH 0.03 effective January 17, 2025. Please explain why you have not provided
additional adjustments for the further reduction in par value to CFH 0.003 and the reverse
share split which are being voted on at your upcoming shareholders' meeting. In this regard,
disclosure throughout your prospectus indicates that the par value reduction and reverse
share split are necessary to meet the Nasdaq initial listing requirement, which is a closing
condition of the Merger Agreement.
Response:
In response to the Staff’s comment, with respect to the anticipated
reverse share split and subsequent par value adjustment, we note that under Swiss corporate law, a reverse share split automatically
results in an increase in the nominal (par) value per share, as the number of outstanding shares is reduced while the stated capital
remains unchanged. As a result, the par value will temporarily increase upon the reverse split.
To align with Nasdaq initial listing requirements, we are proposing
a reverse share split in combination with a simultaneous shareholder resolution to reduce the par value back to its current value (under
an assumption of a 1:10 reverse share split, which we anticipate to be the determined split ratio based on the current share market price
of the NLS Common Shares), which requires a separate shareholder vote. This two-step process—reduction of par value followed by
a reverse split —is mandated by Swiss law and cannot be implemented as a single action.
Be
2025-07-23 - UPLOAD - NewcelX Ltd. File: 333-284075
July 23, 2025
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Amendment No. 5 to Registration Statement on Form F-4
Filed July 18, 2025
File No. 333-284075
Dear Alexander Zwyer:
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.
Amendment No. 5 to Registration Statement on Form F-4
Extraordinary Shareholder Meeting of NLS
Record Date; Outstanding Shares; Shareholders Entitled to Vote, page 105
Please provide us with a rollforward of each class of equity security that reconciles
amounts reported herein to those reported on your December 31, 2024 Consolidated
Balance Sheet. Please also address the following:
•Your disclosure indicates that you hold a certain amount of each equity class as
Treasury shares. However, you do not present Treasury shares on the face of your
financial statements. Please advise or revise accordingly.
Your disclosure indicates that you have issued 606,452 Preferred Participation
Certificates (PPCs) as of the date of this prospectus. Please describe the
significant terms of these securities and clarify when they were issued. To the
extent that you had issued and outstanding PPCs as of December 31, 2024, please •1.
July 23, 2025
Page 2
revise your financial statements to disclose your accounting policy for these
securities and clarify where they are presented in your financial statements.
•Ensure that all equity issuances subsequent to December 31, 2024 are properly
reflected in both your pro forma financial statements and subsequent events
footnote.
Approval of Par Value Reduction, Reverse Split, and Ordinary Share..., page 109
2.We note that your shareholders will be asked to approve a reverse split of the issued
and outstanding NLS Common Shares within a range of two-for-one (2:1) to twenty-
for-one (20:1) and that a table is provided on page 110 reflecting different reverse
split assumptions. We also note your table includes a twenty-five-for-one scenario
(25:1). Given that twenty-five-for-one (25:1) is out of the range being voted on please
remove this assumption or otherwise advise.
Unaudited Pro Forma Condensed Combined Financial Statements
Notes to accompanying Financial Statements
2. Pro Forma Adjustments, page 272
3.Please explain how the share amounts included in adjustment (C) were calculated. In
this regard, you disclose that you received net proceeds of $2,875,000 in connection
with the issuance of 1,249,904 preferred shares, 568,278 PPCs and warrants to
purchase 1,181,818 common shares of NLS. It is unclear how these amounts equate to
the preferred shares par value adjustment of 64,168 presented on page 269.
4.As it relates to adjustments (F) and (G), please revise to specify the dates of these
transactions. As it relates specifically to adjustment (F), you disclose that 551,532
PPCs were converted into 754,384 common shares, which implies that such PPCs
were reflected in your preferred share balance as of December 31, 2024. As
previously requested, please revise your financial statements and relevant disclosures
throughout to disclose the significant terms of your PPCs, your accounting policy for
such securities and where they are classified in your financial statements. Please also
tell us your consideration of presenting PPCs separately from your preferred stock.
5.As it relates to adjustment (K), we note that this adjustment reflects the reduction in
par value of your equity securities from CHF 0.80 to CFH 0.03 effective January 17,
2025. Please explain why you have not provided additional adjustments for the further
reduction in par value to CFH 0.003 and the reverse share split which are being voted
on at your upcoming shareholders' meeting. In this regard, disclosure throughout your
prospectus indicates that the par value reduction and reverse share split are necessary
to meet the Nasdaq initial listing requirement, which is a closing condition of the
Merger Agreement.
6.We note disclosure throughout your prospectus of additional financing investments of
approximately $2.5 million to be raised prior to the closing date of the merger. Please
clarify whether this additional financing is a condition of closing, and if so, your
consideration of giving pro forma effect to this additional financing. Refer to Section
3240.13 of the Division's Financial Reporting Manual and Article 11-01(a)(8) of
Regulation S-X.
July 23, 2025
Page 3
NLS Pharmaceutics Ltd. and Subsidaries
Consolidated Balance Sheets, page F-4
7.The amounts reported on the face of your balance sheet as the par value of your
preferred and common shares as of December 31, 2024 appear to have been
transposed as compared to your Statement of Changes in Equity. Please revise to
address this inconsistency.
Notes to the Consolidated Financial Statements
Notes 13 - Subsequent Events, page F-28
8.Your disclosure on page 272 makes reference to a second closing of a securities
purchase agreement entered into with three accredited investors in June 2025 (the
June 2025 SPA). Please revise your subsequent event disclosure to disclose the
material terms of this transaction, as well as any other significant debt or equity
transactions that have occurred subsequent to December 31, 2024.
Please contact Angela Connell at 202-551-3426 if you have questions regarding
comments on the financial statements and related matters. Please contact Doris Stacey Gama
at 202-551-3188 or Alan Campbell at 202-551-4224 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ron Ben-Bassat, Esq.
2025-06-23 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
June 23, 2025
Via EDGAR
Eric Atallah
Angela Connell
Doris Stacey Gama
Alan Campbell
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re:
NLS Pharmaceutics Ltd. (the “Company,” “we,” “our” and similar terminology)
Amendment No. 3 to Registration Statement on Form F-4
Filed June 9, 2025
File No. 333-284075
Ladies and Gentleman:
The purpose of this letter is to respond to the
comment letter of June 18, 2025, received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission regarding
the above-mentioned Amendment No. 3 to the Registration Statement on Form F-3. For your convenience, your original comments appear in
bold text, followed by our response. We are concurrently filing Amendment No. 4 to the Registration Statement on Form F-4 (“Amendment
No. 4”).
Page references in our responses are to Amendment
No. 4. Unless otherwise stated, any defined terms in Amendment No. 4 apply within this letter.
Amendment No. 3 to Registration Statement on Form F-4 submitted
June 9, 2025
Kadimastem Business
Kadimastem Overview, page 199
1. We note your reference to NCT0348205010. To the extent this is intended to be a reference to NCT03482050,
please revise your disclosure accordingly. Alternatively, please advise.
We further note your statements that
transplantation of AstroRx cells enhances treatment and slows disease progression. Please revise to clarify, if true, that there was no
placebo component in the trial in which AstroRx was evaluated, that the trial was not designed to evaluate efficacy and that it is possible
that effects observed in this trial will not be demonstrated in larger clinical trials in the future.
Response: In response to the Staff’s
comment, we have revised the disclosure on page 199 of Amendment No. 4 to remove the statements referred to above regarding transplantation
of AstroRx cells.
Encap-IsletRx, page 211
2. We note your response to prior comment 3 and reissue. Given that you have yet to conduct studies demonstrating
the efficacy of this product candidate and delivery strategy, please remove references to “efficacy” in the title of your figure
on page 212 labeled “Encap-IsletRx Preclinical Efficacy.”
Response: In response to the Staff’s
comment, we have removed references to “efficacy” in the title of our figure previously on page 212 to now be labeled “Encap-IsletRx
Preclinical Function” on page 211 of Amendment No. 4.
Key Commercial Agreements, page 212
3. We note Kadimastem entered into a collaboration agreement with Pluri, Inc. for clinical manufacturing
of Kadimastem’s product. Please expand the discussion to describe all material terms of the agreement, including a description of each
party’s rights and obligations and a summary of the term and termination provisions.
Response: In response to the Staff’s
comment, we have revised the disclosure discussing Kadimastem’s collaboration agreement with Pluri, Inc. on page 215 of Amendment
No. 4.
Unaudited Pro Forma Condensed Combined Financial Statements
Note 2 - Pro Forma Adjustments, page 268
4. Refer to adjustment (O). We note that you have a pro forma adjustment for approximately $15.5 million
for “Intangible assets – primarily implied R&D.” Please explain what you mean by implied R&D and explain how
the value was determined. Cite any authoritative literature upon which you relied.
Response: In response to the Staff’s
comment, the description in both the pro forma balance sheet and related footnote has been updated to read: “Intangible assets –
In-Process R&D and Goodwill” to reflect the preliminary nature of the estimate and to enhance clarity.
The preliminary allocation of the purchase price
in the unaudited pro forma condensed combined financial statements reflects management’s current estimates based on information
available to date. A significant portion of the total consideration has been preliminarily allocated to in-process research and development
(“IPR&D”) and goodwill, in accordance with International Financial Reporting Standards (“IFRS”) 3, Business
Combinations, which requires recognition of identifiable intangible assets and goodwill at their acquisition-date fair values.
The reference to “Implied R&D”
in Adjustment (O) reflects the portion of the total consideration preliminarily allocated to identifiable intangible assets associated
with IPR&D. Under IFRS 3 (paragraphs 10–13), intangible assets acquired in a business combination—including development-stage
R&D projects—must be recognized separately from goodwill if they meet the definition of an intangible asset and are identifiable.
This applies regardless of whether the acquiree has previously capitalized such expenditures or whether the assets have alternative future
use. Subsequent accounting for such assets is governed by International Accounting Standards (“IAS”) 38, Intangible Assets,
which permits capitalization only if the relevant recognition criteria are met post-acquisition.
The Company’s preliminary allocation of the purchase prices was
as follows:
Amount
Purchase price consideration
$ 19,450,683
Total consideration
$ 19,450,683
Assets acquired:
Cash
$ 4,219,094
Prepayments and other current assets
560,157
Property and equipment
7,290
Intangible assets-primarily In-process R&D
(IPR&D) & Goodwill
15,490,906
Total assets acquired
20,277,447
Liabilities assumed:
Accounts payable and accrued liabilities and other
$ 826,764
Total liabilities assumed
826,764
Estimated fair value of net assets
acquired
$ 19,450,683
2
As part of the analysis to determine whether the transaction represents the acquisition of a business under IFRS 3, Business Combinations,
management considered the following factors:
a) The acquisition of the DOXA program, an active IPR&D platform with multiple potential commercial applications
across various disease areas, which is expected to generate future economic benefits. The program is supported by a robust patent portfolio
based on the Oroxin-1 and Oroxin-2 compounds;
b) The retention of key personnel post-transaction, including the current Chief Scientific Officer (CSO),
who will continue leading the DOXA program as Head of DOXA, and the current Chief Executive Officer (CEO), who will remain involved as
a director, overseeing the Contingent Value Rights (CVR) efforts and assisting with the development of the DOXA program;
c) The existence of an organized workforce and ongoing preclinical development activities led by the CEO
and CSO, supported by a network of independent Contract Research Organizations (CROs) conducting trials in France, with operations expected
to continue post-merger; and
d) The reference to comparable transactions involving early-stage biotechnology R&D assets—such
as those by Harmony Biosciences, Jazz Pharmaceuticals, and Sumitomo Pharma—that were accounted for as business combinations and
have led to successful commercialization of similar assets.
Further, minimal value has been assigned to non-core
legacy R&D assets subject to the CVR agreement, as previously discussed in our correspondence with the Staff dated June 9, 2025. These
assets are not intended to be integrated into the combined company’s operations. If a sale is not achieved, the Company does not
intend to pursue further internal development. Due to the uncertainty surrounding any future sale and the remote likelihood of contingent
proceeds, these assets and any related potential distributions have not been included in the preliminary purchase price allocation.
As a formal third-party valuation has not yet been completed, the preliminary estimate of $15.5 million was derived from management’s
assessment of currently available information. Upon finalization of the purchase price allocation, any portion of the consideration not
attributable to identifiable net assets—including IPR&D—will be allocated to goodwill in accordance with IFRS 3 (paragraphs
32–34). For purposes of this pro forma presentation, the Company has aggregated indefinite-lived intangible assets, and goodwill
as distinguishing between them does not impact the current presentation.
5. As a related matter, we note on the face of your pro forma balance sheet this adjustment has been referred
to as goodwill rather than Intangible assets – primarily implied R&D. Please advise us or revise your filing accordingly.
Response: In response to the Staff’s
comment, we have revised the presentation of the pro forma balance to be consistent with related footnote and the above noted changes
to both to read: “Intangible assets- In-Process R&D and Goodwill.”
If you have any questions or require additional information, please contact our attorneys Ron Ben-Bassat, Esq. at (212) 660-5003 or Oded
Har-Even, Esq. at (212) 660-5002, each of Sullivan & Worcester LLP.
Sincerely,
NLS Pharmaceutics LTD.
By:
/s/ Alexander
Zwyer
Chief Executive Officer
3
2025-06-18 - UPLOAD - NewcelX Ltd. File: 333-284075
June 18, 2025
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Amendment No. 3 to Registration Statement on Form F-4
Filed June 9, 2025
File No. 333-284075
Dear Alexander Zwyer:
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 April 15, 2025 letter.
Amendment No. 3 to Registration Statement on Form F-4
Kadimastem Business
Kadimastem Overview, page 199
1.We note your reference to NCT0348205010. To the extent this is intended to be a
reference to NCT03482050, please revise your disclosure accordingly. Alternatively,
please advise.
We further note your statements that transplantation of AstroRx cells enhances
treatment and slows disease progression. Please revise to clarify, if true, that there was
no placebo component in the trial in which AstroRx was evaluated, that the trial was
not designed to evaluate efficacy and that is it is possible that effects observed in this
trial will not be demonstrated in larger clinical trials in the future.
June 18, 2025
Page 2
Encap-IsletRx, page 211
2.We note your response to prior comment 3 and reissue. Given that you have yet to
conduct studies demonstrating the efficacy of this product candidate and delivery
strategy, please remove references to "efficacy" in the title of your figure on page
212 labeled "Encap-IsletRx Preclinical Efficacy."
Key Commercial Agreements, page 212
3.We note Kadimastem entered into a collaboration agreement with Pluir, Inc. for
clinical manufacturing of Kadimastem's product. Please expand the discussion to
describe all material terms of the agreement, including a description of each party's
rights and obligations and a summary of the term and termination provisions.
Unaudited Pro Forma Condensed Combined Financial Statements
Note 2 - Pro Forma Adjustments, page 268
4.Refer to adjustment (O). We note that you have a pro forma adjustment for
approximately $15.5 million for “Intangible assets – primarily implied R&D.” Please
explain what you mean by implied R&D and explain how the value was
determined. Cite any authoritative literature upon which you relied.
5.As a related matter, we note on the face of your pro forma balance sheet this
adjustment has been referred to as goodwill rather than Intangible assets – primarily
implied R&D. Please advise us or revise your filing accordingly.
Please contact Eric Atallah at 202-551-3663 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please contact Doris Stacey Gama at 202-551-3188 or Alan Campbell at 202-551-
4224 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ron Ben-Bassat, Esq.
2025-06-09 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS
PHARMACEUTICS ltd.
The Circle 6
8058 Zurich, Switzerland
June 6, 2025
Via EDGAR
Eric Atallah
Angela Connell
Doris Stacey Gama
Alan Campbell
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re:
NLS Pharmaceutics Ltd.
Amendment No. 2 Registration Statement on Form F-4
Filed March 31, 2025
File No. 333-284075
Dear Sirs and Madams,
The purpose of this letter is to respond to the
comment letter of April 15, 2025, received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission regarding
the above-mentioned Registration Statement on Form F-4. For your convenience, your original comments appear in bold text, followed by
the responses of NLS Pharmaceutics Ltd. (the “Company,” “we,” “our” and similar terminology). We are
concurrently filing Amendment No. 3 to the Registration Statement on Form F-4 (“Amendment No. 3”).
Page references in our responses are to Amendment
No. 3. Unless otherwise stated, any defined terms in Amendment No. 3 apply within this letter.
Amendment No. 1 to Registration Statement
on Form F-4
Kadimastem Overview, page 133
1. In your response to prior comment 9 your revised disclosure states that you have observed, based on
your data, that the transplantation of your mature cells enhances treatment. You then proceed to discuss results from NCT04786262 which
appears to be a trial conducted by Vertex Pharmaceuticals which is ongoing. Please tell us why it is appropriate for you to describe another
company's clinical data in support of claims that are related to your product candidates. Please note that we may have further comment
after reviewing your response. Alternatively, please remove this disclosure. You may state, if true, that clinical trials of other product
candidates by other companies have shown that the transplantation of mature cells may enhance treatment, but that you have yet to observe
this effect in a clinical trial that you have conducted or sponsored.
Response: In response to the Staff’s
comment, we have revised the disclosure on page 200 of Amendment No. 3 to remove the disclosure regarding results from NCT04786262.
Kadimastem’s Solutions, page 135
2. We note your response to prior comment 10. Please also briefly describe the peer review papers listed
supporting your claims.
Response: In response to the Staff’s
comment, we have revised the disclosure beginning on page 201 of Amendment No. 3.
Encap-IsletRx, page 145
3. Given that you have yet to conduct studies demonstrating the efficacy of this product candidate and
delivery strategy, please remove references to "efficacy" in your figure on page 145 labeled Encap-IsletRx Preclinical Efficacy.
Response: In response to the Staff’s
comment, we have revised the disclosure beginning on page 212 of Amendment No. 3 to remove references to efficacy.
Unaudited Pro Forma Condensed Combined Financial Statements
Unaudited Pro Forma Condensed Combined Balance Sheets, page 193
4. We note the pro forma adjustment columns at the top of page 194 are labeled “NLS” and “Kadimastem”,
rather than “Pre-Merger Transaction Accounting Adjustments” and “Transaction Accounting Adjustments”. Please revise
to present consistently labeled column headings in your pro forma balance sheets.
Response: In response to the Staff’s
comment, we have revised the disclosure in Amendment No. 3 on page 264 of Amendment No. 3 to present the column headings consistently.
Unaudited Pro Forma Condensed Combined Statement
of Operations and Other
Comprehensive Loss, page 195
5. We note from your revised disclosures in response to prior comment 21 that Kadimastem conducted a reverse
share split at a 10-for-1 ratio on March 21, 2024. Please explain why the split is not disclosed as a subsequent event and why EPS has
not been retrospectively adjusted in Kadimastem’s financial statements. Refer to paragraph 22(f) of IAS 10 and paragraphs 26, 27
and 64 of IAS 33.
Response: We respectfully advise the Staff
that we have updated the Unaudited Pro Forma Condensed Combined Financial Statements and Kadimastem’s financial statements dated
as of December 31, 2024 to reflect the reverse share split. See Note (ii) to the Unaudited Pro Forma Condensed Combined Financial Statements
on page 266, and Note 18.K. to Kadimastem’s financial statements dated as of December 31, 2024 on page G-36 of Amendment No.
3.
Note 5 - Estimated Purchase Price Consideration,
page 201
6. We note your response to prior comment 25. Given that the CVRs appear to be an obligation of the combined
company and were executed pursuant to the terms of the merger agreement, it is unclear why the CVRs have not been reflected in your pro
forma financial statements. To the extent the fair value of such CVRs is currently not estimable or material, please consider providing
narrative disclosure in the footnotes to your pro forma financial statements describing the terms of the CVRs and the potential impact
on future operations.
Response: In response to the Staff’s
comment, we have revised the disclosure on page 271 of Amendment No. 3. We respectfully advise the Staff that the Agreement and Plan
of Merger, dated November 4, 2024, between the Company, Kadimastem and NLS Pharmaceutics (Israel) Ltd., as amended on January 30,
2025, February 17, 2025, May 5, 2025 and June 5, 2025 (the “Merger Agreement”) provides that upon the terms and subject to
the conditions thereof, following the closing of the merger, NLS shall work diligently to dispose of any intellectual property, assets,
rights, contracts, agreements, leases, arrangements (regardless of form), approvals, licenses, permits, whether current or future, whether
or not contingent, of NLS and its subsidiaries related solely to any product candidate of NLS and its subsidiaries, other than NLS’s
Dual Orexin Agonist, or DOXA, platform (the “Legacy Assets”). Therefore, these assets are not intended for use in the combined
company’s future operations. It is further expected that the proceeds from any sale or disposition of all or any part of the Legacy
Assets will be distributed to the shareholders and warrant holders of NLS as of immediately prior to the Effective Time pursuant to the
terms and conditions of the CVR Agreement. If a sale is not achieved, the Company does not intend to further develop these assets internally.
Due to the uncertainty surrounding the realization of any sale, the likelihood of contingent proceeds is considered remote and of minimal
value. Accordingly, these legacy assets and any related contingent distribution have not been recognized in the preliminary valuation.
2
General
7. Please revise your preliminary proxy card to reflect all of the proposals being presented to shareholders.
Response: In response to the Staff’s
comment, we have revised the preliminary proxy card.
If you have any questions or require additional
information, please contact our attorneys Ron Ben-Bassat, Esq. at (212) 660-5003 or Oded Har-Even, Esq. at (212) 660-5002, each of Sullivan
& Worcester LLP.
Sincerely,
NLS PHARMACEUTICS LTD.
By:
/s/ Alexander Zwyer
Alexander Zwyer
Chief Executive Officer
3
2025-06-09 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS
PHARMACEUTICS ltd.
The Circle 6
8058 Zurich, Switzerland
June 9, 2025
Via EDGAR
Eric Atallah
Angela Connell
Doris Stacey Gama
Alan Campbell
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re:
NLS Pharmaceutics Ltd.
Amendment No. 2 Registration Statement on Form F-4
Filed March 31, 2025
File No. 333-284075
Dear Sirs and Madams,
The purpose of this letter is to respond to the
comment letter of April 15, 2025, received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission regarding
the above-mentioned Registration Statement on Form F-4. For your convenience, your original comments appear in bold text, followed by
the responses of NLS Pharmaceutics Ltd. (the “Company,” “we,” “our” and similar terminology). We are
concurrently filing Amendment No. 3 to the Registration Statement on Form F-4 (“Amendment No. 3”).
Page references in our responses are to Amendment
No. 3. Unless otherwise stated, any defined terms in Amendment No. 3 apply within this letter.
Amendment No. 1 to Registration Statement
on Form F-4
Kadimastem Overview, page 133
1. In your response to prior comment 9 your revised disclosure states that you have observed, based on
your data, that the transplantation of your mature cells enhances treatment. You then proceed to discuss results from NCT04786262 which
appears to be a trial conducted by Vertex Pharmaceuticals which is ongoing. Please tell us why it is appropriate for you to describe another
company's clinical data in support of claims that are related to your product candidates. Please note that we may have further comment
after reviewing your response. Alternatively, please remove this disclosure. You may state, if true, that clinical trials of other product
candidates by other companies have shown that the transplantation of mature cells may enhance treatment, but that you have yet to observe
this effect in a clinical trial that you have conducted or sponsored.
Response: In response to the Staff’s
comment, we have revised the disclosure on page 200 of Amendment No. 3 to remove the disclosure regarding results from NCT04786262.
Kadimastem’s Solutions, page 135
2. We note your response to prior comment 10. Please also briefly describe the peer review papers listed
supporting your claims.
Response: In response to the Staff’s
comment, we have revised the disclosure beginning on page 201 of Amendment No. 3.
Encap-IsletRx, page 145
3. Given that you have yet to conduct studies demonstrating the efficacy of this product candidate and
delivery strategy, please remove references to "efficacy" in your figure on page 145 labeled Encap-IsletRx Preclinical Efficacy.
Response: In response to the Staff’s
comment, we have revised the disclosure beginning on page 212 of Amendment No. 3 to remove references to efficacy.
Unaudited Pro Forma Condensed Combined Financial Statements
Unaudited Pro Forma Condensed Combined Balance Sheets, page 193
4. We note the pro forma adjustment columns at the top of page 194 are labeled “NLS” and “Kadimastem”,
rather than “Pre-Merger Transaction Accounting Adjustments” and “Transaction Accounting Adjustments”. Please revise
to present consistently labeled column headings in your pro forma balance sheets.
Response: In response to the Staff’s
comment, we have revised the disclosure in Amendment No. 3 on page 264 of Amendment No. 3 to present the column headings consistently.
Unaudited Pro Forma Condensed Combined Statement
of Operations and Other
Comprehensive Loss, page 195
5. We note from your revised disclosures in response to prior comment 21 that Kadimastem conducted a reverse
share split at a 10-for-1 ratio on March 21, 2024. Please explain why the split is not disclosed as a subsequent event and why EPS has
not been retrospectively adjusted in Kadimastem’s financial statements. Refer to paragraph 22(f) of IAS 10 and paragraphs 26, 27
and 64 of IAS 33.
Response: We respectfully advise the Staff
that we have updated the Unaudited Pro Forma Condensed Combined Financial Statements and Kadimastem’s financial statements dated
as of December 31, 2024 to reflect the reverse share split. See Note (ii) to the Unaudited Pro Forma Condensed Combined Financial Statements
on page 266, and Note 18.K. to Kadimastem’s financial statements dated as of December 31, 2024 on page G-36 of Amendment No.
3.
Note 5 - Estimated Purchase Price Consideration,
page 201
6. We note your response to prior comment 25. Given that the CVRs appear to be an obligation of the combined
company and were executed pursuant to the terms of the merger agreement, it is unclear why the CVRs have not been reflected in your pro
forma financial statements. To the extent the fair value of such CVRs is currently not estimable or material, please consider providing
narrative disclosure in the footnotes to your pro forma financial statements describing the terms of the CVRs and the potential impact
on future operations.
Response: In response to the Staff’s
comment, we have revised the disclosure on page 271 of Amendment No. 3. We respectfully advise the Staff that the Agreement and Plan
of Merger, dated November 4, 2024, between the Company, Kadimastem and NLS Pharmaceutics (Israel) Ltd., as amended on January 30,
2025, February 17, 2025, May 5, 2025 and June 5, 2025 (the “Merger Agreement”) provides that upon the terms and subject to
the conditions thereof, following the closing of the merger, NLS shall work diligently to dispose of any intellectual property, assets,
rights, contracts, agreements, leases, arrangements (regardless of form), approvals, licenses, permits, whether current or future, whether
or not contingent, of NLS and its subsidiaries related solely to any product candidate of NLS and its subsidiaries, other than NLS’s
Dual Orexin Agonist, or DOXA, platform (the “Legacy Assets”). Therefore, these assets are not intended for use in the combined
company’s future operations. It is further expected that the proceeds from any sale or disposition of all or any part of the Legacy
Assets will be distributed to the shareholders and warrant holders of NLS as of immediately prior to the Effective Time pursuant to the
terms and conditions of the CVR Agreement. If a sale is not achieved, the Company does not intend to further develop these assets internally.
Due to the uncertainty surrounding the realization of any sale, the likelihood of contingent proceeds is considered remote and of minimal
value. Accordingly, these legacy assets and any related contingent distribution have not been recognized in the preliminary valuation.
2
General
7. Please revise your preliminary proxy card to reflect all of the proposals being presented to shareholders.
Response: In response to the Staff’s
comment, we have revised the preliminary proxy card.
If you have any questions or require additional
information, please contact our attorneys Ron Ben-Bassat, Esq. at (212) 660-5003 or Oded Har-Even, Esq. at (212) 660-5002, each of Sullivan
& Worcester LLP.
Sincerely,
NLS PHARMACEUTICS LTD.
By:
/s/ Alexander Zwyer
Alexander Zwyer
Chief Executive Officer
3
2025-04-15 - UPLOAD - NewcelX Ltd. File: 333-284075
April 15, 2025
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Amendment No. 2 to Registration Statement on Form F-4
Filed March 31, 2025
File No. 333-284075
Dear Alexander Zwyer:
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 March 20, 2024 letter.
Amendment No. 2 to Registration Statement on Form F-4
Kadimastem Overview, page 133
In your response to prior comment 9 your revised disclosure states that you have
observed, based on your data, that the transplantation of your mature cells enhances
treatment. You then proceed to discuss results from NCT04786262 which appears to
be a trial conducted by Vertex Pharmaceuticals which is ongoing. Please tell us why it
is appropriate for you to describe another company's clinical data in support of claims
that are related to your product candidates. Please note that we may have further
comment after reviewing your response. Alternatively, please remove this disclosure.
You may state, if true, that clinical trials of other product candidates by other
companies have shown that the transplantation of mature cells may enhance treatment,
1.
April 15, 2025
Page 2
but that you have yet to observe this effect in a clinical trial that you have conducted
or sponsored.
Kadimastem's Solution, page 135
2.We note your response to prior comment 10. Please also briefly describe the peer
review papers listed supporting your claims.
Encap-IsletRx, page 145
3.Given that you have yet to conduct studies demonstrating the efficacy of this product
candidate and delivery strategy, please remove references to "efficacy" in your figure
on page 145 labeled Encap-IsletRx Preclinical Efficacy.
Unaudited Pro Forma Condensed Combined Financial Statements
Unaudited Pro Forma Condensed Combined Balance Sheets, page 193
4.We note the pro forma adjustment columns at the top of page 194 are labeled “NLS”
and “Kadimastem”, rather than “Pre-Merger Transaction Accounting Adjustments”
and “Transaction Accounting Adjustments”. Please revise to present consistently
labeled column headings in your pro forma balance sheets.
Unaudited Pro Forma Condensed Combined Statement of Operations and Other
Comprehensive Loss, page 195
5.We note from your revised disclosures in response to prior comment 21 that
Kadimastem conducted a reverse share split at a 10-for-1 ratio on March 21,
2024. Please explain why the split is not disclosed as a subsequent event and why EPS
has not been retrospectively adjusted in Kadimastem’s financial statements. Refer to
paragraph 22(f) of IAS 10 and paragraphs 26, 27 and 64 of IAS 33.
Note 5 - Estimated Purchase Price Consideration, page 201
6.We note your response to prior comment 25. Given that the CVRs appear to be an
obligation of the combined company and were executed pursuant to the terms of the
merger agreement, it is unclear why the CVRs have not been reflected in your pro
forma financial statements. To the extent the fair value of such CVRs is currently not
estimable or material, please consider providing narrative disclosure in the footnotes
to your pro forma financial statements describing the terms of the CVRs and the
potential impact on future operations.
General
7.Please revise your preliminary proxy card to reflect all of the proposals being
presented to shareholders.
Please contact Eric Atallah at 202-551-3663 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please contact Doris Stacey Gama at 202-551-3188 or Alan Campbell at 202-551-
4224 with any other questions.
April 15, 2025
Page 3
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ron Ben-Bassat, Esq.
2025-03-31 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS
PHARMACEUTICS ltd.
The Circle 6
8058 Zurich, Switzerland
March 31, 2025
Via EDGAR
Eric Atallah
Angela Connell
Doris Stacey Gama
Alan Campbell
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re:
NLS Pharmaceutics Ltd.
Amendment No. 1 Registration Statement on Form F-4
Filed March 3, 2025
File No. 333-284075
Dear Sirs and Madams,
The purpose of this letter is to respond to the
comment letter of March 20, 2025, received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission regarding
the above-mentioned Draft Registration Statement on Form F-4. For your convenience, your original comments appear in bold text, followed
by the responses of NLS Pharmaceutics Ltd. (the “Company,” “we,” “our” and similar terminology). We
are concurrently filing Amendment No. 2 to the Registration Statement on Form F-4 (“Amendment No. 2”).
Page references in our responses are to Amendment
No. 2. Unless otherwise stated, any defined terms in Amendment No. 2 apply within this letter.
Amendment No. 1 to Registration Statement
on Form F-4
Q: Is the CVR payment secured or guaranteed?,
page xi
1.
You state that even if the Merger is completed, there is no guarantee that any proceeds will be paid to NLS shareholders under the CVR Agreement. Please briefly explain why NLS shareholders may not receive proceeds from the CVR Agreement and the limitations on the combined company’s obligations to sell the Legacy Assets as you do on page 91 and 128.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2.
Table of Contents, page ii
2.
We note your disclosure on page 94 that, based on the Finders Agreement, NLS shall issue H.C. Wainwright warrants to purchase $500,000 worth of NLS common shares. As such, please include H.C. Wainwright’s warrants in this section or please advise.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2.
March 31, 2025
Page 2
The Merger
NLS’s
Background of the Merger, page 93
3.
We note your response to prior comment 22 and reissue in part. Please include a description of how the potential target companies were identified including any criteria considered and quantify the total number of potential target companies considered.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2
4.
You state on page 94 that NLS management considered the feasibility and attractiveness of one or more potential transactions between NLS and Kadimastem. Please briefly discuss the other transactions considered.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2.to clarify that no other transactions with Kadimastem were considered.
5.
You state that on August 19-21, 2024 and August 23, 2024 a series of follow-up meetings transpired discussing deal structure and valuation methodologies. We further note your disclosure that NLS proposed a percentage ownership of 15-17% of the combined company. Please revise to disclose how NLS determined this initial range. Please also revise to describe how the Exchange Ratio was finalized.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2.
6.
You state that between August 29, 2024 and November 4, 2024, Sullivan and Pearl Cohen exchanged drafts and negotiated the terms of the CVR Agreement. Please describe in more detail the material terms of the negotiations. In particular, please discuss how the parties determined which of NLS’s assets would be subject to the CVR Agreement.
Response: In response to the Staff’s
comment, we have revised the disclosure in Amendment No. 2.
7.
We note your statement that NLS and Kadimastem reviewed several comparable companies. Please revise to disclose these comparable companies.
Response: In response to the Staff’s comment, we have
revised the disclosure in Amendment No. 2.
Fairness Opinions and Valuation Reports of Moore Financial Consulting,
page 104
8.
We note your response to prior comment 26 and revised disclosure. Please further revise to provide a cross-reference to the location of the forecasts and underlying assumptions in Annex E.
Response: In response to the Staff’s
comment, we have revised the disclosure in Amendment No. 2.
Kadimastem Overview, page 131
9
We note your response to prior comment 36 and reissue in part. Please clarify, if true, that any enhancement of treatment resulting from the transplantation of mature cells has yet to be observed in a clinical trial.
Response: In response to the Staff’s
comment, we have revised the disclosure in Amendment No. 2.
AstroRx - Development of a Drug for the
Treatment of..., page 132
10.
We note your response to prior comment 38 and reissue. You state that AstroRx were demonstrated to promote neuroprotection and to maintain homeostasis. Please revise to identify and describe the studies or trials where these effects were observed and to clearly present the data supporting your claim. To the extent this statement is based on the Phase 1/2a trial of AstroRx, please revise this statement and other similar statements in the prospectus to clarify that these effects were no longer observed at the 6- and 12-month follow-ups.
Response: In response to the Staff’s
comment, we have revised the disclosure in Amendment No. 2.
March 31, 2025
Page 3
11.
In response to prior comment 41 you state that you have removed the use of p-values but we note they continue to be used on page 135 and in your figures labeled Results AstroRx 30month Follow-up and AstroRx Phase1/2a Study: 1-Year Follow-up Results. As such, please define p-value at first use.
Response: In response to the Staff’s
comment, we have revised the disclosure in Amendment No. 2.
iTOL-102, page 142
12.
You state that the Diabetes Research Institute presented results of iTOL-102 POC that demonstrated it can “effectively restore normoglycemia in a model of diabetes.” We remind you that efficacy determinations are solely within the authority of the FDA or applicable foreign regulators. You may present clinical trial end points and objective data resulting from trials without concluding efficacy. Please revise or remove this statement.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2.
In-Scaffold-IsletRx, page 143
13.
We note your response to prior comment 45 and revised disclosure. Given that you have yet to conduct studies demonstrating the efficacy of this product candidate and delivery strategy, please remove references to “efficacy” and “effective.”
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2.
Key Commercial Agreements
License Agreement with Yeda Research and
Development Ltd., page 144
14.
You state that the agreement stipulates payments to be made to Yeda in accordance with certain milestones as well as royalty payments beginning from the first commercial sale of a product and that the agreement terminates upon expiration of Yeda’s patent licensed to Kadimastem under the agreement, among other things. Please quantify the royalty rate, or a range no greater than 10 percentage points per tier; disclose when royalty provisions expire, and if the expiration is based on a number of years following commercialization disclose the number of years; and state the expiration of Yeda’s patent. Please also file this agreement as an exhibit to your registration statement.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2. In addition, we have filed the agreement as an exhibit to Amendment No. 2.
Intellectual Property, page 145
15.
We note your response to prior comment 19. Please include the expiration date for each patent listed.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2.
NLS’s
Management’s Discussion and Analysis of Financial Condition and Results of
Operations
Overview,
page 160
16.
We note your revised disclosure in response to prior comment 46, however it does not appear that you have disclosed all material terms of your license agreement with Aexon Labs. For example, we note from the disclosure on page E-39, that the agreement required upfront payments of $200,000. Please revise to disclose all material terms of your license agreement.
Response: In response to the Staff’s
comment, we have revised the disclosure in Amendment No. 2.
Capital Resources and Liquidity,
page 168
March 31, 2025
Page 4
17.
We note your revisions in response to prior
comment 47 are only showing the partial effects of the merger transaction with Kadimastem. For example, we note the pro forma balance
sheet presents the recognition of goodwill and the elimination of certain liabilities that are related to other transactions as part of
the merger agreement with Kadimastem. As such, your pro forma presentation only showing partial effects of the merger does not appear
appropriate under Article 11 of Regulation S-X.
Further, it is also unclear how your pro forma
balance sheet disclosure satisfies the requirements in Item 303(b)(1)(ii) of Regulation S-K, which requires a description of your material
cash requirements, the anticipated source of funds needed to satisfy such requirements and any know material trends in your capital resources.
Please revise your filing accordingly.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2 by providing a narrative disclosure.
Kadimastem’s Management’s Discussion
and Analysis of Financial Condition and Results of Operations
Results of Operations, page 173
18.
We note your revised disclosures in response to prior comment 48, cite multiple factors that impacted your R&D expenses and G&A expenses, but you do not quantify the impact of the factors cited. For example, on page 175 you state that the primary factors impacting your R&D expenses were workforce reductions, reduction in external research services and lower laboratory operational costs. Please revise your disclosures to quantify the extent to which each factor contributed to the overall change in that financial statement line item. Refer to Item 5 of Form 20-F.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2.
Executive Compensation and Share
Ownership, page 186
19.
Please update your disclosure to include the executive compensation for the 2024 fiscal year.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2.
Unaudited Pro Forma Condensed
Combined Financial Statements, page 189
20.
You disclose that the historical financial statements of Kadimastem and NLS have been adjusted to give pro forma effect to events that are (i) directly attributable to the Merger, including material subsequent events that will occur either prior to or in connection with the closing of the Merger, (ii) factually supportable, and (iii) with respect to the statements of operations, expected to have a continuing impact on the combined results. SEC Release No. 34-88914 amended Article 11 of Regulation S-K to replace these criteria with three types of adjustments - transaction accounting adjustments, autonomous entity adjustments and management adjustments. Please revise your disclosure accordingly. Refer to Article 11-01(a)(6) of Regulation S-K.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2.
Unaudited Pro Forma Condensed Combined Statement of
Operations and Other Comprehensive Loss, page 194
March 31, 2025
Page 5
21.
We note your response to comment 51. However, it does not appear as though you have reconciled the weighted average number of shares outstanding for Kadimastem. In this regard, we note that Kadimastem’s weighted average shares outstanding presented in your pro forma statement of operations is 4,193,689 compared to 42,424,000 in Kadimastem’s audited financial statements on page G¬40. Please advise or revise your filing accordingly.
Response: In response to the Staff’s comment,
we have revised the disclosure in Amendment No. 2.
Note 2 - Pro Forma Adjustments, page 196
22.
Refer to prior comment 57. We note that adjustment (G) reflects reductions in accounts payable, trade payables and accrued pension liability because of successfully implemented restructuring measures. Please tell us where you have described your restructuring plans. Your management discussion and analysis should describe any restructuring plans you have initiated after the balance sheet date and quantify the effects of any costs incurred and/or cost savings.
Response: We have revised the
disclosure in the Management’s Discussion and Analysis discussion contained in Amendment No. 2 to include a detailed discussion
of our restructuring plans.
23.
Refer to prior comments 58 and 59. Your disclosure related to adjustment (P) indicates that the warrants will not be granted until the loans are converted into shares, which conversions are expected to occur at the timing of Closing. Once issued, the warrants will have an exercise period of 42 months. Given the uncertainties around if and when such warrants will be exercised, please tell us why you believe it is appropriate to reflect the gross proceeds for the exercise of the warrants in your pro forma balance sheet.
Response: We acknowledge the inherent uncertainties
surrounding warrant exercises. However, we have received confirmation from the loan holders that, upon approval of the contemplated merger
with Kadimastem Ltd., the loan holders intend to convert their loans into shares and exercise the associated warrants, all prior to the
closing of the merger. We believe that these confirmations provide a reasonable basis to assume that the warrant exercises will occur.
Furthermore, given the expected market value of the underlying shares, the exercise of the warrants is economically beneficial to the
holders. As a result, we believe the adjustments to reflect the gross proceeds for the exercise of the warrants should be included in
the pro forma financial statements, as they are factually supportable, directly attributable to the transaction, and enhance transparency
for investors.
24.
Refer to adjustment (S). In light of the significant allocation to Goodwill, please explain your analysis related to the recognition of identifiable assets acquired and liabilities assumed.
Response: Due to the nature of the company
as a biotech company, a substantial portion of its patents and related in-process research and development (IPR&D) are not being retained,
except for the DOXA program. Based on our current evaluation, we believe the fair value of the DOXA program will not be significant relative
to the overall transaction.
As a result, the majority of the preliminary purchase
price allocation has been attributed to goodwill. This allocation reflects the absence of significant identifiable intangible assets beyond
the DOXA program, as well as the strategic rationale for the acquisition, including anticipated synergies, workforce, and future growth
potential, which do not meet the criteria for separate recognition under ASC 805.
Additionally, we did not identify any separately
recognizable intangible assets—such as trademarks, customer relationships, or developed technology—based on valuation methodologies
like the income approach (e.g., relief-from-royalty or multi-period excess earnings method). As the purchase price allocation remains
preliminary, we will cont
2025-03-20 - UPLOAD - NewcelX Ltd. File: 333-284075
March 20, 2025
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Amendment No. 1 to Registration Statement on Form F-4
Filed March 3, 2025
File No. 333-284075
Dear Alexander Zwyer:
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 January 27, 2025 letter.
Amendment No. 1 to Registration Statement on Form F-4
Q: Is the CVR payment secured or guaranteed?, page xi
1.You state that even if the Merger is completed, there is no guarantee that any proceeds
will be paid to NLS shareholders under the CVR Agreement. Please briefly explain
why NLS shareholders may not receive proceeds from the CVR Agreement and the
limitations on the combined company's obligations to sell the Legacy Assets as you do
on page 91 and 128.
Q: What is the anticipated ownership of options, warrants...., page xix
2.We note your disclosure on page 94 that, based on the Finders Agreement, NLS shall
issue H.C. Wainwright warrants to purchase $500,000 worth of NLS common shares.
As such, please include H.C. Wainwright's warrants in this section or please advise.
March 20, 2025
Page 2
The Merger
NLS's Background of the Merger, page 93
3.We note your response to prior comment 22 and reissue in part. Please include a
description of how the potential target companies were identified including any
criteria considered and quantify the total number of potential target companies
considered.
4.You state on page 94 that NLS management considered the feasibility and
attractiveness of one or more potential transactions between NLS and Kadimastem.
Please briefly discuss the other transactions considered.
5.You state that on August 19-21, 2024 and August 23, 2024 a series of follow-up
meetings transpired discussing deal structure and valuation methodologies. We further
note your disclosure that NLS proposed a percentage ownership of 15-17% of the
combined company. Please revise to disclose how NLS determined this initial range.
Please also revise to describe how the Exchange Ratio was finalized.
6.You state that between August 29, 2024 and November 4, 2024, Sullivan and Pearl
Cohen exchanged drafts and negotiated the terms of the CVR Agreement. Please
describe in more detail the material terms of the negotiations. In particular, please
discuss how the parties determined which of NLS's assets would be subject to the
CVR Agreement.
7.We note your statement that NLS and Kadimastem reviewed several comparable
companies. Please revise to disclose these comparable companies.
Fairness Opinions and Valuation Reports of Moore Financial Consulting, page 104
8.We note your response to prior comment 26 and revised disclosure. Please further
revise to provide a cross-reference to the location of the forecasts and underlying
assumptions in Annex E.
Kadimastem Overview, page 131
9.We note your response to prior comment 36 and reissue in part. Please clarify, if true,
that any enhancement of treatment resulting from the transplantation of mature
cells has yet to be observed in a clinical trial.
AstroRx - Development of a Drug for the Treatment of..., page 132
10.We note your response to prior comment 38 and reissue. You state that AstroRx were
demonstrated to promote neuroprotection and to maintain homeostasis. Please revise
to identify and describe the studies or trials where these effects were observed and to
clearly present the data supporting your claim. To the extent this statement is based on
the Phase 1/2a trial of AstroRx, please revise this statement and other similar
statements in the prospectus to clarify that these effects were no longer observed at the
6- and 12-month follow-ups.
11.In response to prior comment 41 you state that you have removed the use of p-values
but we note they continue to be used on page 135 and in your figures labeled Results
AstroRx 30month Follow-up and AstroRx Phase1/2a Study: 1-Year Follow-up
Results. As such, please define p-value at first use.
March 20, 2025
Page 3
iTOL-102, page 142
12.You state that the Diabetes Research Institute presented results of iTOL-102 POC that
demonstrated it can "effectively restore normoglycemia in a model of diabetes." We
remind you that efficacy determinations are solely within the authority of the FDA or
applicable foreign regulators. You may present clinical trial end points and objective
data resulting from trials without concluding efficacy. Please revise or remove this
statement.
In-Scaffold-IsletRx, page 143
13.We note your response to prior comment 45 and revised disclosure. Given that you
have yet to conduct studies demonstrating the efficacy of this product candidate and
delivery strategy, please remove references to "efficacy" and "effective."
Key Commercial Agreements
License Agreement with Yeda Research and Development Ltd., page 144
14.You state that the agreement stipulates payments to be made to Yeda in accordance
with certain milestones as well as royalty payments beginning from the first
commercial sale of a product and that the agreement terminates upon expiration of
Yeda's patent licensed to Kadimastem under the agreement, among other things.
Please quantify the royalty rate, or a range no greater than 10 percentage points per
tier; disclose when royalty provisions expire, and if the expiration is based on a
number of years following commercialization disclose the number of years; and state
the expiration of Yeda's patent. Please also file this agreement as an exhibit to your
registration statement.
Intellectual Property, page 145
15.We note your response to prior comment 19. Please include the expiration date for
each patent listed.
NLS's Management's Discussion and Analysis of Financial Condition and Results of
Operations
Overview, page 160
16.We note your revised disclosure in response to prior comment 46, however it does not
appear that you have disclosed all material terms of your license agreement with
Aexon Labs. For example, we note from the disclosure on page E-39, that the
agreement required upfront payments of $200,000. Please revise to disclose all
material terms of your license agreement.
Capital Resources and Liquidity, page 168
We note your revisions in response to prior comment 47 are only showing the partial
effects of the merger transaction with Kadimastem. For example, we note the pro
forma balance sheet presents the recognition of goodwill and the elimination of
certain liabilities that are related to other transactions as part of the merger agreement
with Kadimastem. As such, your pro forma presentation only showing partial effects
of the merger does not appear appropriate under Article 11 of Regulation S-X. 17.
March 20, 2025
Page 4
Further, it is also unclear how your pro forma balance sheet disclosure satisfies the
requirements in Item 303(b)(1)(ii) of Regulation S-K, which requires a description of
your material cash requirements, the anticipated source of funds needed to satisfy
such requirements and any know material trends in your capital resources. Please
revise your filing accordingly.
Kadimastem's Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, page 173
18.We note your revised disclosures in response to prior comment 48, cite multiple
factors that impacted your R&D expenses and G&A expenses, but you do not quantify
the impact of the factors cited. For example, on page 175 you state that the primary
factors impacting your R&D expenses were workforce reductions, reduction in
external research services and lower laboratory operational costs. Please revise your
disclosures to quantify the extent to which each factor contributed to the overall
change in that financial statement line item. Refer to Item 5 of Form 20-F.
Executive Compensation and Share Ownership, page 186
19.Please update your disclosure to include the executive compensation for the
2024 fiscal year.
Unaudited Pro Forma Condensed Combined Financial Statements, page 189
20.You disclose that the historical financial statements of Kadimastem and NLS have
been adjusted to give pro forma effect to events that are (i) directly attributable to the
Merger, including material subsequent events that will occur either prior to or in
connection with the closing of the Merger, (ii) factually supportable, and (iii) with
respect to the statements of operations, expected to have a continuing impact on the
combined results. SEC Release No. 34-88914 amended Article 11 of Regulation S-K
to replace these criteria with three types of adjustments - transaction accounting
adjustments, autonomous entity adjustments and management adjustments. Please
revise your disclosure accordingly. Refer to Article 11-01(a)(6) of Regulation S-K.
Unaudited Pro Forma Condensed Combined Statement of Operations and Other
Comprehensive Loss, page 194
21.We note your response to comment 51. However, it does not appear as though you
have reconciled the weighted average number of shares outstanding for
Kadimastem. In this regard, we note that Kadimastem’s weighted average shares
outstanding presented in your pro forma statement of operations is 4,193,689
compared to 42,424,000 in Kadimastem’s audited financial statements on page G-
40. Please advise or revise your filing accordingly.
Note 2 - Pro Forma Adjustments, page 196
Refer to prior comment 57. We note that adjustment (G) reflects reductions in
accounts payable, trade payables and accrued pension liability because of successfully
implemented restructuring measures. Please tell us where you have described your
restructuring plans. Your management discussion and analysis should describe any 22.
March 20, 2025
Page 5
restructuring plans you have initiated after the balance sheet date and quantify the
effects of any costs incurred and/or cost savings.
23.Refer to prior comments 58 and 59. Your disclosure related to adjustment (P)
indicates that the warrants will not be granted until the loans are converted into shares,
which conversions are expected to occur at the timing of Closing. Once issued, the
warrants will have an exercise period of 42 months. Given the uncertainties around if
and when such warrants will be exercised, please tell us why you believe it is
appropriate to reflect the gross proceeds for the exercise of the warrants in your pro
forma balance sheet.
24.Refer to adjustment (S). In light of the significant allocation to Goodwill, please
explain your analysis related to the recognition of identifiable assets acquired and
liabilities assumed.
Note 5 - Estimated Purchase Price Consideration, page 199
25.We note that in connection with the merger transaction, NLS plans to issue contingent
value rights (CVRs) to its shareholders, which will represent the right to additional
payments based on the proceeds, subject to certain adjustments, received by NLS
from the disposition of the Legacy Assets (including the mazindol ER but excluding
the DOXA platform). Please explain how you evaluated these CVRs as a form of
contingent consideration under paragraphs 39-40 of IFRS 3 and your consideration for
inclusion in your pro forma financial statements.
Exhibits
26.Please file Kadimastem's general framework agreement with the IIA as an exhibit to
your registration statement. Alternatively, please advise.
Please contact Eric Atallah at 202-551-3663 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please contact Doris Stacey Gama at 202-551-3188 or Alan Campbell at 202-551-
4224 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Ron Ben-Bassat, Esq.
2025-02-28 - CORRESP - NewcelX Ltd.
CORRESP
1
filename1.htm
NLS
PHARMACEUTICS ltd.
The Circle 6
8058 Zurich, Switzerland
February 28, 2025
Via EDGAR
Eric Atallah
Angela Connell
Doris Stacey Gama
Alan Campbell
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Re:
NLS Pharmaceutics Ltd.
Registration Statement on Form F-4
Filed December 30, 2024
File No. 333-284075
Dear Sirs and Madams,
The purpose of this letter is to respond to the
comment letter of January 27, 2025, received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission
regarding the above-mentioned Draft Registration Statement on Form F-4. For your convenience, your original comments appear in bold text,
followed by the responses of NLS Pharmaceutics Ltd. (the “Company,” “we,” “our” and similar terminology).
We are concurrently filing Amendment No. 1 to the Registration Statement on Form F-4 (“Amendment No. 1”).
Page references in our responses are to Amendment
No. 1. Unless otherwise stated, any defined terms in Amendment No. 1 apply within this letter.
Registration Statement on Form F-4
Cover Page
1.
We note your statement that after the completion of the Merger, NLS will continue
to trade on Nasdaq under NLS’s existing name and existing trading symbol. However, your disclosure elsewhere in the proxy statement/prospectus
indicates that you are asking shareholders to approve the change of your company’s name to NUCELX AG and that you will choose
a new trading symbol. Please reconcile your disclosure or advise.
Response: In response to the Staff’s
comment, we have revised the disclosure throughout Amendment No. 1 to indicate that Company will ask shareholders to approve the change
of the Company’s name to “NUCELX AG” and that the Company will choose a new trading symbol of “NCEL”.
Table of Contents, page ii
2. Please revise the notation for Annex G to clarify that Annex
G contains Kadimastem’s audited financial statements for the year ended December 31, 2023 and
unaudited financial statements for the six months ended June 30, 2024.
Response: In response to the Staff’s
comment, we have revised Annex G to clarify that Annex G contains Kadimastem’s audited financial statements for the year ended December
31, 2023 and unaudited financial statements for the six months ended June 30, 2024.
Eric Atallah, et al
Securities and Exchange Commission
Division of Corporation Finance
February 28, 2025
Page 2
Questions and Answers About the Proposals, page iii
3. Please revise this section to include a Q&A disclosing
the respective valuations attributed to NLS and Kadimastem in the Merger. In your Q&A please
also disclose the respective companies’ valuations based on the trading prices of their
shares prior to the public announcement of the Merger. Please similarly revise the Summary of
the Proxy Statement/Prospectus.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages vi, 3 and 109.
4. Please revise this section to include a Q&A that discloses
a detailed summary of the anticipated ownership of the combined company following the Merger.
In your Q&A please disclose anticipated common stock ownership as well as options, warrants
and other outstanding equity awards that are anticipated to remain outstanding following the completion
of the Merger.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages xvii and xviii.
5. We note that NLS will enter into a CVR Agreement with VStock
Transfer, LLC where record holders will receive certain contingent value rights for NLS’s legacy
assets. Please include a Q&A to briefly discuss the CVR Agreement, who is entitled to such
rights, what the legacy assets consist of and a cross-reference to a more fulsome discussion.
Please revise elsewhere in the prospectus, where appropriate, to more completely disclose the
material terms of the CVR Agreement including applicable milestones.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages x, xi, 127 and 128.
6. Please revise this section to include a Q&A discussing
the anticipated liquidity position of the combined company following the Merger. In your Q&A
please quantify anticipated transaction expenses and debts of the combined company, including
the credit facility referenced on page 53. In your Q&A, please also discuss whether it is
anticipated that the combined company will have sufficient funds to commence and complete Kadimastem’s
planned Phase IIa trial of AstroRx following the completion of the Merger. Please similarly revise
the Summary of the Proxy Statement/Prospectus.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages viii and 4.
7. Please revise this section, where appropriate, to discuss the
standard(s) that the combined company must meet in order to maintain its listing on Nasdaq. In
your revisions, please disclose whether NLS shareholders will know if the combined company has
been approved for Nasdaq listing prior to the date on which they are required to vote on the Merger
and the associated proposals and clarify whether approval of the combined company’s listing application
is a condition for the closing of the Merger.
Response: In response to the
Staff’s comment, we have revised Amendment No. 1 on pages viii and ix.
Eric Atallah, et al
Securities and Exchange Commission
Division of Corporation Finance
February 28, 2025
Page 3
Q:
What are the tax consequences of the Merger to me?, page ix
8. Please revise this section to provide an overview of the tax
consequences to your shareholders as you do on page 155.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages xi and xii.
Q:
Will the board of directors of NLS and Kadimastem obtain a third-party valuation or fairness opinion...?, page xiv
9. Please revise here and elsewhere in the prospectus where the
fairness opinion is discussed to clarify, if true, that the fairness opinion was not prepared
for the benefit of NLS’s shareholders and that NLS’s shareholders are not entitled
to rely on the fairness opinion. Please also clarify, if true, that the fairness opinion does
not opine on the fairness of the Exchange Ratio to NLS or NLS’s shareholders.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages xvi, 13 and 14.
Kadimastem, page 1
10. We note that AstroRx is in
clinical trials. Please also state here the development status of IsletRx and the three product
candidates under this program (iTOL-102, Encap-IsletRx and In-Scaffold-IsletRx) highlighted
on page 117.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages 2, and 141.
Summary of the Proxy Statement/Prospectus NLS, page
1
11. Please revise here and on
page 107 to reflect your disclosure elsewhere in the proxy statement/prospectus that NLS
plans to dispose of all of its legacy assets with the exception of Dual Orexin Agonist platform;
clarify the candidates that make up the Dual Orexin Agonist platform; and include a discussion
of the status of such candidates.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages 1, 3 and 130.
Reasons for the Merger, page 7
12. You discuss certain factors
the NLS and the Kadimastem board took into consideration when deciding to approve the Merger.
Please balance the discussion here and on pages 86 and 88 to include any negative factors
and risks considered by both companies.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages 9 - 12, and 99 - 104.
13. Please revise the “Complementary
Strengths” bullet here and in the section beginning on page 86 to explain in more detail
the complementary strengths considered by NLS’s board.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages 7 and 99.
14. Please revise the “Expansion
of Market Reach” bullet to disclose the details of the increased market penetration
and geographical coverage considered by NLS’s board. Please similarly revise the “Revenue
Growth” bullet to describe the cross-selling opportunities and potential market expansion.
Please also similarly revise the section beginning on page 86.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages 8 and 99.
Eric Atallah, et al
Securities and Exchange Commission
Division of Corporation Finance
February 28, 2025
Page 4
15. Please revise the “Increased
Value” bullet here and in the section beginning on page 86 to explain how the Merger
is expected to improve financial performance, earnings and potentially returns for shareholders.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages 10 and 101.
16. Please revise the “Industry
Leadership” bullet here and in the section beginning on page 88 to describe the field
that Kadimastem believes that the combined company will lead.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages 12 and 104.
Comparative Per Share Market Price Information, page
16
17. Please revise the table that
appears in this section to show the market capitalizations of each of NLS and Kadimastem
for both rows in the table. Please also revise to briefly explain the information presented
in the third column of the table and remove the fourth column.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on page 21.
Risk Factors
The Merger is subject to the..., page 24
18. Please revise this risk factor
to clarify whether the receipt of tax rulings by the Israel Tax Authority and ISA and the
approval of the Merger by Kadimastem’s shareholders are expected to be obtained prior
to NLS’s shareholders voting on the Merger.
Response:
In response to the Staff’s comment, we have revised Amendment No. 1 on page 31.
Risks
Related to the Combined Company’s Intellectual Property, page 57
19. You state that the combined
company has filed patent applications in countries worldwide. Please revise the proxy statement/prospectus,
where appropriate, to include a discussion of these patents applications including type of
patent protection (for example, composition of matter, use or process), the specific product(s)
to which the patent relates, whether the patent is owned or licensed, the patent expiration
dates and the applicable jurisdictions.
Response:
In response to the Staff’s comment, we have revised Amendment No. 1 on pages 145 - 151.
The
Merger
NLS’s Background of the Merger, page 82
20. Please revise this section
to disclose whether there were any events that occurred that caused NLS’s board to
change its strategic direction towards pursuing a merger or other similar transaction.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages 93 - 95.
21. Please revise your disclosure
to discuss in greater detail the substance of meetings and discussions among representatives
of NLS, Kadimastem and their respective representatives. In your revisions, please identify
the individuals at NLS and Kadimastem who participated in each discussion/negotiation between
August 17, 2024 and November 4, 2024, the material terms that were discussed, how parties’
positions differed and how issues were resolved. For example, clarify how the merger consideration
was determined and how the transaction structure and consideration evolved during the negotiations,
including the proposals and counter-proposals made during the course of the negotiations
with respect to the material terms of the transaction. Please also describe the negotiation
of the CVR Agreement and the NLS Voting Agreement.
Response: In response to the Staff’s
comment, we have revised the NLS’s Background of the Merger section in Amendment No. 1 starting on page 93.
Eric Atallah, et al
Securities and Exchange Commission
Division of Corporation Finance
February 28, 2025
Page 5
22. You state that between June
29, 2024 and July 28, 2024 members of NLS’s management team and the Board, with assistance
of its financial and legal advisors, evaluated and considered several potential target companies
including OQORY and MEDMELIOR. Please identify the financial and legal advisors, include
a description of how the potential target companies where identified including any criteria
considered and quantify the total number of potential target companies considered.
Response: In response to the Staff’s
comment, we have revised Amendment No. 1 on pages 94 and 95.
23. You state that on
2025-01-27 - UPLOAD - NewcelX Ltd. File: 333-284075
January 27, 2025
Alexander Zwyer
Chief Executive Officer
NLS Pharmaceutics Ltd.
The Circle 6
8058 Zurich, Switzerland
Re:NLS Pharmaceutics Ltd.
Registration Statement on Form F-4
Filed December 30, 2024
File No. 333-284075
Dear Alexander Zwyer:
We have reviewed your 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.
Registration Statement on Form F-4
Cover Page
1.We note your statement that after the completion of the Merger, NLS will continue to
trade on Nasdaq under NLS’s existing name and existing trading symbol. However,
your disclosure elsewhere in the proxy statement/prospectus indicates that you are
asking shareholders to approve the change of your company’s name to NUCELX AG
and that you will choose a new trading symbol. Please reconcile your disclosure or
advise.
Table of Contents, page ii
2.Please revise the notation for Annex G to clarify that Annex G contains Kadimastem's
audited financial statements for the year ended December 31, 2023 and unaudited
financial statements for the six months ended June 30, 2024.
January 27, 2025
Page 2
Questions and Answers About the Proposals, page iii
3.Please revise this section to include a Q&A disclosing the respective valuations
attributed to NLS and Kadimastem in the Merger. In your Q&A please also disclose
the respective companies’ valuations based on the trading prices of their shares prior
to the public announcement of the Merger. Please similarly revise the Summary of the
Proxy Statement/Prospectus.
4.Please revise this section to include a Q&A that discloses a detailed summary of the
anticipated ownership of the combined company following the Merger. In your Q&A
please disclose anticipated common stock ownership as well as options, warrants and
other outstanding equity awards that are anticipated to remain outstanding following
the completion of the Merger.
5.We note that NLS will enter into a CVR Agreement with VStock Transfer, LLC
where record holders will receive certain contingent value rights for NLS's legacy
assets. Please include a Q&A to briefly discuss the CVR Agreement, who is entitled
to such rights, what the legacy assets consist of and a cross-reference to a more
fulsome discussion. Please revise elsewhere in the prospectus, where appropriate, to
more completely disclose the material terms of the CVR Agreement including
applicable milestones.
6.Please revise this section to include a Q&A discussing the anticipated liquidity
position of the combined company following the Merger. In your Q&A please
quantify anticipated transaction expenses and debts of the combined company,
including the credit facility referenced on page 53. In your Q&A, please also discuss
whether it is anticipated that the combined company will have sufficient funds to
commence and complete Kadimastem's planned Phase IIa trial of AstroRx following
the completion of the Merger. Please similarly revise the Summary of the Proxy
Statement/Prospectus.
7.Please revise this section, where appropriate, to discuss the standard(s) that the
combined company must meet in order to maintain its listing on Nasdaq. In your
revisions, please disclose whether NLS shareholders will know if the combined
company has been approved for Nasdaq listing prior to the date on which they are
required to vote on the Merger and the associated proposals and clarify whether
approval of the combined company's listing application is a condition for the closing
of the Merger.
Q: What are the tax consequences of the Merger to me?, page ix
8.Please revise this section to provide an overview of the tax consequences to your
shareholders as you do on page 155.
Q: Will the board of directors of NLS and Kadimastem obtain a third-party valuation or
fairness opinion...?, page xiv
9.Please revise here and elsewhere in the prospectus where the fairness opinion is
discussed to clarify, if true, that the fairness opinion was not prepared for the benefit
of NLS’s shareholders and that NLS’s shareholders are not entitled to rely on the
fairness opinion. Please also clarify, if true, that the fairness opinion does not opine on
the fairness of the Exchange Ratio to NLS or NLS's shareholders.
January 27, 2025
Page 3
Kadimastem, page 1
10.We note that AstroRx is in clinical trials. Please also state here the development status
of IsletRx and the three product candidates under this program (iTOL-102, Encap-
IsletRx and In-Scaffold-IsletRx) highlighted on page 117.
Summary of the Proxy Statement/Prospectus
NLS, page 1
11.Please revise here and on page 107 to reflect your disclosure elsewhere in the proxy
statement/prospectus that NLS plans to dispose of all of its legacy assets with the
exception of Dual Orexin Agonist platform; clarify the candidates that make up the
Dual Orexin Agonist platform; and include a discussion of the status of such
candidates.
Reasons for the Merger, page 7
12.You discuss certain factors the NLS and the Kadimastem board took into
consideration when deciding to approve the Merger. Please balance the discussion
here and on pages 86 and 88 to include any negative factors and risks considered by
both companies.
13.Please revise the “Complementary Strengths” bullet here and in the section beginning
on page 86 to explain in more detail the complementary strengths considered by
NLS’s board.
14.Please revise the “Expansion of Market Reach” bullet to disclose the details of the
increased market penetration and geographical coverage considered by NLS’s board.
Please similarly revise the “Revenue Growth” bullet to describe the cross-selling
opportunities and potential market expansion. Please also similarly revise the section
beginning on page 86.
15.Please revise the “Increased Value” bullet here and in the section beginning on page
86 to explain how the Merger is expected to improve financial performance, earnings
and potentially returns for shareholders.
16.Please revise the “Industry Leadership” bullet here and in the section beginning on
page 88 to describe the field that Kadimastem believes that the combined company
will lead.
Comparative Per Share Market Price Information, page 16
17.Please revise the table that appears in this section to show the market capitalizations
of each of NLS and Kadimastem for both rows in the table. Please also revise to
briefly explain the information presented in the third column of the table and remove
the fourth column.
Risk Factors
The Merger is subject to the..., page 24
18.Please revise this risk factor to clarify whether the receipt of tax rulings by the Israel
Tax Authority and ISA and the approval of the Merger by Kadimastem’s shareholders
are expected to be obtained prior to NLS’s shareholders voting on the Merger.
January 27, 2025
Page 4
Risks Related to the Combined Company's Intellectual Property, page 57
19.You state that the combined company has filed patent applications in countries
worldwide. Please revise the proxy statement/prospectus, where appropriate, to
include a discussion of these patents applications including type of patent protection
(for example, composition of matter, use or process), the specific product(s) to which
the patent relates, whether the patent is owned or licensed, the patent expiration
dates and the applicable jurisdictions.
The Merger
NLS's Background of the Merger, page 82
20.Please revise this section to disclose whether there were any events that occurred that
caused NLS’s board to change its strategic direction towards pursuing a merger or
other similar transaction.
21.Please revise your disclosure to discuss in greater detail the substance of meetings and
discussions among representatives of NLS, Kadimastem and their respective
representatives. In your revisions, please identify the individuals at NLS and
Kadimastem who participated in each discussion/negotiation between August 17,
2024 and November 4, 2024, the material terms that were discussed, how parties'
positions differed and how issues were resolved. For example, clarify how the merger
consideration was determined and how the transaction structure and consideration
evolved during the negotiations, including the proposals and counter-proposals made
during the course of the negotiations with respect to the material terms of the
transaction. Please also describe the negotiation of the CVR Agreement and the NLS
Voting Agreement.
22.You state that between June 29, 2024 and July 28, 2024 members of NLS's
management team and the Board, with assistance of its financial and legal advisors,
evaluated and considered several potential target companies including OQORY and
MEDMELIOR. Please identify the financial and legal advisors, include a description
of how the potential target companies where identified including any criteria
considered and quantify the total number of potential target companies considered.
23.You state that on July 19, 2024, NLS received a non-binding letter of intent from
MEDMELIOR and that on July 26, 2024 NLS informed MEDMELIOR that NLS did
not intend to pursue the potential business combination for commercial reasons.
Please include a discussion of the commercial reasons referenced.
24.Please revise this section to describe how NLS and Kadimastem were initially
introduced.
25.Please revise this section to describe the negotiations between NLS and Kadimastem
related to valuation and the Exchange Ratio. In your revisions, please include
descriptions of the initial valuation proposals and how the proposed valuations of the
two companies evolved. Please also disclose the valuations of the two companies
based on their share trading prices and describe the information reviewed by NLS’s
management and board of directors that supported Kadimastem’s final valuation.
January 27, 2025
Page 5
Fairness Opinions and Valuation Reports of Moore Financial Consulting, page 89
26.You state that in arriving at its opinion, Moore considered certain internal financial
analyses and forecasts prepared by management of the companies, among other
things. Please disclose the forecasts considered, who prepared the forecasts, when
they were prepared and any material assumptions made underlying the forecasts.
27.Please revise this section to disclose Kadimastem’s trading price and market
capitalization at the time Moore was preparing its fairness opinion. In your revisions,
please disclosure whether Moore considered these figures in preparing its opinion.
28.You state that in its oral and written opinion, Moore determined that the exchange
ratio in the proposed merger is fair to Kadimastem. We note that Moore provided both
a valuation report and a fairness opinion yet it appears that only a discussion of the
valuation report is included discussing the income approach analysis performed using
the risk-adjusted net present value method to determine that the value of Kadimastem
lies between $53.9 and $88.7 million. Please include a discussion and analysis of the
methods used to determine the exchange ratio in the proposed merger is fair.
29.Please revise this section to fully summarize the valuation analyses performed by
Moore on Kadimastem and NLS that are attached to the proxy statement/prospectus as
Annex E. In your revisions, please describe and quantify the methods and assumptions
used by Moore to determine its valuations of both companies.
The Merger Agreement
Anticipated Accounting Treatment, page 103
30.Your disclosure of the anticipated accounting treatment for the merger varies
throughout the filing. For example, on page 103 you state that the merger will be
accounted for using the acquisition method (as a reverse triangular merger) with no
goodwill or intangibles recorded. In other instances, for example on page 121, you
disclose that goodwill and other identifiable intangible assets will be
recorded. Finally, in your pro forma disclosures on page 149, you disclose that the
merger will be accounted for as a capital transaction accompanied by a
recapitalization with no goodwill or other intangibles recorded. Please revise to
address the inconsistencies throughout your filing. Please also provide us with an
analysis supporting your anticipated accounting treatment with references to
authoritative guidance.
NLS Business, page 107
31.You state that NLS's lead compound is mazindol. Please clarify if the combined
company will continue to pursue this lead compound and if so, please include a
discussion of current status of the compound, including any pre-clinical or clinical
studies conducted.
Kadimastem Business, page 108
Please revise this section to describe the material terms of Kadimastem’s
collaboration and license agreements, including the royalty-bearing IIA agreement,
the collaborations with Hadassah Medical Organization and Yeda Research and
Development Company and the co-developments with iTolerance Inc. and AFDR 32.
January 27, 2025
Page 6
referenced elsewhere in the prospectus. In your revisions, please include:
•each parties' rights and obligations under the agreement;
•quantify all payment made to date;
•the aggregate amount of all potential development, regulatory and commercial
milestone payments;
•quantify the royalty rate, or a range no greater than 10 percentage points per tier;
disclose when royalty provisions expire, if the expiration is based on a number of
years following commercialization, disclose the number of years;
•disclose the expiration date; and
•describe any termination provisions.
33.Please revise this section to describe the intellectual property arrangements applicable
to Kadimastem’s technology and product candidates.
34.Please revise this section to describe applicable government regulations.
35.Please revise this section to include the information required by Item 6.D. of Form 20-
F (incorporated into Form F-4).
Kadimastem Overview, page 108
36.You state that Kadimastem developed a new process to differentiate the cells in the
lab to their mature phenotype before implantation to the patient unlike other
technologies which transplant immature precursors cells and will therefore enhance
the efficiency of the treatment. Please include a discussion of why this process could
potentially enhance treatment as opposed to transplant of immature
precursor cells. Please also clarify, if true, that this enhancement has yet to be
observed in a clinical trial.
37.You make some assertions regarding the safety and/or efficacy of AstroRx and
IsletRx. Safety and efficacy determinations are solely within the authority of the FDA
or applicable foreign regulators. You may present clinical trial end points and
objective data resulting from trials without concluding efficacy and you may state that
Kadimastem's product candidates were well tolerated, if true. Please revise or remove
statements and inferences throughout your prospectus that Kadimastem's product
candidates are safe and/or effective. As an example, and without limitation, we note
the following statements about Kadimastem's product candidates:
•"...AstroRx transplantation may also be effective..." (pg. 110)
•"Good safety profile" (pg. 112 AstroRx Phase 1/2a FIH clinical trial graphic)
•"IsletRx Treatment = Cure" and your claim that IsletRx treatment results in
normal insulin secretion (pg. 115 IsletRx graphic)
•"...enables improved safety and efficacy of IsletRx cells." (pg. 116)
•"It is not yet known how long IsletRx cells will work, but ... at least as
effective..." (pg. 117)
•"... demonstrated supportive efficacy and safety results of iTOL-102." (pg. 117)
January 27, 2025
Page 7
AstroRx - Development of a Drug for the Treatment
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 - 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
2022-12-13 - 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
2022-06-17 - 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 - 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
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.
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