Correspondence 0001213900-25-018986 from NewcelX Ltd. (NCEL)
NewcelX Ltd.
Date: Feb. 28, 2025 · CIK: 0001783036 · Accession: 0001213900-25-018986
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-284075
Letter
Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 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
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
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
Show Raw Text
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