SecProbe.io

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
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AstroRx - Development of a Drug for the Treatment