SecProbe.io

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.