SEC Comment Letter 0000000000-25-006427 to NewcelX Ltd. (NCEL)
NewcelX Ltd.
Date: June 18, 2025 · CIK: 0001783036 · Accession: 0000000000-25-006427
AI Filing Summary & Sentiment
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File numbers found in text: 333-284075
Letter
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.
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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.