Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 238

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 238
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The requirements
that Kadimastem must satisfy to obtain regulatory approval by government agencies in other countries prior to commercialization of any
other product candidate in such countries can be rigorous, costly and uncertain. In the European countries, UK, Canada and Australia,
regulatory requirements and approval processes are similar in principle to those in the United States. Additionally, depending on
the type of drug for which approval is sought, there are currently two potential tracks for marketing approval in the European countries:
mutual recognition and the centralized procedure. These review mechanisms may ultimately lead to approval in all EU countries, but each
method grants all participating countries some decision-making authority in product approval. The UK has a separate review period but
for a transitional period until 31 December 2022, may rely on approvals under the EU mutual recognition and/or centralized procedure.
Foreign governments also have stringent post-approval requirements including those relating to manufacture, labeling, reporting, record
keeping and marketing. Failure to substantially comply with these on-going requirements could lead to government action against the product,
us and/or Kadimastem’s representatives.

Company Information

We were established
as an Israeli company on October 6, 2008. We began trading on the TASE in June 2013.

C. Organizational
Structure

We
are a Swiss stock corporation organized under the laws of Switzerland. Our Swiss enterprise identification number is CHE-447.067.367.
Our registered and principal executive offices are located at The Circle 6, Postfach, 8058 Zurich, Switzerland, our general telephone
number is (41) 44 512 21 50 and our internet address is www. nlspharma. com.

In
April 2021, we formed a wholly owned subsidiary, NLS Pharmaceutics Inc., a Delaware corporation. In November, 2024 we also formed Merger
Sub, our a wholly owned subsidiary, in connection with the Merger. We did not have any other subsidiaries as of December 31, 2024.

D. Property,
Plant and Equipment

Our
principal executive office is located at The Circle 6, Postfach, 8058 Zurich, Switzerland, and consists of approximately 25 square meters
(approximately 270 square feet) of shared office space under an indefinite term lease that may be terminated by either party with one-month
prior notice.

We
consider that our current office space is sufficient to meet our anticipated needs for the foreseeable future and is suitable for