Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 6

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 6
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 significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement
or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

Interim topline and preliminary data from
our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to
audit and verification procedures that could result in material changes in the final data.

From time to time, we may
publish interim topline or preliminary data from our clinical trials. Interim data from clinical trials that we may complete are subject
to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become
available. Preliminary or topline data also remain subject to audit and verification procedures that may result in the final data being
materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with
caution until the final data are available. Adverse differences between preliminary or interim data and final data could significantly
harm our reputation and business prospects.

Changes in methods of product candidate
manufacturing or formulation may result in additional costs or delay.

As product candidates proceed
through pre-clinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various
aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize
processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause
our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted
with the materials manufactured using altered processes. Such changes may also require additional testing, FDA or EMA notification or
FDA approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one
or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commence
sales and generate revenues.

International expansion of our business
exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the
United States, Switzerland or the EU.

Other than our
headquarters and other operations which are located in Switzerland and our wholly owned U. S. subsidiary, NLS Pharmaceutics Inc., a
Delaware corporation (as further described below), we currently have limited international operations,