Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 35

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 35
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, Good Clinical Practices, or GCP, quality system
requirements, or QSR, and Good Laboratory Practices, or GLP, which are regulations and guidelines enforced by the FDA, the Competent
Authorities of the Member States of the European Economic Area, and comparable foreign regulatory authorities for all of our product
candidates in clinical development. Regulatory authorities enforce these regulations through periodic inspections of study sponsors,
principal investigators, study sites and other contractors. If we or any of our CROs or vendors fail to comply with applicable
regulations, the clinical data generated in our clinical studies may be deemed unreliable and the FDA, EMA or comparable foreign
regulatory authorities may require us to perform additional clinical studies before approving our marketing applications. We cannot
assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical
studies comply with GCP regulations. In addition, our clinical studies must be conducted with product candidates which are produced
under cGMP regulations. Our failure to comply with these regulations may require us to repeat clinical studies, which would delay
the regulatory approval process.

We have no manufacturing capacity and anticipate
reliance on third-party manufacturers for our products.

We do not currently operate
manufacturing facilities for clinical production of Quilience and/or Nolazol. We do not intend to develop facilities for the manufacture
of products for clinical trials or commercial purposes in the foreseeable future. We will rely on third-party manufacturers to produce
bulk drug products required for our clinical trials and commercial sales, if any. We plan to continue to rely upon contract manufacturers
and, potentially, collaboration partners to manufacture commercial quantities of our drug product candidates if and when approved for
marketing by the applicable regulatory authorities. Our contract manufacturers have not completed process validation for the drug substance
manufacturing process. Process validation involves a series of activities taking place over the lifecycle of the product and process.
If our contract manufacturers are not approved by the FDA, or other regulatory bodies, our commercial supply of drug substance will be
significantly delayed and may result in significant additional costs. If the FDA does not consider the result of the process validation
or required testing to be satisfactory, regulatory approval and/or commercial supply after launch may be delayed. The FDA and similar
foreign regulatory bodies may also implement new requirements, or change their interpretation and enforcement of existing requirements,
for manufacturers, packaging or testing of products at any time. If we, or our contract manufacturers are unable to comply with such process
validation