Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 128

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 128
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, the combined company’s clinical studies
must be conducted with product candidates which are produced under cGMP regulations. The combined company’s failure to comply with
these regulations may require the combined company to repeat clinical studies, which would delay the regulatory approval process.

The combined company may not be able to
secure and maintain research institutions to conduct its clinical trials.

The combined company relies
on research institutions to conduct its clinical trials. Specifically, the limited number of centers experienced with cell therapy product
candidates heightens its dependence on such research institutions. Its reliance upon research institutions, including hospitals and clinics,
provides it with less control over the timing and cost of clinical trials and the ability to recruit subjects. If the combined company
is unable to reach agreements with suitable research institutions on acceptable terms, or if any resulting agreement is terminated, it
may be unable to quickly replace the research institution with another qualified institution on acceptable terms. The combined company
may not be able to secure and maintain suitable research institutions to conduct its clinical trials, which could have a material adverse
effect on its business and prospects.

The combined company and its collaborators
and contract manufacturers are subject to significant and ongoing regulation with respect to manufacturing its drug substances. The manufacturing
facilities on which it relies may not continue to meet regulatory requirements and have limited capacity.

Manufacturers and their facilities
are required to comply with extensive regulatory requirements, including ensuring that quality control and manufacturing procedures conform
to cGMPs. These cGMP regulations cover all aspects of manufacturing relating to its product candidates. These regulations govern manufacturing
processes and procedures (including record keeping) and the implementation and operation of quality systems to control and assure the
quality of investigational product candidates and products approved for sale. Poor control of production processes can lead to the introduction
of contaminants or to inadvertent changes in the properties or stability of its product candidates that may not be detectable in final
product testing. We, its collaborators or its contract manufacturers must supply all necessary documentation in support of an BLA or MAA
on a timely basis and must adhere to GLP and cGMP QSR regulations enforced by the FDA and other regulatory authorities through their facilities
inspection program. Some of the combined company’s contract manufacturers have never produced a commercially approved pharmaceutical
product and therefore have not obtained the requisite regulatory authority approvals to do so. The facilities and quality systems of some
or all of its collaborators and third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations
as a