Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 95

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 95
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 activities.
Nevertheless, Kadimastem is responsible for ensuring that each of its studies is conducted in accordance with the applicable protocol,
legal, regulatory and scientific standards and its reliance on the CROs does not relieve it of its regulatory responsibilities. Kadimastem
and its CROs and other vendors are required to comply with current cGMP, 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 its product candidates in clinical
development. Regulatory authorities enforce these regulations through periodic inspections of study sponsors, principal investigators,
study sites and other contractors. If Kadimastem or any of Kadimastem’s CROs or vendors fail to comply with applicable regulations,
the clinical data generated in its clinical studies may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities
may require Kadimastem to perform additional clinical studies before approving its marketing applications. It cannot assure you that upon
inspection by a given regulatory authority, such regulatory authority will determine that any of its clinical studies comply with GCP
regulations. In addition, Kadimastem’s clinical studies must be conducted with product candidates which are produced under cGMP
regulations. Kadimastem’s failure to comply with these regulations may require Kadimastem to repeat clinical studies, which would
delay the regulatory approval process.

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Kadimastem may not be able to secure and maintain research institutions to conduct its clinical trials.

Kadimastem 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 Kadimastem 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. Kadimastem 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.

Kadimastem and its collaborators and contract manufacturers