Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 127

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 127
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 loss of manufacturing capacity or a reduction
in the quality of the items manufactured would heighten the risks that the combined company faces. Changes to, failure to renew or termination
of the combined company’s existing agreements or its inability to enter into new agreements with other suppliers could result in
the loss of access to important components of the combined company’s tests and could impair, delay or suspend its commercialization
efforts. Its failure to maintain a continued and cost-effective supply of high-quality components could materially and adversely harm
its business, operating results, and financial condition.

The combined company relies on third parties
to conduct its pre-clinical and clinical studies and perform other tasks for itself. If these third parties do not successfully carry
out their contractual duties, meet expected deadlines or comply with regulatory requirements, the combined company may not be able to
obtain regulatory approval for or commercialize its product candidates and its business could be substantially harmed.

The combined company has relied
upon and plan to continue to rely upon third-party CROs to monitor and manage data for its ongoing pre-clinical and clinical programs.
The combined company relies on these parties for execution of its pre-clinical and clinical studies, and control only certain aspects
of their activities. Nevertheless, the combined company 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. The combined company 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 the combined company or any of the combined company’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 the combined company 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