Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 94

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 94
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 local and federal U.S. regulations, vehicular crashes, rising prices of transportation vendors, fuel prices, taxes, license and registration
fees, insurance premiums, self-insurance levels, difficulty in recruiting and retaining qualified drivers, disruption of its technology
systems, equipment supply, equipment quality, and increasing equipment and operational costs. Its failure to successfully manage its logistics
and fulfillment process could cause a disruption in its inventory supply chain and distribution, which may adversely affect its operating
results and financial condition.

Kadimastem relies on a limited number of suppliers or, in some cases, single suppliers, for some of its laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers on a cost-effective basis, or at all.

Kadimastem sources components
of its technology from third parties and certain components are sole sourced. Obtaining substitute components may be difficult or require
Kadimastem to re-design its products. Any natural or other disasters, such as wild fire, earthquake, acts of war or terrorism, shipping
embargoes, labor unrest or political instability, failure in supply or other logistical channels, electrical outages or other reasons
or similar events at its third-party suppliers’ facilities that cause a loss of manufacturing capacity or a reduction in the quality
of the items manufactured would heighten the risks that Kadimastem faces. Changes to, failure to renew or termination of Kadimastem’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 Kadimastem’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.

Kadimastem 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, Kadimastem may not be able to obtain regulatory approval for or commercialize its product candidates and its business could be substantially harmed.

Kadimastem 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. Kadimastem
relies on these parties for execution of its pre-clinical and clinical studies, and control only certain aspects of their