Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 103

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 103
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, designation from the FDA for some of its product candidates. As described in Section 3033 of the
21stCentury Cures Act, a drug is eligible for RMAT designation if: the drug is a regenerative medicine therapy, which is defined
as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies
or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code
of Federal Regulations; the drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition.
The FDA has broad discretion whether or not to grant this designation, so even if Kadimastem believes a particular product candidate is
eligible for this designation, there can be no assurance that the FDA would decide to grant it. Even if Kadimastem does receive RMAT designation,
Kadimastem may not experience a faster development process, review or approval compared to conventional FDA procedures, and receiving
a RMAT Designation does not provide assurance of ultimate FDA approval. The FDA may withdraw RMAT designation if it believes that the
designation is no longer supported by data from its clinical development program.

Kadimastem may also seek
Fast Track designation from the FDA for some of its product candidates. If a therapy is intended for the treatment of a serious or
life-threatening condition and the therapy demonstrates the potential to address unmet medical needs for this condition, the therapy
sponsor may apply for Fast Track designation. The FDA has broad discretion whether or not to grant this designation, so even if it
believes a particular product candidate is eligible for this designation, there can be no assurance that the FDA would decide to
grant it. Even if Kadimastem does receive Fast Track designation, it may not experience a faster development process, review or
approval compared to conventional FDA procedures, and receiving a Fast Track Designation does not provide assurance of ultimate FDA
approval. The FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from its
clinical development program.

If Kadimastem’s manufacturing, research
and development and operational facilities are damaged or destroyed, its business and prospects would be adversely affected.

If its manufacturing, research
and development and operational facilities, or the equipment in such facilities