Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 69

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 69
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 product candidates qualify for Breakthrough Therapy
designation, the FDA may later decide that such drug substances and product candidates no longer meet the conditions for qualification.

Kadimastem may also seek Regenerative
Medicine Advance Therapy, or RMAT, designation from the FDA for some of its product candidates. As described in Section 3033 of the 21st
Century 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.