Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 102

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 102
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 be able to realize the intended benefits of such designations.

The FDA, and other comparable
regulatory authorities, offer certain designations for drug substances and product candidates that are intended to encourage the research
and development of pharmaceutical products addressing conditions with significant unmet medical need. These designations may confer benefits
such as additional interaction with regulatory authorities, a potentially accelerated regulatory pathway and priority review. There can
be no assurance that Kadimastem will successfully obtain such designation for Kadimastem’s products. In addition, while such designations
could expedite the development or approval process, they generally do not change the standards for approval. Even if Kadimastem obtains
such designations for one or more of its product candidates, there can be no assurance that it will realize their intended benefits.

For example, Kadimastem may
seek a Breakthrough Therapy designation from the FDA for one or more of its product candidates. A Breakthrough Therapy designation is
defined as a therapy that is intended, alone or in combination with one or more other therapies, to treat a serious or life-threatening
disease or condition, if preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
For therapies that have Breakthrough Therapy designation, interaction and communication between the FDA and the sponsor of the trial can
help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control
regimens. Therapies with Breakthrough Therapy designation from the FDA are also eligible for accelerated approval. Designation as a Breakthrough
Therapy is within the discretion of the FDA. Accordingly, even if Kadimastem believes one of Kadimastem’s drug substances and
product candidates meets the criteria for Breakthrough Therapy designation, the FDA may disagree and instead determine not to make such
designation. In any event, the receipt of a Breakthrough Therapy designation for a product candidate may not result in a faster development
process, review or approval compared to therapies considered for approval under conventional FDA procedures and does not assure ultimate
approval by the FDA. In addition, even if one or more of Kadimastem’s drug substances and 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