Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 21

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 21
---
 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
we will successfully obtain such designation for Quilience and/or Nolazol. In addition, while such designations could expedite the development
or approval process, they generally do not change the standards for approval. Even if we obtain such designations for one or more of our
product candidates, there can be no assurance that we will realize their intended benefits.

For example, we may seek a
Breakthrough Therapy designation from the FDA for one or more of our 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 we believe one of our 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 our
product candidates qualify for Breakthrough Therapy designation, the FDA may later decide that such product candidates no longer meet
the conditions for qualification.

We may also seek Fast Track
designation from the FDA for some of our 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 we believe a particular