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

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 25
---
 delayed, our target market
may be reduced and our ability to realize the full market potential of our products will likely be harmed. The inability to meet continuously
evolving regulatory standards for approval may result in our failing to obtain regulatory approval to market our current product candidates,
which could significantly harm our business, results of operations and prospects.

We may be unable to obtain or maintain orphan
drug designation for our product candidates and, even if we obtain such designation, we may not be able to realize the benefits of such
designation, including potential marketing exclusivity of our product candidates, if approved.

Regulatory authorities
in some jurisdictions, including the United States and EU, may designate drugs for relatively small patient populations as
“orphan drugs.” Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to
treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the
United States or a patient population of greater than 200,000 individuals in the United States, but for which there is no reasonable
expectation that the cost of developing the drug will be recovered from sales in the United States. In the EU, the European
Commission grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention or
treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the EU
community. Additionally, designation is granted for products intended for the diagnosis, prevention or treatment of a
life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales of
the drug in the EU would be sufficient to justify the necessary investment in developing the drug.

The FDA granted orphan drug
designation to mazindol for the treatment of narcolepsy in the United States. We also received orphan drug designation for mazindol in
the EU for the treatment of IH. This designation of a product candidate as an orphan product does not mean that any regulatory agency
will accelerate regulatory review of, or ultimately approve, that product candidate, nor does it limit the ability of any regulatory agency
to grant orphan drug designation to product candidates of other companies that treat the same indications as our product candidates prior
to our product candidates receiving exclusive marketing approval.

Generally, if a product candidate
with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation,
the drug may