Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 26

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 26
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 be entitled to a period of marketing exclusivity, which precludes the FDA or the EMA from approving another marketing application
for the same drug for that time period, except in limited circumstances. If another sponsor receives such approval before we do (regardless
of our orphan drug designation), we will be precluded from receiving marketing approval for our product for the applicable exclusivity
period. The applicable period is seven years in the United States and ten years in the EU, which may be extended by six months and two
years, respectively, in the case of product candidates that have complied with the respective regulatory agency’s agreed upon PIP.
The exclusivity period in the EU can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if
the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be revoked if any regulatory
agency determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity
of the drug to meet the needs of patients with the rare disease or condition.

Even if we obtain orphan drug
exclusivity for a product candidate, that exclusivity may not effectively protect the product candidate from competition because different
drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA may subsequently approve another drug for
the same condition if the FDA concludes that the latter drug is not the same drug or is clinically superior in that it is shown to be
safer, more effective or makes a major contribution to patient care. In the EU, marketing authorization may be granted to a similar medicinal
product for the same orphan indication if:

  the second applicant can establish in its application that its medicinal product, although similar to the orphan medicinal product already authorized, is safer, more effective or otherwise clin...  

  the holder of the marketing authorization for the original orphan medicinal product consents to a second orphan medicinal product application; or  

  the holder of the marketing authorization for the original orphan medicinal product cannot supply sufficient quantities of orphan medicinal product.  

Risks Related to Our Financial Condition and
Capital Requirements

Our financial statements for the year ended
December 31, 2024, contained a disclosure in Note 1 regarding substantial doubt about our ability to continue as a going concern. This going
concern disclosure in Note 1 of financial statements could prevent us from obtaining new financing on reasonable terms or at all and risk
our ability to continue operating as a going concern.

To