Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 11

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 11
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 will be considered medically necessary or cost-effective for a specific indication, or that
coverage or an adequate level of reimbursement will be available.

Our product candidates Quilience and Nolazol
contain the active ingredient mazindol, which is currently listed as a Schedule IV controlled substance under the Controlled Substances
Act of 1970, or CSA. Failure to maintain compliance with applicable requirements under the CSA or a change in the drug enforcement agency,
or the DEA, scheduling (e. g., from IV to III) post approval or other applicable federal or state regulations could have an adverse effect
on our operations and business.

Controlled substances are
classified by the DEA as Schedule I, II, III, IV or V, or CI, CII, CIII, CIV, and CV, substances, with CI substances considered to present
the highest risk of substance abuse and Schedule V substances the lowest risk. The active ingredient of our lead and follow-on product
candidates is mazindol, which is classified as a Schedule IV controlled substance under the CSA, and regulations of the DEA. Under the
CSA, subject to certain exemptions, every person who manufactures, distributes, dispenses, imports or exports any controlled substance
must register with the DEA.

Although the CSA’s restrictions
governing substances in CIV are not as stringent as those for substances in CI, CII or CIII, they could still limit our ability to market
and commercialize Quilience and Nolazol, if approved for marketing. In addition, failure to maintain compliance with applicable requirements
under the CSA, particularly as manifested in loss or diversion of regulated substances, can result in enforcement action that could include
civil penalties, refusal to renew registrations or quotas, revocation of registrations or quotas or criminal proceedings, any of which
could have a material adverse effect on our business, results of operations and financial condition. Individual states also regulate controlled
substances, and we along with our contract manufacturers will be subject to state regulation on distribution of these products.

Our market is subject to intense competition,
which may result in others commercializing products before or more successfully than us. If we are unable to compete effectively, Quilience
and/or Nolazol may be rendered non-competitive or obsolete, which may adversely affect our operating results.

The development and commercialization
of new products is highly competitive. Our potential competitors include major pharmaceutical companies, specialty pharmaceutical companies
and biotechnology companies worldwide with respect to Quilience