Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 8

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 8
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 degree of market acceptance by physicians, patients, third-party payors and others in the
medical community necessary for commercial success.

The commercial success of
Quilience and/or Nolazol will depend upon the acceptance of each product by the medical community, including physicians, patients and
third-party payors. The degree of market acceptance of any approved product will depend on a number of factors, including:

  the efficacy and safety of the product;  

  the potential advantages of the product compared to available therapies;                           
  the convenience and ease of administration compared to alternative treatments;                     
  limitations or warnings, including use restrictions contained in the product’s approved labeling;  

  distribution and use restrictions imposed by the EMA, FDA, or other regulatory authority or agreed to by us as part of a mandatory or voluntary risk management plan;  

  availability of alternative treatments, including, in the case of Nolazol, a number of competitive products already approved for the treatment of ADHD or expected to be commercially launched in...  

  pricing and cost effectiveness in relation to alternative treatments;  

  if the product is included under physician treatment guidelines as a first-, second-, or third-line therapy;  

  the strength of sales, marketing and distribution support;                                                                                                                  
  the availability of third-party coverage and adequate reimbursement and the willingness of patients to pay out-of-pocket in the absence of coverage by third-party payors;  

  the strength of sales, marketing and distribution support;  

  the willingness of patients to pay for drugs out of pocket in the absence of third-party coverage; and                 
  the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies.  

If Quilience and/or Nolazol
is approved but does not achieve an adequate level of acceptance by physicians, third party payors and patients, we may not generate sufficient
revenue from the product, and we may not become or remain profitable. In addition, our efforts to educate the medical community and third-party
payors on the benefits of the product may require significant resources and may never be successful.

In addition, we may choose
to collaborate with third parties that have direct sales forces and established distribution systems, either to augment our own sales
force and distribution systems or in lieu of our own sales force and distribution systems. If we enter into arrangements with third parties
to perform sales, marketing and distribution services for our products, the resulting revenues or the profitability from these revenues
to us are likely to be lower than if