Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 133

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 133
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, patients and third -partypayors. 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 the near future; •pricing and cost effectiveness in relation to alternative treatments; 28 •if the product is included under physician treatment guidelines as a first-, second-, or third -linetherapy; •the strength of sales, marketing and distribution support; •the availability of third -partycoverage and adequate reimbursement and the willingness of patients to pay out -of-pocketin the absence of coverage by third -partypayors; •the strength of sales, marketing and distribution support; •the willingness of patients to pay for drugs out of pocket in the absence of third -partycoverage; 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, NLS may not generate sufficient revenue from the product, and NLS may not become or remain profitable. In addition, its efforts to educate the medical community and third -partypayors on the benefits of the product may require significant resources and may never be successful. In addition, NLS may choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment its own sales force and distribution systems or in lieu of its own sales force and distribution systems. If NLS enters into arrangements with third parties to perform sales, marketing and distribution services for its products, the resulting revenues or the profitability from these revenues to it are likely to be lower than if NLS had sold, marketed and distributed its products itself. If NLS is unable to enter into such arrangements on acceptable terms or at all, NLS may not be able to successfully commercialize any of its product candidates that receive regulatory approval. Depending on the nature of the third -party