Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 145

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 145
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 additional pre -clinicaland or clinical trials, provide additional data and information and meet additional standards for regulatory approval. If this were to occur, the time and financial resources required to obtain FDA approval, and complications and risks associated with FDA approval, would substantially increase. NLS may need to obtain additional funding, which could result in significant dilution to the ownership interests of its then existing shareholders to the extent NLS issues equity securities or convertible debt. NLS cannot assure you that NLS would be able to obtain such additional financing on terms acceptable to us, if at all. Moreover, inability to pursue the Section 505(b)(2) regulatory pathway could result in new competitive product candidates reaching the market faster than its product candidates, which could materially adversely impact its competitive position and prospects. Even if NLS is allowed to pursue the Section 505(b)(2) regulatory pathway, NLS cannot assure you that its product candidates will receive the requisite approvals for commercialization. NLS may seek designations for its product candidates with the FDA and other comparable regulatory authorities that are intended to confer benefits such as a faster development process or an accelerated regulatory pathway, but there can be no assurance that NLS will successfully obtain such designations. In addition, even if one or more of its product candidates are granted such designations, NLS may not be able to realize the intended benefits of such designations. The FDA, and other comparable regulatory authorities, offer certain designations for product candidates that are intended to encourage the research and development of pharmaceutical products addressing conditions with significant unmet medical need. These designations may confer benefits such as additional interaction with regulatory authorities, a potentially accelerated regulatory pathway and priority review. There can be no assurance that NLS will successfully obtain such designation for Quilience and/or Nolazol. In addition, while such designations could expedite the development or approval process, they generally do not change the standards for approval. Even if NLS obtains such designations for one or more of its product candidates, there can be no assurance that NLS will realize their intended benefits. For example, NLS may seek a Breakthrough Therapy designation from the FDA for one or more of its product candidates. A Breakthrough Therapy designation is defined as a therapy that is intended, alone or in combination with one or more other therapies, to treat a serious or life -threateningdisease or condition, if preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects