Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 136

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 136
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 achieving or maintaining market acceptance of the affected product candidate and could significantly harm its business, prospects, financial condition and results of operations. Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay. As drug substances and product candidates proceed through pre -clinicalstudies to late -stageclinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results and/or reduce cost of goods sold. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause its drug substances and product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the materials manufactured using altered processes. Such changes may also require additional testing, FDA or EMA notification or FDA approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of Kadimastem’s drug substances and product candidates and jeopardize its ability to commence sales and generate revenue. Legislative or regulatory healthcare reforms in the United States may make it more difficult and costly for the combined company to obtain regulatory clearance or approval of its product candidates and to produce, market and distributecombined company’s products after clearance or approval is obtained. From time to time, legislation is drafted and introduced in United States Congress, or Congress, that could significantly change the statutory provisions governing the regulatory clearance or approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations and guidance are often revised or reinterpreted 46 by the FDA in ways that may significantly affect combined company’s business and products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of the combined company’s product candidates. NLS and Kadimastem cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on the combined company’s business in the future. Such changes could, among other things, require: •changes to manufacturing methods; •change in protocol design; •additional treatment arm (control); •recall, replacement, or discontinuance of one or more of the combined company’s products; and •additional recordkeeping. In addition, in the United States, there have been a number of legislative and regulatory proposals to change the health care system in ways that could