Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 159

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 159
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 candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on its business, operating results and prospects. Even if NLS believes that it has sufficient funds for its current or future operating plans, NLS may seek additional capital if market conditions are favorable or if NLS has specific strategic considerations. If NLS is unable to obtain funding on a timely basis, it may be required to significantly curtail, delay or discontinue one or more of its research or development programs or the development or commercialization, if any, of any product candidates or be unable to expand its operations or otherwise capitalize on its business opportunities, as desired, which could materially affect its business, financial condition and results of operations. NLS Risks Related to its Reliance on Third Parties NLS is dependent on a sole manufacturer for mazindol. Any delay, price increase or unavailability of mazindol could materially adversely affect its ability to conduct clinical trials and, if this were to occur after NLS obtains commercialization and marketing approval, could cause it to cease operations. Currently NLS relies on a single manufacturer for mazindol for its clinical trials conducted to date pursuant to purchase orders and does not have any existing contract with such manufacturer for future supplies. The FDA requires identification of raw material suppliers in applications for approval of drug products. If mazindol were to be 43 unavailable from the specified manufacturer, FDA approval of a new manufacturer, assuming one is found, could delay the manufacture of the drug involved or delay any clinical trial NLS is then conducting or planning to conduct. Either such occurrence could have an adverse effect on its operations and reputation or could cause it to cease operations. Furthermore, there is a risk of a sole approved manufacturer significantly raising prices. If prices for mazindol or other raw materials were to be significantly increased, its profit margins and sales, if any, would be greatly reduced and, assuming its products were approved for commercialization or marketing, delay product launches, or delay clinical trials at earlier stages of development. Such price increase occurrences could be resolved by the successful FDA approval of an alternate supplier; however, such approval process can be lengthy and costly. There can be no guarantee that a resolution would be reached in the event of a significant price increase by its supplier of mazindol. NLS relies on third parties to conduct its pre-clinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected