Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 129

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 129
---
 may adversely affect the holdings or the rights of holders of its securities and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of its NLS Common Shares or its publicly traded Warrants to decline. The incurrence of indebtedness could result in increased fixed payment obligations, and NLS may be required to agree to certain restrictive covenants, such as limitations on its ability to incur additional debt, limitations on its ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact its ability to conduct its business. NLS could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable, and NLS may be required to relinquish rights to some of its technologies or product 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 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. 42