Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 399

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 399
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 to oversee its third -partymanufacturers. This approach allows NLS to maintain a more efficient infrastructure while enabling NLS to focus its expertise on developing and commercializing its product candidates. Reliance on third -partyproviders may expose NLS to more risk than if it was to manufacture product candidates itself. In December 2019, NLS entered into an agreement with Cambrex High Point for the production of NLS’s drug substance, pursuant to which, upon completion of purchase orders, Cambrex High Point may manufacture mazindol for NLS. NLS obtains its supply of the finalized drug product from another third -partymanufacturer, CoreRX with whom NLS signed an agreement in February 2021. NLS does not currently have any contracts binding it to use supply or production services provided for under such agreements. NLS expects to continue to rely on third -partymanufacturers to produce sufficient quantities of its product candidates and their component raw materials for use in its internal research efforts and clinical trials and in relation to any future commercialization of its product candidates. NLS’s third -partymanufacturers are responsible for obtaining the raw materials necessary to manufacture NLS’s product candidates, which NLS believes are readily available from more than one source. Additional third -partymanufacturers are and will be used to formulate, fill, label, package and distribute investigational drug products and eventually NLS’s products, if and when NLS’s product candidates receive approval. This approach allows NLS to maintain a more efficient infrastructure while enabling it to focus its expertise on developing and commercializing its product candidates. NLS believes that its current supplier and manufacturers have the capacity to support both clinical supply and commercial -scaleproduction, but NLS does not have any formal agreements at this time for such supply and production, and NLS may also elect to enter into agreements with additional or alternative parties in the future. 199 Commercialization, Sales and Marketing Given its stage of development, NLS does not currently have an established internal sales, marketing or distribution infrastructure. If its product candidates are approved for marketing, NLS intends to commercialize its product candidates either alone or in partnership with others, where appropriate, to maximize the value of its product candidates. NLS expects to build its commercial infrastructure using a focused and efficient approach, initially, establishing market access, sales and marketing capabilities in a targeted manner that is appropriate for the relevant product opportunity. NLS believes that this approach will allow it to effectively reach patients and physicians and to maximize the commercial potential of its product