Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 402

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 402
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 need, and may seek to in -licensefrom or collaborate with third parties to develop product candidates that NLS believes are highly differentiated, promising therapeutic candidates that address major unmet clinical needs. 199 NLS’s scientifically rigorous approach to evaluating new opportunities includes a robust asset evaluation of key factors, including the unmet medical need, biological rationale, safety profile, as determined by applicable regulatory agencies, feasibility of clinical development, potential for accelerated development path, regulatory approval, intellectual property position, competitive landscape and commercial potential. Manufacturing and Suppliers NLS does not own or operate manufacturing or distribution facilities for the production of its product candidates and NLS currently relies, and expects to continue to rely, on third parties for the manufacturing, packaging, labelling and distribution of its product candidates for pre -clinicaland clinical testing, as well as for future commercial manufacturing, if its product candidates receive marketing approval. NLS requires all of its contract manufacturing organizations to conduct manufacturing activities in compliance with cGMP requirements and although NLS relies on manufacturers, it has engaged with consultants with significant technical, manufacturing, analytical, quality, regulatory, including cGMP, and project management experience 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 N