Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 199

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 199
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 value-driven approach to broaden our sleep-related product portfolio. Our team has extensive experience in CNS research and a strong record of publication in peer-reviewed journals a...  

Manufacturing and Suppliers

We do not own or operate manufacturing
or distribution facilities for the production of our product candidates and we currently rely, and expect to continue to rely, on third
parties for the manufacturing, packaging, labelling and distribution of our product candidates for pre-clinical and clinical testing,
as well as for future commercial manufacturing, if our product candidates receive marketing approval. We require all of our contract manufacturing
organizations to conduct manufacturing activities in compliance with cGMP requirements and although we rely on manufacturers, we have
engaged with consultants with significant technical, manufacturing, analytical, quality, regulatory, including cGMP, and project management
experience to oversee our third-party manufacturers. This approach allows us to maintain a more efficient infrastructure while enabling
us to focus our expertise on developing and commercializing our product candidates. Reliance on third-party providers may expose us to
more risk than if we were to manufacture product candidates ourselves.

In December 2019, we
entered into an agreement with Cambrex High Point for the production of our drug substance, pursuant to which, upon completion of
purchase orders, Cambrex High Point may manufacture mazindol for us. We obtain our supply of the finalized drug product from another
third-party manufacturer, CoreRX with whom we signed an agreement in February 2021. We do not currently have any contracts binding
us to use supply or production services provided for under such agreements. We expect to continue to rely on third-party
manufacturers to produce sufficient quantities of our product candidates and their component raw materials for use in our internal
research efforts and clinical trials and in relation to any future commercialization of our product candidates. Our third-party
manufacturers are responsible for obtaining the raw materials necessary to manufacture our product candidates, which we believe are
readily available from more than one source. Additional third-party manufacturers are and will be used to formulate, fill, label,
package and distribute investigational drug products and eventually our products, if and when our product candidates receive
approval. This approach allows us to maintain a more efficient infrastructure while enabling us to focus our expertise on developing
and commercializing our product candidates. We believe that our current supplier and manufacturers have the capacity to support both
clinical supply and commercial-scale production, but we do not have any formal agreements at this time for such supply and
production