Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 34

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 34
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 sole manufacturer
for mazindol. Any delay, price increase or unavailability of mazindol could materially adversely affect our ability to conduct clinical
trials and, if this were to occur after we obtained commercialization and marketing approval, could cause us to cease operations.

Currently we rely on a single
manufacturer for mazindol for our clinical trials conducted to date pursuant to purchase orders and do 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 we are then conducting or planning to conduct. Either
such occurrence could have an adverse effect on our operations and reputation or could cause us 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,
our profit margins and sales, if any, would be greatly reduced and, assuming our 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 our supplier of mazindol.

We rely on third parties to conduct our
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 deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize
our product candidates and our business could be substantially harmed.

We have relied upon and
plan to continue to rely upon third-party CROs to monitor and manage data for our ongoing pre-clinical and clinical programs. We
rely on these parties for execution of our pre-clinical and clinical studies, and control only certain aspects of their activities.
Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol,
legal, regulatory and scientific standards and our reliance on the CROs does not relieve us of our regulatory responsibilities. We
and our CROs and other vendors are required to comply with current cGMP