Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 173

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 173
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have been diagnosed with narcolepsy with cataplexy.

As agreed with the FDA, we
intend to submit the NDA for Quilience as a new NDA. Nevertheless, a large amount of the original NDA data will be used for this submission.
To license the original mazindol data, we entered into an agreement with Novartis in March 2021 to obtain all preclinical and clinical
data for studies previously conducted on mazindol by Novartis. This data may potentially provide us another avenue to streamline and/or
reduce the costs of our preclinical and clinical programs. Our ability to rely on the FDA’s previous findings of safety studies
published in the scientific literature, and the extent to which licensed innovator data may be utilized will depend on our ability to
demonstrate a scientific bridge to Mazindol ER from the previous formulation.

In November 2022, we launched
an individual Paid-for Named Patient Program, or NPP, to provide access to Mazindol ER for the treatment of IH in Europe where this medication
would not otherwise be available for this indication in certain countries. The NPP for IH was launched in the United Kingdom and we were
expected to expand to other countries including France, Italy and Switzerland. This NPP was terminated in May 2023 for lack of performance
of Calcog (Caligor Coghlan Ltd.), the service provider in charge of the development and execution of this program in Europe. We partnered
with a third-party pharmaceutical company to expand access, early access and compassionate use programs to provide treatment of IH with
Mazindol ER where it would otherwise not be available.

In January 2023, we announced
a technology patent grant covering Mazindol ER for treatment of ADHD and IH in Hong Kong. In October 2024, we announced our patent grant
covering Mazindol ER for the treatment of heroin dependence in Japan. This further supports our global strategy with key patents granted
the following major markets: Hong Kong, Japan, South Korea, the U. S., Europe & Canada.

Compassionate Use Objectives in CDH1in Europe

While “compassionate
use” originally was understood to imply that the drug product is supplied for free, there is a growing understanding with policymakers,
payers and patient organizations, that paid-for CUPs are justifiable. In Europe and other regions of the world (excluding the United States),
it is recognized that CUP funding can provide an