Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 198

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 198
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vanse®, Adderall®and Mydayis®), Neos Therapeutics
Ltd. (Adzenys®XR-ODT and Contempla®XR-ODT), Eli Lilly & Co. (Strattera®), Novartis
AG (Focalin®) and Janssen Pharmaceutica N. V., a subsidiary of Johnson & Johnson (Concerta®). The below
table provides a more in-depth breakdown of Nolazol against certain competing pharmaceutical products, based on the current scheduling
of mazindol by the DEA.

Research and Development Strategy

Subject to obtaining
sufficient funding, we aim to continue conducting research and development activities to expand the commercial potential of both
Quilience and Nolazol, while continuing to examine the development of compounds that could serve as effective treatments for other
CNS disorders. We sponsor and conduct clinical research activities with investigators and institutions to measure key clinical
outcomes that are necessary in order for us to be able to file an NDA with the FDA and equivalent filings with other regulatory
authorities. Our research and development efforts are focused primarily in the following areas and serve as a basis for future
development, if any, of a more diverse product pipeline, of which certain product candidate leads, such as NLS-4 are in preclinical
development stages. As we navigate the competitive landscape of our industry, while focusing on development of our product
candidates, we also intend to continually pursue out-licensing agreements and asset sale transactions that we believe will allow us
to drive greater value for our shareholders. Key elements of our research and development strategy include the following:

  Efficiently                                                                                                                             

  Find partners for out-licensing and asset sale agreements. While we continue with our goal of progressing our product candidates, Quilience and Nolazol, on our own into further clinical develop...  
 ────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────
  Reduce clinical and regulatory risk, limit development costs, and accelerate time to market. Our product candidates, Quilience and Nolazol, incorporate a known molecule in a proprietary CR and ...  

  Develop products with differentiated pharmacological profiles. We are developing product candidates with dual mechanisms of action. For example, Quilience and Nolazol utilize a dual mechanism o...  

  Maximize the therapeutic potential of our                                                                                                                                                             
  Deploy our