Company: NCEL
Filing Date: 2025-09-25
Form Type: F-1
Source: 0001213900-25-091697
Chunk: 5

Company: NewcelX Ltd.
Filing Date: 2025-09-25
Form: F-1
Chunk 5
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 action will also enable mazindol ER Formulation to provide potential therapeutic benefit in other
rare and complex CNS disorders. CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance
use disorders. However, treatment options for these conditions are often limited, inadequate or nonexistent, and the development of new
CNS treatments generally trails behind other therapeutic areas. We are pursuing the development of the next generation of CNS therapies
with high medical impact to address this critical and growing unmet need. Our dual development strategy is designed to optimize the outcome
of our clinical programs by developing new chemical entities from known molecules with strong scientific rationale, and also by re-defining
previously approved molecules with well-established tolerability and safety profiles, as determined by applicable regulatory agencies.
We believe that our streamlined clinical development approach has the potential to advance our product candidates rapidly through early-stage
clinical trials, while carrying an overall lower development risk. A lower development risk, we believe, exists with respect to the development
of our lead product candidate, Quilience, and follow-on product candidate, Nolazol, due to their use of mazindol as the active ingredient,
which was previously approved and marketed in the United States, Japan and Europe to manage exogenous obesity (obesity caused by overeating).
The Merger Agreement (as defined below) provides that, upon the terms and subject to the conditions thereof, following the Closing (as
defined below), we shall work diligently to dispose of any Legacy Assets (as defined in the Merger Agreement), which excludes the Dual
Orexin Agonist platform (the “DOXA Platform”). The DOXA Platform includes AEX-041. It is important to note that AEX-041 is
currently in the preclinical stage of development. This means that the candidate is undergoing early laboratory studies to evaluate its
safety profile and pharmacological properties, and it has not yet been tested in human clinical trials. Consequently, its efficacy, safety
and potential for regulatory approval remain subject to further research and development.

We
were incorporated on June 10, 2015, as a Swiss limited company. Our registered office and principal executive office are located at The
Circle 6, 8058 Zurich, Switzerland. Our telephone number in Switzerland is +41.44.512.2150 and our website address is https://nlspharma.com.
The information contained on, or that can be accessed through, our website is not part of this prospect