Company: NCEL
Filing Date: 2025-10-24
Form Type: POS AM
Source: 0001213900-25-102149
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Company: NewcelX Ltd.
Filing Date: 2025-10-24
Form: POS AM
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 that they believe to be reliable, but they do not guarantee the accuracy or completeness of the information.

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PROSPECTUS SUMMARY</div>

This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our securities. Before you decide to invest in our securities, you should read the entire prospectus carefully, including the sections titled “Risk Factors”, “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes included elsewhere in this prospectus.

Our Company

We
are a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare
and complex central nervous system (“CNS”), and disorders with unmet medical needs. Our lead compound mazindol, a triple monoamine
reuptake inhibitor and partial orexin receptor 2 agonist, in a proprietary extended-release (“ER Formulation”), is being developed
for the treatment of narcolepsy (lead indication) and attention deficit hyperactivity disorder (“ADHD”), (follow-on indication).
We believe that this dual mechanism of 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