Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 239

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 239
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 the
conduct of our business; provided, however, that we may require additional space and facilities as our business expands.

ITEM 4A. UNRESOLVED
STAFF COMMENTS

None.

ITEM 5. OPERATING
AND FINANCIAL REVIEW AND PROSPECTS

The
following discussion and analysis should be read in conjunction with our financial statements and related notes included elsewhere in
this annual report. This discussion and other parts of this annual report contain forward-looking statements based upon current expectations
that involve risks and uncertainties. Our actual results and the timing of selected events could differ materially from those anticipated
in these forward-looking statements as a result of several factors, including those set forth under Item 3. D. “ Risk Factors”
and elsewhere in this annual report. This discussion does not give effect to the possible impacts of the Merger.

Overview

We
are an emerging biopharmaceutical company engaged in the discovery and development of life-improving drug therapies to treat rare and
complex CNS disorders who have unmet medical needs.

Our
lead compound mazindol, a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist, in a proprietary ER formulation,
is being developed for the treatment of narcolepsy (lead indication) and ADHD (follow-on indication). We believe that this dual mechanism
of action will also enable Mazindol ER to provide potential therapeutic benefits in other rare and complex CNS disorders. CNS disorders
are a diverse group of conditions that include neurological, psychiatric, and substance use disorders. Recently, we launched a preclinical
program evaluating Mazindol ER as a treatment for fentanyl dependence, aiming to offer a non-opioid alternative in combating the opioid
crisis.

Our
Dual Orexin Receptor Agonist, or DOXA, platform has made significant strides. The development of AEX-41 and AEX-2 compounds showcases
our dedication to addressing unmet needs in sleep-wake disorders. Preliminary studies have yielded promising results, reinforcing our
confidence in these compounds’ potential to transform patient care.

We have no products approved
for commercialization and have never generated any revenue from product sales. Biopharmaceutical product development is a highly speculative
undertaking and involves a substantial degree of risk. It may be several years, if ever, before we complete pivotal clinical studies and
have a product candidate approved for commercialization and we begin to generate revenues and royalties from product sales. We have also
incurred significant operating