Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 67

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 67
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 caused to patients.                                                                                                            |

Any of these events could
prevent it from achieving or maintaining market acceptance of the affected product candidate and could significantly harm its business,
prospects, financial condition and results of operations.

<div align='center'>48</div>

Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.

As drug substances and product
candidates proceed through pre-clinical studies to late-stage clinical trials towards potential approval and commercialization, it is
common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an
effort to optimize processes and results and/or reduce cost of goods sold. Such changes carry the risk that they will not achieve these
intended objectives. Any of these changes could cause its drug substances and product candidates to perform differently and affect the
results of planned clinical trials or other future clinical trials conducted with the materials manufactured using altered processes.
Such changes may also require additional testing, FDA or EMA notification or FDA approval. This could delay completion of clinical trials,
require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay
approval of Kadimastem’s drug substances and product candidates and jeopardize its ability to commence sales and generate revenue.

Kadimastem will need to obtain FDA approval of any proposed names for its drug substances that gain marketing approval, and any failure or delay associated with such naming approval may adversely impact its business.

Any name Kadimastem intends
to use for its drug substances and product candidates will require approval from the FDA regardless of whether Kadimastem has secured
a formal trademark registration from the U.S. Patent and Trademark Office, or the U.S. PTO. The FDA typically conducts a review of proposed
product names, including an evaluation of whether proposed names may be confused with the names of other medical products and technology.
The FDA may object to any product name it submits if it believes the name inappropriately implies medical claims. If the FDA objects to
any of its proposed product names, Kadimastem may be required to adopt an alternative name for its product candidates, which could result
in further evaluation of proposed names with the potential for additional delays and costs.

Kadimastem may seek designations for its drug substances and product candidates with the FDA and other comparable regulatory authorities that are intended to confer benefits such as a faster development process or an accelerated regulatory pathway, but there can be no