Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 32

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 32
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 minimally invasive
procedure in which encapsulated islets with long-term glucose responsiveness can treat diabetes without the need for immunosuppression
or exogenous insulin supplementation.

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In-Scaffold-IsletRx Plus

Although alginate microcapsules
provide immuno-isolation, their surgical retrievability might be difficult. To ensure removal of IsletRx cells if needed, it is possible
to implant them in a bioengineered device to enable it. The device is a 3D printed scaffold containing encapsulated IsletRxcells.
The 3D printing process, called melt electrospinning writing is a relatively novel solvent-less process that enables the design and fabrication
of micrometer-thin fibres with highly controllable architectures and patterns manufactured at the University of Queensland, Australia.
Preclinical results demonstrated that encapsulated islets placed in scaffolds and implanted subcutaneously or intraperitoneally, produced
human insulin and maintained viability and identity for study duration (~3 months). Future studies are expected to optimize the efficacy
of this delivery strategy. In these studies, a dose response study is planned, to analyze the minimal effective dose needed to achieve
the desired therapeutic effect, which is normoglycemic levels of glucose.

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License Agreements

In August 2009, Kadimastem
entered into a license agreement with Yeda Research and Development Ltd., or Yeda, a subsidiary of the Weizmann Institute, or the License
Agreement, under which Kadimastem received a license to use their invention, patents and knowledge for the purposes of developing, manufacturing,
marketing and selling stem cell-based drugs and treatments for diabetes and neuronal diseases, and in providing various drug development
services, including drug scanning. The License Agreement stipulates payments to be made to Yeda in accordance with certain milestones
as well as royalty payments beginning from the first commercial sale of a product. Specifically, with respect to milestones reached, Kadimastem
will pay the following: (a) annual license fees in the amount of $20,000, which Kadimastem began paying from the fourth year of the Agreement
(Kadimastem is entitled to deduct the annual license fee from the royalties paid by Kadimastem each year); (b) a total of $650,000 after
reaching sales of products (by Kadimastem and/or sublicensees, cumulatively) in the amount of