Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 424

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 424
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 the third quarter of 2025, respectively Encap -IsletRxPlus. 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 IsletRxPlus cells. The 3D printing process, called melt electrospinning writing is a relatively novel solvent -lessprocess that enables the design and fabrication of micrometer -thinfibers 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). Current Future studies aim to optimize this delivery strategy. In these studies, a dose response study is planned, to analyze the minimal dose needed to achieve the desired effect, which is normal levels of glucose. 216 Key Commercial Agreements License Agreement with Yeda Research and Development Ltd. 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 -baseddrugs and treatments for diabetes and neuronal diseases, and in providing various drug development services, including drug scanning. The 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, at a royalty rate of 10% to 14% of the “Net Sales” (as defined in the License Agreement) of product sold. The royalty payments expire upon the earlier of 15 years from the date of the first sale of a licensed product under the License Agreement, and the expiration of Yeda’s licensed patents under the License Agreement (the “Yeda IP”). The Yeda IP expires on separate dates; on August15, 2027, December16, 2027, April13, 2029, November28, 2036, and July23, 2038, each as detailed further below under “— Intellectual Property” beginning on page 219. Specifically, with respect to milestones reached,