Company: NCEL
Filing Date: 2025-02-25
Form Type: 425
Source: 0001213900-25-016794
Chunk: 2

Company: NewcelX Ltd.
Filing Date: 2025-02-25
Form: 425
Chunk 2
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 in moving forward with the next stages of development. Based on the feedback provided
at the pre-IND meeting, Kadimastem and iTolerance are now updating their plans for a safety toxicology study and the preparation of a
First-in-Human clinical trial.

Kadimastem believes its collaboration with iTolerance
signifies a potentially transformative step in diabetes treatment, paving the way towards the potential development of iTOL-100 and requesting
regulatory approvals for commercialization of a potential cure for type 1 diabetes.

iTOL-100 is an immunomodulatory microgel technology
being developed by iTolerance designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation
of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with
Kadimastem’s IsletRx human stem cell-derived islets.

Kadimastem’s IsletRx is a clinical-grade
product candidate comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived
islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical
shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the
necessary amounts of insulin and glucagon.

Dr. Anthony Japour, Chief Executive Officer of iTolerance, commented,
“I believe that the feedback from the FDA is a critical milestone in the development of iTOL-102, and we are encouraged by their
support for our innovative approach to treating Type 1 diabetes. We believe that the successful outcome of this meeting validates our
commitment to bring a game-changing therapy to patients, one that could ultimately eliminate the need for chronic life-long immunosuppression.
We look forward to continuing our collaboration with Kadimastem and working closely with the FDA.”

Alex Zwyer, CEO of NLS, commented, “I
believe that the news demonstrates the strength of the proposed merger of NLS and Kadimastem and its technology platform to build a healthy,
strong merged company that will benefit shareholders.”

Kadimastem Executive Chairman and CEO Ronen Twito said, “The promising results from the fast-track center for testing at the DRI, combined with the comprehensive studies
conducted by iTolerance and Kadimastem, enabled us to complete this