Company: NCEL
Filing Date: 2025-02-25
Form Type: 425
Source: 0001213900-25-016794
Chunk: 1

Company: NewcelX Ltd.
Filing Date: 2025-02-25
Form: 425
Chunk 1
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em and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment

Companies Advance Collaborative Clinical Development of iTOL-102: A Potential

Cure for Diabetes Without the Need for Chronic Life-long Immune Suppression</div>

ZURICH, SWITZERLAND and NESS ZIONA, ISRAEL, February
25, 2025. NLS Pharmaceutics Ltd. (Nasdaq: NLSP”) (“NLS”) and Kadimastem Ltd. (“Kadimastem”), a clinical-stage
company specializing in “off-the-shelf” allogeneic cell therapy products for neurodegenerative diseases and diabetes, in collaboration
with iTolerance Inc. (“iTolerance”), a U.S. based regenerative medicine company, announced today the result from the Type
B pre-IND meeting held by Kadimastem and iTolerance with a committee of the U.S Food and Drug Administration (“FDA”) on February
24, 2025, regarding the development of iTOL-102, a potential cure for diabetes that would not require life-long chronic immune system
suppression. iTOL-102 is an investigational biologic for the treatment and potential cure of Type 1 Diabetes consisting of Kadimastem’s
allogenic human stem cell-derived pancreatic islets (IsletRx cells) combined with iTolerance’s immunomodulator (iTOL-100).

Kadimastem and iTolerance believe that the completion
of the pre-IND meeting is a significant milestone toward the clinical development of iTOL-102, an on-going collaborative research initiative
between iTolerance and Kadimastem, funded in part by grants received from the Israel-U.S. Binational Industrial Research and Development
Foundation.

iTOL-102 was evaluated at the fast-track center
for testing at the Diabetes Research Institute (“DRI”) at the University of Miami School of Medicine, where it was designated
as a potential breakthrough transplantation approach for the treatment of Type 1 Diabetes, as the novel combination of tolerance-inducing
agent and human stem cell-derived islets. iTOL-102 demonstrated functional insulin release and disease reversal in an animal model, with
full compatibility between IsletRx cells and iTOL-100.

Prior to the meeting with the FDA, Kadimastem
and iTolerance received a preliminary response document from the FDA, providing critical feedback on their current preclinical and clinical
development plans. This guidance is instrumental