NewcelX Ltd.

NewcelX is a clinical-stage pharmaceutical company that develops and manufactures "off-the-shelf," allogeneic, proprietary cell products. These products are based on its technology platform for expanding and differentiating human embryonic stem cells (hESCs) into functional cells. The company's primary focus is on developing and commercializing stem cell-based therapies to cure Type 1 Diabetes (T1D) using stem cell-derived islets. It also aims to replace, restore, and repair diseased and malfunctioning cells in various degenerative diseases through transplantation of healthy, functional cells. NewcelX commercializes proprietary cell lines optimized for treating ALS and other neurodegenerative diseases. Additionally, it utilizes the DOXA small molecules platform for clinical development of drug candidates, primarily for narcolepsy, neuroinflammation, and Diabetes-Associated Neurological Disorders (DANS). NewcelX is primarily developing two cell therapy products. NCEL-101 is the company's lead program for diabetes treatment, consisting of enriched pancreatic islet cells, mainly functional, insulin and glucagon producing and releasing cells. It is intended to treat and potentially cure patients with Type 1 diabetes and possibly Type 2 insulin-dependent diabetes. Other diabetes development programs are in the pipeline, including co-development with academic or commercial entities. AstroRx is NewcelX's platform validation product, an off-the-shelf cryopreserved cell therapy product in clinical development for ALS treatment and in pre-clinical studies for other neurodegenerative indications. AstroRx is comprised of fully differentiated astrocytes, which are the main cells that support the Central Nervous System (CNS). NewcelX is also developing the DOXA (Dual Orexin-Receptor Agonist) small molecules platform for several target indications, including sleep disorders (narcolepsy, idiopathic insomnia), neurodegenerative/neuroinflammation diseases (such as -synucleinopathies), and DANS.