Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 678

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 678
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 medications and the unmet needs of patients. Quilience is being designed as an oral, once -dailytreatment, intended for long -termuse. Through the use of mazindol in Quilience and the expected benefits of our proprietary controlled -releaseformulation, we hope that regulatory agencies will conclude that Quilience has a desirable balance of efficacy, safety and tolerability to support marketing authorization. We also anticipate developing additional mazindol based ER product(s) for broader hypersomnia indications, such as IH, where there is a critical unmet need and no currently approved treatments available, in addition to other disorders, such as neurocognitive disorders implicated by EDS. Annex F-43 Quilience has been granted orphan drug designation by both the FDA and European Commission for the treatment of narcolepsy, and if approved for marketing in adults, this designation is expected to provide 7 years and 10 years of market exclusivity in the United States and Europe, respectively, and with the potential for additional market exclusivity, if and when further developed and approved in pediatrics (extended for an aggregate of 7.5 years and 12 years in the United States and Europe, respectively). Additionally, we have been granted formulation patents in several countries including the U.S., Europe, Canada and South Korea for our proprietary ER formulation, which provide patent protection through 2037. After obtaining an IND approval mid -2021, we initiated a Phase 2 clinical trial in the third quarter of 2021 to evaluate Quilience as a once -dailymonotherapy for the treatment of EDS and cataplexy, the primary symptoms of narcolepsy. This proof -of-concept, or PoC, trial was conducted in approximately 20 -25specialized centers across the U.S. and positive top -lineresults were announced on September 27, 2022. On January 30, 2023, we announced the completion of an open label extension study with Quilience(R) (Mazindol ER) for the treatment of narcolepsy. On March 27, 2023, we announced open label extension study six -monthdata for Quilience(R) (Mazindol ER) in the treatment of narcolepsy Type 1 and Type 2. As a result of the subsequent open label extension, or OLE, interim data results discussed more fully below, we intend to pursue an expedited development program with the FDA under