Company: NCEL
Filing Date: 2025-03-03
Form Type: F-4/A
Source: 0001213900-25-018981
Chunk: 718

Company: NewcelX Ltd.
Filing Date: 2025-03-03
Form: F-4/A
Chunk 718
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 we may seek to enter into transactions to sell or out -licenseQuilience, Nolazol or certain other product candidates or intellectual property that we develop. This strategy allows us to potentially create value for our shareholders ahead of our approval timelines. • Reduce clinical and regulatory risk, limit development costs, and accelerate time to market.Our product candidates, Quilience and Nolazol, incorporate a known molecule in a proprietary CR and ER formulation. The former immediate release formulation of mazindol has a well -establishedsafety record from its long history of clinical use across the United States and several countries in Europe and, as a result thereof, a well -characterizedsafety profile that has allowed us to rapidly begin conducting clinical development of Nolazol and to generate supportive phase 2 data in a study conducted in 85 patients with ADHD in the United States in May 2017 and complete a Phase 2 study in patients with narcolepsy in the United States. We believe that this strategy also allows us to potentially seek FDA approval using the 505(b)(2) regulatory pathway for both product candidates. • Develop products with differentiated pharmacological profiles. We are developing product candidates with dual mechanisms of action. For example, Quilience and Nolazol utilize a dual mechanism of action, resulting in a unique pharmacological profile targeting multiple neuronal pathways that are widely thought to be disrupted and lead to the disorders targeted by our product candidates. We believe that products with clearly differentiated features, as compared to currently available drug therapies, will be attractive to patients and physicians and will provide us with a competitive commercial advantage. • Maximize the therapeutic potential of our existing targets and product candidates.Given the central physiological roles played by the distinct targets of our lead and follow -onproduct candidates, we believe that there is significant potential for us to address multiple indications and our goal is to expand the therapeutic and commercial potential of our existing product candidates to additional indications. For example, we plan to explore the development of Quilience for the treatment of IH, another rare CNS disorder for which Quilience received orphan drug designation in the U.S. and in Europe. • Deploy our value -driven approach to broaden our sleep -related product portfolio.Our team has extensive experience in CNS research and a strong record of publication in peer -reviewedjournals and we plan to develop additional product candidates to treat indications with a high unmet medical need, and may seek to in -licensefrom or collaborate with third parties to develop product candidates that we