Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 392

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 392
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 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 NLS 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. NLS believes that this strategy also allows it to potentially seek FDA approval using the 505(b)(2) regulatory pathway for both product candidates. • Develop products with differentiated pharmacological profiles. NLS is 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 NLS’s product candidates. NLS believes that products with clearly differentiated features, as compared to currently available drug therapies, will be attractive to patients and physicians and will provide it with a competitive commercial advantage. • Maximize the therapeutic potential of NLS’s existing targets and product candidates.Given the central physiological roles played by the distinct targets of NLS’s lead and follow -onproduct candidates, NLS believes that there is significant potential for NLS to address multiple indications and NLS’s goal is to expand the therapeutic and commercial potential of NLS’s existing product candidates to additional indications. For example, NLS plans 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 NLS’s value -driven approach to broaden NLS’s sleep -related product portfolio.NLS’s team has extensive experience in CNS research and a strong record of publication in peer -reviewedjournals and NLS plans 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 NLS believes are highly differentiated, promising therapeutic candidates that address major unmet clinical needs. 199 NLS’s scientifically rigorous approach to evaluating new opportunities includes a robust asset evaluation of key factors, including the unmet medical need, biological