Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 400

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 400
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 subsequently develop NLS -4(NCE) for post -COVIDchronic fatigue syndrome for global markets. • Find partners for out -licensing and asset sale agreements.While NLS continues with its goal of progressing its product candidates, Quilience and Nolazol, on its own into further clinical development in order to initiate commercialization of such product candidates, NLS may seek to enter into transactions to sell or out -licenseQuilience, Nolazol or certain other product candidates or intellectual property that it develops. This strategy allows NLS to potentially create value for its shareholders ahead of its approval timelines. • Reduce clinical and regulatory risk, limit development costs, and accelerate time to market.NLS’s 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 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