Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 599

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 599
---
 type 1. In 2023, the Company announced that the FDA provided authorization to proceed with the Phase 3 clinical program (AMAZE) for Mazindol ER. In July 2023, it was announced that the first Phase 3 clinical trial protocol received approval from the independent IRB. The AMAZE Program encompasses two almost -identicaldouble -blindPhase 3 studies (N=50 each) investigating Mazindol ER versus placebo in adult patients with narcolepsy. Along with IRB approval and the green light from the FDA, NLS has retained a CRO and has enrolled in several sites for the phase 3 studies. Once suitable capital has been secured, the phase 3 program will commence as the sites are ready to begin enrolling patients. Nolazol Nolazol is a triple monoamine reuptake inhibitor and orexin receptor -2partial agonist, and its unique pharmacological profile is expected to yield important benefits compared to existing treatments of ADHD. Enhancing the function of the three neurotransmitters well -knownto be implicated in ADHD, norepinephrine, dopamine and serotonin, along with its activity on the orexin -2receptor, Nolazol may produce an optimal reduction in ADHD symptoms over available treatments. Nolazol is supported by a positive pilot clinical trial with mazindol in 24 children with ADHD and a positive Phase 2 clinical trial in 85 adults with ADHD. The Phase 2 clinical trial in adults met all primary and secondary study endpoints and was well -tolerated. Given the positive outcome of the Phase 2 trial in ADHD, the Company may initiate Phase 3 clinical trials if it receives FDA’s green light to proceed at a later stage. The first Phase 3 clinical trial may aim to evaluate doses of Nolazol in approximately 260 adults with ADHD, with subjects randomized to receive Nolazol or placebo for 6 weeks. The second Phase 3 clinical trial may target to evaluate doses of Nolazol in children and adolescents, with an embedded placebo -controlledsub -studyin a laboratory classroom setting for the children age group. A laboratory classroom study provides a simulation of a real academic environment, including the potential for interaction and distraction among children, and allows for assessment by trained observers over the course of a typical extended school day.

| Moore Financial Consulting |

Annex E-38

Research Pipeline In addition to the product candidates, Quilience and Nolazol, N