Company: NCEL
Filing Date: 2025-04-15
Form Type: 425
Source: 0001213900-25-031780
Chunk: 2

Company: NewcelX Ltd.
Filing Date: 2025-04-15
Form: 425
Chunk 2
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p ≤ 0.05 
 vs. vehicle), confirming its potent rewarding effect.       |

| - | Mazindol at 0.5 mg/kg significantly reduced fentanyl-induced                     
 CPP (p ≤ 0.05; p ≤ 0.01 vs. fentanyl-only), bringing behavior close to baseline. |

| - | The 0.25 mg/kg dose showed a trend toward reduction, indicating 
 a dose-dependent effect.                                        |

“We believe that these data provide compelling evidence of the
multi-target potential of Mazindol to address the opioid crisis through a novel mechanism of action,” said Dr. Eric Konofal, MD, PhD, Chief Scientific Officer of NLS Pharmaceutics. “By targeting key pathways—including partial mu-opioid receptor
(MOP) agonism, serotonin 5-HT1A modulation, and orexin-2 receptor (OX2R) activity—Mazindol offers a robust and differentiated
approach to reduce both opioid reward and withdrawal symptoms without the dependence risk associated with substitution therapies. Importantly,
these findings further support the superior potential efficacy profile of Mazindol as already demonstrated in certain ADHD populations.”

This development comes after the company recently raised up to $3 million
and signed a $25 million committed equity facility agreement as part of the planned strategic merger with Kadimastem Ltd. This funding
will enable the merged company to develop Kadimastem cell therapy clinical assets and to continue the development of the NLS assets that
will remain post-merger, including:

| - | Assets to remain with the merged company (NucelX): DOXA platform 
 (Dual Orexin Receptor Agonist).                                  |

| - | Assets to be allocated to the CVR: Mazindol ER, NLS-4, NLS-8, 
 NLS-11, NLS-12.                                               |

Mechanism of Action

Mazindol is a pan-monoamine reuptake inhibitor with additional pharmacological
effects:

| - | Partial mu-opioid receptor (MOP) modulation – to reduce 
 withdrawal symptoms without reinforcing effects.        |

| - | 5-HT1A receptor interaction – to regulate mood, stress, 
 and pain pathways during withdrawal.                    |

| - | OX2R activity – to promote wakefulness and reduce sedation. |

This unique multi-target profile positions Mazindol as a differentiated
and potentially safer alternative to current opioid substitution therapies.

“We believe these compelling preclinical