NLS Pharmaceutics adds AEX-6xx compounds to CNS drug pipeline

NLS Pharmaceutics Ltd. (NASDAQ: NLSP) announced the expansion of its DOXA platform with the AEX-6xx series, a collection of small molecules developed by Aexon Labs targeting arousal stability, cognition, and neuroprotection.

The AEX-6xx series consists of dihydroquinazoline and dihydrobenzothiazine derivatives that combine dual orexin receptor agonism with cathepsin H inhibition. AEX-635, identified as a lead compound, also modulates Multidrug Resistance-Associated Protein 1, which the companies state may enhance neuroprotective effects and improve central nervous system drug bioavailability.

According to the company's press release, preclinical studies showed up to 80% reduction in cataplexy and greater than 70% increase in wakefulness in orexin knockout narcolepsy models. The compounds demonstrated neuroprotective activity under α-synuclein-induced stress conditions.

"The AEX-6xx program significantly extends the translational scope of the DOXA platform," said Dr. Eric Konofal, Founder and Chief Scientific Officer at Aexon Labs and NLS.

The companies plan to target several indications including Type 1 Narcolepsy, Idiopathic Hypersomnia, ADHD with arousal dysregulation, and neurodegenerative diseases including synucleinopathies and Huntington's disease.

NLS reported raising approximately $7 million in equity financing and securing a $25 million equity line of credit agreement. The company stated these funds, along with potential licensing agreements, should support operations for at least 12 months following its planned merger with Kadimastem Ltd.

The AEX-6xx series is protected under international patent applications WO2024141660 and WO2024115797, with national phase applications filed in the United States, European Union, Japan, Canada, Israel, and Australia.

NLS and Aexon Labs plan to begin preclinical partnering discussions in the fourth quarter of 2025. Following the merger completion, the combined entity will operate as NewCelX Ltd. and trade on NASDAQ under the symbol "NCEL."

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