NLS Pharmaceutics expands CNS pipeline with new compounds

ZURICH - NLS Pharmaceutics Ltd. (NASDAQ:NLSP) announced Thursday the expansion of its DOXA platform with a new series of small molecules targeting arousal stability, cognition, and neuroprotection. The micro-cap biotech company, currently valued at just $3.07 million, has seen its share price decline to $0.74, representing an 80.83% drop over the past year according to InvestingPro data.

The Swiss clinical-stage biopharmaceutical company, in collaboration with Aexon Labs, has developed the AEX-6xx series, which includes lead compound AEX-635 that modulates Multidrug Resistance-Associated Protein 1. This approach aims to enhance neuroprotective effects and improve central nervous system drug bioavailability in conditions like Parkinson’s disease.

The DOXA platform integrates dual orexin receptor agonism with cathepsin H inhibition to address pathways underlying sleep-wake regulation, motivation, and neuronal resilience.

"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, according to the press release.

The companies are preparing for investigational new drug-enabling studies and plan to launch preclinical partnering discussions in the fourth quarter of 2025.

NLS has raised approximately $7 million in equity financing and secured a $25 million equity line of credit agreement in recent months. The company believes these funds, along with potential licensing deals, will support operations for at least the next 12 months. InvestingPro analysis shows NLS is quickly burning through cash with a negative EBITDA of $3.36 million, though its current ratio of 2.77 indicates liquid assets exceed short-term obligations.

Preclinical data shows the DOXA compounds reduced cataplexy by up to 80% and increased wakefulness by more than 70% in narcolepsy models. The platform is being developed for potential use in Type 1 Narcolepsy, ADHD, and neurodegenerative diseases.

NLS is in the process of merging with Kadimastem Ltd., after which the combined entity will operate as NewCelX Ltd. and trade on Nasdaq under the symbol "NCEL."

In other recent news, NLS Pharmaceutics has filed updated financial statements related to its planned merger with Kadimastem. The filing includes Kadimastem’s unaudited interim condensed financial statements as of June 30, 2025, along with audited financial statements for the years ending December 31, 2024, and 2023. Additionally, NLS Pharmaceutics provided unaudited pro forma condensed combined financial statements for the six months ending June 30, 2025. This comes after NLS Pharmaceutics shareholders approved the merger with Kadimastem, an Israeli cell therapy company. The approval marks the final corporate step before closing the merger, which will result in the combined company being listed on Nasdaq as NewCelX Ltd. These developments are crucial as they indicate the progress and future trajectory of the merger. Investors are closely watching the integration process and the potential impacts on the company’s financials.

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