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ZÜRICH - NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW), a Swiss biopharmaceutical company with a market capitalization of $5.75 million, has announced encouraging results from its ongoing preclinical study of a novel dual orexin receptor agonist (DOXA) platform. The study is focused on two non-sulfonamide DOXAs, AEX-41 and AEX-2, which are being developed for the treatment of narcolepsy and other neurological disorders. According to InvestingPro data, the company faces financial challenges with negative EBITDA of $6.3 million in the last twelve months.
The preclinical research, which began in October 2024 at the Centre for Neuroscience Research of Lyon, has shown that AEX-41, when administered orally to orexin knockout mice, significantly increased wakefulness and reduced REM sleep duration. This effect is vital for managing narcolepsy symptoms. AEX-41's efficacy is comparable to that of selective OX2R agonists, but with the advantage of targeting both orexin-1 and orexin-2 receptors as well as inhibiting cathepsins, which are involved in various physiological processes.
Dr. Eric Konofal, Chief Scientific Officer of NLS and inventor of the DOXA platform, highlighted the dual-action mechanism of AEX-41, which could offer symptomatic relief and potentially modify the disease course, a step forward from current therapies. The DOXA platform may also synergize with treatments for diabetes and amyotrophic lateral sclerosis (ALS), conditions often associated with sleep-wake dysregulation.
NLS is preparing to broaden its research in 2025 to explore the impact on cathepsin H in animal models of neuroinflammation, which plays a role in neurodegenerative disease progression. The company anticipates filing an Investigational New Drug (IND) application between 2026 and 2027 to support further studies.
Narcolepsy, the primary focus of NLS's research, is a chronic sleep disorder caused by the loss of orexin-producing neurons, leading to symptoms such as excessive daytime sleepiness and cataplexy. The disorder is closely linked to certain human leukocyte antigens and other genetic factors.
NLS Pharmaceutics is pursuing the development of AEX-41 and AEX-2 with plans to evaluate their safety and efficacy in clinical settings further. The company's pipeline also includes potential treatments for idiopathic hypersomnia and neurodegenerative diseases. Trading near its 52-week low of $3.00, the stock has experienced significant volatility, with InvestingPro analysis revealing an 87% decline over the past year. Investors seeking deeper insights into biotech companies can access comprehensive financial health metrics and additional ProTips through InvestingPro's advanced analytics platform.
This announcement is based on a press release statement and contains forward-looking statements subject to risks and uncertainties that could affect the actual results. These include technological changes, delays in clinical trials, regulatory approvals, scientific challenges, and market competition. With the next earnings report due on December 27, 2024, and an overall financial health score rated as 'Weak' by InvestingPro, investors should carefully monitor the company's progress. NLS Pharmaceutics is committed to developing innovative therapies for central nervous system disorders and addressing unmet medical needs.
In other recent news, NLS Pharmaceutics Ltd. has announced significant developments. The company has entered a merger agreement with biotechnology firm Kadimastem Ltd., creating a combined entity that will focus on NLS's Dual Orexin Agonist platform and Kadimastem's allogeneic cell therapy program. Post-merger, NLS plans to divest certain legacy assets, with net proceeds distributed to its shareholders and warrant holders.
In addition to the merger, NLS Pharmaceutics has also implemented a 1-for-40 reverse share split, reducing the number of outstanding common shares from approximately 46.88 million to around 1.17 million. This restructuring is part of the company's ongoing efforts to manage its capital structure.
Furthermore, NLS Pharmaceutics has issued and sold over 3 million common shares and issued warrants in a private placement managed by H.C. Wainwright & Co. The company has also reported successful preclinical results for compounds targeting Parkinson's Disease, with plans to develop two successors, AEX-230 and AEX-231, for neurodegenerative disorders. These recent developments reflect the company's commitment to expanding its pharmaceutical offerings and advancing treatments for neurodegenerative diseases.
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