NLS Pharmaceutics CEO Highlights Progress And Plans For Advancing Rare CNS Disorder Therapies In Sharehol

30 Aug 2023

NLS Pharmaceutics Ltd. has recently published a detailed message from its CEO, Alex Zwyer, to its shareholders. The letter highlights the company's dedication to enhancing the well-being of patients through the development of innovative therapies for rare and complicated central nervous system disorders.

Zwyer appreciates the commitment of the NLS team in bringing their vision of improving the future of patients to fruition. The company underscores its goal of creating improved treatments for uncommon sleep disorders and crippling CNS diseases, always prioritizing the well-being of patients.

In the early months of 2023, NLS established a range of objectives, which involved forming a company dedicated to uncommon central nervous system disorders, propelling the Phase 3 initiative for their main product Mazindol ER, and advancing their collection of groundbreaking products. The company emphasizes notable advancements made in these aspects.

NLS recently secured a $10 million investment from BVF Partners L.P. towards the end of 2022. Currently, the company is considering various possibilities to kickstart its Phase 3 program and strategic plan. To ensure financial stability, NLS has made significant cutbacks in its monthly expenses. Meanwhile, as they finalize their endeavors, the company has received a number of unofficial proposals from potential partners in the pharmaceutical field. While negotiations are ongoing, no official agreement has been signed yet.

The correspondence unveils Keith Dewedoff as the temporary Chief Financial Officer and Elena Thyen-Pighin as the long-term CFO & Head of Finance / Human Resources. Their skillsets are positioned to strengthen NLS's monetary activities and management squad.

Receiving the green signal from the autonomous Institutional Review Board (IRB) and the endorsement of the FDA are major achievements as they indicate crucial steps forward in the Phase 3 clinical trial that aims to examine the safety and effectiveness of Mazindol ER in individuals suffering from narcolepsy. Throughout this trial, the frequency of cataplexy episodes and excessive daytime sleepiness will be monitored on a weekly basis.

NLS filed an application for Mazindol ER to be granted fast-track status by the FDA in order to treat narcolepsy. This special status helps speed up the evaluation of medications designed to address severe or life-threatening conditions, which could ultimately hasten the drug's entry into the market.

NLS shared its research at the SLEEP 2023 event, highlighting the data obtained from the second stage of clinical trials for Mazindol ER. The encouraging outcomes further confirm the effectiveness and safety of the medication, presenting it as a hopeful choice for treatment.

NLS talks about its strong lineup of potential treatments, including lauflumide (NLS-4) for long-lasting fatigue and NLS-11 for diseases that affect the nervous system. The company's exclusive method of addressing the complexities of CNS diseases using individual molecules is emphasized.

The blog post expresses appreciation to investors for their constant backing and highlights the results of NLS's Annual General Meeting (AGM), in which important suggestions were highly accepted.

The letter from Alex Zwyer, the CEO of NLS Pharmaceutics, emphasizes the advancements that the company has made, its focus on innovative treatments that prioritize patients, and its determination to improve the lives of those suffering from rare and complex central nervous system disorders. The accomplishments of NLS, the appointment of key leaders, the progress of its Phase 3 program, and the development of its pipeline all illustrate the significant role that the company plays in the world of biopharmaceuticals.

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