NLS Pharmaceutics CEO says proprietary position on Quilience ‘is strong’

NLS Pharmaceutics announces that its CEO, Alex Zwyer, has issued the following letter to shareholders: "Just under two years ago, NLS Pharmaceutics sought your investment and support to advance our pipeline in rare sleep disorders and other rare and debilitating Central Nervous System disorders. I am pleased to report on the progress that we made towards building a strong foundation for a bright future…Our goal remains focused on building a differentiated global pharmaceutical company that is patient-centered and dedicated to the development of transformative therapies addressing critical unmet needs in rare and complex CNS disorders. As we navigate the competitive landscape of our industry while focusing on the development of our product candidates, we are poised to maximize the therapeutic potential of our current pipeline while still pursuing new candidates that will continue to broaden our product portfolio. Our team has extensive experience in CNS research and a strong record of clinical trial success, regulatory approvals and scientific publications in peer-reviewed journals. Through our rigorous scientific approach in evaluating new opportunities, we plan to evaluate and develop additional product candidates to treat indications with a high unmet medical need. In addition to our lead product candidate, we have early-stage compounds that we are further developing. Our pipeline products are similarly well positioned as we gain ground in establishing future market positions through patents for lauflumide and other new chemical entities and assets. With extensive IP coverage in the U.S. and Europe, and promising pre-clinical data, we anticipate that our wake-promoting agent, lauflumide, could offer a new option for the treatment of chronic fatigue, including fatigue associated with cancer treatment and long-COVID symptoms. We anticipate that clinical trials with lauflumide will begin in 2024. We will continue to explore opportunities and execute on possibilities based on key factors such as unmet medical need, biological rationale, safety profile, feasibility of clinical development, potential for leveraging accelerated development pathways for regulatory approval, strong intellectual property position, favorable competitive landscape, and attractive commercial potential.We continue to build our global presence as evidenced through numerous patent awards this year across the globe. Key patents have been granted in major markets including the U.S., Canada, Europe, Japan, South Korea & Israel, covering the once-daily use of our lead product candidate, Quilience in rare sleep disorders such as narcolepsy and idiopathic hypersomnia, as well as additional uses including opioid withdrawal and attention deficit hyperactivity disorder. Given our patent positioning and the Orphan Drug Designations that we have in both the U.S. and Europe, we believe that our proprietary position on Quilience is strong. More than ever, we at NLS are hard at work and extremely excited to be a part of a company with genuine near and long-term prospects to change the lives of patients with rare CNS diseases. We work together to create a culture that inspires and motivates our team members to do what they do best. Our passionate team makes every effort to remain nimble with an honest approach to transparent communication, empowering leadership, and individual ownership of responsibilities. Our employees thrive in finding innovative and efficient approaches to advance our corporate aspirations."