NLS Pharmaceutics Receives Further Nasdaq Delisting Notice

NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW), a Swiss biopharmaceutical company specializing in therapies for rare and complex central nervous system disorders, disclosed on May 22, 2024, that it received another staff determination letter from Nasdaq. This letter indicated that the company failed to meet the minimum $2.5 million stockholders' equity requirement as outlined in Listing Rule 5550(b). This new violation adds another potential reason for Nasdaq to delist NLS’s securities.

Previously, on April 19, 2024, Nasdaq staff had already informed the company of an impending delisting due to its inability to maintain a minimum $1 bid price per share over 30 consecutive business days, in accordance with Listing Rule 5550(a)(2). Additionally, on January 9, 2024, NLS was notified about its non-compliance with the stockholders' equity requirement, prompting the company to submit a plan on February 23, 2024, to rectify this issue.

In response to these determinations, NLS has requested a hearing before the Nasdaq Hearings Panel, scheduled for June 4, 2024. During this hearing, the company plans to present its strategies and measures to address the noted deficiencies and argue against the delisting decision.

NLS Pharmaceutics Ltd. is led by a team with substantial experience in developing and repurposing treatments for central nervous system disorders. Their leading product candidate, Quilience®, is an extended-release formulation of Mazindol (Mazindol ER), designed primarily for narcolepsy treatment and potentially other sleep-wake disorders like idiopathic hypersomnia (IH). The European Medicines Agency (EMA) recently granted Orphan Disease Designation (ODD) to Quilience® for IH.

Mazindol functions as a triple monoamine reuptake inhibitor and a partial Orexin-2 Receptor agonist. It has a history of use in treating narcolepsy under compassionate use programs. Quilience® has shown promising results in a Phase 2a multi-center U.S. clinical trial involving adults with narcolepsy, meeting its primary endpoint with significant statistical relevance and demonstrating a favorable safety and tolerability profile.

Besides Quilience®, NLS has also achieved success with Nolazol® (Mazindol Controlled-Release) in a Phase 2 study for adult ADHD patients in the U.S. This study met all primary and secondary endpoints, and the drug was well-tolerated. Quilience® has received Orphan Drug Designation in both the U.S. and Europe for treating narcolepsy, with studies indicating that up to one-third of narcoleptic patients are also diagnosed with ADHD.

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