NLS Pharmaceutics Announces Receipt of Additional Staff Delisting Determination from Nasdaq

ZÜRICH, SWITZERLAND / ACCESSWIRE / May 24, 2024 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced that on May 22, 2024, the Company received an additional staff determination letter (the "Letter") from the staff (the "Staff") of the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that it did not comply with the minimum $2,500,000 stockholders' equity requirement for continued listing set forth in Listing Rule 5550(b), and that the additional delinquency may serve as a separate basis for the delisting of the Company's securities from Nasdaq.

On April 19, 2024, the Company was previously notified by the Staff that its securities were subject to delisting unless it timely requested a hearing before a Nasdaq Hearings Panel (the "Panel"), due to the Company's failure to maintain at least a $1 bid price per share over the course of 30 consecutive business days, as set forth in Nasdaq Listing Rule 5550(a)(2). In addition, on January 9, 2024, the Company received a letter from the Staff that it was no longer in compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market. On February 23, 2024, the Company announced that it had submitted a plan to regain compliance with the stockholders' equity requirement.

The Company has requested a hearing before the Nasdaq Hearings Panel to appeal the Staff's delisting determination and intends to present its views and planned measures to cure the deficiencies mentioned herein at its hearing with the Nasdaq Hearings Panel, scheduled to occur on June 4, 2024.

About NLS Pharmaceutics Ltd.

NLS Pharmaceutics Ltd. is a Swiss clinical-stage biopharmaceutical company led by an experienced management team with a track record of developing and repurposing product candidates to treat rare and complex central nervous system disorders. The Company's lead product candidate, Quilience, is a proprietary extended-release formulation of Mazindol (Mazindol ER) and is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders such as idiopathic hypersomnia (IH), for which NLS recently obtained Orphan Disease Designation (ODD) from the European Medicines Agency (EMA). Mazindol is a triple monoamine reuptake inhibitor and partial Orexin-2 Receptor agonist, which was used for many years to treat patients diagnosed with narcolepsy in compassionate use programs. A Phase 2a multi-center U.S. clinical trial evaluating Quilience in adult subjects suffering from narcolepsy met its primary endpoint with high statistical significance and demonstrated a favorable safety and tolerability profile. NLS also successfully completed a Phase 2 study in the U.S. evaluating Nolazol (Mazindol Controlled-Release) in adult subjects suffering from ADHD. The study met all primary and secondary endpoints and Nolazol was well-tolerated. Quilience has received Orphan Drug Designations both in the U.S. and in Europe for the treatment of narcolepsy. Up to 1/3 of narcoleptic patients are also diagnosed with ADHD.