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NLS Pharmaceutics Ltd. (NASDAQ: NLSP, NLSPW) announced a significant milestone in its Phase 2a clinical trial for Quilience (Mazindol ER), with 90% of the 60 patients planned for the study having been randomized. Since the interim results were released in March, patient enrollment has nearly doubled, with 54 patients randomized and many more undergoing screening. Additionally, nearly 90% of patients who completed the trial have transitioned into the open label extension study, remaining on Quilience monotherapy without additional stimulant treatments.

NLS Pharmaceutics Ltd. announced the closing of its registered direct offering, raising approximately US$4.4 million through the sale of 4,200,000 common shares at $1.04 each. Health-care focused institutional investors participated, including the Company's Chairman, Ronald Hafner. Additionally, warrants for 3,150,000 common shares were issued at the same price, exercisable after six months and expiring in five years. The funds will be used for the development of Quilience® (Mazindol ER) for narcolepsy treatment and other corporate purposes.

NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announced that CEO Alex Zwyer will join a fireside chat at the B. Riley Annual Neuro & Ophthalmology Investor Conference on April 28, 2022, at 4 PM EST.

This event will allow investors to gain insights into NLS's innovative therapies targeting rare central nervous system disorders, including the ongoing Phase 2a trial for Quilience, aimed at treating narcolepsy. Registration for the conference can be found here.

NLS Pharmaceutics Ltd. has announced a registered direct offering of 4,200,000 common shares at $1.04 per share, aiming to raise approximately US$4.4 million before expenses. The offering, expected to close around April 25, 2022, also includes warrants for 3,150,000 common shares. Funds will support the development of Quilience® for narcolepsy, alongside business development activities. This follows the effectiveness of a shelf registration statement filed with the SEC.

NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) has received a notification from Nasdaq stating it is not in compliance with the minimum stockholders' equity requirement of at least $2,500,000.

Additionally, the company did not meet the alternative compliance standards concerning the market value of its securities or net income. NLS has 45 days until May 16, 2022, to submit a compliance plan to Nasdaq, which may grant an extension of up to 180 days if the plan is accepted. This notification does not immediately affect its Nasdaq listing.

NLS Pharmaceutics Ltd. has engaged LifeSci Partners as a financial advisor to explore strategic partnership opportunities to advance its lead drug candidate, Quilience® (Mazindol ER), which is being developed for narcolepsy and other sleep-wake disorders. Following positive interim Phase 2a results presented at the World Sleep Congress, the company received interest from multiple third parties for potential collaborations. This move aims to accelerate bringing innovative therapies to market and enhance shareholder value. No assurances of successful transactions are provided.

NLS Pharmaceutics has launched a Named Patient Program (NPP) allowing European patients with Idiopathic Hypersomnia (IH) to access the Mazindol Extended-Release (ER) formulation. This initiative is anticipated to generate revenue and provide crucial treatment options for patients who have not responded to approved therapies. Sales from the NPP are projected to yield mid-to-high single-digit million dollars over the next 36 months, providing additional funding for continued clinical development.

NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announced that CEO Alex Zwyer will participate in a fireside chat at the Maxim Group 2022 Virtual Growth Conference on March 30, 2022, at 2:00 p.m. ET. The company is focused on developing therapies for rare central nervous system disorders, notably narcolepsy. Its leading candidate, Quilience, an extended-release formulation of mazindol, is currently in a Phase 2a trial in the United States, having received Orphan Drug Designation. Registration for the event is available at m-vest.com.

NLS Pharmaceutics announced positive interim top-line data from its Phase 2a clinical trial of Quilience (Mazindol ER) for narcolepsy, demonstrating a 39% reduction in the Epworth Sleepiness Scale (ESS) from baseline. The trial confirmed its statistical power and safety, with no serious adverse events (SAEs) reported. Additionally, 82% of patients opted to continue in the open-label extension study, indicating strong interest in the treatment. The results were presented at the World Sleep Congress, highlighting Mazindol ER's potential to be an effective therapy for narcolepsy.