NLS Pharmaceutics

NLS Pharmaceutics Ltd. is a clinical-stage biopharmaceutical company, which engages in the discovery and development of therapeutics for the treatment of neurobehavioral and neurocognitive disorders. Its product portfolio includes Quilience, a treatment for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy; and Nolazol, a treatment for attention deficit hyperactivity disorder (ADHD). The company was founded by Ronald Hafner, Eric Konofal, and Alexander Zwyer on June 10, 2015 and is headquartered in Zurich, Switzerland.

NLS Pharmaceutics Ltd. is a clinical-stage biopharmaceutical company, which engages in the discovery and development of therapeutics for the treatment of neurobehavioral and neurocognitive disorders. Its product portfolio includes Quilience, a treatment for excessive daytime sleepiness and cataplexy associated with narcolepsy; and Nolazol, a treatment for attention deficit hyperactivity disorder. The company was founded by Ronald Hafner, Eric Konofal, and Alexander Zwyer on June 10, 2015 and is headquartered in Zurich, Switzerland.

ZÜRICH, SWITZERLAND / ACCESSWIRE / February 23, 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 it has submitted the Company's plan, on time, to regain compliance with Nasdaq Listing Rule 5550(b)(1).

NLS Pharmaceutics Submits Plan to Regain Listing Compliance With Nasdaq

ZURICH, SWITZERLAND / ACCESSWIRE / January 12, 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 January 9, 2024, it received a letter from the Listing Qualifications staff of The Nasdaq Stock Market ("Nasdaq") notifying the Company that it is no longer in compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market.

Notice of Deficiency with Nasdaq Continued Listing Requirements

NLS Pharmaceutics (NASDAQ: NLSP ) stock is taking a beating on Monday as the company's shares come down from a rally on Friday. The news that sent shares of NLSP stock higher on Friday concerned an exclusive option to license in-license Aexon Labs' Dual Orexin Receptor Agonists platform.

Why Is NLS Pharmaceutics (NLSP) Stock Down 24% Today?

The option agreement grants NLS Pharmaceutics Ltd. the exclusive option to in-license all of Aexon Labs' assets for the potential treatment of narcolepsy and other neuro-degenerative disorders, and all future indications Exclusive option agreement accesses global rights to multiple highly selective Orexin-1 / Orexin-2 receptor agonists, unique compounds designed for specificity, acting multiple pathways involved in the pathophysiology of narcolepsy and other central disorders of hypersomnolence Additional targets include Cathepsin-H inhibition, sigma-1 receptor agonist, DAT and NET reuptake inhibition, addressing neurotransmission, neuroprotection and neuroinflammation First patent application filed at the end of 2022 for orexin receptors agonists for treating or preventing neurological diseases and psychiatric disorders including narcolepsy NLS continues to strengthen its neuroscience pipeline in sleep medicine with a unique and holistic approach to central disorders of hypersomnolence and neurodegenerative disorders franchise ZÜRICH, SWITZERLAND / ACCESSWIRE / December 1, 2023 / NLS Pharmaceutics Ltd.

NLS Pharmaceutics Announces Exclusive Option Agreement to Develop and Commercialize Next Generation Dual Orexin Agonist Platform of Aexon Labs, Inc.

Professor Claudio L. A. Bassetti, MD, is the Chair, Neurology Department, Inselspital, Bern University Hospital and Dean, Medical Faculty, University of Bern, focused on sleep disorders Professor Florence Allouche Aknin, PharmD, MBA, is a professor at University Paris City, specializing in pharmaceutical innovation, entrepreneurship and fundraising ZURICH, SWITZERLAND / ACCESSWIRE / November 28, 2023 / NLS Pharmaceutics Ltd.

NLS Pharmaceutics Announces Election of Additional Board Members

ZURICH, SWITZERLAND / ACCESSWIRE / November 27, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, 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 Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics, will present at the Oppenheimer Sleep Disorders Summit: Deep Dive into Narcolepsy and Idiopathic Hypersomnia, hosted by Francois Brisebois, Managing Director, Senior Research Biotechnology Analyst, in New York on Friday, December 1, 2023 at 10:30 AM EST.

NLS Pharmaceutics to Participate in the Oppenheimer Sleep Disorders Summit: Deep Dive into Narcolepsy and Idiopathic Hypersomnia

NLS has executed a non-binding term sheet for licensing of NLS intellectual property NLS has secured an additional bridge loan through insiders to extend cash runway NLS has implemented significant internal cost reductions ZURICH, SWITZERLAND / ACCESSWIRE / November 16, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, 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 it is conducting an ongoing process to explore strategic alternatives to maximize shareholder value.

NLS Pharmaceutics Announces Selection of Strategic Partner and Securing a Bridge Loan

ZURICH, SWITZERLAND / ACCESSWIRE / October 25, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP,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 it has received a written notice (the "Notice") from Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is not in compliance with the minimum bid price requirement for continued listing set forth in Listing Rule 5550(a)(2), which requires listed companies to maintain a minimum bid price of $1.00 per share.

NLS Pharmaceutics Announces Receipt of Nasdaq Minimum Bid Price Notification

ZURICH, SWITZERLAND / ACCESSWIRE / October 19, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, 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 it will postpone the company update previously scheduled for Friday, October 20, 2023, due to important developments impacting the timing of the event.

NLS Pharmaceuticals to Reschedule Company Update on Strategic Discussions

Members of Executive Leadership Team to Discuss Company Update on Strategic Discussions and Timeline of Phase 3, NLS to Webcast its Event Friday, October 20 at 11:00am ET ZURICH, SWITZERLAND / ACCESSWIRE / October 12, 2023 / 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 plans to issue an important update on discussion the company is having regarding strategic partnerships, including Timeline for the company's Phase 3 program in narcolepsy The event will be held October 20, 2023, at 11:00 am ET and may will include a video stream on the Investors section of the Company's website.

NLS Pharmaceutics Announces Company Update on Strategic Partnerships

Shares of NLS Pharmaceutics Ltd. NLSP, +19.57% gained 12% premarket on Monday after the Swiss clinical-stage biopharma company said it would proceed with phase 3 clinical studies of Mazindol ER, a treatment for narcolepsy.

NLS Pharmaceutics shares rise as narcolepsy treatment moves to phase 3 studies

ZÜRICH, SWITZERLAND / ACCESSWIRE / July 3, 2023 / 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 the U.S. Food and Drug Administration (FDA) has reviewed the full protocol for the NLS-1031 study, part of the Phase 3 program for Mazindol ER, called AMAZE.

NLS Pharmaceutics to Proceed with Phase 3 Clinical Program (AMAZE) for Mazindol ER for the Treatment of Narcolepsy Following FDA Review and IRB Approval of the Full Study Protocol

ZURICH, SWITZERLAND / ACCESSWIRE / June 30, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, 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 the NLS Shareholders approved all of the Board of Directors' proposals for the 2023 Annual General Meeting (AGM) that took place in Zürich, Switzerland today.

NLS Pharmaceutics Releases the Results from its Annual General Meeting

NLS to Webcast its Event on Thursday, July 6, 2023, at 11:00 am ET ZURICH, SWITERLAND / ACCESSWIRE / June 30, 2023 / 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 it will postpone its webcast previously scheduled for today due to important developments impacting the timing of the company update.

NLS Pharmaceutics Company Update and Webcast Today Postponed

Presentation to take place on Tuesday, June 20, 2023, at 10:30AM ET ZURICH, SWITZERLAND / ACCESSWIRE / June 19, 2023 / NLS Pharmaceutics Ltd. (Nasdaq: NLSP, 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 Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics will present at the Healthcare Virtual Conference Part II, presented by Maxim Group LLC and hosted by M-Vest on Tuesday, June 20, 2023, at 10:30 AM ET.

CORRECTION FROM SOURCE: NLS Pharmaceutics to Participate in the Healthcare Virtual Conference Presented by Maxim Group LLC and Hosted by M-Vest

Members of Executive Leadership Team to Discuss initiation of Phase 3, Pipeline updates, Key Financials, Corporate Development, and the other topics NLS to Webcast its Event Friday, June 30 at 11:00am ET ZURICH, SWITZERLAND / ACCESSWIRE / June 19, 2023 / NLS Pharmaceutics Ltd. (Nasdaq: NLSP, 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 plans to showcase its global strategic R&D progress and platform, including: Feedback from the SLEEP 2023 APSS Conference Initiation of the Phase 3 program AMAZE for Mazindol ER Pipeline Goals for 2023/2024 Key Financials Funding Strategy Update Corporate Development Webcast Information The event will be held June 30, 2023, at 11:00 am ET and will include a video stream on the Investors section of the Company's website here or at the SummitCast event page here.

NLS Pharmaceutics Announces Company Update Webcast

ZURICH, SWITZERLAND / ACCESSWIRE / June 15, 2023 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP, 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 Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics will present at the Healthcare Virtual Conference Part II, presented by Maxim Group LLC and hosted by M-Vest on Wednesday, June 20, 2023 at 10:30 AM ET.

NLS Pharmaceutics to Participate in the Healthcare Virtual Conference Presented by Maxim Group LLC and Hosted by M-Vest

Very low risk for drug-drug interactions (DDI) with Mazindol ER based upon results from in vitro metabolism and transporter studies Demonstrated pharmacological differentiation versus currently available medications used to treat narcolepsy which can have significant DDI effects preventing co-administration or requiring dose adjustments ZURICH, SWITZERLAND / ACCESSWIRE / June 14, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, 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 positive data from five recently completed in vitro drug-drug interaction studies investigating the potential for DDI of mazindol, a triple monoamine reuptake inhibitor and partial orexin-2 agonist, as well as its hydrolyzed metabolite (M6).

NLS Pharmaceutics Announces Positive Safety Data From In Vitro CYP450 and Transporter Mediated Drug-Drug Interaction Studies of Mazindol

ZÜRICH, SWITZERLAND / ACCESSWIRE / May 8, 2023 / 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 Keith Harrison Dewedoff has been appointed to the position of Interim Chief Financial Officer ("CFO").

NLS Pharmaceutics Appoints Keith Harrison Dewedoff as Interim Chief Financial Officer

Oral presentation sharing significant phase 2 results of Mazindol ER in Adults with Narcolepsy Type 1 and Type 2 Five abstracts demonstrating NLS focus on and investment in hypersomnia disorders and rare and complex neurologic diseases ZURICH, SWITZERLAND / ACCESSWIRE / May 4, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, 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 it will present clinical data for the lead compound, Mazindol ER, as well as preclinical data on its pipeline compound, NLS-4, at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), which is being held from June 3 - 7, 2023, in Indianapolis.

NLS Pharmaceutics Presents Latest Clinical and Preclinical Data at SLEEP 2023

ZURICH, SWITZERLAND / ACCESSWIRE / May 2, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, 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 the U.S. Food and Drug Administration (FDA) provided authorization to proceed with the Phase 3 program for Quilience® (Mazindol ER).

NLS Pharmaceutics Receives Green Light from the U.S. FDA to Proceed with Phase 3 Clinical Program (AMAZE) for Quilience(R) (Mazindol ER) for the Treatment of Narcolepsy

ZURICH, SWITZERLAND / ACCESSWIRE / April 25, 2023 / 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 it will present new and compelling preclinical data on four of its pipeline compounds at the annual meeting of the American Society of Clinical Psychopharmacology (ASCP), which is being held from May 30 to June 2, 2023, in Miami, Florida.

NLS Pharmaceutics Presents Latest Preclinical Pipeline Data at American Society of Clinical Psychopharmacology

Patients treated with Mazindol ER in the randomized Phase 2 trial showed continued improvement after rolling over into the open label extension (OLE) study Patients treated with placebo in the randomized Phase 2 trial and who subsequently received Mazindol ER in the OLE study achieved comparable results to the Mazindol ER-treated patients in the Phase 2 trial Safety and tolerability of Mazindol ER were similar between the randomized trial and the OLE study Once-daily monotherapy with Mazindol ER shows potential to meet the unmet needs of currently available narcolepsy treatment options ZURICH, SWITZERLAND / ACCESSWIRE / March 27, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, 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 the final results from its Open Label Extension (OLE) Study for Quilience® (Mazindol ER) in the treatment of narcolepsy.

NLS Pharmaceutics Announces Open Label Extension Study Six-Month Data for Quilience(R) (Mazindol ER) in the Treatment of Narcolepsy Type 1 and Type 2

ZURICH, SWITZERLAND / ACCESSWIRE / March 1, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, 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 Alex Zwyer, CEO, will be presenting at the 35th Annual Roth Conference.

NLS Pharmaceutics to Present at the 35th Annual Roth Conference

Six-month Open Label Extension (OLE) study for patients that completed the POLARIS Phase 2 randomized, double-blind study has achieved its final patient visit 87% of patients who completed the POLARIS Phase 2 study requested to continue monotherapy treatment with Mazindol ER in the six-month OLE, rather than transition to other therapies ZURICH, SWITZERLAND / ACCESSWIRE / January 30, 2023 / 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 the completion of the POLARIS six-month open-label extension study (NLS-1022) with Mazindol ER in patients with narcolepsy.

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