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.

ZURICH, SWITZERLAND / ACCESSWIRE / January 12, 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 received a notification letter from the Nasdaq Listing Qualifications Staff of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that it has regained compliance with the Nasdaq's minimum bid price requirement.

NLS Pharmaceutics Announces Compliance with Nasdaq Bid Price Requirement

ZURICH, SWITZERLAND / ACCESSWIRE / January 11, 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, is pleased to announce its participation in the following upcoming conferences: 2023 BIO CEO & Investor Conference Alex Zwyer, NLS' Chief Executive Officer, will present a company update at the 2023 BIO CEO & Investor Conference on March 12-14, 2023, and will be available for one-on-one meetings with conference attendees.

NLS Pharmaceutics to Participate in Upcoming Investor Conferences

Hong Kong patent relates to Company's lead product candidate, Mazindol ER (extended-release) use in narcolepsy, idiopathic hypersomnia (IH) and attention deficit hyperactivity disorder (ADHD) Further supports NLS global strategy with key patents now granted in major markets including Hong Kong, Japan, South Korea, the U.S., Europe & Canada NLS has accelerated ongoing clinical development of its lead product, Quilience® (Mazindol ER) for the treatment of rare sleep disorders ZURICH, SWITZERLAND / ACCESSWIRE / January 10, 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 Patents Registry, Intellectual Property Department of The Government of the Hong Kong Special Administrative Region has granted approval for Patent Application 42022055879.5, which covers Mazindol ER as a method of treatment for ADHD.

NLS Pharmaceutics Announces Technology Patent Grant Covering Mazindol for Treatment of Attention Deficit Hyperactivity Disorder and Rare Sleep Disorders in Hong Kong

Israeli patent relates to Mazindol use in attention deficit hyperactivity disorder (ADHD) or related arousal deficits (i.e., uncontrollable sleepiness), use in the treatment of reduced alertness (daytime sleepiness), or excessive daytime sleepiness, such as narcolepsy or idiopathic hypersomnia.

NLS Pharmaceutics Announces Israeli Patent Grant Covering Mazindol for Treatment of Attention Deficit Hyperactivity Disorder and Other Sleep Disorders Through 2037

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 closing of its previously publicized purchase agreement with BVF Partners L.P. ("BVF") comprised of an initial closing of $10 million in exchange for 11,494,253 common shares (or equivalents), representing a purchase price per share of $0.87.

NLS Pharmaceutics Announces Closing of Initial Tranche of US$10.0 Million Purchase Agreement with BVF Partners L.P.

Financing provided exclusively by leading healthcare fund BVF Partners L.P. ZURICH, SWITZERLAND / ACCESSWIRE / December 7, 2022 / NLS Pharmaceutics Ltd.

NLS Pharmaceutics Announces Purchase Agreement with BVF Partners L.P. to Raise Aggregate Gross Proceeds of up to $30 Million

More than 100,000 deaths in the U.S. alone each year due to overdose Global Opioid Use Disorder market projected to be approximately $5 Billion by 2028 Mazindol classified by the U.S. Drug Enforcement Agency (DEA) as a Schedule IV controlled substance versus currently available Schedule II treatments ZURICH, SWITZERLAND / ACCESSWIRE / December 1, 2022 / 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 United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application 16/645,306, which covers Mazindol as a method of treatment for heroin dependence and substance use disorders comprising administering mazindol or composition comprising mazindol to a subject, wherein the substance is an opioid and Mazindol is administered daily at a daily dosage range from between 3 mg and 16 mg.

NLS Pharmaceutics Announces Notice of Allowance for U.S. Patent Covering Mazindol for Opioid Dependence and Substance Use Disorder

ZURICH, SWITZERLAND / ACCESSWIRE / November 23, 2022 / 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, announces that it has launched a paid for Named Patient Program (NPP) for patients suffering from idiopathic hypersomnia (IH).

NLS Pharmaceutics Announces Launch of Paid for Named Patient Program with Mazindol ER for Idiopathic Hypersomnia, a Serious Sleep Disorder with No Approved Treatment Options in Europe

ZURICH, SWITZERLAND / ACCESSWIRE / November 14, 2022 / 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, announces that on November 11, 2022, it received a letter from the Nasdaq Hearings Panel (the "Panel"), indicating the Panel's decision to grant the Company's request to continue its listing on the Nasdaq Stock Market LLC ("Nasdaq").

NLS Pharmaceutics Successfully Appeals Nasdaq Delisting Notice

ODD for IH in the U.S. follows July 2022 grant of ODD for treatment of IH in Europe Currently only 1 drug approved in the United States to treat IH while no drugs are currently approved in Europe for IH High unmet medical need in this rare indication ZURICH, SWITZERLAND / ACCESSWIRE / November 2, 2022 / 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, announces that it has received Orphan Drug Designation ("ODD") from the FDA in the United States for Mazindol, the active ingredient in its lead product candidate, Quilience® (Mazindol ER) for the treatment of Idiopathic Hypersomnia ("IH").

U.S. FDA Grants Orphan Drug Designation (ODD) for Quilience(R) (Mazindol ER) for the Treatment of Idiopathic Hypersomnia (IH)

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ZURICH, SWITZERLAND / ACCESSWIRE / October 3, 2022 / 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, announces that it has entered into definitive agreements with investors, alongside participation from the Company's Chairman of the Board of Directors, Ronald Hafner, and George Apostol, the Company's recently appointed Chief Medical Officer, for the purchase and sale on a private placement basis of 5,194,802 of its common shares, and warrants to purchase up to 2,597,401 common shares (the common shares and warrants, together the "Securities"), resulting in total gross proceeds of approximately $4 million before deducting placement agent commissions and other estimated offering expenses.

NLS Pharmaceutics Announces $4 Million Private Placement and Conversion of Existing Short-Term Notes

ZURICH, SWITZERLAND / ACCESSWIRE / September 19, 2022 / 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, announces that it will host a Virtual Key Opinion Leader ("KOL") Event to review top-line results from its Phase 2a clinical trial evaluating Quilience® (Mazindol ER) in the treatment of excessive daytime sleepiness (EDS) and cataplexy, the two core symptoms of narcolepsy.

NLS Pharmaceutics To Host Virtual Key Opinion Leader Event on September 30, 2022 After Release of Quilience(R) Top-Line Phase 2a Narcolepsy Results

Company also announces expected departure of Sylvia Panigone, Ph.D. ZURICH, SWITZERLAND / ACCESSWIRE / September 8, 2022 / NLS Pharmaceutics Ltd.

NLS Pharmaceutics Appoints Dr. George Apostol as Chief Medical Officer and Global Head of Research & Development

Key patents now granted in major markets including the U.S., Europe, Japan, Canada & South Korea Patent claims cover use of the Company's lead product candidate, Quilience® (mazindol ER) in attention deficit hyperactivity disorder (ADHD), narcolepsy & idiopathic hypersomnia ZURICH, SWITZERLAND / ACCESSWIRE / July 28, 2022 / 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, announces that the Japanese Patent Office (JPO) notified the Company of its decision to grant patent application 2018-546837 for the proprietary formulation of Quilience® (Mazindol ER).

NLS Pharmaceutics Announces Decision by Japanese Patent Office to Grant Patent in Japan for Mazindol Extended-Release

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ZURICH, SWITZERLAND / ACCESSWIRE / July 21, 2022 / 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, announces that the European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP) has issued a positive opinion to grant Orphan Drug Designation (ODD) for Mazindol ER (Quilience®), the Company's patented and proprietary formulation of mazindol, for the treatment of idiopathic hypersomnia (IH).

NLS Pharmaceutics Announces Positive Opinion from European Regulators to Grant Orphan Drug Designation for Mazindol ER in Idiopathic Hypersomnia

ZURICH, SWITZERLAND / ACCESSWIRE / June 10, 2022 / 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, announces that it has received a written notice (the "Notice") from Nasdaq Stock Market LLC, 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 securities to maintain a minimum bid price of $1.00 per share.

NLS Pharmaceutics Announces Receipt of NASDAQ Minimum Bid Price Notification

ZURICH, SWITZERLAND / ACCESSWIRE / June 6, 2022 / 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, announces that Chad C.

NLS Pharmaceutics Appoints Chad C. Hellmann as Chief Financial Officer

60-patient enrollment target met plus 12% over-enrollment; top-line Phase 2a results expected to be presented during the European Sleep Research Society Congress in September 2022 Nearly 90% of patients completing the Phase 2a trial to date have rolled over into the open label extension (OLE) study Patients in the OLE study (both NT1 and NT2) remain on Quilience monotherapy, without any additional background stimulant, wake promoting or anti-cataplectic treatment; several patients on Quilience treatment for up to 6 months ZURICH, SWITZERLAND / ACCESSWIRE / June 2, 2022 / 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, announces that its Phase 2a clinical trial for Quilience in the treatment of narcolepsy is now fully enrolled, with top-line results anticipated to be presented at a symposium during the European Sleep Research Society Congress (ESRS), being held September 27-30, 2022 in Athens, Greece.

NLS Pharmaceutics Announces Over Enrollment in its Phase 2a Clinical Trial Evaluating Quilience(R) for the Treatment of Narcolepsy

Since the interim results were released in March, patient enrollment has nearly doubled Of the 60 patients planned for the study, 54 have now been randomized with several others currently undergoing screening Nearly 90% of patients that completed the Phase 2a trial to date have rolled over into the open label extension (OLE) study Patients in the OLE study (both NT1 and NT2) remain on Quilience monotherapy, without any additional background stimulant, wake promoting nor anti-cataplectic treatment, with several on therapy for over 5 months ZURICH, SWITZERLAND / ACCESSWIRE / May 4, 2022 / 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, announces that 90% of the 60 patients required to complete its Phase 2a clinical trial for Quilience (Mazindol ER) have been randomized and the Company continues to expect to report final results from this ground-breaking trial by mid-Q3 2022.

NLS Pharmaceutics Achieves 90% Enrollment Milestone in Quilience(R) Phase 2a Clinical Trial for Patients with Narcolepsy

ZURICH, SWITZERLAND / ACCESSWIRE / April 26, 2022 / 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 disorder, today announced the closing of its previously announced registered direct offering with health-care focused institutional investors alongside participation from the Company's Chairman of the Board of Directors, Ronald Hafner, for the purchase and sale of 4,200,000 of the Company's common shares (or common share equivalents) at a purchase price of $1.04 per common share (or common share equivalent).

NLS Pharmaceutics Ltd. Announces Closing of US$4.4 Million Registered Direct Offering

ZURICH, SWITZERLAND / ACCESSWIRE / April 22, 2022 / 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, announces that Alex Zwyer, CEO and Co-Founder, will participate in a fireside chat at the B.

NLS Pharmaceutics to Participate in the B. Riley Annual Neuro & Ophthalmology Investor Conference

ZURICH, SWITZERLAND / ACCESSWIRE / April 13, 2022 / 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 disorder, today announced that it has entered into definitive agreements with health-care focused institutional investors alongside participation from the Company's Chairman of the Board of Directors, Ronald Hafner, for the purchase and sale of 4,200,000 of the Company's common shares (or common share equivalents) at a purchase price of $1.04 per common share (or common share equivalent) in a registered direct offering priced at-the-market under Nasdaq rules.

NLS Pharmaceutics Ltd. Announces US$4.4 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

ZURICH, SWITZERLAND / ACCESSWIRE / April1, 2022 / 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, announces that it has 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.

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