NLSP NLS Pharmaceutics Ltd.

3.13
+0.05  (+2%)
Previous Close 3.08
Open 3.05
52 Week Low 2.06
52 Week High 7.35
Market Cap $37,773,857
Shares 12,068,325
Float 4,348,325
Enterprise Value $38,920,164
Volume 92,813
Av. Daily Volume 290,931
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Upcoming Catalysts

Drug Stage Catalyst Date
Quilience
Excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Nolazol
ADHD
Phase 2
Phase 2
Phase 2 trial has been completed.

Latest News

  1. STANS, Switzerland, May 28, 2021 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW))) ("NLS" or the "Company"), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that Alex Zwyer, Chief Executive Officer and Co-Founder, is scheduled to present a corporate overview at the MicroCap Rodeo 2021 Summer Solstice: Best Ideas from the Buyside Conference, which is being held virtually June 1June 4, 2021. 

    Mr. Zwyer will deliver his corporate presentation on June 2nd at 8:30am ET (2:30pm CET), and will be available for one-on-one meetings to be held throughout the conference.

    The presentation will be webcast live and available for replay at https://www.webcaster4.com/Webcast/Page/2134/41515

    The MicroCap Rodeo's third edition is a virtual conference that brings together the top 35 "best ideas from the buy side". Qualified institutional investors recommended each of the 35 companies represented as one of their "best ideas".  To receive additional information, request an invitation or to schedule a one-on-one meeting, please email .

    Investors can register here.

    About NLS Pharmaceutics Ltd.

    NLS Pharmaceutics Ltd. is a Swiss-based 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 controlled-release formulation of mazindol (mazindol CR), and is being developed for the treatment of narcolepsy. Mazindol is a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist, which was used for many years to treat patients diagnosed with narcolepsy in compassionate use programs. NLS completed a phase 2 study in the U.S. evaluating mazindol CR in adult subjects with ADHD. The study met all primary and secondary endpoints and was well-tolerated. Quilience has received Orphan Drug Designations both in the U.S. and in Europe for the treatment of narcolepsy.

    Corporate Contact

    Alex Zwyer, CEO: +41 41 618 80 00 

    Investor Relations Contact

    Cindy Rizzo: +1 908-229-7050 

    www.nlspharma.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/nls-pharmaceutics-to-present-at-the-microcap-rodeo-2021-summer-solstice-best-ideas-from-the-buyside-conference-on-june-1-301301428.html

    SOURCE NLS Pharmaceutics Ltd.

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  2. STANS, Switzerland, May 18, 2021 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW))) ("NLS" or the "Company"), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces new study data which support the mechanism of action for mazindol, the active compound in the Company's lead product candidate to treat narcolepsy, Quilience®. Narcolepsy is caused by a deficiency in orexin, a neuropeptide that regulates the sleep-wake cycle. The new data confirm mazindol's Orexin-2 receptor (OX2R) agonist activity.

    In the pre-clinical study conducted by the Department of Biomedical Sciences at the University of Lausanne and sponsored by NLS, mice that were genetically modified not to express OX2R (Knock-Out mice) and Wild-Type mice (normal mice) were investigated for psychostimulant effects when mazindol was administered. The study demonstrated that Knock Out mice were 70% less sensitive to mazindol compared to normal mice, confirming mazindol's potent activity as an OX2R agonist.

    Ongoing studies sponsored by the Company are intended to further confirm and extend this finding to the wake-promoting and anti-cataplexy effects of mazindol, which have been observed in human studies and in clinical practice when the drug was prescribed to treat narcolepsy in compassionate use programs. NLS believes that the new data also support prior in-vitro data from studies conducted by the Company demonstrating the partial binding affinity of mazindol to OX2R, which NLS believes is a key pathway that mediates mazindol's stimulant-like effects. Mazindol is a scheduled IV controlled substance unrelated to amphetamine salts, which are highly regulated and have restricted use.

    "We believe these study results confirm that mazindol has a surprisingly unique mode of action, not only as a reuptake blocker of monoamines in the central nervous system like other stimulants, but also having psychostimulant effects through the activation of OX2R," said Mehdi Tafti, Ph.D., Professor at the University of Lausanne, Department of Biomedical Sciences. "Given that narcolepsy is caused by orexin deficiency, this finding is important as mazindol has the potential to become the first-available treatment targeting Orexin-2 receptors, and the first evidence-based medicine to address this chronic sleep disorder."

    "The results of this Knock Out mouse study demonstrate mazindol's potent binding activity to OX2R, which we believe will translate into clinically meaningful results in humans suffering from the core symptoms of narcolepsy – excessive daytime sleepiness and cataplexy attacks," said Eric Konofal, M.D., Ph.D., Co-founder and interim Chief Scientific Officer of NLS. "Clinical data from real-world mazindol use, as well as trial results from other orexin-activating compounds validate the utility of orexin receptor stimulation and the potential benefits to both narcolepsy Type 1 and narcolepsy Type 2 patients. We believe that Quilience® will provide a differentiated solution in this treatment category given mazindol's dual mechanism of action, namely orexin pathway activation and pan-monoaminergic reuptake inhibition in the brain. Overall, we believe that the unique pharmacological profile of mazindol will offer synergies that could translate into improved efficacy compared to current treatments, as well as those in development that purely target OX2R. 

    "We are dedicated to the development of Quilience®, our proprietary controlled-release formulation of mazindol, which we believe has the potential to provide a superior solution in the treatment of narcolepsy by addressing the disorder at its root cause," said Alexander Zwyer, Chief Executive Officer of NLS. "Mazindol has been used over many years to treat refractory narcoleptic patients off-label, with evidence of favorable efficacy and safety. We believe that these new preclinical results further support the rationale for our clinical program intended to bring mazindol back to the market in an optimized formulation that can benefit patients diagnosed with narcolepsy and potentially other sleep-wake disorders."

    About NLS Pharmaceutics Ltd.

    NLS Pharmaceutics Ltd. is a Swiss-based 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 controlled release formulation of mazindol (mazindol CR), and is being developed for the treatment of narcolepsy. 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. NLS completed a Phase 2 study in the U.S. evaluating mazindol CR in adult subjects with ADHD. The study met all primary and secondary endpoints and was well-tolerated. Quilience® has received Orphan Drug Designations both in the U.S. and in Europe for the treatment of narcolepsy.

    Safe Harbor Statement

    This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses the intent of ongoing and future studies, its belief that the partial binding affinity of mazindol to OX2R is a key pathway that mediates mazindol's psychostimulant effects, the belief that mazindol has a unique mode of action and that mazindol has the potential to become the first-available treatment targeting Orexin-2 receptors and the first evidence-based medicine to address this chronic sleep disorder, that Quilience® may potentially provide a superior solution in the treatment of narcolepsy by addressing its root cause, that the results from the announced preclinical study support results of prior NLS studies, and that the results from the announced preclinical study support the rationale for bringing mazindol back to the market. These forward-looking statements and their implications are based on the current expectations of the management of NLS only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS's products may not be approved by regulatory agencies, NLS's technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; NLS may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with NLS's process; NLS's products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; NLS's patents may not be sufficient; NLS's products may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading "Risk Factors" in NLS's prospectus dated January 28, 2021 filed with the SEC, which is available on the SEC's website, www.sec.gov.

    Corporate Contact:

    Alex Zwyer, CEO: +41 41 618 80 00 

    Investor Relations Contact

    David Moskowitz: +1 202-280-0888 

    www.nlspharma.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/nls-pharmaceutics-announces-new-study-data-confirming-mazindols-unique-orexin-pathway-activation-for-treating-narcolepsy-301293512.html

    SOURCE NLS Pharmaceutics Ltd.

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  3. STANS, Switzerland, May 5, 2021 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW))) ("NLS" or the "Company"), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that the European Patent Office has granted the Company Patent No. EP3426232, entitled A MAZINDOL IR/SR MULTILAYER TABLET AND ITS USE FOR THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD). The patent provides intellectual property protection for oral formulations containing immediate-release and sustained-release layers of mazindol for use in treating attention deficit disorders (ADD or ADHD), related deficit of alertness…

    STANS, Switzerland, May 5, 2021 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW))) ("NLS" or the "Company"), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that the European Patent Office has granted the Company Patent No. EP3426232, entitled A MAZINDOL IR/SR MULTILAYER TABLET AND ITS USE FOR THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD). The patent provides intellectual property protection for oral formulations containing immediate-release and sustained-release layers of mazindol for use in treating attention deficit disorders (ADD or ADHD), related deficit of alertness or decline of vigilance, or excessive daytime sleepiness (e.g., narcolepsy, idiopathic hypersomnia) in particular in children, adolescents and adults.

    "We are pleased to have obtained patent coverage in Europe covering our controlled-release formulation of mazindol as we advance the development of Quilience® (mazindol CR) to treat narcolepsy and potentially other sleep-wake disorders," said Alex Zwyer, Chief Executive Officer of NLS. "Earlier this year, we were granted a similar patent in Canada, and our U.S. patent application is pending review. Additionally, this newly issued patent augments the Orphan Drug Designations that we have for Quilience in both Europe and the U.S. Most patients with narcolepsy remain unsatisfied with current treatment options, and we believe that Quilience has potential to fill a major need in the market given mazindol's long history of safety and evidence of effectiveness in treating the symptoms of narcolepsy. We remain on track to initiate our prospective Phase 2 clinical study for Quilience this summer as we focus on bringing this treatment option to patients suffering from narcolepsy as soon as possible."

    About NLS Pharmaceutics Ltd.

    NLS Pharmaceutics Ltd. is a Swiss-based 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 controlled-release formulation of mazindol (mazindol CR), and is being developed for the treatment of narcolepsy. Mazindol is a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist, which was used for many years to treat patients diagnosed with narcolepsy in compassionate use programs. NLS completed a phase 2 study in the U.S. evaluating mazindol CR in adult subjects with ADHD. The study met all primary and secondary endpoints and was well-tolerated. Quilience has received Orphan Drug Designations both in the U.S. and in Europe for the treatment of narcolepsy.

    Safe Harbor Statement

    This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses its belief that Quilience has potential to fill a major need in the market given mazindol's long history of safety and evidence of effectiveness in treating the symptoms of narcolepsy, its development of other sleep-wake disorders, the novelty of Quilience and the expected timing of the initiation of its Phase 2 clinical study for Quilience. These forward-looking statements and their implications are based on the current expectations of the management of NLS only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS's products may not be approved by regulatory agencies, NLS's technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; NLS may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with NLS's process; NLS's products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; NLS's patents may not be sufficient; NLS's products may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading "Risk Factors" in NLS' final prospectus, dated January 28, 2021, filed with the Securities and Exchange Commission (the SEC"), which is available on the SEC's website, www.sec.gov.

    Corporate Contact

    Alex Zwyer, CEO: +41 41 618 80 00 

    Investor Relations Contact

    David Moskowitz: +1 202-280-0888 

    www.nlspharma.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/nls-pharmaceutics-announces-patent-issuance-in-europe-for-its-mazindol-controlled-release-formulation-mazindol-cr-301284177.html

    SOURCE NLS Pharmaceutics Ltd.

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  4. STANS, Switzerland, April 5, 2021 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW))) ("NLS" or the "Company"), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces the appointment of Silvia Panigone, Ph.D., eMBA as Chief Operating Officer. Dr. Panigone brings to NLS over 25 years of leadership experience in the healthcare industry, founding and operating ADYA Consulting, a boutique advisory firm that provides strategic counseling, access to capital, and M&A advisory services to companies in the life sciences sector, and serving in operational and managerial roles in international pharmaceutical companies…

    STANS, Switzerland, April 5, 2021 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW))) ("NLS" or the "Company"), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces the appointment of Silvia Panigone, Ph.D., eMBA as Chief Operating Officer. Dr. Panigone brings to NLS over 25 years of leadership experience in the healthcare industry, founding and operating ADYA Consulting, a boutique advisory firm that provides strategic counseling, access to capital, and M&A advisory services to companies in the life sciences sector, and serving in operational and managerial roles in international pharmaceutical companies and clinical research organizations.

    "Silvia's outstanding experience in product development and strategic leadership in the life sciences industry is a natural fit for NLS as we pursue the development of Quilience® to treat narcolepsy, and establish our strategy for business development and advancement of our drug pipeline," said Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics. "Her proven ability to guide emerging biotechnology and pharmaceutical companies from their early stages of development through periods of significant growth will be instrumental as we seek to drive our corporate initiatives and build value within the Company. All of us at NLS extend a warm welcome to Silvia."

    "I am delighted to join the NLS team and to oversee the major operational activities at the Company so that we can bring our novel treatments for rare and complex CNS disorders to patients," said Dr. Panigone.  "NLS is focused on the development of therapeutics intended to satisfy unmet medical needs, and our lead product, Quilience,® has the potential to become the first treatment for narcolepsy that targets the orexin-2 receptor, the root cause of the disorder. Given the importance of this product candidate, our top priority is to obtain IND approval in the U.S. and advance Quilience into the clinic as soon as possible."

    Prior to joining NLS, Dr. Panigone was managing director of ADYA Consulting Sagl, a Swiss investment boutique in the life sciences sector operating globally and supporting companies in their corporate strategy and fundraising. She also acted as interim management in approximately one third of ADYA's biotech and pharma clients, and has held several Board positions in private companies, helping some realize M&A exits. Dr. Panigone combines a deep understanding of both corporate finance and drug development processes and execution. Prior to ADYA, she was former Managing Director of Europe at I-Bankers Direct LLC, an equity funding web platform, as well as Advisor for I-Bankers Securities, Inc., a U.S. investment banking group with over 140 lead and co-managed offerings. She previously served as Fund Manager at BSI Healthcapital, a venture capital firm focused on life sciences, and Head of Venture Investments in the Merchant division of the Swiss-based bank, EFG International. Dr. Panigone's extensive R&D experience includes serving in operational and managerial positions at an international level in pharmaceutical companies and CROs. In Bracco SpA, she led international programs in both the preclinical and clinical stages of development with teams of regulatory, intellectual property, CMC, preclinical and clinical internal experts, external providers, and KOLs, overseeing the development program as Sponsor. She was also Global Project Manager at Quintiles Innovex Ltd., a leading global CRO, where she was responsible for managing large clinical programs conducted in the U.S., Europe and Asia. Previously, Dr. Panigone served as Senior Director at XoVenture, a global network of Life Sciences entrepreneurs and executives, Start-Up Coach for the Swiss government (Innosuisse), Board Member of University of Milan, and was a member of the European Network of Narcolepsy (EUNN). She earned a Molecular Biology degree from the University of Milan, a Ph.D. in Molecular Oncology at the National Cancer Institute and Open University, London, and an Executive MBA from SDA Bocconi School of Management, Milan.

    About NLS Pharmaceutics Ltd.

    NLS Pharmaceutics Ltd. is a Swiss-based 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 controlled-release formulation of mazindol (mazindol CR), and is being developed for the treatment of narcolepsy. Mazindol is a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist, which was used for many years to treat patients diagnosed with narcolepsy in compassionate use programs. NLS completed a phase 2 study in the U.S. evaluating mazindol CR in adult subjects with ADHD. The study met all primary and secondary endpoints and was well-tolerated. Quilience has received Orphan Drug Designations both in the U.S. and in Europe for the treatment of narcolepsy.

    Safe Harbor Statement

    This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses Quilience® having the potential to become the first treatment for narcolepsy that targets the orexin-2 receptor, the root cause of the disorder, as well as when it discusses its strategy and pipeline, initiatives and building value, as well as the potential benefits and approval of Quilience® . These forward-looking statements and their implications are based on the current expectations of the management of NLS only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS's products may not be approved by regulatory agencies, NLS's technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; NLS may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with NLS's process; NLS's products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; NLS's patents may not be sufficient; NLS's products may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading "Risk Factors" in NLS' final prospectus, dated January 28, 2021, filed with the SEC, which is available on the SEC's website, www.sec.gov.

    Corporate Contact

    Alex Zwyer, CEO: +41 41 618 80 00 

    Investor Relations Contact

    David Moskowitz: +1 202-280-0888 

    www.nlspharma.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/nls-pharmaceutics-appoints-silvia-panigone-phd-as-chief-operating-officer-301261618.html

    SOURCE NLS Pharmaceutics Ltd.

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  5. STANS, Switzerland, March 29, 2021 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW))) ("NLS" or the "Company"), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that it has been awarded Canadian Patent No. 3016852, entitled A MAZINDOL IR/SR MULTILAYER TABLET AND ITS USE FOR THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD). The patent provides intellectual property protection for oral formulations containing immediate-release and sustained-release layers of mazindol for use in treating attention deficit disorders (ADD or ADHD), related alertness of vigilance or excessive daytime…

    STANS, Switzerland, March 29, 2021 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW))) ("NLS" or the "Company"), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that it has been awarded Canadian Patent No. 3016852, entitled A MAZINDOL IR/SR MULTILAYER TABLET AND ITS USE FOR THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD). The patent provides intellectual property protection for oral formulations containing immediate-release and sustained-release layers of mazindol for use in treating attention deficit disorders (ADD or ADHD), related alertness of vigilance or excessive daytime sleepiness (EDS), narcolepsy, or idiopathic hypersomnia.

    "We are very pleased to have obtained the first patent covering our novel formulation of controlled-release mazindol as we advance the development of Quilience® to treat narcolepsy and other potential sleep-wake disorders," said Alex Zwyer, Chief Executive Officer of NLS. "Our application for a similar patent in Europe received notice of allowance in January, and our U.S. patent application is pending review. Most patients with narcolepsy remain unsatisfied with current treatment options, and we believe that Quilience has potential to fill a major need in the market given mazindol's long history of safety and evidence of effectiveness in treating the symptoms of narcolepsy. We remain focused on initiating our prospective Phase 2 clinical study for Quilience and bringing this treatment option to patients suffering from narcolepsy as soon as possible."

    About NLS Pharmaceutics Ltd.

    NLS Pharmaceutics Ltd. is a Swiss-based 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 controlled-release formulation of mazindol (mazindol CR), and is being developed for the treatment of narcolepsy. Mazindol is a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist, which was used for many years to treat patients diagnosed with narcolepsy in compassionate use programs. NLS completed a phase 2 study in the U.S. evaluating mazindol CR in adult subjects with ADHD. The study met all primary and secondary endpoints and was well-tolerated. Quilience has received Orphan Drug Designations both in the U.S. and in Europe for the treatment of narcolepsy.

    Safe Harbor Statement

    This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses its belief that Quilience has potential to fill a major need in the market given mazindol's long history of safety and evidence of effectiveness in treating the symptoms of narcolepsy and the expected timing of the initiation of its Phase 2 clinical study for Quilience. These forward-looking statements and their implications are based on the current expectations of the management of NLS only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS's products may not be approved by regulatory agencies, NLS's technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; NLS may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with NLS's process; NLS's products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; NLS's patents may not be sufficient; NLS's products may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading "Risk Factors" in NLS' final prospectus, dated January 28, 2021, filed with the SEC, which is available on the SEC's website, www.sec.gov.

    Corporate Contact

    Alex Zwyer, CEO: +41 41 618 80 00 

    Investor Relations Contact

    David Moskowitz: +1 202-280-0888 

    www.nlspharma.com

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/nls-pharmaceutics-announces-issuance-of-canadian-patent-covering-its-novel-formulation-of-controlled-release-mazindol-mazindol-cr-301257319.html

    SOURCE NLS Pharmaceutics Ltd.

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