Announcement • Oct 30
NLS Pharmaceutics Ltd. and Aexon Labs Announces the Expansion of Their Doxa Platform with the AEX-6xx Series NLS Pharmaceutics Ltd. and Aexon Labs announced the expansion of their DOXA platform with the AEX-6xx series, a new generation of small molecules targeting arousal stability, cognition, and neuroprotection. AEX-635, one of the lead DOXA compounds, also modulates Multidrug Resistance-Associated Protein 1 ("MRP1"), offering a synergistic approach to potentially enhance neuroprotective effects and improve CNS drug bioavailability, especially in oxidative stress-driven conditions such as Parkinson's disease and gliopathies. Built on a novel class of dihydroquinazoline and dihydrobenzothiazine derivatives, DOXA integrates dual orexin receptor agonism (OX1R/OX2R) with cathepsin H (CTSH) inhibition, addressing core pathways underlying sleep-wake regulation, motivation, and neuronal resilience. Announcement • Jun 18
NLS Pharmaceutics AG announced that it expects to receive $25 million in funding : NLS Pharmaceutics AG announced an equity facility for the gross proceeds of $25,000,000 on June 17, 2025. Announcement • Jun 12
NLS Pharmaceutics AG, Annual General Meeting, Jun 30, 2025 NLS Pharmaceutics AG, Annual General Meeting, Jun 30, 2025, at 16:00 W. Europe Standard Time. Location: at the premises of baker mckenzie switzerland ag, holbeinstrasse 30, 8034 zurich, Switzerland Announcement • May 21
NLS Pharmaceutics Ltd. to Present New Data on the Dual Efficacy of Mazindol ER in Fentanyl Reward and Withdrawal at the 2025 ASCP Annual Meeting NLS Pharmaceutics Ltd. announced that it will present new preclinical data on Mazindol ER at the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology ("ASCP"). ASCP Annual Meeting will be held at the Fairmont Scottsdale Princess in Scottsdale, Arizona from May 27, 2025, to May 30, 2025. NLS intends to present its poster titled, 'Evaluating the Effects of Mazindol on Fentanyl Reward and Dependence in C57BL/6J Mice and Sprague-Dawley Rats (Study KO-943), during the poster session on May 29, 2025, from 11:15 AM to 1:00 PM. The preclinical study to be featured in the poster was conducted by Key-Obs SAS in collaboration with NLS and other European academic institutions. The study results demonstrate that Mazindol significantly reduced both the rewarding effects of fentanyl and the severity of its withdrawal symptoms in validated rodent models. Highlights from Study KO-943: Experiment 1 (Reward/CPP Model): In C57BL/6J mice, Mazindol at 0.5 mg/kg significantly reduced fentanyl-induced conditioned place preference ("CPP"), effectively neutralizing the behavioral reward effects typically observed with fentanyl exposure. Experiment 2 (Withdrawal Model): In Sprague-Dawley rats, Mazindol administered at 0.5 and 1.0 mg/kg dose-dependently reduced fentanyl withdrawal symptoms, including agitation, salivation, and motor disruptions, as measured by the Gellert-Holtzman scale. These findings are supported by results from both reward and withdrawal animal models, including the CPP paradigm in C57BL/6 J mice and naloxone-precipitated withdrawal in Sprague-Dawley mice. Clinical trials, including the planned NLS-6002 study, are needed to validate these results in humans. While standard stimulant and non-stimulant medications approved for ADHD have shown no significant efficacy in addressing opioid withdrawal or reward, Mazindol's ability to reduce both in fentanyl-exposed animals suggests it may offer advantages over conventional treatments. It brings together leading clinicians, researchers, and innovators to present and discuss the latest advances in CNS therapeutics. Announcement • May 02
NLS Pharmaceutics AG announced delayed 20-F filing On 05/01/2025, NLS Pharmaceutics AG announced that they will be unable to file their next 20-F by the deadline required by the SEC. Announcement • Apr 15
NLS Pharmaceutics Ltd. Announces Positive Results from Study KO-943 Demonstrating Mazindol Reduces F fentanyl-Induced Reward in Animal Models NLS Pharmaceutics Ltd. announced positive results from Study KO-943, a preclinical investigation evaluating the efficacy of Mazindol in mitigating fentanyl-induced conditioned place preference (CPP) in mice. The study, conducted by Key-Obs SAS, a leading preclinical CRO, provides evidence that Mazindol may offer a novel, non-opioid approach for the treatment of fentanyl use disorder -- a condition contributing to over 75% of opioid-related overdose deaths in the United States. This development comes after the company recently raised up to $3 million and signed a $25 million committed equity facility agreement as part of the planned strategic merger with Kadimastem Ltd. This funding will enable the merged company to develop Kadimastem cell therapy clinical assets and to continue the development of the NLS assets that will remain post-merger, including: Assets to remain with the merged company (NucelX): DOXA platform (Dual Orexin Receptor Agonist). Assets to be allocated to the CVR: Mazindol ER, NLS-4, NLS-8, NLS-11, NLS-12. Announcement • Feb 27
Nls Pharmaceutics Announces New Preclinical Data for Aex-2, Expanding the Therapeutic Potential of Its Non-Sulfonamide Dual Orexin Receptor Agonist Platform NLS Pharmaceutics Ltd. in collaboration with Aexon Labs Inc. announced new preclinical findings on AEX-2, reinforcing its potential as a first-in-class non-sulfonamide dual orexin receptor agonist ("DOXA") for narcolepsy and related neurological disorders. These results build upon the Company's multi-target neurodegenerative strategy, which also includes AEX-41, demonstrating a novel and promising approach to addressing sleep disorders, neuroinflammation, and metabolic dysfunction. Recent preclinical advancements have demonstrated the multi-target potential of DOXA compounds, including AEX-41 and AEX-2, in redefining sleep- wake regulation and neuroprotection. Addressing Diabetes-Associated Neurological Disorders ("DANS")): Given the link between orexin signalling, metabolic regulation, and sleep disorders, the multi-target properties of DOXA compounds such as AEX-2 and AEX-41 could provide new therapeutic avenues for diabetes-related neuropathy and cognitive decline. Aexon Labs, known for its cutting-edge computational chemistry and AI-driven drug discovery, has played a key role in optimizing these multi-target molecules, ensuring high blood-brain barrier penetration and selective receptor affinity. Building on these breakthrough findings, NLS Pharmaceutics is advancing AEX- 2 and AEX-41 into IND-enabling studies in 2025, targeting first-in-human clinical trials by 2026. Beyond dual orexin receptor activation, these compounds engage Sigma-1 receptor modulation, cathepsin inhibition, and mitochondrial regulation, reinforcing their first-in-class potential. To validate this multi-target strategy, additional preclinical studies are underway, including an ongoing DANS model, potentially broadening their applications beyond sleep disorders. NLS Pharmaceutics plans to present the definitive results on AEX-2 and A EX-41 at the American Society for Clinical Psychopharmacology (ASCP) Annual Meeting, taking place May 27-30, 2025, at the Fairmont Scottsdale Princess in Scottsdale, Arizona. Announcement • Feb 26
Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment NLS Pharmaceutics Ltd. and Kadimastem Ltd. announced the result from the Type B pre-IND meeting held by Kadimastem and iTolerance with a committee of the U.S Food and Drug Administration ("FDA") on February 24, 2025, regarding the development of iTOL-102, a potential cure for diabetes that would not require life-long chronic immune system suppression. iTOL-102 is an investigational biologic for the treatment and potential cure of Type 1 Diabetes consisting of Kadimastem's allogenic human stem cell-derived pancreatic islets (IsletRx cells) combined with iTolerance's immunomodulator (iTOL-100). Kadimastem and iTolerance believe that the completion of the pre-IND meeting is a significant milestone toward the clinical development of iTOL-102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by grants received from the Israel-U.S. Binational Industrial Research and Development Foundation.iTOL-102 was evaluated at the fast-track center for testing at the Diabetes Research Institute ("DRI") at the University of Miami School of Medicine, where it was designated as a potential breakthrough transplantation approach for the treatment of Type 1 Diabetes, as the novel combination of tolerance-inducing agent and human stem cell-derived islets. iTOL-102 demonstrated functional insulin release and disease reversal in an animal model, with full compatibility between IsletRx cells and iTOL-100.Prior to the meeting with the FDA, Kadimastem and iTolerance received a preliminary response document from the FDA, providing critical feedback on their current preclinical and clinical development plans. This guidance is instrumental in moving forward with the next stages of development. Based on the feedback provided at the pre-IND meeting, Kadimastem and iTolerance are now updating their plans for a safety toxicology study and the preparation of a First-in-Human clinical trial. Kadimastem believes its collaboration with iTolerance signifies a potentially transformative step in diabetes treatment, paving the way towards the potential development of iTOL-100 and requesting regulatory approvals for commercialization of a potential cure for type 1 diabetes.iTOL-100 is an immunomodulatory microgel technology being developed by iTolerance designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem's IsletRx human stem cell-derived islets.Kadimastem's IsletRx is a clinical-grade product candidate comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the necessary amounts of insulin and glucagon. Announcement • Feb 11
NLS Pharmaceutics Ltd. and Kadimastem Ltd. Unveil Multi-Target Approach to Diabetes, Expanding Beyond GLP-1 Therapies NLS Pharmaceutics Ltd. and Kadimastem Ltd. are on a mission to create a leading biotechnology entity. The upcoming expected merger aims to transform the treatment landscape for complex conditions such as diabetes. By uniting the core competencies of both organizations, NLS and Kadimastem believe that this merger is positioned to potentially create a holistic solution that addresses the multifaceted challenges of diabetes management. Cathepsin Inhibition (CTSS/CTSL): Aiming to protect neuronal integrity and b-cell survival, crucial for long-term metabolic health. Sodium-Glucose Cotransporter-2 (SGLT2) Modulation: Aiming to improve glucose metabolism while reducing neuropathic and vascular damage. Adiponectin Receptor Activation: Aiming to enhance insulin sensitivity and mitochondrial function, addressing core metabolic dysfunctions. Preclinical studies to be presented at the 2025 ASCP Annual Meeting demonstrate that DOXA compounds: Restore orexinergic function, improving metabolic balance and sleep- wake disturbances. Reduce inflammatory markers and neurodegeneration, preventing diabetes-induced neuronal damage. Enhance b-cell survival and glucose metabolism, positioning DOXA as a disease-modifying therapy rather than a glucose-dependent intervention. For example, NLS and KadimASTem are using forward-looking statements when they discuss the expected closing of the transaction and the potential benefits of the transaction to NLS and KadimastEM and their respective shareholders, including value creation for shareholders, the expected strategic position of the combined company following the merger, if completed and the expected benefits of DOXA in the treatment of diabetes. These forward-looking statements and their implications are based on the current expectations of the management of NLS and Kadimastimastem 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: risks related to the companies' ability to complete the merger on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of the closing conditions related to the merger agreement and risks and uncertainties related to the failure to timely, or at all, obtain shareholder approvals for the transaction; unexpected costs, charges or expenses resulting from the transaction and potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger; changes in technology and market requirements; either or both companies may encounter delays or obstacles in launching and/or successfully completing their clinical trials; the companies' products may not be approved by regulatory agencies; their technologies may not be validated as they progress and their methods may not be accepted by the scientific community; either of both of the companies may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with the products being advanced by the companies; their products may wind up being more expensive than anticipated; 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; the companies' patents may not be sufficient; their products may harm recipients; changes in legislation may adversely impact either or or or or or any other companies may adversely impact either or or other companies or other companies or other companies may be able to retain or attract key employees who may be able to retain or attracting key employees whose knowledge is essential To the development of their products; unexpected scientific difficulties may develop with the product being advanced by the companies; Their products may wind up being more costly than anticipated; results in the lab may not translate to equally good Results in real clinical settings; results the results of preclinical studies may Not correlate with the results of humanclinical trials; the companies' patents will not be sufficient; their products will harm recipients; changes in legislation will adversely impact either or or or other companies will affect either or or other companies. Announcement • Jan 30
NLS Pharmaceutics Ltd. Announces the Submission of Three Research Abstracts to the 2025 ASCP Annual Meeting NLS Pharmaceutics Ltd. announced the submission of three research abstracts to the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP). NLS Submitted Research Abstracts: Evaluating the Effects of Mazindol on Fentanyl Dependence in Animal Models (Study KO-943). This study explores the therapeutic potential of Mazindol ER, a triple monoamine reuptake inhibitor with additional activity on 5-HT1A, MOP, and OX2R receptors, for fentanyl dependence. Preclinical data will demonstrate its ability to mitigate reward-seeking behavior and withdrawal symptoms, positioning it as a promising non-opioid alternative for managing fentanyl addiction. Non-Sulfonamide Dual Orexin Receptor Agonists: Preliminary Results of AEX-41 and AEX-2 in a Mouse Model of Narcolepsy; This research presents promising preclinical findings on AEX-41 and AEX-2, two novel dual orexin receptor agonists (DOXA), in a mouse model of narcolepsy. In preliminary conclusion, these compounds exhibit wake-promoting properties without the adverse metabolic effects associated with traditional stimulants, making them strong candidates for treating narcolepsy and related hypersomnolence disorders. Comprehensive Multitarget Strategy for Managing Diabetes-Associated Neurological and Sleep Disorders (DANS). This study introduces an innovative pharmacological platform for treating diabetes-related cognitive and sleep disorders. The research integrates dual orexin receptor agonists (DOXA), neuropeptide-based preconditioning, and metabolic modulators to address the interplay between neuroinflammation, ß-cell dysfunction, and circadian rhythm disruption. Announcement • Jan 23
NLS Pharmaceutics AG announced that it has received $0.999998 million in funding On January 22, 2025, NLS Pharmaceutics AG closed the transaction. The company announced that it has received $499,999 in second and final tranches. The company announced that it has received the funding pursuant to Regulation D. New Risk • Dec 30
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 21% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Negative equity (-US$9.3m). Earnings have declined by 22% per year over the past 5 years. Shareholders have been substantially diluted in the past year (100% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.95m market cap). Announcement • Dec 19
NLS Pharmaceutics and Kadimastem Announce the Submission of a Request by Kadimastem and iTolerance, Inc. for an FDA Pre-IND Meeting for an Innovative Breakthrough Type 1 Diabetes Treatment NLS Pharmaceutics Ltd. and Kadimastem Ltd. (Kadimastem) announced in collaboration with iTolerance, Inc, (iTolerance that a request for a Pre-Investigational New Drug ("Pre-IND") meeting has been submitted by Kadimastem and iTolerance to the U.S. Food and Drug Administration (FDA) for iTOL102, an investigational biologic consisting of allogenic human stem cell-derived pancreatic islets combined with an immunomodulator for the treatment of Type 1 Diabetes. Kadimastem believes that this collaboration signifies a potentially transformative step in diabetes treatment. This submission comes after a successful INTERACT ("Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products") meeting, which is a meeting at a specific time early in the product development, between Kadimastem, iTolerance, and the FDA earlier this year. The submission is a significant milestone toward the clinical development of iTOL102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by the Israel-United States Binational Industrial Research and Development Foundation ("BIRD"). iTOL102 combines iTolerance's proprietary SA-FasL microgel (known as iTOL-100), an immune modulator, and IsletRx, insulin-producing islet cells derived from human pluripotent stem cells, to generate an innovative treatment intended for the potential cure of type 1 diabetes. iTOL-100, an immunomodulatory microgel technology being developed by iTolerance is designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem's IsletRx human stem cell-derived islets. Kadimastem's IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the necessary amounts of insulin and glucagon. The iTOL102 product was evaluated at the fast-track center for testing at the Diabetes Research Institute ("DRI") at the University of Miami School of Medicine, where it was designated by DRI to be a novel combination of tolerance-inducing agent and human stem cell-derived islets demonstrating functional insulin release and disease reversal in an animal model. As previously reported, NLS Pharmaceuticals and Kadimastem entered into an agreement and plan of merger in November 2024. The merger is subject to closing conditions, including the approval of the shareholders of each of the NLS Pharmaceutics and Kadimastem. Announcement • Dec 06
NLS Pharmaceutics AG announced that it expects to receive $0.999998 million in funding NLS Pharmaceutics AG has entered into a securities purchase agreement to issue up to 322,580 common shares at a price of $3.10 per share for the gross proceeds of $999,998 on December 4, 2024. The transaction is subject to shareholder approval. The securities are being offered pursuant to an exemption from the registration requirements under Section 4(a)(2) of the Securities Act of 1933, as amended, or the Securities Act, and Rule 506(b) of Regulation D promulgated thereunder. The initial closing of the Offering in the amount of $500,000 is expected to occur on or before January 10, 2025, and the subsequent closing of $500,000 may occur. Announcement • Dec 03
NLS Pharmaceutics Announces Promising Preclinical Data for First-in-Class Non-Sulfonamide, Dual Orexin Receptor Agonists for the Potential Treatment of Narcolepsy and Neurological Disorders NLS Pharmaceutics Ltd. share preclinical data demonstrating the potential of its dual orexin receptor agonist (DOXA) platform. AEX-41 and AEX-2, two first-in-class non-sulfonamide DOXAs, are designed to target both orexin-1 (OX1R) and orexin-2 (OX2R) receptors while concurrently inhibiting cathepsins. Cathepsins play significant roles in a variety of physiological processes and may offer a novel therapeutic approach for narcolepsy and other neurological disorders. Key Preclinical Results: The ongoing preclinical study, initiated in October 2024 at the Centre for Neuroscience Research of Lyon, one of Europe's premier neuroscience research centers, has produced compelling data: Improved Wakefulness and Sleep Architecture: In orexin knockout mice, AEX-41 (administered orally at 40 mg/kg) demonstrated a significant increase in wakefulness and a reduction in REM sleep duration. These effects are crucial for managing the core symptoms of narcolepsy. Comparable Efficacy to Selective OX2R Agonists: The efficacy of AEX-41 was comparable to sulfonamide-derivative selective OX2R agonists under similar experimental conditions, highlighting its potential as a versatile alternative for broader therapeutic application. Multi-Pathway Potential: By targeting both orexin receptors and Cathepsin H (CTSH) inhibition activity, AEX-41 offers a dual-action mechanism that could address not only sleep- wake regulation but also underlying neurodegenerative processes. Starting in 2025, NLS plans to expand its research to investigate the impact on CTSH in animal models of neuroinflammation, a key factor in the progression of neurodegenerative diseases. An Investigational New Drug (IND) application is planned for 2026-2027 to support this new avenue of study. Eric Konofal, MD, PhD, Chief Scientific Officer of NLS and inventor of the DOXA platform, stated, "The dual mechanism of action of AEX-41 marks a transformative approach in treating narcolepsy. By simultaneously targeting orexin receptors and cathepsins, the company aim to provide both symptomatic relief and disease-modifying potential- which would be an advancement over current therapies. In addition, based on cathepsins broad mechanism of action, the company believe the DOXA platform may hold significant synergies with Kadimastem's pipeline, especially in the areas of diabetes, which is often associated with sleep- wake dysregulation manifesting as insomnia, as well as amyotrophic lateral sclerosis. 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: changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS products may not be approved by regulatory agencies, NLS 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' process; NLS' 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 patents may not be sufficient; NLS products may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; and 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. Announcement • Nov 19
NLS Pharmaceutics Ltd. Highlights Innovative Preclinical Program for First-In-Class Non-Sulfonamide Dual Orexin Receptor Agonists (Doxa) in Narcolepsy and Neurological Disorders NLS Pharmaceutics Ltd. provided insights into the preclinical program evaluating its dual orexin receptor agonist (DOXA) platform. AEX-41 and AEX-2, two first-in-class non-sulfonamide DOXAs, are designed to target both orexin-1 (OX1R) and orexin-2 (OX2R) receptors while concurrently inhibiting cathepsins. This unique approach aims to address the unmet therapeutic needs in narcolepsy and related neurological disorders. The ongoing studies are conducted at the Centre for Neuroscience Research of Lyon, a world-class institution specializing in sleep and neurological research. By engaging both OX1R and OX2R receptors and addressing broader neurological pathways, AEX-41 and AX2R offer the potential for enhanced therapeutic outcomes, including greater wakefulness stability and improved sleep quality under real-world conditions. Looking ahead: NLS remains committed to advancing its pipeline and anticipates providing further updates as the preclinical program progresses. First results from the ongoing study are expected to be shared in early December 2024. The Company's broader development plans include exploring the application of its DOXA platform also in other neurological conditions, such as Amyotrophic Lateral Sclerosis (ALS). Announcement • Nov 16
NLS Pharmaceutics AG Announces Resignation of Claudio Bassetti as Member of the Board November 13, 2024, Claudio Bassetti, a member of the Board of Directors of NLS Pharmaceutics Ltd., or the Company, notified the Company of his intention to resign from the Company's Board of Directors, effective November 30, 2024. The resignation of Claudio Bassetti was not based on any material disagreement with the Company on any matter relating to its operations, policies or practice. Announcement • Oct 29
NLS Pharmaceutics Regains Full Compliance with Nasdaq Listing Requirements NLS Pharmaceutics Ltd. (NLS Pharmaceutics AG) announced that it has received notice from the Nasdaq Stock Market LLC (‘NASDAQ’) informing the Company that it has regained full compliance with the bid price requirement in Listing Rule 5550(a)(2) and the equity requirement in Listing Rule 5550(b)(1).’We are pleased to report that Nasdaq has recognized our full compliance with their listing requirements,’ said Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics. ‘Their confirmation follows our successful efforts to improve our balance sheet, including raising new capital and implementing a reverse share split’. Announcement • Oct 15
NLS Pharmaceutics Expects it Regains Compliance with Nasdaq Minimum Bid Price and Stockholders' Equity Requirements NLS Pharmaceutics Ltd. announced that it believes it has regained compliance with the minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2), due to the fact that its common shares have traded above $1.00 for ten consecutive trading days. In addition, due in part to the foregoing transactions, NLS announced that it believes that it satisfies the stockholders' equity requirement of at least $2.5 million pursuant to Nasdaq Listing Rule 5550(b)(1) for continued listing on the Nasdaq Capital Market. Announcement • Aug 15
NLS Pharmaceutics AG Announces Termination of Elena Thyen as Chief Financial Officer, Effective October 31, 2024 On July 26, 2024, NLS Pharmaceutics Ltd., or the Registrant, delivered a notice of termination, or the Notice, to Ms. Elena Thyen, the Chief Financial Officer, or the CFO, and the principal accounting and financial officer of the Registrant notifying Ms. Thyen that Ms. Thyen’s employment contract with the Registrant will be terminated as of October 31, 2024. Announcement • Jul 30
Kadimastem Ltd (TASE:KDST) signed a letter of intent to acquire NLS Pharmaceutics AG (NasdaqCM:NLSP) in a reverse merger transaction. Kadimastem Ltd (TASE:KDST) signed a letter of intent to acquire NLS Pharmaceutics AG (NasdaqCM:NLSP) in a reverse merger transaction on July 29, 2024. In consideration, NLS will issue its shares to the Kadimastem shareholders who, after completing the Transaction, will hold 85% of the issued and outstanding shares of NLS, and the existing shareholders of NLS will hold the remaining 15% of NLS. Tthe combined company is expected to operate under the name Kadimastem and be traded on the Nasdaq Capital Market. Under the proposed terms, existing Kadimastem shareholders will hold 85% of the issued and outstanding shares of the merged company and the existing shareholders of NLS will hold the remaining 15% of the issued and outstanding shares of NLS.
The definitive agreement is expected to be executed in September 2024. The transaction is subject to approval of offer by acquirer shareholders and approval of offer by target shareholders. The expected completion of the transaction is before December 31, 2024. Announcement • Jun 29
NLS Pharmaceutics Ltd. Announces Promising Preclinical Results for Parkinson's Disease Treatments NLS Pharmaceutics Ltd. announced preclinical results from multiple in vitro studies targeting alpha-synuclein (a-synuclein), specifically the A53T mutation, that demonstrate the compounds' potential to advance the treatment of Parkinson's Disease (PD). The compounds may be used by NLS pursuant to its existing and previously announced license agreement with Aexon Labs Inc. (Aexon Labs or AEX). Using the "Alpha-Synuclein (a-synuclein) A53T Parkinson's Disease Genetic Cell-Based Agonist Neurite Outgrowth Assay" by Eurofins, various DOXA compounds demonstrated positive effects on neurite outgrowth, a critical parameter of neuronal health and regeneration. Neurite outgrowth, a critical parameter of neuronal health, was measured using high-content imaging systems to determine the efficacy of AEX compounds. Reducing a-synuclein aggregation or promoting its clearance can alleviate its toxic effects on neurons. The effects of AEX compounds on neurite outgrowth as well as their impact on Cathepsin D (CTSD) and Orexin 1 Receptor (OX1R) activities provide insights into their potential to modulate the impact of a-synuclein. Key findings: AEX-23: Its pronounced action as an OX1R agonist combined with positive effects on neurite outgrowth at specific concentrations suggests that it may modulate neuronal health through pathways influencing a-synuclein dynamics, making it a potential therapeutic candidate to improve neuronal connectivity and resilience in PD. AEX-19: Its effects at low concentrations on neurite growth coupled with OX1R agonist activity and a moderate increase in CTSD activity suggest potential neuroprotective benefits in PD. AEX-24: The increase in CTSD activity and agonist activity on OX1R suggests the potential to enhance a-synuclein degradation, highlighting its promising therapeutic impact on PD. AEX-23 and AEX-19, which target OX1R, show promise in modulating the effects of a-synuclein on neurons, offering potential benefits in treating synucleinopathies like PD. AEX-19 and AEX-24 also present intriguing possibilities due to their effects on CTSD activity, suggesting pathways for reducing a-synuclein aggregation. Further in vitro research and in vivo preclinical studies are necessary to elucidate the precise mechanisms, optimize dosing, and evaluate the long-term efficacy and safety of these compounds in preclinical and clinical settings. Announcement • Jun 27
NLS Pharmaceutics AG, Annual General Meeting, Jun 27, 2024 NLS Pharmaceutics AG, Annual General Meeting, Jun 27, 2024, at 16:00 W. Europe Standard Time. Location: the circle 6, 8058 zurich, Switzerland Announcement • Jun 13
NLS Pharmaceutics AG Publication of New Patent Application for Next-Gen Dual Non-Sulfonamide Orexin Receptor Agonists (Doxa) NLS Pharmaceutics Ltd. announced the publication of the latest patent application (PCT/WO2024115797) by Aexon Labs with the World Intellectual Property Organization (WIPO). The patent will be used by NLS pursuant to its existing and previously announced license agreement with Aexon Labs. Key Highlights: Innovative Dual Orexin Receptor Agonists: The patent application introduces a completely new series of molecules, licensed to NLS from Aexon Labs, acting primarily as dual orexin receptor agonists (OX1R and OX2R). These multitarget compounds have demonstrated efficacy in vitro, showing potential to not only mitigate narcolepsy symptoms, but also to slow the progression of neurodegenerative diseases. Non-Sulfonamide Compounds: Unlike many current treatments acting as orexin receptor agonists, these innovative non-sulfonamide derivatives have the potential to reduce the risk of side effects and adverse reactions associated with traditional sulfonamide medications. This characteristic may both broaden their potential use and improve patient safety. Mechanism of Action: The new molecules enhance neurotransmitter release and protect neuronal health by modulating orexin receptors (OX1R/OX2R) and integrating neuroinflammation protection through cathepsin H (CTSH) inhibition. This combined action targets both sleep regulation and neurodegeneration, offering the potential for significant therapeutic benefits for patients. Therapeutic Implications: CTSH is involved in proteolytic degradation and antigen presentation, influencing autoimmune responses in narcolepsy. Inhibiting CTSH could protect neuronal cells by disrupting the proteolytic pathway. When combined with dual orexin receptor agonist action, this approach could significantly enhance orexin signaling stability and mitigate symptoms. Neuroprotective strategies focusing on reducing neuroinflammation and modulating immune responses could further improve therapeutic outcomes. Focus on Narcolepsy: These compounds are designed primarily to treat narcolepsy by activating orexin pathways, which are crucial for maintaining wakefulness and regulating sleep patterns. By addressing the core pathology of narcolepsy, these dual orexin receptor agonists provide a novel and effective treatment approach. Application in Neurodegenerative Diseases:Beyond narcolepsy, these multitarget molecules show promise for treating conditions like Parkinson’s disease by targeting neurodegenerative processes such as OX1R and a-synuclein. This represents a significant advancement in developing treatments that could improve quality of life and disease outcomes for patients. Recent Advances and Presentations from NLS Pharmaceutics and Aexon Labs: At Sleep 2024 (Houston, June 1-5), data on selective OX2R agonists highlighted their limitations, including receptor desensitization and reduced efficacy at higher doses. In contrast, a new generation of compounds from Aexon Labs, presented at the 2024 ASCP Annual Meeting (Miami, May 27-31), targets both OX1R and OX2R while also preventing the destruction of orexin cells through an inhibitory effect on CTSH. These multitarget compounds, with their broader affinity, show fewer issues related to high-affinity binding and efficacy loss, suggesting a more stable pharmacological profile and better long-term outcomes. Announcement • May 25
NLS Pharmaceutics Announces Receipt of Additional Staff Delisting Determination from Nasdaq NLS Pharmaceutics Ltd. 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. Announcement • May 01
NLS Pharmaceutics Ltd. announced delayed 20-F filing On 04/30/2024, NLS Pharmaceutics Ltd. announced that they will be unable to file their next 20-F by the deadline required by the SEC. Announcement • Apr 04
NLS Pharmaceutics Ltd. announced that it has received $1.75 million in funding On April 3, 2024, NLS Pharmaceutics Ltd. closed the transaction. The transaction included participation from two investors. H.C. Wainwright & Co., LLC received an aggregate fee equal to 8.0% of the gross proceeds raised in the offering and warrants to purchase up to 490,000 common shares. The company paid $140,000 as sales commissions in the transaction. Announcement • Mar 22
NLS Pharmaceutics Ltd. has filed a Follow-on Equity Offering in the amount of $1.75 million. NLS Pharmaceutics Ltd. has filed a Follow-on Equity Offering in the amount of $1.75 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 7,000,000
Price\Range: $0.25
Discount Per Security: $0.0175
Transaction Features: Registered Direct Offering Announcement • Mar 12
Nasdaq Accepts NLS Pharmaceutics’ Plan to Regain Listing Compliance NLS Pharmaceutics Ltd. announced that it has been notified by the Listing Qualifications Department of the Nasdaq Stock Market LLC (Nasdaq) that the Company's plan to regain compliance submitted on February 23, 2024 has been approved. On January 9, 2024, NLS received a letter from the Listing Qualifications staff of Nasdaq Stock Market LLC notifying the Company that it was no longer in compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires listed companies to maintain stockholders' equity of at least $2,500,000. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company had been granted a period of 180 calendar days to regain compliance with the minimum bid price requirement. Upon the expiration of that grace period, on February 23, 2024, NLS submitted the Company's plan, on time, to regain compliance with Nasdaq Listing Rule 5550(b)(1). On March 7, 2024, the Listing Qualifications Department of Nasdaq notified NLS that they had accepted the plan submitted and the Company has been afforded an additional 180 day calendar days from the date of the letter, or until July 8, 2024, to evidence compliance. Announcement • Oct 26
NLS Pharmaceutics Announces Receipt of Nasdaq Minimum Bid Price Notification NLS Pharmaceutics Ltd. ("NLS" or the "Company") 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 in Listing Rule 5550(a)(2), which requires listed companies to maintain a minimum bid price of $1.00 per share. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company has been granted a period of 180 calendar days to regain compliance with the minimum bid price requirement. The Notice has no immediate effect on the Company's Nasdaq listing or the trading of its common shares or warrants, and during the grace period, as may be extended, NLS' common shares and warrants will continue to trade on the Nasdaq Capital Market under the symbols "NLSP" and "NLSPW", respectively. According to the Notice, the Company has until April 16, 2024 to regain compliance with the minimum bid price requirement. The Company can regain compliance if at any time during this 180 day period the closing bid price of its common shares is at least $1.00 for a minimum of ten consecutive business days, in which case the Company will be provided with written confirmation of compliance and this matter will be closed. In the event that NLS does not regain compliance after the initial 180 day period, the Company may then be eligible for an additional 180 day compliance period if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum bid price requirement. In this case, NLS will need to provide written notice of its intention to cure the deficiency during the second compliance period, including by implementing a reverse stock split, if necessary. If the Company cannot demonstrate compliance by the alloted compliance period(s), Nasdaq's staff will notify the Company that its common shares and warrants are subject to delisting. Announcement • Jul 04
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 NLS Pharmaceutics Ltd. 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. In addition, the Company announced that the Phase 3 clinical trial protocol to evaluate the safety and efficacy of Mazindol ER in patients with narcolepsy type 1 received approval from the independent Institutional Review Board ("IRB"). The AMAZE Program will encompass two almost-identical double-blind Phase 3 studies (N=50 each) investigating Mazindol ER versus placebo in adult patients with narcolepsy commencing this summer at multiple sites exclusively in the U.S. Based on the FDA's recommendations, both Phase 3 trials will measure the weekly cataplexy episodes as the primary endpoint over 8 weeks of treatment and excessive daytime sleepiness as a secondary objective using the Patient-Reported Outcomes Measurement Information System (PROMIS-SRI) and the Epworth Sleepiness Scale (ESS). Patients who complete these studies will be offered participation in a 12-month open-label extension (OLE) study To be eligible for enrollment into the OLE study, patients must be at least 18 years of age and have been diagnosed with narcolepsy with cataplexy. NLS previously reported on the Phase 2 study results in narcolepsy in which Mazindol ER met all primary and secondary endpoints. Patients treated with Mazindol ER in the randomized Phase 2 trial showed continued improvement after rolling over into the OLE study and patients treated with placebo in the randomized Phase 2 trial and who subsequently received Mazindol ER in the OLE study showed similar efficacy with the Mazindol ER-treated patients in the randomized trial. Data from the Phase 2 studies were presented in early June at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS). An IRB operates under FDA regulations and is an FDA registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure the protection of the rights and welfare of human subjects of research. Announcement • Jul 01
NLS Pharmaceutics Ltd. Approves Board Appointments NLS Pharmaceutics Ltd. at its Annual General Meeting held on June 30, 2023 approved the election of Audrey Greenberg and Dr. Anthony Walsh to the Board of Directors. Audrey Greenberg, Co-Founder and Chief Business Officer, Center for Breakthrough Medicines, and Anthony Walsh, PhD, Chief Business Officer of Ability Biologics, were both elected to the NLS Pharmaceutics Board of Directors, broadening the board membership to include U.S. representation. Announcement • Jun 15
NLS Pharmaceutics Announces Positive Safety Data From In Vitro CYP450 and Transporter Mediated Drug-Drug Interaction Studies of Mazindol NLS Pharmaceutics Ltd. 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). Typical DDI studies include Cytochrome P450 (CYP), UDP glucuronosyltransferase (UGT) and transporter inhibition and induction studies to evaluate whether mazindol affects the pharmacokinetic (PK) effect of other drugs (mazindol as a "perpetrator"). In addition, in vitro studies are conducted with CYP and transporter substrates to evaluate whether other drugs can affect mazindol PK (mazindol as a "victim"). Following U.S. Food and Drug Administration (FDA) guidelines, the in vitro DDI studies were designed to evaluate the drug interaction potential across a wide range of metabolic enzymes and transporters when co-administered with mazindol. The mazindol in vitro studies examined the following: CYP Inhibition in Human Liver Microsomes. CYP Induction in Cultured Human Hepatocytes. CYP and UGT Reaction Phenotyping. UGT Inhibition in Human Liver Microsomes. ATP-binding case (ABC) and solute carrier (SLC) Transporter Inhibition and Substrate Potential in Cells and Vesicles. Results of the in vitro victim studies showed that mazindol is not metabolized by CYPs or UGTs and is not transported by BCRP, OAT1, OAT3 and OCT2. Only the hydrolysis metabolite (but not mazindol) is a P-glycoprotein (Pgp) substrate; thus a clinical DDI study of mazindol is planned to quantify the potential for an increase in the hydrolyzed metabolite (M6) exposure in the presence of a Pgp inhibitor (e.g., Itraconazole). Otherwise, concomitant medications are not expected to affect the PK of mazindol. DDI studies are a standard and necessary step required by the FDA and other regulatory agencies globally for approving a new drug to market. DDI studies help identify potential adverse reactions that may be caused by interactions between multiple drugs, leading to unintended reactions, toxic side effects, or in some cases, a lack of therapeutic efficacy. With the rise in polypharmacy to treat comorbidities, alongside prevalent substance abuse, drug-drug interactions have become a critical factor to consider when treating narcolepsy. Approximately 50% of prescribed drugs currently on the market are known to cause drug interactions with CYP3A4 inhibitors and can lead to side effects. Findings from DDI studies help to inform drug labeling that is then used by healthcare providers to aid in therapeutic decision-making. Currently available medications used to treat narcolepsy can have significant DDI effects which prevent co-administration or require dose adjustments of drugs like hormonal contraceptives, proton-pump inhibitors or anti-epileptic drugs. Announcement • Jun 10
NLS Pharmaceutics AG, Annual General Meeting, Jun 30, 2023 NLS Pharmaceutics AG, Annual General Meeting, Jun 30, 2023, at 16:00 Central European Standard Time. Location: Wenger Vieli AG Metallstrasse 9 Zug Swaziland Agenda: To consider the approval of the statutory financial statements of the Company for the business year 2022; to consider the approval of the compensation report for the business year 2022; to approve that the net loss of CHF 8,834,612 for the business year 2022 is added to the loss brought forward of CHF 14,470,141 resulting in a new balance of loss brought forward of CHF 23,304,753; and to consider any other matter thereof. New Risk • Jun 10
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 79% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Shareholders have been substantially diluted in the past year (79% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$12m net loss in 3 years). Market cap is less than US$100m (US$30.6m market cap). Announcement • May 09
NLS Pharmaceutics Appoints Keith Harrison Dewedoff as Interim Chief Financial Officer NLS Pharmaceutics Ltd. announced that Keith Harrison Dewedoff has been appointed to the position of Interim Chief Financial Officer ("CFO"). A versatile strategic leader within healthcare, Mr. Dewedoff brings more than 20 years of experience in the life sciences industry, ranging from biotech venture-backed start-ups to commercial publicly traded companies. Mr. Dewedoff also serves as a CFO and Advisor for Danforth Advisors, LLC, an advisory firm focused on providing financial strategy to life sciences organizations. Most recently, Mr. Dewedoff served as CFO for Code Biotherapeutics Inc., overseeing all accounting and finance functions, and advising on strategic financing activities. He previously served as CFO of Ceptur Therapeutics Inc. and more than 10 other privately held and public companies at various life cycle stages, managing finance, accounting, corporate development, and other corporate operational functions. Prior to Danforth Advisors, Mr. Dewedoff was CFO of Kaizen Bioscience where he currently serves as Chairman of the board of directors. Keith holds a Bachelor of Science degree in Economics & Management from Northeastern University where he began his career as a research analyst advising research institutions and venture capital firms on portfolio planning strategies, as well as a Graduate Diploma in Portfolio Management from Villanova University. He is an active member of Kellogg College alumni, Northeastern University, and the Investments & Wealth Institute. NLS also announces that Chad Hellmann has resigned as CFO of the Company and will remain with the Company through May 31, 2023, to assist with the CFO transition. In his capacity as CFO, Mr. Hellmann has been an invaluable member of the NLS team and has made a significant contribution to the organization over the last year. Announcement • May 06
NLS Pharmaceutics Ltd. Announces the Resignation of Chad Hellmann as Chief Financial Officer On May 1, 2023, Mr. Chad Hellmann resigned as the Chief Financial Officer of NLS Pharmaceutics Ltd. Mr. Hellmann will continue to provide transition services to the company through May 31, 2023. Announcement • Jan 31
NLS Pharmaceutics Announces Completion of Open Label Extension Study with Quilience(R) (Mazindol ER) for the Treatment of Narcolepsy NLS Pharmaceutics Ltd. announced the completion of the POLARIS six-month open-label extension study (NLS-1022) with Mazindol ER in patients with narcolepsy. POLARIS NLS-1022 OLE is an open-label extension clinical study of Mazindol ER in patients with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2) who completed participation in the previously reported POLARIS NLS-1021 Phase 2 clinical study, a four-week, randomized, double-blind, placebo-controlled, multi-center U.S. clinical study in 67 patients with NT1 or NT2. All patients who completed the POLARIS Phase 2 study were eligible to participate in the OLE and continue once-a-day treatment with Mazindol ER for up to six months as monotherapy (no concomitant wake-promoting or anti-cataplexy treatments). The objectives of the NLS-1022 study are to evaluate the long-term safety and tolerability of Mazindol ER and to evaluate its long-term therapeutic effect in the treatment of Excessive Daytime Sleepiness (EDS) and cataplexy. Previously shared interim OLE data showed that patients treated with Mazindol ER in the randomized double-blind Phase 2 study continued to improve after rolling into the OLE study and that patients treated with placebo in the randomized Phase 2 study who received Mazindol ER in the OLE study achieved comparable results to patients treated with active drug in the Phase 2 study. Those results demonstrated further improvement in efficacy of Mazindol ER in the treatment of EDS and cataplexy with longer treatment duration as a potential first in class monotherapy. Safety and tolerability of Mazindol ER were shown to be similar between the double-blind and OLE studies. NLS Pharmaceutics plans to have the complete results of the OLE study in the first quarter of 2023 and to present these results at a future scientific meeting. Announcement • Jan 26
NLS Pharmaceutics Regains Compliance with Nasdaq Stockholders' Equity Requirement NLS Pharmaceutics Ltd. ("NLS" or the "Company") announced that it received a notification letter from the Hearings Panel (the "Panel") of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that it has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires listed companies to maintain stockholders' equity of at least $2,500,000. The Company has now successfully resolved both outstanding Nasdaq compliance issues.As previously announced, on April 1, 2022, NLS was first notified by Nasdaq of its failure to comply with Nasdaq Listing Rule 5550(b)(1). As reported on November 14, 2022, following an appeal by NLS, the Panel granted the Company's request to continue its listing on Nasdaq and further requested that the Company demonstrate compliance with Listing Rule 5550(b)(1) no later than February 28, 2023. On January 24, 2023, the Panel confirmed the Company's compliance with the previously communicated conditions and determined that the Company regained compliance with Listing Rule 5550(b)(1). Accordingly, the Panel has determined to continue the listing of the Company's securities on Nasdaq and considers this matter closed. Announcement • Jan 24
NLS Pharmaceutics Ltd. Announces New in Vitro Study Results Demonstrating the Agonist Effect of Mazindol ER At the Orexin-2 Receptor NLS Pharmaceutics Ltd. announced new in vitro study results demonstrating the agonist effect of mazindol ER at the Orexin-2 Receptor (OX2R). Two identical studies measuring differing concentrations of mazindol ER confirmed significant OX2R partial agonist activity at 30µM or higher. Notably, findings show that mazindol ER showed strong OX2R partial agonist activity by cellular and nuclear receptor functional assays. Results showed pEC50 (a logarithm measure of drug potency expressing a concentration that is effective in producing 50% of the maximal response) values of 4.7 to 5 for mazindol on the OX2R, indicating a strong OX2R partial agonist. Orexin, also known as hypocretin, is a neuropeptide that regulates arousal, wakefulness, and appetite. Orexin plays a critical role in regulating the sleep-wake cycle and the most common form of narcolepsy, type 1 (NT1), in which the individual experiences brief losses of muscle tone, known as or cataplexy, is caused by a lack of orexin in the brain due to destruction of the cells that produce it. Mazindol ER is an OX2R partial agonist that was developed to address the loss of orexin signaling in NT1. Currently available treatments for NT1 only address the associated symptoms but not the underlying loss of orexin. Orexin, also known as hypocretin, is a neuropeptide that regulates arousal, wakefulness, and appetite. Orexin plays a critical role in regulating the sleep-wake cycle and the most common form of narcolepsy, type 1 (NT1), in which the individual experiences brief losses of muscle tone, known as or cataplexy, is caused by a lack of orexin in the brain due to destruction of the cells that produce it. Mazindol ER is an OX2R partial agonist that was developed to address the loss of orexin signaling in NT1. Currently available treatments for NT1 only address the associated symptoms but not the underlying loss of orexin. Additional pre-clinical in vivo studies are currently underway to confirm OX2R activity. A pilot study in OXR2 KO mice animal model compared favorably with investigational drug, TAK-925, an orexin 2 receptor agonist. Supplementary studies to further characterize OX2R activity as well as activity at OX1R are planned for the first half of 2023. NLS Pharmaceutics plans to present the study results at a scientific meeting later this year. The Phase 3 program for Quilience (mazindol ER) is currently on track to commence in mid- 2023. Announcement • Dec 22
NLS Pharmaceutics Announces Israeli Patent Grant Covering Mazindol for Treatment of Attention Deficit Hyperactivity Disorder and Other Sleep Disorders Through 2037 NLS Pharmaceutics Ltd. announced that the Israeli Patent Office has granted approval for Patent Application 261418, which covers Mazindol as a method of treatment for Attention Deficit/Hyperactivity Disorder (ADHD). This patent is expected to expire no earlier than 2037. Mazindol is not currently available in Israel and has not been promoted for use in ADHD. Quilience (Mazindol ER), the Company's lead product candidate and proprietary extended-release formulation of Mazindol (Mazindol ER), is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders such as idiopathic hypersomnia (IH). Top-line results from their Phase 2a clinical trial evaluating Quilience (Mazindol ER), in the treatment of narcolepsy, resulted in positive favorable results, meeting the primary endpoint with high statistical significance. Announcement • Dec 02
NLS Pharmaceutics AG Pharmaceutics Announces Notice of Allowance for U.S. Patent Covering Mazindol for Opioid Dependence and Substance Use Disorder NLS Pharmaceutics Ltd. 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 expects this patent to be issued within the next few months and it is expected to expire no earlier than 2038. The global opioid use disorder (OUD) market is valued at just under $3 billion and is projected to grow to nearly $5 billion by 2028 period. Opioids are a class of drugs that includes the illegal drug heroin as well as powerful pain relievers available by prescription, such as oxycodone (Oxycontin), hydrocodone (Vicodin), codeine, morphine, fentanyl, methadone, and many others. In the U.S. alone, over 100,000 lives were lost in 2021 due to drug overdoses, at an average of nearly 295 people per day. Drug overdoses are the leading cause of death for Americans ages 18-45, with approximately two-thirds being attributable to opioids. Announcement • Nov 24
NLS Pharmaceutics Ltd. 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 NLS Pharmaceutics Ltd. announced that it has launched a paid for Named Patient Program (NPP) for patients suffering from idiopathic hypersomnia (IH). NLS has partnered with Caligor Coghlan Pharma Services, a globally active pharmaceutical company specializing in named patient, expanded access, early access and compassionate use programs. The NPP will provide access to Mazindol ER for the treatment of IH where this medication would not otherwise be available for this indication in certain countries. The NPP for IH was launched in the United Kingdom this week and is expected to expand into other countries over the coming weeks and months. IH is a chronic, neurological disorder that is characterized by excessive sleepiness, an uncontrollable need to sleep or daytime sleepiness that persists for at least three months even with adequate or prolonged night-time sleep. IH affects approximately three in 10,000 people in the European Union (EU). This is equivalent to a total of around 156,000 people. As of November 23, 2022, no therapies are authorised in the EU for the treatment of IH. Patients with IH usually receive advice on lifestyle changes to help regulate their sleeping pattern. NLS' Mazindol ER is an alternative therapeutic option that has been historically used to treat a number of conditions. It is undergoing clinical trials in narcolepsy and other sleep disorders. This NPP will allow physicians to prescribe Mazindol ER off-label for use in treating IH. On November 2,2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for Mazindol ER for the treatment of IH. Previously, Mazindol ER was granted ODD for IH in Europe on July 21, 2022. Announcement • Nov 15
NLS Pharmaceutics Successfully Appeals Nasdaq Delisting Notice NLS Pharmaceutics Ltd. announced 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"). The continued listing is subject to the conditions that: (i) on or before January 19, 2023, the Company shall provide the Panel with updated proforma financial statements for the year ended December 31, 2022, and the period ended March 31, 2023, for review; and (ii) on or before February 28, 2023 (the "Exception Period"), the Company will demonstrate compliance with Listing Rule 5550(b)(1), which requires that the Company maintain stockholders' equity of at least $2,500,000. In order to fully comply with the terms of this exception, the Company must be able to demonstrate compliance with all requirements for continued listing on Nasdaq. In the event the Company is unable to do so, its securities may be delisted from Nasdaq. During the Exception Period, the Company is required to provide prompt notification of any significant events that occur during this time that may affect the Company's compliance with Nasdaq requirements, including, but not limited to, any event that may call into question the Company's ability to meet the terms of the exception granted. Announcement • Nov 08
NLS Pharmaceutics Provides Open Label Extension Study Update for Quilience(R) (Mazindol ER) in the Treatment of Narcolepsy NLS Pharmaceutics Ltd. announces an interim update from its Open Label Extension (OLE) Study for Quilience® (Mazindol ER) in the treatment of narcolepsy. The OLE study offers patients completing the 4-week randomized, double blind (DB) Phase 2 trial for Quilience® the option to receive the drug candidate for an additional 6 months as monotherapy on an open-label basis. Of the 60 patients who completed the randomized controlled Phase 2 trial, 52 patients (or 87% of completers) elected to roll over into the OLE study. Excessive Daytime Sleepiness: For patients treated with Quilience® in the randomized Phase 2 trial, excessive daytime sleepiness (EDS) based on the Epworth Sleepiness Scale (ESS) improved by an additional 1.8 points in the OLE study by the fourth month of treatment (DB and OLE treatment combined). At that timepoint, the mean ESS score for these patients reached 9.2, with lower scores denoting an improvement in the condition (improved wakefulness). Importantly, ESS scores of 10 or below are considered to be typical scores for patients without narcolepsy. As an extension of the 4-week randomized treatment period in the Phase 2 trial, these data indicate that maximum efficacy for EDS with Quilience® is reached at approximately 3 months of treatment. Overall, the mean score for these patients declined by approximately 8.7 points from their baseline levels at the start of the randomized Phase 2 trial to month 3 in the OLE. For patients receiving placebo in the DB Phase 2 trial and rolling over to receive Quilience® in the OLE study, EDS scores declined to levels comparable to those treated with Quilience® in the randomized trial at Week 4. This effect was maintained through month 3 in the OLE study, with EDS scores just above the "normal" range. Weekly Cataplexy Episodes: For patients diagnosed with cataplexy and treated with Quilience® in the randomized Phase 2 trial, the mean number of weekly cataplexy episodes was approximately 8 at the end of the 4-week DB period, down from a baseline level of approximately 17.5 at the beginning of the trial. During the OLE study, mean weekly cataplexy episodes for these patients declined to 2.1, and remained relatively stable in the 2 to 4 range through week 12. For patients with cataplexy receiving placebo in the DB Phase 2 trial, the mean number of weekly cataplexy episodes was approximately 10.9 at the end of the 4-week double-blind period. During the OLE study, these patients, when treated with Quilience®, were able to catch up to previously treated patients, achieving mean weekly cataplexy episodes of 2.7 at 8 weeks of treatment. This favorable effect was maintained for these patients in the 2-5 episodes per week range through week 12. Announcement • Oct 06
NLS Pharmaceutics Announces Receipt of Staff Delisting Determination from Nasdaq NLS Pharmaceutics AG (NLS Pharmaceutics Ltd.) announced that on September 29, 2022, it received a determination letter (the "Letter") from the staff (the "Staff") of the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company of the Staff's determination that, unless the Company timely requests a hearing before a Nasdaq Hearings Panel (the "Panel"), the Company's securities would be subject to delisting from The Nasdaq Capital Market due to the Company's failure to regain compliance with the minimum stockholders' equity requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(b)(1). Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. In that regard, pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an extension through March 28, 2023. At the hearing, the Company intends to present a plan to achieve compliance with all applicable Nasdaq listing requirements and to request that the Panel allow the Company additional time to regain such compliance. However, there can be no assurance that the Panel will grant the Company's request for an extension or that the Company will ultimately regain compliance with all applicable requirements for continued listing. Announcement • Sep 28
NLS Pharmaceutics Ltd. Announces Positive Top-Line Results from Phase 2a Clinical Trial of Once-Daily Quilience(R) (Mazindol ER) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy NLS Pharmaceutics Ltd. announced positive top-line results from its Phase 2a clinical trial evaluating its lead product candidate, Quilience® (Mazindol ER), in the treatment of narcolepsy. The trial met its primary endpoint with high statistical significance. Treatment with Quilience® 3mg per day (NLS-2) resulted in a 7.1 point mean reduction from baseline in excessive daytime sleepiness (EDS) over the 4-week treatment period based on the Epworth Sleepiness Scale (ESS), compared to a 3.2 point reduction for placebo (p=0.0081). The two treatment groups separated early and consistently throughout the study period confirming Mazindol ER's rapid onset of action and durable benefit. Total Score Observed by Visit; All Narcolepsy Types; Intent to Treat Patients: For the ESS score, the least squares (LS) means change from baseline to each visit and the standard error (SE) of Quilience® (NLS-2) versus placebo were all statistically significant at week 1 -4.3 (1.13) versus -1.1 (1.06) (p=0.0055), at week 2 -4.7 (1.14) versus -1.3 (1.06) (p=0.0035), at week 3 -5.0 (1.18) versus -1.6 (1.09) (p=0.0045), and at week 4 -5.8 (1.23) versus -2.1 (1.14) (-6.26, -1.15; p=0.0045). The treatment arms were balanced in terms of patient demographics, baseline levels, and disease characteristics. Quilience® was well-tolerated and no safety concerns were identified. No serious adverse events (SAEs) were reported. With regard to the reduction in cataplexy attacks in narcolepsy Type 1 patients (NT1), a key secondary endpoint, Quilience® consistently outperformed placebo at all time points. In the trial's open label extension (OLE) study, 85% of patients including those with NT1, elected to rollover and receive Quilience® for up to 6 months as a monotherapy. NLS plans to release interim results from the OLE study before year-end and announce final results in the first quarter of 2023. NLS will host a Key Opinion Leader (KOL) Event on September 30, 2022 to review the top-line Phase 2a results. The KOL Event will also feature study investigators and an independent practitioner that will discuss the clinical results and offer perspectives on the potential for Quilience to treat patients with both NT1 and narcolepsy type 2 (NT2). A Question-and-Answer session will follow the presentation of the results and KOL discussion. About the Phase 2a trial (NLS-1021): NLS-1021 is a multi-center, randomized, prospective Phase 2a clinical trial evaluating Quilience® (Mazindol ER) as a once-daily monotherapy for the treatment of EDS and cataplexy, the primary symptoms of narcolepsy. The trial was designed to enroll 60 patients diagnosed with NT1 or NT2 to receive treatment with either Quilience® up to 3mg once daily for 28 days, or placebo. A total of 67 patients were enrolled and randomized 1:1 into each treatment arm. The primary endpoint of the trial is the change from baseline in EDS as measured by the ESS, and a key secondary endpoint is the change from baseline in mean weekly number of cataplexy attacks in the subset of patients with cataplexy. Patients completing the 4-week clinical study period were eligible to enroll in an open label extension study (NLS-1022), where each patient was given the option to receive Quilience® monotherapy for up to an additional 6 months. Announcement • Sep 09
NLS Pharmaceutics Ltd. Announces Management Changes NLS Pharmaceutics Ltd. announced that Dr. George Apostol has been appointed to the position of Chief Medical Officer and Global Head of Research and Development. Serving most recently as Global Head of Research and Development at Endo Pharmaceuticals Inc., Dr. Apostol brings significant expertise in the management and execution of early, mid- and late-stage drug development. The Company also announces that Sylvia Panigone, Ph.D., M.B.A. will leave her position as Chief Operating Officer on November 30, 2022. Chad Hellmann, Chief Financial Officer of the Company, will assume responsibility for non-clinical operations at NLS. Dr. Apostol joins NLS from Endo where he was Executive Vice President, Head of Global Research and Development and led the transformation of the R&D organization from a generic-focused group into a dynamic specialty-pharmaceutical R&D organization. He has over 20 years of experience with global pharmaceutical companies in drug development program management and clinical trial design. His development experience covers a wide range of compounds designed to treat central nervous system disorders such as Attention-Deficit/Hyperactivity Disorder (“ADHD”), anxiety, depression, migraine, Parkinson’s disease, multiple sclerosis, dyskinesia, schizophrenia, as well as rare diseases such as Fragile X syndrome. Dr. Apostol attended Carol Davila Medical School in Bucharest, Romania where he earned his M.D. degree, and the University of Minnesota, where he earned a Master of Science in Clinical Research. Following the end of his graduate studies, Dr. Apostol attended a post-doctorate drug development program at Eli Lilly & Co. in Indianapolis, Indiana. Subsequently, Dr. Apostol attained broad drug development expertise across early, middle and late phases while working in the global R&D organizations of Pfizer and Abbott in the United States, as well as Novartis and Shire in Switzerland. Price Target Changed • Sep 06
Price target decreased to US$8.63 Down from US$10.00, the current price target is an average from 3 analysts. New target price is 1,337% above last closing price of US$0.60. Stock is down 77% over the past year. The company is forecast to post a net loss per share of US$0.56 next year compared to a net loss per share of US$1.00 last year. Announcement • Jul 23
NLS Pharmaceutics Ltd. Announces Positive Opinion from European Regulators to Grant Orphan Drug Designation for Mazindol ER in Idiopathic Hypersomnia NLS Pharmaceutics Ltd. announced 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). The COMP plenary session took place July 12-14, 2022, and NLS was subsequently notified by the EMA that it will receive the relevant documentation package for ODD shortly. The Company's formulation of mazindol also has been granted ODD in both Europe and the U.S. for the treatment of narcolepsy. Announcement • Jun 11
NLS Pharmaceutics Announces Receipt of NASDAQ Minimum Bid Price Notification NLS Pharmaceutics Ltd. announced 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. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company has been granted a period of 180 calendar days to regain compliance with the minimum bid price requirement. The Notice has no immediate effect on the Company's Nasdaq listing or the trading of its common shares, and during the grace period, as may be extended, NLS's common shares will continue to trade on the Nasdaq Capital Market under the symbol "NLSP". According to the Notice, the Company has until December 5, 2022 to regain compliance with the minimum bid price requirement. The Company can regain compliance, if at any time during this 180 day period, the closing bid price of its common shares is at least $1.00 for a minimum of ten consecutive business days, in which case the Company will be provided with written confirmation of compliance and this matter will be closed. In the event that NLS does not regain compliance after the initial 180-day period, the Company may then be eligible for an additional 180-day compliance period if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum bid price requirement. In this case, NLS will need to provide written notice of its intention to cure the deficiency during the second compliance period. If the Company cannot demonstrate compliance by the alloted compliance period(s), Nasdaq's staff will notify the Company that its common shares are subject to delisting. Announcement • Jun 07
NLS Pharmaceutics AG Appoints Chad C. Hellmann as Chief Financial Officer NLS Pharmaceutics Ltd. announces that Chad C. Hellmann has been appointed to the position of Chief Financial Officer ("CFO"). Serving most recently as CFO and co-portfolio manager of Arcus Ventures, Mr. Hellmann brings to NLS significant expertise in developing and implementing operational strategies and capital markets solutions for life sciences companies. NLS also announces that Subhasis Roy has resigned as Interim CFO and will remain a consultant to the Company through June 30, 2022 to assist with the CFO transition. NLS expresses its deep appreciation to Mr. Roy for his many contributions to the Company. Mr. Hellmann joins NLS from Arcus Ventures, where he continues to consult as CFO and co-portfolio manager. He also maintains an advisory role at Rosebank Capital Partners, where he co-created the investment strategy for the long/short fund, which incorporates a liquid private equity approach for micro and small cap public companies in the biotech and cleantech sectors. From 2004 through 2011, Mr. Hellmann served as CFO of Cat Trail Management ("CTM"), a single-family office and partner in Cat Trail Capital ("CTC"), a private equity fund focused on technology, biotech and cleantech companies both in the private and public markets. While at CTM, he led the firm's private equity fund investing in both debt and equity instruments, where he managed several investments through the bankruptcy process both as a senior secured and subordinated unsecured lender. Additionally, in this role, Mr. Hellmann acquired assets in the Chapter 7 process. Prior to CTC, he founded Bison Ventures, an early-stage venture capital fund focused on investing in media and technology companies. Over the past 15 years, Mr. Hellmann has served on several boards of directors including ET Water Inc., NuVision Inc. [Chairman], Vertebron Inc., and Yachtstore Ltd. Announcement • May 12
NLS Pharmaceutics AG, Annual General Meeting, May 31, 2022 NLS Pharmaceutics AG, Annual General Meeting, May 31, 2022, at 16:00 Central European Standard Time. Location: the premises of Wenger Vieli AG, Metallstrasse 9 Zug Zug Switzerland Agenda: To consider Election of the independent proxy; to consider Approval of the statutory financial statements of the Company for the business year 2021; to consider Advisory Vote Compensation Report 2021; to consider Appropriation of the Balance Sheet Results 2021; to consider Discharge of the Members of the Board of Directors and the Executive Management; to consider Re-elections of the Board of Directors; to consider Election of the members of the Compensation, Nomination and Governance Committee; to consider Re-election of the Auditors; to consider Increase of authorized share capital; and to transact other matters. Price Target Changed • Apr 27
Price target decreased to US$7.50 Down from US$10.00, the current price target is an average from 2 analysts. New target price is 736% above last closing price of US$0.90. Stock is down 76% over the past year. The company is forecast to post a net loss per share of US$0.36 next year compared to a net loss per share of US$1.00 last year. Announcement • Mar 29
NLS Pharmaceutics AG Announces Early Access Program (EAP) Allowing Patients with Idiopathic Hypersomnia to Receive Treatment with Mazindol ER NLS Pharmaceutics Ltd. announced that it has entered into an agreement with Caligor Coghlan Pharma Services (CCPS) to administer a Named Patient Program enabling European patients with Idiopathic Hypersomnia (IH) to have pre-approval access to treatment with the company's novel Mazindol ER formulation. CCPS will provide Mazindol ER under this program, in which physicians can prescribe Mazindol ER to patients who are not receiving adequate relief from currently approved IH treatments. NPPs involve pre-approval access to drugs in response to requests by physicians on behalf of specific, or "named," patients before those medicines are licensed in the patient's home country. Without this NPP, Mazindol ER would not otherwise be available to patients suffering from IH in participating countries. The key objectives of the NPP are (i) to provide access to Mazindol ER for people suffering from IH and develop groups of physicians and patients who utilize this treatment option to manage the symptoms of IH, and (ii) to raise awareness of Mazindol ER in the IH community as a potential treatment option and alternative to current therapies. The health authority in each country where the NPP is available is responsible for the national regulations governing the pre-approval access to investigational products. Processes for obtaining approval, documentation, monitoring and reporting requirements are some of the aspects that may differ from country to country. NLS will support physicians requesting named patient access in those countries where the NPP is available. Subject to required approvals, the NPP is expected to open in the coming months in the following countries: UK, France, Italy, Sweden, Belgium, Netherlands and Switzerland. NLS and CCPS plan to expand the NPP into other countries over time. Announcement • Feb 08
NLS Pharmaceutics to Present Interim Top-Line Data for Quilience® (Mazindol ER) in Patients with Narcolepsy at the World Sleep Congress in March 2022 NLS Pharmaceutics Ltd. announced that it will present interim top-line data from its Phase 2a clinical trial evaluating its lead product candidate, Quilience® (Mazindol ER), for the treatment of narcolepsy at this year’s World Sleep Congress (World Sleep 2022), taking place in Rome, Italy March 11-16, 2022. The data will be presented and discussed during a symposium sponsored by NLS at World Sleep 2022. While retaining the Phase 2a trial’s double-blind design, the presentation will provide an interim analysis on mean Epworth Sleepiness Scale (ESS) scores, the trial’s primary endpoint, comparing patients treated with Quilience and patients on placebo. Additionally, the presentation will feature interim safety and tolerability data for patients that have completed the randomized portion of the trial. Information on the Open Label Extension (OLE) study, whereby patients completing the randomized double-blind portion of the trial may elect to receive treatment with Quilience for up to 6 months, is also expected to be discussed. Rigorous standards and screening methods are being applied to ensure high quality cohorts of patients diagnosed with both narcolepsy type 1 (with cataplexy) and type 2 (without cataplexy) in the trial. To date, 36 patients have been enrolled in the Phase 2a trial and NLS expects to complete the 60-patient trial in the second quarter of 2022. Announcement • May 19
NLS Pharmaceutics Announces New Study Data Confirming Mazindol's Unique Orexin Pathway Activation for Treating Narcolepsy NLS Pharmaceutics Ltd. announced 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. Announcement • May 02
NLS Pharmaceutics AG announced delayed 20-F filing On 04/30/2021, NLS Pharmaceutics AG announced that they will be unable to file their next 20-F by the deadline required by the SEC. Announcement • Mar 14
NLS Pharmaceutics AG Obtains License to Full Regulatory Data Package and Proprietary Know-How for Sanorex NLS Pharmaceutics Ltd. announced that it has entered into a License Agreement with Novartis Pharma AG, whereby the Company has obtained, on an exclusive basis in the United States, all of the available data referred to and included in the original NDA for Sanorex® (mazindol) submitted to the United States Food and Drug Administration in February 1972. The Agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and periodic safety reports from 1973 forward. Under the Agreement, NLS has obtained the same rights on an non-exclusive basis in all territories outside of the U.S, except for Japan, with the right to cross-reference the Sanorex NDA with non-U.S. regulatory agencies in the licensed territories. The Agreement includes the right to sublicense or assign the license to third parties, subject to such third parties meeting certain obligations. Announcement • Mar 12
NLS Pharmaceutics AG Announces Change in Company’s Executive Management Team NLS Pharmaceutics AG announced that Effective March 4, 2021, Mr. Rob Dickey IV and the board of directors of NLS Pharmaceutics Ltd. (the “Company”) mutually agreed that Mr. Dickey will cease to be the Chief Financial Officer of the Company, effective as of the date thereof. The determination was based on personal reasons and not as a result of any disagreement between Mr. Dickey and the Company. The Company has already initiated a search to identify Mr. Dickey’s successor. Executive Departure • Mar 10
Independent Director has left the company On the 28th of February, Pascal Brenneisen's tenure as Independent Director ended after less than a year in the role. We don't have any record of a personal shareholding under Pascal's name. Pascal is the only executive to leave the company over the last 12 months. Announcement • Mar 04
NLS Pharmaceutics AG Announces Resignation of Pascal Brenneisen as A Member of the Board of Director NLS Pharmaceutics AG announced that effective February 28, 2021, Pascal Brenneisen resigned as a member of the board of directors of the Company. Mr. Brenneisen’s resignation was for personal reasons and not due to any disagreement with the Company. As a result of the resignation of Mr. Brenneisen, the Company is no longer in compliance with Nasdaq Listing Rule 5605(c)(2) which requires that the Company have an audit committee consisting of at least three independent members. Announcement • Feb 03
NLS Pharmaceutics Ltd. Approves Board and Committee Appointments On January 29, 2021, NLS Pharmaceutics Ltd. (the 'Registrant') held a special meeting of its shareholders (the “Meeting”), pursuant to which, the shareholders of the company elected Myoung-Ok Kwon and Stig Løkke Pedersen to the Registrant’s board of directors (the “Board”). At the Meeting, Ms. Kwon was elected to serve on the Board’s Compensation Committee. The Board has appointed both Ms. Kwon and Mr. Pederson to its Audit Committee.