OUR NEW PROFILE IS: (NASDAQ: NLSP)

NLSP HAS OVER 100 PATENTS IN 140 DIFFERENT COUNTRIES

JASON MCCARTHY FROM MAXIM GROUP INITIATED A “BUY RATING”  ON NLSP WITH A $4.00 PRICE TARGET BACK IN JAN

NLSP HAS A LOW FLOAT WITH 14.8 MILLION SHARES COUPLED WITH A WELL FUNDED CASH POSITION OF $8.9MILLION (AS OF DEC. 31 2022)

NLSP HAS SEVERAL COMPANIES THAT ARE LOOKING TO PARTNER WITH THEM FOR THEIR PHASE 3 TRIALS AFTER LOOKING AT THE INITIAL DATA

READ THE INVESTOR PRESENTATION HERE

NLS Pharmaceutics today announced that the U.S. Food and Drug Administration (FDA) has reviewed the full protocol for the NLS-1031 study, part of the Phase 3 program for Mazindol ER, called AMAZE.

Read the full article here: https://t.co/pK3sqKztDz#nlspharmaceutics $NLSP pic.twitter.com/VDwgxHz6Bq

— NLS Pharmaceutics (@NLSPharma) July 3, 2023

__________

Hello Everyone,

We are extremely excited to bring you this next profile.

We just had you take a look at this one back in July where it ran all the way to 1.11 after closing at .83 the session before we released our profile on the company. Then we looked again back in August when it made another double digit move during the session.

Right now it is sitting back in the .90 range and has a smaller float of just over 14 Million.

It has made a 25% move over 2 sessions and has the potential to head back up over a buck.

Pull up NLSP right away.

NLSP is a clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system, or CNS, disorders, who have unmet medical needs.

CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance abuse disorders. Their discovery platform currently focuses on single molecules that function through multiple mechanisms designed to target the complexity of the CNS disease state. They believe that this approach may potentially offer new treatment options for patients, including those who are refractory to currently available treatments. Their current focus is in the therapeutic areas of rare hypersomnia disorders (conditions characterized by excessive daytime sleepiness, or EDS, such as narcolepsy) and complex neurodevelopmental disorders. Their drug development pipeline features our lead product candidate, Quilience®, for the treatment of EDS and cataplexy associated with narcolepsy, and our follow-on drug candidate Nolazol®, for the treatment of ADHD.

The MAJOR Catalyst comes in the form of an update from the CEO released on back in August.

There were two catalysts in this release that caught my eye:

First, this caught my eye:  “At this time we have received several non-binding term sheets for a potential partnership agreement within the pharmaceutical industry. The Company is still in negotiations, has not executed a definitive agreement, and no party is under any obligation to enter into or continue negotiations regarding a definitive agreement related to any transaction.” 

This means that they have several companies that are looking to partner with them for their Phase 3 trials after looking at the initial data.  This could be a good sign for the company moving forward. 

Also, In the article it stated: “OnAugust 25, 2023, NLS submitted a fast-track designation application for Mazindol ER for the treatment of narcolepsy to the FDA. Fast track is a designation by the FDA of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. A drug may be granted Fast Track Designation if it is believed to have an impact on patient survival, day-to-day functioning, or if it is believed that the condition will progress in severity if left untreated. Standard reviews by the FDA for drug approval generally take about one year. A medicine that receives Fast Track Designation can be on the market within six months of the regulatory application.”   This could be huge for the company.  

“Fast Track” has the potential to be on the market as fast as 6 months.  

Read the full release here:

NLS PHARMACEUTICS CEO ISSUES LETTER TO SHAREHOLDERS

ZURICH, SWITZERLAND / ACCESSWIRE / August 28, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, NLSPW) (“NLS” or the “Company”), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced that its Chief Executive Officer, Alex Zwyer, has issued the following letter to shareholders:

NLS Pharmaceutics CEO Issues Letter to Shareholders

To our Shareholders and Friends,

Though we may have been quiet recently, I wanted to assure you that the team here at NLS has been very busy behind the scenes ensuring that we realize our vision of awakening a brighter future for patients. Your investment and support to advance our pipeline in rare sleep disorders and other rare and debilitating Central Nervous System (CNS) disorders is our driving force as we put patients first to develop better therapies to safeguard and empower the brain throughout all stages of life. I am pleased to report on the progress that we have made towards achieving both our short and our long-term goals.

At the outset of 2023, we outlined a number of objectives including:

• Continuing to build an organization dedicated to rare and complex CNS disorders
• Solidifying the opportunity for lead product Mazindol ER’s success through a rigorous Phase 3 program
• Realizing Mazindol ER’s full potential across a variety of rare sleep disorders
• Progressing pipeline of innovative products to meet the unmet needs of patients and transforming the lives of patients with rare diseases

In addition to making significant progress on our objectives, we have advanced in our overall efforts by participating in global medical conferences, building investor relations and partaking in discussions regarding promising opportunities. As we are at the precipice of beginning our Phase 3 program for Mazindol ER, I wanted to take the opportunity to share the promises that we have kept and the advances that we have made, which we could not have achieved without your help.

Financing

In late 2022, we completed a $10 million private placement with BVF Partners L.P., a prestigious life sciences investor. The offering and shared vision reinforced our confidence in our development program, which has the potential to benefit more than three million people across the globe challenged with narcolepsy.

We are now in the process of assessing different options to initiate our Phase 3 program as well as our strategic plan, which includes: the potential need for capital, partnerships, venture debt opportunities and business development opportunities. We have significantly reduced our monthly expenditures to extend our cash runway while finalizing our efforts. At this time we have received several non-binding term sheets for a potential partnership agreement within the pharmaceutical industry. The Company is still in negotiations, has not executed a definitive agreement, and no party is under any obligation to enter into or continue negotiations regarding a definitive agreement related to any transaction.

Leadership

In May of this year, we announced the appointment of Keith Dewedoff to the position of Interim Chief Financial Officer (CFO). Mr. Dewedoff’s depth of expertise in finance within biotech, and his experience in executing growth capital initiatives, as well as corporate development and equity research, brought crucial talents into the Company at the right time. Mr. Dewedoff’s contributions have been significant.

Following Mr. Dewedoff’s appointment and after an exhaustive international search, in June we engaged Elena Thyen-Pighin, an experienced finance executive, to transition into the role of permanent CFO & Head of Finance / Human Resources. Ms. Thyen-Pighin’s position will be effective on September 1, 2023. Ms. Thyen-Pighin holds extensive experience in leadership and management functions as both head of finance and human resources across a number of industries, including organizations similar to NLS. Based in Switzerland, Ms. Thyen-Pighin speaks 5 languages and has a strong and successful track record, most notably in accounting for both private and publicly listed enterprises. Her responsibilities will include oversight of all financial operations as well as those related to human resources. We are thrilled to welcome her to the leadership team.

Mazindol ER

In July of 2023, NLS announced that the Phase 3 clinical trial (which we call the AMAZE Program) 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 encompasses 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 U.S. Food and Drug Administration’s (FDA) 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).

Along with IRB approval and the green light from the FDA, NLS has retained a contract research organization (CRO) and has enrolled a number of sites for the phase 3 studies. Once suitable capital has been secured, the phase 3 program will immediately commence as the sites are ready to begin enrolling patients.

On August 25, 2023, NLS submitted a fast-track designation application for Mazindol ER for the treatment of narcolepsy to the FDA. Fast track is a designation by the FDA of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. A drug may be granted Fast Track Designation if it is believed to have an impact on patient survival, day-to-day functioning, or if it is believed that the condition will progress in severity if left untreated. Standard reviews by the FDA for drug approval generally take about one year. A medicine that receives Fast Track Designation can be on the market within six months of the regulatory application.

Medical Congress Activities

At SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), NLS presented our findings highlighting data from the recently completed Phase 2 multi-center U.S. clinical study evaluating Mazindol ER, a triple monoamine reuptake inhibitor and partial Orexin-2 Receptor agonist, in adult patients suffering from narcolepsy, which study met its primary endpoint with high statistical significance and demonstrated a favorable safety and tolerability profile. We believe that these results confirm the efficacy of Mazindol ER, as well as the safety and tolerability profile established in over 40 years of on-label and off-label use. Additional data from our Open Label Extension study (NLS-1022) further validated the positive results from our Phase 2 double-blind trial for Mazindol ER in narcolepsy and demonstrated the potential long-term efficacy, tolerability, and safety of the treatment.

In addition to presenting our findings, we spoke to hundreds of clinicians at our booth as well as presented to a packed room in our symposium entitled, Mazindol ER: Pioneering the Combination of SNDRI and OX2R in the Treatment of Narcolepsy, in which we, along with internationally renowned key opinion leaders (KOLs) in sleep medicine, Bruce Corser, M.D., Medical Director, Sleep Management Institute, Cincinnati, and Clete Kushida, MD, PhD, Chief and Medical Director, Division of Sleep Medicine, Stanford School of Medicine, presented on:

• Unmet needs in the treatment of Narcolepsy
• Phase 2 Clinical Data presentation for Mazindol ER (Studies NLS-1021 & NLS-1022)
• Phase 3 Program Summary for Mazindol ER (Studies NLS-1031, NLS-1032 & NLS-1033)
• NLS’ Pipeline

Progressing our Pipeline

The NLS current pipeline bridges the present to the future, providing a holistic approach and further strengthening the Company’s vision to awaken a brighter future for patients by overcoming rare and complex CNS diseases. We believe that our pipeline products are well positioned as we gain ground in establishing future market positions through patents for lauflumide (NLS-4) and other new chemical entities and assets. With extensive intellectual property (IP) coverage in the U.S., Japan and Europe, and promising pre-clinical data, we anticipate that our wake-promoting agent, lauflumide (NLS-4), could also offer a new option for the treatment of chronic fatigue, including fatigue associated with cancer treatment and long-COVID symptoms. We anticipate that clinical trials with lauflumide (NLS-4) will begin in 2024.

As we strive to develop better therapies to safeguard and empower the brain throughout all stages of life, these compounds, including Mazindol ER for the treatment of narcolepsy, along with NLS-4 focused on idiopathic hypersomnia and chronic fatigue, and NLS-11, addressing Kleine-Levin Syndrome and neurodegenerative diseases (e.g. Lewy body dementia), would offer much-needed treatment options to fill the gaps for patients with these disorders.

Current NLS pipeline products focused on Sleep disorders:

In May of this year, NLS presented new and compelling preclinical data on four of our pipeline compounds at the annual meeting of the American Society of Clinical Psychopharmacology (ASCP), in Miami, Florida. NLS’ Chief Scientific Officer, Eric Konofal, MD, PhD, presented data highlighting the Company’s focus on and investment in therapeutic areas of rare hypersomnia disorders and complex neurologic disorders:

• Effects of NLS-4 (Lauflumide) and modafinil in a rat model of chronic severe fatigue
• Effects of NLS-8 (Melafenoxate) on memory in a model of Alzheimer’s Disease, the scopolamine-induced amnesia in the novel object recognition test in mice
• Effects of NLS-11 (Benedin) on memory in the novel object recognition test in mice
• Effects of NLS-12 (Oxafuramine) on memory in the novel object recognition test in mice

We will continue to explore opportunities and execute on possibilities based on key factors such as unmet medical needs, biological rationales, safety profiles, feasibility of clinical development, potential for leveraging accelerated development pathways for regulatory approval, strong IP positions, favorable competitive landscapes, and attractive commercial potential.

The NLS discovery platform continues to focus on single molecules that function through multiple mechanisms designed to target the complexity of the CNS disease state. Our goal remains building a differentiated global pharmaceutical company that is patient-centered and dedicated to the development of transformative therapies addressing critical unmet needs. As we navigate the competitive landscape of our industry while focusing on the development of our product candidates, we are poised to maximize the therapeutic potential of our current pipeline while still pursuing new candidates that will continue to broaden our product portfolio.

Unwavering Support

At our Annual General Meeting (AGM) in July, NLS shareholders approved all of the Board of Directors’ proposals for the AGM that took place in Zürich, Switzerland on June 30, 2023. This included the election of Audrey Greenberg and Dr. Anthony Walsh to the Board of Directors, shareholder approval of financial statements, the compensation report and the balance sheet results of the Company for the fiscal year 2022. Shareholders also approved the total compensation budgets for NLS’ Board of Directors and Executive Management for the financial year 2024. PricewaterhouseCoopers AG was re-elected as NLS’ independent auditors for another term. Other key highlights from the meeting include 64% percent of the shares entitled to votes being represented and the Board of Directors receiving the highest voting approval in the Company’s history with 99.5% of votes cast in favor of the proposals.

A Bright Future

More than ever, we at NLS are committed and passionate to be a part of a company with genuine near and long-term prospects to change the lives of patients with rare CNS diseases. We work together in order to create a culture that inspires and motivates our team members to do what they do best. Our leadership team remains nimble with an honest approach to transparent communication, empowerment and individual ownership of responsibilities. Our team members thrive in finding innovative and efficient approaches to advance our corporate aspirations.

Together with our co-founder, Dr. Eric Konofal, I want to offer my sincerest gratitude to the clinical investigators and participating patients making it possible for Mazindol ER to be a potential class-leading treatment for narcolepsy in the future. I must also thank the many women and men across Europe and the U.S. that are part of the NLS team, from pre-clinical to regulatory affairs to supply chain and all in between, that endeavor every day to progress our objectives in treating these rare diseases. And finally, I would like to thank you, our shareholders and investors, for your continued support for and shared commitment to NLS.

With gratitude,

Alex ZwyerChief Executive Officer

Check out the new episode of https://t.co/t7Sg4BYOzU with our CEO Alexander Zwyer and CMO George Apostol. We discuss the story of Mazindol ER and how it helps patients with narcolepsy. https://t.co/MO6EnNbD2C#nlspharmaceutics #narcolepsy #SleepingAroundThePodcast $NLSP

— NLS Pharmaceutics (@NLSPharma) October 5, 2023

COMPANY HIGHLIGHTS

• Mazindol ER has successfully completed a Phase 2 trial, including OLE, for narcolepsy treatment: projected to be $4.5B annual market by 2027**
• Orphan Drug Designation (ODD) granted in the US and Europe
• AMAZE phase 3 program starting in July 2023, secured funding for current projects and existing operations through 2025. Development of Mazindol ER is in the spotlight for progression purposes, particularly for the treatment of EDS and cataplexy in adult patients who suffer from narcolepsy
• Named Patient Program for patients suffering from idiopathic hypersomnia launched in target markets across Europe
• Key Executive Leadership roles filled
• Pipeline progressed and expanded with long-dated IP protections in major markets
• Over 100 patents in over 140 countries including technology and application for a variety of diseases such as ADHD, Cancer Fatigue, Parkinson’s and more. Not to mention that several products are nearing the end of Phase 2 and approaching NDA filing
• POLARIS: Mazindol ER Phase 2 Program in Narcolepsy, consisted of two US clinicaltrials approved by the FDA, met its primary endpoint with high statistical significance and demonstrated a favorable safety and tolerability profile. These results were promising, i.e, Sustained EDS and cataplexy improvements at all time points. OLE conclusions: 6-month OLD, displayed good subject participation (87%) and retention (11.5%)
• Partnership with Université de Lausanne (UNIL) (preclinical projects), University of Berne (narcolepsy reserach), Swiss Narcoslpsy Network (narcolepsy reserach) ( (BVF Partners L.P (financial partnership) 
• Partnerships with Patient advocacy groups including Narcolepsy Network, The Narcolepsy Foundation, The Sleep Consortium, Hypersomnia Foundation, and Wake Up Narcolepsy

PIPELINE

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

ZÜRICH, SWITZERLAND / ACCESSWIRE / July 3, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP)(Nasdaq:NLSPW) (“NLS” or the “Company”), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) has reviewed the full protocol for the NLS-1031 study, part of the Phase 3 program for Mazindol ER, called AMAZE. In addition, the Company is pleased to announce 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).

“In addition to IRB approval of the Phase 3 study protocol for AMAZE obtained last week, with this regulatory milestone acheived, we can recruit U.S. clinical sites quickly and efficiently, allowing us to move forward with providing Mazindol ER to patients with narcolepsy type 1,” commented George Apostal, MD, MS, Chief Medical Officer of NLS.

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.

Alex Zwyer, Chief Executive Officer of NLS, said, “We are pleased with the FDA’s review of the Phase 3 protocol and now expect to move quickly to begin enrolling patients in the AMAZE program in centers across the U.S. in the coming days.”

For more information on the AMAZE Program, please visit https://amaze.nlspharma.com/.

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). A recording of the Phase 2 data presentation can be found here: https://nlspharma.com/news/nls-satellite-symposium/.

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.

LEAD ASSET: MAZINDOL ER

Mazindol ER is a patented and proprietary formulation of the active compound mazindol, and are designed for once-daily dosing. Mazindol has a well-established safety record from its long history of clinical use in the United States and in Europe when the drug was approved in an immediate release formulation for the management of obesity. Mazindol was marketed for nearly 30 years under the trade name Sanorex® before being voluntarily withdrawn from the market, and the drug is no longer available nor marketed in these regions. During its time on the market, mazindol was also widely used off-label and prescribed under compassionate use for the treatment of narcolepsy for several decades. Use in these compassionate use programs has yielded evidence of positive efficacy in patents suffering from the symptoms of narcolepsy including patients that were refractory to approved treatments for the disorder. Additionally, these same programs, a retrospective analysis of investigator sponsored studies, and NLS’s own trial evaluating Mazindol ER in patients with ADHD provide evidence of the drug’s favorable safety profile at doses that yielded efficacy signals.

We believe that our lead product candidate,  Mazindol ER, offers a differentiated profile with clincally meaningful advantages over current treatment options for narcolepsy for the following reasons:

MECHANISM OF ACTION

If approved, Mazindol ER would be the only partial orexin 2 receptor agonist as well as the only triple monoamine reuptake inhibitor approved by the FDA for the treatment of narcolepsy. Narcolepsy is caused by a profound loss of orexin producing neurons. A partial orexin 2 receptor agonist may help to replace missing endogenous orexin peptide, addressing the underlying cause of the disease. In addition, the drug’s action as a triple monoamine reuptake inhibitor can further reduce disease specific symptoms, offering patients a treatment option that may address the two primary symptoms of narcolepsy – excessive daytime sleepiness (EDS) and cataplexy attacks – in a convenient once-daily oral tablet.

LOW POTENTIAL FOR ABUSE, MISUSE, AND DIVERSION.

Mazindol is currently classified by the DEA as a Schedule IV controlled substance . The DEA defines Schedule IV controlled substances as those “with a low potential for abuse and a low risk of dependence”. Unlike Xyrem® (sodium oxybate), the top-selling treatment for narcolepsy in the United States deemed to have a high potential for abuse/misuse (Schedule III), mazindol was never required by the FDA to have a risk evaluation and mitigation strategy (REMS) program in place to manage known or potential serious risks associated with its use.

QUILIENCE® HAS POTENTIAL TO BE ADMINISTERED AS A MONOTHERAPY.

Narcolepsy is a difficult disorder to manage and even with available treatments, the majority of narcolepsy patients often require multiple medications to treat their symptoms. According to the current treatment guidelines (initially published in 2007) of the American Academy of Sleep Medicine, or AASM, medications for narcolepsy, at best, provide only moderate improvement in narcolepsy symptoms, and their respective side effects may limit their use. The AASM specifically highlights that future investigations should be directed toward more effective and better tolerated therapies for treatment. The Voice of the Patient report from the FDA’s patient-focused drug development initiative, published in 2014, concluded that, based on the overall benefit-risk assessment of current medications, there is a continued need for additional effective and tolerable treatment options for patients with narcolepsy. A retrospective analysis (Nittur et.al, Sleep Med. 2013 Jan;14(1):30-6) showed that mazindol has a long-term, favorable benefit/risk ratio in 60% of drug-resistant patients with hypersomnia, including a clear benefit on the two primary symptoms of narcolepsy–EDS and cataplexy.

MAZINDOL ER IS BEING DEVELOPED AS A ONCE-DAILY ORAL TABLET ADMINISTERED IN THE MORNING UPON WAKENING.

Patients have identified a need for treatment options that are easier to take, dosed less frequently, do not disrupt nighttime sleeping, and provide full day coverage of symptoms. We believe that once-daily dosing with Mazindol ER may address this need and may help improve patient compliance and adherence with treatment. Mazindol ER utilizes our patented and proprietary extended-release (ER) formulation and is being designed to optimize its pharmacokinetic and pharmacodynamic properties with a rapid onset of action and prolonged controlled therapeutic effect, allowing for a daily oral dose that effectively provides consistent and long-acting symptom control to uniquely meet the needs of patients.

RELATIONSHIP BETWEEN NARCOLEPSY AND ADHD

Narcolepsy and psychiatric disorders have a significant but under-recognized relationship in which the two may coexist. However, narcolepsy is frequently misdiagnosed initially as a psychiatric condition, contributing to protracted times for accurate diagnosis and treatment. Narcolepsy is a disabling neurological condition that carries a high risk for the development of social and occupational dysfunction. Deterioration in function associated with narcolepsy may lead to the secondary development of psychiatric symptoms and inversely, the development of psychiatric symptoms can lead to a deterioration in function and quality of life. The overlap in treatments may further enhance the difficulty to distinguish between diagnoses.

ADHD is the most common neurobehavioral disorder characterized by symptoms of inattention, impulsivity and hyperactivity with an estimated prevalence rate of approximately 4-12% worldwide, as reported by the paper, “Understanding Attention Deficit/Hyperactivity Disorder From Childhood to Adulthood,” by Drs. Timothy E. Wilens and Thomas J. Spencer.

On the surface, ADHD may appear to be the opposite of narcolepsy; however, there may actually be significant clinical similarities between the two disorders. Cumulative data on sleep problems in children and adolescents with ADHD have shown that children with ADHD have had a higher rate of restless sleep, impaired sleep, and daytime sleepiness than children without ADHD. However, it is unclear whether EDS in ADHD is due to nocturnal sleep disturbances or primary vigilance disorders because shorter sleep onset latency is assessed in ADHD patients by the Multiple Sleep Latency Test, rather than in the control group irrespective of the presence/absence of sleep disturbances.

Alternatively, problems with sleep may represent an intrinsic component of ADHD. The presence of ADHD symptoms in children and adolescents with narcolepsy has been found to be about two-fold higher than in the general control population. Adults with narcolepsy have been found to have a much greater likelihood of having a diagnosis of ADHD in childhood compared to the general control population. Hyperactivity seen in ADHD may, in fact, be a compensatory response for individuals who are under-aroused or sleepy, and ADHD symptoms contribute to poor quality of life and increased frequency of depressive symptoms, similar to narcolepsy. To the best of our knowledge, almost all of the treatments used in ADHD have mechanistic overlap with treatments used in narcolepsy for EDS, and researchers suggest that the symptoms of EDS, fatigue, and sleep fragmentation may be the cause for ADHD symptoms, which is consistent with similar findings in other hypersomnia disorders.

http://polaris.nlspharma.com/

NLS PHARMACEUTICS RECEIVES GREEN LIGHT FROM THE U.S. FDA TO PROCEED WITH PHASE 3 CLINICAL PROGRAM (AMAZE) FOR QUILIENCE(R) (MAZINDOL ER) FOR THE TREATMENT OF NARCOLEPSY

ZURICH, SWITZERLAND / ACCESSWIRE / May 2, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, NLSPW) (“NLS” or the “Company”), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) provided authorization to proceed with the Phase 3 program for Quilience® (Mazindol ER). The AMAZE Program will encompass two double-blind Phase 3 trials (N=50 each) investigating Mazindol ER versus placebo in adult patients with narcolepsy, commencing this summer at multiple sites in the U.S.

Both phase 3 trials, NLS-1031 and NLS-1032, will measure the weekly cataplexy episodes as the primary endpoint over 8 weeks of treatment. Patients who complete these studies will be offered participation in a 12-month open-label extension (OLE) study (Study NLS-1033). To be eligible for enrollment into the program, patients must be at least 18 years of age and have been diagnosed with narcolepsy with cataplexy.

Alex Zwyer, Chief Executive Officer of NLS, said, “We thank the FDA for the approval of this clinical program to evaluate Quilience® in chronically ill patients suffering from narcolepsy and we are thrilled to start recruiting for the U.S. clinical trial this summer. Today’s announcement builds on our commitment and focus to awaken a brighter future for patients with rare and complex central nervous system diseases.”

NLS previously reported on the Phase 2 study results in narcolepsy in which Quilience (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 achieved comparable results to the Mazindol ER-treated patients in the Phase 2 trial. Data from the Phase 2 studies will be presented at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), which is being held from June 3 – 7, 2023, in Indianapolis.

“We are pleased that the FDA has approved our clinical development plan in narcolepsy patients. We believe that the FDA’s approval affirms the Company’s path to securing approval for Mazindol ER in order to treat a life-long chronic disorder with high unmet medical needs,” says George Apostol, Chief Medical Officer.

NEWS

PUBLISHED

JUL 3, 2023

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

PUBLISHED

JUN 30, 2023

NLS PHARMACEUTICS RELEASES THE RESULTS FROM ITS ANNUAL GENERAL MEETING

PUBLISHED

JUN 30, 2023

NLS PHARMACEUTICS COMPANY UPDATE AND WEBCAST TODAY POSTPONED

PUBLISHED

JUN 15, 2023

NLS PHARMACEUTICS TO PARTICIPATE IN THE HEALTHCARE VIRTUAL CONFERENCE PRESENTED BY MAXIM GROUP LLC AND HOSTED BY M-VEST

PUBLISHED

JUN 15, 2023

NLS PHARMACEUTICS ANNOUNCES COMPANY UPDATE WEBCAST

PUBLISHED

JUN 14, 2023

NLS PHARMACEUTICS ANNOUNCES POSITIVE SAFETY DATA FROM IN VITRO CYP450 AND TRANSPORTER MEDIATED DRUG-DRUG INTERACTION STUDIES OF MAZINDOL

PUBLISHED

MAY 8, 2023

NLS PHARMACEUTICS APPOINTS KEITH HARRISON DEWEDOFF AS INTERIM CHIEF FINANCIAL OFFICER

PUBLISHED

MAY 4, 2023

NLS PHARMACEUTICS PRESENTS LATEST CLINICAL AND PRECLINICAL DATA AT SLEEP 2023

PUBLISHED

MAY 2, 2023

NLS PHARMACEUTICS RECEIVES GREEN LIGHT FROM THE U.S. FDA TO PROCEED WITH PHASE 3 CLINICAL PROGRAM (AMAZE) FOR QUILIENCE(R) (MAZINDOL ER) FOR THE TREATMENT OF NARCOLEPSY

PUBLISHED

APR 25, 2023

NLS PHARMACEUTICS PRESENTS LATEST PRECLINICAL PIPELINE DATA AT AMERICAN SOCIETY OF CLINICAL PSYCHOPHARMACOLOGY

PUBLISHED

MAR 27, 2023

NLS PHARMACEUTICS ANNOUNCES OPEN LABEL EXTENSION STUDY SIX-MONTH DATA FOR QUILIENCE(R) (MAZINDOL ER) IN THE TREATMENT OF NARCOLEPSY TYPE 1 AND TYPE 2

PUBLISHED

MAR 1, 2023

NLS PHARMACEUTICS TO PRESENT AT THE 35TH ANNUAL ROTH CONFERENCE

PUBLISHED

JAN 30, 2023

NLS PHARMACEUTICS ANNOUNCES COMPLETION OF OPEN LABEL EXTENSION STUDY WITH QUILIENCE(R) (MAZINDOL ER) FOR THE TREATMENT OF NARCOLEPSY

PUBLISHED

JAN 25, 2023

NLS PHARMACEUTICS REGAINS COMPLIANCE WITH NASDAQ STOCKHOLDERS’ EQUITY REQUIREMENT

PUBLISHED

JAN 23, 2023

NLS PHARMACEUTICS ANNOUNCES NEW IN-VITRO DATA RECONFIRMING QUILIENCE’S(R) (MAZINDOL ER) UNIQUE DUAL MECHANISM OF ACTION INVOLVING SIGNIFICANT OREXIN-2 RECEPTOR ACTIVITY

PUBLISHED

JAN 12, 2023

NLS PHARMACEUTICS ANNOUNCES AN R&D UPDATE WEBCAST TO REVIEW THE COMPANY’S GROWING PORTFOLIO OF PRE-CLINICAL COMPOUNDS

MANAGEMENT TEAM

Alex Zwyer (CEO and Founder): 

Co-founder of the company, serial entrepreneur, served as COO at Viforpharma AG (global pharmaceutical company with a revenue of 1.99B in 2021) and a director since the company’s incorporation in 2015, been there since the beginning. Over 25 years of International business experience, notably when he served under Vifor International, global regulatory affairs, sales and marketing, furthermore was involved in the forefront of business development where he lead over 100 BD deals

Eric Konofal M.D. (CSO and Co-Founder):

Drug hunter and co-founder of NLS pharmaceutics, main expertise lies in his knowledge for clinical and scientific research. He’s a senior medical consultant for the Pediatric Sleep Disorders Center as well as the Principal Clinical Investigator at the Clinical Pharmacology and Pharmacogenetic Department at Robert-Debre University of Paris. Dr. Konofal has authored over 70 peer-reviewed publications in the area of sleep disorders and other CNS diseases, in fact it was Dr. Konofal that obtained the U.S. patent for mazindol (used in the treatment of ADHD), one of the key ingredients to the growth and development for the NLS pipeline (Mazindol ER Clinical Development Program.

George Apostol M.D. (CMO, Global Head R&D)

Worked in large pharma R&D organizations for more than 20 years. Broad drug development expertise across early,middle and late phases of development at the Global R&D organizations of Eli Lilly,Pfizer, Abbott, Novartis, Shire and Endo. Received distinguished R&D awards and achieved multiple regulatory approvals inUS, EU and Japan.

Keith Dewedoff (CFO)

More than 20 years of experience in the life science industry, ranging from biotech venture-backed start-ups to commercial publicly traded companies. Extensive expertise in strategic financial management, serving as CFO in organizations including Danforth Advisors, Code Bio, Ceptur Therapeutics and more than 10 other privately held and public companies at various life cycle stages.

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