Full Press Release Details
NLS Pharmaceutics to Present
Interim Top-Line Data for Quilience (Mazindol ER) in Patients with Narcolepsy at the World Sleep Congress in March 2022
Switzerland/Zurich, February 7, 2022 -
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical
company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders,
announces that it 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
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.
"Physician and patient interest in Quilience
remain high, and with our industry-leading execution on the Phase 2a clinical trial, we remain on track to deliver the planned interim
top-line results in March 2022 at the World Sleep Congress," said Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics. "There
is a significant need for additional therapeutic options, with over 90% of narcolepsy patients unsatisfied with their current treatment
regimen. Given this need and the history of mazindol, the active ingredient in Quilience, we are focused on demonstrating the efficacy
and safety of our convenient once-daily ER formulation and bringing this novel treatment candidate to patients as soon as possible."
Details for NLS Pharmaceutics'
Narcolepsy Symposium:
Date/Time: March 16, 2022,
12:30pm - 2:00pm (CET)
Open to all registered attendees of the World Sleep 2022 Congress
J. Thorpy, MD, Professor of Neurology at the Albert Einstein College of Medicine and Director of the Sleep-Wake Disorders Center at Montefiore
Corser, M.D., Medical Director at the Sleep Management Institute
Mehdi Tafti, Ph.D., Professor at the
University of Lausanne, Department of Biomedical Sciences
Konofal, M.D., Ph.D., Co-Founder & Chief Scientific Officer of NLS Pharmaceutics
Camozzi, M.D., Ph.D., Medical Director of NLS Pharmaceutics
About World Sleep 2022
The international Congress of the World Sleep
Society is the most important meeting of Sleep Research Scientists worldwide. Now in its 16th iteration, the World Sleep Congress consistently
gathers the best minds in sleep medicine and research for multiple days of scientific sessions and networking. World Sleep 2022 will be
held in Rome, Italy, March 11-16, 2022, with fourteen keynote speakers selected to represent a broad range of sleep medicine
and research. Twenty-two sleep medicine and research courses are in development, and attendees will have access to presentations
by world-class researchers in chronomedicine, narcolepsy, sleep surgery, insomnia, sleep-focused basic research, and more. A truly
global meeting, 77 countries were represented at World Sleep 2019 which featured 89 symposia, 192 oral abstracts, and over 1100 poster
presentations. World Sleep 2022 presents a unique opportunity for sleep medicine professionals no matter their specialty or career stage.
About NLS Pharmaceutics Ltd.
Pharmaceutics Ltd. is a Swiss clinical-stage biopharmaceutical company led by an experienced management team with a track record of developing
and repurposing product candidates to treat rare and complex central nervous system disorders. The Company's lead product candidate, Quilience,
is a proprietary extended-release formulation of mazindol (mazindol ER) and is being developed for the treatment of narcolepsy, and potentially
other sleep-wake disorders such as idiopathic hypersomnia. Mazindol is a triple monoamine reuptake inhibitor and partial orexin-2 receptor
agonist, which was used for many years to treat patients diagnosed with narcolepsy in compassionate use programs. A Phase 2a clinical
trial evaluating Quilience in adult subjects suffering from narcolepsy is currently ongoing in the United States. Previously, NLS successfully
completed a phase 2 study in the U.S. evaluating Nolazol (mazindol
controlled-release) in adult subjects suffering from ADHD. The study met all primary and secondary endpoints and Nolazol
was well-tolerated. Quilience has received Orphan Drug Designations both in the
U.S. and in Europe for the treatment of narcolepsy. Up to 1/3 of narcoleptic patients are also diagnosed with ADHD.
Safe Harbor Statement
This press release contains
express or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements
when it discusses the expected timing of the release of interim top-line results, as well as the timing for the completion of its Phase
2a trial. These forward-looking statements and their implications are based on the current expectations of the management of NLS only,
and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in
the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described
in the forward-looking statements: changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or
successfully completing its clinical trials; NLS' 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; loss of market share and pressure on pricing resulting from competition, which could cause
the actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise
required by law, NLS undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events
or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks
and uncertainties affecting NLS is contained under the heading "Risk Factors" in NLS' annual report on Form 20-F filed with
the Securities and Exchange Commission (SEC), which is available on the SEC's website, www.sec.gov.
Alex Zwyer, CEO: +41 41 618 80 00
Investor Relations Contact
Cindy Rizzo: +1 908-229-7050
Pascal Nigen: +1 917-385-2160