Full Press Release Details
Pharmaceutics Announces Over Enrollment in its Phase 2a Clinical Trial Evaluating Quilience for the Treatment of
June 2, 2022 - NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage
biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central
nervous system disorders, announces that its Phase 2a clinical trial for Quilience in the treatment of narcolepsy is now fully enrolled,
with top-line results anticipated to be presented at a symposium during the European Sleep Research Society Congress (ESRS), being held
September 27-30, 2022 in Athens, Greece. Additionally, the Company reports that enrollment and ongoing patient dosing in its OLE study
for Quilience monotherapy continue to exhibit favorable trends.
patient enrollment now complete, we remain on track to report top-line efficacy and safety results from our Phase 2a narcolepsy trial
for Quilence during the ESRS conference in late September," said Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics. "I
believe that the over-enrollment of the trial demonstrates the high interest in our novel Mazindol ER formulation, as enrollment has
significantly accelerated since we reported our positive interim results at the World Sleep Congress in March 2022. As we continue to
execute on completing this trial, we are also continuing to work with our financial advisor to evaluate potential strategic partnerships
and opportunities to bring Quilience to patients as quickly as possible."
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. EAPs
have great potential to benefit all stakeholders involved, from the patient who receives the medicine early, to the pharmaceutical company
who provides it. Although EAPs can represent a significant undertaking, companies who invest in them should see considerable benefit
in terms of launch preparedness, relationship building and market penetration.
This press release contains
expressed 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 reporting the results for its clinical trial, the belief that the over-enrollment of the trial
demonstrates the high interest in its novel Mazindol ER formulation, and that it is evaluating potential strategic partnerships and opportunities
to potentially bring Quilience to patients as quickly as possible. 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 for the year ended December 31, 2021 filed with the Securities and Exchange Commission
(SEC), which is available on the SEC's website, www.sec.gov, and in subsequent filings made by NLS with the SEC.
Zwyer, CEO: +41 44 512 21 50
Rizzo: +1 908-229-7050
Nigen: +1 917-385-2160