Full Press Release Details
Successfully Appeals Nasdaq Delisting Notice
November 14, 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 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.
About NLS Pharmaceutics
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 (IH), for which NLS recently obtained Orphan Disease Designation (ODD) from
the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). 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 2 multi-center U.S. clinical trial evaluating Quilience
in adult subjects suffering from narcolepsy met its primary endpoint with high
statistical significance and demonstrated a favorable safety and tolerability profile. NLS also 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
expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements
when it discusses that it intends to comply with the Panel's requirements and that it intends to cure its Nasdaq deficiency. 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.
Alex Zwyer, CEO: +41 44 512 21 50
Investor Relations Contact