<SEC-DOCUMENT>0001213900-22-012705.txt : 20220316
<SEC-HEADER>0001213900-22-012705.hdr.sgml : 20220316
<ACCEPTANCE-DATETIME>20220316073104
ACCESSION NUMBER:		0001213900-22-012705
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20220316
FILED AS OF DATE:		20220316
DATE AS OF CHANGE:		20220316

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NLS Pharmaceutics Ltd.
		CENTRAL INDEX KEY:			0001783036
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			V8
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39957
		FILM NUMBER:		22743293

	BUSINESS ADDRESS:	
		STREET 1:		THE CIRCLE 6
		STREET 2:		8058
		CITY:			ZURICH
		STATE:			V8
		ZIP:			CH-6370
		BUSINESS PHONE:		41-41-618-80-00

	MAIL ADDRESS:	
		STREET 1:		THE CIRCLE 6
		STREET 2:		8058
		CITY:			ZURICH
		STATE:			V8
		ZIP:			CH-6370
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>ea156904-6k_nlspharma.htm
<DESCRIPTION>REPORT OF FOREIGN PRIVATE ISSUER
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Washington, D.C. 20549</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Form 6-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Report of Foreign Private Issuer</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Pursuant to Rule 13a-16 or 15d-16</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">under the Securities Exchange Act of 1934</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">For the month of March 2022 (Report No. 2)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Commission file number: 001-39957</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>NLS PHARMACEUTICS LTD.</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Translation of registrant&rsquo;s name into English)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>The Circle 6</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>8058 Zurich, Switzerland</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Address of principal executive offices)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Form 20-F &#9746;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form
40-F &#9744;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulations S-T Rule 101(b)(1):_____</P>

<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulations S-T Rule 101(b)(7):_____</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>CONTENTS</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">On March 16, 2022, NLS
Pharmaceutics Ltd, or the Registrant, issued a press release titled: &ldquo;NLS Pharmaceutics Announces Positive Interim Top-Line Data
for Quilience&reg; (Mazindol ER) in Patients with Narcolepsy.&rdquo; A copy of this press release is furnished herewith as Exhibit 99.1.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>

<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">This first through fifth paragraphs, the seventh
paragraph and the section entitled &ldquo;Safe Harbor Statement&rdquo; contained in Exhibit 99.1 to this report are incorporated by reference
into the Registrant&rsquo;s Registration Statement on Form F-3 (File No. 333-262489), filed with Securities and Exchange Commission, to
be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed
or furnished.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>EXHIBIT INDEX</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

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    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Exhibit Number</B></P></TD>
    <TD STYLE="width: 1%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 90%; border-bottom: black 1.5pt solid; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Description of Document</B></FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF">
    <TD STYLE="vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99.1</FONT></TD>
    <TD STYLE="vertical-align: bottom; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="text-align: justify; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="ea156904ex99-1_nlspharma.htm">Press release titled: &ldquo;NLS Pharmaceutics Announces Positive Interim Top-Line Data for Quilience&reg; (Mazindol ER) in Patients with Narcolepsy.&rdquo;</A></FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>SIGNATURES</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in">Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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    <TD>&nbsp;</TD>
    <TD COLSPAN="3"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>NLS Pharmaceutics Ltd.</B></FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Date: March 16, 2022</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By:</FONT></TD>
    <TD COLSPAN="2" STYLE="border-bottom: black 1.5pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/ Alexander Zwyer</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 60%">&nbsp;</TD>
    <TD STYLE="width: 4%">&nbsp;</TD>
    <TD STYLE="width: 5%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Name:&nbsp;</FONT></TD>
    <TD STYLE="width: 31%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Alexander Zwyer</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Title:</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Executive Officer</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt">2</P>

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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ea156904ex99-1_nlspharma.htm
<DESCRIPTION>PRESS RELEASE TITLED: "NLS PHARMACEUTICS ANNOUNCES POSITIVE INTERIM TOP-LINE DATA FOR QUILIENCE (MAZINDOL ER) IN PATIENTS WITH NARCOLEPSY."
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Exhibit 99.1</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B><IMG SRC="ex99-1_001.jpg" ALT="">&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>NLS Pharmaceutics Announces Positive Interim
Top-Line Data for Quilience&reg; (Mazindol ER) in Patients with Narcolepsy</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><I>Clinically
meaningful results with Mazindol ER exhibiting a 39% reduction in ESS from baseline (-4.3 points placebo-adjusted); confirms statistical
powering of the ongoing Phase 2a trial</I></B></FONT></TD>
</TR></TABLE>



<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><I>Safety
and tolerability data consistent with prior mazindol clinical trials, no reported SAEs</I></B></FONT></TD>
</TR></TABLE>



<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><I>&#9679;</I></B></FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><I>82%
</I>of patients that completed the randomized trial to date have rolled over into the open label extension (OLE) study</B></FONT></TD>
</TR></TABLE>



<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><I>&#9679;</I></B></FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><I>Majority
of patients that enrolled in the OLE (both NT1 and NT2) </I>remain in the study and on Mazindol ER monotherapy</B></FONT></TD>
</TR></TABLE>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Switzerland/Zurich, March 16, 2022</B> - NLS
Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) (&ldquo;NLS&rdquo; or the &ldquo;Company&rdquo;), 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 positive interim top-line data from its Phase 2a clinical trial evaluating its lead product candidate, Quilience&reg; (Mazindol
ER), in the treatment of narcolepsy. The data are being presented and discussed today during a symposium sponsored by NLS at the World
Sleep Congress (World Sleep 2022), being held in Rome, Italy.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Quilience (Mazindol ER) Interim Efficacy Data
Summary</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Of the 60 patients targeted for full enrollment
in the U.S. Phase 2a trial (Study NLS-1021), 27 were randomized and completed the study for the interim analysis. The interim analysis
database included 13 patients on treatment and 14 patients on placebo, with balanced mean baseline Epworth Sleepiness Scale (ESS) scores
(18.6 +/-2.81 for treatment and 18.0 +/-2.72 for placebo). All patients enrolled in the interim analysis were utilizing combination therapy
before the trial&rsquo;s wash out period, with the majority of participants on stimulant or wake-promoting agents to treat their excessive
daytime sleepiness (EDS). Approximately one-third of patients enrolled in the interim analysis were diagnosed with narcolepsy type 1 (NT1)
and suffer from both EDS and cataplexy symptoms. Eligible NT1 patients must have moderate to severe disease according to the study protocol
- defined as having more than 3-4 cataplexy attacks per week. Study participants on treatment are required to undergo a 1-2-week wash
out period (depending on prior therapy). After the wash out period, participants are randomized to receive either once-daily treatment
with Mazindol ER 2mg for week 1 and 3mg for weeks 2-4, or placebo for 4 weeks.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For EDS, the trial&rsquo;s primary endpoint, patients
on Mazindol ER exhibited a mean decrease of 7.3 points on the ESS compared to a 3.0 point decrease for patients on placebo. Patients on
Mazindol ER showed a mean 39% improvement on ESS from baseline. The placebo-adjusted reduction of 4.3 points is deemed to be clinically
meaningful and is competitive compared to current narcolepsy treatments, despite the short duration and relatively small number of patients
in the interim analysis. These interim results confirm the statistical power of the ongoing Phase 2a trial, which will continue as planned.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In the figure below, a rapid onset of action is
observed for Mazindol ER, with treated patients exhibiting consistent and sustained EDS improvement over the 4-week treatment period.
The placebo effect in the interim analysis exhibits stabilization after week 3, consistent with other narcolepsy therapeutic clinical
trials.<FONT STYLE="text-underline-style: double; background-color: white"><U STYLE="text-decoration: none"><SUP>1,2</SUP></U></FONT><FONT STYLE="background-color: white">.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Epworth Sleepiness Scale (ESS) Total Score: Change from Baseline
to Last Visit (ITT Population)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><IMG SRC="ex99-1_002.jpg" ALT="">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Quilience (Mazindol ER) Phase 2a Interim Safety/Tolerability
Data Summary</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">To date, Mazindol ER was generally safe and well-tolerated
in the current Phase 2a trial, and the interim data are consistent with prior mazindol studies, including the Company&rsquo;s trials evaluating
treatment of attention deficit hyperactive disorder (ADHD). No patients dropped out of the study due to safety or efficacy concerns, and
only one patient in the interim analysis discontinued the study for personal reasons. This compares favorably to other clinical trials
for narcolepsy treatments, for which study discontinuation rates can be as high as 15% or more for efficacy and safety reasons.<FONT STYLE="text-underline-style: double; background-color: white"><U STYLE="text-decoration: none"><SUP>3</SUP></U></FONT>
No serious adverse events were reported in the interim analysis and all reported adverse events were mild or moderate and resolved immediately
with no intervention required.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&ldquo;These interim data are very encouraging
and demonstrate the potential for Mazindol ER to address the core symptoms of narcolepsy with a rapid onset of action and a favorable
safety and tolerability profile,&rdquo; said <FONT STYLE="background-color: white">Bruce Corser, M.D., Medical Director at the Cincinnati-based
Sleep Management Institute and</FONT> a clinical investigator in the NLS-1021 trial. &ldquo;Mazindol&rsquo;s dual mechanism of action
as a partial orexin agonist and pan-monoaminergic reuptake inhibitor distinguishes this therapeutic candidate and is of particular interest
in the field given the drug&rsquo;s potential to treat narcolepsy at its root cause. I am looking forward to the final results from this
trial and the potential to utilize this novel therapy in more of my patients.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Quilience (Mazindol ER) Open Label Extension
(OLE) Study Update</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Study NLS-1022 (OLE study) enables patients completing
the randomized controlled trial to access treatment with Mazindol ER without any background stimulant and or anti-cataplexy treatment
for up to 6 months. As of the data collection date for the Phase 2a interim analysis (February 25, 2022), 82% of patients who completed
the randomized controlled study elected to participate in the OLE study. A majority of those patients remain in the OLE study and on treatment
with Mazindol ER, including participants suffering from NT1, with one patient on single agent therapy for over 3 months.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&ldquo;We are extremely pleased with these interim
results, which offer the first evidence from a prospective randomized clinical trial that Mazindol ER has the potential to become a disruptive
treatment for narcolepsy,&rdquo; said Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics. &ldquo;I am very proud of the NLS clinical
team&rsquo;s execution and thankful for our clinical sites who are recruiting participants at among the fastest pace in the industry as
we focus on bringing this important treatment to patients as soon as possible. Importantly, we are seeing strong participation from NT1
patients in this trial. Given that the interim results are in-line with the documented historical utility of mazindol in treatment-resistant
narcolepsy patients under compassionate use, we are confident that our proprietary Mazindol ER formulation will prove to be a safe and
effective therapy that can address a broad spectrum of narcolepsy symptoms.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&ldquo;These interim results have exceeded on
our expectations with regard to the beneficial effects of Mazindol ER&rsquo;s unique mechanism of action and validate the body of retrospective
evidence that support the compound&rsquo;s efficacy and safety in the treatment of narcolepsy,&rdquo; said Eric Konofal, PhD, MD Chief
Scientific Officer of NLS Pharmaceutics. &ldquo;The rapid onset of action and large effect size between treatment and placebo are superb
in this dataset and are consistent with the results that we generated in our two ADHD trials, in addition to affirming Mazindol ER&rsquo;s
benign safety and tolerability profile. Mazindol is thought to address a wide spectrum of narcolepsy symptoms including EDS, cataplexy,
sleep paralysis, and nocturnal hallucinations, and we are excited to obtain the final Phase 2a results to fully understand the drug&rsquo;s
therapeutic potential, and to move this product candidate into advanced clinical trials.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>About World Sleep 2022</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">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&ndash;16, 2022, with fourteen keynote speakers&nbsp;selected to represent a broad range of sleep medicine
and research. Twenty-two sleep medicine and research courses&nbsp;are in development, and attendees will have access to presentations
by world-class researchers in chrono-medicine, narcolepsy, sleep surgery, insomnia, sleep-focused basic research, and more.&nbsp;A truly
global meeting, 77 countries were represented at World Sleep 2019 which featured 89 symposia, 192 oral abstracts, and over 1,100 poster
presentations. World Sleep 2022 presents a unique opportunity for sleep medicine professionals no matter their specialty or career stage.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B>About NLS Pharmaceutics
Ltd. </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif">NLS
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&rsquo;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</FONT><FONT STYLE="font-family: Symbol"><SUP>&Ograve;</SUP></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif">(mazindol
controlled-release) in adult subjects suffering from ADHD. The study met all primary and secondary endpoints and Nolazol</FONT><FONT STYLE="font-family: Symbol"><SUP>&Ograve;</SUP></FONT>
<FONT STYLE="font-family: Times New Roman, Times, Serif">was well-tolerated. Quilience has received Orphan Drug Designations both in the
U.S. and in&nbsp;Europe&nbsp;for the treatment of narcolepsy. Up to 1/3 of narcoleptic patients are also diagnosed with ADHD.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B>Safe Harbor Statement</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">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 <FONT STYLE="background-color: white">that the interim results confirm the power of the ongoing Phase 2a trial and demonstrate
the potential for Mazindol ER, that the trial will continue as planned, that Mazindol ER has the potential to be used in more patients
and be a disruptive treatment for narcolepsy, the belief that the interim clinical trial results confirm the beneficial effects of Mazindol
ER&rsquo;s unique mechanism of action and validate the body of retrospective evidence that support the compound&rsquo;s efficacy and safety
in the treatment of narcolepsy, the confidence that its </FONT>Mazindol ER formulation will prove to be a safe and effective therapy that
can address a broad spectrum of narcolepsy symptoms <FONT STYLE="background-color: white">and the timing of the final results of the trial</FONT>.
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&rsquo; products may not be approved by regulatory agencies, NLS&rsquo; 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&rsquo; process; NLS&rsquo; 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&rsquo; patents may not be sufficient; NLS&rsquo; 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 &ldquo;Risk Factors&rdquo; in NLS&rsquo; annual report on Form 20-F for the year ended December 31, 2020 filed
with the Securities and Exchange Commission (SEC), which is available on the SEC&rsquo;s website,&nbsp;www.sec.gov, and in subsequent filings
made by NLS with the SEC.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="background-color: white"><B><U>References:</U></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0in; margin-bottom: 0in; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="text-underline-style: double"><U STYLE="text-decoration: none">[1]</U></FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="text-decoration: none; background-color: white"><I>Kollb-Sielecka
et al. The European Medicines Agency Review of Pitolisant for Treatment of Narcolepsy: Summary of the Scientific Assessment by the Committee
for Medicinal Products for Human Use. Sleep Medicine February 2017;(33):125-129</I></FONT></TD>
</TR></TABLE>



<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0in; margin-bottom: 0in; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="text-underline-style: double"><U STYLE="text-decoration: none">[2]</U></FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="text-decoration: none; background-color: white"><I>Black
J; Houghton WC; and the Xyrem&reg; International Study Group. Sodium Oxybate Improves Excessive Daytime Sleepiness in Narcolepsy. SLEEP
2006;29(7):939-946</I></FONT></TD>
</TR></TABLE>



<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0in; margin-bottom: 0in; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="text-underline-style: double"><U STYLE="text-decoration: none">[3]</U></FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="text-decoration: none; background-color: white"><I>Thorpy,
M et al. A Randomized Study of Solriamfetol for Excessive Sleepiness in Narcolepsy. ANN NEUROL 2019;(85):359&ndash;370</I></FONT></TD>
</TR></TABLE>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Corporate Contact:</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Alex Zwyer, CEO: +41 44 512 21 50</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Investor Relations Contact: </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Cindy Rizzo: +1 908-229-7050</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Media Contact: Alpha Bronze, LLC: </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Pascal Nigen: +1 917-385-2160</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">www.nlspharmaceutics.com</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">##</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">4</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
