<SEC-DOCUMENT>0001213900-21-047893.txt : 20210914
<SEC-HEADER>0001213900-21-047893.hdr.sgml : 20210914
<ACCEPTANCE-DATETIME>20210914092644
ACCESSION NUMBER:		0001213900-21-047893
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210914
FILED AS OF DATE:		20210914
DATE AS OF CHANGE:		20210914

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:		211251516

	BUSINESS ADDRESS:	
		STREET 1:		ALTER POSTPLATZ 2
		CITY:			STANS
		STATE:			V8
		ZIP:			CH-6370
		BUSINESS PHONE:		41-41-618-80-00

	MAIL ADDRESS:	
		STREET 1:		ALTER POSTPLATZ 2
		CITY:			STANS
		STATE:			V8
		ZIP:			CH-6370
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>ea147367-6k_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">&nbsp;</P>

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

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

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

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

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

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">For the month of September 2021</P>

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

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

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B><U>CH-6370 Stans, Switzerland </U></B></P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">Form 20-F&nbsp;&nbsp;&#9746;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Form
40-F&nbsp;&nbsp;&#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="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; text-align: center">&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="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="background-color: white">The Registrant
issued a press release titled: &ldquo;NLS Initiates Phase 2 Trial for Quilience and Announces First Patient Enrolled.&rdquo; A copy of
this press release is furnished herewith as exhibit 99.1.</FONT></P>

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 9%; border-bottom: black 1.5pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Exhibit&nbsp;No.</B></FONT></TD>
    <TD STYLE="width: 1%; text-align: justify">&nbsp;</TD>
    <TD STYLE="width: 90%; text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99.1</FONT></TD>
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="ea147367ex99-1_nlspharma.htm">Press release titled: &ldquo;NLS Initiates Phase 2 Trial for Quilience and Announces First Patient Enrolled.&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; text-align: center"><B></B></P>

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    <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
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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>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 0; text-indent: 0.45in">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>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <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: September 14, 2021</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>
  </TABLE>
<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</P>

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

<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">3</P>

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

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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ea147367ex99-1_nlspharma.htm
<DESCRIPTION>PRESS RELEASE TITLED: "NLS INITIATES PHASE 2 TRIAL FOR QUILIENCE AND ANNOUNCES FIRST PATIENT ENROLLED."
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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">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><IMG SRC="ex99-1_001.jpg" ALT=""></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 Initiates Phase 2 Trial for Quilience in
Narcolepsy and Announces First Patient Enrolled </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: justify; background-color: white"><B>Switzerland/Stans,
September 14, 2021</B> - NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) (&ldquo;NLS&rdquo; or the &ldquo;Company&rdquo;), a Swiss clinical-stage
pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous
system disorders, announces the initiation of its Phase 2 clinical trial evaluating Quilience&reg; (mazindol extended release or &ldquo;ER&rdquo;)
as a once-daily monotherapy for the treatment of excessive daytime sleepiness (EDS) and cataplexy, the primary symptoms of narcolepsy.
The Company has begun enrolling patients and plans to conduct the trial in approximately 30 specialized centers across the U.S. and Europe.</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"><FONT STYLE="background-color: white">The
trial is expected to enroll 60 patients with both narcolepsy Type 1 and Type 2, who will receive treatment with either a 3mg dose of Quilience
(mazindol ER) once daily for 28 days, or placebo. Patients in the trial will be randomized 1:1 into each treatment arm. The primary endpoint
of the trial is the change from baseline in EDS as measured by the Epworth Sleepiness Scale (ESS), and a key secondary endpoint is the
change from baseline in mean weekly number of cataplexy attacks in the anticipated subset of patients with cataplexy. </FONT>Patients
who complete the 4-week clinical study period will have the option to enroll in an open label extension (OLE) study, where each patient
will be eligible to receive Quilience for an additional 6 months.</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">&ldquo;Initiating this clinical trial is an
important milestone for NLS, and we remain focused on delivering top line results by year-end to demonstrate the potential benefits and
safety profile of Quilience in the treatment of narcolepsy,&rdquo; said Alex Zwyer, Chief Executive Officer of NLS. &ldquo;Quilience&rsquo;s
unique mechanism of action, including its partial agonism of the orexin-2 receptor, has the potential to provide significant benefits
to patients suffering from narcolepsy, which remains a major unmet medical need. I am thankful for all of the centers that are participating
in this trial on behalf of their patients, and to our internal clinical and medical teams who have worked hard to move this trial along
expediently as we seek to bring Quilience to the market as rapidly as possible.&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 NLS Pharmaceutics Ltd.</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"><FONT STYLE="font-family: Times New Roman, Times, Serif">NLS
Pharmaceutics Ltd. is a Swiss-based 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&reg; is a proprietary extended-release formulation of mazindol (mazindol ER) and is being developed for the treatment
of narcolepsy. 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. NLS completed a phase 2 study in the U.S. evaluating Nolazol</FONT><SUP>&Ograve;</SUP>
<FONT STYLE="font-family: Times New Roman, Times, Serif">(mazindol controlled-release) in adult subjects with ADHD. The study met all
primary and secondary endpoints and was well-tolerated. Quilience has received Orphan Drug Designations both in the U.S. and in&nbsp;Europe&nbsp;for
the treatment of narcolepsy.</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"><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 the expected patient enrollment, clinical sites, dosing and primary endpoints of the clinical trial, the potential for
trial patients to participate in an OLE study, the expected timing of the announcement of topline results and the potential benefits of
Quilience. 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's products may not be approved by regulatory agencies, NLS's 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's process; NLS's
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's patents may
not be sufficient; NLS's 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 &quot;Risk Factors&quot; in NLS' annual report on Form
20-F filed with the SEC, which is available on the SEC's website,&nbsp;www.sec.gov.</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>Corporate Contact </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Alex Zwyer, CEO: +41 41 618 80 00</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">www.nlspharma.com</P>

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