UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

 

For the month of April 2022

 

Commission file number: 001-39957

 

NLS PHARMACEUTICS LTD.

(Translation of registrant’s name into English)

 

The Circle 6

8058 Zurich, Switzerland

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒       Form 40-F ☐

 

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):_____

 

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):_____

 

 

 

 

CONTENTS

 

On April 1, 2022, NLS Pharmaceutics Ltd., or the Registrant, issued a press release titled: “NLS Pharmaceutics Announces Receipt of Notice of Deficiency with Nasdaq Continued Listing Requirements.” A copy of this press release is furnished herewith as Exhibit 99.1.

 

The press release furnished as Exhibit 99.1 to this report is incorporated by reference into the Registrant’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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

EXHIBIT INDEX

 

Exhibit Number

   Description of Document
99.1   Press release titled: “NLS Pharmaceutics Announces Receipt of Notice of Deficiency with Nasdaq Continued Listing Requirements.”

 

1

 

 

SIGNATURES

 

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.

 

  NLS Pharmaceutics Ltd.
     
Date: April 1, 2022 By: /s/ Alexander Zwyer
    Name:  Alexander Zwyer
    Title: Chief Executive Officer

 

2

 

 

 

 

 

 

 

Exhibit 99.1

 

 

NLS Pharmaceutics Announces Receipt of Notice of Deficiency with Nasdaq Continued Listing Requirements

 

Switzerland/Zurich, April 1, 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 has received a letter from the Listing Qualifications staff of The Nasdaq Stock Market ("Nasdaq") notifying the Company that it is no longer in compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires listed companies to maintain stockholders' equity of at least $2,500,000. Further, the Company did not meet the alternative compliance standards relating to the market value of listed securities or net income from continuing operations, as set forth in Nasdaq Marketplace Rule 5550(b)(1). In accordance with Nasdaq Marketplace Rule 5810(c)(2)(A), the Company has 45 calendar days, or until May 16, 2022, to submit a plan to regain compliance. If the plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from the date of the letter to evidence compliance. The notification letter has no immediate effect on the Company's listing on the Nasdaq Capital Market.

 

About NLS Pharmaceutics Ltd.

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'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). 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 QuilienceÒ 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 NolazolÒ (Mazindol Controlled-Release) in adult subjects suffering from ADHD. The study met all primary and secondary endpoints and NolazolÒ was well-tolerated. QuilienceÒ 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. NLS has announced that it plans to enable patients diagnosed with IH to access treatment with QuilienceÒ through an Early Access Program (EAP). 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 can see considerable benefit in terms of launch preparedness, relationship building and market penetration.

 

Corporate Contact

Alex Zwyer, CEO: +41 44 512 21 50

 

Investor Relations Contact

Cindy Rizzo: +1 908-229-7050

 

Media Contact

Pascal Nigen: +1 917-385-2160

Alpha Bronze, LLC

 

www.nlspharmaceutics.com