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 July 2024 (Report No. 2)
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 ☐
CONTENTS
On July 29, 2024, NLS Pharmaceutics Ltd., or the
Registrant, issued a press release titled: “NLS Pharmaceutics and Kadimastem Announce Binding Term Sheet to Merge.” A copy
of this press release is furnished herewith as Exhibit 99.1.
The first eight paragraphs and the section
titled “Safe Harbor Statement” in the press release furnished as Exhibit 99.1 are incorporated by
reference into this Report of Foreign Private Issuer on Form 6-K is incorporated by
reference into the Registrant’s Registration Statements on Form F-3 (File No. 333-262489,
and 333-268690 and 333-269220),
filed with the 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extent not superseded by documents or reports subsequently filed or furnished.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
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.
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NLS Pharmaceutics Ltd. |
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| Date: July 30, 2024 |
By: |
/s/ Alexander Zwyer |
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Name: |
Alexander Zwyer |
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Title: |
Chief Executive Officer |
2
Exhibit 99.1
NLS Pharmaceutics and Kadimastem Announce Binding
Term Sheet to Merge
The proposed transaction will create a Nasdaq-traded,
biotechnology company with product candidates in advanced stages of clinical development and focused on advancing Kadimastem’s allogeneic
cell therapy platform
Each of Kadimastem and NLS Pharmaceutics has received
commitments of support for the transaction from shareholders representing more than 40% of their respective outstanding shares
Zurich, Switzerland and Ness Ziona, Israel- [July
29, 2024] - NLS Pharmaceutics Ltd. (NASDAQ: NLSP) (“NLS”), a biopharmaceutical company. and Kadimastem Ltd (“KDST.TA”,
“Kadimastem”), a clinical-stage cell therapy company developing and manufacturing “off-the-shelf” allogeneic cell
products for the treatment of neurodegenerative diseases and potential cure of diabetes, announced today that they have entered into a
binding term sheet for a transaction under which Kadimastem is anticipated to become a wholly owned subsidiary of NLS, and Kadimastem’s
shareholders will acquire an 85% interest in NLS (the “Transaction”). Upon completion of the Transaction, which is subject
to, among other things, approval by NLS and Kadimastem stockholders, the combined company is expected to operate under the name Kadimastem
and be traded on the Nasdaq Capital Market. Under the proposed terms, existing Kadimastem shareholders will hold 85% of the issued and
outstanding shares of the merged company and the existing shareholders of NLS will hold the remaining 15% of the issued and outstanding
shares of NLS.
About the Proposed Transaction
The proposed Transaction will be affected through
a reverse triangular structure in which Kadimastem will become a wholly owned subsidiary of NLS. In consideration, NLS will issue its
shares to the Kadimastem shareholders who, after completing the Transaction, will hold 85% of the issued and outstanding shares of NLS,
and the existing shareholders of NLS will hold the remaining 15% of NLS.
The Transaction is subject to approval by Nasdaq
and is structured so that NLS will remain an SEC reporting company whose shares are listed on the Nasdaq Capital Market. All but one of
the NLS officers and directors is expected to resign from their positions at NLS.
Following the Transaction, the parties expect
to continue developing NLS’s promising, first-in class Dual Orexin Agonist platform (“DOXA”) within the merged company.
The remaining NLS assets are expected to be divested subject to a contingent value rights (“CVR”) agreement, the proceeds
of which will be distributed entirely to the current shareholders of NLS.
At the closing of the Transaction, Kadimastem
will be required to have $3.5 million of cash on hand and NLS will be required to have $0.6 million of cash on hand.
The binding term sheet has been approved by the
boards of directors of both companies. The definitive agreement will include customary closing conditions, including certain regulatory
approvals, and approval from the shareholders of both NLS and Kadimastem Each of Kadimastem and NLS has received commitments of support
for the Transaction from shareholders representing more than 40% of its outstanding shares.
In addition, as a condition to the consummation
of the Transaction, the liabilities of NLS to its vendors and insiders will be settled and removed from its balance sheet.
The definitive agreement is expected to be executed
in September 2024. The Transaction is expected to close before December 31, 2024.
‟We
are pleased to be working together with Kadimastem as our pipelines hold significant synergies, especially in the area of diabetes which
is often associated with sleep-wake dysregulation manifesting as insomnia, excessive daytime sleepiness and altered sleep architecture,″
said Alex Zwyer, Chief Executive Officer of NLS. ‟The merger with
Kadimastem reflects the continued commitment of our management team and board of directors to deliver long-term value to our stockholders.
In particular, NLS shareholders will have the opportunity to benefit from the equity of the merged company and, through the contingent
value rights agreement, from the value of our legacy assets, including Mazindol.″
Professor Michel Revel, Kadimastem’s CSO
said, "I'm thrilled about this merger, and believe the combined company presents a great opportunity to enhance our portfolio and
product candidates. In the past, I had the privilege of working on a medicine for multiple sclerosis, Rebif®, taking it from the lab
to the market and transforming it into a blockbuster product. Similarly, I see tremendous potential here to develop our AstroRx® product
candidate for ALS patients, as well as advancing our diabetes product IsletRx. Together with the assets from NLS. The completion of the
Transaction is expected to promote and expand the development of Kadimastem's groundbreaking technological platform."
Ronen Twito, Kadimastem's Executive Chairman and
President, commented, "The merger with NLS will enhance our visibility to the market as a Nasdaq listed company and strengthen our
portfolio with the addition of DOXA. Moreover, as previously reported, our AstroRx® product candidate for Amyotrophic Lateral
Sclerosis, also known as ALS, treatment received FDA approval for a Phase IIa multi-site clinical trial in the U.S. In addition, our joint
development of a diabetes product with iTolerance, a U.S.-based company,
proceeding towards pre-Investigational New Drug submission to the FDA. We believe that the exposure of the merged company to the U.S.
capital markets will enable us to develop the company’s clinical assets and increase shareholder value.”
About Kadimastem
Kadimastem is a clinical stage cell therapy company
whose shares are listed on the Tel Aviv Stock Exchange “KDST.TA”. Kadimastem is developing "off-the-shelf", allogeneic,
proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs)
into functional cells. AstroRx®, Kadimastem‘s lead product, is an astrocyte cell therapy in clinical development for the treatment
for ALS and in pre-clinical studies for other neurodegenerative indications
IsletRx is Kadimastem‘s treatment for diabetes.
IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon. IsletRx is intended to treat and
potentially cure patients with insulin-dependent diabetes.
Kadimastem was founded by Professor Michel Revel,
CSO of Kadimastem, who is Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the
Israel Prize for the invention and development of Rebif®, a multiple sclerosis drug sold worldwide.
About NLS Pharmaceutics Ltd.
NLS Pharmaceutics Ltd. is a global development-stage
biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists. NLS is focused on
the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders. Headquartered
in Switzerland and founded in 2015, NLS is led by an experienced management team with a track record of developing and commercializing
product candidates. For more information, please visit www.nlspharma.com.
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
the expected execution of a definitive agreement, and the expected timing of the execution of the definitive agreement and closing of
the Transaction, the expected structure of the Transaction, the potential benefits of NLS’ and Kadimastem’s products and product
candidates, the positive effects observed by Kadimastem’s compounds, the potential development of additional compounds and that
the new product candidates are expected to further enhance the understanding and treatment of neurodegenerative processes. These forward-looking
statements and their implications are based on the current expectations of the management of NLS and Kadimastem, 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; either or both companies may encounter delays or obstacles in launching and/or successfully
completing their clinical trials; the companies’ products may not be approved by regulatory agencies; their technologies may not
be validated as they progress and their methods may not be accepted by the scientific community; either of both of the companies may be
unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties
may develop with the products being advanced by the companies; their products may wind up being more expensive than anticipated; 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; the companies’ patents may not be sufficient; their products may harm recipients; changes
in legislation may adversely impact either or both of the companies; inability to timely develop and introduce new technologies, products
and applications; and loss of market share and pressure on pricing resulting from competition, which could cause the actual results or
performance of candidate products to differ materially from those contemplated in such forward-looking statements. Except as otherwise
required by law, neither Kadimastem nor NLS undertakes any 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, 2023, 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.
Kadimastem Contact:
Sarah Bazak
Business Operations Manager
s.bazak@kadimastem.com
NLS Contact:
Investor Relations Contact
InvestorRelations@nls-pharma.com
www.nlspharma.com
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