Full Press Release Details
NLS Pharmaceutics Announces the Launch of a
Preclinical Program for Mazindol ER in the Treatment of Fentanyl Dependence
Zurich, Switzerland - January 28, 2025 - NLS Pharmaceutics
Ltd. (NASDAQ: NLSP) (NASDAQ: NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company
dedicated to developing therapies for rare and complex central nervous system disorders, is proud to announce the launch of a preclinical
program evaluating Mazindol ER (Extended-Release) as a novel treatment for fentanyl dependence. Fentanyl dependence is a major global
health crisis and was recently declared a national public health emergency by the new Trump administration. In 2023, the CDC reported
105,007 drug overdose deaths with 90% involving synthetic opioids like fentanyl.
"The opioid epidemic, and specifically the rise of fentanyl dependence,
presents an urgent medical need for innovative, non-opioid treatment approaches," said Alex Zwyer, Chief Executive Officer of NLS.
"We are committed to exploring the unique pharmacological profile of Mazindol, which targets multiple neurotransmitter systems implicated
in opioid addiction. This preclinical program represents an important step in developing a potentially transformative therapy."
Highlights of the Preclinical Program
Mazindol, a tetracyclic compound with a distinct pharmacological profile, has shown potential in mitigating opioid dependence by acting
on multiple neurotransmitter pathways, including:
Scientific Rationale
Fentanyl, a synthetic opioid that is up to 50 times more potent than heroin, has driven a global health crisis due to its high abuse potential
and severe withdrawal symptoms. Traditional treatments, such as methadone and buprenorphine, often come with limitations, including risk
of dependence and regulatory hurdles.
Mazindol ER offers a potential non-opioid alternative, addressing the
underlying neurochemical imbalances associated with fentanyl addiction while supporting recovery through its multimodal action on neurotransmitter
systems. The sustained-release formulation provides a long-acting therapeutic effect, improving patient compliance and minimizing withdrawal-related
Mechanism of Action of Mazindol ER
Mazindol's unique pharmacodynamic properties position it as a promising candidate for opioid dependence treatment. Its mechanisms
Preclinical Study Objectives and Next Steps
The preclinical study, designated Study KO-943, will focus on:
The study is expected to be completed within 12-18 months. Upon successful
results, NLS will potentially seek regulatory pathways to advance to clinical development.
"We believe that Mazindol ER could offer a paradigm shift in opioid
addiction treatment," added Dr. Konofal, M.D./PhD, Chief Scientific Officer of NLSP. "Our stepwise development plan prioritizes
early-stage investment to generate critical data that will pave the way for larger-scale studies and potential commercialization opportunities."
Existing Patent Portfolio
NLS Pharmaceutics has secured several patents supporting the development
These patents strengthen the Company's intellectual property position
and support the ongoing development of Mazindol ER for various indications.
NLS aims to utilize initial findings to expanded research and potential
commercialization of Mazindol ER in the treatment of fentanyl dependence. Other pipeline candidates include:
About NLS Pharmaceutics Ltd.
NLS is a global development-stage biopharmaceutical company, working
with a network of world-class partners and internationally recognized scientists, focused on the discovery and development of innovative
therapies for patients with rare and complex central nervous system disorders who have unmet medical needs. 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.
NLS has recently filed a Registration Statement on Form F-4 with the U.S. Securities and Exchange Commission (the "SEC"),
outlining the details of the proposed merger between NLS and Kadimastem (the "Merger"). Kadimastem is a leading clinical stage
cell therapy company, developing "off-the-shelf", proprietary cell products including human pancreatic islet-like cells capable
of secreting insulin to generate an innovative treatment intended for the potential cure of type 1 diabetes.
Following the Merger, NLS and
Kadimastem expect to continue developing NLS's promising, first-in class Dual Orexin Agonist platform within the combined company. The
remaining NLS assets are expected to be divested subject to a contingent value rights agreement, the proceeds of which will be distributed
entirely to the current shareholders of NLS. For more information, please visit www.nlspharma.com.
Kadimastem is a clinical stage cell therapy company, 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 , the company'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 the company's treatment for diabetes. IsletRx is comprised
of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with
insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, Chief Scientific Officer of Kadimastem and 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 blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).
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 use of Mazindol as
a potential novel treatment for fentanyl dependence, regulatory approval timelines, clinical trial outcomes, market acceptance and its
expected preclinical program. Further, NLS and Kadimastem are using forward-looking statements when they discuss the expected closing
of the transaction and the potential benefits of the transaction to NLS and Kadimastem and their respective shareholders, as well as the
expected strategic position of the combined company following the merger, if completed. 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: risks related to the combined
company's or NLS's ability to have future successful meetings with the FDA; risks related to the companies' ability to complete
the merger on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of the closing conditions
related to the merger agreement and risks and uncertainties related to the failure to timely, or at all, obtain shareholder approvals
for the transaction; unexpected costs, charges or expenses resulting from the transaction and potential adverse reactions or changes to
business relationships resulting from the announcement or completion of the proposed merger or resulting from the trial or preclinical
program and potential adverse reactions or changes to business relationships resulting from the announcement of the trial or preclinical
program; 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's annual report on Form
20-F for the year ended December 31, 2023, filed with the SEC, which is available on the SEC's website, www.sec.gov, and in subsequent
filings made by NLS with the SEC, including under the heading "Risk Factors" in NLS's registration statement on Form F-4, filed
with the SEC on December 27, 2024.
No Offer or Solicitation
This communication is not intended to and shall not constitute an offer
to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there
be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification
under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act of 1933, as amended.
Additional Information about the Transaction and Where to Find It
In connection with the proposed transaction, NLS has filed a Registration
Statement on Form F-4, including a proxy statement/prospectus, with the SEC. NLS may also file other relevant documents with the SEC regarding