Full Press Release Details
NLS Pharmaceutics Announces Publication of
New Patent Application for Next-Gen Dual Non-Sulfonamide Orexin Receptor Agonists (DOXA)
Zurich, Switzerland - June 11, 2024 -
NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical
company dedicated to pioneering therapies for rare and complex central nervous system disorders, today announced the publication of the
latest patent application (PCT/WO2024115797) by Aexon Labs with the World Intellectual Property Organization (WIPO). The patent will be
used by NLS pursuant to its existing and previously announced license agreement with Aexon Labs.
"This new patent application covers groundbreaking
advancements in a novel series of dual orexin receptor agonists targeting narcolepsy as the primary indication and neurodegenerative conditions
such as Parkinson's disease as secondary indications," said Eric Konofal, MD, PhD, Chief Scientific Officer of NLS Pharmaceutics,
President of Aexon Labs, and inventor of the Dual Orexin Receptor Agonist platform (DOXA). "This application highlights the continued
commitment from NLS to pioneer therapeutic approaches to address significant unmet medical needs."
Presentations from NLS Pharmaceutics and Aexon Labs:
At Sleep 2024 (Houston,
June 1-5), data on selective OX2R agonists highlighted their limitations, including receptor desensitization and reduced efficacy at higher
doses. In contrast, a new generation of compounds from Aexon Labs, presented at the 2024 ASCP Annual Meeting (Miami, May 27-31), targets
both OX1R and OX2R while also preventing the destruction of orexin cells through an inhibitory effect on CTSH. These multitarget compounds,
with their broader affinity, show fewer issues related to high-affinity binding and efficacy loss, suggesting a more stable pharmacological
profile and better long-term outcomes.
Narcolepsy is a lifelong sleep disorder caused
by the autoimmune-mediated loss of 70,000-90,000 orexin-producing neurons in the hypothalamus. It is characterized by excessive
daytime sleepiness, cataplexy, and rapid eye movement (REM) sleep abnormalities, and is tightly associated with the human leukocyte antigen
HLA-DQB1*06:02. Other predisposing factors for narcolepsy include associations with polymorphisms in the T-cell receptor alpha and beta
genes, whose products recognize antigens presented by HLA molecules, and the CTSH gene.
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. For more information, please visit www.nlspharma.com.
Aexon Labs is conducting
leading edge research on new compounds to address unmet needs in neurodegenerative disorders, defined by the breakdown of neurons over
time. Alzheimer's, Parkinson's, Huntington's, Narcolepsy and Amyotrophic Lateral Sclerosis are just a few examples of
brain disorders that have no cure. Current treatments do not address the root cause of each disorder and often lack therapeutical effectiveness
and safety for these neurological disorders. Eric Konofal, MD, PhD, Chief Scientific Officer of NLS Pharmaceutics, is also the president
and founder of Aexon Labs. Both Dr. Konofal and Alex Zwyer, CEO of NLS Pharmaceutics are shareholders of Aexon Labs.
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 potential benefits of NLS' and Aexon Labs' products and the new patent. 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' products may not be approved by regulatory agencies, NLS' 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' process; NLS' 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' patents may not be sufficient;
NLS' products may harm recipients; changes in legislation may adversely impact NLS; 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 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 "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.