Full Press Release Details
NLS Pharmaceutics Announces Exclusive Option
Agreement to Develop and
Commercialize Next Generation Dual Orexin Agonist Platform of Aexon Labs, Inc.
Z rich, Switzerland,
December 1, 2023 - 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 ("CNS") disorders, today announced that NLS has entered into an exclusive worldwide option agreement with Aexon
Labs, Inc., a privately held U.S. company ("Aexon Labs"), under which NLS may acquire global development and commercialization
rights to Aexon Labs' Dual Orexin Receptor Agonists platform, new molecular entities, highly selective dual oral orexin-1 and orexin-2
receptor agonists (OX1R and OX2R) with potential applications in the treatment of narcolepsy and idiopathic hypersomnia, as well as neuro-degenerative
disorders such as Parkinson's and Alzheimer's disease. This option agreement represents a potentially leading next-generation,
first-in-class, oral, dual orexin receptor agonist (AEX-2) that is expected to address high unmet medical needs and has shown promising
results in pre-clinical in vitro assays. Aexon Labs has plans to initiate clinical development, including Phase 1 First-in-Human and Phase
1b Proof-of-Concept (POC) studies, as early as 2024.
The transaction will
be structured as an exclusive worldwide license for the development and commercialization by NLS of the Aexon Labs' compounds and
their derivatives. Under the terms of the option agreement, NLS must exercise its option by no later than March 31, 2024. NLS will pay
Aexon Labs an upfront payment of $30,000 for the option exclusivity, and $170,000 upon execution of the definitive agreement to exercise
the option. In addition, Aexon Labs will receive 15% of all proceeds earned by NLS in any future sub-licensing agreements which include
upfront payments, regulatory milestones, commercial milestones and royalties earned during the first three years of commercialization
in the U.S. and in the EU. Royalties will be payable, on a country-by-country basis, from the date of first commercial sale of a product
in a given country until the date of patent expiry or the entry of a generic version of the product in such country.
NLS will be the sole
party responsible for the design and execution of the research and development plan, for the conduct and management of the preclinical
as well as clinical studies, and for the interactions with the U.S. Food and Drug Administration and/or any other regulatory agency. NLS
will pay all costs associated with executing and completing those studies, as well as those associated with the preparation and submission
of a new drug application. NLS will pay for all studies in all indications and regulatory filings in the U.S. as well as outside of the
Eric Konofal, MD, PhD,
who works under a part-time consulting agreement for NLS as its Chief Scientific Officer, is the president and founder of Aexon Labs,
and owns 59% of Aexon Labs. Alexander Zwyer, Chief Executive Officer of NLS, owns 35% of Aexon Labs. Mr. Zwyer holds no board or executive
position at Aexon Labs.
"I believe the potential acquisition of this novel and unique platform, which consists of over 300 compounds, bridges the
present to the future treatment of sleep disorders as well as other neuro-degenerative disorders. These new compounds, in addition
to our current pipeline, including Mazindol ER for the treatment of narcolepsy, along with NLS-4 focused on idiopathic hypersomnia,
long-COVID and chronic fatigue syndrome, and NLS-11, addressing Kleine-Levin Syndrome and neurodegenerative diseases, will further
complement and strengthen our hypersomnia franchise."
Orexin receptor pathways
play vital regulatory roles in many physiological processes and studies have shown that orexin receptor pathways are involved in pathological
processes of neurological diseases such as narcolepsy, depression, ischemic stroke, drug addiction and Alzheimer's disease.
life-long sleep disorder caused by the autoimmune-mediated loss of 70,000-90,000 orexin-producing neurons in the hypothalamus,
characterized by excessive daytime sleepiness, cataplexy and rapid eye movement sleep abnormalities, and is tightly associated with
human leukocyte antigen HLA-DQB1*06:02. Other predisposing factors for narcolepsy are associations with a polymorphism in
the T-cell receptor alpha and beta genes, whose products recognize antigens presented by human leukocyte
antigens (HLA) molecules, and Cathepsin H (CTSH).
About NLS Pharmaceutics
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. For more information, please visit www.aexonlabs.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 potential benefits of NLS' and Aexon Labs' products, development plans and timing of studies, and the
timing and the expected outcome of the option agreement. 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, 2022 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.
For additional information:
Marianne Lambertson (investors & media)
NLS Pharmaceutics Ltd.