RCS - NLS Pharmaceutics AG - NLS Pharmaceutics Issues Letter to Shareholders

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22/12/2022 15:00

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RNS Number : 6638K  NLS Pharmaceutics AG  22 December 2022

NLS Pharmaceutics CEO Issues Letter to Shareholders

ZURICH, SWITZERELAND / ACCESSWIRE / December 22, 2022 / NLS Pharmaceutics Ltd.
(NASDAQ:NLSP)(NASDAQ: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, today announces that its Chief Executive Officer, Alex Zwyer, has
issued the following letter to shareholders:

To our Shareholders and Friends,

Just under two years ago, NLS Pharmaceutics sought your investment and support
to advance our pipeline in rare sleep disorders and other rare and
debilitating Central Nervous System disorders. I am pleased to report on the
progress that we made towards building a strong foundation for a bright
future.

At the outset of 2022, we outlined a number of objectives including:

·      Complete Phase 2a clinical program for Quilience® (Mazindol ER)

·      Report top-line results for Quilience in the treatment of
narcolepsy

·      Receive final U.S. patent protecting Quilience's novel once-daily
technology

·      Secure funding for current programs and operations

·      Initiate paid early access programs for Quilience in target
countries

Not only have we delivered on all of these, but we have also accomplished so
much more, including numerous investor conference presentations, long-term
cash runway potentially secured beyond NDA submission, addition of crucial
leadership positions, multiple patent and orphan drug status grants, and a key
opinion leader event, to name a few! As we near the end of 2022 and close out
this exciting, and at times challenging year, I wanted to take the opportunity
to share the promises that we have kept and the progress that we have made,
which we could not have achieved without your help.

Phase 2 Successes

Earlier this year, we reported on positive top-line results from the Phase 2
clinical trial (NLS-1021) evaluating our lead product candidate, Quilience
(Mazindol ER), in the treatment of narcolepsy. The trial met its primary
endpoint with high statistical significance. We believe that these results
confirm the efficacy of Mazindol ER, as well as the safety and tolerability
profile established in over 40 years of on-label and off-label use. Additional
data from our Open Label Extension study (NLS-1022) further validated the
positive results from our Phase 2 trial for Quilience in narcolepsy, and we
believe they also demonstrate the longer-term efficacy, tolerability, and
safety of the treatment. We plan to present the final study results from these
trials at a scientific meeting in 2023 and look forward to meeting with the
U.S. Food and Drug Administration (FDA) to discuss the design of a pivotal
clinical program as we focus on bringing this important solution to patients.

Financing

This year saw several financing successes, including private placement
offerings and culminating with an exclusive purchase agreement with aggregate
gross proceeds of up to $30.0 million in a two-tranche private placement with
BVF Partners L.P., a prestigious life sciences investor. This third-party
validation and shared vision reinforces our confidence in our development
program, which has the potential to benefit the more than three million people
across the globe challenged with narcolepsy. With this financing, NLS expects
to have adequate capital to execute on our goal of expeditiously advancing
Mazindol ER through pivotal studies and through the submission of an NDA in
the US, as well as support business development and licensing activities to
continue to grow our pipeline. With up to $30 million in gross proceeds, NLS
expects to be able to fund its operations through 2025, beyond the anticipated
submission of its New Drug Application for Mazindol ER in narcolepsy. It is
worth noting that management and insiders have not sold any shares since NLS'
initial public offering.

Generating pre-approval, non-dilutive revenues

In November 2022, NLS Pharmaceutics launched a paid for Named Patient Program
(NPP) for patients suffering from idiopathic hypersomnia (IH), partnering with
Caligor Coghlan Pharma Services, a globally active pharmaceutical company
specializing in named patient, expanded access, early access and compassionate
use programs. The program will provide access to Mazindol ER for people living
with IH who currently have no approved treatment options. The NPP has launched
in the United Kingdom and will expand into other countries over the coming
weeks and months. As of today, no therapies are authorized in the EU for the
treatment of IH.

Upgrading the team

This year has also welcomed the addition of experienced healthcare executives
to the NLS family. Serving most recently as CFO and co-portfolio manager of
Arcus Ventures, Chad Hellmann joined NLS in June and brings significant
expertise in developing and implementing operational strategies and capital
markets solutions for life sciences companies. Mr. Hellman has already had a
significant impact on our financial situation and has positioned NLS to fund
operations for at least three more years. In September, Dr. George Apostol was
appointed to the position of Chief Medical Officer and Global Head of Research
and Development. Serving most recently as Global Head of Research and
Development at Endo Pharmaceuticals Inc., Dr. Apostol brings significant
expertise in the management and execution of early, mid and late-stage drug
development. As we advance Mazindol ER into phase 3 and further develop our
pipeline of products, Dr. Apostol will be invaluable in achieving our mission
to bring differentiated therapies to patients with debilitating CNS disorders.

In December we welcomed three more key individuals to the leadership team.
First, Astrid Sommer, Head of HR, is a seasoned Swiss-based human resources
consultant with more than 20 years of experience and an accomplished
background in our industry, having previously worked at Roche, Alnylam,
Versantis & Genfit. Tom Curatolo, Head of U.S. Commercial, has over 25
years of commercial leadership experience spanning sales, marketing, strategy,
training, market access, and commercial operations. Mr. Curatolo served as
Chief Commercial Officer of Tris Pharma and EVP of Marketing, Commercial
Strategy and Operations for Ironshore Pharmaceuticals, following ten years
with Shire Pharmaceuticals ultimately as VP of Global Commercial Operations.
Finally, we welcomed Marianne Lambertson as our Head of Corporate
Communications & Investors Relations. Ms. Lambertson has spent nearly
three decades in healthcare in the global biopharmaceutical industry working
on psychotropic, neurologic and oncologic medications, for organizations
including Schering-Plough (Merck), élan Pharma, Altana Pharma AG, Bayer
Healthcare, and Verastem Oncology. As we look towards 2023 and beyond, we know
that we have a strong and proficient team in place to meet and exceed our
goals.

Progressing and Expanding our Pipeline

Our goal remains focused on building a differentiated global pharmaceutical
company that is patient-centered and dedicated to the development of
transformative therapies addressing critical unmet needs in rare and complex
CNS disorders. As we navigate the competitive landscape of our industry while
focusing on the development of our product candidates, we are poised to
maximize the therapeutic potential of our current pipeline while still
pursuing new candidates that will continue to broaden our product portfolio.
Our team has extensive experience in CNS research and a strong record of
clinical trial success, regulatory approvals and scientific publications in
peer-reviewed journals. Through our rigorous scientific approach in evaluating
new opportunities, we plan to evaluate and develop additional product
candidates to treat indications with a high unmet medical need.

In addition to our lead product candidate, we have early-stage compounds that
we are further developing. Our pipeline products are similarly well positioned
as we gain ground in establishing future market positions through patents for
lauflumide (NLS-4) and other new chemical entities and assets. With extensive
IP coverage in the U.S. and Europe, and promising pre-clinical data, we
anticipate that our wake-promoting agent, lauflumide (NLS-4), could offer a
new option for the treatment of chronic fatigue, including fatigue associated
with cancer treatment and long-COVID symptoms. We anticipate that clinical
trials with lauflumide (NLS-4) will begin in 2024. We will continue to explore
opportunities and execute on possibilities based on key factors such as unmet
medical need, biological rationale, safety profile, feasibility of clinical
development, potential for leveraging accelerated development pathways for
regulatory approval, strong intellectual property position, favorable
competitive landscape, and attractive commercial potential.

Strong Footing

We continue to build our global presence as evidenced through numerous patent
awards this year across the globe. Key patents have been granted in major
markets including the U.S., Canada, Europe, Japan, South Korea & Israel,
covering the once-daily use of our lead product candidate, Quilience (mazindol
ER) in rare sleep disorders such as narcolepsy and idiopathic hypersomnia, as
well as additional uses including opioid withdrawal and attention deficit
hyperactivity disorder (ADHD). Given our patent positioning and the Orphan
Drug Designations that we have in both the U.S. and Europe, we believe that
our proprietary position on Quilience is strong.

A Bright Future

More than ever, we at NLS are hard at work and extremely excited to be a part
of a company with genuine near and long-term prospects to change the lives of
patients with rare CNS diseases. We work together to create a culture that
inspires and motivates our team members to do what they do best. Our
passionate team makes every effort to remain nimble with an honest approach to
transparent communication, empowering leadership, and individual ownership of
responsibilities. Our employees thrive in finding innovative and efficient
approaches to advance our corporate aspirations.

Together with our co-founder, Dr. Eric Konofal, I want to offer my sincerest
gratitude to the clinical investigators and participating patients making it
possible for Quilience to be a potential class-leading treatment for
narcolepsy in the future. I must also thank the many women and men across
Europe and the U.S. that are part of the NLS Pharmaceutics team, from
pre-clinical to regulatory affairs to supply chain and all in between, that
endeavor every day to progress our objectives in treating these rare diseases.
And finally, I would like to thank you, our shareholders and investors, for
your continued support for and shared commitment to NLS Pharmaceutics.

I wish all our stakeholders a happy and healthy year-end as we look forward to
a prosperous and productive 2023!

With gratitude,

Alex Zwyer

Chief Executive Officer

Safe Harbor Statement

This 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 timing of the release of final study
results and meetings with the FDA, that it has adequate capital to execute on
its goal of expeditiously advancing Mazindol ER through pivotal studies and
through the submission of an NDA, the expectation that it will be able to fund
its operations through 2025 and the development of its product candidates and
expected timing of the commencement of various studies.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; 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, 2021 filed with the U.S. 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.

+1 239.682.8500
ml@nls-pharma.com (mailto:ml@nls-pharma.com)
www.nlspharmaceutics.com (https://pr.report/EDVwxreR)

SOURCE: NLS Pharmaceutics AG

 

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