RCS - NLS Pharmaceutics AG - NLS Pharmaceutics Announces Closing of Initial

NLS Pharmaceutics AGAnnouncement

14/12/2022 14:45

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RNS Number : 7137J  NLS Pharmaceutics AG  14 December 2022

NLS Pharmaceutics Announces Closing of Initial Tranche of US$10.0 Million
Purchase Agreement with BVF Partners L.P.

·      Financing provided exclusively by leading healthcare fund BVF
Partners L.P.

·      Cash runway potentially secured beyond pivotal studies and NDA
submission for Quilience® (Mazindol ER) in narcolepsy

ZURICH, SWITZERLAND / ACCESSWIRE / December 14, 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 announced the closing of its previously publicized purchase
agreement with BVF Partners L.P. ("BVF") comprised of an initial closing of
$10 million in exchange for 11,494,253 common shares (or equivalents),
representing a purchase price per share of $0.87.

As part of the financing, in a second potential closing, BVF will have the
right, following a successful end of phase 2 meeting with the U.S. Food and
Drug Administration ("FDA"), among other closing conditions, to purchase units
at a per unit purchase price of $1.50, which units will consist of common
shares (or equivalents), as well as a common share warrant to purchase up to
one and a half common shares at an exercise price of $2.03 per share. If this
option is exercised in full, BVF will receive 20 million common shares plus
common share warrants to purchase 20 million NLS common shares at $2.03 per
share.

Laidlaw & Company (UK) Ltd. acted as exclusive introducing broker for the
offering.

NLS intends to use the net proceeds from the offering to accelerate the
ongoing clinical development of its lead product, Mazindol ER for the
treatment of narcolepsy, to advance NLS-4 and other product candidates, to
support business development and licensing activities, and for general
corporate purposes. With this financing, 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, expected in late 2024 or early
2025.

The offering is being made in the United States pursuant to the exemption from
securities registration afforded by Section 4(a)(2) of the Securities Act of
1933, as amended, and Rule 506 of Regulation D as promulgated by the
Securities and Exchange Commission (the "SEC"). The Securities have not been
registered under the Securities Act of 1933, as amended, or applicable state
securities laws, and accordingly may not be offered or sold in the United
States absent registration with the SEC or an applicable exemption from such
registration requirements. The Company has agreed to file a registration
statement with the SEC covering the resale of the common shares and common
shares issuable upon the exercise of the warrants.

This press release shall not constitute an offer to sell or the solicitation
of an offer to buy nor shall there be any sale of these securities in any
state or jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the securities laws of
any such state or jurisdiction.

About NLS Pharmaceutics Ltd.

NLS Pharmaceutics Ltd. is a Swiss clinical-stage biopharmaceutical company led
by an experienced management team with a track record of developing and
repurposing product candidates to treat rare and complex central nervous
system disorders. The Company's lead product candidate, Quilience®, is a
proprietary extended-release formulation of Mazindol (Mazindol ER) and is
being developed for the treatment of narcolepsy, and potentially other
sleep-wake disorders such as idiopathic hypersomnia (IH), for which NLS
recently obtained Orphan Disease Designation (ODD) from the U. S. Food and
Drug Administration (FDA) and the European Medicines Agency (EMA). Mazindol is
a triple monoamine reuptake inhibitor and partial Orexin-2 Receptor agonist,
which was used for many years to treat patients diagnosed with narcolepsy in
compassionate use programs. A Phase 2 multi-center U.S. clinical trial
evaluating Quilience(®) in adult subjects suffering from narcolepsy met its
primary endpoint with high statistical significance and demonstrated a
favorable safety and tolerability profile. NLS also successfully completed a
Phase 2 study in the U.S. evaluating Nolazol(®) (Mazindol Controlled-Release)
in adult subjects suffering from ADHD. The study met all primary and secondary
endpoints and Nolazol(®) was well-tolerated. Quilience(®) has received
Orphan Drug Designations both in the U.S. and in Europe for the treatment of
narcolepsy. Up to 1/3 of narcoleptic patients are also diagnosed with ADHD.

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 intended use of proceeds, its
expected cash runway, the timing of its New Drug Application for Quilience and
the prospect of a second closing. 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 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/GmuFvygd)

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SOURCE: NLS Pharmaceutics AG

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