RCS - NLS Pharmaceutics AG - NLS Pharmaceutics Announces Purchase Agreement

NLS Pharmaceutics AGAnnouncement

07/12/2022 14:30

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RNS Number : 9401I  NLS Pharmaceutics AG  07 December 2022

NLS Pharmaceutics Announces Purchase Agreement with BVF Partners L.P. to Raise
Aggregate Gross Proceeds of up to $30 Million

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

ZURICH, SWITZERLAND / ACCESSWIRE / December 7, 2022 / 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
disorders, today announced that it has entered into a definitive agreement
with BVF Partners L.P. ("BVF") to raise aggregate gross proceeds of up to
$30.0 million in a two-tranche private placement. The purchase is 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, and an option
to purchase up to $20 million of additional common shares (or equivalents) and
common share purchase warrants following a successful end of phase 2 meeting
with the U.S. Food and Drug Administration (FDA), among other closing
conditions. In addition, NLS will have the potential to receive $40.6 million
upon the full exercise of warrants being issued in connection with the
agreement. The transaction is expected to close on December 13, 2022.

NLS intends to use the net proceeds from the offering to accelerate the
ongoing clinical development of its lead product, Quilience® (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 Quilience (Mazindol ER) in narcolepsy, expected in late
2024.

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 FDA, to purchase
units at a per unit purchase price of $1.50, which units 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.

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,
the prospect of a second closing and the expected date of the initial 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

www.nlspharmaceutics.com (https://pr.report/6RrfCiY1)

###

SOURCE: NLS Pharmaceutics AG

 

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