RADNOR,
Pa., June 6, 2023 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP), ("NRx Pharmaceuticals" or the
"Company"), a clinical-stage biopharmaceutical company, today
announced that it has entered into definitive agreements for
the purchase and sale of 9,670,002 shares of common stock at a
purchase price of $0.65 per share of
common stock in a registered direct offering. In a concurrent
private placement, the Company will issue unregistered warrants to
purchase up to 9,670,002 shares of common stock at an exercise
price of $0.6525 per share that will
be exercisable six months following issuance for five years
following the initial exercise date. The exercise price of
the warrants is not subject to future price adjustment, other than
for stock splits. The closing of the offering is expected to occur
on or about June 8, 2023, subject to
the satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement
agent for the offering.
The gross proceeds from the offering are expected to be
approximately $6.28 million before deducting placement agent
fees and other offering expenses. The Company intends
to use the net proceeds from the offering for working capital and
general corporate purposes and may use the net proceeds to initiate
research into the use of NRX-101 for the treatment of PTSD and
Chronic Pain. In connection with this offering, the company
anticipates servicing its current debt on a current-interest basis
through the end of 2023 in order to devote maximum available
capital to the advancement of its pharmaceutical assets.
The shares of common stock (but not the warrants or the shares
of common stock underlying the warrants) described above are being
offered by the Company pursuant to a "shelf" registration statement
on Form S-3 (File No. 333-265492) that was filed with the
Securities and Exchange Commission (the "SEC") on June 9, 2022 and declared effective by the SEC on
June 14, 2022. The offering of the
shares of common stock is being made only by means of a prospectus,
including a prospectus supplement, forming a part of the effective
registration statement. A final prospectus supplement and
accompanying prospectus relating to the registered direct offering
will be filed with the SEC. Electronic copies of the final
prospectus supplement and accompanying prospectus may be obtained,
when available, on the SEC's website at http://www.sec.gov. and may
also be obtained by contacting H.C. Wainwright & Co., LLC at
430 Park Avenue, 3rd Floor, New York, New
York 10022, by phone at (212) 856-5711 or e-mail at
placements@hcwco.com.
The warrants described above are being offered in a private
placement under Section 4(a)(2) of the Securities Act of 1933, as
amended (the "Securities Act"), and/or Regulation D promulgated
thereunder and, along with the shares of common stock underlying
the warrants, have not been registered under the Securities Act, or
applicable state securities laws. Accordingly, the warrants and
underlying shares of common stock may not be offered or sold in
the United States except pursuant
to an effective registration statement or an applicable exemption
from the registration requirements of the Securities Act and such
applicable state securities laws.
In connection with the offering, the Company also has agreed to
amend certain existing preferred investment options to purchase up
to an aggregate of 9,622,778 shares of the Company's common stock
that were previously issued in August
2021 and February 2022, with
exercise prices ranging from $3.07 to
$12.00 per share and expiration dates
ranging from August 2024 to
August 2027, such that, effective
upon the closing of the offering, the amended warrants will have a
reduced exercise price of $0.6525 per
share, will be exercisable six months following the closing of the
offering, and will terminate five and one-half years following the
closing of the offering.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there
be any sale of these securities in any jurisdiction in which such
offer, solicitation or sale would be unlawful prior to the
registration or qualification under the securities laws of any such
jurisdiction.
About NRX-101
Up to 50% of people with bipolar disorder attempt suicide over
their lifetime, and estimates indicate that up to 20% may succumb
to suicide. The only FDA-approved treatment for patients with
treatment-resistant suicidal bipolar depression remains
electroconvulsive therapy.
Conventional antidepressants can increase the risk of suicide in
certain patients; hence their labels contain a warning to that
effect. NRX-101 is a patented, oral, fixed dose combination of
D-cycloserine and lurasidone, neither of which has shown addiction
potential in preclinical models. Based on the results of a Phase 2
proof-of-concept study, NRX-101 received Breakthrough Therapy
Designation from the FDA for the treatment of severe bipolar
depression in patients with Acute Suicidal Ideation & Behavior
(ASIB) after initial stabilization with ketamine or other effective
therapy.
NRX-101 is one of the first oral antidepressants currently in
late-stage clinical studies targeting the NMDA-receptor in the
brain, which represents potentially a key new mechanism to treat
depression with and without suicidality, as well as PTSD and other
indications. To date, NRX-101 is the only oral NMDA investigational
medicine focused on bipolar depression in patients with acute and
sub-acute suicidality.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical
company developing therapeutics for the treatment of central
nervous system disorders, specifically bipolar depression with
suicidality and post-traumatic stress disorder (PTSD). The
company's lead program NRX-101, an oral, fixed-dose combination of
D-cycloserine and lurasidone, targets the brain's
N-methyl-D-aspartate (NMDA) receptor and is being investigated in a
Phase 2b/3 clinical trial for Suicidal Treatment-Resistant
Bipolar Depression, which includes patients with both acute and
sub-acute suicidality, an indication for which the only approved
treatment is electroshock therapy. The company's prior Phase 2
STABIL-B clinical trial evaluating NRX-101 in patients with Severe
Bipolar Depression with Acute Suicidal Ideation & Behavior
(ASIB) demonstrated a substantial improvement over available
therapy in reducing depression and suicidality compared to placebo
when patients were treated with NRX-101 after a single dose of
ketamine. Based on the findings from the STABIL-B trial, the U.S.
Food and Drug Administration (FDA) granted a Special Protocol
Agreement and Breakthrough Therapy Designation for NRX-101 in
patients with Severe Bipolar Depression with ASIB.
Cautionary Note Regarding Forward-Looking Statements
This announcement of NRx Pharmaceuticals, Inc. includes
"forward-looking statements" within the meaning of the "safe
harbor" provisions of the U.S. Private Securities Litigation Reform
Act of 1995, which may include, but are not limited to, statements
regarding our financial outlook, product development, business
prospects, and market and industry trends and conditions, as well
as the Company's strategies, plans, objectives, and goals and the
completion of the offering, the satisfaction of closing conditions
in the offering and the intended use of proceeds in the offering.
These forward-looking statements are based on current beliefs,
expectations, estimates, forecasts, and projections of, as well as
assumptions made by, and information currently available to, the
Company's management.
The Company assumes no obligation to revise any forward-looking
statement, whether as a result of new information, future events or
otherwise, except as required by law. Accordingly, you should
not place reliance on any forward-looking statement, and all
forward-looking statements are herein qualified by reference to the
cautionary statements set forth above.
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SOURCE NRx Pharmaceuticals, Inc.