- HOPE Therapeutics is dedicated to bringing NRX-100 (IV
Ketamine) for Suicidal Depression to patients
- Company to be initially owned by NRx and current NRx
shareholders via a planned tax-free dividend
- A New Drug Application (NDA) for NRX-100 is expected to be
filed in 1H24
- Initiating actions to gain a public listing
- Shareholder meeting planned for February 7, 2024, is cancelled, and will be
rescheduled, if necessary; Company expects to convene a new meeting
to vote on the HOPE transaction and share dividend, subject to
Board approval
RADNOR,
Pa., Feb. 5, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced the incorporation of HOPE Therapeutics™, a biotechnology
company dedicated to bringing NRX-100 (IV Ketamine), which will be
re-designated HTX-100, a potentially lifesaving treatment option
for patients with Suicidal Depression. The company will initially
be owned by NRx and its current shareholders, who will receive
their shares in the form of a dividend with an accompanying royalty
coupon tied to future sales of HTX-100, subject to Board approval.
This is designed with counsel to not be a taxable event for
shareholders.
"Incorporating HOPE Therapeutics is another important step in
building value for NRx shareholders. As previously disclosed, this
initiative allows HTX-100 to be valued on its own merits and to
focus on commercialization together with the future addition of
digital therapeutics, a series of activities quite different from
the drug development activities of NRx. As such, HOPE offers
shareholders a very different investment profile, one that has
already attracted a $30 million
investment commitment upon HOPE's planned public listing," said Dr.
Jonathan Javitt, Founder, Chairman
and Chief Scientist of NRx Pharmaceuticals. "This year, we hope to
bring this potentially lifesaving acute care medicine to the 3.5
million people in the United
States who make a plan to commit suicide annually (CDC
Suicide Data). Particularly in the case of bipolar depression, the
only FDA approved treatment option is electroconvulsive
therapy (ECT)."
HOPE is dedicated to providing an FDA-approved presentation of
IV Ketamine, manufactured to current federal standards, in a
diversion- and abuse-deterrent presentation. A New Drug Application
(NDA) is planned for the first half of 2024, based on more than
1,000 patients treated in well-controlled trials of ketamine in
Suicidal Depression together with HOPE's expertise in sterile
products formulation.
Importantly, the Company intends to provide state-of-the-art
patient and reimbursement support for all of its patients and their
clinics. Access to insurance coverage is critical for providing
treatment to this vulnerable population and can only be achieved
through development of an FDA-approved product. Additionally,
providing an approved, compliant product for patients allows
clinics to deliver state-of-the-art care to people suffering from
suicidality without fear of legal and regulatory actions.
NRx also expects to convene a shareholder meeting in the coming
weeks to vote on the planned structure of the spin-out of Hope
Therapeutics and the stock dividend. The company further announces
cancellation of the previously announced February 7 shareholder meeting to approve the
option of a reverse stock split to maintain NASDAQ compliance;
this will be rescheduled, if necessary.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a
clinical-stage biopharmaceutical company developing therapeutics
based on its NMDA platform for the treatment of central nervous
system disorders, specifically suicidal bipolar depression, chronic
pain and PTSD. The Company is developing NRX-101, an FDA-designated
investigational Breakthrough Therapy for suicidal
treatment-resistant bipolar depression and chronic pain. NRx has
partnered with Alvogen Pharmaceuticals around the development and
marketing of NRX-101 for the treatment of suicidal bipolar
depression. NRX-101 additionally has potential to act as a
non-opioid treatment for chronic pain, as well as a treatment for
complicated UTI.
NRx has recently announced plans to submit a New Drug
Application for NRX-100 (IV ketamine) in the treatment of suicidal
depression, based on results of well-controlled clinical trials
conducted under the auspices of the US National Institutes of
Health and newly obtained data from French health authorities,
licensed under a data sharing agreement. NRx was awarded Fast Track
Designation for development of ketamine (NRX-100) by the US FDA as
part of a protocol to treat patients with acute suicidality.
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. 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. 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.