- Companies continue to work collaboratively to advance
NRX-101 through registrational trials
- NRx remains eligible for an additional $324 million in development and sales milestones,
as well as tiered double-digit royalties upon approval and
commercialization of NRX-101.
- Payment materially extends the Company's cash
runway
RADNOR,
Pa., Feb. 12, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced the advance of the first $5
million milestone payment based on the Company's partnership
agreement with Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd.
(1975.TW).
Under the terms of the updated agreement, the Company will
immediately receive $5 million of the
first milestone, which NRx will use to fund development of NRX-101
through the phase 2 meeting with FDA. As compensation for advancing
the milestone, Alvogen and Lotus will receive 4.1 million warrants
to purchase the Company's common stock, at a strike price of
$0.40 with a three (3) year
term. The second portion of the milestone will be
$4 million and, as before, be
triggered by a positive response to the Company's planned end of
phase 2 meeting with FDA.
NRx then remains eligible to receive up to $320 million in future development and sales
milestones, as well as royalty payments escalating to mid-teen
percentages on Net Sales, subject to achievement of certain sales
volumes. Additionally, Alvogen and Lotus will be responsible
for future development and commercialization costs for NRX-101 in
treatment of bipolar depression with suicidality.
"In a market environment where biotech companies have been
increasingly challenged to fund clinical development, we appreciate
the confidence of partners that share our view that NMDA-antagonist
drugs potentially represent a new and potent class of medicines to
treat bipolar depression with suicidality. Over the past six
months, NRx, Lotus, and Alvogen have formed a close working
relationship and we share a joint commitment to bringing this
potentially life-saving drug to patients." said Stephen Willard, Chief Executive Officer of NRx
Pharmaceuticals.
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 and Lotus 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