WILMINGTON, DE - Media OutReach
- 29 October 2019 - NeuroRx, Inc
(NeuroRx) announced that it has signed an agreement with GEM Global Yield LLC
SCS ("GEM"), the New York based
private alternative investment group to provide the NeuroRx with up to HK$ 750
million over a 30 month term following a
public listing of NeuroRx's common stock.
NeuroRx will use the funds to complete its phase 3 clinical trials and GMP
manufacturing requirements in both the US and China for NRX-101, an
FDA-designated Breakthrough Therapy in development for suicidal bipolar
depression. The company further plans to initiate phase 2 clinical trials in
the treatment of Suicidal Post-traumatic Stress Disorder (PTSD) under its
Cooperative Research and Development Agreement with the US Department of
Veterans Affairs.
The
initial HK$ 750 Million will be in the form of a capital commitment that allows
NeuroRx to draw down funds during the 30-month term by issuing shares of
NeuroRx's common stock to GEM (or such persons as it may direct) and subject to
share lending arrangement(s) being in place.
NeuroRx will control the timing and maximum amount of drawdown under this
facility and has no minimum drawdown obligation. Concurrent with a public
listing of NeuroRx shares, the company will issue warrants to GEM to purchase
up to seven and a half per cent (7.5%) of the outstanding common stock of the company
on a fully diluted basis. The warrants will have an exercise price per share
equal to the lesser of (i) the closing bid price on the first day of public trading
or (ii) the pro rata portion of HK$ 1,725 Million valuation for the company. There can be no guarantee that the company
will achieve a future public listing in the near future, or at all.
"This agreement with GEM helps to secure funding for continued growth and
development of the company as we attempt to bring a Breakthrough therapy to
market for an unmet medical need that kills more than 1000 people worldwide each
day," stated Dr. Jonathan Javitt, CEO and Chairman of NeuroRx. Today, patients with suicidal bipolar
depression and PTSD have no FDA-approved treatment other than electroconvulsive
therapy. We aim to offer a safe,
effective alternative.
About The GEM Group:
Global Emerging Markets ("GEM") is a $3.4
billion alternative investment group based in Paris, New York and Los Angeles.
GEM manages a diverse set of investment vehicles focused on emerging markets
that provide the group and its investors with a diversified portfolio of asset
classes that span the global private investing spectrum. Each investment vehicle has a different
degree of operational control, risk-adjusted return and liquidity profile. The
family of funds and investment vehicles provide GEM and its partners with
exposure to: Small-Mid Cap Management Buyouts, Private Investments in Public
Equities (PIPEs) and select venture investments.
About NeuroRx, Inc.:
NeuroRx draws upon 30 years of basic science and clinical
expertise in the role of N-methyl-D- aspartate (NMDA), a receptor that
regulates human thought processes, particularly depression and suicidality, as
well as PTSD. The company is privately funded and led by former senior
executives of Johnson & Johnson, BMS, Eli Lilly, Pfizer, and Sunovion.
NeuroRx's Board of Directors and Advisors includes Prof. Shoubin Chen, Senior
Medical Advisor to the Li Ka Shing Foundation, Hon. Sherry Glied, former
Assistant Secretary, U.S. Dept. of Health and Human Services; Lt. Gen. HR
McMaster, the 23rd National Security Advisor, Wayne Pines, former
Associate Commissioner of the U.S. Food and Drug Administration, and Daniel
Troy, former Chief Counsel, U.S. Food and Drug Administration,.
About NRX-101
NRX-101 is designed to address suicidal bipolar depression for
which there is no currently approved drug and for which the only FDA-approved
treatment remains electroconvulsive therapy (ECT). NRX-101 is a patented, oral,
fixed-dose combination of two FDA approved drugs: D-cycloserine, an N-
methyl-D-aspartate (NMDA) receptor modulator, and lurasidone, which has
D2/5-HT2a receptor antagonist activity. The combination has shown
statistically-significant reduction in both depression and suicidal ideation in
phase 2 studies and was awarded FDA Breakthrough Therapy Designation and Fast
Track Designation. A pivotal phase 3
study is ongoing under an FDA Special Protocol Agreement that targets patients
who present for emergency care with Severe Bipolar Depression and Acute Suicidal
Ideation.
Forward Look Statements
This release may contain "forward-looking" statements, as
that term is defined in the Private Securities Litigation Reform Act of 1995 or
by the SEC in its rules, regulations and releases. These forward-looking
statements include, among other things, statements of plans, objectives,
expectations or intentions. Forward-looking statements involve risks,
uncertainties and assumptions and actual results may differ materially from
those expressed in these forward-looking statements. You should not put undue
reliance on any forward-looking statements in this communication. We do not
have any intention or obligation to update forward-looking statements after the
date of this communication, except as required by law.
Learn more at www.NeuroRxpharma.com
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