Attached files
| file | filename |
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| EX-2.1 - MERGER AGREEMENT - NRX Pharmaceuticals, Inc. | brpa_ex2-1.htm |
| EX-99.2 - INVESTOR PRESENTATION - NRX Pharmaceuticals, Inc. | brpa_ex992.htm |
| 8-K - CURRENT REPORT - NRX Pharmaceuticals, Inc. | brpa_8k.htm |
Exhibit 99.1
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FOR IMMEDIATE RELEASE
BIG ROCK PARTNERS ACQUISITION CORP. ANNOUNCES MERGER WITH NEURORX,
INC.
COMBINED COMPANY TO HAVE AN ESTIMATED POST-TRANSACTION EQUITY VALUE
IN EXCESS OF $500 MILLION (EXCLUDING POTENTIAL EARNOUT PAYMENTS),
ASSUMING A SHARE PRICE OF AT LEAST $10.00 PER SHARE
NeuroRx, Inc. is a clinical stage, small molecule pharmaceutical
company which develops novel therapeutics for the treatment of
COVID-19 (RLF-100 or “ZYESAMI™ (aviptadil)”) and
Bipolar Depression (NRX-100, 101)
Delray Beach, FL – December 14, 2020 – Big Rock
Partners Acquisition Corp. (“Big Rock”) (NASDAQ:
BRPA), a special purpose acquisition company, announces that it has
entered into an Agreement and Plan of Merger with NeuroRx, Inc.
(“NeuroRx”), a clinical stage, small molecule
pharmaceutical company. NeuroRx develops novel therapeutics for the
treatment of COVID-19 (RLF-100 or “ZYESAMI™
(aviptadil)”) and Bipolar Depression (NRX-100, 101). Under
the terms of the transaction, Big Rock and NeuroRx will merge and
the company is expected to continue to trade on the Nasdaq Stock
Market under the symbol “NRXP.” The transaction is
expected to occur in the first or second quarter of 2021. As a
public Nasdaq-listed company, NeuroRx expects to have increased
access to capital to continue development of its innovative drug
pipeline targeting Central Nervous System (CNS)/Psychiatry and
Respiratory Disease.
An Innovator in Mental Health and Respiratory Drug
Development
NeuroRx
is a clinical stage, small molecule pharmaceutical company which
develops novel therapeutics for the treatment of central nervous
system disorders and life-threatening pulmonary disease.
NeuroRx’s two main drugs are “ZYESAMI™ (aviptadil)”
which is an application for COVID-related respiratory failure and
“NRX-101”, which
focuses on suicidal bipolar depression and PTSD. ZYESAMI is a
synthetic human Vasoactive Intestinal Peptide (VIP), a 28
amino-acid natural peptide with 50 years of research evidence led
by the late Prof. Sami Said, documenting protection from Lung
Injury by protecting type II epithelial cells. NRX-101 is a
fixed-dose combination of D-cycloserine and lurasidone that has
advanced to phase 3 with FDA Breakthrough Therapy Designation, a
Special Protocol Agreement, Biomarker Letter of Support, and Fast
Track Designation.
ZYESAMI (aviptadil) – Therapeutic for Respiratory Failure in
COVID-19 and other life-threatening respiratory
conditions
NeuroRx
established a commercial development partnership with Relief
Therapeutics Holding AG (SWX:RLF, OTCQB:RLFTF)
(“Relief”) in March 2020 for global commercialization
of aviptadil which has been the subject of previous press
releases.
NRX 100/101 – Anti-Depressant Drug Regimen
NRX-100/101 is being developed based on Prof. Daniel
Javitt’s (Chair of NeuroRx’s Scientific Advisory Board)
patented discovery that drugs targeting both the NMDA and 5-HT2A
receptors in the brain have the potential to treat both depression
and suicidality without the hallucinations caused by most NMDA
inhibitors and without the potential for suicide attributable to
other 5-HT2A inhibitor drugs:
●
Specific Focus on Suicidal Bipolar
Depression: Over 50% of individuals with Bipolar Disorder
attempt suicide over their lifetime. Competitors’ pipeline
products are focused on Major Depressive Disorder (MDD) and
Treatment Resistant Depression (TRD)
●
Potential Stabilization for acutely suicidal
patients after a single dose of NRX-100 (ketamine): The
sequential drug treatment regimen aspires to maintain remission
from depression and suicidal ideation after a single, initial
administration of NRX-100 (ketamine). In numerous clinical studies,
ketamine has shown rapid-onset, antidepressant/anti-suicidal
effects. Ketamine is well known to have potential for addiction,
hallucination, vomiting, and neurotoxicity with repeated
use.
●
Convenience: In contrast to repeated use
of ketamine, NRX-101 is expected to allow treatment at home after
an initial stabilization with NRX-100 (ketamine) in a clinical
setting
●
NRX-101 Not Expected To Be a Controlled
Substance: Unlike ketamine and its derivatives, the two
active ingredients of NRX-101 are not classified as controlled
substances by the Drug Enforcement Administration
(DEA)
Seasoned Management and Board
NeuroRx’s
management team is comprised of seasoned industry veterans, led by
Founder, Chairman & CEO Jonathan C. Javitt, MD, MPH, Robert
Besthof, MIM (Chief Commercial Officer), William Fricker, MBA, CPA
(Chief Financial Officer) and Alessandra Daigneault, JD (Corporate
Secretary), who are expected to continue to run the combined
company, post-transaction.
All
officers and members of the Board of Directors of Big Rock will
resign in connection with the closing of the transactions. The
Board of Directors of the combined company will initially consist
of seven members, including Prof. Jonathan Javitt.
Management Commentary
Prof.
Javitt stated, “We at NeuroRx are excited to be combining
with Big Rock Partners and its base of dedicated investors. Our
focus from the outset has been to serve patients with
life-threatening conditions who are not served by traditional
pharmaceutical approaches. As we have gotten to know our new
partners at Big Rock Partners, it is clear to us that they share
the same values and commitment to putting the patient
first.”
Summary of Transaction
Under
the terms of the transaction, Big Rock will issue to
NeuroRx’s current equity holders an aggregate of 50 million
shares of Big Rock common stock for their interests in NeuroRx,
representing $500 million of equity consideration, assuming a value
of $10.00 per common share.
Subject
to certain conditions, an aggregate of 25 million additional shares
of Big Rock common stock will be issued to NeuroRx pre-merger
equity holders if, prior to December 31, 2022, (1) RLF-100 receives
emergency use authorization by the FDA and (2) the FDA accepts the
Company’s filing of its application to approve
RLF-100.
In
addition, subject to certain conditions, a $100 million cash
earnout may be payable to NeuroRx pre-merger equity holders if,
prior to December 31, 2022, either (1) FDA approval of the
Company’s COVID-19 Drug is obtained and the Company’s
COVID-19 Drug is listed in the FDA’s “Orange
Book” or (2) FDA approval of the Company’s
Antidepressant Drug Regimen is obtained and the Company’s
Antidepressant Drug Regimen is listed in the FDA’s
“Orange Book”.
The
Boards of Directors of both NeuroRx and Big Rock have unanimously
approved the proposed transaction. Completion of the transaction is
subject to approval by stockholders of NeuroRx and Big Rock and
other customary closing conditions.
For
additional information on the transaction, see Big Rock’s
Current Report on Form 8-K, which will be filed promptly and which
can be obtained, without charge, at the Securities and Exchange
Commission’s internet site (http://www.sec.gov).
EarlyBirdCapital,
Inc. (“EBC”) served as financial advisor to Big Rock.
Graubard Miller acted as
legal advisor to Big Rock and Paul, Weiss, Rifkind, Wharton &
Garrison LLP acted as legal advisor to NeuroRx.
About
Big Rock Partners Acquisition Corp.
Big
Rock Partners Acquisition Corp. is a blank check company formed for
the purpose of entering into a merger, stock exchange, asset
acquisition, stock purchase, recapitalization, reorganization, or
other similar business combination with one or more businesses or
entities. Big Rock’s management team includes Richard
Ackerman, Chairman, President, and Chief Executive Officer, and
Bennett Kim, Chief Financial Officer, Chief Investment Officer,
Corporate Secretary and Director. Big Rock’s common stock,
units, rights and warrants are quoted on the Nasdaq Capital Market
under the ticker symbols BRPA, BRPAU, BRPAR and BRPAW,
respectively.
About NeuroRx
NeuroRx draws upon more than 100 years of collective drug
development experience and is led by former senior executives of
major pharmaceutical companies. In addition to its work on RLF-100,
NeuroRx has been awarded Breakthrough Therapy Designation and a
Special Protocol Agreement to develop NRX-101 in suicidal bipolar
depression and is currently in Phase 3 trials. Its executive team
is led by Prof. Jonathan C. Javitt, MD, MPH, who has served as a
health advisor to four Presidential administrations and worked on
significant drug development projects for major pharmaceutical
companies, together with Robert Besthof, MIM, who served as senior
executive in the neuroscience and pain division of a major
pharmaceutical company. Current directors and advisors of NeuroRx
include Hon. Sherry Glied, former Assistant Secretary, U.S. Dept.
of Health and Human Services; Mr. Chaim Hurvitz, former President
of the Teva International Group, Lt. Gen. HR McMaster, the 23rd
National Security Advisor, Wayne Pines, former Associate
Commissioner of the U.S. Food and Drug Administration, Judge
Abraham Sofaer, and Daniel Troy, former Chief Counsel, U.S. Food
and Drug Administration.
Additional Information and Where to Find It
This
document relates to a proposed transaction between NeuroRx and Big
Rock. This document does not constitute an offer to sell or
exchange, or the solicitation of an offer to buy or exchange, any
securities, nor shall there be any sale of securities in any
jurisdiction in which such offer, sale or exchange would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. Big Rock intends to file
a registration statement on Form S-4 (“Registration
Statement”), which will include a proxy statement for the
solicitation of Big Rock shareholder approval, a prospectus for the
offer and sale of Big Rock securities in the transaction and a
consent solicitation statement of NeuroRx, and other relevant
documents with the Securities and Exchange Commission
(“SEC”). The proxy statement/consent solicitation
statement/prospectus will be mailed to stockholders of Big Rock and
NeuroRx as of a record date to be established for voting on the
proposed business combination. INVESTORS AND SECURITY HOLDERS OF
BIG ROCK AND NEURORX ARE URGED TO READ THE REGISTRATION STATEMENT,
PROXY STATEMENT/CONSENT SOLICITATION STATEMENT/PROSPECTUS AND OTHER
RELEVANT DOCUMENTS THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN
THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and
security holders will be able to obtain free copies of the
registration statement, proxy statement, prospectus and other
documents containing important information about Big Rock and
NeuroRx once such documents are filed with the SEC, through the
website maintained by the SEC at http://www.sec.gov.
Additional Information Posted to Website
Big Rock will post information regarding the proposed transaction
promptly at
www.bigrockpartners.com. An
investor presentation will also be furnished promptly by Big Rock
to the SEC on a current report on Form 8-K, which can be viewed at
the SEC’s website at www.sec.gov and
www.bigrockpartners.com. Big
Rock intends to use its website as additional means of disclosing
information to investors, the media, and others interested in Big
Rock. It is possible that certain information that Big Rock posts
to its website could be deemed material information, and Big Rock
encourages investors, the media, and others interested in Big Rock
to review the business and financial information that Big Rock
posts on its website as such information could be deemed to be
material information.
Participants in the Solicitation
Big
Rock, NeuroRx and EBC and their respective directors and executive
officers, under SEC rules, may be deemed to be participants in the
solicitation of proxies of Big Rock’s shareholders in
connection with the proposed transaction. Investors and
securityholders may obtain more detailed information regarding the
names and interests in the proposed transaction of Big Rock’s
directors and officers in Big Rock’s filings with the SEC,
including the forthcoming proxy statement/consent solicitation
statement/prospectus statement. You may obtain a free copy of these
documents as described in the preceding paragraph.
No Offer or Solicitation
This
communication shall neither constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be
any sale of securities in any jurisdiction in which the offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of any such
jurisdiction.
Cautionary Note Regarding Forward Looking Statements
Neither
Big Rock, NeuroRx nor any of their respective affiliates makes any
representation or warranty as to the accuracy or completeness of
the information contained in this press release. This press release
is not intended to be all-inclusive or to contain all the
information that a person may desire in considering the proposed
transaction discussed herein. It is not intended to form the basis
of any investment decision or any other decision in respect of the
proposed transaction.
This
press release includes “forward-looking statements”
within the meaning of the federal securities laws with respect to
the proposed transaction between NeuroRx, Inc. and Big Rock,
including statements regarding the benefits of the transaction, the
anticipated timing of the transaction, the drugs under development
by NeuroRx and the markets in which it operates. Big Rock’s
and NeuroRx’s actual results may differ from its
expectations, estimates and projections and consequently, you
should not rely on these forward-looking statements as predictions
of future events. These forward-looking statements generally are
identified by the words “aspire,” “expect,”
“estimate,” “project,”
“budget,” “forecast,”
“anticipate,” “intend,” “plan,”
“may,” “will,” “will be,”
“will continue,” “will likely result,”
“could,” “should,”
“believe(s),” “predicts,”
“potential,” “continue,”
“future,” “opportunity,”
“strategy,” and similar expressions are intended to
identify such forward-looking statements. These forward-looking
statements include, without limitation, Big Rock’s and
NeuroRx’s expectations with respect to future performance and
anticipated financial impacts of the proposed
transaction.
These
forward-looking statements involve significant risks and
uncertainties that could cause the actual results to differ
materially from the expected results. Most of these factors are
outside Big Rock’s and NeuroRx’s control and are
difficult to predict. Factors that may cause such differences
include, but are not limited to: (1) the approvals, timing, and
ability to complete the proposed business combination, which may
adversely affect the trading price of Big Rock’s securities;
(2) Big Rock’s ability to remain listed on the Nasdaq Capital
Market prior to the closing of the proposed business combination;
(3) the combined company’s continued listing on the NASDAQ
Capital Market after closing of the proposed business combination;
(4) the benefits of the proposed business combination, including
future financial and operating results of the combined company; (5)
the inherent uncertainty associated with the FDA approval process;
(6) the risk that the proposed transaction disrupts current plans
and operations of NeuroRx as a result of the announcement and
consummation of the transaction described therein and herein; (7)
costs related to the proposed business combination; (8) changes in
applicable laws or regulations; (9) the possibility that the
combined company may be adversely affected by other economic,
business, and/or competitive factors; (10) the impact of COVID-19
or other adverse public health developments; and (11) other risks
and uncertainties that will be detailed in the proxy
statement/consent solicitation statement/prospectus and
registration statement to be filed on Form S-4 with the SEC and as
indicated from time to time in Big Rock’s filings with the
SEC. These filings identify and address other important risks and
uncertainties that could cause actual events and results to differ
materially from those contained in the forward-looking
statements.
Big
Rock and NeuroRX caution that the foregoing list of factors is not
exclusive. Big Rock and NeuroRx caution readers not to place undue
reliance upon any forward-looking statements, which speak only as
of the date made. Neither Big Rock nor NeuroRx undertake or accept
any obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements to reflect any change
in its expectations or any change in events, conditions or
circumstances on which any such statement is based.
CORPORATE CONTACTS
Big Rock Partners
Richard Ackerman
Chief Executive Officer
Big Rock Partners Acquisition Corp.
rackerman@bigrockpartners.com
NeuroRx, Inc.
Jonathan C. Javitt, M.D., MPH
Chief Executive Officer
NeuroRx, Inc.
ceo@neurorxpharma.com
MEDIA CONTACT
NeuroRx (United States):
David Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310
INVESTOR RELATIONS
NeuroRx (United States)
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122