NRX Pharmaceuticals, Inc 8-K, filed Mar 29, 2021
NRX Pharmaceuticals, Inc. (NRXP)
8-K
2021-03-29
For: 2021-03-09
View Original
Added on
April 11, 2026
About this 8-K
NRX Pharmaceuticals, Inc filed this 8-K on March 29, 2021, reporting on events of March 9, 2021.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
______________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event
reported): March 9,
2021
BIG ROCK PARTNERS ACQUISITION CORP.
(Exact Name of Registrant as Specified in Charter)
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Delaware
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001-38302
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82-2844431
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(State
or Other Jurisdiction
of
Incorporation)
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(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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2645 N.
Federal Highway, Suite 230
Delray
Beach, FL
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33483
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(Address
of Principal Executive Offices)
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(Zip
Code)
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Registrant’s telephone number, including area
code: (310)
734-2300
Not Applicable
(Former Name or Former Address, if Changed Since Last
Report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
below):
☒ Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
☐ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
☐ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
☐ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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Units, each consisting of one share of Common Stock, one Right and
one-half of one Warrant
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BRPAU
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The Nasdaq Stock Market LLC
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Common Stock, par value $0.001 per share
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BRPA
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The Nasdaq Stock Market LLC
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Rights, exchangeable into one-tenth of one share of Common
Stock
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BRPAR
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The Nasdaq Stock Market LLC
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Warrants, each whole warrant exercisable for one share of Common
Stock at an exercise price of $11.50
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BRPAW
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The Nasdaq Stock Market LLC
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Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this
chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act. □
Item 7.01. Regulation FD Disclosure.
As previously announced, Big Rock Partners Acquisition Corp. a
Delaware corporation (“BRPA”),
NeuroRx, Inc., a Delaware corporation (“NeuroRx”),
and Big Rock Merger Corp., a Delaware corporation and wholly-owned
subsidiary of BRPA (“Merger
Sub”), entered into an
Agreement and Plan of Merger providing that Merger Sub will merge
with and into NeuroRx, with NeuroRx surviving the merger and
becoming a wholly-owned subsidiary of BRPA and the stockholders of
NeuroRx becoming stockholders of BRPA.
On March 9, 2021, NeuroRx announced that it had entered into a
feasibility and material transfer agreement (“Feasibility
Agreement”) with TFF Pharmaceuticals, Inc.
(“TFF”). Under the Feasibility Agreement, NeuroRx is
delivering ZYESAMI™ (aviptadil) materials to TFF in order to
perform feasibility formulation work and testing of a dry powder
form of ZYESAMI™. NeuroRx previously engaged TFF to perform
certain research and development activities. The press release is
attached as Exhibit 99.1 hereto.
On March 26, 2021, NeuroRx announced completion of data analysis of
the 60-day results in its phase 2b/3 clinical trial of
ZYESAMI™, performed in collaboration with Relief Therapeutics
Holdings, AG, in patients with respiratory failure due to critical
COVID-19, which was conducted under Fast Track Designation of the
Food and Drug Administration. The press release also announced that
NeuroRx would hold a conference call at 8:30am EDT on March 29,
2021, and that further details are available on NeuroRx’s
website, at www.neurorxpharma.com. The press release is attached as
Exhibit 99.2 hereto.
On March 29, 2021, NeuroRx announced that ZYESAMI™ met the
primary endpoint of its phase 2b/3 clinical trial. The press
release is attached as Exhibit 99.3 hereto.
The information set forth under this Item 7.01, including the
exhibits hereto, is intended to be furnished and shall not be
deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended
(“Exchange
Act”) or otherwise
subject to the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of
1933, as amended (“Securities
Act”) or the Exchange
Act, except as expressly set forth by specific reference in such
filing.
Cautionary Note Regarding Forward Looking Statements
This Current Report on Form 8-K and the exhibits furnished herewith
include “forward-looking statements” within the meaning
of the federal securities laws with respect to the proposed
transaction between NeuroRx and BRPA, including statements
regarding the drugs under development by NeuroRx. Actual results
may differ from BRPA’s and NeuroRx’s expectations 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 involve significant risks and uncertainties that could
cause the actual results to differ materially from the expected
results. Most of these factors are outside BRPA’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
BRPA’s securities; (2) BRPA’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 are
detailed in the proxy statement/consent solicitation
statement/prospectus and registration statement filed on Form S-4
with the Securities and Exchange Commission
(“SEC”) and as indicated from time to time in
BRPA’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.
Additional Information and Where to Find It
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. BRPA has filed a registration statement on Form S-4
(“Registration
Statement”), which
includes a preliminary proxy statement for the solicitation of the
approval of BRPA’s stockholders, a preliminary prospectus for
the offer and sale of BRPA’s securities in the transaction
and a preliminary consent solicitation statement of NeuroRx, and
other relevant documents with the SEC. The definitive proxy
statement/prospectus/consent solicitation statement will be mailed
to stockholders of BRPA and NeuroRx as of a record date to be
established for voting on the proposed business combination.
INVESTORS AND SECURITY HOLDERS OF BRPA AND NEURORX ARE URGED TO
READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS/CONSENT
SOLICITATION STATEMENT 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 TRANSACTIONS. 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 BRPA and NeuroRx once such documents are filed
with the SEC, through the website maintained by the SEC at
http://www.sec.gov. In addition, copies of the documents filed with
the SEC by BRPA can be obtained free of charge on BRPA’s
website at www.bigrockpartners.com or by directing a written
request to BRPA at 2645 N. Federal Highway, Suite 230 Delray Beach,
FL 33483.
Participants in the Solicitation
BRPA, NeuroRx and their respective directors and executive
officers, under SEC rules, may be deemed to be participants in the
solicitation of proxies of BRPA’s stockholders in connection
with the proposed business combination. Investors and
securityholders may obtain more detailed information regarding the
names and interests in the proposed business combination of
BRPA’s directors and officers in BRPA’s filings with
the SEC, including the proxy statement/prospectus/consent
solicitation statement. You may obtain a free copy of these
documents as described in the preceding paragraph.
Item
9.01 Financial Statements and
Exhibits.
(d) Exhibits:
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Exhibit
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Description
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Press
release, dated March 9, 2021.
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Press
release, dated March 26, 2021.
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Press
release, dated March 29, 2021.
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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BIG
ROCK PARTNERS ACQUISITION CORP.
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Dated: March
29, 2021
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By:
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/s/ Richard
Ackerman
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Name:
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Richard
Ackerman
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Title:
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Chairman,
President and Chief Executive Officer
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Exhibit
99.1
NeuroRX and TFF Pharmaceuticals
Announce Entering Into Feasibility
Collaboration
Feasibility work underway to determine the compatibility of
NeuroRx’s ZYESAMI™ (aviptadil, synthetic VIP) as a dry
powder formulation using TFF’s Thin-Film Freezing
technology
Dry powder inhalation technology has the potential to deliver
ZYESAMI directly to the lungs
RADNOR, Pa. & AUSTIN, Texas, March 9,
2021--(BUSINESS
WIRE)--NeuroRx, Inc. and TFF
Pharmaceuticals, Inc. (NASDAQ: TFFP) are announcing that the
companies have entered into a feasibility and material transfer
agreement (Feasibility Agreement). Under the Feasibility Agreement,
NeuroRx is delivering ZYESAMI™ (aviptadil, synthetic VIP)
materials to TFF in order to perform feasibility formulation work
and testing. The goal of this feasibility work is to formulate and
identify an optimal, long-term stable formulation of ZYESAMI™
into a dry powder form, which has superior aerosol properties for
delivery directly to the lungs.
ZYESAMI is a synthetic form of a naturally occurring peptide found
in the lung called Vasoactive Intestinal Peptide (VIP), which is
known to protect the Alveolar Type II cell that is targeted by the
SARS-CoV-2 virus. The symptoms of COVID-19 are attributable to
decreased surfactant production and increased cytokine production
caused by Coronavirus infection of the Type II cell. This may also
be a common pathway in sepsis-induced Acute Respiratory Distress
Syndrome (ARDS) and Checkpoint Inhibitor induced pneumonitis
associated with certain cancer drugs.
Loss of surfactant production in the lung may be the direct cause
of the profound hypoxia or respiratory failure seen in COVID-19.
The ability to deliver VIP directly to the lung via inhalation
could have important therapeutic implications and potentially
broaden the application of the drug to patients less severely
affected with COVID-19.
“We are excited that ZYESAMI has demonstrated a highly
significant reduction in time to hospital discharge for seriously
ill COVID-19 patients treated with High Flow Nasal Oxygen, along
with an increased likelihood of recovery and excellent
safety,” said Jonathan C. Javitt, M.D., M.P.H., CEO of
NeuroRx. “Although our current production methods yield a
drug that is sufficiently stable for emergency use, a long-term,
shelf-stable formulation will be needed for ongoing use of ZYESAMI,
once the pandemic subsides. The thin-film freezing technology holds
great promise in potentially making this available to patients with
other stages of COVID-19 with an inhaled form of
ZYESAMI.”
“The work being done by the NeuroRx team with ZYESAMI on
behalf of critically ill patients with COVID-19 respiratory failure
is both remarkable and gratifying,” said Glenn Mattes,
President & CEO of TFF Pharmaceuticals. “The potential
opportunity to bring this important new therapeutic to patients
earlier in the treatment cycle is exciting. We are very pleased to
be collaborating with the NeuroRx Team with our thin-film freezing
technology.”
About VIP in COVID-19
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the
late Dr. Sami Said in 1970, for whom ZYESAMI™ is named.
Although first identified in the intestinal tract, VIP is now known
to be produced throughout the body and to be primarily concentrated
in the lungs. VIP has been shown in more than 500 peer-reviewed
studies to have potent anti-inflammatory/anti-cytokine activity in
animal models of respiratory distress, acute lung injury, and
inflammation. Most importantly, 70% of the VIP in the body is bound
to a rare cell in the lung, the alveolar type II cell (ATII), that
is critical in the production of lung surfactant that is essential
to transmission of oxygen from the air to the blood by the
pulmonary epithelial cells that line the air sacs (alveoli) of the
lung. Initial radiographic changes in COVID-19 are suggestive of
collapse of these alveoli.
COVID-19-related respiratory failure is caused by selective
infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells
are vulnerable because of their (ACE2) surface receptors, which
serve as the route of entry for the virus. These specialized cells
manufacture surfactant that coats the lung and is essential for
oxygen exchange. Loss of surfactant causes collapse of the air sacs
(alveolae) in the lung and results in respiratory
failure.
VIP is shown to block Coronavirus replication in the ATII cell,
block cytokine synthesis, block viral-induced cell death
(cytopathy), and upregulate surfactant production. To our
knowledge, other than ZYESAMI™, no currently proposed
treatments for COVID-19 specifically target these vulnerable Type
II cells. Recent laboratory findings suggest that VIP directly
interferes with the spike protein complex of the SARS-CoV-2
virus.
About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug
development experience from senior executives of AstraZeneca, Eli
Lilly, Novartis, Pfizer, and PPD. In addition to its work on
ZYESAMI™, 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, M.D., M.P.H.,
who has served as a health advisor to four Presidential
administrations and worked on paradigm-changing drug development
projects for Merck, Allergan, Pharmacia, Pfizer, Novartis and
MannKind, together with Robert Besthof, MIM, who served as the
Global Vice President (Commercial) for Pfizer’s Neuroscience
and Pain Division. NeuroRx recently announced a plan to complete a
business combination with Big Rock Partners Acquisition Corp
(NASDAQ:BRPA) (“BRPA”) and intends to apply for
listing on the NASDAQ under the proposed symbol “NRXP”.
For more information, visit www.neurorxpharma.com.
About TFF Pharmaceuticals’ Thin Film Freezing technology
platform
TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was
designed to improve the solubility and absorption of poorly
water-soluble drugs and is particularly suited to generate dry
powder particles with properties targeted for inhalation delivery,
especially to the deep lung, an area of extreme interest in
respiratory medicine. The TFF process results in a “Brittle
Matrix Particle,” which possesses low bulk density, high
surface area, and typically an amorphous morphology, allowing the
particles to supersaturate when contacting the target site, such as
lung tissue. Based upon laboratory experiments the aerodynamic
properties of the particles are such that the portion of a drug
deposited to the deep lung has the potential to reach as high as 75
percent.
About TFF Pharmaceuticals
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical
company focused on developing and commercializing innovative drug
products based on its patented Thin Film Freezing, or TFF,
technology platform. Early testing confirms that the TFF platform
can significantly improve the solubility and absorption of poorly
water-soluble drugs, a class of drugs that comprises approximately
one-third of the major pharmaceuticals worldwide, thereby improving
their pharmacokinetics. TFF Pharmaceuticals has two lead drug
candidates: Voriconazole Inhalation Powder and Tacrolimus
Inhalation Powder. The Company plans to add to this pipeline by
collaborating with large pharmaceutical partners. The TFF Platform
is protected by 42 patents issued or pending in the US and
internationally. To learn more about TFF Pharmaceuticals and its
product candidates, visit the Company’s website
at https://tffpharma.com.
Cautionary Note Regarding Forward Looking Statements – TFF
Pharmaceuticals:
This press release contains forward-looking statements regarding
TFF Pharmaceuticals, Inc., including the benefits of the
Company’s TFF platform and a potential its dry powder version
of NeuroRx’s ZYESAMI. Those forward-looking statements
involve known and unknown risks, uncertainties and other factors
that could cause actual results to differ materially. Among those
factors are: (i) the risk that NeuroRx and the Company may not be
able to produce a dry powder version NeuroRx’s ZYESAMI, (ii)
the risk that NeuroRx and the Company may not be able to
successfully conclude clinical testing or obtain pre-market
approval of a dry powder version of NeuroRx’s ZYESAM, (iii)
no drug product incorporating the TFF platform has received FDA
pre-market approval or otherwise been incorporated into a
commercial drug product, and (iv) those other risks disclosed in
the section “Risk Factors” included in the
Company’s prospectus supplement filed with the SEC on
December 8, 2020. TFF Pharmaceuticals cautions readers not to place
undue reliance on any forward-looking statements. TFF
Pharmaceuticals does not undertake, and specifically disclaims, any
obligation to update or revise such statements to reflect new
circumstances or unanticipated events as they occur, except as
required by law.
Cautionary Note Regarding Forward Looking Statements –
NeuroRx:
Statements contained in this press release that are not historical
facts may be forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements
generally relate to future events or NeuroRx’s future
financial or operating performance. In some cases, you can identify
forward-looking statements because they contain words such as
"may," "will," "should," "expects," "plans," "anticipates,"
"could," "intends," "target," "projects," "contemplates,"
"believes," "estimates," "predicts," "potential" or "continue" or
the negative of these words or other similar terms or expressions
that concern NeuroRx’s expectations, strategy, plans or
intentions. Such forward-looking statements may relate to, among
other things, the outcome of any discussions or applications for
the future use of ZYESAMI, the approvals, timing, and ability to
complete the proposed business combination with BRPA, and the
combined company’s ability to continue listing on Nasdaq
after closing the proposed business combination. Such
forward-looking statements do not constitute guarantees of future
performance and are subject to a variety of risks and
uncertainties. NeuroRx does not undertake any obligation to update
forward-looking statements as a result of new information, future
events or developments or otherwise.
Additional Information and Where to Find It
This press release relates to a proposed business combination and
related transactions (the “Transactions”) between
NeuroRx and BRPA. This press release 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. BRPA has filed a
registration statement on Form S-4 (“Registration
Statement”), which includes a preliminary proxy statement for
the solicitation of the approval of BRPA’s stockholders, a
preliminary prospectus for the offer and sale of BRPA’s
securities in the Transactions and a preliminary consent
solicitation statement of NeuroRx, and other relevant documents
with the SEC. The proxy statement/prospectus/consent solicitation
statement will be mailed to stockholders of NeuroRx and BRPA as of
a record date to be established for voting on the proposed business
combination. INVESTORS AND SECURITY HOLDERS OF NEURORX AND BRPA ARE
URGED TO READ THE REGISTRATION STATEMENT, PROXY
STATEMENT/PROSPECTUS/CONSENT SOLICITATION STATEMENT 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 TRANSACTIONS. 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 NeuroRx and BRPA
once such documents are filed with the SEC, through the website
maintained by the SEC at http://www.sec.gov. In addition, copies of the documents filed with
the SEC by BRPA can be obtained free of charge on BRPA’s
website at www.bigrockpartners.com or by directing a written request to BRPA at
2645 N. Federal Highway, Suite 230 Delray Beach, FL
33483.
Participants in the Solicitation
NeuroRx, BRPA and their respective directors and executive
officers, under SEC rules, may be deemed to be participants in the
solicitation of proxies of BRPA’s stockholders in connection
with the proposed Transactions. Investors and securityholders may
obtain more detailed information regarding the names and interests
in the proposed Transactions of NeuroRx’s and BRPA’s
respective directors and officers in BRPA’s filings with the
SEC, including the proxy statement/consent solicitation
statement/prospectus statement. You may obtain a free copy of these
documents as described in the preceding paragraph.
Contacts
NeuroRx contacts:
NeuroRx, Inc.
Jonathan C. Javitt, M.D., MPH
Chairman and Chief Executive Officer
ceo@neurorxpharma.com
Media Contact:
NeuroRx (US):
David Schull
Russo Partners, LLC
David.schull@russopartnersllc.com
858.717.2310
Investor Relations Contact:
NeuroRx (US):
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917.653.5122
TFF Pharmaceuticals Contacts:
Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc.
gmattes@tffpharma.com
737-802-1973
Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
817-989-6358
Investor Relations and Media Contact:
Paul Sagan
LaVoieHealthScience
psagan@lavoiehealthscience.com
617-865-0041
Exhibit 99.2
NeuroRx Announces Completion of Data Analysis in Phase 2b/3
Clinical Trial of ZYESAMI™ for the Treatment of COVID-19
Respiratory Failure
Results to be Presented at Investor Call on Monday, March 29th at
8:30am EDT
RADNOR, Pa., March 26, 2021 /PRNewswire/ -- NeuroRx, Inc.
announces completion of top line data analysis of the 60-day
results in its phase 2b/3 clinical trial, conducted under FDA
Fast Track Designation, of ZYESAMI™ (aviptadil acetate) for
the treatment of critically-ill patients with COVID-19 respiratory
failure (www.clinicaltrials.gov 04311697).
The results for the primary endpoint of recovery from respiratory
failure and the secondary endpoint of survival through day 60 are
in the process of final review by the investigators of the
multicenter clinical trial. A conference call will be held
at 8:30am EDT on Monday, March 29th with
attendance from corporate leadership and lead investigators. Those
wishing to attend should access details on www.neurorxpharma.com.
Those wishing to ask questions should submit those questions in
advance to ceo@nrxpharma.com.
NeuroRx, Inc. has signed an agreement to merge with Big Rock
Partners Acquisition Corp. Details may be viewed
at http://irdirect.net/filings/viewer/index/1719406/000119312521019278
About VIP in COVID-19
Vasoactive Intestinal Polypeptide (VIP) was first discovered by the
late Dr. Sami Said in 1970. Although first identified in
the lung, it was purified from the intestinal tract. VIP is now
known to be produced throughout the body and to be primarily
concentrated in the lungs. VIP has been shown in more than 100
peer-reviewed studies to have potent
anti-inflammatory/anti-cytokine activity in animal models of
respiratory distress, acute lung injury, and inflammation. Most
importantly, VIP binds specifically to the alveolar type II cell
(ATII) in the air sac (alveolus) of the lung. VIP stimulates ATII
cells to make the surfactant that must coat the lining of the lung
in order for the lung to exchange oxygen with the blood. Loss of
surfactant causes respiratory failure and alveolar collapse, which
is a hallmark of COVID-19.
COVID-19-related respiratory failure is caused by selective
infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells
are vulnerable because of their (ACE2) surface receptors, which
serve as the route of entry for the virus. Coronavirus infection of
the ATII cell shuts down surfactant production, triggers the
formation of inflammatory cytokines, and causes cell death
(cytopathy). VIP is shown to upregulate surfactant production,
block Coronavirus replication in the ATII cell, block cytokine
synthesis, and prevent viral-induced cell death (cytopathy). To our
knowledge, other than ZYESAMI™, no currently proposed
treatments for COVID-19 specifically target this mechanism of
action.
About NeuroRx, Inc.
NeuroRx draws upon more than 100 years of collective drug
development experience from senior executives of AstraZeneca, Eli
Lilly, Novartis, Pfizer, and PPD. In addition to its work on
Aviptadil, 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 paradigm-changing drug development projects for Merck,
Allergan, Pharmacia, Pfizer, Novartis, and Mannkind, together with
Robert Besthof, MIM, who served as the Global Vice President
(Commercial) for Pfizer's Neuroscience and Pain Division. NeuroRx
recently announced a plan to complete a business combination with
Big Rock Partners Acquisition Corp (NASDAQ:BRPA) ("BRPA"), and
intends to apply for listing on the NASDAQ under the proposed
symbol "NRXP".
Cautionary Note Regarding Forward Looking Statements
Statements contained in this press release that are not historical
facts may be forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements
generally relate to future events or NeuroRx's future financial or
operating performance. In some cases, you can identify
forward-looking statements because they contain words such as
"may," "will," "should," "expects," "plans," "anticipates,"
"could," "intends," "target," "projects," "contemplates,"
"believes," "estimates," "predicts," "potential" or "continue" or
the negative of these words or other similar terms or expressions
that concern NeuroRx's expectations, strategy, plans or intentions.
Such forward-looking statements may relate to, among other things,
the outcome of any discussions or applications for the future use
of ZYESAMI, the approvals, timing, and ability to complete the
proposed business combination with BRPA, and the combined company's
ability to continue listing on Nasdaq after closing the proposed
business combination. Such forward-looking statements do not
constitute guarantees of future performance and are subject to a
variety of risks and uncertainties. NeuroRx does not undertake any
obligation to update forward-looking statements as a result of new
information, future events or developments or
otherwise.
Additional Information and Where to Find It
This press release relates to a proposed business combination and
related transactions (the "Transactions") between NeuroRx and BRPA.
This press release 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. BRPA has filed a
registration statement on Form S-4 ("Registration Statement"),
which includes a preliminary proxy statement for the solicitation
of the approval of BRPA's stockholders, a preliminary prospectus
for the offer and sale of BRPA's securities in the Transactions and
a preliminary consent solicitation statement of NeuroRx, and other
relevant documents with the SEC. The proxy
statement/prospectus/consent solicitation statement will be mailed
to stockholders of NeuroRx and BRPA as of a record date to be
established for voting on the proposed business combination.
INVESTORS AND SECURITY HOLDERS OF NEURORX AND BRPA ARE URGED TO
READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS/CONSENT
SOLICITATION STATEMENT 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 TRANSACTIONS. 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 NeuroRx and BRPA once such documents are filed
with the SEC, through the website maintained by the SEC
at http://www.sec.gov.
In addition, copies of the documents filed with the SEC by BRPA can
be obtained free of charge on BRPA's website
at www.bigrockpartners.com or
by directing a written request to BRPA at 2645 N. Federal Highway,
Suite 230 Delray Beach, FL 33483.
Participants in the Solicitation
NeuroRx, BRPA and their respective directors and executive
officers, under SEC rules, may be deemed to be participants in the
solicitation of proxies of BRPA's stockholders in connection with
the proposed Transactions. Investors and securityholders may obtain
more detailed information regarding the names and interests in the
proposed Transactions of NeuroRx's and BRPA's respective directors
and officers in BRPA's filings with the SEC, including the proxy
statement/consent solicitation statement/prospectus statement. You
may obtain a free copy of these documents as described in the
preceding paragraph.
Exhibit 99.3
NeuroRx Announces
ZYESAMI™ (aviptadil, RLF-100) Met the Primary Endpoint of Its
Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful
Benefit in Survival from Critical COVID-19
RADNOR,
Pa., March 29, 2021 /PRNewswire/ -- NeuroRx, Inc.
today reports 60-day results of the Phase 2b/3 trial of
intravenously-administered ZYESAMI™ (aviptadil acetate) for
the treatment of respiratory failure in critically-ill patients
with COVID-19, which is being developed in collaboration with
Relief Therapeutics Holding AG (SIX:RLF,OTCQB:RLFTF). Across all patients and sites,
ZYESAMI™ met the primary endpoint for successful recovery
from respiratory failure at days 28 (P = .014) and 60 (P = .013)
and also demonstrated a meaningful benefit in survival (P = <
..001) after controlling for ventilation status and treatment
site.
In
addition to the robust overall significance across all 196 treated
patients at all 10 clinical sites, the prespecified analysis of
recovery from respiratory failure is clinically and statistically
significant in the 127 patients treated by High Flow Nasal Cannula
(HFNC) (P = .02), compared to those treated with mechanical or
non-invasive ventilation at tertiary care hospitals. In this group,
ZYESAMI™ patients had a 71% chance of successful recovery by
day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of
successful recovery by day 60 vs. 55% in the placebo group (P =
..036). Eighty-four percent (84%) of HFNC patients treated at
tertiary medical centers with ZYESAMI™ survived to day 60
compared with 60% of those treated with placebo (P =
..007).
To the
company's knowledge, ZYESAMI™ is the first COVID-19
therapeutic to demonstrate advantages in both survival and recovery
from critical COVID-19 in a randomized, double-blind multicenter
trial. On the basis of these findings, NeuroRx plans to apply
immediately to the United States Food and Drug Administration
("FDA") for Emergency Use Authorization (EUA) and to subsequently
submit a New Drug Application (NDA).
Recovery
from respiratory failure (without relapse) with discharge from
acute care and survival through the observation period was the
prespecified primary endpoint specified by FDA for the study,
originally intended to be assessed at 28 days and then extended to
60 days based on recently-published FDA guidance. The above
analysis includes all 196 participants who were randomized and
treated in the placebo-controlled, double-blind clinical trial
(www.clinicaltrials.gov NCT04311697)
conducted at 10 US hospitals. Treatment with ZYESAMI™ or
placebo was in addition to standard of care treatment that included
steroids, convalescent plasma, antiviral therapy, anticoagulants,
and various anti-cytokine drugs.
NeuroRx
has announced the commencement of a clinical trial of inhaled
ZYESAMI™ for the treatment of patients with moderate and
severe COVID-19 with the aim of preventing progression to
respiratory failure. NeuroRx has also announced the inclusion of
inhaled ZYESAMI™ in the I-SPY clinical trial platform for
patients with COVID-19 respiratory failure. The company has signed
a clinical trial participation agreement with the National
Institutes of Health.
The
study's coordinating committee, including Professors Dushyantha
Jayaweera, MD, FACP (University of Miami), Richard Lee, MD,
(UC Irvine), and J. Georges Youssef, MD (Houston Methodist
Hospital) commented, "The 60-day
observation framework implemented last month by FDA for critically
ill patients with COVID-19 is more consistent with the clinical
course of this lethal disease than the 28-day time frame originally
adapted from other conditions that cause respiratory distress. The
association of baseline oxygenation status (high flow nasal oxygen
vs. ventilation) is not surprising in that patients who require
mechanical or noninvasive ventilation in order to maintain blood
oxygen are likely to have substantially more damage to the lining
of their lungs compared to patients whose blood oxygen level can be
maintained with high-flow oxygen delivered to the nose. The finding
that patients fared substantially better in tertiary care centers
as compared to regional hospitals may be influenced by the
intensity of the public health crisis at the regional hospitals
that participated in the study, all of which were operating at 200%
or higher overcapacity in their intensive care units with
implementation of temporary ICU beds and shortages of critical care
staff."
Prof. Jonathan
Javitt, MD, MPH, Chairman and CEO of NeuroRx, said, "ZYESAMI has now demonstrated itself in a phase
2/3 trial, conducted under FDA Fast Track Designation, not only to
shorten hospitalization (as was previously reported) but also to
save lives and increase the likelihood of patients returning safely
home to their families. In exactly 12 months, a lifesaving drug has
advanced from concept to clinical success in partnership with
Relief Therapeutics in the midst of a public health emergency that
has claimed the lives of millions. Today's findings confirm
the often dramatic clinical success that has been seen in numerous
patients treated in the US and abroad under emergency use
protocols. We look forward to working with the National
Institutes of Health, the Department of Defense, the FDA, and
regulators around the world to bring this treatment to patients as
quickly as possible."
An
investor conference call will be held today, March
29th at 8:30am
EDT. Participants can dial (+1) 866-373-3402 or join via webcast
at https://bit.ly/3sqPyDS.
Those wishing to ask questions should submit those questions
to ceo@nrxpharma.com.
NeuroRx,
Inc. has signed an agreement to merge with Big Rock Acquisition
Corp. Details may be viewed at http://irdirect.net/filings/viewer/index/1719406/000119312521019278/
About VIP in COVID-19
Vasoactive
Intestinal Polypeptide (VIP) was first discovered by the late
Dr. Sami Said in 1970. Although first identified in the
lung, it was purified from the intestinal tract. VIP is now known
to be produced throughout the body and to be primarily concentrated
in the lungs. VIP has been shown in more than 100 peer-reviewed
studies to have potent anti-inflammatory/anti-cytokine activity in
animal models of respiratory distress, acute lung injury, and
inflammation. Most importantly, VIP binds specifically to the
alveolar type II cell (ATII) in the air sac (alveolus) of the
lung. VIP stimulates ATII cells to make the surfactant that
must coat the lining of the lung in order for the lung to exchange
oxygen with the blood. Loss of surfactant causes respiratory
failure and alveolar collapse, which is a hallmark of
COVID-19.
COVID-19-related
respiratory failure is caused by selective infection of the ATII
cell by the SARS-CoV-2 virus. The ATII cells are vulnerable because
of their (ACE2) surface receptors, which serve as the route of
entry for the virus. Coronavirus infection of the ATII cell shuts
down surfactant production, triggers the formation of inflammatory
cytokines, and causes cell death (cytopathy). VIP is shown to
upregulate surfactant production, block Coronavirus replication in
the ATII cell, block cytokine synthesis, and prevent viral-induced
cell death (cytopathy). To our knowledge, other than
ZYESAMI™, no currently proposed treatments for COVID-19
specifically target this mechanism of action.
About NeuroRx, Inc.
NeuroRx
draws upon more than 100 years of collective drug development
experience from senior executives of AstraZeneca, Eli Lilly,
Novartis, Pfizer, and PPD. In addition to its work on Aviptadil,
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
paradigm-changing drug development projects for Merck, Allergan,
Pharmacia, Pfizer, Novartis, and Mannkind, together
with Robert Besthof, MIM, who served as the Global Vice
President (Commercial) for Pfizer's Neuroscience and Pain
Division. NeuroRx recently announced a plan to complete a
business combination with Big Rock Partners Acquisition Corp
(NASDAQ:BRPA) ("BRPA"), and
intends to apply for listing on the NASDAQ under the proposed
symbol "NRXP".
About Relief Therapeutics Holding AG
Relief
focuses primarily on clinical-stage programs based on molecules of
natural origin (peptides and proteins) with a history of clinical
testing and use in human patients or a strong scientific rationale.
Currently, Relief is concentrating its efforts on developing new
treatments for respiratory disease indications. Its lead drug
candidate RLF-100™ (aviptadil) is being investigated in
two placebo-controlled U.S. phase 2b/3 clinical trials in
respiratory failure due to COVID-19. Relief also holds a patent
issued in the United States and various other countries
covering potential formulations of RLF-100™. Relief is
listed on the SIX Swiss Exchange under the symbol RLF and quoted in
the U.S. on OTCQB under the symbol RLFTF. www.relieftherapeutics.com.
Cautionary Note Regarding Forward Looking Statements
Statements
contained in this press release that are not historical facts may
be forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Forward-looking statements generally relate
to future events or NeuroRx's future financial or operating
performance. In some cases, you can identify forward-looking
statements because they contain words such as "may," "will,"
"should," "expects," "plans," "anticipates," "could," "intends,"
"target," "projects," "contemplates," "believes," "estimates,"
"predicts," "potential" or "continue" or the negative of these
words or other similar terms or expressions that concern NeuroRx's
expectations, strategy, plans or intentions. Such forward-looking
statements may relate to, among other things, the outcome of any
discussions or applications for the future use of ZYESAMI, the
approvals, timing, and ability to complete the proposed business
combination with BRPA, and the combined company's ability to
continue listing on Nasdaq after closing the proposed business
combination. Such forward-looking statements do not constitute
guarantees of future performance and are subject to a variety of
risks and uncertainties. NeuroRx does not undertake any obligation
to update forward-looking statements as a result of new
information, future events or developments or
otherwise.
Additional Information and Where to Find It
This
press release relates to a proposed business combination and
related transactions (the "Transactions") between NeuroRx and BRPA.
This press release 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. BRPA has filed a
registration statement on Form S-4 ("Registration Statement"),
which includes a preliminary proxy statement for the solicitation
of the approval of BRPA's stockholders, a preliminary prospectus
for the offer and sale of BRPA's securities in the Transactions and
a preliminary consent solicitation statement of NeuroRx, and other
relevant documents with the SEC. The proxy
statement/prospectus/consent solicitation statement will be mailed
to stockholders of NeuroRx and BRPA as of a record date to be
established for voting on the proposed business combination.
INVESTORS AND SECURITY HOLDERS OF NEURORX AND BRPA ARE URGED TO
READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS/CONSENT
SOLICITATION STATEMENT 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 TRANSACTIONS. 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 NeuroRx and BRPA once such documents are filed
with the SEC, through the website maintained by the SEC
at http://www.sec.gov. In
addition, copies of the documents filed with the SEC by BRPA can be
obtained free of charge on BRPA's website at www.bigrockpartners.com or by
directing a written request to BRPA at 2645 N. Federal Highway,
Suite 230 Delray Beach, FL 33483.
Participants in the Solicitation
NeuroRx,
BRPA and their respective directors and executive officers, under
SEC rules, may be deemed to be participants in the solicitation of
proxies of BRPA's stockholders in connection with the proposed
Transactions. Investors and securityholders may obtain more
detailed information regarding the names and interests in the
proposed Transactions of NeuroRx's and BRPA's respective directors
and officers in BRPA's filings with the SEC, including the proxy
statement/consent solicitation statement/prospectus statement. You
may obtain a free copy of these documents as described in the
preceding paragraph.