NRX Pharmaceuticals, Inc 8-K, filed Feb 24, 2021
NRX Pharmaceuticals, Inc. (NRXP)
8-K
2021-02-24
For: 2021-02-23
View Original
Added on
April 11, 2026
About this 8-K
NRX Pharmaceuticals, Inc filed this 8-K on February 24, 2021, reporting on events of February 23, 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): February 23,
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 for the merger of Merger Sub
will merge with and into NeuroRx, with NeuroRx surviving the merger
and becoming a wholly-owned subsidiary of BRPA, with the
stockholders of NeuroRx becoming stockholders of
BRPA.
On February 23, 2021, NeuroRx announced that its Phase 2b/3 trial
of ZYESAMI™ (aviptadil) for the treatment of patients with
respiratory failure due to critical COVID-19, which was performed
in collaboration with Relief Therapeutics Holdings, AG, has
demonstrated 10-day accelerated recovery from respiratory failure
in critically ill patients with COVID-19 treated with high flow
nasal oxygen at the day 28 interim endpoint, and that NeuroRx
intends to file for Emergency Use Authorization if positive results
continue to be demonstrated at the day 60 endpoint in line with new
guidance from the Food and Drug Administration. The press release
is attached as Exhibit 99.1 to this Current Report on Form
8-K.
The information set forth under this Item 7.01 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 filed or 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 February 23, 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: February
23, 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 Announces that ZYESAMI™ (Aviptadil) has Successfully
Demonstrated 10-Day Accelerated Recovery from Respiratory Failure
in Critically Ill Patients with Covid-19 Treated with High Flow
Nasal Oxygen at 28 Day Interim Endpoint
NeuroRx to File for Emergency Use Authorization in This Patient
Population if Positive Results Continue to be Demonstrated at
Day-60 Endpoint in Line with FDA's New Guidance
RADNOR,
Pa., Feb. 23, 2021 – NeuroRx, Inc. announced
today that the Phase 2b/3 trial1 of ZYESAMI™
(aviptadil, previously RLF-100™) for the treatment of
Respiratory Failure in critically ill patients with
Covid-19
has demonstrated multidimensional benefit around its prespecified
primary endpoint of Recovery from Respiratory Failure with
discharge from hospital and ICU (without relapse) by day 28 in
patients with critical Covid-19 who were treated with High Flow
Nasal Oxygen. Although not envisioned at the start of the clinical
trial, High Flow Nasal Oxygen has become the predominant form of
treatment in Covid-19 respiratory failure, with mechanical
ventilation reserved for those whose blood oxygen levels cannot be
maintained on this less invasive modality. The trial was conducted
at 10 U.S. hospitals under the direction of NeuroRx in
collaboration with RELIEF
THERAPEUTICS Holding AG (SIX: RLF;OTCQB: RLFTF).
NeuroRx has signed an agreement to complete a business combination
with Big Rock Partners Acquisition Corporation (NASDAQ:
BRPA).
The clinical trial was originally approved as a 28 day study at
FDA’s direction. In December, NeuroRx added a 60 day
endpoint based on the recognition that the traditional
28-day endpoint adopted in the 1990s for trials in Acute
Respiratory Distress Syndrome is not appropriate for critically ill
patients with Covid-19, who are frequently maintained in the ICU
with advanced technologies well beyond this time point. NeuroRx and
other clinical trial sponsors alerted FDA to this trend
and yesterday
the FDA published formal guidance2 changing the required time
for measuring the prespecified endpoint of “alive and free of
respiratory failure” in critically ill patients to 60 days.
Interim data are being reported because they were unblinded as per
the original protocol and the last patient in the trial reached day
60 yesterday. Therefore, study conduct cannot be adversely
influenced by release of these interim
findings.
At 28 days, patients treated with ZYESAMI™ demonstrate 35%
higher likelihood of recovery from respiratory failure with
continued survival compared to patients treated with placebo
(Hazard Ratio 1.53; P=.08). In tertiary care hospitals,
ZYESAMI-treated patients were 46% more likely to recover and return
home before day 28 (Hazard Ratio controlling for age and severity
1.84; P=.058). Should these trends continue through day 60, they
have the potential to reach statistical significance. At day 28, a
highly significant 10-day difference in median time to recovery and
hospital discharge has emerged in ZYESAMI-treated patients compared
to those treated with placebo (P<.006).
Should the above trends continue through day 60, NeuroRx
anticipates filing a request for Emergency Use Authorization in
this population of critically-ill patients (i.e. those on High Flow
Nasal Oxygen) who have exhausted all currently approved treatments.
FDA decisions implement a benefit/risk framework. NeuroRx
previously announced the high degree of safety observed with use of
ZYESAMI. This safety has continued to be documented in the more
than 300 additional patients treated under the Expanded Access
Protocol and in patients who have filed requests under the federal
Right to Try act.
Yesterday’s guidance emphasizes the importance of analyzing
patient outcomes by treatment subgroup and, in this case, the study
did not recruit enough patients treated with mechanical ventilation
to confirm the benefit seen in open-label studies. In the seven
months that have elapsed since the trial began, mechanical
ventilation has gone from first line therapy to treatment of last
resort for patients with Covid-19. Recognizing this, NeuroRx signed
clinical trial agreements with the I-SPY clinical trial platform
and the National Institutes of Health under which ZYESAMI will
continue to be evaluated in patients who require mechanical
ventilation.
The study’s principal investigators, Dushyantha Jayaweera,
M.D., FACP (University of Miami), Professors J. Georges Youssef,
M.D. (Houston Methodist Hospital), and Richard Lee, M.D.
(University of California, Irvine) commented, “We are excited to report that ZYESAMI
demonstrates a highly significant reduction in time to recovery
compared to patients treated with placebo in those treated with
High Flow Nasal Oxygen, together with increased likelihood of
recovery and excellent safety. We look forward to learning whether
this benefit can also be shown for patients treated with other
stages of Covid-19 with inhaled forms of ZYESAMI. We look
forward to working with the sponsor to secure emergency use
authorization for ZYESAMI in this population of
patients.”
Jonathan C. Javitt, M.D., M.P.H., CEO of NeuroRx, added,
“We look
forward to reporting the final 60 day efficacy data shortly. We are
indebted to the researchers, patients, and families who have helped
us demonstrate this meaningful clinical benefit for ZYESAMI. We are
honored to name the drug in honor of the late Prof. Sami Said who
discovered its active ingredient, VIP. Additional efficacy data on
patients who require mechanical ventilation will be obtained from
ongoing research supported by BARDA and the National Institutes of
Health, in addition to our newly initiated study of inhaled use
ZYESAMI in hospitalized patients who have not yet developed
respiratory failure”
1 (www.clinicaltrials.gov
NCT04311697)
2 COVID-19: Developing Drugs and Biological
Products for Treatment or Prevention.
https://www.fda.gov/media/137926/download
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 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-100TM (aviptadil) is
being investigated in two placebo-controlled U.S. late-stage
clinical trials in respiratory deficiency due to COVID-19. Relief
holds a patent issued in the United States and various other
countries covering potential formulations of RLF-100TM.
RELIEF
THERAPEUTICS Holding AG 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 Follow
us on LinkedIn
|
CORPORATE
CONTACTS
NeuroRx,
Inc.
Jonathan C. Javitt,
M.D., MPH
Chairman and Chief
Executive Officer
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
|
Disclaimer - Relief:
This
communication expressly or implicitly contains certain
forward-looking statements concerning RELIEF THERAPEUTICS Holding
AG. The results reported herein may or may not be indicative of the
results of future and larger clinical trials for the treatment of
respiratory failure from COVID-19 or other respiratory diseases.
Such statements involve certain known and unknown risks,
uncertainties and other factors, which could cause the actual
results, financial condition, performance or achievements of RELIEF
THERAPEUTICS Holding AG to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Such forward-looking statements do not
constitute guarantees of future performance and are subject to a
variety of risks and uncertainties, including whether the results
described herein will be sufficient to gain any regulatory
approvals for RLF-100™. RELIEF THERAPEUTICS Holding AG is
providing this communication as of this date and do not undertake
to update any forward-looking statements contained herein as a
result of new information, future events or otherwise.
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.