Form 425 Big Rock Partners Acquis Filed by: Big Rock Partners Acquisition Corp.
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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 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 8.01. Other Events.
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 9, 2021, NeuroRx reported preliminary results from the
Phase 2b/3 trial of ZYESAMI™ (aviptadil), performed in
collaboration with Relief Therapeutics Holdings, AG, in patients
with respiratory failure due to critical COVID-19. The press
release is attached as Exhibit 99.1 to this Current Report on Form
8-K and incorporated herein by reference.
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 9, 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
9, 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
reports Initial Phase 2b/3 Study Results Demonstrating Significant
Benefit of ZYESAMI™ (aviptadil) in
Reducing
Hospital Stay among Patients with Respiratory Failure due to
Critical COVID-19
If Authorized for Use, ZYESAMI™ Would be First Treatment
Specifically for Critically Ill Patients with Respiratory
Failure
RADNOR, Pa. Feb. 9, 2021 0730– NeuroRx, Inc. today
reported preliminary results from their Phase 2b/3 trial of
ZYESAMI™ (aviptadil, previously RLF-100) performed in
collaboration with Relief Therapeutics Holdings, AG (SIX:RLF;
OTCQB:RLFTF) in patients with respiratory failure due to Critical
COVID-19. The study showed that patients who were treated
with the maximal standard of care plus ZYESAMI were discharged
sooner from the hospital compared to those treated with placebo
plus maximal standard of care (SOC). If authorized for use, ZYESAMI
would be the first drug indicated specifically for COVID-19
patients who are critically ill with respiratory
failure.
Jonathan
Javitt, M.D., M.P.H., CEO of NeuroRx, said: “We are greatly
encouraged by these preliminary findings and believe they are
indicative of a biologic effect of aviptadil in hastening recovery
from Critical COVID-19. We expect to discuss with the Food and Drug
Administration and other regulatory authorities the submission of
an Emergency Use Authorization (EUA) so that ZYESAMI can be
available for treating this population that is at immediate risk of
death and for which there is no approved
therapy.”
With
the improvement in survival since the start of the pandemic,
differences in patient survival were not seen at day 28, and
patients are now being followed through day 60. The study has not
identified an overall difference in the stated primary endpoint of
recovery from respiratory failure from summary data. However,
investigators are in the process of confirming the timing of each
case of recovery from medical records, following which the
study’s investigators’ committee will review each case
prior to patient-level unblinding of this endpoint. Those data are
expected within a few weeks and will provide further insight into
the benefits of ZYESAMI. A blinded substudy of radiographic
improvement is similarly underway.
Among
the secondary efficacy endpoints evaluated in patients treated with
High Flow Nasal Cannula (HFNC) therapy and with Mechanical
Ventilation, ZYESAMI showed an advantage in 15 of 16 comparisons
and demonstrated a 40% or better advantage (hazard ratio <0.7).
The likelihood of this magnitude of advantage being seen by chance
alone is about 1 in 2,000 (P=.0005). This difference includes at
least a five-day median reduction in hospital stay. (P=.043). The
largest difference observed was among those treated with HFNC who
experienced a median of 11 fewer days in hospital (15 vs.
26).
Dr.
Javitt said: “The data provide preliminary support for
ZYESAMI as a drug that may help get critically-ill patients home to
their families sooner. The hospitalization data further suggest
that patients treated at an earlier stage of illness (i.e., those
who can be managed with HFNC) may have a better response to
treatment. We have launched a phase 2/3 trial to explore
ZYESAMI’s inhaled use in patients who are not yet in
respiratory failure.
“Further
study of ZYESAMI’s role in critical COVID-19 will be
conducted under the BARDA and DOD Medical Countermeasures-funded
I-SPY trial.
Dr.
Javitt added: “To our knowledge this is the first
demonstration of clinically and statistically-significant benefit
by any therapeutic agent in patients with COVID-19 respiratory
failure in a randomized, double blind, prospective trial. Other
COVID-19 therapeutics have demonstrated clinical advantage in
patients with non-critical COVID-19 (ordinal scale 4 and 5) but
have not demonstrated benefit in those with Critical COVID-19
(ordinal scale 6 and 7). Steroids have demonstrated benefit in open
label studies. However, no randomized controlled trial to
date has shown efficacy when patients are in respiratory failure
and require High Flow Nasal Cannula, Non-invasive ventilation, or
Mechanical Ventilation to maintain blood oxygenation. ZYESAMI, if
authorized, would be the first drug for such critically ill
patients. Of note, the patients who received either drug or placebo
in this trial also received all approved and standard of care
treatments including Remdesivir, anti-cytokine drugs, steroids, and
anticoagulants.”
Dr.
Javitt added: “We are forever indebted to the study
coordinators, nurses, respiratory therapists, and doctors who
carried out this study in the midst of a public health calamity
that so far has claimed the lives of nearly half a million
Americans and millions worldwide. Our study teams kept the effort
going despite contracting COVID themselves, losing family members,
and dealing with an unimaginable daily reality.
The
data were generated in multicenter clinical trial whose subjects
were COVID-19 patients with respiratory failure being treated with
the maximal standard of care that included anti-coagulants,
steroids, convalescent plasma and antiviral drugs. The
primary endpoint was the resolution of respiratory failure within
28 days after treatment started. The secondary endpoints were
patient survival, time to ICU discharge, time to hospital
discharge, time to return to NIAID score of 6-8, and
safety.
A total
of 203 patients were screened and consented to participate in the
study; 136 were given ZYESAMI. while 67 received the standard of
care. All patients were evaluated through Day 28 with planned
long-term follow-up through day 60. A total of 138 patients (91
ZYESAMI, 47 SOC) survived through Day 28. Ninety-six patients (65
ZYESAMI, 31 SOC) were discharged from the hospital by Day 28. Data
analysis per protocol is ongoing.
The
study, conducted in 10 medical centers, also showed the safety of
the drug when administered by intravenous infusion in the ICU. No
unexpected side effects identified. The most common side effects of ZYESAMI in the
clinical trial were mild to moderate diarrhea (seen in 30% of
ZYESAMI-treated vs. 1.5% of placebo-treated patients) and systemic
hypotension (low blood pressure) seen in 31 ZYESAMI-treated
patients vs. 25 placebo patients. There were two deaths in the
study related to hypotension, both of which occurred more than a
week after treatment. One patient was in the ZYESAMI group, and the
other was in the placebo group. All potentially serious adverse
effects were investigated by a board-certified critical care
physician together with site investigators, and none was deemed
drug-related.
Conference Call Information
NeuroRx
will host a conference call and webcast on February 9, 2021 at 9:00
a.m. EST to discuss study results. To participate in the conference
call, dial +1 866-373-3402 (Toll-Free) or +1 201-689-7825
(International), shortly before 9:00 a.m. EST. The webcast can also
be accessed directly at https://78449.themediaframe.com/dataconf/productusers/nrx/mediaframe/43588/indexl.html.
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 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, 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 to
transmission of oxygen to the body.
COVID-19-related
respiratory failure is caused by selective infection of the ATII
cell by the SARS-CoV-2 virus. They 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.
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. The Company recently
announced a plan to merge with Big Rock Partners Acquisition Corp
(NASDAQ:BRPA)
(“Big Rock”), following which it is expected to trade
on the NASDAQ as 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 the Company's future financial or
operatingperformance. 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 the Company’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. Such forward-looking statements do not
constitute guarantees of future performance and are subject to a
variety of risks and uncertainties. The Company 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
document relates to a proposed Business Combination and related
transactions (the “Transactions”) between the Company
and Big Rock Partners Acquisition Corp. (“BRPA”). 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 the Company, and
other relevant documents with the SEC. The proxy
statement/prospectus/consent solicitation statement will be mailed
to stockholders of the Company and BRPA as of a record date to be
established for voting on the proposed business combination.
INVESTORS AND SECURITY HOLDERSOF THE COMPANY 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 BECAUSETHEY 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 the Company 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
The
Company, 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 the Company’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.
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