Full Press Release Details
NeuroRx Responds to Issues Raised by Relief Therapeutics Regarding
RADNOR, Pa. April 19, 2021 / PRNewswire/
issues raised by Relief Therapeutics in its release dated April 19,
2021 have no bearing on NeuroRx's ability or commitment to
deliver a safe, effective, and stable lifesaving drug on a
worldwide basis. However, NeuroRx was obligated to
disclose Relief's nonpayment of development costs required
under the signed collaboration agreement.
NeuroRx reaffirms its commitment to honoring its collaboration
agreement with Relief Therapeutics. NeuroRx has repeatedly advised Relief that it will
share all clinical trial data with European and other international
regulators as soon as those data are released to the US
FDA. However, NeuroRx has declined to provide unreleased
clinical trial data to Relief in a manner that could compromise
study integrity. Relief's nonpayment of
costs for the recently completed 60 day
phase 2b/3 trial has not impeded
NeuroRx's path to seeking Emergency Use Authorization or
progressing towards New Drug Approval. The first scientific
report of 60 day data from the phase 2b/3 trial is expected to be released
Similarly, Relief's failure to approve or fund the
inhaled use trial has not impeded the start of that
Relief noted in today's press release that it was well
aware of the stability issues related to aviptadil
when the collaboration agreement
was signed and committed to paying the costs of remediating those
issues. When the merger agreement was signed with BRPA and the S-4
was filed, NeuroRx noted that the stability data provided by Relief
had not yet been validated or replicated and identified this as a
potential risk factor for investors. Solving stability challenges is a
common feature of late stage drug development programs, particularly with
peptides such as aviptadil. NeuroRx's formulation,
manufacturing, and GMP quality team is led by veteran executives
who have piloted similar
projects at leading pharmaceutical companies. Relief's
nonpayment of those remedial formulation and manufacturing
costs has not impeded
NeuroRx's progress to delivering a lifesaving drug to
patients in any way. Indeed, NeuroRx is actively
collaborating with NIH to provide remediated formulation and
stability data to European and South American Regulatory
Authorities so that NIH can extend its recently-announced TESICO
is committed resolving these issues with Relief in an amicable
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
( BRPA ), and intends to apply for listing on the
NASDAQ under the proposed symbol
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
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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