- Company to present full compliance plan, based on achieving
clinical milestones, to Nasdaq on January 4, 2024
RADNOR, Pa., Jan. 2, 2024 /PRNewswire/ -- NRx Pharmaceuticals,
Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a
clinical-stage biopharmaceutical company today announced an update
on plans to achieve compliance with Nasdaq market requirements
related to minimum bid price and total Market Value of Listed
Securities (MVLS). As has been previously disclosed, Nasdaq
presented NRx with two deficiency notices, one related to failure
to maintain the minimum $1 bid price
and the other related to failure to maintain the minimum MVLS for
the Nasdaq Global Market (i.e., and MVLS of $50 million). Because there were two simultaneous
deficiencies, the Company did not qualify for a second automatic
180-day compliance period on the bid price deficiency.
As was shared by the Company's CEO at the annual meeting of
shareholders held on December 19,
2023, NRx has requested that Nasdaq move its listing to the
Nasdaq Capital Market, where the MVLS is set at $35 million. The Company is pleased to
announce that it has demonstrated compliance with the $35 million MVLS since Dec
18, 2023, and aim to maintain compliance with this
requirement going forward. Achieving compliance with the Nasdaq
Capital Markets MVLS threshold renders NRXP eligible for a second
180-day compliance period to reach a bid price of $1.
The Company will present its going-forward compliance plan to
Nasdaq on January 4, 2024. That
compliance plan is largely based on achieving clinical and
regulatory milestones as outlined previously and summarized below.
As part of that compliance plan, we are required to demonstrate a
capacity to effect a reverse stock split if needed to achieve bid
price compliance by the end of the second 180 period that occurs on
April 15, 2024. Accordingly, we filed
a Form 14A preliminary proxy statement on December 29, 2023 announcing a meeting of
shareholders to be held on February 7,
2024, at which shareholders are asked to vote to authorize
the Board of Directors to effect a reverse split, in the event that
the Company does not reach compliance with the $1/share bid price by April 15, 2024. This is required by the
Nasdaq committee to demonstrate the Company's commitment to
regaining compliance. Based on the forward momentum that has been
achieved, the Company does not anticipate a need to effect a
reverse split. Should bid price compliance be reached prior
to February 7, the shareholder
meeting will be cancelled.
NRx currently has four (4) near-term drug approval opportunities
with meaningful commercial and/or monetization prospects:
NRX-100 – Intravenous Ketamine
With recent failures in attempts to develop nasal ketamine, NRx
has the only potential near-term path through the FDA for a labeled
ketamine product that will address the needs of acutely suicidal
patients with both bipolar and unipolar depression. In March 2024, we aim to submit a New Drug
Application based on data from two well-controlled, randomized
trials together with GMP manufacturing data, aiming for two-year
stability at launch. NRx has incorporated HOPE Therapeutics
(HTX) as a vehicle for taking NRX-100 to market. We are developing
this as a spinout that will focus on current income for investors
in a market that could be accessed by the end of 2024.
NRX-101 – Treatment-Resistant Bipolar Depression
Phase 2b/3 trial enrollment is
nearing completion with data expected in early 2024. NRx has
partnered this program with Alvogen for $330
million in potential milestones a ~15% royalty, including a
$10 million milestone payment on
successful readout and FDA comment; Alvogen is responsible for all
development and commercialization costs, following receipt of
positive data and FDA response.
NRX-101 – Chronic Pain
D-cycloserine (DCS) has been shown to reduce nociceptive pain
(~$70b market opportunity) while
demonstrating no potential for addiction and potentially reducing
opioid craving. Expecting imminent readout from U.S. DoD-funded
study evaluating DCS in chronic, refractory low back pain and have
submitted NRX-101 for HEAL funding from NIH.
NRX-101 – Complicated Urinary Tract Infection
While 90% of organisms show resistance to common antibiotics,
data show that DCS is effective against many of these pathogens and
is highly concentrated in the urine. NRx has an open IND for cUTI
and is eligible for FDA Qualified Infectious Disease Product
status. Exploring spin-out or licensing opportunities.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical
company developing therapeutics based on its NMDA platform for the
treatment of central nervous system disorders, specifically
suicidal bipolar depression, chronic pain and PTSD. The Company is
developing NRX-101, an FDA-designated investigational Breakthrough
Therapy for suicidal treatment-resistant bipolar depression and
chronic pain. NRx has partnered with Alvogen Pharmaceuticals around
the development and marketing of NRX-101 for the treatment of
suicidal bipolar depression. NRX-101 additionally has potential to
act as a non-opioid treatment for chronic pain.
NRx has recently announced plans to submit a New Drug
Application for ketamine in the treatment of suicidal depression,
based on results of well-controlled clinical trials conducted under
the auspices of the US National Institutes of Health and newly
obtained data from French health authorities, licensed under a data
sharing agreement. NRx was awarded Fast Track Designation for
development of ketamine (NRX-100) by the US FDA as part of a
protocol to treat patients with acute suicidality.
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SOURCE NRx Pharmaceuticals, Inc.