Four potential near-term milestones, including
data from two clinical trials, an NDA filing and a share
dividend
RADNOR,
Pa., March 28, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announces its anticipated financial results for the quarter and
year ended December 31, 2023 and
provides the following summary of its expected annual report to be
filed later today.
- Improvement in negative Earnings per Share to ($0.40) in FY 2023 vs ($0.60) in prior 12 month period. Management
projects positive cash flow by year-end 2024 via partnerships and
HOPE Therapeutics activities.
- Raised $9.2 in new capital
during FY 2023 with $7.8 million
of additions to working capital during Q1 2024. Reduced corporate
indebtedness by more than 50% from $11.0
million to approximately $5.4
through Q1 2024.
- Signed a development partnership with Alvogen, Inc.,
and Lotus Pharmaceuticals, Inc. (1795.TW) under which the partners
take over phase 3 and commercial costs for NRX-101 in bipolar
depression and fund $330 million in
commercial milestones together with a double digit royalty on
sales, contingent on successful clinical trial data and FDA
meeting.
- Completed enrollment and last patient visit of the Phase
2b/3 trial of NRX-101 in Suicidal
Bipolar Depression with >94% rater concordance through
conclusion of the trial, a measure that substantially exceeds
current industry standards. Final Data Lock expected this week with
Top line data expected in April 2024.
- Acceptance of two new Investigational New Drug applications
(INDs) by the FDA in Chronic Pain and Complicated Urinary Tract
Infection/Pyelonephritis.
- Final statistical analysis plan achieved this week in
200-person DOD-funded trial in treatment of chronic pain with
D-cycloserine (DCS), the key component of NRX-101. The study center
has indicated that data-lock will occur next week. Top-line data
expected in April 2024. Positive data
would support a final registration trial in this multi-billion
dollar indication.
- Incorporated HOPE Therapeutics, Inc. as a
specialty pharma company. HOPE is supporting distribution of
intravenous ketamine, currently listed by FDA on nationwide drug
shortage list to qualified ketamine clinics through nationwide 503a
and 503b FDA-inspected pharmacy
partners. First manufactured lot released for shipment this week by
partner Nephron Pharmaceuticals.
- Obtained patient-level data from three efficacy studies
of ketamine funded by US National Institutes of Health (two
trials) and Government of France
(one trial). Demonstration statistically significant reduction in
severe depression and acute suicidality. US Patient Centered
Outcomes Research Initiative (PCORI) trial published in 2023
documents non-inferiority of ketamine vs Electroconvulsive Therapy
in treatment of Severe Depression with fewer negative side effects
compared to ECT.
- Completed first commercially-manufactured lot
of ketamine (NRX100/HTX-100) in proprietary
diversion-resistant presentation and initiated manufacture of two
additional commercial batches. Anticipates filing of New Drug
Application for treatment of Acute Suicidality by June 2024 upon completion of required 9 month
stability and CMC with anticipated 2024 PDUFA date.
- HOPE has received term sheets for more than $60 million in funding from new investors upon
public listing and is expected to be spun out as a separate
company to be owned by NRx, current NRx shareholders, and new
investors upon completion of final audit and financial
statements
- IND for NRX-101 in the treatment of Complicated Urinary
Tract Infection (cUTI) is based on in vitro data just accepted for
peer-reviewed publication in Antibiotics, an MDPI journal. On the
basis of these findings, FDA granted Qualified Infectious Disease
Product (QIDP),Fast Track and Priority Review designations NRx is
seeking a clinical phase partner for this multi-hundred million
dollar indication.
- Elected nationally recognized attorney in highly regulated
industries, and healthcare specialist, Janet Rehnquist, Esq.,
to the Company's Board of Directors
- Management has taken action to restore Nasdaq listing
compliance and combat illegal naked shorting of NRx securities
- Management to host a conference call April 1, 2024 at 8:30am (conference call to be conducted after
Easter market holiday.
"Over the past year the Company has navigated the most
challenging business environment in the history of the
biotechnology industry. Despite unprecedented headwinds, we
negotiated a critical commercial partnership for our lead compound
in bipolar depression, while retaining rights to the far larger
indications of chronic pain and PTSD," said Stephen Willard, J.D., Chief Executive Officer
and Director of NRx Pharmaceuticals. "We augmented our intellectual
property portfolio to include the use of our lead compound in
chronic pain and anticipate results of a 200-person efficacy trial
that could open a multibillion dollar opportunity in this
therapeutic area. We have acquired sufficient data on safety and
efficacy of ketamine to support a New Drug Application for ketamine
in acute suicidality. We established the foundation of a specialty
pharmaceutical business around ketamine that we expect to yield
positive cash flow by the end of 2024. Finally, we received
unanticipated data supporting the use of our lead compound to treat
complicated Urinary Tract Infection and Pyelonephritis, a condition
that affects 3 million Americans and results in more than 15,000
deaths annually. We believe that NRx is poised for substantial
growth in 2024 look forward sharing further results in our upcoming
filing and conference call."
A final press release on the 10-k filing will be issued
Monday April 1, following the market
holiday.
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 and Lotus 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, as well as a treatment for
complicated UTI.
NRx has recently announced plans to submit a New Drug
Application for HTX-100 (IV ketamine), through Hope Therapeutics,
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.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a
Specialty Pharmaceutical Company, wholly-owned by NRX
Pharmaceuticals focused on development and marketing of an
FDA-approved form of intravenous ketamine for the treatment of
acute suicidality and depression together with a digital
therapeutic-enabled platform designed to augment and preserve the
clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and Section 27A of the Securities
Act of 1933, as amended, including statements about
the planned dividend of shares of HOPE Therapeutics,
the potential effects of the Company's reverse stock split,
potential future stock splits, data from clinical
trials that have not yet been released, and planned
filings with the FDA. These statements include, among others,
statements regarding the proposed public offering and the timing
and the use of the proceeds from the offering. Forward-looking
statements generally include statements that are predictive in
nature and depend upon or refer to future events or conditions, and
include words such as "may," "will," "should," "would," "expect,"
"plan," "believe," "intend," "look forward," and other similar
expressions among others. These statements relate to future events
or to the Company's future financial performance, and involve known
and unknown risks, uncertainties and other factors that may cause
the Company's actual results to be materially different from any
future results, levels of activity, performance or achievements
expressed or implied by these forward-looking statements. You
should not place undue reliance on forward-looking statements since
they involve known and unknown risks, uncertainties and other
factors which are, in some cases, beyond the Company's control and
which could, and likely will, materially affect actual results,
levels of activity, performance or achievements. Any
forward-looking statement reflects the Company's current views with
respect to future events and is subject to these and other risks,
uncertainties and assumptions relating to the Company's operations,
results of operations, growth strategy and liquidity. More detailed
information about the Company and the risk factors that may affect
the realization of forward-looking statements is set forth in the
Company's most recent Annual Report on Form 10-K and other filings
with the Securities and Exchange Commission. Investors and security
holders are urged to read these documents free of charge on the
SEC's website at http://www.sec.gov. Except as may be required by
applicable law, The Company assumes no obligation to publicly
update or revise these forward-looking statements for any reason,
or to update the reasons actual results could differ materially
from those anticipated in these forward-looking statements, whether
as a result of new information, future events or otherwise.
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SOURCE NRx Pharmaceuticals, Inc.