Four potential near-term milestones, including
data from two clinical trials, an NDA filing and an upcoming share
dividend
-- 50% reduction in corporate overhead and 25% reduction in
overall net loss in 2023, compared to 2024 with $0.20 per share improvement in negative earnings.
Additions to working capital of $8
million in Q1 2024.
-- Company forecasts first commercial revenue in 2024 from
sales of ketamine and related technologies. Company received
advance of first milestone payments in 2024 for ongoing development
of NRX-101 from Alvogen and Lotus Pharmaceuticals, Inc.
(1975.TW)
-- Company announces new partnership around the first drug to
potentially modify the underlying cause of schizophrenia
-- Data lock this week and top-line data expected this month,
after completed enrollment of the Phase 2b/3 trial of NRX-101 in Treatment Resistant
Bipolar Depression (TRBD); trial demonstrated 94% rater
concordance, far in excess of industry norms and exceeded industry
norms in medication compliance
-- Two new Investigational New Drug applications (INDs)
accepted by the US Food and Drug Administration (FDA) for NRX-101
in Chronic Pain and Complicated UTI.
-- Data lock expected this week in 200-person DOD-funded
trial of D-cycloserine (DCS), the key component of NRX-101, to
treat chronic pain, conducted by Northwestern
University
-- Grant of Qualified Infectious Disease Product (QIDP), Fast
Track and Priority Review designations for NRX-101 in the treatment
of Complicated Urinary Tract Infection (cUTI); Publication last
week of QIDP-qualifying data in a peer-reviewed journal. NRx is
reviewing partnership options
-- Established HOPE Therapeutics to develop and launch IV
Ketamine together with related technologies with FDA New Drug
Application to be submitted this year. In advance of FDA approval,
HOPE is partnered with national 503b
and 503a pharmacies to address the ketamine shortage declared by
FDA. HOPE is planned to be spun out as a separate company to be
owned by NRx, current NRx shareholders via a tax-free dividend, and
new investors; Term Sheets received from prospective anchor
investors for $60 million of new
investment, once publicly listed
-- HOPE is presenting data from four randomized, prospective
trials demonstrating safety and efficacy in 800 patients of IV
Ketamine in treating severe and suicidal depression as the clinical
basis for New Drug Application (NDA) for HTX-100 (IV Ketamine);
expecting stability and CMC data sufficient for NDA filing by
June 2024.
-- Added over $8 million in
working capital, including an advance of a $5.1 million milestone payment from partners
Alvogen, Inc. and Lotus Pharmaceuticals
-- Elected nationally recognized attorney in highly regulated
industries, and healthcare specialist, Janet Rehnquist, Esq., to the Company's Board of
Directors
-- Management has taken actions to address NASDAQ listing
compliance and naked shorting of NRx securities
-- Management to host a conference call, April 1, 2024, at 8:30 AM
ET
RADNOR,
Pa., April 1, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company"), a clinical-stage biopharmaceutical company, today
announced its financial results for the quarter and year ended
December 31, 2023 and provided a
business update.
"2023 was a pivotal year for NRx in which we advanced from a
single clinical trial in a single indication to a dramatically
streamline its operations with a 50% reduction in overhead costs, a
25% reduction in overall costs, and a $0.20 per share improvement in negative earnings,
while completing our clinical trial objectives. We expect data from
two key trials this month and predict our first commercial revenue
by the end of 2024. 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 IV
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 and look forward sharing further results in our
conference call."
Fourth Quarter Clinical, Regulatory and Corporate
Highlights
Development of NRX-101 for Treatment-Resistant Suicidal Bipolar
Depression
The Company has announced today that it expects data lock this
week and release of top line data this month in its Phase
2b/3 trial of NRX-101 in Suicidal
Bipolar Depression. In 2023, the Company published results of a
phase 2 trial demonstrating that oral NRX-101 extends the effect of
IV ketamine in reducing both suicidality and depression in patients
presenting to the hospital. This trial is designed to determine
whether oral NRX-101 can reduce depression and suicidality in
outpatients, which would be a massive broadening of the potential
market for the drug. This potential expansion was guided by the
Company's January 2023 meeting with
the FDA in which NRx was advised to seek approval for NRX-101 as a
drug for bipolar depression as a chronic, intermittent disease, a
far broader indication.
With the completion of data collection, an unprecedented data
integrity standard (94% agreement between site raters and central
raters) has been achieved across the completed cohort of
patients.
In 2023, the Company completed manufacture and Chemical
Manufacturing Controls for NRX-101. This initiative is expected to
yield stability data sufficient to support a shelf life in excess
of two years at time of potential drug launch (should the clinical
trials be successful). The completion of this manufacturing
milestone allowed the Company to decrease its ongoing expenditure
associated with manufacturing and development of chemical
manufacturing controls.
During Q4 and in early 2024, the Company has continued to
solidify its working relationship with Alvogen and Lotus, and begun
working in unison to plan the final development and
commercialization of NRX-101. These partners recently advanced
$5 million of the first milestone to
the Company. As previously announced, a successful readout from
this trial and FDA interaction will trigger an additional
$4 million milestone payment together
with transfer of future development costs to our partner. The
partnership provides for potential milestones of $329 million and a royalty reaching 15% on Net
Sales.
NRX-101 for Treatment of Chronic Pain:
The Company has previously detailed the scientific basis for
treatment of chronic pain with DCS as outlined in a 2016 scientific
paper published by Schnitzer, et. al. and in the White Paper posted
by the Company's Scientific Leadership (Sappko, et. al.). In
2023, the Company licensed US Patent 8,653,120 for the use of
DCS in chronic pain and filed a now-accepted Investigational New
Drug (IND) application with the FDA to initiate commercial drug
development of NRX-101 in chronic pain.
Chronic pain affects more than 50 million American adults,
compared to the approximately 3 million who report thoughts of
suicide on an annual basis. There has been no new non-opioid class
of drugs to treat nociceptive pain in the past two decades and
NRX-101 has the potential to be the first N-methyl-D-aspartate
(NMDA)-antagonist drug to seek approval for this indication. Today,
ketamine is used off label to treat nociceptive pain, despite its
clear limitations (addiction, neurotoxicity, hallucination, and the
need for IV administration.)
The Company is advised that data lock will occur this week in a
200-person randomized prospective trial funded by the US DOD (NCT
03535688) in which patients with chronic pain were randomly
assigned to DCS 400mg/day vs. placebo. Top line results will
follow. Should these results support efficacy of DCS in the
treatment of chronic low back pain, they are expected to provide a
Breakthrough Therapy path towards treatment of chronic pain with
DCS and DCS-containing medicines.
Spin out of HOPE Therapeutics and progress towards an NDA for
NRX-100 (ketamine) in the treatment of suicidal
depression.
When NRx met with the FDA in January
2023, the agency strongly encouraged the Company to develop
NRX-100 (IV Ketamine) as a labeled drug, rather than rely on prior
stabilization of suicidality and depression achieved via the common
clinical practice of infusing generic ketamine compounded in
licensed pharmacies. Shortly thereafter, the FDA issued the first
of two advisory letters warning physicians against using compounded
forms of ketamine and began a program of rigorous inspections of
such pharmacies. Although there was once an expectation that
intranasal administration of ketamine would be effective in
treating suicidality, the attempts to demonstrate the clinical
efficacy of nasal racemic ketamine for acute suicidality have not
succeeded.
Accordingly, in Q3 the Company finalized a scientific
collaboration with Prof. Marion
Leboyer of Paris, France
and Prof. Mocrane Abbar of Lyon,
France in order to incorporate the results of a 156-person
inpatient trial of intravenous ketamine vs. placebo for the
stabilization of patients admitted for acute suicidality (the KETIS
trial). The findings of the trial demonstrate a statistically
significant reduction in both suicidality (the primary endpoint)
and depression (the secondary endpoint) among patients treated with
intravenous ketamine compared to those treated with placebo.
(Link)
In the fourth quarter, the company similarly licensed data from
Columbia University. In this trial,
Dr. Michael Grunebaum and colleagues demonstrated a rapid
and statistically significant reduction in Suicidal Ideation (SSI)
at day 1 (p=0.0003) and in depression (P=0.0234), as measured by
the Profile of Mood States (POMS) among patients randomized to IV
Ketamine compared to those randomized to midazolam. This trial
was published in the American Journal of Psychiatry
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5880701/.
The patient-level deidentified data from both studies have now
been received by the Company and are being assembled in the
electronic format required by the FDA. The Company believes that
these randomized, blinded prospective trials encompassing nearly
240 participants, when submitted for review at a patient level
could be sufficient to demonstrate preliminary safety and efficacy
of intravenous ketamine in acutely suicidal patients. Data are
expected to be transmitted to FDA by the end of 2Q23.
Submission of an NDA for the use of IV Ketamine is dependent
upon submission of a manufacturing file documenting the manufacture
of a presentation of ketamine suitable for single-patient use in
the treatment of suicidal depression. In November 2023, the Company initiated manufacture
of ketamine together with Nephron Pharmaceuticals, Inc.
(West Columbia, SC) to develop a
single patient presentation of ketamine. This formulation is
expected to overcome some of the formulation deficiencies of
existing forms of ketamine (developed for anesthesia) and is
expected to have diversion-resistant and tamper-resistant
features.
On March 30, 2024, the Company
booked first commercial delivery of ketamine manufactured to
503b pharmacy standards from Nephron.
HOPE will be distributing this presentation to qualified ketamine
clinics in coordination with Nephron under Nephron's 503b pharmacy license in light of the current
FDA-declared drug shortage of ketamine, starting this month
(April 2024).
Treatment of Urinary Tract Infection (UTI) and Urosepsis:
Although treatment of UTI is quite different from use of NRX-101
to treat Central Nervous System disorders, D-cycloserine was
originally developed as an antibiotic because of its role in
disrupting the cell wall of certain pathogens. This is true of a
number of drugs used in psychiatry today. D-cycloserine fell out of
favor as an antibiotic in the 1970s because of the CNS effects
caused by its NMDA-blocking properties and because of the
widespread availability of effective first and second-generation
antibiotics.
During Q3 2023, NRx tested NRX-101 and its components against
resistant pathogens that appear on the Congressionally-mandated
Qualified Infectious Disease Product (QIDP) list and proved in
vitro effectiveness against antibiotic-resistant E. coli,
Pseudomonas, and Acinetobacter. Accordingly, NRx was granted
QIDP designation, Fast Track Designation, and Priority Review by
the US FDA.
In recent years, increased antibiotic resistance to common
pathogens that cause urinary tract infections and urosepsis (i.e.,
sepsis originating in the urinary tract) has resulted in a marked
increase in cUTI, hospitalization, and death from urosepsis. The US
Center for Disease Control and Prevention reports that more than
1.7 million Americans contract sepsis each year, of whom at
least 350,000 die during their hospitalization or are
discharged to hospice (CDC Sepsis Ref.). There are
approximately 3 million patients per year who contract cUTI in the
US annually (Lodise, et. al.). Additionally, should NRX-101 succeed
in clinical trials, the Company will consider developing a
follow-on product that is anticipated to achieve another 20 years
of patent exclusivity.
Qualification for QIDP affords a sponsor five years of
additional market exclusivity from FDA, regardless of patent
status.
The Company does not anticipate funding this initiative with
core NRx assets and is exploring structures for partnership
opportunities. Should the Company or its partners succeed in
serving 10% of the cUTI market, the Company believes that the
revenue from NRX-101 has the potential to hundreds of million
annually, based on 3 million cases per year (Lodise, et. al.) in
the US and potential pricing of over $3,500/course of therapy.
Cash runway and financing
The Company continues to believe cash on hand is sufficient to
fund operations through potential delivery of the upcoming
milestones described herein.
Financial Results for the Quarter and Year Ended December 31, 2023
For the three months ended December 31,
2023, we at NRx Pharmaceuticals reduced our net loss from
$10.2 million in the final quarter of
2022 to $4.3 million in 2023,
representing nearly a 60% improvement year over year. For that same
period, we reduced research and development expenses from
$4.5 million in 2022 to $2.5 million in 2023, while substantially
improving and finalizing our clinical trial enrollment. The
$2.0 million decrease is related
primarily to a decrease of $1.1
million in clinical trial expenses, $0.6 million in stock-based compensation, and
$0.2 million in consulting and
personnel wage costs. Also in that 3 month period we recorded
a 67% reduction in general and administrative expenses, from
$5.4 million in 2022 to $1.8 million in 2023. The decrease of
$3.6 million is related primarily to
a decrease of $1.3 million in
insurance expenses, $1.3 million in
stock-based compensation, $0.5 million in employee expenses,
$0.2 million in legal and
professional consulting fees, and $0.2
million in franchise tax expenses.
For the year ended December 31,
2023, NRx Pharmaceuticals reduced its net loss to
$30.2 million compared to
$39.8 million in the prior year.
These efficiencies represent an improvement in net loss of nearly
$10.0 million year over and a
20 cent, or 34%, improvement in net
loss per share year over year. Over that annual period we
recorded $13.4 million of research
and development expenses compared to $17.0
million for the same period in 2022 representing a 21%
decrease year over year. The decrease of $3.6 is related primarily to a decrease of
$2.1 million in clinical trial and
development expenses, $0.9 million
related to fees paid to regulatory and process development
consultants, $0.8 million in
stock-based compensation while offset by a $0.2 million increase in patent costs as our
patent portfolio has expanded.
Please note that the improvement in G&A expenses is even
larger than the improvement in other areas. We decreased G&A by
$13.1 million, from $27.3 million in 2022 to $14.2 million in 2023, nearly a 50% decrease year
over year.
As of December 31, 2023, we had
$4.6 million in cash and cash
equivalents. Over the first three months of 2024 we improved our
access to working capital by $8
million total, representing $2.9
million from equity sales and $5.1
million from the Alvogen milestone advance, while reducing
our corporate indebtedness by 50% as shown in our financial
statements.
We continue to implement operational efficiencies to extend
runway and focus on our path to generating revenue. We
believe that the near-term delivery of clinical trial data and the
planned the launch of HOPE Therapeutics will be defining events in
the second quarter of 2024.
Conference Call and Webcast Details
A live webcast of the conference call will be available on the
Company's website at 8:30 a.m. ET
today, at https://ir.nrxpharma.com/events. An archive of the
webcast will be available on the Company's website for 30
days. Participants that are unable to join the webcast can
access the conference call via telephone by dialing domestically
1-877-704-4453 or internationally 1-201-389-0920.
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. 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.