- Initiated filing of a New Drug Application ("NDA") to the FDA
for NRX-100 (IV Ketamine) for the treatment of Suicidal Depression;
planned filing of an NDA for Accelerated Approval under
Breakthrough Designation and Priority Review of NRX-101 for the
treatment of bipolar depression in people at risk of akathisia.
Both have anticipated PDUFA dates prior to December 31, 2025
- The Company has accepted non-binding potential terms from a
commercial pharmaceutical company to license and distribute
NRX-100, providing over $300 million
in milestones plus tiered double-digit royalties based on net
sales
- Retained a leading regulatory law firm to file a citizen's
petition with the US Food and Drug Administration ("FDA") to remove
benzethonium chloride – a toxic preservative -- from presentations
of ketamine intended for intravenous use; planned 2Q25 filing of an
Abbreviated New Drug Application ("ANDA") for the use of
preservative-free ketamine in all current indications
- HOPE Therapeutics, a wholly owned subsidiary of NRx, signed
non-binding letters of intent to acquire three precision psychiatry
centers and is currently completing financial due diligence and
definitive agreements. Currently negotiating the terms for the
acquisition of six additional centers
- The HOPE acquisitions are planned to form the foundation for a
national network offering interventional psychiatry services to
treat suicidal depression, post-traumatic stress disorder ("PTSD")
and related conditions
- Received and negotiating a term sheet from a publicly-traded
strategic investor currently engaged in manufacturing Transcranial
Magnetic Stimulation ("TMS") devices to provide capital in support
of expansion of further HOPE clinic acquisitions.
- Engaged BTIG as financial advisor for clinic acquisition and
capital formation; leading global financial services firm
specializing in investment banking, institutional trading,
research, and related brokerage services for strategic growth
opportunities
- Regained compliance with the NASDAQ market value of listed
securities ("MVLS") requirement
- Substantially reduced operating costs compared to prior
year
- Management continues to forecast, although no assurances can be
given, profitability on a forward-looking run-rate basis by year
end 2025
WILMINGTON, Del., March 17,
2025 /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, 2024, and provided a business
update.
"Our work in the fourth quarter of 2024 and into 2025 has driven
significant advances for our company and investors. We have retired
debt that was impeding the launch of HOPE Therapeutics and brought
new investors into the Company who are aligned with our objectives.
We launched the filing of a New Drug Application for NRX-100 for
the treatment of Suicidal Depression: a major milestone for NRx.
We also moved NRX-101 toward it's NDA for Accelerated
Approval in bipolar depression in patients at risk of akathisia,
and made meaningful progress building HOPE's best-in-class network
of Interventional Psychiatry Clinics. Additionally, two
potential strategic transactions that are under negotiation could
further accelerate our progress. These accomplishments
advance our mission of preventing and treating suicide: work that
is critical to our patients, their families and our country," said
Jonathan Javitt, MD, MPH, Chairman,
and CEO of NRx Pharmaceuticals. "I would like to thank our team for
its dedication and hard work, and thank our shareholders for their
ongoing support of our mission to bring hope to life."
Key Research and Development and Corporate Activities
NRX-100 (IV, preservative-free
ketamine)
According to the CDC, more than 13 million
adults contemplate suicide each year; NRX-100 – IV ketamine for
Suicidal Depression - can help address this national crisis.
The Company filed Module 3 (manufacturing) of its New Drug
Application ("NDA") for NRX-100 (preservative-free sterile IV
ketamine) in a tamper-resistant, diversion resistant packaging
presentation in the fourth quarter of 2024. NRX-100 was previously
granted Fast Track Designation by FDA in combination with use of
NRX-101. Ketamine efficacy data from four clinical trials are
intended to support the filing. Three manufacturing lots are now
complete, with filed stability data suitable for shelf life
exceeding two years at room temperature. The anticipated PDUFA date
for this NDA is prior to December 31,
2025.
NRX-100 is poised to address the >$3 billion Suicidal Depression market in the
US.
The Company has accepted non-binding potential terms from a
commercial pharmaceutical company to license and distribute NRX-100
(preservative-free IV ketamine) that provides for over $300 million in potential milestones plus a
tiered double-digit royalty, subject to further due diligence and
finalized agreement.
In December 2024 the company
demonstrated long term stability and sterility of a patentable
formulation of preservative-free ketamine, despite longstanding
commercial practice of adding benzethonium chloride as a
preservative to commercially supplied ketamine. This
preservative is a known caustic and toxic substance that has
previously demonstrated corneal neurotoxicity and conjunctival
toxicity in patients, and generalized neurotoxicity in the
laboratory at microgram concentrations. The concentration in
current ketamine preparations is substantially higher, with an
extensive body of scientific literature documenting concern.
Additionally, chronic administration of ketamine is known to
increase the risk of cystitis ( Ref ); the relationship of this
adverse event to benzethonium chloride is unknown. Now that a
long-term stable and sterile preservative-free formulation is
available, the Company is filing a citizens petition to seek
removal of benzethonium chloride from the human and veterinary
ketamine drug supply.
The Company believes that the preservative-free feature of
NRX-100 will be deemed of benefit to patients and is consistent
with evolving federal policy on toxic preservatives in the US food
and drug supply chain. Therefore, in addition to the NDA
designed to add treatment of depression to the current ketamine
label, the Company plans to file an Abbreviated New Drug
Application ("ANDA") in the second quarter of 2025 for the use of
preservative-free ketamine in all currently indicated human and
veterinary applications. The Company believes it has met all
requirements of the ANDA approval process, has demonstrated
manufacturing capacity in excess of one million vials per month,
and is prepared to supply the broad ketamine market.
As a next-generation product, the Company has developed a novel,
patentable pH neutral formulation of ketamine (designed as HTX-100)
based on a proprietary excipient that overcomes ketamine's
insolubility, that will be suitable for both intravenous and
subcutaneous administration. Initial laboratory lots demonstrate
shelf stability and ongoing stability is being assessed. Ketamine
in its current commercial presentations cannot be administered
subcutaneously because of its high acidic (pH 3.5-4.0) properties,
an acidity range that is known to cause pain and skin ulcers. This
product is expected to undergo clinical testing in 2025/2026 and be
ready for FDA approval in late 2026. Oral forms of ketamine
and intranasal racemic ketamine have failed to demonstrate
sufficiently stable blood levels to replace intravenous ketamine.
However, a ketamine formulation capable of achieving clinical
benefit via subcutaneous use – in the manner that diabetes drugs
are currently administered – could facilitate far broader clinical
use of ketamine to treat life-threatening CNS diseases.
The Company has retained a leading regulatory law firm to file
the citizen's petition with the US Food and Drug Administration to
remove benzethonium chloride, a known neurotoxic substance, from
presentations of ketamine intended for intravenous use. The Company
believes that the preservative-free feature of NRX-100 will be
deemed of benefit to patients because of the known toxicity of
benzethonium chloride in current generic products.
NRX-101 (oral D-cycloserine/lurasidone)
Bipolar
depression affects approximately seven million people in the
US. Current treatment options all carry the risk of suicide
and akathisia, a side-effect of serotonin active antidepressants
which is closely related to suicide. People with bipolar
depression and akathisia or suicidality are at imminent risk of
self-harm. These patients need better treatment options
urgently.
The Company announced its intention to file an NDA for
Accelerated Approval under Breakthrough Designation and Priority
Review of NRX-101 for the treatment of bipolar depression in people
at risk of akathisia, based on the Phase 2b/3 and STABIL-B data. Three
manufacturing lots are now complete with more than 12 months of
room temperature shelf-stability. The anticipated PDUFA date for
this application is prior to December 31,
2025.
The Company estimates that the market for the initial
indication is over $2 billion, while
the broad bipolar market could exceed $5
billion.
HOPE Therapeutics
HOPE Therapeutics, a wholly
owned subsidiary of NRx Pharmaceuticals, is developing a new
clinical paradigm for the treatment of depression, PTSD,
obsessive-compulsive disorder, and related CNS conditions. While
there is clinical evidence that NMDA-targeted drugs such as NRX-100
and NRX-101 have the potential to offer clinical benefit, many
patients additionally require neuromodulatory techniques, such as
Transcranial Magnetic Stimulation ("TMS"), digital therapeutics,
traditional psychotherapy and medication management to achieve
long-term remission from suicidal depression and PTSD. Despite the
proliferation of "ketamine clinics" in the US, few psychiatrist-led
entities are successful in offering a comprehensive solution to
patients and families.
During the second half of 2024, the Company began outlining the
plan for HOPE Therapeutics as a national and ultimately
international network of Interventional Psychiatry centers that
will combine NMDA-targeted and future psychedelic drugs with
neuroplastic treatments in an integrated and reproducible manner.
The business model for HOPE Therapeutics is similar to that of
leading national dialysis providers, companies that were
instrumental in making kidney dialysis reliable and reproducible in
a manner that transformed the industry and routinely trade at
double digit P/E multiples.
In 2024, the Company announced a non-binding Letter of Intent to
acquire Kadima, LLC, a pioneering interventional psychiatry clinic
in La Jolla, CA. Kadima's founder, Dr. David Feifel agreed to serve as HOPE's Chief
Medical Innovation Officer post-acquisition. He is one of the first
academic psychiatrists to move ketamine and TMS therapy to the
community care model and was recently featured on Dr. Sanjay Gupta's broadcast entitled "The Wild West
of Ketamine Treatment" as an advocate for how ketamine therapy can
be delivered reliably and responsibly. Link: Wild West of
Ketamine.
Subsequent to the Kadima commitment, the Company has, or
anticipates, contracting to acquire and/or partner with eight
facilities in Florida, aiming for
15-20 facilities in Florida by
year-end 2025.
The clinical centers that are being incorporated in the 2025
acquisition program are currently operating and profitable centers
that the Company believes can experience substantial revenue growth
through the addition of a broader array of comprehensive services.
Management estimates that the acquisition of 20 clinic networks,
each with current revenue of approximately $5 million will be required to meet its 2025
growth target.
Financings
The Company has consummated a series
of financing agreements with an institutional investor for up to
$16.3 million in debt capital, for
which we closed on $10.9 million in
2024 and subsequently closed $8.5
million in a combination of convertible debt and an
above-market common stock and warrant offering in January
2025. Subsequently, we terminated a planned $2 million investment from a smaller fund with
less favorable terms.
The Company has also received and is currently negotiating a
term sheet with a publicly-traded entity engaged in the manufacture
of FDA-cleared devices for Transcranial Magnetic Stimulation to
provide acquisition capital to support the expansion of HOPE
Therapeutics clinics. In addition, it is negotiating with several
commercial lenders to support expansion of HOPE clinics with
standard commercial loans. Although business plans are
subject to change, assuming consummation of the financings on terms
currently contemplated by management, the Company would achieve its
objective of financing less than 50% of the proposed acquisition
costs, thereby enabling the Company to optimize its cost of
acquisition capital as it expands the HOPE clinic network.
Our current financing activities are intended to supplant the
previously announced equity investment in HOPE on more favorable
terms.
Financial Results for the Quarter and Year Ended December 31, 2024
For the three months
ended December 31, 2024, NRx Pharmaceuticals reduced its loss
from operations by approximately $2.0
million to $2.4 million
from $4.4 million in the fourth quarter of 2023,
representing nearly a 45% improvement quarter over quarter
primarily driven by lower research and development costs and a
settlement gain, which were partially offset by an increase in
general and administrative expense. For the three months ended
December 31, 2024, research and
development expense decreased by approximately $1.5 million to $1.0
million as compared to $2.5
million during the fourth quarter ended December 31, 2023. The $1.5
million decrease is primarily related to a decrease in
clinical trial and development expense due to the conclusion of the
phase 2b/3 study for NRX-101.
Finally, general and administrative expense for the three month
period ended December 31, 2024
increased by approximately $0.7
million to $2.6 million as
compared to approximately $1.9
million for the three month period ended December 31, 2023, which was primarily driven by
higher consulting fees related to the potential acquisition of
several psychiatry clinics in support of the growth model for HOPE
Therapeutics.
For the year ended December 31, 2024, NRx Pharmaceuticals
reduced its loss from operations by approximately $9.3 million, or 33.5%, to $18.5
million from $27.8 million for the year ended
December 31, 2023, which was
primarily driven by a decrease in research and development expense.
For the year ended December 31, 2024,
research and development expense decreased by approximately
$7.2 million, or 53.6%, to
$6.2 million as compared to
$13.4 million for the year ended
December 31, 2023 primarily driven by
a decrease in clinical trial and development expense due to
the conclusion of the phase 2b/3
study for NRX-101. Finally, general and administrative expense
for the year ended December 31, 2024
decreased by approximately $0.7
million to $13.5 million as
compared to $14.2 million for the
year ended December 31, 2023
primarily driven by a reduction in insurance and employee costs,
and partially offset by an increase in consulting fees related to
the potential acquisition of several psychiatry clinics in support
of the growth model for HOPE Therapeutics.
As of December 31, 2024, we had approximately
$1.4 million in cash and cash
equivalents. As noted above, in January
2025, the Company completed two financings with aggregate
gross proceeds of approximately $8.5
million. Management believes that current available cash
resources will be sufficient to support ongoing operations through
at least the end of 2025.
NRx continues to implement operational efficiencies to extend
cash runway and maintain focus on our path to generating revenue
and value for our shareholders.
Please see detailed financials on our Form 10-K, filed with the
SEC and available on our website.
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 Monday
March 17, 2025, 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 1-800-717-1738 or internationally 1-646-307-1865.
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 plans to file an NDA for Accelerated Approval for
NRX-101 in patients with bipolar depression and suicidality or
akathisia. 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 initiated a New Drug Application filing for
NRX-100 (IV ketamine) for 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 development stage healthcare
delivery company that intends to develop a best-in-class network of
interventional psychiatry clinics to offer ketamine
transcranial magnetics stimulation (TMS) and other lifesaving
therapies to patients with suicidal depression and related
disorders, 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. 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, including
risks arising from uncertainties and assumptions relating to the
Company's operations, results of operations, growth strategy,
liquidity, HOPE Therapeutic's ability to consummate the
acquisitions of providers for its national network, the Company's
ability to raise adequate capital to fund such acquisitions, and
the Company's ability to spin-off HOPE Therapeutics. 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.
For further information:
Matthew Duffy
Chief Business Officer,
NRx Pharmaceuticals
Co-Chief Executive Officer, HOPE
Therapeutics, Inc.
mduffy@nrxpharma.com
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SOURCE NRx Pharmaceuticals, Inc.
