- The Keynote Address, entitled "Beyond Ketamine:
Combined Interventional Treatment of Suicidal Depression and
PTSD," will be presented at 10:30AM
PT on Sunday January 12th, 2025
- Prof. David Feifel MD PHD, designated Chief Medical
Innovation Officer of HOPE and Founder of the Kadima
Neuropsychiatry Institute, is an international thought leader in
the interventional psychiatry space
- NRx Pharmaceuticals recently initiated filing of its NDA for
NRX-100 (IV ketamine) for the treatment of suicidal
depression
- Recent announcement of Kadima Neuropsychiatry Institute
and Dura Medical as planned cornerstone acquisitions for HOPE
Therapeutic's international network of interventional psychiatry
clinics
- $27 Million in anticipated
funding for HOPE Clinic acquisitions and pharmaceutical operations
under a binding Term Sheet with an Institutional Investor
MIAMI,
Jan. 7,
2025 /PRNewswire/ -- HOPE Therapeutics™, Inc.,
("HOPE"), a medical and technology driven company and wholly-owned
subsidiary of NRx Pharmaceuticals, Inc. ("NRx", and
collectively with HOPE, the "Company") (Nasdaq:NRXP), today
announced that Jonathan Javitt MD
MPH, Founder and CEO of NRx and Co-CEO of HOPE, and Prof.
David Feifel MD PHD, designated
Chief Medical Innovation Officer of HOPE and Founder of the Kadima
Neuropsychiatry Institute, will present the Keynote Address at the
8th Annual Neuroscience Innovation Forum on January 12, 2025, at the Marines' Memorial Club
in San Francisco at 10:30am PT. They will also be available for
one-on-one meetings with investors and partners at this meeting and
the JPM healthcare conference (see contact information below
to request a meeting).
The keynote will focus on the integration of
NMDA-targeted drug therapy (such as ketamine) with other emerging
modalities such as Transcranial Magnetic Stimulation (TMS) and
Digital Therapeutics to produce synergistic therapeutic effects
that will permanently alter the clinical trajectory of patients
with suicidal depression, PTSD, and other debilitating
neuropsychiatric conditions for which there is a great need for
better treatments. Although the introduction of ketamine for these
and other indications has been a medical breakthrough, intravenous
ketamine alone is not sufficiently efficacious for many patients,
and may not create a sufficiently durable response for many for
whom it is highly efficacious. Recent data suggest that the
integration of ketamine with other emerging neuromodulation,
pharmacologic and Digital Therapeutics may be key to inducing
improvements that are sufficiently strong and durable to allow all
patients who suffer from suicidal depression and PTSD lead
productive and rewarding lives.
The Sachs Forum, held annually during the JP
Morgan Healthcare Conference week, brings together leaders and
innovators in neuroscience to explore cutting-edge advancements in
therapeutics, neurotechnology, and diagnostics. Lifesaving
therapies for CNS diseases that are widely deployed today were
first presented at this event. Drs. Javitt and Feifel look
forward to sharing insights on the unmet needs in psychiatric care
for patients with suicidal depression and PTSD and the path forward
for HOPE Therapeutics.
Prof. David Feifel, MD PHD, HOPE's newly
designated Chief Medical Innovation Officer, has been a pioneer and
international thought leader for advanced interventional treatment
of psychiatric disorders such as depression, anxiety, PTSD and
related disorders for more than three decades. Among other things,
he is a co-author on a recent landmark expert consensus paper for
treating depression with TMS, endorsed by three leading
organizations in the field (ref). He also established the
first clinical program to use subanesthetic dose ketamine infusions
for neuropsychiatric disorders at UC San Diego, where he is
currently Professor Emeritus of Psychiatry. His 150 peer-reviewed
publications and several patents have provided global thought
leadership on advanced approaches to treating psychiatric
conditions, including integration of medicines like ketamine with
neuromodulation, such as Transcranial Magnetic Stimulation and
Digital Therapeutics.
A replay of the presentation will be available
shortly after the conference on the NRx website.
https://ir.nrxpharma.com/events
HOPE and NRx Key Recent Developments
- Binding term sheet for $27
Million in anticipated funding for HOPE Clinic acquisitions
and pharmaceutical operations
- Announced Kadima Neuropsychiatry Institute and Dura
Medical as the first planned acquisitions for its international
network of interventional psychiatry clinics
- Initiated filing of its NDA to the FDA for NRX-100 (IV
Ketamine) for the treatment of suicidal depression and preparing to
file an NDA for Accelerated Approval of NRX-101 for bipolar
depression with suicidality or akathisia
Upcoming Milestones
- 1Q 2025 - Planned completion of NRX-100 filing with the
FDA
- 1Q 2025 - Targeted NDA filing for NRX-101 (Oral
DCS/Lurasidone) for Accelerated Approval
- 1Q 2025 - Further HOPE clinic acquisitions
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.
About NRx Pharmaceuticals, Inc.
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.
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 satisfaction of closing conditions
necessary to consummate the acquisition of Kadima and Dura, and
obtaining financing necessary to consummate the acquisitions.
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 the risk that the transactions
contemplated by the LOI are not consummated, 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.