HOPE Therapeutics™, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announce Dr. Jonathan Javitt and Dr. David Feifel to Present Keynote Address, Beyond Ketamine Monotherapy: Combined Interventional Treatment of Suicidal Depression and PTSD, at the 8th Annual Neuroscience Innovation Forum in San Francisco

Rhea-AI Summary

NRx Pharmaceuticals (NASDAQ:NRXP) and its subsidiary HOPE Therapeutics have announced that Dr. Jonathan Javitt and Dr. David Feifel will deliver a keynote address at the 8th Annual Neuroscience Innovation Forum in San Francisco on January 12th, 2025. The presentation, titled 'Beyond Ketamine: Combined Interventional Treatment of Suicidal Depression and PTSD,' will focus on integrating NMDA-targeted drug therapy with emerging treatments like Transcranial Magnetic Stimulation and Digital Therapeutics.

Key developments include:

• A binding term sheet for $27 Million in anticipated funding for HOPE clinic acquisitions and pharmaceutical operations
• Planned acquisitions of Kadima Neuropsychiatry Institute and Dura Medical
• Initiation of NDA filing for NRX-100 (IV ketamine) for suicidal depression treatment

Upcoming milestones for Q1 2025 include the completion of NRX-100 filing, targeted NDA filing for NRX-101, and further HOPE clinic acquisitions.

• The Keynote Address, entitled "Beyond Ketamine: Combined Interventional Treatment of Suicidal Depression and PTSD," will be presented at 10:30AM PT on Sunday January 12^th, 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 8^th 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.

FAQ

What is the significance of NRXP's keynote presentation at the 2025 Neuroscience Innovation Forum?

The keynote will showcase NRXP's approach to combining ketamine therapy with other treatments like TMS and Digital Therapeutics for enhanced treatment of suicidal depression and PTSD, potentially offering more effective and durable patient outcomes.

How much funding is NRXP securing for HOPE Therapeutics' clinic acquisitions?

NRXP has secured a binding term sheet for $27 Million in anticipated funding for HOPE clinic acquisitions and pharmaceutical operations.

What are NRXP's key regulatory milestones for Q1 2025?

NRXP plans to complete the NRX-100 FDA filing and submit an NDA for NRX-101 for Accelerated Approval in Q1 2025.

Which clinics is HOPE Therapeutics planning to acquire first?

HOPE Therapeutics is planning to first acquire Kadima Neuropsychiatry Institute and Dura Medical as cornerstone acquisitions for its international network of interventional psychiatry clinics.

What treatments is NRXP developing for suicidal depression?

NRXP is developing NRX-100 (IV ketamine) and NRX-101 (Oral DCS/Lurasidone) for the treatment of suicidal depression, with NDAs planned for both treatments.