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$NRX Pharmaceuticals(NRXP.US)$ RADNOR, Pa., Feb. 5, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced the incorporation of HOPE Therapeutics, a biotechnology company dedicated to bringing NRX-100 (IV Ketamine), which will be re-designated HTX-100, a potentially lifesaving treatment option for patients with Suicidal Depression. The company will initially be owned by NRx and its current shareholders, who will receive their shares in the form of a dividend with an accompanying royalty coupon tied to future sales of HTX-100, subject to Board approval. This is designed with counsel to not be a taxable event for shareholders.
"Incorporating HOPE Therapeutics is another important step in building value for NRx shareholders. As previously disclosed, this initiative allows HTX-100 to be valued on its own merits and to focus on commercialization together with the future addition of digital therapeutics, a series of activities quite different from the drug development activities of NRx. As such, HOPE offers shareholders a very different investment profile, one that has already attracted a $30 millioninvestment commitment upon HOPE's planned public listing," said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. "This year, we hope to bring this potentially lifesaving acute care medicine to the 3.5 million people in the United States who make a plan to commit suicide annually (CDC Suicide Data). Particularly in the case of bipolar depression, the only FDA approved treatment option is electroconvulsive therapy (ECT)."
HOPE is dedicated to providing an FDA-approved presentation of IV Ketamine, manufactured to current federal standards, in a diversion- and abuse-deterrent presentation. A New Drug Application (NDA) is planned for the first half of 2024, based on more than 1,000 patients treated in well-controlled trials of ketamine in Suicidal Depression together with HOPE's expertise in sterile products formulation.
Importantly, the Company intends to provide state-of-the-art patient and reimbursement support for all of its patients and their clinics. Access to insurance coverage is critical for providing treatment to this vulnerable population and can only be achieved through development of an FDA-approved product. Additionally, providing an approved, compliant product for patients allows clinics to deliver state-of-the-art care to people suffering from suicidality without fear of legal and regulatory actions.
NRx also expects to convene a shareholder meeting in the coming weeks to vote on the planned structure of the spin-out of Hope Therapeutics and the stock dividend. The company further announces cancellation of the previously announced February 7 shareholder meeting to approve the option of a reverse stock split to maintain NASDAQ compliance; this will be rescheduled, if necessary.

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