RADNOR, PA — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has announced the incorporation of HOPE Therapeutics™, a biotechnology company with an ambitious goal: to offer a lifesaving treatment for patients grappling with suicidal depression.
The newly formed company will focus on the development of NRX-100 (IV Ketamine), now rebranded as HTX-100. This treatment is designed to provide a new option for the estimated 3.5 million people in the U.S who make a plan to commit suicide annually, according to CDC data. For individuals with bipolar depression, the only FDA-approved treatment currently available is electroconvulsive therapy (ECT).
“HOPE offers shareholders a very different investment profile, one that has already attracted a $30 million investment commitment upon HOPE’s planned public listing,” said Dr. Jonathan Javitt, Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals.
The company plans to submit a New Drug Application (NDA) for HTX-100 in the first half of 2024. The application will draw on data from trials involving more than 1,000 patients treated with ketamine for suicidal depression.
HOPE’s mission includes providing an FDA-approved presentation of IV Ketamine, manufactured to current federal standards, in a diversion- and abuse-deterrent presentation. Moreover, the company intends to offer state-of-the-art patient and reimbursement support for all its patients and their clinics.
Achieving insurance coverage is crucial for this vulnerable population and can only be accomplished through the development of an FDA-approved product. Furthermore, offering an approved, compliant product allows clinics to deliver top-quality care to people suffering from suicidality without fear of legal and regulatory repercussions.
NRx will continue to be involved with HOPE Therapeutics. The company and its current shareholders will initially own HOPE, and shareholders will receive their shares in the form of a dividend with an accompanying royalty coupon tied to future sales of HTX-100. This arrangement, subject to Board approval, is designed to not be a taxable event for shareholders.
The incorporation of HOPE Therapeutics represents an important step in NRx’s strategy to create value for its shareholders. By enabling HTX-100 to be valued on its own merits, NRx can focus on drug development activities while HOPE concentrates on commercialization and the future addition of digital therapeutics.
NRx plans to hold 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 has also announced the 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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