A Main Line pharmaceutical developer is creating a new company to bring its experimental drug candidate targeting suicidal depression to patients, should that medicine receive regulatory approval.

NRx Pharmaceuticals of Radnor said the new business, called Hope Therapeutics, will initially be owned by NRx and its current shareholders via a planned tax-free dividend with an accompanying royalty coupon tied to potential future sales of the drug.

NRx said it is “initiating actions” to gain a public listing for Hope Therapeutics, and the company said it has secured a multimillion-dollar investment for the new company once that listing is secured.

The company did not disclose where Hope Therapeutics will be based or the size of its initial staff.

A new drug application for the suicidal depression drug, which was originally called NRX-100 and will now be designated as HTX-100, is expected to be filed during the first half of this year.

NRx (NASDAQ: NRXP) has canceled its shareholder meeting for Feb. 7 and, subject to board approval, expects to convene a new meeting to vote on the planned structure of spinning off Hope Therapeutics and the share dividend.

The shareholder meeting to approve the option of a reverse stock split to maintain the company’s Nasdaq compliance will be rescheduled if necessary. NRx Pharmaceuticals' stock was down slightly at less than 38 cents per share in early afternoon trading Monday.

NRx is also planning to spin off a second company that will focus on its drug candidate targeting urinary tract infections.

Dr. Jonathan Javitt, founder and chief scientist of NRx Pharmaceuticals, called incorporating Hope Therapeutics “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,” Javitt said. “Hope offers shareholders a very different investment profile, one that has already attracted a $30 million investment commitment upon Hope's planned public listing.”

Javitt said HTX-100, an IV Ketamine product, is a potentially lifesaving acute care medicine to the 3.5 million people in the United States who make a plan to commit suicide annually. He noted the only FDA-approved treatment for such patients, particularly in the case of bipolar depression, is electroconvulsive therapy."

The company has announced positive study results for HTX-100, which features a diversion- and abuse-deterrent presentation, from late-stage clinical trials of the new drug candidate in more than 1,000 patients.

Founded in 2015, NRx has about two dozen employees. During the first three quarters of 2023, the company posted a net loss of $25.8 million, an improvement over the $29.5 million deficit for the same period the previous year.

Author: John George

Publication: The Philadelphia Business Journal

Link: NRx Pharmaceuticals to spin off Hope Therapeutics for its depression drug - Philadelphia Business Journal (bizjournals.com)