‘Rare among small-cap biotech companies’ — NRx Pharmaceuticals expects to turn profit in 2025

NRx Pharmaceuticals (NRXP) says it is on the path to profitability in 2025 as it pushes for regulatory approval of a new drug and builds a national network of centers providing psychiatry services.

The clinical biopharma company has initiated a filing to the Food and Drug Administration (FDA) for NRx100, a form of intravenous ketamine that has a shelf life of two years and is designed to tackle suicidal depression.

Executives say this is a $3 billion market in the U.S. alone.

"We have proven manufacturing capacity to supply more than 1,000,000 doses per month should we gain FDA approval," NRx's founder and chairman Jonathan Javitt said on an earnings call.

NRx also announced that it has entered into a non-binding agreement with a commercial pharmaceutical firm that would allow this drug to be licensed and distributed, which would unlock over $300 million in milestone payments.

Javitt believes the company will achieve profitability by the end of the year — and says this is "rare among small-cap biotech companies."

Unveiling its full-year results, NRx went on to confirm that it is planning to request "accelerated approval" of NRx101, which is designed to treat bipolar depression.

Losses for 2025 stood at $18.5 million, down 33.5% compared with a year earlier, which was "primarily driven by a decrease in research and development expense." Shares rose by 7.3% in Tuesday's trading.

Hope Therapeutics expands

NRx's wholly owned subsidiary, Hope Therapeutics, aims to become an "international network of interventional psychiatry centers" — primarily beginning in Florida with an ambition to acquire up to 20 sites this year.

Each of these existing facilities attracts revenues of up to $5 million each per year, with operating margins of about 30% and "significant opportunities for further growth."

But Javitt says Hope Therapeutics may not be under the NRx umbrella for long. He expects the network of treatment centers will eventually be spun out into an independent company

"We expect that a portion of the earnings generated through HOPE will support NRx's path to profitability and support our planned path to a spin out of the company and subsequent listing on a national stock exchange."

Javitt also stressed that, while this $300 million deal for NRx100 with a pharmaceutical firm is promising, "a deal is never done until it's done."

"We've moved closer to having a marketable drug," he said. "There's a real desire out there on the part of already commercial organizations to be able to offer such a drug to patients. I don’t think anybody questions the size of the available market."