Aug 17, 2026 earnings call — Ketamine ANDA and NRX-101 military trial progress
FDA ANDA review has one remaining major deficiency and 5 million units of launch stock have been ordered.
Revenue $0.0B (est $0.0B) · EPS $-0.44 (est $-0.11)
Key quotes
"This attestation has been provided to the FDA and the company aims for 2026 approval."
"Successful clinical results could lead to widespread adoption of this drug with robotic TMS for treatment of depression in the military and first responder organizations and in the general population."
"So it's been shown that perhaps as many as 50% of patients who come into French and German psychiatric hospitals with acute psychosis have the HERV-W envelope protein in the blood and in their CSF."
Analyst Q&A 3
KETAFREE launch vs NDA ketamine
Q (Thomas Shrader · BTIG): How should we think about launching KETAFREE when an NDA ketamine is coming? Are they effectively the same drug and how will reimbursement or substitution work?
A: Management said KETAFREE targets a $750 million ketamine market used mainly in hospitals and clinics. They explained the ANDA had to match the old Ketalar salt concentration (6.4 milligrams per mL), so the preservative-free ANDA product is legally a different drug than NRX-101 with different NDC numbers and commercial pathways. He also said the KETAFREE label never will include treatment of depression.
"First of all, KETAFREE, targets the market, and we believe it's a $750 million current market of ketamine that's used in hospitals and clinics, some has certainly used to treat depression." — Jonathan Javitt (CEO·CHAIR)
SPARC-TMS and GNK-301 funding
Q (Luis Santos · H.C. Wainwright): Does DARPA support a separate indication for SPARC-TMS and does that change timing or priority for the NRX-101 NDA? For GNK-301 (GeNeuro) will NRx fund the IND and trials or use nondilutive sources?
A: He said the military funder focuses on research to empower the military, not on FDA indications, and that NDAs are expensive to submit (the PDUFA fee alone is close to $5 million). If SPARC-TMS funding comes through, it would be a large nondilutive opportunity and the company would consider pursuing both indications if they have resources. For GNK-301, he said they expect to develop it with nondilutive sources, described the NIH partnership and patent/royalty structure, and noted they applied for $3 million and were invited to submit a best and final bid by September 30, with additional congressional funding discussions ongoing.
"The PDUFA fee alone is close to $5 million." — Jonathan Javitt (CEO·CHAIR)
International opportunities
Q (Edward Woo · Ascendiant Capital): Is it too early to consider international opportunities for your programs in Canada or Europe?
A: He said there are international opportunities and suppliers for ketamine. NRX-101 has worldwide or mostly worldwide patent coverage, SPARC-TMS could have large international implications if the trial succeeds, and the GeNeuro assets began internationally with most patent coverage remaining and patents disclosed on geneuro.us. He added that if these drugs show promise, one would expect they will become global drugs.
"On NRX-101, we have worldwide or mostly worldwide patent coverage." — Jonathan Javitt (CEO·CHAIR)