NRX-101 Looks to Leverage the NRX-100 Experience. Expanded Access for NRX-101 After the FDA Agrees to Review Real World Data in Support of NRX-100.

研报英文原文证据摘录

NRX-101 Looks to Leverage the NRX-100 Experience. Expanded Access for NRX-101 After the FDA Agrees to Review Real World Data in Support of NRX-100.

Investment Thesis

We believe the value in NRXP is based on the combination of developing novel therapeutics for ASIB and the integration of these

therapeutics into the HOPE Therapeutics network. The drug development component of NRXP seems relatively de-risked as both

NRX-100 and NRX-101 are known molecules or their combinations and significant data already exist supporting both their efficacy

and safety. On the broader integration front, The HOPE Therapeutics network is currently being assembled as NRx’s treatment

arm with an eye toward eventually spinning the effort out as an independent company. The hope for HOPE is first to maximize

the patient experience with ketamine to include proper monitoring in order to reduce the chances of bad “highly dissociative”

experiences as well as to employ a better (preservative-free) branded version of ketamine (NRX-100). In addition, HOPE will offerBIOTECHNOLOGY other state-of-the-art treatments such as modern TMS (based on the new coil technologies). The overall hope is to maximize

the remission rates for ASIB patients as TMS and ketamine each deliver ~50% remission rates in quality centers and combination

remission rates are expected to eclipse 80%. Upcoming catalysts include NRXP's progress in completing the FDA submission for

NRX-100 and NRX-101 and resulting FDA feedback leading to FDA approvals starting around YE25.EQUITY

Upcoming Catalysts Price Performance

■ NRX-100 (IV Ketamine) for Suicidal Depression - Completion of NDA filing - mid26 $5

■ NRX-101 (NMDA and 5-HT2A) - NDA submission for the potential accelerated $4.5

approval - 1H26 $4