Investment Highlights for NRx Pharmaceuticals, Inc.

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NRx Pharmaceuticals, Inc.
1201 N Orange St., Suite 600
Wilmington, DE 19801
Phone: (484) 254-6134 

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NRx Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company developing novel therapeutics for the treatment of central nervous system disorders with high unmet medical needs.
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  • NRx Pharmaceuticals, Inc. (“NRx” or “the Company”) is a clinical stage biopharmaceutical company developing novel therapeutics targeting the brain’s N-methyl-D-aspartate (NMDA) receptors for the treatment of central nervous system disorders with high unmet medical needs.

  • The Company’s foundation product, NRX-101, is a patented combination of two FDA-approved drugs—D-cycloserine (DCS), an NMDA receptor modulator; and lurasidone, an antipsychotic medication. The Company is assessing the use of NRX-101 in four different indications: suicidal bipolar depression, chronic pain, post-traumatic stress disorder (PTSD), and complicated urinary tract infections (cUTI).

  • NRx’s technology platform is based on the discovery by Professor Daniel Javitt (NRx Co-founder and Chair of its Scientific Advisory) that: (1) the psychedelic effects of NMDA antagonist drugs could be reversed combining them with serotonin-targeted compounds; and (2) NMDA inhibitors, in turn, block the akathisia side effect normally associate with serotonin-targeted drugs such as lurasidone.

    • The previously undiscovered synergy between these two drug classes is the subject of 48 issued patents and 43 pending patents owned by or licensed to NRx Pharmaceuticals, and as such, is the medical and scientific basis for the Company’s technology.

  • NRx entered into a collaboration with Alvogen Pharmaceuticals for the development and commercialization of NRX-101 in suicidal bipolar depression, with the potential for up to $330 million in milestones and double-digit royalties.

    • NRx is conducting a single Phase 2b/3 trial of NRX-101 for Suicidal Treatment Resistant Bipolar Depression (S-TRBD), with topline clinical data readout expected by Q1 2024, and potentially an NDA shortly after. The Company may be able to begin commercialization of NRX-101 on this indication in 2024.

    • Under the Alvogen agreement, a successful data readout and completion of a Type B meeting with the FDA (expected by 1Q 2024) would trigger a $10 million payment to NRx, at which point, Alvogen would be responsible for all future development and commercialization costs for this indication.

  • NRx is also developing a proprietary form of Ketamine (NRX-100) for the treatment of acute suicidality. The Company has signed a data sharing agreement with the KETIS study leadership (a trial of ketamine on 156 patients hospitalized for acute suicidality in seven French Government Hospitals) and signed a development and manufacturing agreement with Nephron Pharmaceuticals, Inc., to develop and manufacture a presentation of ketamine suitable for treating suicidal depression.

    • The Company believes that these two initiatives provide NRx with the necessary requirements for a submission of an NDA for ketamine (Q1 2024), with a targeted PDUFA date in Q4 2024.

    • NRx does not anticipate funding this initiative with its core NRx assets and plans to establish a ketamine-focused spinoff company that would potentially provide current and new investors with both capital appreciation and a royalty stream.

  • NRX-101 is also being evaluated for the treatment of chronic pain, as a non-addicting substitute of opioid products. The Company is planning to start a pharmacokinetic study following result readout of a 200-person U.S. Department of Defense-funded trial in the treatment of chronic pain with DCS.

    • The Company obtained IND approval for NRX-101 in the treatment of chronic pain, and plans to seek Fast Track Designation, Priority Review, and Breakthrough Therapy Designation for this indication.

  • NRx is also assessing NRX-101 for the treatment of PTSD and cUTI.

    • Based on the in vitro study performed by NRx in the cUTI indication, the Company has submitted an IND application, requesting Qualified Infectious Disease Product (QIDP), Fast Track, and Priority Review designation. FDA approval of this IND is expected by year-end 2023.

    • As with the NRX-100 development project, the Company does not anticipate funding the cUTI program with core NRx assets and is exploring structures for a new entity that would provide current and new investors with both capital appreciation and a royalty stream.

  • NRx finalized transfer of its Phase 3-level commercial drug manufacturing processes to the U.S. and completed production required for its clinical trials (over 1 million capsules).

  • The Company believes that its cash on hand is sufficient to fund operations through the upcoming milestones described in this report (page 17). NRx is conducting key initiatives to minimize the need to utilize current financial assets to continue the development of its different programs, including: (1) funding of ketamine-related and cUTI-related initiatives under new entities (spinoffs) with alternative financing; (2) seeking non-dilutive sources of capital for its chronic pain program, such as its submission for consideration to the HEAL initiative; and (3) the capital influx prior to approval of NRX-101 and assignment of development costs resulting from the Alvogen agreement.

  • NRx is led by a highly experienced management team with proven success within pharmaceutical research, development, and commercialization.

  • As of September 30, 2023, NRx’s cash and cash equivalent position was $8.9 million.

  • In its November 14, 2023 earnings press release, NRx announced that it had received a $30 million term sheet for the anchor investment in its planned ketamine spinoff.

* Updated on December 1, 2023.

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