Shareholder Update
June 20, 2025
Dear Shareholders,
As we seek FDA approval for NRX-100 and accelerated approval for NRX-101, shareholders have increasingly asked us to clarify timelines and the pathways under which we intend to seek approval. Now that the FDA has announced the newly-created Commissioner’s National Priority Voucher Program (CNPV) we are able to offer additional guidance. As was announced on June 17, the Commissioner of the US Food and Drug Administration has now announced a new pathway, the Commissioner’s National Priority Voucher (CNPV)[1] for approval of drugs to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission. The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices.
The FDA plans in the first year of the program to give a limited number of vouchers to companies aligned with U.S. national priorities. In addition to receiving the benefits of this program, the agency may also grant accelerated approval, if the product for which the voucher is used meets the applicable legal requirements for accelerated approval.
The FDA Commissioner will use specific criteria to make the vouchers available to companies that are aligned with the national health priorities of:
- Addressing a health crisis in the U.S.
- Delivering more innovative cures for the American people.
- Addressing unmet public health needs.
- Increasing domestic drug manufacturing as a national security issue.
We believe that the products being developed by our company are aligned with the aims and requirements of the CNPV. Suicidal depression and PTSD have been identified by the President of the United States and members of the Cabinet as a health crisis in the US. At the televised April 30, 2025 cabinet meeting, the President asked VA Secretary Collins “what are you doing about suicide in Veterans?” The Secretary identified development of psychedelic drugs as a priority. The FDA has already determined that both NRX-100 and NRX-101 address unmet public health needs through the award Fast Track Designation and Breakthrough Therapy Designation, respectively. NRx Pharmaceuticals is manufacturing NRX-100 in West Columbia, SC and NRX-101 in Wilmington, NC. Both manufacturers are highly experienced FDA-inspected facilities engaged in sterile products and solid dose manufacturing respectively.
In addition to the above requirements, the CNPV program requires that sponsors submit the chemistry, manufacturing, controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application. CMC can be a high bar for companies that have not yet completed final manufacturing processes and accumulated several years of stability data on commercially manufactured drug product. Many biotechnology companies defer full CMC and assume that a commercial partner will step in to perform the final manufacturing steps, once phase 3 is completed. From our inception, NRx has operated according to the manufacturing principles of pharmaceutical company, led by a head of manufacturing who is a veteran of domestic and international Fortune 50 pharmaceutical companies. We have US manufactured drug product for both NRX-100 and NRX-101 in the warehouse with sufficient stability data to justify at least three years of shelf life, and ongoing stability monitoring that may further extend that shelf life.
In December 2024 we announced submission of the FDA Module 3 (CMC) section of the NRX-100 NDA and anticipate submitting the NRX-101 Module 3 by July 2025. While we and our investors would always like to see these submissions happen sooner, CMC submission depends upon accumulation of real-time and accelerated stability data, which requires the finished drug to sit in a stability chamber and be tested at prespecified intervals to ensure lack of degradation over time.
The CNPV program, as announced, requires domestic drug manufacture at a time when much of the US pharmaceutical supply chain comes from offshore sources. As we have shared in the past, we moved all of our drug manufacture out of China to the United States in 2021 during the Covid pandemic. Hence, NRx may be one of the first US Pharmaceutical companies with US manufactured drug on hand and multiple years of stability for that US manufactured product that is required for receipt of a National Priority Voucher. Similarly, we moved Aviptadil manufacture to the United States.
In summary, we are highly encouraged by the newly announced FDA Commissioner’s National Priority Voucher Program and by the forward-thinking policy development both at the Agency and the Cabinet level that underlies it. As previously determined by FDA, our products are innovative treatments that address the current health crisis of suicidal depression and PTSD and address an unmet medical need. We will be seeking New Drug Approval for NRX-100 in the treatment of suicidal depression and PTSD together with accelerated approval for NRX-101 in the treatment of suicidal bipolar depression with akathisia. Investors have previously asked why NRx was focused on completion of all CMC information and reporting that progress to our investors. The FDA has now validated that focus by identifying CMC as a pre-requisite to seeking a Commissioner’s National Priority Voucher. Similarly, our focus on US manufacture of our products is now shown to be aligned with national priorities at the level of the FDA and above. The timelines announced for the CNPV program are consistent with NRx’s previous guidance of an FDA decision (PDUFA date) by year-end 2025.
Our application under the CNPV program will be in addition to the Abbreviated New Drug Application (ANDA) filed last week for preservative-free ketamine, for which we are seeking priority review. Approval of the ANDA will enable us to market ketamine for all currently-labeled uses[2] with the advantage that our proposed product is preservative free and packaged in a single-use, diversion resistant vial. Because of our blow-fill-seal manufacturing process, our manufacturing cost is less than that of traditional glass vial packaging. As previously announced, we are submitting a citizen petition to seek withdrawal of preservative-containing forms of ketamine, based on the toxicity associated with the benzethonium chloride preservative used in the historic formulation. We have also filed a patent on our preservative-free manufacturing process. Approval of either the citizen petition or the patent would be expected to enable us to gain market share in the current $750 million ketamine market that is expected to reach $3-5 billion annually by 2033.
We look forward to continuing to share significant developments as they occur.
Sincerely,
Jonathan C. Javitt, MD, MPH
Chairman and CEO
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. These statements relate to future events or to the Company’s future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements, including, without limitation, whether the Company will receive the FDA’s approval for its CNPV applications for NRX-100 and NRX-101, whether the FDA will approve the Company’s NDA to market and sell NRX-100 and NRX-101, whether the Company will receive approval for its products by year-end 2025, and whether the USPTO will approve the Company’s patent application. Any forward-looking statement reflects the Company’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company’s operations, results of operations, growth strategy, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
For further information:
Matthew Duffy
Co-CEO, Hope Therapeutics, Inc.
Chief Business Officer, NRx Pharmaceuticals, Inc.
mduffy@nrxpharma.com
Brian Korb
Managing Partner, astr partners
(917) 653-5122
brian.korb@astrpartners.com
[2]https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016812s040lbl.pdf
