Shareholder Update
October 17, 2025
Dear Shareholders,
We want to share an important development related to ketamine, which NRx is developing both as a preservative-free generic drug (KETAFREE™) for use in anesthesia and an innovative drug (NRX-100) for use in treating suicidal ideation in depression and potentially other Central Nervous System (CNS) disorders. As you know, in August, FDA advised NRx that a suitability petition was granted to support the Abbreviated New Drug Application (ANDA) for KETAFREE™ and FDA additionally awarded Fast Track Designation to support the New Drug Application (NDA) for NRX-100. NRx has applied to the FDA for a Commissioner’s National Priority Voucher for NRX-100 for the use defined in the Fast Track Designation, based on the national crisis of suicide as articulated by key members of the administration and FDA’s recognition in the Fast Track Designation that NRX-100 has the potential to address this unmet medical need.
Yesterday, FDA announced the award of a Commissioner’s National Priority Voucher (CNPV) to Phlow Corp. for the manufacture of ketamine’s Active Pharmaceutical Ingredient (API). This CNPV award is not for a ketamine drug product, but rather focuses on the critical need for ketamine API, which is essential to manufacturability of ketamine drug product. All drug products are made of drug substance or API, together with various inactive ingredients. When the public uses the name of a drug, typically the discussion centers around the drug product that is distributed to pharmacies and administered to patients. In this case, the CNPV is for the API, which is also referred to as ketamine.
API is a small but critical component of the cost of goods in any sterile drug product and ketamine is no exception. Unlike sterile drug product manufacture, which NRx conducts in South Carolina, API manufacture is historically a “smokestack” industry that has largely moved offshore. In awarding a CNPV to encourage manufacture of ketamine API to a domestic company, FDA has taken a strong and critically-important stance in support of domestic API manufacture. NRx has previously be forced to purchase ketamine API from offshore sources of supply because there was no US manufacture and today’s CNPV award promises to rectify that situation.
The award of CNPV to a US company for manufacture of ketamine API is a positive one because it highlights the administration’s focus on the strategic nature of ketamine and the need to avoid shortages of ketamine API in the US drug manufacturing supply chain. The administration has now recognized that ketamine is a highly strategic drug whose manufacturability must be assured. Previously, NRx worked with its manufacturing partner to assure that more than two years of ketamine API was in stock in manufacturer’s warehouse to assure short-term manufacturability of KETAFREE™ and NRX-100. However, should demand for KETAFREE™ or NRX-100 exceed expectations, this would place additional demand on our API reserves. FDA has correctly noted that in the past ketamine API from foreign sources has been in short supply. Hence, today’s announcement by FDA is highly encouraging in terms of assurance of our future ability to manufacture ketamine-based products at scale but does not affect NRx’s ability to manufacture ketamine today.
We look forward to continuing to update you on developments such as this.
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. 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. 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, Quarterly Reports on Form 10-Q, 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
September 2, 2025
Dear NRx Shareholders,
Shareholders have inquired about the Company’s recent progress regarding progress of the Abbreviated New Drug Application (ANDA) for preservative-free ketamine with intended use in anesthesia and other applications currently on the KETALAR® label. The Company has filed for the trademark KETAFREE™ in association with this product. The application for KETAFREE™ is distinct from the New Drug Application process for NRX-100, recently awarded Fast Track Designation for the Treatment of Suicidal Ideation in Depression, Including Bipolar Depression.
Management’s long-term strategy has been to establish distinctions between NRX-100 and generic forms of ketamine (including KETAFREE™) to support commercialization of NRX-100 as an innovative drug to treat depression and other CNS conditions while simultaneously creating a “branded-generic” market for preservative-free ketamine. As disclosed in our 8K filing, FDA advised the Company that the formulation on file for NRX-100 differed by 0.6 mg/ml from generic ketamine (i.e. KETALAR®) with respect to the level of a single inactive ingredient – Sodium Chloride – and, hence could not be approved under an Abbreviated New Drug Application (ANDA) as a generic drug.
The FDA has thus made a clear ruling that generic ketamine and NRX-100 are not equivalent and therefore not substitutable at the pharmacy level. Accordingly, NRX-100 and KETAFREE™ will have different National Drug Code (NDC) numbers and will have distinct commercialization strategies. The Company will continue to develop NRX-100 under its Fast Track Designation for the Treatment of Suicidal Ideation in Depression and to develop KETAFREE™ as a preservative-free alternative for the currently-labeled generic uses of ketamine. The two products, if approved, will likely have different pricing and distribution pathways.
Whereas the formulation of NRX-100 is subject to the module 3 already submitted to FDA and the Company has substantial flexibility in the formulation of this NDA product, FDA has now ruled that KETAFREE™ formulation is required to be within 5% of reference product with respect to inactive ingredients while still maintaining isotonicity as is required for all intravenous medications. The level of Sodium Chloride, an inactive ingredient in NRX-100 was set at 7 mg/ml to maintain isotonicity in the absence of the Benzethonium Chloride preservative.
Management has now met with the FDA’s Office of Generic Drug Products about the appropriate level of Sodium Chloride to be used in KETAFREE™ and we have identified a path forward that leverages the two years of stability accrued with the original formulation while bringing the inactive ingredient concentration within range of the generic reference product. As previously indicated, the Company does not expect this adjustment to cause a material delay in approval of KETAFREE™, and views this as a positive development given the commercial clarity that has now been created by FDA’s ruling.
This adjustment in the Sodium Chloride level of the generic product does not impact the formulation of NRX-100 or its approvability in any way because the requirement to match a reference standard with regard to inactive ingredients does not apply to innovative drugs. However, it does result in a formulation for NRX-100 that is distinct from generic ketamine formulations. Accordingly, the Company anticipates that generic ketamine will not be eligible for “A/B” substitution in place of NRX-100, once the Company’s drug is released for use in treating suicidal ideation in depression, thus supporting the future market exclusivity of NRX-100.
Respectfully,
Jonathan C. Javitt, MD, MPH
CEO and Chairman
NRx Pharmaceuticals, Inc.
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. 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. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. 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. Any forward-looking statement reflects the Company’s current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company’s operations, results of operations, growth strategy, and, among other things, 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.
July 31, 2025
Dear Friends of NRx,
Some shareholders have asked for NRX-100 stability data to be reported on an interim basis. As noted in our most recent 10K, management considers long-term stability and sterility of NRX-100, preservative free IV ketamine, to be assured based on data already filed with FDA.
Accordingly, shareholders should expect ongoing stability data to be included in quarterly filings but expect further interim filings regarding stability only if a material deviation is identified from current data.
As a reminder, the Chemistry, Manufacturing, and Controls (CMC, Module 3) section of our NRX-100 ANDA/NDA has already been filed with the FDA, as a part of both applications.
Again, thank you for your support and we look forward to continuing to share significant developments on NRX-100 and our other programs as they occur, as we bring HOPE to life.
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. 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. 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, Quarterly Reports on Form 10-Q, 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
July 31, 2025
Dear Shareholders,
Yesterday our Chairman and CEO Dr. Jonathan Javitt joined a Fireside Chat at the BTIG Virtual Biotechnology Conference with BTIG Research Analyst Dr. Thomas Shrader and Prof. Samuel Wilkinson, MD, of the Yale School of Medicine, a widely published psychiatrist who has been a pioneer in the understanding of ketamine and other neuroplastic and psychedelic drugs for the treatment of depression, suicidality, and PTSD.
The discussion focused on neuroplasticity in the treatment of CNS disorders, including the role of ketamine and NRX-100 as well as future directions in mental health research and treatment. No non-public information was disclosed.
Those wishing to view a replay may request access by emailing mduffy@nrxpharma.com.
Thank you for your support and we look forward to continuing to share significant developments as they occur, as we bring HOPE to life.
Sincerely,
Matthew Duffy
Chief Business Officer
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. 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. 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, Quarterly Reports on Form 10-Q, 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
