Key highlights for the first full year of operation under the new management team include:
- A year-over-year reduction in operating expenses with
$7.8 Million cash on hand at year end. With ongoing revenue from operations and current ATM trends, the Company anticipates adequate resources to support operations through 2026, with anticipation of continued revenue growth. As ofDecember 31, 2025 , all previously issued convertible debt had been converted into common stock. - Anticipated FDA approval of at least one new drug – Preservative Free Ketamine under an ANDA—during Q3 2026. A favorable preliminary bioequivalence determination was received from the FDA last week.
- A Type C in-person meeting with the
FDA Division of Psychiatry Products together with leadership of theFDA Center for Drug Evaluation and Research (CDER) to identify a path to approval of NRX-100 (preservative-free ketamine) under a New Drug Application with an indication for treatment of Severe Depression in Patients who may have suicidality. In meeting minutes, FDA expressed willingness to review existing randomized clinical trial data and Real World Evidence as a potential basis for approval without a requirement for conduct of additional clinical trials. - Appointment of Prof.
Joshua Brown , MD, PhD, of Harvard/Mclean as Chief Medical Innovation Officer.Dr. Brown is Principal Investigator onNIH - andDARPA -funded projects that highlight the future of neuroplastic care, including use of D-cycloserine and TMS for treating depression, PTSD, and suicidality. - Filing of an Investigational New Drug application with the FDA to study the use of NRx’s Breakthrough-designated candidate, NRX-101, for the enhancement of Transcranial Magnetic Stimulation (TMS) supported by non-dilutive governmental funding sources.
- Development of a patentable, sustained-release presentation of D-cycloserine to provide an extended release profile suitable for enhancement of TMS efficacy. Prior clinical trials have shown a doubling of clinical response in patients with depression and an 8-fold increase in remission from depression versus standard TMS therapy.
- Implementation of a business plan for
HOPE Therapeutics, Inc. with the aim of developing interventional psychiatry centers focused on neuroplastic therapy – including ketamine, D-cycloserine, Transcranial Magnetic Stimulation, and Hyperbaric Oxygen Therapy – for patients with severe and suicidal depression and PTSD, with future applications for Traumatic Brain Injury, Autism, and Alzheimer’s. - First revenue from acquired and partnered interventional psychiatry clinics at five sites of care that provide neuroplastic therapy to treat severe and suicidal depression and PTSD, with funding from the
Department of Veterans Affairs , theDepartment of War , private insurers, and self-pay. Company expects to substantially increase this revenue-generating footprint in 2026. - Announcement of a nationwide partnership with neurocare AG, a leading manufacturer of TMS technology to develop their growing combined clinic base, currently at 20 sites of care in the US together with an installed base of more than 400 TMS machines into a nationwide accountable care network providing psychiatrist-led neuroplastic therapy.
“2025 was a pivotal year for NRx and HOPE Therapeutics as we have advanced two lifesaving drugs towards FDA approval with the aim of initiating commercial pharmaceutical operations by the end of this year. We ended the year debt-free and attracted fundamental long-term investors who believe in our mission,” said Dr.
As noted in the 10K filing, NRx is a clinical-stage bio-pharmaceutical company which develops and will distribute, through its wholly-owned operating subsidiary,
Financial Results for the Year Ended
For the year ended December 31, 2025,
As of December 31, 2025, we had approximately
Detailed financials are available in our Form 10-K, filed with the
The Company looks forward to meeting investors on today’s conference call and further reviewing a year of strong operational achievements, solidified financial foundation, revenue growth, and important near term opportunities for to bring value to patients and shareholders alike.
Conference Call Information
A live webcast will be available on the Company’s website at:
https://ir.nrxpharma.com/events
Participants may also join by telephone by dialing 1-800-717-1738 (
About
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
For further information:
Managing Partner, astr partners
(917) 653-5122
brian.korb@astrpartners.com
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