NRXP

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved a regulatory inflection point with the FDA identifying only a single, non-drug-related deficiency regarding a vial component for the preservative-free ketamine ANDA. Advanced the NRX-100 NDA for depression by leveraging new federal guidance and executive orders that encourage the use of real-world evidence for psychedelic-based treatments. Pivoted the NRX-101 strategy to include a military-partnered Phase II/III trial (SPARC-TMS) combining the drug with robotic transcranial magnetic stimulation to address force readiness. Expanded the addressable market for NRX-101 from suicidal bipolar depression to the broader treatment-resistant depression market, representing over 15 million potential patients. Acquired the GeNeuro asset portfolio, establishing a long-term research pipeline focused on human endogenous retroviruses as potential drivers of ALS and schizophrenia. Scaled the HOPE Therapeutics clinical footprint to five locations in Florida, focusing on a high-standard care model utilizing neuronavigation and neuroplastic-assisted treatments. Strengthened the balance sheet through a $22 million public offering, providing a stable platform for the anticipated near-term commercial launch of the ketamine family of products. Targeting 2026 approval for preservative-free ketamine, with 5 million units of launch stock already ordered to ensure immediate market availability upon clearance. Aiming for 2027 approval of the NRX-100 NDA, contingent on finalizing the application with aligned drug vial specifications used in the ANDA product. Anticipating the first-in-human trial for GNK-301 in ALS by July 2027, supported by anticipated federal funding and partnerships with the NIH. Executing contract negotiations for the SPARC-TMS trial to be funded by the military, which will include 400 total patients across civilian and military treatment facilities. Projecting that current cash resources and anticipated clinic revenue growth will be sufficient to support operations for at least one year. The GeNeuro acquisition includes two clinical-stage monoclonal antibodies, GNK-301 for ALS and temelimab for MS and schizophrenia, acquired via Swiss court proceedings. Management identified a single 'major deficiency' in the ANDA related to the Luer lock vial component, which has been addressed via a manufacturer's attestation. Operating losses increased to $11.3 million primarily due to ramped-up R&D and SG&A spending in preparation for the near-term commercial launch of ketamine. The company is utilizing non-dilutive funding strategies for high-risk programs, specifically targeting the $80 million added to the 2027 defense appropriation for ALS research. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained that KETAFREE is legally distinct due to a specific hypotonic salt concentration (6.4 mg/mL) required to match the legacy reference drug. NRX-100 will have a different NDC number and a label specifically for depression, preventing insurance substitution with the generic anesthetic product. This dual-track strategy allows the company to target the $750 million existing ketamine market while protecting the proprietary reimbursement path for depression. The DARPA-funded SPARC-TMS trial focuses on military readiness and does not replace the need for FDA indication filings. Management intends to pursue both the breakthrough therapy indication for suicidal bipolar depression and the broader treatment-resistant depression market simultaneously. The military trial provides 'massively transformative' non-dilutive funding that expands the drug's strategic utility beyond inpatient psychiatric settings. NRx intends to fund the ALS program primarily through non-dilutive sources, including NIH partnerships and congressional medical research programs. The company has already been invited to submit final bids for initial federal funding rounds and is targeting the 2027 defense appropriation for clinical trials. Management emphasized that core capital from recent raises is strictly reserved for the commercial launch of the ketamine product family.

This article first appeared on GuruFocus. Net Loss (Six Months Ended June 30, 2026): Reported a net loss of $18 million, compared to a net loss of $23.1 million in the same period of 2025. Net Operating Loss (Six Months Ended June 30, 2026): Reported a net operating loss of $11.3 million, versus a net operating loss of $7.6 million in the comparable period of 2025. Cash and Cash Equivalents: Approximately $26.7 million as of June 30, 2026, versus $7.8 million as of December 31, 2025. Public Offering Proceeds: Gross proceeds of more than $22 million from a completed public offering of common stock. Warning! GuruFocus has detected 3 Warning Signs with NRXP. Is NRXP fairly valued? Test your thesis with our free DCF calculator. Release Date: August 17, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. NRX Pharmaceuticals Inc (NASDAQ:NRXP) completed the first cycle of FDA review for its preservative-free ketamine ANDA with only one remaining major deficiency, which has been addressed, positioning the company for a potential 2026 approval and commercial launch. The company received White House and congressional guidance directing the FDA to use real-world evidence for ketamine and psychedelic drug approvals, supported by data from 65,000 patients showing IV ketamine's comparable or superior efficacy, strengthening the NRX-100 NDA path. NRX Pharmaceuticals Inc (NASDAQ:NRXP) was selected as the prime contractor for the DARPA-funded SPARC-TMS trial, a Phase 2/3 study combining NRX-101 with robotic TMS, potentially expanding the drug's market to over 15 million Americans with treatment-resistant depression. The acquisition of GeNeuro's assets, including GNK-301 for ALS and temelimab for multiple sclerosis and schizophrenia, adds a potentially transformative pipeline with NIH partnership and nondilutive funding opportunities. The company's cash position improved significantly to $26.7 million as of June 30, 2026, up from $7.8 million at year-end 2025, providing a runway of at least one year to support operations and near-term launches. NRX Pharmaceuticals Inc (NASDAQ:NRXP) reported an increased net operating loss of $11.3 million for the first half of 2026, up from $7.6 million in the prior year, driven by higher R&D and SG&A costs related to the ketamine launch preparation. The FDA identified a major deficiency in the ANDA for preservative-free ketamine related to the Luer lock component, which required additional manufacturer attestation and could delay approval if not resolved promptly. The company's reliance on real-world evidence for NRX-100 approval is subject to regulatory and political uncertainties, as FDA guidance may not guarantee a smooth or timely approval process. The SPARC-TMS trial is still in the contracting process with DARPA, and the company has not yet secured final funding, creating execution risk for this potentially pivotal study. The GeNeuro acquisition involves complex intellectual property and regulatory challenges, including the need to secure funding for GNK-301's first-in-human trial, which is not yet fully committed and may face delays. Q: How should we think about launching KETAFREE when the NDA ketamine (NRX-100) is coming on its tail, given they are the same drug but likely have different reimbursement potential?A: Jonathan Javitt, Chairman and CEO, clarified that KETAFREE targets the $750 million current market for ketamine used in hospitals and clinics, primarily as an anesthetic and for pain control. By law, KETAFREE must have a comparable inert ingredient composition to the reference drug, Ketalar. Because of this, the ANDA product is legally a different drug from NRX-100, with different NDC numbers and commercial pathways. The label for NRX-100 will hopefully include the treatment of depression, while the label for KETAFREE will not, meaning they are not substitutable and will have distinct reimbursement paths. Q: Does DARPA's support for the SPARC-TMS trial mean a separate indication filing for NRX-101 in broader treatment-resistant depression, and does this change the timing or priority for the NRX-101 NDA for suicidal bipolar depression?A: Jonathan Javitt explained that DARPA is focused on research to empower the military, not on drug approvals, which is the FDA's role. Since submitting an NDA is incredibly expensive (the PDUFA fee alone is close to $5 million), the company will likely take guidance from shareholders on whether to pursue both indications at once. However, the bipolar depression indication remains a priority as it is a breakthrough therapy designation with nothing else shown to reduce suicidality and akathisia. The SPARC-TMS trial, if successful, represents a massively transformative opportunity for NRX-101. Q: What will be NRx's role in the GeNeuro GNK-301 program to reach the IND for ALS, and will it commit funding or use nondilutive sources?A: Jonathan Javitt stated that the company's key objective with current funds is the commercial launch of the ketamine family of products. For ALS, there is a massive stream of available funding. The drug was coinvented with the Head of ALS at the NIH, and the company has already been selected in the first round of the Congressional-directed medical research program, invited to submit a best and final bid by September 30. An additional $80 million has been added to the 2027 Defense appropriation for ALS. The company expects to develop this program with nondilutive sources, including philanthropic and government money, especially given the strong association between combat veterans and ALS. Q: Is it too early to think about international opportunities for any of the company's initiatives, either in Canada or Europe?A: Jonathan Javitt noted that on the ketamine front, there are international opportunities and suppliers. NRX-101 has worldwide or mostly worldwide patent coverage, and the robotic TMS opportunity has massive international implications if the SPARC-TMS trial succeeds. The GeNeuro assets began internationally, and while some coverage was lost during a Swiss bankruptcy, there is still extensive patent coverage worldwide, which is disclosed on the geneuro.us website. If these drugs show promise, they are expected to become global drugs. Q: Can you provide an update on the ANDA for preservative-free ketamine and the timeline for approval?A: Jonathan Javitt reported that the FDA identified no major deficiencies related to the drug or manufacturer. A single major deficiency was identified regarding the Luer lock component of the vial, which has been resolved by providing the manufacturer's attestation that the vials are made in the same manner as for three other approved drugs shipping over 12 million units a year. The company aims for 2026 approval and has ordered 5 million units of launch stock. Q: What is the significance of the White House and Congress guidance for NRX-100, and what evidence supports its approval?A: Jonathan Javitt explained that a presidential executive order and congressional budget language now guide the FDA to use real-world evidence for approval of ketamine and other psychedelic products to treat depression. Evidence from 65,000 Americans was presented at the American Society of Clinical Psychopharmacology meeting, demonstrating that intravenous ketamine has greater or comparable efficacy to intranasal S-ketamine with more rapid onset. The company is now poised to finalize its NDA, aiming for 2027 approval. Q: Can you elaborate on the SPARC-TMS trial and its potential to expand the market for NRX-101?A: Jonathan Javitt detailed that the SPARC-TMS trial is an FDA-approved Phase 2/3 trial combining NRX-101 with robotic TMS, funded by DARPA. The trial will include 240 patients in HOPE clinics and at Harvard/McLean, plus 160 patients at military treatment facilities. The technology uses functional MRI to locate the depression focus and treats it with sub-millimeter precision, while NRX-101 creates a neuroplastic environment that has doubled or tripled the effect of TMS in small studies. This potentially expands the market for NRX-101 to all patients with treatment-resistant depression, an addressable market of more than 15 million Americans. Q: What are the financial highlights for the second quarter of 2026?A: Michael Abrams, CFO, reported a net loss of $18 million for the six months ended June 30, 2026, versus a net loss of $23.1 million in the comparable 2025 period. The net operating loss was $11.3 million versus $7.6 million in 2025, driven by increased R&D and SG&A costs related to the anticipated commercial launch of preservative-free ketamine. The company had approximately $26.7 million in cash as of June 30, 2026, up from $7.8 million at the end of 2025, primarily due to a public offering with gross proceeds of over $22 million. Management believes current resources will support operations for at least a year. Q: What is the significance of the GeNeuro acquisition and the potential for GNK-301 in treating ALS?A: Jonathan Javitt explained that GeNeuro owns two clinical-stage monoclonal antibody drugs. GNK-301 targets the HERV-K envelope protein found in the vast majority of patients with sporadic ALS. The drug was coinvented at the NIH and is potentially the first disease-modifying drug for ALS. The first-in-human trial is targeted for July 2027. The acquisition was finalized in June by Swiss courts, and the company has already been selected for the first round of congressionally-directed medical research program funding. Q: How is the For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Key recent and second quarter highlights include: Completed first-cycle FDA review of the Company’s ANDA for preservative-free ketamine with no drug-related major deficiencies. The sole remaining item, a manufacturer's attestation on the vial, has been submitted to FDA. Initiation of commercial scale manufacturing of preservative-free ketamine building to launch stock of 5 million doses to be ready for commercialization in 2026. Selected by the Defense Advanced Research Projects Agency (DARPA) as prime contractor for SPARC-TMS, an FDA-approved Phase 2/3 trial of NRX-101 with robotic TMS. Anticipated non-dilutive funding exceeds $11.5 million, subject to completion of contracting The Company is advancing its NRX-100 NDA on Real World Evidence from more than 65,000 patients, leveraging a Presidential Executive Order and Congressional budget language that encourage FDA use of such evidence in approving treatments for depression. Closed an institutionally-supported, underwritten public offering of common stock for gross proceeds of $22.3 million, including full exercise of the underwriters’ option. The Company expects existing cash to fund operations for at least one year. HOPE Therapeutics expanded its clinical footprint with new sites in Sarasota and Boca Raton, Florida, and became the first commercial site in the US to treat patients using Zeta Surgical’s FDA-cleared TMS navigation system. Appointed Glenn Tyson as the Company’s first Chief Commercial Officer and retained a commercial launch team for preservative-free ketamine. WILMINGTON, Del., Aug. 17, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”, the “Company”, “we”, “us” or “our”) a clinical-stage biopharmaceutical company, today announced financial results for the quarter ended June 30, 2026, and provided a corporate update. The quarter was marked by significant progress on multiple fronts and strengthening of the Company’s balance sheet to provide adequate funds for at least one year of operations and commercial launch. The quarter’s key development was advancement of the ANDA for preservative-free ketamine toward FDA approval and commercialization, which would represent a transformational milestone . The FDA identified no major deficiencies related to the drug or its manufacture. A single major deficiency was identified related to the luer lock component of the vial (i.e. the element of the drug container that connects to a syringe) wherein FDA requested that the Company provide a manufacturer’s attestation that the vial is manufactured in the same manner as it is for 3 other currently approved drugs that ship more than 11.9 million units per year. This attestation has been provided to the FDA and the Company aims for 2026 approval and commercialization. Accordingly, five million units of launch stock is currently in the manufacturing process with anticipated post launch manufacture of 1 million units per month. NRx has continued to advance its New Drug Application for NRX-100 (Preservative-free ketamine) to treat depression. During Q2, a Presidential Executive Order was signed and Congressional Budget Language was approved guiding the FDA to use Real World Evidence for approval of ketamine to treat depression. Evidence gathered from 65,000 Americans was presented at the American Society of Clinical Psychopharmacology meeting in Miami demonstrating that intravenous ketamine has greater or comparable efficacy to intranasal S-ketamine with more rapid onset in treating depression. With alignment on the drug packaging matter, the Company is now poised to finalize its NDA, aiming for 2027 approval. In a potentially federally-funded expansion of the Company’s business plan for NRX-101, (D-cycloserine/lurasidone) NRx was selected as Prime Contractor by the Defense Advanced Research Projects Agency for the SPARC-TMS trial led by Prof. Josh Brown, the Company’s Chief Medical Innovation Officer in partnership with Harvard McClean Hospital and multiple US Military Treatment Facilities. SPARC-TMS measures the efficacy of the Company’s neuroplastic drug (NRX-101) in combination with robotic assisted TMS (www.clinicaltrials.gov NCT 07227103). Successful clinical results could lead to widespread adoption of NRX-101+Robotic TMS for treatment of depression in the military, first responder organizations, and the general population, with initial published results rivaling or exceeding psychedelic drugs. Until now, NRX-101 was positioned only for the treatment of suicidal bipolar depression, a sub million patient market. This military partnered and FDA-approved phase 3 trial potentially expands the market for NRX-101 to all patients with treatment-resistant depression, with an addressable market of more than 15 million Americans (see www.nrxdefense.com). NRx invested in the formation of Geneuro, Inc., with two clinical-stage monoclonal antibody drugs to treat ALS (GNK-301), Schizophrenia (Temelimab®), Multiple Sclerosis, and Type 1 Diabetes (see www.geneuro.us). These patented biologics target Human Endogenous RetroVirus (HERV) envelope proteins that are shown to be neurotoxic and etiologic in neurodegenerative disorders. Temelimab has shown promising, validating clinical results in now-completed European trials for treatment of multiple sclerosis and Type-1 Diabetes. In partnership with the Fondation FondaMental (Paris, FR) and French government funding, GeNeuro aims to launch a clinical trial of Temelimab to treat Schizophrenia. GNK-301 was co-invented at the US National Institute for Neurologic Diseases and Stroke and GeNeuro is partnered with the US National Institutes of Health. GeNeuro, Inc. has already been selected in the first round of the Congressionally-Directed Medical Research Program for drug development and biomarker funding. GNK-301’s first-in-human trial is targeted for July 2027. Should initial clinical activities succeed, substantial funds have been added to the 2027 Defense appropriation to support ongoing activities. “The second quarter of 2026 was a major inflection point for NRx as we advance our mission to bring hope to the most vulnerable patients battling depression and suicidal ideation,” said Dr. Jonathan Javitt, the Company’s CEO and Chairman. “We have continued to drive towards our key objective of first commercial ketamine sales in 2026 with corresponding manufacturing operations and build-out of our first commercial team. Our path to approval of NRX-100 has been advanced by support from the White House and Congress for the use of Real World Evidence that our drug has comparable or superior efficacy to that of current market leaders. Our partnership with the Department of War and its Defense Advanced Research Projects Agency led by Prof. Brown and Dr. Dennis McBride is the culmination of a multi-year endeavor. Similarly, our acquisition of the GeNeuro assets and the resulting partnership with NIH offers a clinical stage and potentially humanity-changing opportunity for the Company – including potentially the first disease-modifying drug to treat ALS – in ALS and other serious disorders, with strong governmental partnership and support from non-dilutive sources of capital. Combat veterans face a two-fold increased risk of ALS, and advancing a cure remains a high priority with strong Congressional support.” Financial Results for the Quarter Ended June 30, 2026 For the six months ended June 30, 2026, NRx reported a net loss of $18.0 million, versus a net loss of $23.1 million during the comparable period in 2025. The change was primarily related to the impact of certain fair value accounting measurements and other non-recurring charges related to the conversion and restructuring of previously issued convertible notes incurred during the six months ended June 30, 2025. For the six months ended June 30, 2026, NRx reported a net operating loss of $11.3 million versus a net operating loss of $7.6 million for the comparable period in 2025. The change was primarily driven by certain research and development costs related to the acquisition of certain assets which management believes will drive significant long-term value for shareholders, as well as increased selling, general and administrative costs including, but not limited to, the addition of key personnel and other expenses related to the Company’s anticipated commercial launch of its ANDA for preservative-free ketamine. As of June 30, 2026, the Company had approximately $26.7 million in cash and cash equivalents versus $7.8 million as of December 31, 2025. The increase was primarily related to the Company’s completion of a public offering of common stock with gross proceeds of more than $22 million. Management believes current cash resources, anticipated growth in clinic revenue, and opportunistic utilization of the Company's active at-the-market offering facility will be sufficient to support operations for at least one year. Conference Call Details The Company will host a conference call at 4:30pm ET on Monday, August 17, 2026. In addition to reviewing the Company's financial results for the fiscal year ended December 31, 2025, the Company will provide an update on the significant progress achieved across its drug development programs and the HOPE Therapeutics clinical network, milestones that bring the Company closer to its founding mission of preventing suicide and transforming the treatment of depression and PTSD to improve the lives of patients and bring hope to life. A live webcast of the conference call will be available on the Company’s website at https://ir.nrxpharma.com/events. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically 1-800-717-1738 or internationally +1-646-307-1865. About NRx Pharmaceuticals, Inc.NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression. Notice Regarding Forward-Looking StatementsThe 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. For further information:Brian KorbManaging Partner, astr partners(917) [email protected]

This article first appeared on GuruFocus. Net Loss: $1.4 million or $0.04 per share for Q1 2026, a 74% reduction from $5.5 million or $0.34 per share in Q1 2025. Loss from Operations: $4.7 million for Q1 2026, compared to $3.8 million in Q1 2025. Research and Development Expense: $1.3 million for Q1 2026, up from $0.8 million in Q1 2025. General and Administrative Expense: $3.8 million for Q1 2026, compared to $2.9 million in Q1 2025. Cash and Cash Equivalents: $6.7 million as of March 31, 2026. Additional Funding: $7 million raised post-quarter through sale of common stock. Warning! GuruFocus has detected 3 Warning Signs with NRXP. Is NRXP fairly valued? Test your thesis with our free DCF calculator. Release Date: May 18, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. NRX Pharmaceuticals Inc (NASDAQ:NRXP) has made significant progress on regulatory pathways for preservative-free ketamine and initiated commercial manufacturing. The company is debt-free and has raised $7 million since the end of the quarter, ensuring sufficient cash for immediate operating needs. FDA has issued positive feedback on KETAFREE, with only minor administrative changes requested, positioning the company well for market entry. NRX-101 has advanced into a registrational trial with FDA clearance, and the company anticipates non-dilutive federal funding for the MIND1 trial. The acquisition of GeNeuro assets expands NRX Pharmaceuticals Inc (NASDAQ:NRXP)'s pipeline into serious neurological and autoimmune diseases. NRX Pharmaceuticals Inc (NASDAQ:NRXP) reported a loss from operations of $4.7 million for the quarter, an increase from the previous year. Research and development expenses increased to $1.3 million, reflecting higher costs associated with strategic initiatives. General and administrative expenses rose to $3.8 million, driven by costs related to strategic initiatives. The company faces challenges in addressing the ketamine shortage, although it has plans to mitigate this with high-volume manufacturing. There is uncertainty regarding the FDA's response to the preservative-free ketamine and the potential impact on the broader industry. Q: For KETAFREE, what does the distribution channel look like? Are the centers your customers, or will this go through larger distributors? A: Michael Abrams, CFO, explained that there are two channels: the existing hospital channel for ketamine and the rapidly growing clinic market. The hospital channel will rely on traditional distribution, while the clinic market, which struggles to access wholesalers, will be targeted directly to replace compounded products with FDA-approved ones. Q: Regarding the real-world ketamine data, what is the level of understanding with the FDA about what they want to see in those records? A: Jonathan Javitt, CEO, stated that they have agreed with the FDA to submit a statistical analysis plan before analyzing the data. This ensures that the analysis meets FDA's expectations and avoids multiple data crunching. Q: Can you help us understand the ketamine shortage and how you plan to overcome it? A: Jonathan Javitt, CEO, mentioned that while they can't pinpoint the exact reasons for the shortage, they are prepared to address it with sufficient raw materials and high-volume manufacturing capabilities. Q: If KETAFREE is approved, what do you anticipate the FDA's action would be towards a Preservative-Free Ketamine as the solution across the industry? A: Jonathan Javitt, CEO, noted that while it's hard to predict regulatory actions, there is a general regulatory trend towards safety and removing toxic preservatives, which could favor their preservative-free formulation. Q: Once you file the NRX-100 NDA, how soon do you anticipate learning whether you got the priority review voucher? A: Jonathan Javitt, CEO, indicated that the process generally takes about six months. They already have fast track approval, which entitles them to priority review. Q: What inventory level do you expect to have available at the time of KETAFREE's launch? A: Jonathan Javitt, CEO, stated they plan to have at least 1 million units in the warehouse, potentially increasing to 1.5 million or 2 million units depending on demand. Q: Could you talk more about the MIND1 trial for NRX-101 plus TMS, and whether it could be registration-enabling if positive? A: Jonathan Javitt, CEO, explained that if the trial shows dramatically positive results, it could potentially lead to approval based on one trial. However, the focus is on conducting the trial in partnership with military and academic colleagues. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in NRx Pharmaceuticals, Inc.? Here are five stocks we like better. KETAFREE moved closer to a potential summer 2026 approval after the FDA issued mostly minor review comments, and NRx said it has already begun commercial manufacturing at scale. Management believes the product could serve both hospital and ketamine clinic markets, where supply shortages persist. NRx said it plans to file an NDA for NRX-100 in Q2, supported by trial data from more than 1,000 patients and real-world evidence from over 65,000 patients. The FDA also indicated it may consider approval based on existing data and broader depression indications, with priority review pathways available. The company reported a smaller Q1 net loss of about $1.4 million versus $5.5 million a year earlier, and said it ended the quarter with $6.7 million in cash. NRx also said it raised about $7 million after quarter-end and expects current resources to support operations through at least 2026. 5 Biotech stocks tapping into unmet mental health treatment needs NRx Pharmaceuticals (NASDAQ:NRXP) said it advanced several regulatory, manufacturing and clinical initiatives during the first quarter of 2026, including progress toward potential approval of its preservative-free ketamine product, KETAFREE, and preparations for an NDA filing for NRX-100. Founder, Chairman and Chief Executive Officer Dr. Jonathan Javitt said the quarter was “productive” and contrasted the company’s current position with a year earlier, when he said NRx had not yet filed for its first drug approval and had $8.7 million in debt. Javitt said the company is now debt free, has sufficient cash for immediate operating needs and raised $7 million after the end of the quarter. → 3 Crucial Aerospace Component Makers That Analysts Love Doing Your Holiday Shopping? These Stocks Might Make Great Gifts Javitt said NRx continued to make progress with the FDA review of KETAFREE, its preservative-free ketamine formulation. In March, the company said the FDA notified it of a preliminary determination of bioequivalence to the reference branded drug KETALAR. Since then, Javitt said the company has continued clearing remaining review disciplines. According to Javitt, the FDA issued a labeling letter in April requesting only minor formatting changes and a positive discipline review letter on quality that requested administrative changes the agency identified as minor. He said leadership of the FDA Office of Generic Drugs expressed support for addressing remaining items within the current review cycle, consistent with the company’s goal of summer 2026. → McDonald's Is the Cheapest It’s Been in Years—Does That Make It a Buy? Javitt said NRx transmitted its first commercial manufacturing order on May 5 at the 1 million unit per batch scale. The company is using a blow-fill-seal process, which Javitt said provides more than tenfold throughput compared with traditional glass vial techniques and is scalable at lower manufacturing cost. He said NRx calculates it can manufacture 1 million units per week. Javitt said sterile ketamine remains in shortage and that the market shortage is larger than hospital data may indicate because ketamine clinics often cannot obtain product through commercial supply chains and rely on compounding pharmacies. In a question-and-answer exchange with BTIG analyst Thomas Shrader, Javitt said NRx sees two channels for KETAFREE: the traditional hospital channel and the clinic market, which he said has limited access to wholesalers. → 3 Stocks to Own If Gas Prices Keep Rising “We intend to displace that compounded product with reliably manufactured, FDA-approved GMP product,” Javitt said. NRx appointed Glenn Tyson as Chief Commercial Officer in April to support the anticipated launch. Javitt said Tyson has 25 years of commercial leadership experience at GSK and Indivior, including work on the launch of SUBLOCADE. Javitt said NRx expects to file an NDA for NRX-100 in the second quarter. He said a Type C meeting with FDA psychiatry leadership confirmed the agency’s willingness to review existing clinical trial data alongside real-world evidence as a potential basis for approval without requiring additional trials. The planned NDA will be supported by clinical trial data from more than 1,000 patients and real-world evidence from more than 65,000 patients through a partnership with Osmind, Javitt said. He added that the FDA guided NRx to seek a broader indication of depression in patients who may have suicidality, rather than only patients who have suicidality. During the Q&A, Shrader asked about the real-world ketamine data. Javitt said NRx agreed with the FDA that it would submit a statistical analysis plan before analyzing the data, including which tests would be used and how patients would be included, excluded and categorized. He said the company was waiting for the FDA’s response and expected it approximately by the end of the month. Javitt also discussed an April 18 executive order signed by President Trump titled “Accelerating Medical Treatments for Serious Mental Illness,” which he said directs acceleration of approval pathways for psychedelic medicines to treat depression, PTSD and suicidality and encourages the use of real-world evidence. Javitt said NRx has applied for a Commissioner’s National Priority Voucher in support of the NDA. He also said NRX-100 already has fast track status, making it entitled to priority review. NRx is also advancing NRX-101 on multiple tracks. Javitt said the company has initiated an NDA filing for suicidal bipolar depression by submitting module 3 manufacturing files and is requesting rolling review under its breakthrough therapy designation. Separately, Javitt said the FDA cleared the MIND1 trial on May 7. The phase II-B/III study will evaluate NRX-101 versus placebo as an adjunct to robotic-assisted transcranial magnetic stimulation, or TMS, using an accelerated one-day protocol. The trial is designed to enroll 400 participants across an academic teaching hospital, HOPE Therapeutics clinics and U.S. military treatment facilities, with non-dilutive federal funding anticipated, he said. Javitt said recent data showed a doubling of clinical response and an eightfold increase in remission from depression when D-cycloserine is added to standard TMS therapy. He said the market opportunity for this indication exceeds $1 billion. In response to a question from H.C. Wainwright analyst Patrick Trucchio, Javitt said the trial could potentially support approval if it produced a dramatic result, though he cautioned that the data would determine the path forward. Javitt said HOPE Therapeutics operated five Florida clinics during the quarter and expects eight or more locations by the end of the second quarter. In February, the company appointed Professor Joshua Brown of Harvard/McLean as Chief Medical Innovation Officer, joining Medical Director Dr. Rebecca Cohen. HOPE also announced a partnership with Emobot Health in March to deploy an AI-driven “depression thermometer,” a smartphone application that Javitt said can measure depression levels with high correlation to standard depression measures. He said the application passively analyzes facial expressions, vocal tones and actigraphy and is intended to help detect relapse between visits. NRx also formed Geneuro, Inc., a Florida-based subsidiary built around assets acquired from the Swiss court-supervised liquidation sale of Geneuro SA. Javitt said the portfolio targets Human Endogenous Retroviruses, or HERVs, which he said are implicated in schizophrenia, multiple sclerosis, ALS, autism and optic neuritis. The acquired assets include patents, cell lines, antibodies, regulatory files and data from three completed human clinical trials. Dr. Hervé Perron, formerly Chief Scientist at Geneuro SA, joined as Chief Scientist, while Professor Marion Leboyer will lead the anti-HERV-W antibody program in schizophrenia, Javitt said. Chief Financial Officer Michael Abrams said NRx reported a first-quarter net loss of approximately $1.4 million, or $0.04 per share, compared with a net loss of approximately $5.5 million, or $0.34 per share, in the prior-year period. He said the 74% year-over-year reduction was primarily related to fair value accounting measures and other non-recurring charges. Loss from operations was $4.7 million, compared with $3.8 million in the same quarter of 2025. Abrams said the increase was driven by costs tied to strategic initiatives, including progress toward drug approvals, resources for an anticipated commercial launch, clinic expansion, intellectual property development and pipeline growth. Research and development expense was approximately $1.3 million, compared with $0.8 million a year earlier. General and administrative expense, including selling costs, was approximately $3.8 million, compared with $2.9 million in the prior-year period. NRx had approximately $6.7 million in cash and cash equivalents as of March 31, 2026. Abrams said management believes current cash resources, anticipated clinic revenue growth, cost reduction initiatives and access to the company’s active at-the-market offering will support operations through at least 2026. Subsequent to quarter end, the company generated approximately $7 million in gross proceeds from common stock sales under the ATM facility. NRx Pharmaceuticals, Inc is a clinical-stage specialty biopharmaceutical company focused on the development and repurposing of small-molecule therapeutics for central nervous system and rare disease indications. The company's research strategy centers on advancing compounds with established safety profiles into new neurological and inflammatory conditions, leveraging translational science and biomarker-driven trial design to accelerate clinical development. NRx's pipeline includes Ifenprodil, an NMDA receptor antagonist in investigation for acute respiratory distress syndrome and inflammatory muscle disorders, as well as investigational formulations targeting depressive and cognitive disorders. Since securing global rights to its lead assets, NRx has initiated multiple proof-of-concept studies in the United States and Europe, collaborating with academic institutions and clinical research organizations to evaluate safety and efficacy across a range of indications. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "NRx Pharmaceuticals Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Key highlights from the first quarter of operations under the expanded management team include the following: Anticipated FDA decision on the Company's ANDA for Preservative-Free Ketamine in Q3 2026, with favorable preliminary determinations already received from the FDA Office of Generic Drugs on bioequivalence, labeling, drug product, drug substance, and safety. Initiation of commercial manufacturing of Ketamine at the 1 million dose per month level with recent FDA inspection of the manufacturing facility and granting of inspection status consistent with launch of an ANDA drug. Completed a Type C meeting with the FDA Division of Psychiatry Products and CDER leadership, in which the Agency expressed openness to existing clinical trial data and Real World Evidence supporting approval without additional trials. Presidential Executive Order signed and Congressional Appropriations Language filed encouraging the use of Real World Evidence in the approval of drugs for suicidal depression and PTSD. Appointment of Prof. Joshua Brown, MD, PhD (Harvard/McLean) as Chief Medical Innovation Officer, bringing NIH- and DARPA-funded expertise in D-cycloserine and TMS for depression, PTSD, and suicidality. FDA acceptance of an Investigational New Drug (IND) application for NRX-101 as an adjunct to robotic-enabled Transcranial Magnetic Stimulation (TMS), with anticipated non-dilutive federal funding supporting study at military and civilian sites. Development of a patentable, sustained-release formulation of D-cycloserine designed to enhance TMS efficacy, building on prior trial data showing a doubling of clinical response and 8-fold increase in remission versus standard TMS. First revenue generated from five interventional psychiatry clinics treating severe depression and PTSD, with funding from the VA, Department of War, private insurers, and self-pay; footprint expected to expand meaningfully in 2026. Pending acquisition of Geneuro, SA assets through a now complete Swiss court-supervised liquidation process, including a patent portfolio, antibodies, cell lines, and Phase 2 data targeting HERVs implicated in Schizophrenia, ALS, MS, Autism, and Type 1 Diabetes. WILMINGTON, Del., May 18, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”, the “Company”, “we”, “us” or “our”) a clinical-stage biopharmaceutical company, today announced financial results for the quarter ended March 31, 2026, and provided a corporate update. The quarter was marked by continued progress advancing NRx’s drug candidates toward commercialization, further development of the HOPE Therapeutics subsidiary, FDA acceptance of an IND for a federally-supported trial of NRX-101 as an adjunct to robotic Transcranial Magnetic Stimulation (TMS), and the pending acquisition of a Phase 2 monoclonal antibody portfolio targeting Human Endogenous Retroviruses (HERVs) implicated in Schizophrenia, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Autism, and Type 1 Diabetes. “The first quarter of 2026 was a pivotal one for NRx, as we advanced two lifesaving drugs towards FDA approval with the aim of initiating commercial pharmaceutical operations by the end of this year. We started the year debt-free, and made targeted investments in several critical strategic operating initiatives that drove 1) substantial progress toward the approval of our first drug product, 2) initiated commercial manufacture in anticipation of drug launch, 3) advanced profitable clinic operations with an expanded footprint, 4) burgeoned our overall intellectual property portfolio, 5) augmented our development pipeline and 6) attracted fundamental long-term investors who believe in our mission,” said Dr. Jonathan Javitt, the Company’s CEO and Chairman. “We are deeply grateful for the trust that has been afforded to us by our patients, their families, and our shareholders.” Key Research and Development and Corporate Activities NRX-100 and KETAFREE™ (Preservative-Free Ketamine) NRx advanced both regulatory pathways for its preservative-free ketamine programs during the quarter. The KETAFREE™ ANDA progressed through FDA Office of Generic Drugs review with no major deficiencies, and the FDA reclassified the manufacturing site to "VAI" status, enabling the Company to initiate commercial manufacturing at a one-million-unit-per-batch scale. FDA is endeavoring to complete the product review by Summer 2026. As of April 7, 2026, sterile intravenous ketamine remained listed on the American Society of Health-System Pharmacists (ASHP) national drug shortage database, with ongoing supply constraints reported across multiple manufacturers, underscoring the need for additional reliable, domestically manufactured ketamine supply. The NRX-100 NDA, expected to be filed in Q2 2026, will be supported by clinical trial evidence in more than 1,000 patients and Real World Evidence on more than 65,000 U.S. patients through a partnership with Osmind, Inc. Following a Type C meeting, the FDA agreed to consider both data sources in its review. Management believes that the current generic ketamine market exceeds $750 million per year, while SPRAVATO® generates approximately $2 billion annually. NRX-101 (D-cycloserine/lurasidone) NRX-101 advanced on two tracks during the quarter. In its original indication of suicidal bipolar depression, the Company initiated an NDA filing with submission of the Module 3 manufacturing file and is requesting rolling review, building on Breakthrough Therapy Designation previously awarded by the FDA. Separately, the Company received FDA clearance to proceed with the MIND1 trial, a Phase 2b/3 study of NRX-101 versus placebo as an adjunct to robotic-assisted Transcranial Magnetic Stimulation in conjunction with an accelerated one-day TMS protocol (ONE-D). The trial is designed to enroll 400 participants across Military Treatment Facilities, HOPE Therapeutics clinics, and a prominent university teaching hospital, with non-dilutive U.S. Government funding anticipated. The Company also achieved non-clinical validation of a proprietary extended-release form of D-cycloserine designed to support TMS augmentation. NRx Defense Systems, Inc. To advance its military-focused neuroplastic therapy initiatives, the Company incorporated NRx Defense Systems, Inc. in April 2026 to support the MIND1 trial and broader development of military-grade TMS technology. The subsidiary is led by Dr. Dennis K. McBride, PhD (CAPT US Navy, Ret.), a former Program Manager at DARPA and senior executive at the National Defense University and Office of the Secretary of Defense, with development conducted in partnership with Zeta Surgical (Cambridge, MA). HOPE Therapeutics, Inc. HOPE Therapeutics, a majority-owned subsidiary, continued to scale its interventional psychiatry network during the quarter, operating five Florida clinics with eight or more locations anticipated by the end of Q2 2026. In February 2026, HOPE appointed Prof. Joshua Brown, MD, PhD, of Harvard/McLean as Chief Medical Innovation Officer, joining Rebecca Cohen, MD, as Medical Director. The subsidiary further expanded its footprint through partnerships with neurocare AG, focused on NRX-101 as a TMS-enhancing therapy, and EMOBOT, Inc., to deploy continuous patient monitoring across HOPE's clinical network. Geneuro, Inc. NRx broadened its therapeutic platform through the formation of Geneuro, Inc., a Florida-based subsidiary focused on the anticipated acquisition of a portfolio of assets targeting Human Endogenous Retroviruses (HERVs) implicated in Schizophrenia, Multiple Sclerosis, ALS, Autism, and Optic Neuritis. The portfolio was offered through a Swiss court-supervised liquidation sale process of Geneuro, SA, and the Company was recently notified that it had submitted the winning bid. The acquisition is expected to close during the second quarter of 2026 with cash in an existing, prefunded escrow account, and includes a broad patent portfolio, cell lines, antibodies, regulatory files, and data from three completed human clinical trials. Dr. Hervé Perron, PhD, formerly Chief Scientist of Geneuro, SA, has joined as Chief Scientist alongside Prof. Marion Leboyer, MD, PhD, who will lead the anti-HERV-W antibody program. The Company anticipates supporting Geneuro through non-dilutive investment channels. Financial Results for the Quarter Ended March 31, 2026 For the three months ended March 31, 2026, NRx reported a net loss of $1.4 million, versus a net loss of $5.5 million during the comparable quarter in 2025. The change was primarily related to the impact of certain fair value accounting measurements and other non-recurring charges incurred during the three months ended March 31, 2025. For the three months ended March 31, 2026, NRx reported a net operating loss of $4.7 million versus a net operating loss of $3.8 million for the comparable quarter in 2025. The change was primarily driven by certain costs related to several targeted strategic initiatives advanced during the quarter ended March 31, 2026, which management believes will drive significant short and long-term value for shareholders including, but not limited to, progress toward the approval of our first drug product, aligning resources for an anticipated near-term commercial launch, augmenting and expanding profitable clinic operations, enhancing our overall intellectual property portfolio, and growing our development pipeline with new assets. As of March 31, 2026, the Company had approximately $6.7 million in cash and cash equivalents. Management believes current cash resources, anticipated growth in clinic revenue, ongoing cost reduction initiatives, and continued availability under the Company's active at-the-market offering will be sufficient to support operations through 2026. Subsequent to quarter-end, the Company generated approximately $7 million in gross proceeds from its at-the-market (ATM) facility through the sale of common stock. Detailed financials are available in the Company's Form 10-Q. About NRx Pharmaceuticals, Inc.NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression. Notice Regarding Forward-Looking StatementsThe 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. For further information:Brian KorbManaging Partner, astr partners(917) [email protected]

WILMINGTON, Del., May 14, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company, today announced that it will release its first quarter 2026 financial results before the market opens on Monday, May 18, 2026 via press release, which will be available on the Company’s website at https://ir.nrxpharma.com/. The Company will host a conference call at 8:00am ET the same day. A live webcast of the conference call will be available on the Company’s website at https://ir.nrxpharma.com/events. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically 1-800-717-1738 or internationally +1-646-307-1865. About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression. 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. For further information: Brian Korb Managing Partner, astr partners (917) 653-5122 [email protected]

This article first appeared on GuruFocus. Loss from Operations: Reduced by approximately $2.3 million to $16.2 million from $18.5 million year-over-year. Research and Development Expense: Decreased by approximately $2.4 million to $3.8 million from $6.2 million year-over-year. General and Administrative Expense: Decreased by approximately $0.4 million to $13.1 million from $13.5 million year-over-year. Cash and Cash Equivalents: Approximately $7.8 million as of December 31, 2025. Warning! GuruFocus has detected 4 Warning Signs with NRXP. Is NRXP fairly valued? Test your thesis with our free DCF calculator. Release Date: March 24, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. NRX Pharmaceuticals Inc (NASDAQ:NRXP) anticipates drug approval for KETAFREE over the summer and potential approval for NRX-100 within the year. The company has demonstrated EBITDA positive revenue growth through its HOPE Therapeutics clinics. NRX Pharmaceuticals Inc (NASDAQ:NRXP) has eliminated all convertible debt from its balance sheet and ended the year with $7.8 million in cash. The FDA has shown willingness to review real-world evidence for NRX-100, potentially broadening its indication to a larger patient population. The company has launched a nationwide expanded access program for NRX-101, with a market estimate for its new indication exceeding $1 billion. NRX Pharmaceuticals Inc (NASDAQ:NRXP) still faces risks and uncertainties that could affect its forward-looking statements. The company is reliant on FDA approval processes, which can be unpredictable and may delay product launches. Despite progress, NRX Pharmaceuticals Inc (NASDAQ:NRXP) reported a loss from operations of $16.2 million for the year ended December 31, 2025. The companys commercial strategy for KETAFREE is still in development, with reliance on external organizations for hospital sales. NRX Pharmaceuticals Inc (NASDAQ:NRXP) must continue to manage its cash resources carefully to support operations through 2026. Q: Can you provide an update on the KETAFREE inventory and its potential market impact? A: Jonathan Javitt, Chairman and CEO, explained that NRX Pharmaceuticals has already manufactured three registration batches of KETAFREE, which are in the warehouse. The company plans to have a couple of hundred thousand units ready at the time of generic approval. The potential market impact, if KETAFREE becomes the only preservative-free ketamine available, could lead to a significant pricing model shift, though exact projections would be better assessed by analysts. Q: Regarding the extended-release D-cycloserine, is there clinical data supporting its efficacy, or is further research needed? A: Jonathan Javitt noted that while there is a lot of reason to believe that continued exposure to D-cycloserine is beneficial, further in vitro work is needed to confirm its neuroplastic effects. The aim is to maintain a steady state of the drug to create a biological response. Q: How does the recent Type C meeting with the FDA impact the NDA filing for NRX-100, and what role does real-world data play? A: The FDA has indicated that they will review existing clinical trials data and real-world evidence without requiring additional clinical trials. The real-world data set of 65,000 to 70,000 patients is crucial in demonstrating the efficacy of NRX-100, potentially leading to a broader treatment-resistant depression label. Q: What is the commercial strategy for KETAFREE if approved in Q3 2026? A: Jonathan Javitt stated that the commercial strategy involves targeting two main segments: hospital surgery centers and clinics using ketamine for psychiatric and pain control. The company plans to collaborate with existing organizations for hospital sales and establish a medical liaison service for clinics, ensuring a compact and financeable commercial footprint. Q: What remains before the final approval of KETAFREE in the third quarter of this year? A: The approval process involves continued examination of stability data, a pre-approval plant inspection, and final checks associated with any drug approval. Clearing the bioequivalence hurdle is considered a major turning point in this process. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

NRx Pharmaceuticals, Inc. (NRXP) came out with quarterly earnings of $0.19 per share, beating the Zacks Consensus Estimate of a loss of $0.09 per share. This compares to a loss of $0.3 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +323.53%. A quarter ago, it was expected that this company would post a loss of $0.11 per share when it actually produced a loss of $0.18, delivering a surprise of -63.64%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. NRx Pharmaceuticals, which belongs to the Zacks Medical - Drugs industry, posted revenues of $0.98 million for the quarter ended December 2025, missing the Zacks Consensus Estimate by 84.4%. This compares to zero revenues a year ago. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. NRx Pharmaceuticals shares have lost about 31.7% since the beginning of the year versus the S&P 500's decline of 5%. While NRx Pharmaceuticals has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for NRx Pharmaceuticals was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.01 on $14.25 million in revenues for the coming quarter and $0.13 on $83.6 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the top 36% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Vivos Therapeutics, Inc. (VVOS), another stock in the same industry, has yet to report results for the quarter ended December 2025. This company is expected to post quarterly loss of $0.53 per share in its upcoming report, which represents a year-over-year change of -89.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Vivos Therapeutics, Inc.'s revenues are expected to be $7.2 million, up 94.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report NRx Pharmaceuticals, Inc. (NRXP) : Free Stock Analysis Report Vivos Therapeutics, Inc. (VVOS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

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 of December 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 the FDA 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 on NIH- and DARPA-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, the Department 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. WILMINGTON, Del., March 24, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”, the “Company”, “we”, “us” or “our”) announces the filing of its Form 10-K for the year ended December 31, 2025. “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. Jonathan Javitt, the Company’s CEO and Chairman. We have opened our first HOPE Therapeutics Clinics and are witnessing firsthand the impact that properly coordinated neuroplastic care can have on patients and their families who suffer from depression, PTSD, and suicidality. Clinical response rates approaching 90% have been reported in the medical literature for the combination of neuroplastic drugs, Transcranial Magnetic Stimulation, and Hyperbaric Oxygen Therapy. We look forward to a world in which physician-led neuroplastic care replaces a world of older antidepressants and electroshock therapy. We are deeply grateful to the trust that has been afforded us by our patients, their families, and our shareholders.” 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, NeuroRx, Inc., (NeuroRx), novel therapeutics for the treatment of central nervous system disorders including suicidal depression, chronic pain, post-traumatic stress disorder (PTSD) and schizophrenia. NRx is additionally the founder and majority owner of HOPE Therapeutics, Inc. (HOPE), a medical services company that offers interventional psychiatry care to patients with treatment-resistant depression and PTSD with a combination of neuroplastic drugs, transcranial magnetic stimulation (TMS), digital therapeutics, and hyperbaric therapy. All of our current drug development activities are focused on drugs that enhance neuroplasticity by modulating the N-methyl-D-aspartate (NMDA) receptor in the brain and nervous system, a neurochemical pathway that has been disclosed in detail in our annual filings. The Company has three lead drug candidates – NRX-100, a preservative-free formulation of ketamine for intravenous infusion, a generic preservative-free formulation of ketamine (KETAFREE™) and NRX-101, an oral fixed dose combination of D-cycloserine (DCS) and lurasidone, all of which are in the process of submission for Food and Drug Administration (FDA) approval. Financial Results for the Year Ended December 31, 2025 For the year ended December 31, 2025, NRx Pharmaceuticals reduced its loss from operations by approximately $2.3 million to $16.2 million from $18.5 million for the year ended December 31, 2024, which was primarily driven by a decrease in research and development expense. For the year ended December 31, 2025, research and development expense decreased by approximately $2.4 million to $3.8 million as compared to $6.2 million for the year ended December 31, 2024 primarily driven by a decrease in clinical trial and development expense. Finally, general and administrative expense for the year ended December 31, 2025 decreased by approximately $0.4 million to $13.1 million as compared to $13.5 million for the year ended December 31, 2024 primarily driven by certain ongoing cost reduction initiatives. As of December 31, 2025, we had approximately $7.8 million in cash and cash equivalents. Management believes that current available cash resources in concert with anticipated growth in total clinic revenue, ongoing cost reduction initiatives, and current availability and trends in connection with the Company’s active at-the-market offering will be sufficient to support ongoing operations through the end of 2026. Detailed financials are available in our Form 10-K, filed with the SEC and on our website. 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 NRx Pharmaceuticals will host a conference call today at 8:00 a.m. ET to review full-year 2025 financial results and provide a corporate update. 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 (U.S.) or +1-646-307-1865 (international). About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression. 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. For further information: Brian Korb Managing Partner, astr partners (917) 653-5122 [email protected]