LJ-Bodhi
2週前
The Kadima agreement was signed May 9, 2025, and contained extensive warranties and representations made by Kadima and Feifel. Extensive, and it took time to vet the accuracy. By August, NRX/Hope filed an arbitration claim which most certainly means the allegation was Kadima breached one or more warranties/representations.
The August quarterly report from NRX very clearly identified issues with Kadima in the Legal Procedings section. Either the parties needed to agree on new terms to seal the deal, or find some other mutually agreeable resolution. It's right there in the August filing, so the litigation spin from this lawyer who filed this lawsuit is complete BS!
Legal Proceedings
The Company is, from time to time, involved in various legal proceedings incidental to the conduct of our business. Historically, the outcome of nearly all such legal proceedings has not, in the aggregate, had a material adverse effect on our business, financial condition, results of operations or liquidity. Other than as set forth below, there are no material pending or threatened legal proceedings at this time.
On May 9, 2025, Hope entered into the Kadima Purchase Agreement (the “Agreement”), with HTX Management Company, LLC, Kadima Neuropsychiatry Institute, Medical Corp., Kadima Holdings, Inc., and David Feifel, M.D., PH.D. (collectively, “Kadima”), pursuant to which the Company agreed to purchase, and Kadima agreed to sell, on the Closing Date, as defined in the Agreement, certain assets of Kadima, subject to the satisfaction of certain closing conditions (the “Acquisition”). As of the date of this Report, the parties have not closed the Acquisition, and, while no assurances can be given, remain in active discussions to either i) close the Acquisition per the terms of the Agreement, or ii) pursue potential alternative outcomes mutually agreeable to all parties.
The only representation by NRX/Hope is so very basic and common:
[t]4.4. Sufficiency of Funds. Purchaser has sufficient cash on hand or other sources of immediately available funds to enable it to pay the Closing Payment and other amounts required to be paid by Purchaser hereunder and to consummate the transactions contemplated by this Agreement and by the Related Agreements.
[/t]
As we have all seen over the past year, NRX has zero problem accessing "immediate" funds by offering stock with its shelf registration offering, open for business whenever they need it. For those who read public filings, they increased the registration to $20 million in available stock offerings in April 2025, just a month before the May 2025 Kadima agreement was signed:
https://www.otcmarkets.com/filing/html?id=18378655&guid=QZF-kKnxA_V8Oth
I hope all of this gives folks peace of mind. Good riddance Kadima. They will never get specific performance when all of their own breaches come to light. I hope someone checks Kadima insider stock purchases of NRXP after this BS lawsuit and press release. The share price seems to have stabilized, which says more about NRX/Hope compared to Kadima/Feifel.
LJ-Bodhi
2週前
NRX promptly disclosed potential red flags with Kadima in the August 2025 quarterly report (first quarterly report after the deal was announced), and the concerns were based on questions about Kadima's representations and warranties:
As of the date of this Report, the transactions contemplated by each of the Dura Purchase Agreement and the Kadima Purchase Agreement have not yet been consummated, and, as disclosed below, with respect to Kadima the parties are working to close the transaction on terms contemplated by the Kadima Purchase Agreement or pursue an alternative outcome acceptable to the parties.
In the Legal Proceedings section, NRX disclosed:
On May 9, 2025, Hope entered into the Kadima Purchase Agreement (the “Agreement”), with HTX Management Company, LLC, Kadima Neuropsychiatry Institute, Medical Corp., Kadima Holdings, Inc., and David Feifel, M.D., PH.D. (collectively, “Kadima”), pursuant to which the Company agreed to purchase, and Kadima agreed to sell, on the Closing Date, as defined in the Agreement, certain assets of Kadima, subject to the satisfaction of certain closing conditions (the “Acquisition”). As of the date of this Report, the parties have not closed the Acquisition, and, while no assurances can be given, remain in active discussions to either i) close the Acquisition per the terms of the Agreement, or ii) pursue potential alternative outcomes mutually agreeable to all parties.
NRX has been disclosing arbitration with Kadima in quarterly reports since the November 2025 quarterly report:
The Kadima Purchase Agreement also contains customary indemnification provisions whereby Kadima will indemnify the Company for certain losses arising out of inaccuracies in, or breaches of, the representations, warranties and covenants of Kadima, pre-closing taxes of Kadima, and certain other matters, subject to certain caps and thresholds.
As of the date of this Report, the parties have not closed the Acquisition and the matter has entered arbitration. At this stage of the arbitration, it is too early to determine if the matter would reasonably be expected to have a material adverse effect on our financial condition.
The March 2026 annual report also disclosed the Kadima legal/arbitration proceedings based on Kadima representations, as did the most recent May 2026 quarterly report and the recent stock offering:
The Kadima Purchase Agreement also contains customary indemnification provisions whereby Kadima will indemnify the Company for certain losses arising out of inaccuracies in, or breaches of, the representations, warranties and covenants of Kadima, pre-closing taxes of Kadima, and certain other matters, subject to certain caps and thresholds.
As of the date of this Report, the parties have not closed the Acquisition and the matter has entered arbitration. At this stage of the arbitration, it is too early to determine if the matter would reasonably be expected to have a material adverse effect on our financial condition.
NRX did not air its Kadima arbitration strategy/grievances in public and instead proceeded with contractual arbitration with full disclosure to shareholders. It appears Kadima was either not satisfied with changed terms offered in arbitration, OR made a preemptive public strike to file a lawsuit accusing NRX of wrongdoing when the story will likely come out publicly soon that it was Kadima that made misrepresentations about its financial/tax condition which has caused NRX to either back out of the deal from May 2025, or seek better terms based on what was learned about Kadima after the initial agreement.
The lawsuit 100% says Kadima wants NRX to honor the original deal. This was likely 100% requested by Kadima and refused by NRX in the arbitration. In fact, I would wager Kadima LOST the private binding arbitration, and then fired this missile as NRX "fraud/misrepresentation" in some futile attempt to get around the arbitration result.
Stay tuned, because the NRX response to the lawsuit is going to be interesting. When the most basic reported Kadima claims from the public lawsuit and news release about alleged failures by NRX to make shareholder disclosures are so easily refuted by SEC public filings, as they say.....the truth shall prevail.
By the way, the endless senseless bashers on other boards (especially the Stocktwits idiots) are beyond suspicious. Those folks obviously don't know how to read public SEC reports. Why oh Why oh Why would Kadima want to still be purchased by such a deceitful, shitty company??? With the good Dr. Feifel and his stellar reputation following through and coming aboard as Cheif Medical Officer???
Seems to me this is a scorned lover, sour grapes scenario where Kadima got caught and now they want to "punish" NRX with a public lawsuit right before Ketafree approval. Wonder how many Kadima insiders and family members are "buying the dip" LOL.
Good Luck Everyone!
ProfitScout
2週前
$NRXP News: NRx Pharmaceuticals Announces FDA Grant of Expanded Access Protocol for Use of D-Cycloserine-based NRX-101 for Augmentation of Transcranial Magnetic Stimulation in the Treatment of Depression
D-Cycloserine (DCS) has been reported to augment the effect of Transcranial Magnetic Stimulation (TMS) in remission from depression and suicidality in several published clinical studies.
NRx Pharmaceuticals is developing NRX-101, a fixed dose combination of DCS+lurasidone for the augmentation of TMS and has initiated a pivotal clinical trial in both civilian and military treatment facilities.
The Expanded Access protocol is designed to make NRX-101 available under FDA-authorized compassionate care mechanisms for patients who cannot access the pivotal trial.
Physicians who wish to provide NRX-101 in association with accelerated TMS for patients with Treatment-Resistant Depression may register at http://www.nrxpharma.com/EAP
WILMINGTON, Del., June 22, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a biopharmaceutical company that focuses on neuroplastic therapies for depression, PTSD, and related conditions, today announces the approval by FDA of an Intermediate Population Expanded Access Protocol for the use of NRX-101, a fixed dose combination of D-cycloserine (DCS) and lurasidone for the augmentation of accelerated Transcranial Magnetic Stimulation (TMS). Expanded Access Protocols are part of FDA’s compassionate care approach to making investigational drugs available to patients with serious or life-threatening medical conditions1.
In recent years, there have been multiple scientific reports which suggest that DCS may enhance the effectiveness of TMS in treating Treatment Resistant Depression and Suicidality.2,3 DCS has been demonstrated to have potent neuroplastic effects in laboratory studies. Neuroplasticity is the scientific term for the creation of new connections or synapses between brain cells and is believed to be key to the reversal of depression and suicidality. The Company has announced initiation of a pivotal clinical trial (the Synaptic Plasticity Augmented Rapid Circuit Stimulation (SPARC-TMS) study) to assess the effect of NRX-101 in augmenting TMS to achieve remission from Depression and Suicidality in patients being treated with mechanism-guided augmentation of neuronavigated robotic TMS, a study that will be conducted in both civilian and military treatment facilities.
While the use of DCS is increasingly discussed and adopted within the professional community based on Real World Evidence, the doses required are below the dose of DCS that is currently marketed and sold for the treatment of tuberculosis (the currently approved indication), which has led to an increasing use of compounded versions of DCS. Compounded drugs are neither supervised nor approved by the US FDA. In the case of DCS, compounding is particularly challenging because the DCS pharmaceutical ingredient is highly susceptible to degradation without special formulation processes. When NRx first developed NRX-101, two years of research and development was required to properly control impurities and achieve long-term stability. Compounded drugs (except those eligible for 503b manufacture, which DCS is not) are not assessed for stability and impurities by compounding pharmacists, who lack the chromatography equipment required for FDA Good Manufacturing Practices (GMP) controls. Accordingly, NRx Pharmaceuticals has elected to make NRX-101 available to physicians and their patients under the Expanded Access Protocol while pivotal clinical trials are underway in an effort to assure that this potentially life-saving drug is immediately available for patients who qualify. Initially, the Company will be charging only for shipping and FDA-required data collection costs, but not for the investigational drug.
“We at NRx deeply appreciate the engagement of the FDA Division of Psychiatry Products and their support of expanded access to regulated and GMP-manufactured D-cycloserine to enhance TMS effectiveness,” said Prof. Joshua Brown, MD, PhD, the Company’s Chief Medical Innovation Officer. “We look forward to reporting the results of our upcoming pivotal trial, SPARC-TMS, which aims to determine the efficacy of the NRX-101–TMS combination in achieving remission from depression and suicidality in patients with Treatment-Resistant Depression.” Dr. Brown serves as Editor-in-Chief of the Transcranial Magnetic Stimulation journal, and as immediate past President of the Clinical TMS Society, and as an Assistant Professor at Harvard Medical School and McLean Hospital.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor 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
brian.korb@astrpartners.com
1 https://www.fda.gov/news-events/public-health-focus/expanded-access
2 M Cole J, et.al. Efficacy of Adjunctive D-Cycloserine to Intermittent Theta-Burst Stimulation for Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022;79(12):1153–1161. doi:10.1001/jamapsychiatry.2022.3255
3 Vaughn, Donald & Marino, Brooke & Engelbertson, Alex & Dojnov, Aleksandra & Weiss, Nick & Vila-Rodriguez, Fidel & Nanos, Georgine & Downar, Jonathan. (2024). Real-world effectiveness of a single-day regimen for transcranial magnetic stimulation using Optimized, Neuroplastogen-Enhanced techniques in Depression (ONE-D). Transcranial Magnetic Stimulation, 2025; 5. DOI: 10.1016/j.transm.2025.100200
https://www.globenewswire.com/newsroom/ti?nf=OTc1MDE1NyM3NjcxMDc0IzIwODQxMjI=
https://ml.globenewswire.com/media/NmNmYmU4YTMtOTgyNy00NjNjLTk3ZjUtYjk0NGJiYjIzZWIwLTEwOTU2OTMtMjAyNi0wNi0yMi1lbg==/tiny/NRx-Pharmaceuticals-Inc.png
Source: NRx Pharmaceuticals, Inc.
Trooperstocks
1月前
$NRXP News: NRx Pharmaceuticals (Nasdaq: NRXP) Subsidiary HOPE Therapeutics Becomes First Commercial Site to Deploy Zeta Surgical's FDA-Cleared Zeta TMS Navigation System
NRx Pharmaceuticals, Inc.
Wed, May 27, 2026 at 7:00 AM EDT 5 min read
Deployment at HOPE's West Palm Beach clinic brings AI-powered, sub-millimetric image guidance to the delivery of Transcranial Magnetic Stimulation (TMS) for patients with Major Depressive Disorder and other neurological conditions
Installation complements HOPE's interventional psychiatry platform and aligns with NRx's previously announced clinical trial of NRX-101 in combination with robotic-enabled TMS
WEST PALM BEACH, Fla., May 27, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, today announced that its wholly-owned subsidiary, HOPE Therapeutics, Inc. ("HOPE"), has become the first commercial site to deploy Zeta Surgical's FDA-cleared Zeta TMS Navigation System. The system has been installed at HOPE's West Palm Beach, Florida clinic, where it will be used to deliver high-precision, image-guided Transcranial Magnetic Stimulation (TMS) for patients with Major Depressive Disorder and other neurological conditions.
"Being selected as the first commercial site for Zeta's FDA-cleared TMS Navigation System validates the integrated treatment model we are building at HOPE," said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals and HOPE Therapeutics. "Zeta's AI-driven image guidance brings neurosurgical-grade targeting precision into our outpatient clinics, and it sets the stage for our planned trial of NRX-101 in combination with robotic-enabled TMS in patients with depression and suicidality."
TMS is a non-invasive therapy widely used for treatment-resistant depression, which affects approximately one-third of patients with major depression. The clinical efficacy of TMS depends heavily on the accurate targeting of specific neural circuits. The Zeta TMS Navigation System uses proprietary RealTrack™ computer vision and artificial intelligence to continuously align a patient's MRI or CT scan with their facial anatomy in real time, delivering sub-millimetric precision and reducing setup times to under two minutes per session without the need for conventional fiducial markers.
The deployment complements HOPE's broader interventional psychiatry platform, which includes ketamine and Spravato® delivery, TMS, Hyperbaric Oxygen Therapy, and other neuroplastic therapies offered across the HOPE network of clinics. It also aligns with NRx's previously announced clinical trial program of NRX-101 (oral D-cycloserine/lurasidone) in combination with robotic-enabled TMS for patients with depression and suicidality, which is planned to be conducted across a leading US academic teaching hospital, three HOPE Therapeutics clinics, and two military treatment facilities.
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.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com), a subsidiary of NRx Pharmaceuticals, is a healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine and other neuroplastic medications, transcranial magnetic stimulation (TMS), Hyperbaric Oxygen Therapy, and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. HOPE is the first network in Florida to offer the AMPA One Day (ONE-D) treatment that combines TMS, physician-prescribed D-cycloserine, and lisdexamfetamine to achieve remission from treatment-resistant 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
brian.korb@astrpartners.com
Trooperstocks
2月前
$NRXP News: NRx Pharmaceuticals (Nasdaq:NRXP) Reports First Quarter 2026 Financial Results and Provides Corporate Update
NRx Pharmaceuticals, Inc.
Mon, May 18, 2026 at 7:00 AM EDT 10 min read
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 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
brian.korb@astrpartners.com