NRX Pharmaceuticals (NRXP) Q1 2026 earnings call transcript

Thank you, Operator, and welcome, everyone. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U. S. federal securities law. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.

The forward-looking statements made during this call speak only as of the date hereof and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release issued today and in the company's Form 10-Q, which may be accessed from the investor page of the NRX Pharmaceuticals website. Joining me on today's call is Dr. Jonathan Javitt, our founder, chairman, and CEO, and Michael Abrams, our chief financial officer.

Dr. Javitt will provide an overview of the company's progress during the first quarter, following which Mike will review our financial results. Following our prepared remarks, we will address investor questions. I will now turn the call over to Jonathan. Jonathan, please go ahead.

Thank you, Brian. Good morning, everyone. Thank you for joining us. The first quarter of 2026 was a productive one for NRX. We made progress on both regulatory pathways for preservative-free ketamine, initiated commercial manufacturing, advanced NRX 101 into a registrational trial, continued to grow the Hope Therapeutics Network and acquired the Genuro assets. A year ago, we had not yet filed for our first drug approval, and we were $8.7 million in debt. Now we are debt-free, we have sufficient cash for our immediate operating needs, and we've raised $7 million since the end of the quarter. We've reduced our financial statement loss by 74% year over year.

Let me start with Ketafree. As we reported in March, FDA notified us of a preliminary determination of bioequivalence to the reference-branded drug Ketalar. Since then, we've continued to clear the remaining review disciplines. In April, FDA issued a labeling letter requesting only minor formatting changes and a positive discipline review letter on quality, requesting only administrative changes that FDA itself identified as minor. Leadership of the FDA Office of Generic Drugs expressed support for addressing the remaining items within the current review cycle, consistent with our summer 2026 goal.

We're at the verge of entering a robust market where ketamine is in drug shortage at the exact moment when reliability matters most, and we're positioned to deliver it. From our perspective, the market shortage of ketamine is larger than is apparent from hospital data because the rapidly growing ketamine clinic market segment is frequently unable to obtain ketamine through the commercial supply chain and must rely on compounding pharmacies. FCA has now reclassified our manufacturing site to VAI status consistent with the launch of an antedrug. And on May 5, we transmitted our first commercial manufacturing order at the 1 million unit per batch scale.

The blow-fill-seal process we're using delivers more than tenfold throughput compared to traditional glass vial techniques and is readily scalable at substantially lower manufacturing cost.

Simply put, the most expensive component in traditional manufactured ketamine is the glass vial. With blow-fill seal or BFS, there is no glass vial, no rubber stopper, and we calculate that we are capable of manufacturing 1 million units per week. Timing matters here. As of April, sterile intravenous ketamine remains on the ASHP National Drug Shortage Database. Ketafree will be the first U. S. -manufactured preservative-free ketamine. Free of benzathonia and chloride, a preservative that is not generally recognized as safe.

and is no longer permitted even in hand cleansers and topical antiseptics. To prepare for launch, in April we appointed Glenn Tyson as our first chief commercial officer. Glenn brings 25 years of commercial leadership at GSK and Indivior where he led the successful launch of Sublicate. Glenn is in the process of bringing on his launch team of accomplished pharmaceutical executives and we look forward to introducing them you in the near future. As we prepare for anticipated approval of our preservative-free ketamine, we're entering a market that is already well-established but structurally undersupplied.

Sterylketamine has remained on national drug shortage listings, as we mentioned, with intermittent back orders, product discontinuations, and inconsistent availability across hospital and outpatient settings. At the same time, clinical demand continues to expand across both anesthesia and psychiatric use, supported by widespread off-label adoption and established infusion infrastructure. It's important to recognize that ketamine is rapidly becoming a substitute for opioids in many pain control protocols, and federal law is increasingly discouraging the use of opioids as a state law. We believe this creates a highly attractive initial commercial opportunity where reliability of supply and quality of manufacturing are as important as price. With U. S. -based production, scalable manufacturing capability, and a preservative-free profile, our goal is to provide a consistent and trusted source of ketamine at a time when clinicians are actively seeking alternatives to constrain supply on one hand and alternatives to using opioids on the other.

We believe our product represents the first domestically manufactured source of preservative-free ketamine, and we further reinforce this position through our previously filed Physician Petitions Supporting Standards for Preservative-Free Formulations.

Turning to NRX100, as we shared in March, our Type C meeting with the leadership of the FDA Division of Psychiatry Products and the Center for Drug Evaluation and Research confirmed FDA's willingness to review existing clinical trial data together with real-world evidence as potential basis for approval without a requirement for additional trials. The NDA, which we expect to file in the second quarter, will be supported by clinical trial data on more than 1,000 patients and real-world evidence on more than 65,000 patients through our partnership with Osmite.

FDA also guided us to seek the broader indication of depression in patients who may have suicidality rather than simply seeking an approval for patients who have suicidality, which applies to more than 10 million Americans. In April, the regulatory environment evolved further. On April 18th, President Trump signed an executive order titled Accelerating Medical Treatments for Serious Mental Illness, directing acceleration of approval pathways for psychedelic medicines to treat depression, PTSD, and suicidality. and directing FDA to award commissioners' national priority vouchers to qualifying drugs.

The presidential order specifically directs the use of real-world evidence in the approval process for this class of drugs. Congressional appropriations language has similarly been filed, encouraging the use of real-world evidence in approval of drugs for suicidal depression and PTSD. We've applied for a commissioners' national priority voucher in support of our NDA. For context, the current generic ketamine market exceeds $750 million per year, not counting the shadow market of ketamine that's being bought through compounding pharmacies, while Spravato generates approximately billion annually despite labeling that does not include reduction of suicidality Moving to NRX 101 when we advance two parallel tracks in our original indication of suicidal bipolar depression, we've initiated an NDA filing with submission of Module 3 manufacturing files, and we're requesting rolling review under our breakthrough therapy designation.

Separately, however, on May 7, we received FDA clearance to proceed with the MIND-1 trial, a Phase 2B3 study of NRX-101 versus placebo as an adjunct to robotic-assisted TMS using an accelerated one-day protocol. The trial is designed to enroll 400 participants across a leading academic teaching hospital, folk therapeutics clinics, and U. S. military treatment facilities with non-dilutive federal funding anticipated. This use of NRX 101 was not anticipated until recent data have shown a doubling of clinical response and an eightfold increase in remission from depression when decyclocerin is added to standard transcranial magnetic stimulation therapy.

The market opportunity for this indication is in excess of $1 billion. We've also achieved nonclinical validation of a proprietary extended release form of d-cyclycerin designed to support TMS augmentation.

The MIND-1 trial will be conducted by NRX Defense Systems, a Florida-based R&D subsidiary we incorporated in April. NRX Defense Systems is led by Dr. Dennis McBride, a retired Navy captain, a former DARPA program manager. He served two terms as a DARPA program manager. And former senior executive, both in the National Defense University and in the office of the Secretary of Defense. The robotic-enabled TMS prototype is being developed in combination with Zeta Surgical, whose AI-powered neuro-navigation platform has already received FDA 5-plane clearance for TMS navigation.

We plan to unveil the prototype with Zeta at the Clinical TMS Society annual meeting in Boston in early June. Depression, if you want to see it, touch it, feel it firsthand, please join us. Depression and PTSD carry a five-fold increased risk in frontline troops and first responders, and personnel who are on standard antidepressants are not combat deployable. A short-term, non-disqualifying treatment is both a health care imperative and a force readiness priority, not only in the military setting, but in the setting of firefighters, police officers, and other first responders.

Turning to Hope Therapeutics, we operated five Florida clinics during the quarter and expect eight or more locations by the end of the second quarter. In February, we appointed Professor Josh Brown of Harvard-McLean as Chief Medical Innovation Officer, joining Dr. Rebecca Cohen, our Medical Director. In March, Hope announced a partnership with Emobot Health to deploy its AI-driven depression thermometer.

That's a cell phone app that can actually measure your level of depression at a very high correlation with standard depression measures. EMABOT passively analyzes facial expressions, vocal tones, and a typography through a background smartphone application with clinical validation showing strong concordance against both Madras and PHQ-9. This addresses a critical blind spot in the care of patients with depression and suicidality.

Approximately 50% of patients with treatment-resistant depression relapse within 6 to 12 months, and that relapse is often undetected between visits. As I have said, we expect every patient in our network to be on Emobot. We continue to integrate our partnership with NeuroCare AG, which brings together the combined clinic base together with an installed base of more than 400 Apollo TMS machines across the U. S. Finally, an important pipeline expansion occurred just in the past few weeks.

We just last week formed Gineuro Incorporated, a Florida-based subsidiary built around a newly acquired portfolio targeting human endogenous retroviruses, or PERS, which are implicated in schizophrenia, multiple sclerosis, ALS, autism, and optic neuritis. The portfolio was acquired through a Swiss court supervised liquidation sale of Genuro SA, a Swiss company funded with existing cash, and includes a broad patent portfolio, cell lines, antibodies, regulatory files, and data from pre-completed human clinical trials. Dr. Hervé Perón, formerly chief scientist of Genuro SA has joined as our chief scientist, and Professor Marion Le Boyer, who joined our advisory board several years ago, and whose intellectual property, whose patents led us to this portfolio, will lead the anti-HERV-W antibody program in schizophrenia.

We anticipate supporting Genuro through non-dilutive investment channels. With that, I'll turn it over to Mike to review our financial results. Mr. Abrams?

Thank you, John. For the three months ended March 31st, 2026, NREX Pharmaceuticals reported a net loss of approximately $1.4 million, or $0.04 per share, as compared to a net loss for approximately $5.5 million, or $0.34 per share, for the three months ended March 31st, 2025, representing a 74% year-over-year reduction. This change is primarily related to the impact of certain fair value accounting measures and other non-recurring charges. For the three months ended March 31, 2026, NRX reported a loss from operations of $4.7 million versus a loss from operations of $3.8 million for the comparable quarter in 2025.

The change is 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. for the three months ended March 31, 2026. Research and development expense was approximately $1.3 million as compared to approximately $0.8 million for the three months ended March 31, 2025.

General administrative expense, which includes selling costs for the three months ended March 31, 2026, was approximately $3.8 million as compared to approximately $2.9 million for the three months ended March 31, 2025. The drivers of the changes of both research and development and GAA expense were both primarily driven, as mentioned above, certain costs related to our execution towards several targeted strategic initiatives advanced during the quarter ended March 31, 2026.

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 of the company's active at-the-market offering will be sufficient to support operations through at least 2026. Subsequent to quarter end, the company generated approximately $7 million in gross proceeds from its at-the-market facility through the sale of common stock.

With that, I turn the call back over to John. Jonathan?

Jonathan Cain Thank you, Mike. We made meaningful progress on each of our programs in the first quarter. Caterfree continues to advance through final FDA review. The NRX100 NDA is on track for submission this quarter. The MIND trial has FDA clearance to proceed and we expect non funding to support it in partnership with the military sites that plan to deploy the trial Hope Therapeutics continues to add clinical sites and generate revenue. Genero adds a new platform for serious neurological and autoimmune disease, supported through non-dilutive channels. Just to give you one example, the patent for treatment of endogenous retrovirus infection that is shown to be implicated in ALS is co-owned with the U. S. National Institutes of Health, and the prior company had a cooperative research and development agreement with the NIH.

We're deeply grateful to our team, to our patients and their families, to our shareholders for the trust they've placed in us, our goal of bringing hope to life is closer than ever. Operator, we're now ready to take questions.

Well, you're describing – thank you, Tom. And, you know, as always, you get right to the heart of the matter. You're describing two different channels. There's the existing hospital channel for ketamine, the reference drug, is Ketalar. and given the drug shortages and what we believe will be a perception of not only of quality, but U. S. manufacturing reliability, we believe that with standard blocking and tackling, for lack of a better word, and as you see the team that Glenn is bringing on to support that process in terms of payer outreach, in terms of major accounts outreach.

Part of our preservative-free ketamine strategy is that traditional market. But the other part is the clinic market that right now really doesn't have access to the wholesalers. And we've tested this. We've had our clinics call and try to buy from the wholesalers. And so far, not a single one of our clinics has succeeded in obtaining a single vial of ketamine from any of the traditional wholesalers. The wholesalers really are uninterested in the most rapidly growing area of the clinic space. So those clinics are required to rely on a web of compounding pharmacies. And we intend to displace that compounded product with reliably manufactured FDA-approved GMP product. So it's a two-pronged strategy at a time when not only is the psychiatry clinic market for ketamine rapidly growing, But as opioids are increasingly restricted in their availability and their prescribability, there's an increasing reliance on ketamine to treat pain syndromes as well.

And when we say records, we mean records on 65,000 unique patients. at the risk of sounding, you know, humorous. Everything with the FDA is a negotiation, but, you know, it's a negotiation that occurs through well-established channels. So what we agreed to in our meeting with FDA was we would, you know, they acknowledged that the preliminary cuts at the data look promising. OSMIND has previously published data on about 20,000 patients, and that was part of our meeting package. So, what we agreed is that we would submit a statistical analysis plan just in the same way that one submits a statistical analysis plan for a proposed clinical trial, so that before we spin the data, before we do the first analysis, we will have agreed with FDA on what statistical tests will be used, which patients will be included and excluded, how they'll be categorized, so that when we do the analysis, we're not going to be in a position where we keep, you know, crunching the data over and over again, but, you know, sort of measure twice, cut once.

So right now, we're waiting for FDA's response to our statistical analysis plan, And as soon as we've agreed on exactly what tests will be used, we'll apply that and submit the data.

Well, there are some regulatory clocks involved. So we're expecting FDA to come back to us approximately by the end of the month.

I don't want to give you an exact date, but I don't have it at my fingertips, but that's about the time frame.

Thank you.

Well, we're not in a very good position to understand other people's products. We know there is a shortage, whether it's a lack of glass vials, a lack of manufacturing capability. For whatever reason, that shortage exists. All we can really do is worry about our business and make sure we can address the shortage. and do that by having a couple of years of ketamine drug ingredient in the warehouse, by having high-volume assembly lines using blow-fill seal that are capable of making a million units in a single week if you run the line around the clock. by having a manufacturing partner that literally has the loading dock capacity to get the raw materials in and the finished goods out the door.

So we know how to address the shortage, but I'm not sure I can tell you exactly why the supply chain is undersupplied.

Yeah. It not an issue for us Availability of raw material is not a problem I can tell you the exact situation with pharmaceutical glass today I can tell you that during COVID, people were backed up a year.

Pharmaceutical glass is kind of a problem worldwide.

And somewhat related, if cata-free is approved, what do you anticipate the FDA's action would be towards preservative-free cata-mean as the solution across the industry?

Well, I would never want to predict what a regulatory agency will do. So I can say that the current Secretary of Health has been quite vocal in his view of the need to remove toxic preservatives from certainly from foods and vaccines.

He's certainly not been quiet about that throughout his career. The new acting commissioner of the FDA has been quite vocal about his view of safety and removal of toxic preservatives in various contexts. And the law says that all ingredients in a drug should be safe. This particular preservative was put into ketamine back in the 1970s. And in general, nobody's really looked at the formulation until we got involved. You know, quite frankly, when we got involved, I asked, well, why is it there? And the answer was, oh, it's a necessary excipient. The ketamine will come out of solution without it.

And I said, really? And part of the reason that happened was I was involved back in the mid-1990s. we tried to figure out why does everybody with glaucoma have dry eye syndrome, and it turned out that it was the benzalconium chloride in the eye drops that was killing the essential lipid component of human tears.

So that's how I first learned about this class of preservatives, and that's why you see preservative-free eye drops on all the drugstore shelves.

Yeah, generally that's a six-month process.

But remember, we already have FastTrack approved for NRX 100, so we're already entitled to priority review.

Thank you so much.

You know, at the time of the launch, we'll have at least a million units in the warehouse. And depending on what we see between now and then, you know, we may take that up by half a million or a million units.

Well, I don't know if anybody knows exactly how much a CMPV speeds up the process. but priority review is a pretty well-established pathway, and we know it does speed up the process. So could CMPV further speed the process? Could CMPV further increase the likelihood of an approval? I think those are all questions that remain to be seen. I think the most important thing is to come to agreement with FDA on the real-world evidence and get that submitted. And, you know, in that regard, the president's executive order from April is enormously supportive. And, you know, completely apart from the executive order from the White House, if you look at the appropriations language in the FDA budget appropriation for this year, you know, Congress has focused on the use of real-world evidence in the approval of drugs for depression and suicidality.

So I think there's an increasing recognition that this is just something that's needed for the health of the American people, and it ought to get the most serious possible and expeditious possible review.

Well, it's certainly a large enough sample that, you know, if one had a dramatically positive result, and, you know, but that wouldn't be P of 0.05, but P of 0.01 or better.

Given the priority that currently exists around treating depression and suicidality, again, back to the president's executive order, back to many things the secretary said, back to things Congress is saying, a dramatic effect in this trial on par with previous results that have been seen where d-cycloserine doubled the effect of transcranial magnetic stimulation on depression but increased that effect more than eightfold with respect to reducing suicidality. I think if we saw something that was as dramatic as that, the possibility of seeking an approval based on one trial would be a very real possibility. But until the data is in hand, I'm not sure that our speculation matters.

What matters is our getting this trial fielded in partnership with our military colleagues, with our academic colleagues.

Well, thank you. As I hope you can tell, this has been a quarter of, you know, heads down work. Our team has grown. Our proximity to market. market we believe has substantially uh increased or gotten shorter to be precise uh and we're incredibly grateful to the investors who've come on board uh who've lent their support and given us their confidence so thank you very much and we look forward to seeing you soon Thank you, ladies and gentlemen.