NRx Pharmaceuticals, Inc. ($NRXP)

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals First Quarter 2026 Earnings Conference Call. [Operator Instructions] I would now like to turn the conference call over to Brian Korb from [ Investor ] Officer. Please go ahead.

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 laws. 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 in this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during [ this ] 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, Brad. 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 [ Jenero ] assets. A year ago, we have 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 bioequivalents to the reference branded drug, [ Kettler ]. 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 disciplined review letter on quality, requesting only administrative changes that FDA itself identified is 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 are 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 [ it's ] 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. SCA has now reclassified our manufacturing site to VAI status, consistent with the launch of an ANDA drug. And in 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 file techniques and is scalable at substantially lower manufacturing cost. Simply put, the most expensive components in traditional manufactured ketamine in the glass file with blow-fill seal or BFS, there is no glass file, no rubber stopper and we calculate that we are capable of manufacturing 1 million units per week. Timing matters here. As of April, [ Sterling ] for venous Ketamine remains on the AHP National Drug Shortage Database. KETAFREE will be first U.S. manufactured preservative-free ketamine. Free of [ benzothoniand ] chloride a preservative that is not generally recognized as safe and is no longer permitted, even in hand cleansers and topical [ aseptic ]. To prepare for launch, in April, we appointed [ Glenn Tyson ], as our first Chief Commercial Officer. Glenn brings 25 years of commercial leadership in GSK and Indivior where he led the successful launch of SUBLOCADE. Glen is in the process of bringing on his launch team of accomplished pharmaceutical executives, and we look forward to introducing them to 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. [ Ser ] ketamine has remained on national 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 [ odioids ] as a state law. We believe this creates a highly attractive initial commercial opportunity where reliability of supply and quality of manufacturing or its importance is 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 [ frecademy ], and we further reinforced this position through our previously filed business in petition supporting standards for preservative-free formulations. Turning to NRX-100. 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 a 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 stations through our partnership with [ so ] 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 evolve further on April 18, President Trump signed an executive order titled Accelerating Medical Treatments for Serious Mental Illness, directing acceleration of approval pathways for psychodelic medicines to treat depression, [ TSC ] and suicidality and directing FDA to award Commission's 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 PTSD. We've applied for a [ commission ] national priority voucher and support of Brand. For context, the current generic [ atom ] market exceeds $750 million per year, not counting the shadow market of ketamine that's being bought through compounding pharmacies, whilst [ Privado ] generates approximately $2 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 MIND1 trial, a Phase IIb/III study of NRX-101 versus placebo as an adjunct to robotic-assisted TMS using an accelerated ONE-D protocol. The trial is designed to enroll 400 participants across a leading academic teaching hospital, HOPE therapeutics clinics and U.S. military treatment facilities with nondilutive 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 [ cycloserine ] 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 lease form of D-cycloserine designed to support TMS augmentation. The MIND1 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 ], retired Navy Captain, a former DARPA program manager who served two terms as the 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 data Surgical, whose AI-powered neuronavigation platform has already received FDA [ 5 ]10 clearance for TMS navigation. We plan to unveil the prototype of data at the Clinical TMS Society Annual Meeting in Boston in early June. Depression, if you want to see it, touch it, feel it first hand, please join us. Depression and PTSD carry a fivefold increased risk in frontline troops and first responders and personnel who are on standard antidepressants are not combat deployed a short-term nondisqualifying 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 8 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 cellphone app that can actually measure your level of depression at a very high correlation with standard depression measures. EMOBOT NR[indiscernible] analyzes facial expressions, vocal tones and [ actigraphy ] through a background smartphone application with clinical validation showing strong concordance against both [ MADRS ] and [ PHQ-9 ], this addresses a critical bit in the care of patients with depression who is [ cidality ] approximately 50% of patients with treatment-resistant depression relapse within 6 to 12 months, and that relapse is often undetected between visits. As I've said, we expect every patient in our network to be on [ MBO ]. We continue to integrate our partnership with neurocare AG, which brings together the combined [ cenicbase ] 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 Geneuro Incorporated, a Florida-based subsidiary built around a newly acquired portfolio targeting human endogenous retroviruses or [ IRF ], which are implicated in schizophrenia, multiple sclerosis, ALS, autism and optic neuritis. The portfolio was acquired through a Swiss Court Supervised liquidation sale of Geneuro, SA, 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. Herve Perron, formerly Chief Scientist of Geneuro, SA, has joined as our Chief Scientist and Professor Marion Leboyer, 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 program in schizophrenia. We anticipate supporting Geneuro 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 3 months ended March 31, 2026, Rx Pharmaceuticals reported a net loss of approximately $1.4 million or $0.04 per share as compared to a net loss of approximately $5.5 million or $0.34 per share for the 3 months ended March 31, 2025, representing a 74% and year-over-year reduction. This change is primarily related to the impact of certain fair value accounting measures and other nonrecurring charges. For the 3 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 certain -- several targeted strategic initiatives [ event ] 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 towards 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. [ The ] 3 months ended March 31, 2026, Research and development expense was approximately $1.3 million as compared to [ at ] $0.8 million for the 3 months ended March 31, 2025. General administrative expense, diluted selling costs for the 3 months ended March 31, 2026, was approximately $3.8 million as compared to approximately $2.9 million for the 3 months ended March 31 and 2025. The drivers of the changes of both research and development and G&A expense were both primarily drive 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 running, 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 ] market facility through the sale of common stock. With that, I turn the call back over to Jon. Jonathan?

Thank you, Mike. We made meaningful progress on each of our programs in the first quarter. KETAFREE continues to advance through final FDA review. The NRX-100 NDA is on track for submission this quarter. the MIND1 trial has FDA clearance to proceed, and we expect nondilutive 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. Geneuro adds a new platform for serious neurological and autoimmune disease supported through nondilutive 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 place in us, our goal of bringing hope to life is closer than ever. Operator, we're now ready to take questions.

[Operator Instructions] Your first question is from Tom Shrader from BTIG.

A couple of operational ones for me. For KETAFREE, I understand there's need. What does the channel look like for distribution? How much do you have to build? Do you -- are the centers your customers? Or will this go through larger distributors. I'm just curious how much on the ground work is involved here? And then I have a real-world follow-up.

Well, you're describing -- thank you, Tom. And 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 [ ADAR ] and given the drug shortages and what we believe will be a perception of not only of quality but U.S. manufacturing and reliability. We belie that with standard locking 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 at reach, 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 wholesalers. And so far, not a single one of our clicks 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 products, which reliably manufactured FDA-approved [ GMP ] product. So it's a two-point 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 is an increasing reliance on ketamine to treat pain syndromes as well.

Got it. Got it. Okay. And then on the real-world ketamine data, I understand you have 65,000 records. What is the level of understanding with the FDA as to what they really want to us see in those records? And is that all negotiated we have 65,000 records that show the boxes you want to see filled? Or is that a negotiation that's on go away. I mean 65,000 is a lot. It's probably 60,000 more than you need the record. So I'm just kind of curious where that process is agreeing on what these records need to show.

And when we say records, we said record -- we mean records on 65,000 unique patients. At the risk of sounding [ tumorous ] everything with the FDA's negotiation, but it's a negotiation that occurs through well-established channels. So what we agreed to in our meeting with FDA was we would they acknowledge that the preliminary cuts of the data looks promising. As [ Min ] 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 the 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 crunching the data over and over again but sort of [ more ] 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 beta.

And any time marks for any of that, that you can share?

Well, there are some regulatory costs involved. So we're expecting FDA to put [ 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.

Your next question is from [ Elemer Piros ] post Capital Market.

Jonathan, I was wondering if you could help us understand the shortage, the ketamine shortage. What are the bottlenecks there, whether it's raw material or the scale of manufacturing and how do you plan to overcome that shortage?

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 files, the 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 ingredients in the warehouse by having high-volume assembly lines using blow-fill seal that are capable of making 1 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 good 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.

Yes. So raw material doesn't seem to be an issue?

It's not an issue for us. Availability of raw material is not a problem. I can't tell you the exact situation with pharmaceutical grids last today. I can tell you that during COVID, people were backed up a year. Pharmaceutical glass is kind of a problem worldwide.

Yes. And somewhat related, 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?

Well, I would never want to predict what a regulatory agency will do. I can say that the current [ secretary ] itself 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 losses that all ingredients and the drug should be safe. This particular preservative was put into ketamine back in the 1970s. And in general, nobody has really looked at the formulation until we got involved. Quite frankly, when we got involved, I asked, well, why is it there? And the answer was, oh, it's a necessary existent that cedent come out of solution without it. And really and -- 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 benzalkonium 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 drops on all the drug store shelves. Yes. So it will be interesting to see how the regulatory world ultimately reacts to this. But I think in general, the regulatory environment is [ Pro ] safety and antipreservative.

Okay. And maybe one last question. Once you file the NRX-100 NDA, how soon do you anticipate to learn whether you got the priority review, the voucher?

Generally, that's a 6-month process. So remember, we already have -- we already have fast track approved for NRX-100. So we're already entitled to priority review.

And your next question is from Patrick Trucchio from H.C. Wainwright.

Just first on KETAFREE. I thought you mentioned that the commercial manufacturing is now initiated a $1 million per dose month level. I'm wondering what inventory level do you expect to have available at the time of the launch?

Yes. At the time of the launch, we'll have at least 1 million units in the warehouse. And depending on what we see between now and then, we may take that up by 0.5 million or 1 million units.

Got it. And for NRX-100, I mentioned that you have fast track review and that maybe hearing back on the [ CMPV ] could take 6 months. Does -- I guess, does this imply that you might be able to get a quicker review just with the standard fast track?

Well, I don't know if anybody knows exactly how much the [ CMPB ] speeds up the process. But priority review is a pretty well-established pathway and we know it does feed up the process. so could CMPB further speed the process, could CNTV 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 the cost agreement with FDA on the real-world evidence and get that submitted. And in that regard, the President's executive order from April is enormously supportive and 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, 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.

Yes. That makes sense. And then just lastly, on the MIND1 trial for NRX-101 plus [ TMS ] I'm wondering if you could talk a little bit more about this trial and including whether you would expect it to be registration-enabling if positive.

Well, it's certainly a large enough sample that if one had a dramatically positive result and that wouldn't be 405 but P01 or better. Given the priority that currently is around treating depression and suicidality. Again, back to the President's executive order back to many things the Secretary said, back to things Congresses a dramatic effect in this trial on par with previous results that have been seen where [ decyclaserian ] doubled the effect of [ transcranial ] magnetic stimulation on depression, but increase 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 are getting this trial fielded in partnership with our military colleagues with our academic colleagues and if you take a look at the success that Professor Brown has had in this area over the last couple of years were extraordinarily excited to have him as the principal investigator for this work.

There are no further questions at this time. I will now hand the call back over to Jonathan Javitt for the closing remarks.

Well, thank you. As I hope you can tell, this has been a quarter of heads down work. Our team has grown our proximity to market, we believe, has substantially increased or in fact, shorter to be precise. And we're incredibly grateful to the investors who've come on board who have lent their support and giving us their confidence. So thank you very much, and we look forward to seeing you soon.

Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. You may now disconnect your lines.