NRx Pharmaceuticals Q1 2026 Earnings Call Transcript

Quartr
Provided by Quartr
May 18, 2026

Key Takeaways

  • Positive Sentiment: KETAFREE moved closer to launch after FDA issued only minor labeling and quality-related comments, and management said the company remains on track for a summer 2026 approval target.
  • Positive Sentiment: The company said it has already initiated commercial manufacturing for KETAFREE, expects at least 1 million units of inventory at launch, and believes its blow-fill-seal process will support much higher throughput at lower cost.
  • Positive Sentiment: NRX-100 is expected to be filed as an NDA in the second quarter, backed by clinical data from more than 1,000 patients and real-world evidence from over 65,000 patients, with FDA open to using that evidence for approval.
  • Positive Sentiment: FDA cleared the company to proceed with the MIND1 trial for NRX-101 plus robotic-assisted TMS, a 400-patient study that management believes could become registration-enabling if results are strong.
  • Neutral Sentiment: NRx ended the quarter debt free with about $6.7 million in cash, raised another $7 million after quarter-end, and said its clinic network and new Geneuro acquisition expand its pipeline and long-term growth options.
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Earnings Conference Call
NRx Pharmaceuticals Q1 2026
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Operator

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals first quarter 2026 earnings conference call. At this time, all lines are in listen-only mode. If at any time during this call you require immediate assistance, please press star zero for the operator. I would now like to turn the conference call over to Brian Korb from Astr Partners. Please go ahead.

Brian Korb
Managing Partner at Astr Partners

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 statement 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. 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.

Brian Korb
Managing Partner at Astr Partners

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.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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, acquired the GeNeuro 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.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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 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 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.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

FDA has now reclassified our manufacturing site to VAI status consistent with the launch of an ANDA drug. On May 5, we transmitted our first commercial manufacturing order at the one 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 one million units per week. Timing matters here. As of April, Sterlin's Revenna ketamine remains on the ASHP National Drug Shortage database.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

KETAFREE will be the first U.S. manufactured preservative-free ketamine, free of benzethonium 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 SUBLOCADE. Glenn 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. Sterile ketamine has remained on national drug shortage listings, as we mentioned, with intermittent back orders, product discontinuations, and inconsistent availability across hospital and outpatient settings.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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. 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 constrained supply on one hand and alternatives to using opioids on the other.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

We believe our product represents the first domestically manufactured source of preservative-free ketamine, and we further reinforce this position through our previously filed citizen 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 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 Osmind.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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 Commissioner'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 and PTSD. We've applied for Commissioner's National Priority Voucher in support of our NDA.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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 $2 billion annually, despite labeling that does not include reduction of suicidality. Moving to NRX-101. When we advanced two parallel tracks. In our original indication of suicidal bipolar depression, we've initiated an NDA filing with submission of module three 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 II-B/III study of NRX-101 versus placebo as an adjunct to robotic-assisted TMS using an accelerated one-day protocol.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

The trial is designed to enroll 400 participants across a leading academic teaching hospital, HOPE 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 eight-fold increase in remission from depression when D-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 non-clinical validation of a proprietary extended-release 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, a retired Navy captain, a former DARPA program manager.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

He 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 Zeta Surgical, whose AI-powered neuronavigation platform has already received FDA 510(k) 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 healthcare imperative and a force readiness priority, not only in the military setting, but in the setting of firefighters, police officers, and other first responders.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

Turning to HOPE Therapeutics, we operated five Florida clinics during the quarter and expect eight or more locations by the end of the 2Q. In February, we appointed Professor Joshua 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. Emobot passively 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 blind spot in the care of patients with depression and suicidality. Approximately 50% of patients with treatment-resistant depression relapse within 6-12 months, and that relapse is often undetected between visits.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

As I've said, we expect every patient in our network to be on Emobot. We continue to integrate our partnership with neurocare Group AG, which brings together the combined clinic base together with an install 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've just last week formed GeNeuro, Inc., a Florida-based subsidiary built around a newly acquired portfolio targeting Human Endogenous Retroviruses, or HERVs, 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, a Swiss company funded with existing cash, and includes a broad patent portfolio, cell lines, antibodies, regulatory files, and data from from completed human clinical trials.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

Dr. Hervé Perron, formerly Chief Scientist at 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 antibody 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.

Michael Abrams
Michael Abrams
CFO at NRx Pharmaceuticals

Thank you, John. For the three months ended March 31, 2026, NRx 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 three months ended March 31, 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.

Michael Abrams
Michael Abrams
CFO at NRx Pharmaceuticals

The change is primarily driven by certain costs related to certain, 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 products, allowing 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.

Michael Abrams
Michael Abrams
CFO at NRx Pharmaceuticals

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 G&A expense were 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.

Michael Abrams
Michael Abrams
CFO at NRx Pharmaceuticals

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 Jonathan.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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 non-dilutive 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 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.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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.

Operator

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone. Should you wish to cancel your request, you may press star two. Once again, that is star one should you wish to ask a question. Your first question is from Tom Shrader from BTIG. Your line is now open.

Tom Shrader
Tom Shrader
Analyst at BTIG

Good morning. Congratulations on another busy quarter. 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? 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.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

Well, Thank you, Tom. 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.

Tom Shrader
Tom Shrader
Analyst at BTIG

Yeah.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

Given the drug shortages, and what we believe will be a perception not only of quality, but U.S. manufacturing reliability, we believe 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 outreach. Part of our preservative-free ketamine strategy is that traditional market. The other part is the clinic market that right now really doesn't have access to the wholesalers. We've tested this. You know, we've had our clinics call and try to buy from the wholesalers. So far, not a single one of our clinics has succeeded in obtaining a single vial of ketamine from any of the traditional wholesalers.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

The wholesalers really are uninterested in the most rapidly growing area of the clinic space. Those clinics are required to rely on a web of compounding pharmacies. We intend to displace that compounded product with reliably manufactured, FDA-approved GMP product. 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.

Tom Shrader
Tom Shrader
Analyst at BTIG

Got it. Got it. Okay. 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 wanna see in those records? Is that all negotiated? We have 65,000 records that show the boxes you wanna see filled, or is that a negotiation that's going? I mean, 65,000 is a lot. It's probably 60,000 more than you need if they like the records. I'm just kinda curious where that process is in agreeing on what these records need to show. Thank you.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

When we say records, we say record. We mean records on 65,000 unique patients. At the risk of sounding, you know, humorous, everything with the FDA is a negotiation. You know, it's a negotiation that occurs through well-established channels. What we agreed to in our meeting with FDA was we would, you know, that they acknowledge that the preliminary cuts of the data look promising. Osmind had previously published data on about 20,000 patients, and that was part of our meeting package.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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

Tom Shrader
Tom Shrader
Analyst at BTIG

Any time marks for any of that that you can share?

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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

Tom Shrader
Tom Shrader
Analyst at BTIG

That's very useful. Thank you for all the details.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

I don't wanna give you an exact date. I don't have it at my fingertips. That's about the timeframe.

Tom Shrader
Tom Shrader
Analyst at BTIG

Okay. Thanks.

Operator

Thank you. Your next question is from Elemer Piros Lucid Capital Markets. Your line is now open.

Elemer Piros
Analyst at Lucid Capital Markets

Yes, good morning. 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?

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

Well, you know, we're not in a very good position to understand other people's products. We know there is a shortage, whether it's, you know, a lack of glass files, 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. 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 a million units in a single week if you run the line around the clock. You know, 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.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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

Elemer Piros
Analyst at Lucid Capital Markets

Yeah. raw material doesn't seem to be an issue.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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 grade glass today. I can tell you that during COVID, people were backed up a year. Pharmaceutical glass is kind of a problem worldwide.

Elemer Piros
Analyst at Lucid Capital Markets

Yeah. Somewhat related, if KETAFREE is approved, what do you anticipate the FDA's action would be towards preservative-free ketamine as the solution across the industry?

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

Well, I would never wanna predict what a regulatory agency will do. You know, 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. The law says that, you know, all ingredients in a drug should be safe. This particular preservative was put into ketamine back in the 1970s, and in general, you know, nobody's really looked at the formulation till we got involved.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

You know, quite frankly, when we got involved, I asked, "Well, why is it there?" The answer was, "Oh, it's a necessary excipient. The ketamine will come out of solution without it." I said, "Really?" 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. It turned out that it was the benzalkonium chloride in the eye drops that was killing the essential lipid component of human tears.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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

Elemer Piros
Analyst at Lucid Capital Markets

Yeah.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

It'll be interesting to see how the regulatory world ultimately reacts to this. I think in general, the regulatory environment, is, you know, pro-safety and anti-preservative.

Elemer Piros
Analyst at Lucid Capital Markets

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

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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

Elemer Piros
Analyst at Lucid Capital Markets

Okay.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

Remember.

Elemer Piros
Analyst at Lucid Capital Markets

Thanks.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

We already have fast track approved for NRX-100, so we're already entitled to priority review.

Elemer Piros
Analyst at Lucid Capital Markets

Okay. Well, thank you so much.

Operator

Thank you once again. Please press star one should you wish to ask a question. Your next question is from Patrick Trucchio from H.C. Wainwright. Your line is now open.

Patrick Trucchio
Patrick Trucchio
Analyst at H.C. Wainwright

Thanks. Good morning and congrats on all the progress. Just first on KETAFREE, I thought you mentioned that the commercial manufacturing is now initiated at a million per dose month level. I'm wondering, you know, what inventory level do you expect to have available at the time of the launch?

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

Yeah, 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.

Patrick Trucchio
Patrick Trucchio
Analyst at H.C. Wainwright

Got it. For NRX-100, mentioned that, you know, have fast track review, and that, you know, maybe hearing back on the CMPV could take six months. Does this imply that, you know, you might be able to get a quicker review just with the standard fast track?

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

I don't know if anybody knows exactly how much a CMPV speeds up the process, you know, priority review is a pretty well-established pathway, we know it does speed up the process. 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 that the most important thing is to come to agreement with FDA on the real-world evidence, get that submitted. You know, in that regard, the president's executive order from April is enormously supportive.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

You know, completely apart from the executive order from the White House, if you know, 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. 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.

Patrick Trucchio
Patrick Trucchio
Analyst at H.C. Wainwright

Yeah, that makes sense. 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.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

Well, it's certainly a large enough sample that, you know, if one had a dramatically positive result and, you know, that wouldn't be p of 0.05 and, you know, p 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, you know, doubled the effect of transcranial magnetic stimulation on depression, but increased that effect more than eight-fold 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.

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

Until the data's 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. If you take a look at the, you know, success that Professor Brown has had in this area over the last couple of years, we're extraordinarily excited to have him as the principal investigator for this work.

Patrick Trucchio
Patrick Trucchio
Analyst at H.C. Wainwright

Well, terrific. Thank you so much.

Operator

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

Jonathan Javitt
Jonathan Javitt
Founder, Chairman, and CEO at NRx Pharmaceuticals

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, we believe, has substantially increased or got shorter, to be precise. We're incredibly grateful to the investors who've come on board, who've lent their support, and given us their confidence. Thank you very much, and we look forward to seeing you soon.

Operator

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

Executives
    • Jonathan Javitt
      Jonathan Javitt
      Founder, Chairman, and CEO
    • Michael Abrams
      Michael Abrams
      CFO
Analysts
    • Brian Korb
      Managing Partner at Astr Partners
    • Elemer Piros
      Analyst at Lucid Capital Markets
    • Patrick Trucchio
      Analyst at H.C. Wainwright
    • Tom Shrader
      Analyst at BTIG
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