NRx Pharmaceuticals Q3 2025 Earnings Call Transcript

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Provided by Quartr
November 17, 2025

Key Takeaways

  • Positive Sentiment: Regulatory momentum — The Ketaphree ANDA revision received a "no significant deficiencies" communication and the NDA for preservative‑free ketamine (NRx 100) is nearly complete with Fast‑Track/CNPV pathways that could materially accelerate review timelines.
  • Positive Sentiment: NRx 101 / D‑cycloserine (DCS) data and strategy — Company highlights published RCT and real‑world results showing low‑dose DCS markedly augments one‑day TMS (reported 87% response / 72% remission), has manufactured inventory, launched an expanded‑access program, and plans a confirmatory Phase 3 in early 2026.
  • Positive Sentiment: Clinic roll‑out and early revenue — Hope Therapeutics closed acquisitions (Durra, Cohen), generated first‑time revenue (~$240k for a partial quarter), launched the 1D TMS protocol in Florida, and expects to expand to 6+ clinics with an acquisition pipeline the company says represents >$20M of annual revenue.
  • Negative Sentiment: Financial runway and losses — Q3 operating loss was $4M and cash was ~$7.1M (or ~$10.3M including a receivable), with management projecting funding into Q2 2026, indicating a limited runway that may require additional financing or rapid clinical revenue growth to meet upcoming milestones.
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Earnings Conference Call
NRx Pharmaceuticals Q3 2025
00:00 / 00:00

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Operator

Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals Q3 2025 earnings conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Monday, November 17, 2025. I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please go ahead.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Thank you, Joelle, 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 security 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 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 forward-looking statements. Information presented on this call is contained in the press release issued this morning and in the company's Form 10Q, which may be accessed from the investors' page of the NRx Pharmaceuticals website. Joining me on the call today are Dr.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Jonathan Javitt, our founder, chairman, and CEO, and Michael Abrams, our Chief Financial Officer. We'll provide an overview of our company's progress as reported in today's 10Q, following which Mike will give a review of the company's financials and results. Following their prepared results, we'll address investor questions. Jonathan's having a couple of technical issues this morning, so I'll start us off. Since the beginning of the third quarter, NRx Pharmaceuticals has made transformative progress in developing our business. We have advanced each of our programs with drug approval applications in process for Ketaphree, NRx 100, and NRx 101. We also expanded our NRx 101 pipeline and closed on multiple acquisition targets for a network of interventional psychiatry clinics, Hope Therapeutics. In conjunction with closing our first clinics, we are now generating revenue and on a path to a highly promising company.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

The point of our call today is not three weeks of revenue from a single clinic, just a few hundred thousand dollars that hit our third-quarter income statement. Rather, it's the revolutionary and generational shift that we see in the treatment of severe depression and PTSD today, along with the potential to use the same technologies to treat traumatic brain injury, autism spectrum disorder, Parkinson's, and even cognitive decline in coming years. This past quarter has been a watershed moment in that generational shift from our perspective. Last week, a group of highly respected scientists presented real-world data showing an 87% treatment response and 72% remission from severe depression following a single day of treatment with a newly developed TMS, or transcranial magnetic stimulation coil, and a low dose of D-cycloserine, or DCS. Note that the active ingredient in NRx 101 is also DCS.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

This publication comes on the heels of a well-controlled clinical trial in which DCS was shown to more than double the effect of conventional TMS in treating both depression and suicidality. Rather than rely on this call, we urge you to read the underlying science referenced on our website on the publications page. As we announced last week, our company, Hope Therapeutics, is the first one to deploy this 1D protocol in Florida in partnership with AMPA Health. We are actively partnering with established clinics and seeking to open new clinics in Florida and nationwide. The scientists involved in that trial will be the first to say that theirs is not the only TMS machine capable of affecting a one-day beta burst protocol. However, no drug other than DCS so far has demonstrated the augmentation of TMS in the literature.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Accordingly, this quarter's results should be viewed as seeing the first green shoots come out of the ground, not as an indication of whether these shoots will ultimately be a bush or a giant tree. We anticipate that our growing enterprise will be far easier to discern by our next conference call. As you know, we have been working with DCS since our founding in 2015, and our co-founder, Dr. Daniel Javitt, began research with this class of compounds in 1987. NRx holds rights to more than 70 patents around the world that relate to the use of DCS in treating depression, PTSD, and other life-changing brain disorders. We have extensive experience in the formulation and stabilization of this highly challenging and unstable molecule.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

A breakthrough therapy designation IND opened with the FDA and manufactured drug in our warehouse that is actively being deployed in an expanded access protocol to enable doctors to replicate last week's dramatic 1D findings. Although a raft of compounding pharmacies are offering DCS for sale in response to these dramatic scientific results, we will be releasing chromatography and other foundational science demonstrating the need for manufacturing controls that are essential for preventing rapid degradation of DCS and the formation of various impurities, controls, and techniques that we have devised over nearly 10 years of active preclinical and clinical development. The reason to be excited about combining DCS, which is a highly neuroplastic drug, along with TMS, which is also a neuroplastic therapy, is not the simple notion that two neuroplastic treatments may be better than one, as in 1 plus 1 equals 2.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Rather, the scientific legacy of leaders in the field increasingly proves that drugs such as DCS make the brain cells far more receptive to TMS and other neuroplastic therapies, akin to fertilizing the field as you plant the seeds. For those who are new to this conversation, neuroplasticity is the process by which brain cells are constantly growing new connections to other brain cells. In a digital computer, transistors are always turning on and off under the control of software, but the circuits stay the same. In the brain, those transistors or neurons polarize and depolarize, the cellular equivalent of turning on and off, but also constantly form new connections and prune those connections to other cells. That's called neuroplasticity.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Over the past 20 years, we have come to understand that the loss of neuroplasticity in different parts of the brain is at the root of depression, PTSD, autism spectrum disorder, and other conditions that I've mentioned. In Dr. Javitt's 45-year medical and scientific career, predominantly focused on the visual axis of the brain, the last time he was involved in a technological change that is this profound was the introduction of the first anti-VEGF drug to treat macular degeneration that led to a whole generation of injectable eye drugs that forever changed the potential for people to preserve their sight in the face of previously hopeless and blinding conditions.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

In our view, we're witnessing a similar tectonic split shift in the neuroplastic drugs, devices, and digital therapeutics that are being combined to transform the treatment of severe depression and PTSD today and the brain diseases that affect more than a billion people on the planet tomorrow. If those publishing this science are correct, it is likely that oral antidepressant drugs with their life-threatening complications, their effects on disfiguring weight gain and sexual dysfunction, their propensity to cause suicidal ideation, and their dismal 30% success rate may lose their place as first-line treatment for those with life-threatening brain diseases.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

More importantly, this generational shift in our understanding will finally cause us to abandon the notion that brain diseases that result in behavioral symptoms such as depression and anxiety are biologically different from brain diseases that cause Parkinson's or cognitive dysfunction and that the patients who suffer these supposedly behavioral health problems are somehow less deserving of medical care than those who suffer from other neurological or CNS diseases. One reason we founded Hope Therapeutics was to have the ability to directly engage the payer community in this changing paradigm. That brings us to corporate and financial results achieved in the past quarter and the objectives we think are meaningful over the coming quarters. Our quarterly report reflects only the first three weeks of revenue from our first two clinics.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

By year-end, we anticipate growing from two clinics to six or more clinics within our current orbit, and we expect these revenues to demonstrate strong growth over the coming quarters as we integrate the clinics, help grow them, and add to their numbers. Most importantly, the historic revenue is based on ketamine treatment sessions and traditional TMS treatment sessions that are generally reimbursed at less than $500 a session. Much of our future growth is likely to be focused on day and other short-term multimodality treatments with rapid clinical results that are already reimbursed by payers at higher levels. To give you just one of many real-life illustrations of why this is economically viable, consider the situation of a highly trained essential first responder who is suffering from depression and PTSD. In many cases, antidepressants are incompatible with a return to duty. For many frontline roles, this is a disqualification.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Hence, the desire of the patient and the family for relief from a debilitating and life-threatening condition aligns with the urgent need of military, law enforcement, emergency services, and other organizations to maintain their force readiness. The financial and other resource cost of replacing frontline personnel is astronomical. While medical insurance decisions are often made by executives who many Americans view as not caring enough about the individual, health insurance payment policies are increasingly dictated by the employers who pay the premiums and who care deeply about their ability to maintain a workforce in whom they have invested. Often, the decision-makers at that level are the military leaders, police and fire commissioners, and others who have come up through the ranks and who think about their people first. When Dr.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Javitt presented last month at Fort Belvoir to a room containing generals, admirals, and elected officials. He sat with a senior advisor to the Secretary of the Veteran Affairs Administration who reminded him of the public statements from the VA that stopping veterans' suicide is their top priority. We hope to release a video of that briefing to you in the coming weeks. Our balance sheet is considerably stronger than it was at the end of the second quarter, owing in part to the support of long-term healthcare specialist investors who joined us during the third quarter and purchased common stock with no warrant overhang, no pricing provisions, and no convertible debt feature. At this point, NRx has secured operating capital that is anticipated to be sufficient to fund drug development operations through 2026.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Additionally, as just noted, we expect to continue to add revenue from the clinical operations and believe it is likely that we will see revenue from sales of ketamine under an ANDA in mid-2026. As you can see from our balance sheet, and as Michael Abrams will be discussing in greater detail later, we are well-positioned to achieve numerous milestones on both sides of our business with existing cash. Our goal in doing so is to substantially enhance shareholder value while advancing our mission of bringing hope to life. Now, let's review each program, starting with our preservative-free ketamine, which was previously required to use a toxic preservative, which is benzalkonium chloride, to maintain stability and sterility. Our stability data remains on track for a three-year room temperature shelf life. We're pursuing two parallel approval processes: a generic pathway and an innovative pathway using two different formulations to prevent price confusion.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

As you saw in August, the FDA ruled that those two formulations create two different drug identities. The first pathway is a new drug application, or NDA, for NRx 100 and suicidal ideation for patients with depression, including bipolar depression. The second is an abbreviated new drug application, or ANDA, to make Ketaphree available for ketamine's existing generic indications. NDA preparation is nearly complete, and we anticipate transmitting the entire submission in the coming weeks. The key development is that we are adding more than 60,000 patient encounters of real-world efficacy data, which demonstrates statistically significant advantages of intravenous ketamine over nasal S ketamine. Combined with the data from U.S. and European trials in more than 1,000 participants, we believe this to be a compelling case for efficacy. This will be an important step forward for both the company and for patients suffering from suicidal depression.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

There is currently no medication approved for treating suicidal ideation, and the Spravato label clearly states that it has not been shown to be effective for reducing suicidality. The only current alternative for patients with suicidal ideation is ECT or electroconvulsive therapy. As you know, the PCORI trial, which is posted on our website, demonstrated a 30% incidence of memory loss with ECT and none with IV ketamine. In what we feel is strong validation, the FDA granted us an expanded fast-track designation in August to now include all patients with suicidal ideation and depression, including bipolar depression. Suicidality is a massive problem in the U.S. In fact, the CDC estimates that nearly 13 million Americans seriously consider suicide each year, and this leads to an American dying from suicide every 11 minutes.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Our leadership team was invited to Fort Belvoir last month, where we presented to senior military and veterans' affairs leaders and will be repeating the briefing at VA headquarters and Nellis Air Force Base to the Air Force leadership. As Secretary Collins has said publicly, stopping veterans' suicide is his top priority. In June, the FDA created the Commissioner's National Priority Voucher Program that affords substantially faster review times of one to two months versus the standard 10-12 month review. Enhanced communication throughout the review process creates potential for accelerated approval of NRx 100. Commissioner McCreary has publicly stated that safe and effective drugs to prevent suicide are a top priority for him. More importantly, after some publicly reported personnel changes, the FDA Centers for Drugs now has a leader who has been a long-term proponent of accelerated approval for life-saving drugs that meet an unmet medical need.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

To receive a CNPV, a product must meet at least one of the following criteria: address a U.S. public health crisis, address a large unmet medical need, deliver more innovative cures for the American people, reshore key strategic drugs to the U.S., or reduce healthcare costs. NRx meets all of these criteria. In Q3, we filed an abbreviated new drug application for ketamine with priority review requested. We call this product Ketaphree. After meeting with the FDA in August of 2025, we refiled the ANDA following FDA notification of the suitability position for NRx's proposed strength of Ketaphree. Last week, we received a communication from FDA noting no significant deficiencies in the revised Ketaphree filing, and we believe the filing is on track for a second quarter GDUFA date, or that's the generic drug equivalent of a GDUFA date.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

The company has additionally submitted a citizen petition seeking to have benzethonium chloride, a toxic preservative included in all currently approved ketamine products, for antiquated reasons, removed from all presentations of ketamine. This preservative is the subject of a detailed toxicology report we have published, which details the concerns that led FDA to ban BZT from topical antiseptics and hand cleansers. Notably, benzethonium chloride is not categorized by FDA as GRAS or generally recognized as safe. This report has been submitted to the FDA in support of our citizen petition. As a preservative-free formulation of ketamine is an important invention, we have filed a patent application with the US Patent and Trademark Office to protect our intellectual property surrounding this product. The existing generic market for ketamine has been projected at approximately $750 million.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

We believe Ketaphree, made in the U.S. and offered without any toxic preservatives, offers patients and clinicians a superior option. We'll continue to work diligently with the FDA to move our application forward as rapidly as possible and provide a safer version of this critical product to the American public. Our program around NRx 101, our oral combination of D-cycloserine and lurasidone, took an extremely positive and unanticipated direction, as outlined in the opening. As you know, we received breakthrough therapy designation for this drug in the treatment of suicidal bipolar depression and continue to advance that agenda. Our manufacturing data is on file with stability trending towards five years, and we have a million doses in the warehouse.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

There are more than 7 million patients suffering from bipolar depression in the U.S., and many of these are at risk of akathisia, a terrible side effect caused by serotonin-active or SSRI drugs that is closely related to suicide. These patients are at tremendous risk of self-harm. We have demonstrated statistically significant superiority of NRx 101 over lurasidone, the current standard of care, in reducing suicidality and akathisia in two well-controlled trials. Both NRx 101 and lurasidone are potent antidepressants, and one of those trials also demonstrated a superiority in reducing depression. Remember that we are comparing to a known, effective drug, not placebo. Because of the huge unmet need, we are optimistic that FDA will be receptive to an application for accelerated approval in the 600,000 patients who suffer from suicidal ideation in bipolar depression despite treatment with a currently approved medication.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

A few days ago, a new director of the FDA Center for Drugs was appointed who pioneered the accelerated approval pathway and has been a staunch advocate for early approval of medicines for life-threatening conditions for which there is no currently available therapy. Last week, we saw a publication of the exciting and unanticipated finding that low-dose D-cycloserine, again, the active ingredient in NRx 101, when combined with a one-day protocol of TMS, recently there's been exceptional interest in the use of DCS, the active component, to enhance the efficacy in the treatment of depression. D-cycloserine, like ketamine, blocks the NMDA receptor and enhances neuroplasticity. Recently published real-world data provides confirmatory evidence seen in a prior randomized controlled trial that low-dose DCS more than doubles the antidepressant effect and anti-suicidal effect of TMS.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Unfortunately, DCS alone is contraindicated in patients with depression, which may impact the willingness of patients and practitioners to use this new protocol. Importantly, NRx 101, while including DCS in its formulation, does not carry this contraindication, as the addition of lurasidone blocks the effect of the NMDA inhibition in one key side effect. This creates a significant need for the development of NRx 101 for the use in conjunction with TMS to treat depression, PTSD, and other disorders. We have more than 25,000 manufactured doses of NRx 101 at the appropriate strength on hand and have launched a nationwide expanded access program to enable physicians to access this medication at no charge to the patient under expanded access and federal right to try laws. A confirmatory phase three trial of NRx 101 to augment the effects of TMS is planned for early 2026.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

The market estimate for this newly validated indication for NRx 101 is in excess of $1 billion. On September 8, 2025, Hope Therapeutics initiated revenue generation upon closing of its acquisition of Durra Medical with clinics located in Naples and Fort Myers, Florida. Hope subsequently added Cohen and Associates in Sarasota, Florida, another revenue-generating EBITDA-positive clinic, to the Hope network. Dr. Rebecca Cohen, founder of Cohen and Associates, has been appointed as Hope's medical director. Last week, Hope was the first organization in Florida to launch one-day TMS treatment for severe depression and 1D protocol using the Appofit TMS device. The 1D protocol has been reported in the peer-reviewed literature to achieve 87% response and 72% remission from severe depression at six weeks following a single day of TMS treatment combined with D-cycloserine.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Hope is in the process of adding three more facilities this year and is in active discussion with numerous acquisition opportunities around the country. With our significant advances in the third quarter and a committed investor base, we believe we are better positioned than ever in our history to build shareholder value and to address the national crisis of suicide. We will do everything in our power to continue bringing hope to life. With that, I'll turn it over to Mike Abrams, our CFO, to review our financial results from the third quarter. Mike. Thank you, Matt. For the three months ended September 30, 2025, the company reported a loss of operations of $4 million versus a loss from operations of $3 million for the comparable quarter in 2024.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

The difference is primarily attributable to $800,000 of additional research and development expenses to support our FDA initiatives for NRx 100 and NRx 101, including the previously discussed ANDA submission for preservative-free IV ketamine, and $400,000 of additional general administrative expense, which included our efforts to close, operate, and identify clinic acquisition targets for Hope. As of September 30, 2025, NRx Pharmaceuticals had approximately $7.1 million in cash and cash equivalents, including approximately $3.1 million from a subscription receivable for which the company received the cash in early October. Total cash as of September 30, 2025, would have been $10.3 million. For the third quarter ended September 30, 2025, the company reported revenue for the first time in its history driven by the acquisition of Durra Medical, which closed September 8.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

While revenue of approximately $240,000 was relatively modest, it reflects 22 days of the full quarter and a single clinic group. Management anticipates the ability to include results from the full period for Durra in future quarters. Closing anticipated additional acquisitions and organic growth of previously acquired clinics will drive meaningful revenue growth in the fourth quarter and through 2026. Transactions where we acquire a non-controlling interest are expected to improve our overall financial position but not directly increase revenue. Finally, we remain in active discussions with several additional potential acquisition candidates, and while no assurances can be given that we will close any or all of such opportunities, together they represent total revenue of more than $20 million on an annual basis.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

The company believes that its current cash position will support operations at least through the second quarter of 2026, as well as provide sufficient capital to reach expected regulatory inflection points and complete potential additional select acquisition opportunities to expand the growing footprint of Hope Clinics. Our singular focus remains advancing our primary drug development initiatives and planned clinic acquisitions to build long-term value for our shareholders. With that, I turn the call back. Thank you, Mike, and thank you guys for sparing my voice this morning. I look forward to taking questions. Operator, I believe we can begin to take questions. Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the one on your touch-tone phone. You will hear a prompt that your hand has been raised.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Should you wish to decline from the polling process, please press star followed by the two. If you are using a speakerphone, please let the hands up before pressing any keys. Your first question comes from Tom Schrader with BTIG. Your line is now open. Good morning. Thanks for all the details. I have a couple of questions on this remarkable DCS result with TMS. Historically, is it clear that DCS is much better than ketamine in this position? Is this truly unique to the drug, or is it a general combination effect? Can you give us a sense of how you would use 101 in this procedure? I assume it is not a hard co-formulation that your 101 is simply available, but how cumbersome is it to add a drug, your DCS, and can you get paid for it? Just the logistics.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

I know you have a lot of drug. It looks like it's exciting. Can you guys run us through the steps to actually use it? Thank you. Those are great questions. A lot of this work, the basic science work, has been done and published by Dr. Josh Brown at Harvard McLean, with a number of others supporting the science. The most important thing to recognize is that DCS has to be used at a non-NMDA antagonist dose. I know this is a little more science than we sometimes do on a conference call, but in this case, it's critical. DCS is what's called a mixed agonist-antagonist. Unlike ketamine, unlike fenciclizine, unlike all of the NMDA drugs that block the NMDA channel, DCS affects a side unit of NMDA called the glycine site.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

At low doses, it's actually an NMDA agonist, but much more importantly, it's a highly neuroplastic drug. There's evidence that ketamine plus TMS actually decreases the effectiveness of TMS. There are even people who believe that ketamine shouldn't be used in conjunction with electroshock therapy because it may decrease the effectiveness of electroshock therapy. All of the work that's been done is at low doses of D-cycloserine, 150, 175 milligram dose. It just happens that when we formulated NRx 101, that was one of the strengths that we made. That's why we have it in the warehouse. In fact, it was not made to be the main strength of NRx 101. It was manufactured to be a potential step-down strength in our clinical trial. So far, nobody else has identified a different neuroplastic drug that works in combination with TMS the way D-cycloserine does.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Do me a favor and repeat the second part of your question where you were asking about the procedure. Just the procedure to use your drug because it's in the works at the FDA. How hard is it for somebody to get your drug if they want to add it to TMS in your clinic or anywhere else? We have an expanded access protocol for DCS under the law. It's been required to be made available for expanded access. If somebody writes to us, we're happy to provide it for this purpose as long as they provide us with the data of what happened. You'll see that clinicaltrials.gov has been a little backed up because of the government shutdown, but as clinicaltrials.gov catches up, you'll see those expanded access protocols for DCS and TMS showing up online. Okay. Great. Thanks for the detail.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Your next question comes from Patrick Tuccio with H.C. Wainwright. Your line is now open. NRx 100 and suicidal depression. The FDA has identified no significant deficiencies to date. I'm wondering first, what feedback have you received on the accelerated approval strategy? Secondly, do you still anticipate a year-end PDUFA decision? Separately, when do you anticipate learning if the CMPV is granted and what impact that could have on the PDUFA? As we've said, we're in the CMPV process, and therefore the NDA under Fast-Track designation for NRx 101 has not been filed in its totality yet. We've said that several times. We're expecting to hear about the CMPV this year.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

The main advances with that NDA are that we now have access to the real-world data that we believe massively augments the filing that we will make under accelerated approval once we learn whether we're doing it under CMPV or not, where we're expecting not only to file the original clinical trials that we've told people about, but more than 60,000 patients' worth of real-world data as well that we believe provide a solid case for accelerated approval. Right. With the citizen petition now on file to remove benzathionine chloride, can you discuss how this regulatory action could reshape the market for IV ketamine and how you would ensure adequate domestic supply if the FDA moves to ban these preservative-containing formulations? Yeah.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

This is actually the first ketamine that's packaged in what's called a blow-fill seal presentation, where instead of a glass bottle, the machinery takes a drop of polyester resin, heats it up, blows it into a container, fills it, and puts it out the back of the assembly line completely packaged and ready to ship. It takes your production capacity from a couple hundred thousand bottles a month to a million or more bottles a month per assembly line. Therefore, if we had to, we could supply every vial that's required for ketamine in the United States at that kind of manufacturing capacity. Everything else that's coming in for ketamine is glass vials. Right. Just one maybe on Hope. The 1D protocol combines TMS and DCS, and it shows rapid onset of antidepression effects.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

I'm just wondering how you'll be positioning Hope to become an early adopter and data generator for that combined treatment pathway. And as well, just separately, assuming approval of NRx 100 and NRx 101, how will you integrate those treatments into the HopeCare model once they're approved, assuming they are approved? Those are two fantastic questions. The 1D protocol is legal under the medical device laws. The coil that was used was manufactured by a company called AMPA, which has some very exciting technology, not only in terms of their pioneering of the 1D protocol, but in terms of having built the first portable CMS, one that can be taken to nursing homes, extended living facilities. You could even do it in a firehouse because it fits in two Pelican cases.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

We announced last week that we've partnered with AMPA, that we are the first site in Florida to be doing the 1D protocol, so it's readily deployable. Now, it's not specific only to that machine, but all of the 1D results so far that have been reported have been reported on that machine. Great. Thanks so much. Ladies and gentlemen, as a reminder, should you have a question, please press star one. Your next question comes from Ed Wood with Ascendiant Capital. Your line is now open. Yeah. Congratulations on all the progress. As NRx 100 and 101 have potential approval dates relative within the next year, hopefully, or much sooner than that, have you talked about your clinical or commercialization strategy for both? Ed, I'd like to listen to that question again. Oh, sure. Have you talked about your commercial strategy?

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Will you need to have a sales force to market NRx 100 and 101 when you get approval? They are very different drugs, and they will need different strategies. NRx 100, we are talking about a drug that can only be deployed in a clinic setting by a physician. We anticipate that there will be a REMS of some sort in the same way that there is a REMS for Spravato. The NRx 100 project, the preservative-free ketamine project, is very much something that a company our size can undertake. You are talking about much more of what is called a medical science liaison function than a sales function because physicians who are treating with ketamine in their office know that they want to do that. What they need is medical liaison support. It is not traditional pharmaceutical detailing.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

NRx 101, we're seeking an indication where we want to treat people with severe bipolar depression who have suicidal ideation despite having been treated with best available therapy. If you take a look at the people who are currently prescribing drugs like lurasidone to treat bipolar depression, there are approximately 1,600 doctors like that in the United States. Many physicians do not want to be treating suicidal bipolar patients. That is actually a sales force also that a company like ours could build. We anticipate it is a requirement of about 50 salespeople. We have talked to larger commercial partners in the past about NRx 101, and it is possible that we would partner with a larger commercial partner. Bottom line, NRx 100 is within our launch capabilities. NRx 101 is still within our launch capabilities, but we know that there is significant interest from larger partners. Great.

Matthew Duffy
Matthew Duffy
Chief Business Officer at NRx Pharmaceuticals

Thank you for that answer. I wish you guys good luck. Thank you. There are no further questions at this time. I will now turn the call over to Matthew Duffy for closing remarks. Thank you, everyone, for joining us this morning. We're extremely excited about the path ahead with three potential drug approvals and a subsidiary targeting multiple profitable mental health clinics, as well as our new indication with NRx 101. This concludes the NRx Pharmaceuticals third quarter 2025 results conference call. Thank you all for participating. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

Executives
    • Matthew Duffy
      Matthew Duffy
      Chief Business Officer
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