NRx Pharmaceuticals Q1 2025 Earnings Report

NRx Pharmaceuticals EPS Results

• Actual EPS: -$0.34
• Consensus EPS: -$0.40
• Beat/Miss: Beat by +$0.06
• One Year Ago EPS: N/A

NRx Pharmaceuticals Revenue Results

• Actual Revenue: $1.14 million
• Expected Revenue: $1.14 million
• Beat/Miss: Met Expectations
• YoY Revenue Growth: N/A

NRx Pharmaceuticals Announcement Details

• Quarter: Q1 2025
• Date: 5/15/2025
• Time: After Market Closes
• Conference Call Date: Thursday, May 15, 2025
• Conference Call Time: 4:30PM ET

NRx Pharmaceuticals (NASDAQ:NRXP) is a clinical-stage specialty biopharmaceutical company focused on the development and repurposing of small-molecule therapeutics for central nervous system and rare disease indications. The company’s research strategy centers on advancing compounds with established safety profiles into new neurological and inflammatory conditions, leveraging translational science and biomarker-driven trial design to accelerate clinical development. NRx’s pipeline includes Ifenprodil, an NMDA receptor antagonist in investigation for acute respiratory distress syndrome and inflammatory muscle disorders, as well as investigational formulations targeting depressive and cognitive disorders.

Since securing global rights to its lead assets, NRx has initiated multiple proof-of-concept studies in the United States and Europe, collaborating with academic institutions and clinical research organizations to evaluate safety and efficacy across a range of indications. The company’s development programs are designed to address high-unmet-need patient populations, applying precision-medicine principles to optimize dosing regimens and patient selection. By building on decades of prior clinical experience with these molecules, NRx aims to reduce development timelines and costs relative to novel drug discovery.

Headquartered in New York, NRx Pharmaceuticals operates a lean corporate structure, with R&D activities supported by a network of external partners and contract research organizations. The company is led by a management team with deep expertise in pharmaceutical development, regulatory affairs and commercial strategy, drawing on experience at major biotech and global healthcare companies. Through strategic collaborations and disciplined capital allocation, NRx seeks to advance its product candidates efficiently toward regulatory milestones and, ultimately, market approval.

NRx Pharmaceuticals Q1 2025 Earnings Call Transcript

Key Takeaways

• We filed our NDA for NRx100, a preservative-free IV ketamine for suicidal depression, supported by four controlled trials and stability data for a three-year shelf life, with a PDUFA date expected later this year.
• We submitted a patent for our novel preservative-free ketamine formulation, potentially securing exclusivity through 2045 and enabling an ANDA to replace toxic benzethonium chloride–preserved products.
• We plan to file an accelerated NDA this quarter for NRx101, an oral desmethylserine–lurasidone combo that demonstrated rapid reduction in suicidal ideation and akathisia in bipolar depression trials, aiming for a 2025 PDUFA date.
• Hope Therapeutics signed binding agreements to acquire three interventional psychiatry clinics and secured over $10 million in debt and equity capital, advancing our non-dilutive roll-up strategy toward early profitability.
• First-quarter net loss narrowed to $5.5 million versus $6.5 million year-over-year, with $5.5 million in cash on hand and operational efficiencies expected to fund our pipeline through at least the end of 2025.

Presentation

[Operator]

Afternoon, ladies and gentlemen, and welcome to the NRx Pharmaceuticals First Quarter 2025 Earnings 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 Thursday, May 15th, 2025. I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please go ahead.

[Matthew Duffy, CBO at NRx Pharmaceuticals]

Thank you, Andrew, 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 on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release issued today and the company's Form 10-Q, which may be accessed from the investors' page of the NRx Pharmaceuticals website.

[Matthew Duffy, CBO at NRx Pharmaceuticals]

Joining me today on the call are Jonathan Javitt, our founder, Chairman, and CEO, and Michael Abrams, our Chief Financial Officer. Dr. Javitt will provide an overview of our company's progress as reported in today's Form 10-Q, following which Mike will review our company's financial results. Following their prepared remarks, we will address investor questions. I will now turn the call over to Jonathan. Jonathan?

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

Thank you, Matt. Good evening, everyone, and thank you for joining us. NRx has had an exceptional start to 2025 with important advances across each of our programs. Suicidality remains a national epidemic. Approximately 13 million Americans seriously consider suicide every year, and 3.8 million of those make an active plan to do so according to the CDC. An American dies from suicide every 11 minutes, and worldwide, somebody dies from suicide every minute. These appalling statistics drive our mission. We've advanced our lead candidates, NRx-100 and NRx-101, in the regulatory process with the U.S. FDA. We've taken concrete steps toward establishing HOPE Therapeutics clinic network across the U.S. We've also substantially reduced our core corporate expenses. We're ending our quarter with more cash on the balance sheet than in prior quarters.

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

We have capital on the balance sheet for the end of the year and anticipate clinic revenue well before that. Clinic acquisition is being financed in a manner that does not require dilution of NRx stock. The founding of NRx was based on our mission to help patients and caregivers address our country's national epidemic of suicidality, depression, PTSD, and related disorders. We aim to do so with innovative medicines and now HOPE Therapeutics to offer direct patient care for these lethal conditions. Our mission has not changed. Importantly, we've accelerated our path to revenue, with all three of our lead programs having potential to generate revenue in the foreseeable future. This extraordinary progress has been facilitated by the dedicated team at NRx and Hope, as well as our committed investors. I'd like to take a moment to thank everyone for their tremendous efforts and support.

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

Our timing is fortuitous as well. The U.S. government, and in particular the new administration, has increased focus on treatment of suicidal depression and PTSD, with particular emphasis on our military and veterans' communities. Two weeks ago, in the televised White House cabinet meeting, the president asked the Secretary of Commerce, "What was being done to address suicide in veterans?" The secretary's response included the need for psychedelic therapies. Ketamine, a drug we are developing, is one such therapy. The Secretary of Health and other members of the administration have specifically endorsed our class of medicines, as well as clinical approaches that are central to our business.

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

NRx has two separate operating groups: NRx Pharmaceuticals, a traditional biotech drug development company with multi-billion dollar opportunities, HOPE Therapeutics, our patient care company, currently a wholly owned subsidiary that is expected to be revenue-generating, profitable in the near term, and ultimately spun out as its own company. With NRx, we've initiated filing of a new drug application, or NDA, for NRx-100, our preservative-free intravenous ketamine for the treatment of suicidal depression. There are no medicines approved to help people with this condition. We aim to change that this year. The application is supported by data from four well-controlled clinical trials showing that the preferred dosing of ketamine has strong statistical efficacy compared to placebo, to active comparators such as midazolam, and to electroconvulsive therapy.

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

No other drug in history has demonstrated efficacy that meets or exceeds that of ECT without the debilitating memory loss and the other side effects of ECT. The FDA new drug application is further supported by stability data that now supports three years of labeled room temperature shelf stability, the maximum allowed by FDA. To protect NRx-100 exclusivity, this month we filed a patent for our novel preservative-free formulation of NRx-100 with the U.S. Patent and Trademark Office, potentially protecting our ketamine product into 2045 with a potential Orange Book listing. Crucially for American and the disproportionately impacted veteran and warfighter communities, together with first responders and others who suffer from this condition, we have manufacturing capacity to supply more than one million doses a month should we gain FDA approval.

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

Because of our success in achieving long-term stability for preservative-free ketamine, we are also filing an Abbreviated New Drug Application, or ANDA, for this product because of the administration's new focus on eliminating toxic substances such as preservatives and dyes from the food and drug supply. The benzethonium chloride family of preservatives currently used in all commercial forms of ketamine has been shown to be neurotoxic and also toxic to epithelial cells. Now that we've shown there is no need for that preservative in the setting of modern drug manufacturing, we have the potential to deliver a ketamine-based product for all current uses of ketamine, not just to treat psychiatric conditions.

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

In parallel, we're preparing a New Drug Application requesting accelerated approval for NRX-101, our fixed-dose oral combination of D-cycloserine and lurasidone for the treatment of suicidal depression in patients with suicidality or akathisia, with the anticipation that we will initiate the filing in the current quarter. NRX-101 is the only antidepressant ever shown to decrease akathisia compared to standard-of-care antidepressants. Akathisia is the side effect of all previously marketed antidepressants most closely associated with suicidality. In our clinical trial, NRX-101 was also associated with a more rapid resolution of suicidal ideation than the standard-of-care antidepressants. Last year, we HOPE Therapeutics, a wholly owned subsidiary, in order to develop a national network of clinics to provide treatment directly to patients with suicidality, depression, PTSD, and other life-threatening conditions. These clinics focus on delivering integrated neuroplastic therapies, all under one safe, reliable umbrella.

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

Although people talk about psychedelic drugs focusing on the hallucinations that may be a side effect of many drugs in the class, science continues to teach us that these drugs work by stimulating the brain to form new connections or synapses, a process known as neuroplasticity. New treatments such as transcranial magnetic stimulation, or TMS, and some forms of hyperbaric therapy also have neuroplastic effects. The treatment paradigm for these diseases is rapidly evolving, and we intend to be on the forefront of that paradigm. The totality of evidence, as we see it, suggests that no one treatment can dependably yield the long-term remission from a disease that claims the lives of well over 50,000 Americans each year.

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

The clinical data, along with practitioners' experience, suggests that most patients contacting interventional psychiatry clinics for care will require a combination ofNMDA antagonist drugs plus additional neuroplastic therapies such as TMS or [ANDA] digital therapeutics in order to achieve long-term remission. These approaches are believed to work by raising the level of glutamate and other chemicals in the brain and causing the brain to form new healthy connections. As we become increasingly familiar with pioneers in the field, we routinely hear that as isolated therapies, a 60% or so remission from suicidal depression and PTSD can be seen. However, when therapies are integrated, some practitioners believe they are seeing sustained remission rates approaching 90%.

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

The fact that successful clinics are able to provide patients with integrated care continues to grow, as distinct from the pop-up ketamine clinics that come and go, tells us that patients and their families embrace this model. Hope has signed purchase agreements and a binding letter of intent to acquire three state-of-the-art interventional psychiatry practices: Kadima Neuropsychiatry Institute in La Jolla, California, Dura Medical in Southwest Florida, and NeuroStar TMS in the Tampa Bay area of Florida. The expansion pipeline includes a number of additional clinics in Florida, the Mid-Atlantic, and Midwest, with whom we are in discussion or active negotiation. We continue to navigate the complexities of purchasing medical treatment facilities under state regulations as we move forward to closing and consummating these transactions.

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

As reported earlier, Hope signed a term sheet with Universal Capital, a global investment firm, for $7.8 million in debt facility to fund Hope's growth and acquisition strategy. This, in addition to the previously announced term sheet with a strategic investor, brings $10.3 million in expected capital to Hope in the coming weeks, providing sufficient resources for clinic acquisition and growth in a manner that is anticipated to be non-dilutive to shareholders of NRx stock. As you can see, we're making important progress building NRx into a company that will bring lifesaving treatment to patients and financial returns to our investors. Shareholders routinely ask us when and why we expect to become a revenue-generating company. We believe that if we continue to execute according to plan, we'll be able to offer our proprietary ketamine drug, NRx-100, to the marketplace by early next year.

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

Ketamine, for example, is available today almost exclusively to those who can afford to pay out of pocket. It will remain so until FDA approval for ketamine to treat suicidal depression is obtained. We have initiated filing our NDA for NRx-100, the intravenous preservative-free ketamine for treatment of suicidal depression. As noted, the NDA is supported with powerful efficacy data from multiple well-controlled trials, accelerated stability data sufficient to support a three-year shelf life, and an already filed manufacturing module. Once filed, we expect receiving a PDUFA date from the FDA for later this year. Long-term ketamine safety is an issue that we believe will receive increased attention in the future as clinician prescribing and patient acceptance of ketamine becomes more widespread.

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

There are data available not just from primate studies but from human studies as well that show repeated ketamine doses on the order of 60 doses or more of the currently available commercial formulations of intravenous ketamine may be toxic to the brain. Repeated ketamine use is associated with damage to the urinary tract and bladder. The currently available ketamine preparation was designed in the 1970s in a multi-use vial in order for the product to be used in anesthesia. This multi-dose vial was anticipated to be drawn for multiple doses in various patients, necessitating the addition of a preservative. Back in the 1950s, when this preparation was formulated, they used a potentially toxic preservative, benzethonium chloride. While there's no evidence that benzethonium chloride is toxic at its current concentration for the intended one-time use in anesthesia, its safety has never been shown or even proposed for repeated use.

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

Indeed, the manufacturers of benzethonium chloride identify it as caustic, toxic, and capable of causing severe burns. This class of preservatives has already been removed from many eye drop formulations because of clear evidence of toxicity to the cornea and conjunctiva, even at the currently allowed levels. Chronic use of ketamine is associated with development of ulcerative cystitis, potentially a dangerous bladder condition. This condition may be caused by the excretion of the preservative rather than by ketamine itself. We also note that we are not aware of any cases of interstitial cystitis reported following the use of Spravato, a nasal form of esketamine that does not contain benzethonium chloride. Accordingly, we're filing a citizens' petition with the FDA to remove ketamine preparations with benzethonium chloride from the market, given that this substance is now shown to be unnecessary for stability and sterility of ketamine.

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

The company also plans to file an abbreviated NDA, or ANDA, for preservative-free ketamine so that this drug can be used as broadly as possible. Although we'll never lose sight of our core mission to treat lethal CNS [diseases], including suicidal depression and PTSD, the market for NRx-100 may be far larger than originally anticipated based on the current scenario. As I discussed previously, we have current manufacturing capacity to supply one million vials of ketamine each month. We also have potential to scale up capacity if needed. As noted, we have taken steps to protect our preservative-free formulation with the filing of a patent that has the potential to protect the product into 2045. The toxic preservative is not the only challenge associated with currently available 60-year-old ketamine formulation. As produced, ketamine hydrochloride has a pH of less than 4.

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

This isn't a problem for intravenous use where it's diluted, but precludes subcutaneous administration as dosing of any drug with this pH can cause pain and even cause skin ulcers. If you try to raise the pH of the current ketamine formulation, the ketamine precipitates out of solution, rendering it unusable. Further, administration challenges face those who have tried to give it by mouth. So aside from the obvious safety risks of unmonitored administration of a schedule-free drug, people have learned that the resulting blood levels from oral ketamine administration are highly inconsistent. Similar problems have occurred with ketamine intranasal spray. While intravenous administration is completely reliable in achieving the blood levels, this requires skilled nurses in clinic facilities. With these challenges to administration, we hope to offer an attractive alternative: subcutaneous ketamine delivered in the same way that insulin and newer obesity drugs are given.

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

However, this route of administration is only possible with a pH-neutral form of ketamine. We've now developed that patentable version of pH-neutral ketamine, one that remains stable at room temperature and is expected to begin human bioequivalence trials this year. As is well known, bioequivalence is far simpler and less expensive to prove than safety and efficacy. Our goal in gaining FDA approval for NRx-100 is to significantly expand the number of patients who have access to the benefit from this important treatment. The current off-label use of ketamine in CNS disorders is generally only available to patients who can pay out of pocket because insurance companies do not pay for unlabeled treatments. We expect NRx-100, once approved, to be widely reimbursed, thus providing access for the vast majority of people in need, not just those within means to spend thousands of dollars in cash for treatment.

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

NRx-100 represents a major opportunity for our company. The current market for intranasal ketamine is significant. [J&J] recently released [first-quarter] 2025 sales data on Spravato and is on track to generate $1.3 billion in sales this year, all while the label states that Spravato has not demonstrated anti-suicidal properties. Thus, NRx-100 represents a multi-billion dollar opportunity for NRx, and we are getting closer and closer to providing this lifesaving opportunity to patients. Let's now discuss our treatment for bipolar depression in patients with suicidality or akathisia, NRx-101. While bipolar depression affects approximately 7 million people in the U.S., people with bipolar depression, akathisia, or suicidality are at imminent risk of self-harm. There are no medications approved to treat these patients in the U.S. Current treatment options all carry the risk of suicide and akathisia, which are known side effects of serotonin-active antidepressants.

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

These patients need better treatment options urgently. Today, the only FDA-approved treatment is electroshock therapy. NRx-101 is our oral combination of D-cycloserine, an NMDA receptor blocker, and lurasidone, the standard of care in bipolar depression. NRx-101 has the opportunity to offer a breakthrough in the care of patients with bipolar depression. In clinical trials we have demonstrated comparable or greater antidepressant effect compared to the standard of care with a statistically significant improvement in the safety of NRx-101 due to a reduction in suicidality and akathisia. In our clinical trials, NRx-101 demonstrated strong antidepressant efficacy comparable to the standard of care with a more favorable safety profile.

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

A recently completed phase 2B/3 clinical trial of NRx-101 presented last May at the American Society of Clinical Psychopharmacology demonstrated both a reduction in depression scores as well as symptoms of suicidality and is now the first oral antidepressant to reduce symptoms of akathisia compared to standard of care of potentially lethal side effects of nearly all antidepressants. This would represent a new paradigm for the treatment of bipolar depression if approved. Akathisia is not commonly discussed as a side effect of serotonin-active medications. However, key opinion leaders and patients who suffered from akathisia regard it as the worst side effect of these antidepressants. Patients frequently describe it as a feeling of jumping out of their skin. Patients with akathisia are known to jump off of roofs and in front of oncoming trains.

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

In fact, in 2024, a patient petitioned the British Columbia Supreme Court for the right to end her life rather than continue to suffer from akathisia. Currently, patients have no option other than simply enduring the side effect in order to achieve the critical antidepressant effects that are needed to control bipolar depression or choose to have electroshock therapy. The data we presented at ASCP confirms data from our earlier STABLE trial demonstrating that NRx-101 is the first oral antidepressant to have effective antidepressant properties while simultaneously decreasing akathisia and suicidality. We believe this product profile could lead to NRx-101 becoming the drug of choice in bipolar depression. We plan to initiate filing of our NDA for accelerated approval of NRx-101 for suicidal bipolar depression in patients at risk of akathisia or suicidality this quarter.

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

With the lack of treatment options for this segment of people with bipolar depression and our strong data, we and our regulatory counsel believe this to be a vital unmet medical need and appropriate for consideration of accelerated approval. We anticipate a 2025 PDUFA date. Based on prevalence data, prescribing frequency of serotonin-active medications in bipolar depression, and the risk of akathisia, the company anticipates that the market for the initial indication is over $2 billion, while the broad bipolar market could markedly exceed $5 billion. Since the beginning of the year, we've accelerated progress towards establishing HOPE Therapeutics interventional Psychiatry Clinic Network. We've outlined our plan to establish and grow the Hope Network as a national and ultimately international network of interventional psychiatry centers. These centers would be designed to combine the latest neuroplastic treatments and protocols in an integrated and reproducible manner across the Hope platform.

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

The business model HOPE Therapeutics is somewhat similar to that of DaVita, a company that was instrumental in making kidney dialysis reliable and reproducible in a manner that has transformed the industry and continues to reward its investors. So far in 2025, we've signed definitive purchase agreements to acquire Kadima Neuropsychiatry Institute, a pioneering interventional psychiatry clinic in La Jolla, California, and Dura Medical, an extraordinary clinic group in Southwest Florida. Further, we've executed a binding letter of intent with NeuroStar TMS Holdings, a pioneer in TMS offerings, to acquire their clinic group in the Tampa Bay area on the West Coast of Florida. Our objective for the year is to create a ring HOPE Therapeutics clinics that starts in Naples on the Southwest Coast, runs through Tampa and Orlando, back down to Miami.

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

With these three clinics collectively on a forward-looking revenue, we are anticipated to represent $15 million or more in annual revenue just on their own. Kadima's Founder, Dr. David Feifel, has agreed to serve as Hope's Chief Medical Innovation Officer post-acquisition. He's one of the first academic psychiatrists to move ketamine and TMS therapy to the community care model and is frequently featured in the national media, such as in Rolling Stone, on Peacock as one of their most knowledgeable experts on the safe and appropriate use of ketamine and other advanced therapies in mental health treatment. Some of you may have seen his recent interview with Dr. Sanjay Gupta. Over the remaining months of 2025, we expect to announce the inclusion of additional EBITDA-positive centers in the Hope Network.

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

Looking at the market, we anticipate that the acquisition of 20 clinics, each with current revenue of approximately $5 million, will enable us to meet our forward-looking revenue targets. Looking ahead, these best-in-class clinics can generate operating margins of 30% or higher, with significant opportunities for future growth. On the financing front, Hope has announced signing term sheets for more than $10 million in acquisition capital in the form of both debt and equity to fuel our initial acquisitions, with strong interest expressed by investors in continuing to support our roll-up strategy. As we've always said and as these term sheets illustrate, we continue to expect funding for Hope to be independent of NRx stock and thus non-dilutive to NRx shareholders.

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

Additionally, we expect that a portion of the earnings generated through HOPE may support NRx's path to profitability, and our planned spin-out of HOPE and subsequent listing on a national stock exchange will provide balance sheet value both to NRx and to its shareholders. As you can see in our Form 10-Q, we have substantially reduced operating expenses and are forecasting profitability on a going-forward run rate basis by the end of 2025 with revenue and EBITDA HOPE Therapeutics, along with potential sales of our medications. I'll now ask Mr. Michael Abrams, our CFO, to review our financial results from the first quarter of 2025. Mike?

[Michael Abrams, CFO at NRx Pharmaceuticals]

Thank you, Jonathan. The three-month ended March 31, 2025.

[Michael Abrams, CFO at NRx Pharmaceuticals]

The company reported a net loss of $5.5 million versus a net loss of $6.5 million for the comparable quarter in 2024, and a loss from operations of $3.8 million versus a loss from operations of $6 million for the comparable quarter in 2024. Research and development and general administrative expenses were $0.8 million and $2.9 million as compared to $1.7 million and $4.3 million for the comparable quarter ended March 31st, 2024, respectively. As of March 31st, 2025, NRx Pharmaceuticals had approximately $5.5 million in cash and cash equivalents. The company believes that its current capital position, combined with ongoing financing discussions and partnerships, will support operations through at least the end of 2025. NRx continues to implement operational efficiencies to extend cash runway and maintain focus on our path to generating revenue and value for our shareholders. With that, I turn it back to Jonathan. Jonathan?

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

Thank you, Mike. We founded NRx with the goal of preventing and treating suicidality in patients with depression and PTSD. This is close to my heart and to the hearts of everybody who works with us. Our planned 2025 PDUFA dates for two NDAs in this space and continuing the development HOPE Therapeutics national network for care delivery are transformative steps for the company and for the treatment of mental health in the U.S.. I'd like to thank the NRx team, our investors, and most importantly, the patients who've participated in our clinical trials for their steadfast support of our pursuit of this vision. We're ready to take questions from the audience.

[Operator]

Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touchstone phone.

[Operator]

You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question is from Tom Schrader from BTIG. Please go ahead.

[Tom Shrader, CFA, Managing Director, and Healthcare Analyst at BTIG]

Good afternoon. Congratulations on the whirlwind of progress. I had a kind of a remedial question on the recent IP. What does that buy you if, in fact, you get approved? As far as I understand it, the IP you really care about is the pH-neutral version. Just your thoughts on, one, how strong the patent application is to leave the preservative out, and two, how important is it for you to get that if you get approval? Thanks.

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

I would never make predictions about how strong any individual patent is. I know that the patent counsel filing the patent is highly experienced and strongly believes in the claims that we're filing with the USPTO. Why does it matter? It matters because, in our view, drugs with toxic preservatives are going to be withdrawn from the market. If we're coming to market with an Orange Book patented form of ketamine, we potentially have market exclusivity for an extended period of time. We always said that ketamine was a generic drug, and by adding a new use, the maximum we were going to get was three years of data exclusivity under paragraph four from the FDA. We kind of surprised ourselves. It turns out that we may have much longer exclusivity on racemic ketamine in a preservative-free preparation than we originally anticipated.

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

If that happens, that's certainly good for our shareholders. The pH-neutral form of ketamine is certainly proprietary, certainly patentable, and it's expected to have long-term protection. It turns out we may have longer-term protection than we ever predicted from a better version of old-fashioned racemic ketamine, given the focus of the current Secretary of Health and Human Services on getting toxic preservatives out of the food and drug supply.

[Tom Shrader, CFA, Managing Director, and Healthcare Analyst at BTIG]

Good. Thank you. That's a useful answer. Thank you.

[Operator]

Your next question is from Ed Woo, who's a private investor. Please go ahead.

[Operator]

Yes. Matthew with Ascendiant Capital. Congratulations on all the progress. Obviously, it's going to be a very exciting year for you guys. Have you given any consideration for NRx-100 and HOPE Therapeutics to either be able to go internationally beyond the U.S.?

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

Certainly, we intend to make NRx-100 available more broadly.

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

European countries are actually more sensitive to toxic substances in foods and drugs than the United States historically has been. If we're able to make this case in the U.S., we would anticipate that there is significant international potential for NRx-100. In fact, we've been approached by a number of international entities for that specific purpose.

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

Great. That sounds good. Thanks for answering my questions. I wish you guys good luck. Thank you.

[Operator]

There are no further questions at this time. Please proceed.

[Matthew Duffy, CBO at NRx Pharmaceuticals]

That's all the time we have for questions, folks. Thank you very much for joining us this evening. We're extremely excited about the year ahead with two potential drug approvals and a subsidiary targeting multiple large profitable mental health clinics moving ahead. This concludes the NRx Pharmaceuticals First Quarter 2025 Results Conference Call. Thank you all for participating.

[Operator]

Ladies and gentlemen, this concludes the conference call for today. We thank you for participating and ask that you please disconnect your lines.

Participants

Executives

• Matthew Duffy, CBO
• Michael Abrams, CFO
• Jonathan Javitt, Founder, Chairman, and CEO

Analysts

• Analyst at Ascendiant Capital Markets
• Tom Shrader, CFA, Managing Director, and Healthcare Analyst at BTIG