NRXP - NASDAQ

Good afternoon, ladies and gentlemen, and welcome to the NRx Pharmaceuticals First Quarter 2025 Earnings Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] This call is being recorded on Thursday, May 15, 2025. I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please go ahead.

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. 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?

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. And 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 the HOPE Therapeutics Clinic network across the United States. 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. We have capital on the balance sheet through 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 with 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. 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 VA Secretary Collins, what was being done to address suicide and 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. NRx has two separate operating groups. NRx Pharmaceutical, a traditional biotech drug development company with multibillion-dollar opportunities; and 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 have 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 electroshock therapy. 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 support 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 Americans, and the disproportionately impacted veteran and war fighter communities, together with first responders and others who suffer from this condition, we have manufacturing capacity to supply more than 1 million doses a month should we gain FDA approval. 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 have 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 use of ketamine, not just to treat psychiatric conditions. In parallel, we are preparing a new drug application requesting the 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 organized 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. 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. The clinical data, along with practitioners' experience, suggests that most patients contacting interventional psychiatry clinics for care will require a combination of NMDA antagonist drugs plus additional neuroplastic therapies such as TMS and/or 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%. 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, Edelman [ph] Neuroscience Institute in La Jolla, California; Dura Medical in Southwest Florida, and Neurospa TMS in the Tampa Bay Area, Florida. The expansion pipeline includes a number of additional clinics in Florida, the Mid-Atlantic, and the 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. As reported earlier, HOPE signed a term sheet with Universal Capital, a global investment firm, for a $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 nondilutive to shareholders of NRx stock. As you can see, we're making important progress building NRx into a company that will bring life-saving 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. 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've initiated filing our NDA for NRX-100, the intravenous preservative-free ketamine for treatment of suicidal depression. And 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. 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 1960s, 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. 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 the 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 the substance is now shown to be unnecessary for the stability and sterility of ketamine. 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 1 million vials of ketamine each month. We also have the 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 the currently available 60-year-old ketamine formulation. As produced, ketamine hydrochloride has a pH of less than four. This isn't a problem for intravenous use, where it's diluted, but it 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've tried to give it by mouth. So, aside from the obvious safety risks of unmonitored administration of a Schedule 3 drug, people have learned that the resulting blood levels from oral ketamine administration are highly inconsistent. Similar products have occurred with the ketamine intranasal spray. While intravenous administration is completely reliable in achieving the blood levels, this requires skilled nurses and 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. 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 benefits 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 with the means to spend thousands of dollars in cash for treatment. 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 multibillion-dollar opportunity for NRx, and we are getting closer and closer to providing this life-saving 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 and 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. These patients need better treatment options urgently. Today, the only approved FDA treatment or 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've 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. Our 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, a potentially lethal side effect 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 regarded as the worst side effect of these antidepressants. Patients frequently describe it as a feeling and jumping out of their skin. Patients with akathisia are known to jump off of roofs and in front of oncoming trains. In fact, in 2024, a patient petitioned the British Columbia Supreme Court for the right to enter 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 STABIL-B 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. With the lack of treatment options for this segment of people with bipolar depression and our strong data, we and our regulatory council believe this to be a vital unmet medical need and appropriate for consideration of accelerated approval. We anticipated 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 the 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. The business model for 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 continue to reward its investors. So far in 2025, we've signed definitive purchase agreements to acquire Kadima Neuroscience 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 Neurospa 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 of HOPE Therapeutics clinics that starts in Naples on the Southwest Coast, run through Tampa and Orlando back down to Miami. But these three clinics collectively on a forward-looking revenue are anticipated to represent $15 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 the 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. 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. Additionally, we expect that a portion of the earnings generated through HOPE may support NRx's path to profitability and our planned spinout 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 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 from HOPE Therapeutics, along with potential sales of our medications. I'll now ask Mr. Michael Abrahams, our CFO, to review our financial results from the first quarter of 2025. Mike?

Thank you, Jonathan. For the three months ended March 31, 2025, 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 and 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 31, 2024, respectively. As of March 31, 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?

Thank you, Mike. So, 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 of HOPE Therapeutics National Network for care delivery are transformative steps for the company and for the treatment of mental health in the United States. I'd like to thank the NRx team, our investors and most importantly, the patients who participated in our clinical trials for their steadfast support of our pursuit of this vision. We're ready to take questions from the audience.

Thank you. [Operator Instructions] Your first question is from Tom Shrader from BTIG. Please go ahead.

Good afternoon. Congratulations on the whirlwind of progress. I had a kind of remedial question on the recent IP. What does that buy you if, in fact, you get approved? And as far as I understand it, the IP you really care about is the pH-neutral version. So 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.

Well, 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. And 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 exclusive data exclusivity under Paragraph IV from the FDA. And then we kind of surprised ourselves. And it turns out that we may have much longer exclusivity on racemic ketamine and a preservative-free preparation than we originally anticipated. So if that happens, that's certainly good for our shareholders. The pH-neutral form of ketamine is certainly proprietary, certainly patentable and is expected to have long-term protection. But 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.

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

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

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

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

Great, that sounds good. Thanks for answering my questions and I wish you guys good luck. Thank you.

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

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.