NRX Pharmaceuticals, Inc.

Afternoon ladies and gentlemen and welcome to the NRX Pharmaceuticals first quarter 2025 earnings call. At this time all lines are in a lesson 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 0 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. Thank you Andrew and welcome everyone.

Before we proceed with the call I would like to remind everyone the certain statements made during this call are forward-looking statements under US Federal Security laws. These statements are subject to risks and uncertainties because they could cause actual results to be different materially from historical experience or from expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call contain their periodic reports filed with the FCC. The forward-looking statements made during this call speak only as of the day 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 investor's page of the NRCF Robin.

Thank you Matt. Good evening everyone and thank you for joining us. NRC 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 act of time to do so according to the CDC. An American dies from every 11 minutes and worldwide somebody dies from suicide every minute. These appalling statistics drive our nation. We've advanced our lead candidates NRX100 and NRX101 in the regulatory process with the US FDA. We've taken concrete steps for establishing the whole therapeutic 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 sheets to 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 doc. The founding of NRX is based on our mission to help patients and caregivers address our country's national epidemic of suicidality, depression, PTSD and related disorders. We have been able to do so with innovative medicines and now with whole therapeutics to offer direct patient care for these legal conditions. Our mission has not changed. Importantly, we've accelerated our path for revenue with all three of our lead programs having the 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 veteran communities. Two weeks ago in the televised White House cabinet meeting, the president asked the what was being done to address suicide in veterans. The secretary's response included the needs of psychedelic therapy. Ketamine, a drug we're developing, is one such therapy. The secretary of health and other members of the administration have specifically endorsed our class of medicine as well as clinical approaches that are central to our business. NRX has two separate operating groups. NRX formed a critical and traditional biotech drug development company with multi-billion dollar opportunities and HOPE therapeutic, 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 MDA for NRX100, 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 adazolam and to electroshock therapy. No other drug in history has demonstrated efficacy that meets or defeats that of ECT without 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 labelled room temperature shelf stability, the maximum allowed by FDA. To protect NRX100 exclusivity, this month we filed a patent for our novel preservative free formulation of NRX100 with the U.S. Patent and Trademarks Office, potentially protecting our ketamine product into 2045 with a potential orange foglisten. Crucially for Americans and the disproportionately impacted veteran and warfighter communities, together with first responders and others who suffer from this condition, we have meant vaccine 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 bentathione and chloride family preservative currently used in all commercial forms of ketamine has been showing to be neuro-toxic and also toxic to epithelial cells. Now that we've shown there's 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. In parallel, we're preparing a new drug application requesting accelerated approval for NRX101, our fixed dose oral combination of de-sexuotering and lirazodone for the treatment of suicidal depression of patients with suicidality or aches and thies with the anticipation that we will initiate the filing in the current quarter. NRX101 is the only antidepressant ever shown to decrease aches and thies compared to standard of care antidepressants. Aches and thies is the side effect of all previously marketed antidepressants most closely associated with suicidality. In our clinical trial, NRX101 was also associated with a more rapid resolution suicidal ideation than the standard of care antidepressants. Last year, we organized co-paramedics, 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 independently yields a long-term remission from a disease such as TMS or TMS. The clinical data, along with practitioner experience, suggest that most patients contacting the interventional psychiatry clinic 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 a 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% of their 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 continue to grow, as distinct from the pump-up pedamine clinics that some go, tells us that patients and their families embrace this model. Foltz has signed purchase agreements and a binding letter of intent to acquire three -the-art interventional psychiatry practices, the Human Neuroscience Institute in La Jolla, California, Dura Medical in southwest Florida, and NeuroPlot 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 for 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, Foltz signed a term sheet with Universal Capital, a global investment firm, for $7.8 million in debt facility to fund Foltz'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 hold 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 NREG stock. As you can see, we're making important progress building NREG 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, NREG-100, to the marketplace by early next year. Ketamine, for example, is available today almost exclusively to those who've been looking forward to pay out of pocket. It will remain so until FDA approval for ketamine to treat suicidal depression is attained. 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 two-year shelf life, and an already filed manufacturing module. One filedly expects receiving a productive 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 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 positive 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 file in order for the product to be used in anesthesia. This multi-dose file 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 the potentially toxic preservative, benthythonium chloride. While there's no evidence that benthythonium 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 benthythonium 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 level. 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 reporting following the use of spravato, a nasal form of S-ketamine that does not contain benthythonium chloride. Accordingly, we're filing a citizen's petition with the FDA to remove ketamine preparations with benthythonium chloride from the market, given that this substance is now shown to be unnecessary for stability and ferility of ketamine. The company also plans to file an abbreviated NDA or ANDA for preservative pre-ketamine so that this drug can be used as broadly as possible. Although we'll never lose sight of our core mission to treat legal CNS diseases, including suicidal depression and PTSD, the market for NRX100 may be far larger than originally anticipated based on the current scenario. As I discussed previously, we have a potential to increase the current manufacturing capacity to supply 1 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 pre-formulations with the filing of a patent that has the potential to protect the product into 2045. The cost of preservative is not the only challenge associated with the current ketamine formulation. As produced, ketamine hydrochloride has a pH of less than 4. This isn't a problem for intravenous use where it's diluted, but for food subcutaneous administration, as joking 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 now. So aside from the obvious safety risks of unmonitored administration of a schedule of three drugs, people have learned that the resulting blood levels from oral ketamine administration are highly inconsistent. Similar products have occurred with ketamine intranasal spread. While intravenous administration is completely reliable in achieving the blood levels, this requires field nurses and clinic facilities. With these challenges to administration, we hope to offer an attractive alternative such to tenuous ketamine delivered in the same way that insulin and neurodicity drugs are given. However, this route of administration is only possible with a pH-reperform of ketamine. We've now developed that patentable version of pH-info ketamine, one that remains stable at room temperature and is expected to begin human bioequivalent 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 NRX100 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 and 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 NRX100, once approved, to be widely reimbursed, thus providing access to the vast majority of people in need, not just those who then need to spend thousands of dollars in cash for treatment. NRX100 represents a major opportunity for our company. The current market for intranasal ketamine is significant. J&J recently released fourth quarter 2025 sales data on Spervato and is on track to generate 1.3 billion dollars in sales this year, all while the label states that Spervato has not demonstrated anti-suicidal properties. Thus, NRX100 represents a multi-billion dollar opportunity for NRX, and we are getting closer and closer to providing this life-saving opportunity to patients. Let's have a look at our treatment for bipolar depression in patients with suicidality or apathisia, NRX101. While bipolar depression affects approximately 7 million people in the U.S., people with bipolar depression, apathisia, 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 apathisia, which are known as our suicide 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. NRX101 is our oral combination of de-suspirin, an NMDA receptor blocker, and lorazodone, the standard of care in bipolar depression. NRX101 has the opportunity to offer a breakthrough in the care of patients with bipolar depression. In clinical trials, we demonstrated comparable or greater antidepressant effects compared to the standard of care with a statistically significant improvement in the safety of NRX101 due to a reduction in suicidality and apathisia. In our clinical trials, NRX101 demonstrated strong antidepressant efficacy comparable to the standard of care with a more favorable safety profile. Our recently completed case 2B-SRI3 clinical trial of NRX101 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 combination of all antidepressants to reduce symptoms of apathisia compared to standard of care of a potentially lethal side effect of nearly all antidepressants. This would represent a new paradigm for the treatment of bipolar depression if approved. Apathisia is not commonly discussed as a side effect of virulence and serotonin active medication. However, key opinion leaders and patients who suffered from apathisia regarded as the worst side effect of these antidepressants. Patients frequently describe it as a feeling of jumping out of their skin. Patients with apathisia are known to jump off a roof and in front of oncoming trains. In fact, in 2024, patients petitioned the British Columbia Supreme Court with a right to enter life rather than continue to suffer from apathisia. Currently, patients have no option other than simply enduring the side effects in order to achieve the critical antidepressant effects that are needed to control bipolar depression or to have electroshock therapy. The data we presented at ASPP confirmed data from our earlier stable B trial demonstrating that NRX101 is the first oral antidepressant that has effective antidepressant properties while simultaneously decreasing achepthisia and suicidality. We believe this product profile could lead to NRX101 becoming the drug of choice in bipolar depression. We plan to initiate filing of our NDA for accelerated approval of NRX101 for suicidal bipolar depression in patients at risk of achepthisia 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 anticipate 2025 to do okay. Based on prevalence data, restriving frequency of serotonin active medications in bipolar depression and the risk of achepthisia, the company anticipates that the market for the initial indication is over two billion dollars while the broad bipolar market could markedly exceed five billion dollars. Since the beginning of the year, we've accelerated progress for establishing the Hope Therapeutics Interventional Psychiatry Clinic Network. We've outlined our established 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 whole platform. The business model for Hope Therapeutics is somewhat similar to that of Hidden 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 the Demon Neuroscience Institute, a pioneering interventional psychiatry clinic in La Jolla, California, Enduro Medical, and extraordinary clinic group in Douglas, Florida. Further, we've executed a binding letter of intent with NeuroSpot 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 April on the southwest coast, runs through Tampa and Orlando, back down to Miami. The three clinics collectively on a forward-looking revenue are anticipated to represent $15 or more in annual revenue just on the run. To be misfounded, Dr. David Spipal has agreed to serve as Hope's Chief Medical Innovation Officer, post-adquisition. He's one of the first academics to hire 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 PCOC as one of the most knowledgeable experts on the safe and appropriate use of ketamine and other adjunct 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 e-Bizon 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 second-class clinics can generate operating margins of 30% or higher, with significant opportunities for future growth. On the financial front, Hope has announced signing term sheets for more than $10 million in acquisition capital in the form of off-debt and equity to fuel our initial acquisitions, with strong interest expressed by investors in continuing to support our role of strategy. As we've always said, and as these term sheets illustrate, we continue to expect funding for Hope to be independent of NREX stock and thus non-dilutive to NREX shareholders. Additionally, we expect that a portion of the earnings generated through Hope may support NREX's past the profitability, and our plans spin out of Hope and subsequent listing on a national stock exchange will provide balance and value both to NREX and to its shareholders. As you can see in expenses and our forecasting profitability on a building 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 Abrams, our CFO, to review our financial results from the first quarter of 2025. Mike?

Thank you, Jonathan. So 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 administrative expenses were $0.8 million and $2.9 million, as compared to $1.7 million and $4.3 million for the comparable quarter as of March 31, 2025. NREX 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. NREX continues to implement operational efficiencies through spend cash runways 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 NREX with the goal of preventing and treating suicidality and patients with depression and PCNC. This is close to my heart and to the hearts of everybody who works with us. Our plan 2025 is to do the dates for short, end the age in the space, and continuing the development of whole therapeutic national networks for care delivery, our transformative steps for the company, and for the treatment of mental health in the United States. I'd like to thank the NREX 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 Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touch phone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the phone process, please press the star followed by the number two. If you are using a speaker phone, 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.

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? And as far as I understand it's 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 Council filing the patent is highly experienced and strongly believed in the claims that we're filing with the USPTO. Why does it matter? It matters because in our view

drugs with positive preservatives are going to be withdrawn from the market. And if we're coming to market with

an orange full patented form of ketamine, are we potentially have market exclusivity for any set 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 exclusivity, data exclusivity under paragraph four from the FDA. And then we kind of surprised ourselves and it turns out that we may have much longer exclusivity on racemic ketamine in a preservative-free preparation than we originally anticipated. So if that happens, that's certainly good for our shareholders. The P-exclusive 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 racine academy given the focus of the current secretary of health and human services on getting toxic preservatives out

of the food and drug supply. Thank you, that's a useful answer. Thank you. So our next question is from Ed Wills

who is a private investor. Please go ahead.

Yes, I'm actually with Appendian 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 NRX100 and also hope that they're going to either

be able to go internationally beyond the U.S.? Certainly we intend to make NRX100

available more broadly and, you know, 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 a case in the U.S., we would anticipate that there is significant international potential for NRX100 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. All right, no other 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 subsidiaries targeting multiple large profitable mental health clinics moving ahead. This concludes the NRX Pharmaceuticals First Quarter 2025 Results Conference. Thank you all for participating.

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