NRX Pharmaceuticals, Inc.

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

Thank you, Joelle, and welcome everyone. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal security laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise forward-looking statements. Information presented on this call is contained in the press release issued this morning and in the company's Form 10-Q, which may be accessed from the investors page of the NRX Pharmaceuticals, Inc. website. Joining me on the call today are Dr. Jonathan Javitt, our founder, chairman, and CEO, and Michael Abrams, our chief financial officer. We'll provide an overview of our company's progress as reported in today's 10Q, following which Mike will give a review of the company's financials and results. Following their prepared results, we'll address investor questions. Jonathan's having a couple of technical issues this morning, so I'll start us off. Since the beginning of the third quarter, NRX has made transformative progress in developing our business. We have advanced each of our programs with drug approvals applications in process for CataFree, NRX100, and NRX101. It also expanded our NRX101 pipeline and closed on multiple acquisition targets for our network of interventional psychiatry clinics, Hope Therapeutics. In conjunction with closing our first clinics, we are now generating revenue and on a path to a highly promising company. The point of our call today is not three weeks of revenue from a single clinic, just a few hundred thousand dollars, that hit our third quarter income statement. Rather, it's the revolutionary and generational shift that we see in the treatment of severe depression and PTSD today, along with the potential to use the same technologies to treat traumatic brain injury, autism spectrum disorder, Parkinson's, and even cognitive decline in coming years. This past quarter has been a watershed moment in that generational shift from our perspective. Last week, a group of highly respected scientists presented real-world data showing an 87% treatment response and 72% remission from severe depression following a single day of treatment with a newly developed TMS or transcranial magnetic stimulation coil, and a low dose of d-cycloserine, or DCS. Note that the active ingredient in NRX-101 is also DCS. This publication comes on the heels of a well-controlled clinical trial in which DCS was shown to more than double the effect of conventional TMS in treating both depression and suicidality. Rather than rely on this call, we urge you to read the underlying science referenced on our website on the publications page. As we announced last week, our company Hope Therapeutics is the first one to deploy this 1D protocol in Florida in partnership with AMPA Health. And we're actively partnering with established clinics and seeking to open new clinics in Florida and nationwide. The scientists involved in that trial will be the first to say that theirs is not the only TMS machine capable of affecting a one-day theta burst protocol. However, no drug other than DCS so far has demonstrated the augmentation of TMS in the literature. Accordingly, this quarter's results should be viewed as seeing the first rain shoots come out of the ground, not as an indication of whether these shoots will ultimately be a bush or a giant tree. We anticipate that our growing enterprise will be far easier to discern by our next conference call. As you know, we have been working with DCS since our founding in 2015, and our co-founder, Dr. Daniel Javid, began research with this class of compounds in 1987. NRX holds rights to more than 70 patents around the world that relate to the use of DCS in treating depression, PTSD, and other life-changing brain disorders. We have extensive experience in the formulation and stabilization of this highly challenging and unstable molecule. A breakthrough therapy designation IND opened with the FDA and manufactured drug in our warehouse that is actively being deployed in an expanded access protocol to enable doctors to replicate last week's dramatic 1D findings. Although a raft of compounding pharmacies are offering DCS for sale in response to these dramatic scientific results, We will be releasing chromatography and other foundational science demonstrating the need for manufacturing controls that are essential for preventing rapid degradation of DCS and the formation of various impurities, controls, and techniques. We have devised over nearly 10 years of active preclinical and clinical development. The reason to be excited about combining DCS, which is a highly neuroplastic drug, along with TMS, which is also a neuroplastic therapy, is not the simple notion that two neuroplastic treatments may be better than one, as in one plus one equals two. Rather, the scientific legacy of leaders in the field increasingly proves that drugs such as DCS make the brain cells far more receptive to TMS and other neuroplastic therapies, akin to fertilizing the field as you plant the seeds. For those who are new to this conversation, neuroplasticity is the process by which brain cells are constantly growing new connections to other brain cells. In a digital computer, transistors are always turning on and off under the control of software, but the circuits stay the same. In the brain, those transistors or neurons polarize and depolarize. The cellular equivalent of turning on and off, but also constantly form new connections and prune those connections to other cells. That's called neuroplasticity. Over the past 20 years, we have come to understand that the loss of neuroplasticity in different parts of the brain is at the root of depression, PTSD, autism spectrum disorder, and other conditions that I've mentioned. Dr. Javits' 45-year medical and scientific career predominantly focused on the visual axis of the brain. The last time he was involved in a technological change that is this profound was the introduction of the first anti-VEGF drug to treat macular degeneration. that led to a whole generation of injectable eye drugs that forever changed the potential for people to preserve their sight in the face of previously hopeless and blinding conditions. In our view, we're witnessing a similar tectonic split shift in the neuroplastic drugs, devices, and digital therapeutics are being combined to transform the treatment of severe depression and PTSD today and the brain diseases that affect more than a billion people on the planet tomorrow. If those publishing this science are correct, it is likely that oral antidepressant drugs with their life-threatening complications, their effects on disfiguring, weight gain, and sexual dysfunction, their propensity to cause suicidal ideation, and their dismal 30% success rate may lose their place as first-line treatment for those with life-threatening brain diseases. More importantly, this generational shift in our understanding will finally cause us to abandon the notion that brain diseases that result in behavioral symptoms, such as depression and anxiety, are biologically different from brain diseases that cause Parkinson's or cognitive dysfunction, and that the patients who suffer these supposedly behavioral health problems are somehow less deserving of medical care than those who suffer from other neurological or CNS diseases. One reason we founded Hope Therapeutics was to have the ability to directly engage the payer community in this changing paradigm. That brings us to corporate and financial results achieved in the past quarter and the objectives we think are meaningful over the coming quarters. Our quarterly report reflects only the first three weeks of revenue from our first two clinics. By year end, we anticipate growing from two clinics to six or more clinics within our current orbit, and we expect these revenues to demonstrate strong growth over the coming quarters as we integrate the clinics, help grow them, and add to their numbers. Most importantly, the historic revenue It is based on ketamine treatment sessions and traditional TMS treatment sessions that are generally reimbursed at less than $500 a session. Much of our future growth is likely to be focused on day and other short-term multimodality treatments with rapid clinical results that are already reimbursed by payers at higher levels. To give you just one of many real-life illustrations of why this is economically viable, consider the situation of a highly trained essential first responder who is suffering from depression and PTSD. In many cases, antidepressants are incompatible with a return to duty. For many frontline roles, this is a disqualification. Hence, the desire of the patient and the family for relief from a debilitating and life-threatening condition aligns with the urgent need of military, law enforcement, emergency services, and other organizations to maintain their force readiness. The financial and other resource cost of replacing frontline personnel is astronomical. While medical insurance decisions are often made by executives who many Americans view as not caring enough about the individual, health insurance payment policies are increasingly dictated by the employers who pay the premiums and who care deeply about their ability to maintain a workforce in whom they have invested. Often the decision makers at that level are the military leaders, police and fire commissioners and others who have come up through the ranks and who think about their people first. When Dr. Jabbitt presented last month at Fort Belvoir to a room containing generals, admirals, and elected officials, he sat with a senior advisor to the Secretary of the Veterans Affairs Administration who reminded him of the public statements from the VA that stopping veteran suicide is their top priority. We hope to release a video of that briefing to you in the coming weeks. Our balance sheet is considerably stronger than it was at the end of the second quarter, owing in part to the support of long-term healthcare specialist investors who joined us during the third quarter and purchased common stock with no warrant overhang, no pricing provisions, and no convertible debt feature. At this point, NRX has secured operating capital that is anticipated to be sufficient to fund drug development operations through 2026. Additionally, as just noted, We expect to continue to add revenue from the clinical operations and believe it is likely that we will see revenue from sales of ketamine under an ANDA in mid-2026. As you can see from our balance sheet, and as Mike Abrams will be discussing in greater detail later, we are well positioned to achieve numerous milestones on both sides of our business with existing cash. Our goal in doing so is to substantially enhance shareholder value while advancing our mission of bringing hope to life. Now let's review each program, starting with our preservative-free ketamine, which was previously required a toxic preservative, which is benthaminoidium chloride, to maintain stability and sterility. Our stability data remains on track for a three-year room temperature shelf life. We're pursuing two parallel approval processes. a generic pathway and an innovative pathway, using two different formulations to prevent price confusion. As you saw in August, FDA ruled that those two formulations create two different drug identities. The first pathway is a new drug application, or NDA, for NRX100 in suicidal ideation for patients with depression, including bipolar depression. The second is an abbreviated new drug application Oranda to make Ketafree available for ketamine's existing generic indications. NDA preparation is nearly complete, and we anticipate transmitting the entire submission in the coming weeks. The key development is that we are adding more than 60,000 patient encounters of real-world efficacy data, which demonstrates statistically significant advantages of intravenous ketamine over nasal S-ketamine. Combined with the data from U.S. and European trials in more than 1,000 patient participants, We believe this to be a compelling case for efficacy. This will be an important step forward for both the company and for patients suffering from suicidal depression. There is currently no medication approved for treating suicidal ideation, and the Spravato label clearly states that it has not been shown to be effective for reducing suicidality. The only current alternative is for patients with suicidal ideation is ECT, or electroconvulsive therapy. As you know, the PCORI trial, which is posted on our website, demonstrated a 30% incidence of memory loss with ECT and none with IV ketamine. In what we feel is strong validation, the FDA granted us an expanded fast-track designation in August to now include all patients with suicidal ideation and depression, including bipolar depression. Suicidality is a massive problem in the U.S. In fact, the CDC estimates that nearly 13 million Americans seriously consider suicide each year, and this leads to an American dying from suicide every 11 minutes. Our leadership team was invited to Fort Belvoir last month, where we presented to senior military and veterans affairs leaders, and will be repeating the briefing at VA headquarters and Nellis Air Force Base to the Air Force leadership. As Secretary Collins has said publicly, stopping veteran suicide is his top priority. In June, the FDA created the Commissioner's National Priority Voucher Program that affords substantially faster review times of one to two months versus the standard 10 to 12-month review, enhanced communication throughout the review process, and creates potential for accelerated approval of NRX 100. Commissioner Macri has publicly stated that safe and effective drugs to prevent suicide are a top priority for him. More importantly, after some publicly reported personnel changes, the FDA Centers for Drugs now as a leader has been a long-term proponent of accelerated approval for lifesaving drugs that meet an unmet medical need. To receive a CNPV, a product must meet at least one of the following criteria. Address a U.S. public health crisis. Address a large unmet medical need. Deliver more innovative cures for the American people. reshore key strategic drugs to the US, or reduce healthcare costs. NRX meets all of these criteria. In Q3, we filed an abbreviated new drug application for ketamine with priority review requested. We called this product Ketafree. After meeting with the FDA in August of 2025, we've refiled the ANDA following FDA notification of the suitability petition for NRX's proposed strength of Ketafree. Last week, we received a communication from FDA noting no significant deficiencies in the revised Ketofree filing, and we believe the filing is on track for a second quarter GDUFA date, or that's a generic drug equivalent of a GDUFA date. The company has additionally submitted a citizen petition seeking to have benzothonium chloride, a toxic preservative included in all currently approved ketamine products, for antiquated reasons, removed from all presentations of ketamine. This preservative is the subject of a detailed toxicology report we have published, which details the concerns that led FDA to ban BZT from topical antiseptics and hand cleansers. Notably, benzothonium chloride is not categorized by FDA as grass or generally recognized as safe. This report has been submitted to the FDA in support of our citizen petition. As a preservative, free formulation of ketamine is an important invention, We have filed a patent application with the US Patent and Trademark Office to protect our intellectual property surrounding this product. The existing generic market for ketamine has been projected at approximately 750 million. We believe Ketafree, made in the US and offered without any toxic preservatives, offers patients and clinicians a superior option. We'll continue to work diligently with the FDA to move our application forward as rapidly as possible. and provide a safer version of this critical product to the American public. Our program around NRX-101, our oral combination of d-cycloserine and lorazodone, took an extremely positive and unanticipated direction as outlined in the opening. As you know, we received breakthrough therapy designation for this drug in the treatment of suicidal bipolar depression and continue to advance that agenda. Our manufacturing data is on file with stability trending towards five years, and we have a million doses in the warehouse. There are more than 7 million patients suffering from bipolar depression in the U.S., and many of these are at risk of akathisia, a terrible side effect caused by serotonin-active or SSRI drugs that is closely related to suicide. These patients are at tremendous risk of self-harm. We have demonstrated statistically significant superiority of NRX-101 over lorazodone, the current standard of care, in reducing suicidality and akathisia in two well-controlled trials. Both NRX101 and lorazabine are potent antidepressants, and one of those trials also demonstrated a superiority in reducing depression. Remember that we are comparing to a known, effective drug, not placebo. Because of the huge unmet need, we are optimistic that FDA will be receptive to an application for accelerated approval in the 600,000 patients who suffer from suicidal ideation in bipolar depression despite treatment with a currently approved medication. A few days ago, a new director of the FDA Center for Drugs was appointed who pioneered the accelerated approval pathway and has been a staunch advocate for early approval of medicines for life-threatening conditions for which there is no currently available therapy. Last week, we saw publication of the exciting and unanticipated finding that low-dose D-cycloserine again, the active ingredient in NRX101, when combined with a one-day protocol of TMS. Recently, there's been exceptional interest in the use of DCS, the active component, to enhance the efficacy in the treatment of depression. D-cycloserine, like ketamine, blocks the NMDA receptor and enhances neuroplasticity. Recently published real-world data provides confirmatory evidence seen in a prior randomized controlled trial that low-dose DCS more than doubles the antidepressant effect and anti-suicidal effect of TMS. Unfortunately, DCS alone is contraindicated in patients with depression, which may impact willingness of patients and practitioners to use this new protocol. Importantly, NRX 101, while including DSCS in its formulation, does not carry this contraindication. as the addition of lorazinib blocks the effect of the NMDA inhibition in one key side effect. This creates a significant need for development of NRX101 for the use in conjunction with TMS to treat depression, PTSD, and other disorders. We have more than 25,000 manufactured doses of NRX101 at the appropriate strength on hand and have launched a nationwide expanded access program to enable physicians to access this medication at no charge to the patient under expanded access and federal right to try laws. A confirmatory phase three trial of NRX-101 to augment the effects of TMS is planned for early 2026. The market estimate for this newly validated indication for NRX-101 is in excess of $1 billion. On September 8, 2025, Hope Therapeutics initiated revenue generation upon closing of its acquisition of Dura Medical, with clinics located in Naples and Fort Myers, Florida. Hope subsequently added Cohen and Associates in Sarasota, Florida, another revenue-generating, EBITDA-positive clinic, to the Hope network. Dr. Rebecca Cohen, founder of Cohen and Associates, has been appointed as Hope's medical director. Last week, Hope was the first organization in Florida to launch one-day TMS treatment for severe depression and 1D protocol using the APPA TMS device. The 1D protocol has been reported in the peer-reviewed literature to achieve 87% response and 72% remission from severe depression at six weeks following a single day of TMS treatment combined with d-cycloserine. FOCUS is in the process of adding three more facilities this year and is in an active discussion with numerous acquisition opportunities around the country. With our significant advances in the third quarter and a committed investor base, we believe we are better positioned than ever in our history to build shareholder value and to address the national crisis of suicide. We will do everything in our power to continue bringing hope to life. With that, I'll turn it over to Mike Labrums, our CFO, to review our financial results from the third quarter. Mike? Thank you, Matt.

For the three months ended September 30th, 2025, the company reported a loss of operations of $4 million versus a loss from operations of $3 million for the comparable quarter in 2024. The difference is primarily attributable to $800,000 of additional research and development expenses to support our FDA initiatives for NRX100 and NRX101, including the previously discussed antisubmission for preservative-free IV ketamine, and $400,000 of additional general administrative expense, which includes our efforts to close, operate, and identify clinic acquisition targets for hope. As of September 30th, 2025, NRX Pharmaceuticals had approximately $7.1 million in cash and cash equivalents, including approximately $3.1 million from a subscription receivable for which the company received the cash in early October. Total cash as of September 30th, 2025 would have been $10.3 million. For the third quarter ended September 30th, 2025, The company reported revenue for the first time in its history, driven by the acquisition of Dura Medical, which closed September 8th. While revenue of approximately $240,000 was relatively modest, it reflects 22 days of the full quarter and a single clinic group. Management anticipates the ability to include results for the full period for Dura in future quarters, closing anticipated additional acquisitions, and organic growth of previously acquired clinics will drive meaningful revenue growth in the fourth quarter and through 2026. Transactions where we acquire a non-controlling interest are expected to improve our overall financial condition, but not directly increase revenue. Finally, we remain in active discussions with several additional potential acquisition candidates, and while no assurances can be given that we will close any or all of such opportunities, together they represent total revenue of more than $20 million on an annual basis. The company believes that its current cash position will support operations at least through the second quarter of 2026, as well as to provide sufficient capital to reach expected regulatory reflection points and complete potential additional select acquisition opportunities to expand the growing footprint of Hope Clinics. Our singular focus remains advancing our primary drug development initiatives and planned clinic acquisitions to build long-term value for our shareholders.