NRX Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the NRX Pharmaceuticals 3rd Quarter 2024 Earnings Conference Call. At this time, all lines are in listen-only mode. From 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 Monday, November 18, 2024. I would now like to turn the conference over to Mr. Matthew Duffy, Chief Business Officer. Please go ahead.

Thank you, Ina, 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, or issued last week, as well as the Form 10-Q, which may be accessed from the investor page of the NRX Pharmaceuticals website. Joining me today on the call are Dr. Jonathan Javitt, our founder, chairman, and CEO, and chief scientist, as well as Richard Narito, our interim chief financial officer and treasurer, and Michael Abrams, our incoming CFO. Jonathan will provide a summary of our company's progress. Rich will review the company's financial results. Mike will make some comments. And then Jonathan will review our upcoming milestones before making closing comments. Following their prepared remarks, we will address investor questions. I'll now turn the call over to Jonathan.

Thank you, Matt. Good evening, everyone, and thank you for joining us. As you saw, we decided to do our conference call a day or two after our quarterly report in order to make our calls a bit more convenient for the increasing number of analysts who are covering our company and to encompass today's important news. The last few months have been incredibly productive for NRX and for Hope Therapeutics. In our view, they represent a positive inflection point in our path to market entry and profitability. On the NRX side, we continue to advance our lifesaving products, NRX100, that's our IV ketamine, and NRX101, our oral treatment for suicidal bipolar depression for new drug application filings in 2024. Further, our wholly-owned subsidiary, Hope Therapeutics, aims to be in the business of delivering life-saving care to people with suicidal depression and PTSD by year-end, with its first revenues being generated. To that end, Hope has signed non-binding letters of intent to acquire two foundational interventional psychiatry groups, which are currently revenue-generating and EBITDA-positive. We have received initial non-binding commitments from lenders for non-dilutive acquisition financing of Hope Clinics and are in the final stages of the underwriting process for those acquisitions. This puts NRX in a unique position as the only company dedicated to developing a comprehensive care path for the prevention and treatment of suicidality. We recognize the need to augment drug development with a care delivery model. because of the emerging evidence that ketamine may be essential, but not sufficient to achieve a long-term benefit for people with suicidal depression. For at least some patients, a precision psychiatry approach is required. It includes ketamine, transcranial magnetic stimulation, and other modalities. This model of care is difficult to access for many patients, and is not available in a typical ketamine clinic, as most people think of it. Only by building this comprehensive model and rolling it out nationwide can we fulfill our mission of bringing hope to life. At the same time, the HOPE clinics are able to generate ravages that support NREX in advance of FDA approval of our breakthrough medicines. Today, we have a key personnel appointment to announce. Mr. Michael Abrams will serve as our new Chief Financial Officer. Mike is a senior finance professional with almost three decades of experience as an executive officer, investment banker, director, and senior advisor, which includes serving as the Chief Financial Officer of Arch Therapeutics, Rise IT Solutions, and FitLife Brands. Mr. Abrams has deep experience across multiple functional areas, including but not limited to financial operations, accounting, mergers and acquisition, financial engineering, capital raising, and shareholder communications. Mike earned his MBA with honors from the Booth School of Business at the University of Chicago and received his BBA with honors from the University of Massachusetts Amherst as a William F. Field Alumni Scholar. Rich Narito has been an inspiration as our interim CFO and a valued member of our team. He will continue to support our Hope Therapeutics acquisitions as he has so ably done. Pending finalization of those initial acquisitions, Dr. David Feifel, the founder and president of Kadima Clinic in La Jolla, California, has joined us as a key advisor. Dr. Feisal is an internationally recognized expert in the use of precision psychiatry to treat suicidal depression and PTSD. He's believed to be the first to have taken ketamine outside the walls of university-based psychiatry clinics and demonstrated that it can safely be used in the outpatient setting. David will be working hand-in-hand with leading professors of psychiatry at Harvard, Yale, Columbia, Baylor Northwestern, and the University of Nimes and Inserm in France to advance our medicines through the FDA and the European Medicines Agency while bringing our network of hope clinics to life. On the financial front, we are pleased to share that last year we achieved a 74% reduction in net operating losses compared to third quarter 2023, and we're forecasting probability in 2025 with revenue and EBITDA from Hope Therapeutics, along with projected sales of our medications. Further, we recently announced the closing of our second tranche of funding from an institutional investor, bringing the total amount of funding to $10.8 million. In connection with this financing, we retired our prior and more expensive debt and settled outstanding litigation with Streeterville Capital. Collectively, these actions position us to enter the next business stage for the company in 2025, with two potential drug approvals to make us a revenue-generating biotechnology company, as well as an EBITDA-positive care delivery company. In sum, we're building a company that is now poised to bring life-saving treatment to patients and financial returns to investors. What drives this mission for the NRS team? It's simple. suicidality is a national epidemic. Approximately 3.8 million Americans make an active plan to commit suicide each year, according to the CDC. An American dies from suicide every 11 minutes in the United States, and worldwide someone dies of suicide every minute. Our overriding goal at NRX is to ensure that all patients who need life-saving precision psychiatry care with ketamine, and other therapies are able to get it. That's not currently the case. For the most part, ketamine is available today only to those who can pay out of pocket and will remain so until FDA approval of ketamine for treating suicidal depressions obtained. Our planned NDA, if approved, would bring NRX100, clearly a lifesaving product, to patients in a safe, accessible format as a preservative-free formulation that has insurance coverage. The current market for intranasal ketamine is already approximately a billion dollars a year, and the label for intranasal ketamine states that it has not demonstrated anti-suicidal properties. Let's talk specifically about what we need to do to bring NRX100 through the FDA. Originally, FDA granted us fast track designation for NRX100 in 2017 for use in combination with NRX 101 to treat bipolar depression. We've now asked FDA to expand that fast track designation and grant priority review to our NDA for use of NRX 100 in all forms of depression, including bipolar depression. To get a new drug approved, the manufacturer must demonstrate efficacy, safety, and manufacturability. The slides on nrxpharma.com summarize the data we will be sharing with FDA that includes nearly 1,000 patients treated in randomized controlled trials against placebo, active comparator, and electroshock therapy. In summary, intravenous ketamine is far more effective than both placebo and active comparator in treating suicidal depression. It is non-inferior to and may in fact be superior to electroshock therapy without the memory loss caused by ECT. The patients treated in randomized trials are supplemented by data on more than 20,000 patients treated in the real-world setting, where a 50% reduction in depression scores is seen. Last June, the aggregator of those data reported results from intravenous ketamine were superior to those seen with intranasal S-ketamine, although that real-world comparison was not based on a randomized trial. A key component of any new drug application is a comprehensive chemistry manufacturing and control, or CMC, package, also known as Module 3. In our last conference call, we pointed to this requirement and to our nine-month stability data. We've now completed this requirement with the 12-month stability data required to file an application for new drug approvals. Another key requirement for FDA to file an NDA is alignment on a pediatric study plan as required by law. As noted previously, we've reached this critical alignment with FDA, and I would like to commend the clinical regulatory team at NREX for achieving this milestone. Our development of a preservative pre-ketamine may be surprising to some. The basis for this development path is the result of data from both primate and human studies that show repeated doses on the order of 60 doses or more of the currently available commercial intravenous ketamine may be toxic to the brain. The currently available ketamine preparation was designed for use of the product in anesthesia. Ketamine is currently sold in a multi-dose vial where it was anticipated that doctors would draw from the same vial for multiple patients. But, of course, in anesthesia, it's expected that the patient will only get the medicine once. Back in the 1960s, when this preparation was formulated, it was manufactured with a potentially toxic preservative, benzothonium chloride. While there's no evidence that benzothonium chloride is toxic at its current concentration for the intended use in anesthesia, its safety has never been shown or even proposed for repeated use. Hence, we believe we are poised to file the first new drug application for a novel preparation of ketamine that will bring substantial value to patients and will be reimbursable by payers. Access to NRX100 is a critical focus of our company. The current off-label use of ketamine in CNS disorders is generally only available to patients who can pay out of pocket. We expect NRX 101, once approved, to be widely reimbursed, thus providing access to the vast majority of people in need, not just to those with the means to spend thousands of dollars in cash for treatment. Let's turn to NRX 101, our oral combination of D-cycloserine, which is an NMDA blocker, and lorazodone, which is the standard of care in bipolar depression. We believe the product represents a paradigm-changing breakthrough in the care of bipolar depression. This breakthrough is driven by a dramatic improvement in the safety of our medicine compared to the standard of care in bipolar depression in clinical trials. In our recently completed clinical trial, we demonstrated that NRX101 is comparable in its ability to reduce symptoms of depression when compared to the market-leading drug lorazodone. Critically, however, NRX 101 demonstrated that it's the first and only oral antidepressant to receive symptoms of suicidality and the first oral antidepressant to reduce symptoms of akathisia, a highly dangerous side effect of nearly all antidepressants. The NRX 101 data presented at the American Society of Clinical Psychopharmacology demonstrated a new paradigm for the treatment of bipolar depression. Now, akathisia is not a household term. However, key opinion leaders regard it as the worst side effect of any antidepressant. Akathisia is frequently described as an irresistible urge to move. Patients frequently describe it as a feeling of jumping out of their skins. Patients with akathisia are known to jump off of roofs and in front of oncoming trains. Currently, there's a petition before the Supreme Court of British Columbia regarding a Canadian citizen who's applied to end her life by medically-assisted suicide because she cannot tolerate the akathisia caused by common antidepressant medication. Serotonin-targeted drugs for the treatment of depression are known to cause akathisia and suicidality. Doctors and patients have lived with those side effects in order to achieve the critical antidepressant effects that are needed to control life-threatening depression. The data we presented at ASCP, however, confirms data from our earlier stable B trial, demonstrating that NRX101 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. To that end, we're filing an NDA for accelerated approval of NRX-101 for suicidal bipolar depression with suicidality or apathhesia. Given our strong data and the lack of treatment options for this segment of people with bipolar depression, we and our regulatory council believe this to be a vital unmet medical need. and worthy of accelerated approval. Finally, let's turn to our progress with Hope Therapeutics. In the six months since Hope was founded, we've considered nearly 100 potential flagship acquisitions. If you Google on ketamine clinics, you'll find many. However, they're known to come and go, and too many of them administer ketamine one day, vitamin drips another day, and a variety of services that are colloquially known as med spa services throughout the week. Our objective is to build a national umbrella of precision psychiatry clinics that can safely treat the 3.8 million Americans who make a plan to kill themselves each year, prevent another death every 11 minutes, and take the stigma out of suicidal depression. We've shared with investors that we aim to assemble an organization generating $25 million in revenue by the end of this year and an organization generating more than $100 million in revenue by the end of next year. Those who wish to gain insight into the market value of such an achievement might wish to look at the early development of similar entities, such as DaVita, for treating kidney failure. Although we and others have used the colloquial term ketamine clinic in association with Hope Therapeutics, you'll hear us increasingly use the term precision psychiatry. The data from the field demonstrate that ketamine alone is not sufficient to maintain remission from suicidality in many patients with depression and PTSD. There seems to be little question that ketamine has achieved a 50% reduction in suicidal ideation in numerous trials and real-world settings. The magnitude and rapidity of effect is a dramatic change from the prior 50 years of experience with SSRI and other serotonin-targeted antidepressants. However, maintaining that ketamine effect and enhancing it will, in our view, require additional therapies such as transcranial magnetic stimulation and FDA-approved therapy, newly developed digital therapeutics, and oral medicines such as NRX-101. Our focus is built on building a comprehensive site of care that can achieve remission in 80 to 90 percent of patients, not just 50. Over the past two quarters, we've obtained preliminary funding commitments from financial institutions and have identified several leading precision psychiatry organizations and signed non-binding letters of intent to acquire key clinics on both the east and west coasts of our country. We've initially targeted these clinics because they'll serve as foundational elements of our network. From our perspective, they epitomize the compassionate, comprehensive, and efficient operational structure that will serve as a model for additional facilities as we bring them into the HOPE network. These are critical steps in our quest to make a range of life-saving treatments available to patients across the country. As of last week, our accounting teams have finished confirming the financial statements of these flagship acquisitions, and we've moved into the financial underwriting phase. Hope Therapeutics will offer a comprehensive menu of state-of-the-art precision psychiatry treatments, including IV ketamine, Spravato, transcranial magnetic stimulation, or TMS, and medication management, together with planned digital therapeutics designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. On the financial front, the best-of-class clients we target are already generating profit margins of around 30% with significant opportunities for growth. We expect funding for HOPE to be independent and thus non-dilutive to NRX and to its shareholders. We expect that a portion of the earnings generated through HOPE will support NRX's path to profitability. Now that the Streeterville litigation is settled, we continue to work toward a distribution of shares of HOPE Therapeutics to existing shareholders, and we plan to seek a public listing for HOPE on a national exchange. Our auditors have finalized the initial audit for HOPE Therapeutics, and we're now able to draft and file the SEC forms to register the stock. I want to once again thank Rich Navrito for his exceptional service as our interim CFO over the past year as we financially re-engineered our company and worked to build what we hope will be a bright future. Rich will now review our third quarter financials.