NRX Pharmaceuticals, Inc.

Good morning, ladies and gentlemen. Welcome to NRX Pharmaceuticals Q2 2025 Earnings Conference Call. At this time, all lines are in a 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 Wednesday, August 20, 2025. I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please go ahead, sir.

Thank you, Ludi, 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 vary 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 Monday and in the company's Form 10-Q, which may be accessed from the investor page of the NRX Pharmaceuticals, Inc. 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 Monday's 10Q, following which Mike will review the company's financial results. Following their prepared remarks, we will address investor questions. I'll now turn it over to Jonathan.

Jonathan? Thank you, Matt. Good morning, everyone, and thank you for joining us. The past several months have been nothing short of exceptional for NRX. We've made vital advances across each of our programs with free drug approval applications in progress and our evolving network of interventional psychiatry clinics hope therapeutics taking place. At the same time, as we position for near-term revenue, we've reduced our quarterly operating loss by approximately 50% year over year, while filing more than 80,000 pages of regulatory data in the last quarter alone with a small team of dedicated scientists. As we announced on Monday, we've strengthened our balance sheet and added long-term healthcare specialist investors with extensive experience in biotechnology, as well as experience in managing multi-unit retail operations. Led by Mr. Brandon Mull and the B Group, these investors have demonstrated their long-term commitment to our success by way of their one-year lockup agreement not to trade short or otherwise hypothecate our stock, while also foregoing warrants and other dilutive features that are so destructive to biotechnology stocks today. We at NRX look forward to their ongoing partnership. As you can see from our balance sheet, we have substantially reduced the burden of convertible debt that was in place when I rejoined as CEO, in order to create a more straightforward growth path for long-term appreciation-oriented investors. Let me start with a high-level overview for each program, starting with NRX100. Our preservative-free intravenous ketamine is following two parallel approval processes. First, however, let me take a moment to explain how this came about. As many of you know, my original medical discipline is ophthalmology. And for 10 years, I cared for patients with chronic glaucoma, first at Johns Hopkins and then at Georgetown Universities. Around 1995, one of my colleagues noticed that glaucoma patients were far more likely to suffer from dry eye and tear film deficiency than most other eye patients. The problem was tracked down to benzalkonium chloride, a preservative that was in most glaucoma medicines. And the problem was compounded by the presence of benzalkonium chloride in the artificial teardrops that were used to try to help the dry eye that was caused by the glaucoma drops in the first place. Clear evidence emerged that benzalkonium chloride was toxic to the epithelial cells that cover the eye and to the nerves of the cornea. That's why so many eye drops have gone preservative-free over the years. Well, the first cousins of benzalkonium chloride Benzethonium chloride, or BZT, is found in ketamine. BZT is similarly toxic to epithelial surfaces. It was added to ketamine when the drug was first formulated 70 years ago, so that the same vial of drug could be used for multiple doses of drug without contaminating the bottle. In today's hospital environment, multidose administration is increasingly infrequent. The BCT and ketamine may not pose much risk when ketamine is used once in the operating room for anesthesia. The problem is patients who get ketamine for depression often get repeated administrations. As we have shown the FDA in our citizen's petition, and as you can see from the scientific paper identified in the queue and the earnings release, multiple doses of ketamine with BCT preservatives can approach toxic doses of BZT. That's why we filed the citizen's petition with FDA to have BZT removed from all forms of ketamine. Our basis for this petition is expert toxicology analysis documenting that BZT has never been shown to be safe, is not on the list of preservatives generally recognized as safe. That's called the grass list by the FDA. Indeed, FDA's concern about BZT is high to the point where FDA no longer allows its use in hand cleaners and topical antiseptics. Thus, we believe that BZT has no legitimate place in a parenteral drug that will be administered repeatedly. As I said, we're following two regulatory paths for ketamine. The first 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 or ANDA to make preservative-free ketamine available for ketamine's existing indications. Data are clear in our view that NRX100 can offer effective and safe options for patients with suicidal depression whose only current treatment alternative is ECT or electroconvulsive therapy. Our corporate presentations highlight randomized controlled trials demonstrating superiority of ketamine to placebo, to active comparator, along with demonstration of equivalence to ECT overall in more than 1,000 patients. We'll be presenting real-world data for FDA's consideration on nearly 180,000 patients treated with both ketamine and Spravato. We aim to submit these data in support of an application for accelerated approval and have already filed the Module 3 manufacturing information and the draft proposed label. You can read about accelerated approval on the FDA website. It represents an approval pathway for fast-track and breakthrough drugs whereby intermediate clinical data are presented in support of an initial approval with a concomitant commitment by the sponsor to present dispositive clinical proof of efficacy within five years. Last week, FDA granted a major expansion of the fast-track designation originally granted to NRX100 in 2017. Whereas the initial designation was related to bipolar depression, FDA has now broadened our fast-track designation to encompass all patients with suicidal ideation in depression, including bipolar depression. The CDC estimates that 13 million Americans consider suicide each year, and that an American dies from suicide every 11 minutes. Hence, FDA's broad and fast track designation offers NRX a tenfold greater opportunity to make a real difference in one of the largest public health crises to face our nation. FDA, under its new leadership and the Maha program, has dramatically focused on national public health crises by creating 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, provides enhanced communication throughout the review process, and creates potential for accelerated approval of NRX 100. To receive a CNPV, a product must meet at least one of the following criteria. It must address a U.S. public health crisis. It must deliver more innovative cures for the American people. It must address a large unmet medical need. And this was noted in our fast track designation that we do, in fact, address a large unmet medical need. It must onshore drug development and manufacturing to advance the health interests of Americans. strengthen the US supply chain, or increase affordability. Our team believes that NRX 100 meets all of CNPB's criteria. On the second approval path, we filed the ANDA in June of this year utilizing existing manufacturing data found in Module 3 of our Suicidal Depression NDA. We've since received comments from the FDA identifying only one scientific discrepancy along with some easily remediated administrative deficiencies. Specifically, FDA asked us to justify the level of a single inert ingredient in the formulation. We're actively addressing this matter with FDA and do not believe it will cause undue delay in the approval process. The existing market for ketamine has been projected at approximately $750 million a year, and we believe NRX100, made in the United States, and offered without any toxic preservatives, offers patients and clinicians a superior option. Approval of the citizen's petition removing benzothonium chloride from the U.S. ketamine supply would give NRX a substantial position in that existing $750 million generic ketamine market. We'll continue to work diligently with the FDA to move our application as rapidly as possible and provide a safer version of this critical product to the American public. NRX 101, our oral product for the treatment of suicidal bipolar depression, recently achieved an important milestone, that is the filing of the initial module known as Module 3, the Chemistry Manufacturing Control Section, or CMC, with the US FDA last week. This was filed under the previously granted breakthrough therapy designation awarded to NRX 101. And therefore, we anticipate rolling review of this application. We're working diligently to complete this filing and will request priority review, which, if granted, would confer a six-month review period. 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 related to serotonin active drugs that is closely related to suicide and can cause an irresistible need to move, inability to sit still, and all too often is associated with patients jumping off of roofs, jumping in front of trains, and otherwise harming themselves in horrible ways. These patients are at tremendous risk of self-harm, and there are no current treatment options available that have been shown to reduce akathisia, although newer generations of atypical antipsychotics have demonstrated less akathisia than their predecessors. NRX 101, in our estimate, offers the only current treatment option that both reduces depression, suicidality, and akathisia in this patient group, and as an oral treatment, should generate widespread accessibility and benefit in these patients. We look forward to coming interactions with the FDA on this application. Hope Therapeutics continues to make great progress developing what we believe will be the nation's premier interventional psychiatry clinic network. We expect to finalize the purchase of our first clinics and continue to evaluate new opportunities in the field. We aimed to achieve this goal some months ago, but needed to wait for state regulatory approval to acquire Duramedical. That approval is now in hand, as we announced last week. With that milestone reached, we anticipate that you will shortly see closing of acquisition financing that is well along in the closing process. Our goal of delivering the most comprehensive, high-quality care possible in each of our clinics continues to drive us, and we look forward to continuing to update you on the progress of our network. The clinics we have under contract currently will provide strong revenue and EBITDA for the growth of our entire network. We've identified additional milestones reached in our 10-Q filing, including the FDA's grant of a PDUFA fee waiver saving the company $4.3 million in filing fees. Waivers are granted at the discretion of FDA to small business entities and for drugs that are deemed necessary to the public health. With the key milestones reached in Q2 and with the addition of a committed investor group based composed of experienced biotechnology investors, We now have the balance sheet capacity to continue our quest to bring hope to life well into the coming year. I will now turn it over to Mr. Michael Abrams, our CFO, to review our financial results from the second quarter of 2025. Mike?