NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Q3 2023 Earnings Call Transcript

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Q3 2023 Earnings Call Transcript November 14, 2023

Operator: Thank you for standing by. This is the conference operator. Welcome to NRX Pharmaceuticals’ Third Quarter 2023 Earnings Conference Call. As a reminder, all participants are in listen-only mode. The conference is being recorded. After the presentation, there will be an opportunity to questions. [Operator Instructions] I would now like to turn the conference over to Mr. Matthew Duffy, Chief Business Officer. Please go ahead.

Matthew Duffy: Thank you, Ashia. 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 US 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.

A scientist in a lab coat holding a vial filled with a blue glowing liquid, representing the clinical-stage biopharmaceutical company’s research in rare diseases.

Information presented on this call is contained in the press release issued earlier today and in the company’s Form 10-Q that was filed earlier today, which may be accessed from the Investor’s page of the NRX Pharmaceuticals, Inc. website. Joining me on the call are Stephen Willard, our Chief Executive Officer; Dr. Jonathan Javitt, our Founder and Chief Scientist; and Richard Narido, Chief Financial Officer and Treasurer. Stephen and Jonathan will provide a summary of the company’s progress. Richard will review the company’s financial results, and then Stephen will review upcoming milestones before making closing comments. Following their prepared remarks, we will address investor questions. I’ll now turn the call over to Stephen. Steve?

Stephen Willard: Thank you, Matt. Good afternoon everyone and thank you for joining us. The third quarter represents a potential turning point for our company as we are approaching our clinical trial enrollment goals for our partnered foundation product, NRX-101, while opening new clinical initiatives in chronic pain, urinary tract infection, and NRX-100 for suicidal depression. We expect four potential upcoming milestones. First, our core clinical trial of NRX-101 for treatment-resistant bipolar depression with suicidality. Second, the near-term readout of the Department of Defense funded clinical trial of D-cycloserine for chronic pain. Third, our program to seek a new drug approval for intravenous ketamine, which we have designated as NRX-100, and established that drug in a new firstly-capitalized company that aims to be cash flow positive by year-end 2024.

And fourth, the near-term approval of our investigational new drug application and award of qualified infectious disease product classification to NRX-101 in complicated urinary tract infection, which is called CUTI. Achieving any one of those catalysts has the potential to unlock substantial shareholder value. Our success on more than one front has the potential to unlock exponential growth. I’m incredibly proud of our team, our collaborators, and partners, and most of all, the patients who have made such an important contribution to these efforts. All of us at NRX are deeply grateful to the many shareholders who have reached out to us, encouraged us, and supported us for a period of immense challenge in the biotechnology market. Together, we are pursuing NRX’s goal of bringing hope to life on a daily basis.

Now I would like to invite Dr. Jonathan Javitt, our Chief Scientist to review our clinical development program

Jonathan Javitt: Thank you, Steve. Let’s lead off with our foundational program or NRX-101 for Suicidal Bipolar Depression. We restarted this program in March 2022 on the tail of the COVID pandemic. In the subsequent 18 months, we’ve transferred our manufacturing to the US, gained FDA alignment for our CMC instability program, manufactured approximately 1 million capsules of NRX-101 and relaunched our clinical program. We’re excited to announce today that the company is near completing enrollment of the originally targeted 70 patients in the Phase 2b/3 trial. I believe as of yesterday, the number was 69. We’ve decided to continue enrollment through the end of the month and to target 74 evaluable patients randomized to NRX-101 versus standard of care medicine.

The results of this trial have the potential to be used for registration filings. This target population is based on the company’s January 2023 meeting with the FDA in which the company was guided to expand its intended use of NRX-101 from the original population of patients with acute suicidality who might be treated in a hospital environment to the broader population of patients with subacute suicidal ideation, which we now describe as treatment-resistant bipolar depression. In other words, patients who are treated in the outpatient setting. Based on the guidance of the FDA and the company’s completion of manufacturing for Phase 3 commercial stage investigational products, we upgraded the ongoing clinical trial to a Phase 2b/3 trial earlier this year.

In our last call, I shared with you the steps that we’ve taken to set a new standard for reliability of the MADRS, that is the Montgomery-Åsberg Depression Rating Scale measurement in trials such as this. The MADRS scale is our primary endpoint in this study and then virtually all industry depression studies. The industry has previously accepted a six points disparity between psychometric raters and study sites and master raters who check those evaluations. Moreover, the industry has often settled for comparing only the baseline ratings between site raters and master raiders. Over the past year, several clinical trials of promising investigational medicine for depression have failed. So we decided to set a far more rigorous standard. First, we set our standards for agreements between the sites and the master raters at three points of difference on a 60-point rating scale rather than six points of difference.

Second, we decided to acquire a 90% agreement between sites and master raters in order to keep a site in the program. Third, we decided to check the agreement on every patient rating, not just the baseline ratings. As of today, I’m pleased to tell you that our clinical team has maintained 95% agreement between study sites and master raters. That doesn’t just mean that our drug will work. It still has to beat the standard of care. It does mean, however, that we have markedly increased the chance of determining a difference between the drug group and the standard of care group. In our last call, I shared with you the steps that we took to implement a nationwide recruiting strategy with one in Health. That investment paid off for the substantial acceleration in our enrollment rate over the past quarter, a capability that will serve us well should the drug demonstrate efficacy in this upcoming readout.

Also on that last call, I described the advances we made in manufacture of NRX-101, resulting in more than one million commercial rate capsules in our warehouse. Product stability work has continued to support the targeted two-year plus shelf life at potential drug launch. In other words, at such time as this drug is approved, we intend to be immediately ready to ship it to patients. As you know, last June, we entered into an exclusive global development, supply, marketing and license agreement with Alvogen Incorporated and affiliated companies. Alvogen will pay NRx a $10 million milestone upon delivery of positive Phase 2b/3 results and the FDA’s concurrence followed by, as you know, $330 million of additional milestones and royalties of up to 15%.

Further, Alvogen assumes essentially all development and commercialization costs associated with this indication from that point forward. The company solidified its working relationship with Alvogen over the last quarter we’ve begun working in unison to plan the final development and commercialization of NRX-101. Based on the milestones achieved during this quarter, the NRX-101 project is on track for completion of a pivotal trial in coordination with a commercial stage partner in less than two years from its reinitiation in March 2022. So now let’s talk about NRX-101 for chronic pain. That’s an indication that we only began talking to you about a quarter ago. The company has previously detailed the scientific basis for treatment of chronic pain with D-cycloserine as outlined in the 2016 scientific paper published by Dr. Schnitzer and his colleague and in the White Paper that we’ve posted on our website and on the scientific servers.

In the third quarter, we licensed the US Patent for the use of D-cycloserine in treating chronic pain. And now we filed an investigational new drug application that was accepted by the FDA to initiate commercial drug development of NRX-101 in chronic pain. As you know, chronic pain affects more than 15 million American adults compared to the approximately $3 million who report cost of suicide on an annual basis. There has been no new non-opioid class of drugs to treat nociceptive pain, that’s pain that’s caused by stimulation of peripheral nerves such as low back pain, knee pain, that most common pain that people talk about in the past two decades. And NRX-101 has the potential to be the first NMDA antagonist drug to seek approval for this indication.

Today, ketamine is used off label to treat nociceptive pain, despite its clear limitations, which we’ve prescribed as addiction, neurotoxicity, hallucination, and the need for IV administration. We now await results with 200-person randomized prospective trial funded by the US Department of Defense in which patients with chronic pain were randomly assigned to 400 milligrams a day of D-cycloserine versus placebo. The investigators have identified primary completion of this trial is occurring this months. We’ve received a communication from the investors yesterday that the investigational review board has cleared the study database for analysis, and the study statisticians are now beginning their final work. Should these trial results support efficacy of DCS, in the treatment of chronic pain vaccine, the results are expected to provide a breakthrough therapy path for treatment of chronic pain with D-cycloserine and DCS containing medicines.

Today, we’re announcing that we’ve entered NRX-101 for consideration by the multibillion-dollar The National Institute of Health HEAL Initiative, that’s HEAL and its National Consortium of clinical trial sites known as EPPIC-Net. This initiative was funded by the US Congress to test innovative non-opioid pain medicines for chronic pain. We believe that NRX-101 represents the first NMDA targeted non-addictive medicine to be offered to this program. Should the DOD-funded trial yield encouraging data, we anticipate that non-dilutive sources of capital will be available to us, given the national focus on the opioid crisis. Progress in treating chronic pain with NRX-101, may open a far larger market for NRX-101 than anything we’ve talked about related to the psychiatry indications.

Now let’s discuss our other NMDA target therapy, NRX-100, which is a proprietary presentation of IV Ketamine for suicidal depression. Prior to this past quarter, we didn’t prioritize this initiative because, frankly, we expected Intranasal Racemic Ketamine to demonstrate efficacy in reducing Suicidality in depressed patients. Unfortunately, the intranasal drug failed two months ago in clinical trials in patients for suicidal ideation. That’s a drug that’s obviously not connected to our company. Intranasal Ketamine previously failed for the treatment of chronic pain in 2006. So in our view, the manner in which Ketamine is absorbed through the nose may be fundamentally different from its effect as an IV drug. When we met with FDA in January 2023, the agency strongly encouraged us to develop Ketamine as a label drug, rather than rely on prior stabilization of Suicidality and depression, that’s achieved through the common clinical practice through today’s clinical practice of infusing generic Ketamine that’s compounded in licensed pharmacies.

Shortly thereafter, the FDA issued the first of two advisory letters, warning against the practice of compounding of Ketamine and FDA began a program of rigorous inspections of compounding pharmacies, significantly upgrading the standards that FDA requires and forcing some pharmacies to close. The challenge we faced in responding to FDA’s guidance, is that a definitive trial of IV Ketamine in large numbers of patients with acute Suicidality is far more complex and expensive things could be achieved by a small company such as ours. Moreover, it would take an additional two to three years. Indeed, no US entity has performed a large clinical trial or a multi-center clinical trial of Ketamine in suicidal patients. Fortunately, however, the government of France did invest in such a trial starting in 2015, a trial conducted in seven French psychiatric hospitals among 156 patients with acute Suicidality.

So based on the FDA’s advice on ketamine, we established a scientific collaboration with Professor Marion Leboyer, of INSERM, one of France’s leading universities and Professor Mocrane Abbar of Lyon, France, under which we gained government support to obtain the patient level results from their groundbreaking trial and to submit those results to FDA in support of a new drug approval for intravenous ketamine. As you’ve seen in our presentations, the findings of the trial demonstrated overwhelmingly positive, statistically significant reduction in both suicidality, the primary endpoint of the trial and depression to secondary end point, among patients treated with intravenous ketamine compared to those treated with placebo. The patient level de-identified data from France have now been received by our team of statisticians and are being assembled in the electronic format required for submission to the FDA.

Today, I’m pleased to share that the company is now negotiating access and has a preliminary agreement on confirmatory patient-level data from a US-based trial performed at a leading university and funded by the National Institute of Health. Having taken advice from our regulatory legal consultants, we believe that these two multicenter randomized prospective trials that encompass more than 240 participants, combined with randomized prospective data on more than 200 US patients, when submitted for a view, provide evidence of safety and efficacy of intravenous ketamine in reducing both suicidality and depression, among suicidal patients. We expect to transmit those data to FDA by the end of the quarter. Although the biotech industry rightly focuses on safety and efficacy is key to securing drug approval, submission of an NDA for the use of IV ketamine is also dependent on documenting the manufacture and packaging of a new drug presentation in a long-term, shelf-stable manner with control of impurities and other hallmark of good manufacturing practices.

Indeed, Phase 3 biotechnology products are often delayed by unexpected manufacturing failures, perhaps more often than by unexpected clinical trial results. That’s why we’re excited to announce the signing of a development and manufacturing agreement with Nephron Pharmaceuticals, Incorporated. to develop a single patient presentation of ketamine that’s expected to overcome some of the formulation deficiencies of existing forms of ketamine that were originally developed for anesthesia and is expected to have diversion resistance and tamper-resistant features. We believe this latter aspect is important because of the well-known uses of ketamine as a drug of abuse and also as a vehicle PDUFA date. We’ve worked with Nephron and stationery founder and owner, Lou Kennedy on previous projects and have great confidence in the Nephron team.

In this case, Nephron is particularly suited as a partner because of their enormous investment in sterile blow-fill seal technology that’s ideally suited to our planned commercial presentation. Our current time line project submission of a new drug application for ketamine in the first quarter of 2024 with a targeted PDUFA date in the fourth quarter of 2024. Now we don’t anticipate funding the ketamine initiative with core NRX. And our guidance in today’s Q, advisers, investors of our plan to establish a ketamine focused spin-off company that will potentially provide current and new investors with both capital appreciation and a royalty stream. Last week, we received a term sheet for up to $30 million in anchor financing for this new business entity.

In this plan, a portion of the equity to be built in the ketamine assets will be allocated to existing shareholders as of a record date to be established, potentially with an ongoing royalty stream to NRX to those shareholders and to the new investors. This structure will be discussed at the upcoming Annual Meeting of Shareholders, which we hope of you will attend. There’s an acute public health need for a safely manufactured diversion and abuse resistant form of ketamine, particularly in light of drug shortages caused by newly and appropriately rigorous FDA manufacturing standards. NRX anticipates pursuing a near-term potential solution to address this public health need by the end of 2024. Finally, we expect that our focus on urinary tract infection is a bit surprising, given our identity as a CNS for this company.

Although treatment of UTI is quite different from the use of NRX-101 to treat central nervous system disorders, these sites of serum was originally developed as antibiotic, because of its role in disrupting the cell wall of certain bacteria. Now surprising as that may sound, that’s true of a number of growth used in psychiatry today. They all began as antibiotics. These types of [indiscernible] fell out of favor as antibiotic in the 1970s because of the CNS effects caused by NMDA blocking properties and because of the widespread availability of effective first and second-generation antibiotics. However, DCS is unique as antibiotic and that it’s nearly 100% excreted unmetabolized in the urine and therefore, it achieves high urinary tract levels with oral administration.

As you probably know, many of the newer third- and fourth-generation antibiotics require intravenous administration to treat complicated UTI. Our clinical experience in psychiatry suggests that the lurasidone component of NRX-101, blocks unwanted CNS side effects and unlocks the potential of D-cycloserine to treat antibiotic-resistant, urinary tract infections with a decreased propensity to cause unwanted CNS effects. In recent years, increased antibiotic resistance to common pathogens that cause urinary tract infections on urosepsis. In other words, steps that originates in the urinary tract has resulted in a marked increase in complicated urinary tract infection, hospitalization and death from urosepsis. Probably everyone on this call knows someone who’s developed a UTI and ended up receiving IV antibiotics in the hospital or at home.

The US Center for Disease Control and Prevention reports that more than 1.7 million Americans contract exit each year of from at least 350,000 die during their hospitalization or a discharge to hospice. In 2015, DCS was demonstrated to be effective against pathogens that are increasingly like it across sepsis and increasingly resistant to first and second line antibiotics. So in Q3, we tested NRX-101 and its components against resistant pathogens that appear on the congressionally mandated qualified infectious disease product list, and we proved in vitro effectiveness that is effectiveness in the laboratory against antibiotic resistance E coli, Pseudomonas and Acinetobacter. These are bugs that kill patients every day. And in vitro effectiveness is what’s required to meet the requirements of the QIDP program.

Qualification for QIDP affords a sponsor five years of additional market exclusivity from FDA regardless of whether or not you have a patent on the drug and we do have a composition of banner patent on NRX-101, together with fast track designation and priority review. We believe that NRX-101 as an oral medicine has the potential to demonstrate benefit in patients who would otherwise require intravenous third and fourth-generation antibiotics. We believe there are approximately 3 million such patients a year who contract with complicated UTI. Should NRX-101 succeed in clinical trials, the company has a planned follow-on product that’s anticipated to achieve another 20 years of patent exclusivity. Based on the in vitro study that we performed, we now have submitted an investigational new drug application requesting QIDP status, fast track designation and priority review from the FDA.

We’re expecting the FDA to approve this IND by the end of this year, by the end of 2023. As with the ketamine development project, we don’t anticipate funding this initiative with core NRX assets, and we’re exploring structures for a new entity that would provide current and new investors with both capital appreciation and the royalty stream. However, the cost of bringing NRX-101 to market is an antibiotic is far lower than one might imagine, because we’ve already manufactured the drug, we already have the necessary preclinical safety, toxicity, pharmacokinetics, pharmacodynamics data in our hands from our bipolar program. We’ve already begun conversations with investor groups who recognize the extraordinary public health need. Should the company succeed in serving 10% of the cUTI market we believe the revenue from NRX-101 for this indication has the potential to reach hundreds of millions of dollars annually based on 3 million cases per year in the US.

Finally, I’d like to address a challenging issue, it’s frequently raised with us by investors. Investors have contacted us with the belief that the company’s share price may be adversely affected by short sales of stock that may frequently accompany positive news. While coverage short sales, such as those sales that are associated with borrowing and existing share of stock are legal, naked shorting without an underlying borrowed share is clearly illegal. Importantly, a recent federal court decision holds brokerages liable for damages to companies associated with persistent naked short positions. Based on these queries from investors, in Q3, we contracted with Share Intel Incorporated to examine disparities between NRX stock positions as reported by brokerages and NRx shares reported by DTC, the electronic clearinghouse for the Nasdaq exchange.

Today, we’re announcing that persistent disparities of approximately 1 million to 1.5 million shares were identified. In other words, those may be naked short positions. The company has now instructed its counsel to initiate outreach to compliance departments of the identified — identifying that all uncovered short positions in the company’s stock be closed via a force delivery of shares. The company has been advised by counsel that this action has resulted in positive share action in the past when implemented by other issuers of NASDAQ stock. Now I’m going to ask Rich Narido, Chief Financial Officer, to review the third quarter financials. Rich?

Richard Narido: Thank you, Jonathan, and good afternoon, everyone. I will now review the highlights of our third quarter 2023 financial results. Before reviewing the numbers, it’s important to recognize that we have consistent to reduce our cash expenditures and expect to further reduce load expenditures as we complete the NRX-101 clinical trial. In August, the company entered into a securities purchase agreement pursuant to which the company issued 3 million shares of the company’s Series A convertible preferred spot and one investor want for every share of Series A preferred stock issue. The aggregate proceeds of the company from the private placement was approximately $1.2 million before expenses. The company intends to use the net proceeds from such offering for working capital and general corporate purposes.

For the three months ended September 30, 2023, NRx Pharmaceuticals recorded $3.3 million of research and development expenses compared to $4.1 million for the three months ended September 30, 2022. The decrease is related primarily to clinical development expenses and fees paid to regulatory and product development expenses. For the same three-month period, we recorded a 50% reduction in general and administrative expenses from $5 million in the third quarter of 2022 to $2.5 million for the three months ended September 30, 2023. The decrease of $2.5 million in related primarily to peak leases and employee-related expenses, legal, insurance and accounting costs. The nine-month period from January through September 2023 similarly shows decreased expenditures as reflected in our financial statements compared to the prior year.

As of September 30, 2023, we had $8.9 million in cash and cash equivalents. These working capital assets are expected to fund the company’s operations through the expected achievement of the four key milestones discussed today. Additionally, we are evaluating operational efficiencies associated with the completion of manufacturing activities to extend this runway. With that, I will turn it back to Steve for closing remarks. Steve?

Stephen Willard: Thanks, Rich. In the next several months, we expect to see multiple efforts at NRx come to fruition, which we believe may provide significant upside to our investors. We are near completion of enrollment in our suicidal bipolar depression trial with NRX-101 and are moving towards data early next year. We await data from Northwestern University’s Department of Defense funded trial in chronic pain. We expect to receive our response from FDA on our qualified infectious disease product request for NRX-101 in urinary tract infection, and we expect to position NRX-100 in a new entity to file an NDA for IV ketamine and suicidal depression in the first part of next year. Investors have expressed some concern about whether we will maintain compliance with NASDAQ listing requirements.

We are working closely with NASDAQ staff and outside consultants in that regard. As we said in our 8-K filing, achieving any of the four milestones identified above has the potential to lift our stock to price range required by NASDAQ. As those milestones play out, we will continue to act in a manner that is most supportive of our shareholders. For a small biotechnology company, we have tremendous amount of opportunity to build shareholder value arriving in the near-term. I’m incredibly proud of our team, our collaborators, and partners and most of all, the patients, who have made such an important contribution to these efforts. Together, we are pursuing NRX’s goal of bringing hope to life on a daily basis. Operator, we are ready to take questions.

Operator: Thank you. We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Ed Woo with Ascendiant Capital. Please go ahead.

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Q&A Session

Ed Woo: Thank you for taking my question. My question is as you guys start pursuing opportunities with chronic pain and infectious disease, does this affect your partnership with Lotus or Alvogen? And do they have any opportunities to have first rights to get involved with this with you?

Stephen Willard: There is a right of — thank you, Ed. There is a right of first negotiation, but it’s not a right of first refusal.

Ed Woo: Great. And what kind of negotiation process? And when do they have to make a decision process? Or is it something that’s going to be ongoing with your clinical trials?

Stephen Willard: I believe the — it will be ongoing. But I believe that they have 10 days from when we make a proposal to give us a decision. And then we’re free to partner the product in ways that are no less favorable to NRX.

Ed Woo: Great. Thank you for providing the question — answers to my question. Thank you and I wish you guys good luck.

Matthew Duffy: Ashia, this is Matt Duffy, and I have received some electronic questions for management here. The first one, I think you would go to Stephen, it looks like it dovetails off that last one, which is how is the partnership with Alvogen going so far in general?

Stephen Willard: I think it’s going really well. I mean I have a good working relationship with the CEO of Alvogen. We’ve established a number of committees to meet regularly. And it seems like we’re generally storaging alignment on our goals for development and commercialization of the project.

Matthew Duffy: Okay, great. Another question came in and just I think for Dr. Javitt. Can you tell us more about your plans for the ketamine spin-off, the assets, potential funding benefit to NRX shareholders?

Jonathan Javitt: Well, I think it’s important to start out by understanding the challenge that that we have, we’re — on one hand, we’ve been working for many years to develop NRX-101 as a core asset, a drug that could readily be worth multiple billions of dollars if it succeeds in clinical trials compared to the projects in ketamine and complicated UTI that while they’re enormously attractive and they’re nearer term in terms of their opportunity, ultimately, there’s smaller revenue opportunity with very meaningful revenue opportunities. I mentioned, for example, if ketamine generated $100 million a year of profit well, you’re talking about a company like ours at its current cap table, that’s more than $1 a share. So there are enormously attractive opportunities for shareholders and at the same time, creating dilution within the core company wouldn’t make all that much sense for shareholders.

And that’s why, in our view, the most attractive opportunity for our current shareholders is to create these spin-offs where we’ve already seen appetite from new investors to come in, help fund the spin-offs, but do it in a way that current investors will benefit in proportion to their current shareholder. Now we can’t talk too much about the details because that’s something that’s going to be part of our upcoming annual meeting and deliberation with our shareholders. But that’s the general reason for thinking about the spin-off structure.

Matthew Duffy: Okay. And sticking with the IV ketamine, One other question is it’s more of a clinical one for you. I think Dr. Javitt. Is IV ketamine really that much better than inhaled?

Jonathan Javitt: Well, we know from extensive literature and now from two well controlled randomized prospective trials and IV ketamine works against acute suicidality. And in health ketamine has never demonstrated that in a large multi-center trial. What’s important to recognize is that when you give ketamine IV, you know exactly what your blood levels are at every moment of the infusion. When you put ketamine in the nose, you get an immediate spike at ketamine, followed by a tailing off and you have a much less stable blood level. But more importantly, just because you put ketamine in the nose, you don’t really know how it’s flowing to get into the bloodstream of any individual patient. Some will go down the back of the throat into the stomach can get absorbed, some may go across the tissues of the nose directly into the bloodstream.

And it’s going to vary patient-by-patient. It’s going to vary in terms of how the nasal administration is carried out. And in fact, you wind up in a situation where you’re creating a drug device combination with a nasal spray that has to be regulated as a medical device. So nasal ketamine has a history of disappointing industry. In 2006, there was a major failure associated with the clinical trial for nasal ketamine and treatment of chronic pain. So from our perspective, IV ketamine is something that’s ready for the market. It’s being used widely off-label. It’s essentially become a national standard of care and we believe that an FDA labeled tamper-resistant diversion resistant form of ketamine that’s manufactured to current standards, not just the standards that were in place when ketamine was developed as anesthetic, but manufactured to current standards is an important public health initiative.

And that’s why we’ve chosen to embrace it.

Matthew Duffy: Okay. Very good. Thanks. We have time for one more question. And here it is the Department of Defense study in pain is positive. What do you see as the clinical and regulatory pathway for NRX-101 in pain?

Jonathan Javitt: Well, we’ve already filed an investigational new drug application with the FDA for the use of NRX-101 in pain and received an enthusiastic response or response that we’ve seen is enthusiastic from the FDA Division of Anesthesia, analgesia and addiction products, which is a division that regulates pain products. Clearly, if the DoD trial is positive, that would be a critical piece of evidence, but additional randomized controlled trials with NRX-101 in its commercial presentation would be required. We’ve talked about some of the non-dilutive capital that’s available, not only through the NIH, but we would expect that the Department of Defense would want to continue development of this drug because there’s such an acute need within DoD and elsewhere for a non-addictive non-opioid pain medication.

And certainly, a major initiative in chronic pain would require a capital raise from NRX side. But we have ample belief that, that capital would be available in the face of a positive readout in the 200-person trial.

Stephen Willard: Thank you very much. Thank you, everyone. That’s all the time we have for questions tonight. We appreciate you joining us. I’m just talking about our journey, reaching these important milestones for the company over the coming months and look forward to your participation in future calls. This concludes the NRX Pharmaceuticals third quarter conference call. Thank you all for participating.

Operator: This concludes today’s conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day.