NRx Pharmaceuticals Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 14, 2023

There are 6 speakers on the call.

Operator

Thank you for standing by. This is the conference operator. Welcome to the NRx Pharmaceuticals Third Quarter 2023 Earnings Conference Call. As a reminder, all participants are in listen only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions.

Operator

I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please go ahead.

Speaker 1

Thank you, Asiya, and welcome, everyone. Before we proceed with the call, I would like to remind everyone that certain statements That could cause actual results to differ from the 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 yesterday and in the company's Form 10 Q that was filed earlier today, which may be accessed from the Investors page on the NRx Pharmaceutical Incorporated website. Joining me today on today's call Steven Willard, Chief Executive Officer Doctor.

Speaker 1

Jonathan Javitt, our Founder and Chief Scientist and Richard Merito, Chief Financial Officer and Treasurer. Stephen and Jonathan will provide a summary of the company's progress, Rich will review the company's financial results, and then Steven 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?

Speaker 2

Thank you, Matt. Good afternoon, everyone, and thank you for joining us. The Q3 represents a potential turning point for our company as we are approaching our clinical trial enrollment goals For our partnered foundation product, NRX101, while opening new clinical initiatives in chronic pain, Urinary Tract Infection and NRX-one hundred for suicidal depression. We expect 4 potential upcoming milestones. First, our core clinical trial of NRX101 for treatment resistant bipolar depression with suicidality.

Speaker 2

2nd, the near term readout of the Department of Defense funded clinical trial of dcycloserine for chronic pain. 3rd, our program to seek a new drug approval for intravenous ketamine, which we have designated as NRX-one hundred And establish that drug in a new freshly capitalized company that aims to be cash flow positive by year end 2024 and 4th, the near term approval of our investigational new drug application and award of qualified infectious disease product classification To NRX101 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 Many shareholders who have reached out to us, encouraged us and supported us through a period of immense challenge in the biotechnology market.

Speaker 2

Together, we are pursuing NRx's goal of bringing hope to life on a daily basis. Now, I would like to invite Doctor. Jonathan Javitt, our Chief Scientist to review our clinical development program.

Speaker 3

Thank you, Steve. Let's lead off with our foundational program around NRX-one hundred and one for suicidal bipolar depression. We restarted this program in March 2022 on the tail of the COVID pandemic. In the subsequent 18 months, of NRX101 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 2bthree trial, I believe as of yesterday the number was 69.

Speaker 3

We've decided to continue enrollment through the end of the month and to target 74 evaluable patients randomized to NRX101 versus standard of care medicine. The results of this trial have the potential to be used for registrational filing. 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 ENERX101 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 product, we upgraded the ongoing clinical trial to a Phase 2bthree trial early this year.

Speaker 3

In our last call, I shared with you the steps that we've taken to set a new standard for reliability of the MADRIS that is the Montgomery Asperg Depression Rating Scale measurements in trials such as this. The MADRS scale is our primary endpoint in this study and in virtually all industry depression studies. The industry has previously accepted a 6 point disparity between psychometric raters at study sites and master raters who check those evaluations. Moreover, the industry has often settled for comparing only the baseline ratings between CytRaders and Macerators. Over the past year, several clinical trials of promising investigational medicines for depression have failed.

Speaker 3

So we decided to set a far more rigorous standard. First, we set our standard for agreement 2nd, we decided to require 90% agreement between sites and master raters in order to keep a site in the program. 3rd, 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 mean that our drug will work.

Speaker 3

It still has to beat the standard of care. It does mean, however, that we have markedly increased the chance of Terminating 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 Health. That investment paid off with Also on that last call, I described the advances we made in manufacture of NRX101, resulting in more than a 1000000 commercial grade capsules in our warehouse. Product stability work has continued to support the targeted 2 year plus shelf life at potential drug launch.

Speaker 3

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, an Affiliated Companies. Alvogen will pay NRx a $10,000,000 milestone Upon delivery of positive Phase 2bthree results and the FDA's concurrence followed by, as you know, $330,000,000 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.

Speaker 3

We've begun working in unison to plan the final development and commercialization of NRX101. Based on the milestones achieved during this quarter, The NRX101 project is on track for completion of a pivotal trial in coordination with a commercial stage partner in less than 2 years from its reinitiation in March 2022. So now let's talk about NRX101 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 dcyclicirine, as outlined in the 2016 scientific paper published by Doctor.

Speaker 3

Schnitzer and his colleague and in the white paper that we've posted on our website and on the scientific servers. In the 3rd quarter, We licensed the U. S. Patent for the use of dcycloserine 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 NRX101 in chronic pain. As you know, chronic pain affects more than 50,000,000 American adults compared to the approximately 3,000,000 to report thoughts of suicide on an annual basis.

Speaker 3

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 2 decades and NRX101 has the potential to be the 1st 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 described as addiction, neurotoxicity, hallucination and the need for IV administration, We now await results for 200 person randomized prospective trial funded by the U. S. Department of Defense in which patients with chronic pain were randomly assigned to 400 milligrams a day of dcycloserine versus placebo.

Speaker 3

The investigators have identified primary completion of this trial occurring this month. We've received a communication from the investors Today 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 low back pain, The results are expected to provide a breakthrough therapy path for treatment of chronic pain with desecisirine and DCS containing medicines. Today, we're announcing that we've entered NRX101 for consideration by the multibillion dollar National Institute of Health HEAL Initiative, that's HEAL, and its national consortium of clinical trial sites known as This initiative was funded by the U. S.

Speaker 3

Congress to test innovative non opioid pain medicines For chronic pain, we believe that NRX101 represents the 1st 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 NRX101 They open a far larger market for NRX101 than anything we've talked about related to the psychiatry indications. Now let's discuss our other NMDA target therapy, NRX-one hundred, 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 racemicketamine to demonstrate efficacy in reducing suicidality in depressed patients. Unfortunately, The intranasal drug failed 2 months ago in clinical trials in patients for suicidal ideation.

Speaker 3

That's a drug that's Obviously not connected to our company. Intranasal Ketamine previously failed for the treatment of chronic pain in 2,006. 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, 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 2 advisory letters Warning against the practice of compounding of Ketamine, an FDA began a program of rigorous inspections of Compounding Pharmacies, significantly upgrading the standards that FDA requires and forcing some pharmacies to close.

Speaker 3

The challenge we faced in responding to FDA's guidance is that a definitive trial of IV Ketamine in large numbers of patients Moreover, it would take an additional 2 to 3 years. Indeed, no U. S. Entity has performed A large clinical trial or a multicenter 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 7 French psychiatric hospitals among 156 patients with acute suicidality.

Speaker 3

So based on the FDA's advice on Ketamine, we established a scientific collaboration with Professor Marion Leboisier of INCRM, One of France's leading universities and Professor Mokranabar 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 demonstrate an overwhelmingly positive statistically significant reduction in both suicidality, the Primary endpoint of the trial and depression, the secondary endpoint 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 U. S.-based trial performed at a leading university and funded by the National Institutes of Health.

Speaker 3

Having taken advice from our regulatory legal consultants, we believe that these 2 multicenter Randomized prospective trials that encompass more than 240 participants combined with randomized prospective data On more than 200 U. S. Patients, when submitted for review, 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 as 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 hallmarks 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.

Speaker 3

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 for Daybreak. We've worked with Nephron and its visionary 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 low fill seal technology, it's ideally suited to our planned commercial presentation. Our current timeline projects submission of a new drug application for Ketamine in the Q1 of 2024 with a targeted PDUFA date in the Q4 of 2024.

Speaker 3

Now we don't anticipate funding the Ketamine initiative Our guidance in today's Q Advises 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 $30,000,000 and Anchor Financing for this new business entity. In this plan, a portion of the equity to be built in the Ketamine asset 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, the structure will be discussed at the upcoming Annual Meeting of Shareholders, which we hope all of you will attend. There is 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. Enorex anticipates pursuing a near term potential solution to address this public health need by the end of 2024.

Speaker 3

Finally, we expect that our focus on urinary tract infection is a bit surprising, Given our identity as a CMS focused company, although treatment of UTI is quite different From the use of NRX101 to treat central nervous system disorders, these types of siren was originally developed as an 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 drugs used in psychiatry today. They all began as antibiotics. These type of serine Fell out of favor as an antibiotic in the 1970s because of the CNS effects caused by its NMDA blocking properties and because of the widespread availability of effective first and second generation antibiotics. However, DCS is unique as an antibiotic And that it's nearly 100% excreted, unmetabolized in the urine.

Speaker 3

And therefore, it achieves high urinary tract levels With oral administration, as you probably know, many of the newer 3rd and 4th generation antibiotics require intravenous administration to treat complicated UTI. Our clinical experience in psychiatry suggests that the lirazodone component of NRX101 Bluffs unwanted CNS side effects and unlocks the potential of Dcycloserine to treat antibiotic resistant Urinary tract infections with a decreased propensity to cause unwanted CNS effects. In recent years, increased antibiotic resistant to common pathogens that cause urinary tract infections And urocepsis, in other words, sepsis that originates in the urinary tract, has resulted in a marked increase in complicated urinary tract infection, hospitalization and death from uricepsis. Probably everyone on this call knows someone who has developed a UTI and ended up receiving IV antibiotics in the hospital or at home. The U.

Speaker 3

S. Center For Disease Control and Prevention reports that more than 1,700,000 Americans contract Texas each year, of whom at least 350,000 died during their hospitalization or discharged to hospice. In 2015, DCS was demonstrated to be effective against pathogens that are increasingly likely to cause sepsis And increasingly resistant to first and second line antibiotics. So in Q3, we tested NRX101 and its components against resistant pathogens that appear on a congressionally mandated qualified infectious disease product list. And we proved in vitro effectiveness, that is effectiveness in the laboratory against antibiotic resistant E.

Speaker 3

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 5 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 patent on NRX101, Together with Fast Track Designation and Priority Review, we believe that NRX101 as an oral medicine has the potential to demonstrate benefit in patients who would otherwise require intravenous 3rd and 4th generation antibiotics. We believe there are approximately 3,000,000 such patients a year who contract a complicated UTI. Should NRX101 succeed in clinical trials, the company has a planned follow on product that's anticipated to achieve another 20 years of patent exclusivity.

Speaker 3

Based on the in vitro study that we've 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 CoreRx 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 NRX101 The 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.

Speaker 3

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 NRX101 for this indication has the potential to reach 100 of 1,000,000 of dollars annually based on 3,000,000 cases per year in the U. S. Finally, I'd like to address a challenging issue that's frequently raised with us by investors. Investors 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.

Speaker 3

While covered short sales such as those sales that are associated with borrowing an 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 Approximately $1,000,000 to $1,500,000 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 to be identified Identifying that all uncovered short positions in the company's stock be closed via a forced delivery of shares.

Speaker 3

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 Noridowar, Chief Financial Officer, to review the Q3 financials. Rich?

Speaker 4

Thank you, Jonathan, and good afternoon, everyone. I will now review the highlights of our Q3 2023 financial results. Before reviewing the numbers, it's important to recognize that we have consistently reduced Our cash expenditures and expect to further reduce those expenditures as we complete the NRX101 clinical trial. In August, the company entered into a securities purchase agreement pursuant to which the company issued 3,000,000 shares of the company's Series A convertible preferred stock and one investor warrant for every share of Series A preferred stock issued. The aggregate proceeds of the company from the private placement was approximately $1,200,000 before expenses.

Speaker 4

The company intends to use the net proceeds from such offering for working capital and general corporate purposes. For the 3 months ended September 30, 2023, NRx Pharmaceuticals recorded $3,300,000 of research and development expenses compared to $4,100,000 for the 3 months ended September 30, 2022. The decrease is related primarily to clinical development expenses and fees paid to regulatory and pharma development consultants. For the same 3 month period, We recorded a 50% reduction in general and administrative expenses from $5,000,000 in the Q3 of 2022 to $2,500,000 for the 3 months ended September 30, 2023. The decrease of $2,500,000 is related primarily to These pieces of employee related expenses, legal, insurance and accounting costs.

Speaker 4

The 9 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 $8,900,000 in cash and cash equivalents. These working capital assets are expected to fund the company's operations through the expected achievements of the 4 key milestones of success today. Additionally, we are evaluating operational efficiencies associated with the completion of manufacturing activities to extend its runway. With that, I will turn it back to Steve for closing remarks.

Speaker 4

Steve?

Speaker 2

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 NRX101 and are moving toward 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-one hundred and one in urinary tract infection And we expect to position NRX-one hundred in a new entity to file an NDA for IV Ketamine in suicidal depression in the 1st part of next year.

Speaker 2

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 ks filing, Achieving any of the 4 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. We're a small biotechnology company.

Speaker 2

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. The first question comes from Ed Woo with Ascendiant Capital. Please go ahead.

Speaker 5

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?

Speaker 2

There is a right of thank you, Ed. There is a right of first Negotiation? Not a right of first refusal.

Speaker 5

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?

Speaker 2

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 are free to partner the product in ways that are no less favorable to NRx.

Speaker 5

Great. Thank you for providing the answers to my question. Thank you and

Speaker 2

I wish you guys good luck.

Speaker 1

Ashish, this is Matt Duffy, and I have received some electronic questions For management here. The first one, I think, would go to Steve and it looks like it dovetails off that last one, which is How is the partnership with Alvogen going so far in general?

Speaker 2

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. They meet regularly. And it seems like we're generally forging alignment on our goals for development and commercialization of the product.

Speaker 1

Okay, great. Another question came in and this is probably I think for Doctor. Javed. Can you tell us more about your plans for the Ketamine spin off, the assets, potential funding benefit to NRx shareholders?

Speaker 3

Well, I think it's important to start out by understanding the challenge That we have where on one hand we've been working for many years to develop NRX101 as a core asset, Yes, a drug that could readily be worth multiple 1,000,000,000 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, but very meaningful revenue opportunities. Yes, imagine for example, if ketamine generated $100,000,000 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 shareholders. 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 Yes, with our shareholders, but that's the general reason for thinking about the spin off structure.

Speaker 1

Okay. And sticking with the IV Ketamine, one other question is It's more of a clinical one for you, I think, Doctor. Javits. Is IV ketamine really that much better than inhaled?

Speaker 3

Well, we know from extensive literature and now from 2 Well controlled randomized prospective trials that IV Ketamine works against acute suicidality And inhaled Ketamine has never demonstrated that in a large multicenter trial. What's important to recognize is that when you give Ketamine ID, 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 of 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 going to get into the bloodstream of any individual patient. Some will go down the back of the throat into the stomach and get absorbed. Some may go across the Tissues of the nose directly into the bloodstream and it's going to vary patient by patient.

Speaker 3

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 sprayer 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.

Speaker 3

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 an anesthetic, but manufactured Current standards is an important public health initiative, and that's why we've chosen to embrace it.

Speaker 1

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 NRX101 in pain?

Speaker 3

Well, we've already filed an investigational new drug application with the FDA for the use of NRX101 in pain and received an enthusiastic response or a response that we've deemed as enthusiastic from the FDA Division of Anesthesia, Analgesia and Addiction Products, which is the 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 NRX101 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 We'd 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's side, But we have ample belief that that capital would be available in the face of a positive readout in the 200 person trial.

Speaker 1

Thanks. Thank you very much. Thank you, everyone. That's all the time we have for questions tonight. We appreciate you joining us to talk about our journey reaching these important milestones for the company over the coming months and look forward to your participation in future calls.

Speaker 1

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.

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