Q1 2025 NRx Pharmaceuticals Inc Earnings Call
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Unknown Executive: Copyright 2019, NRX, LLC Good afternoon, ladies and gentlemen, and welcome to the NRX Pharmaceuticals first quarter 2025 earnings 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.
Speaker Change: Good afternoon, ladies and gentlemen, and welcome to the <unk> Pharmaceuticals first quarter 2025 earnings call.
Speaker Change: At this time all lines are in a listen only mode.
Speaker Change: Following the presentation, we will conduct a question and answer session.
Speaker Change: If at any time during this call you require immediate assistance. Please press star zero for operator.
Unknown Executive: This call is being recorded on Thursday, May 15th, 2025.
Speaker Change: This call is being recorded on Thursday may 15th 2025.
Matthew Duffy: I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please go ahead. Thank you, Andrew, and welcome, everyone.
Speaker Change: I would now like to turn the conference over to Matthew Duffy Chief Business Officer. Please go ahead.
Speaker Change: Okay.
Matthew Duffy: Thank you Andrew and welcome everyone.
Matthew Duffy: 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. 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 statement.
Matthew Duffy: 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.
Matthew Duffy: These statements are subject to risks and uncertainties could they could cause actual results to differ differ materially from historical experience or present expectations.
Matthew Duffy: Additional information concerning factors that could cause actual results to differ from statements made on this call I stated that our periodic reports filed with the SEC.
Matthew Duffy: The forward looking statements made during this call speak only as of the date hereof.
Matthew Duffy: And the company undertakes no obligation to update or revise the forward looking statements.
Matthew Duffy: Information presented on this call is contained in the press release issued today in the company's form 10-Q, which may be accessed from the investor's page of the NRX Pharmaceuticals website.
Matthew Duffy: <unk> presented on this call is convinced that contained in the press release issued today and the company's Form 10-Q, which may be accessed from the investors page of the Enel X Pharmaceuticals website.
Matthew Duffy: Joining me today on the call are Jonathan Javitt, our founder, chairman and CEO, and Michael Abrams, our chief financial officer. Director Javitt will provide an overview of our company's progress as reported in today's Form 10-Q, following which Mike will review our company's financial results. Following their prepared remarks, we will address investor questions.
Speaker Change: Joining me today on the call are Jonathan gathers all founder Chairman and CEO and Michael Abrams, Our Chief Financial Officer.
Speaker Change: Thank you Janet will provide an overview of our company's progress as reported in today's Form 10-Q filing, which Mike will review our company's financial results.
Speaker Change: Following their prepared remarks, we will address investor questions I will now turn the call over to Jonathan Johnson.
Jonathan Javitt: I will now turn the call over to Jonathan. Jonathan. Thank you, Matt.
Jonathan Johnson: Thank you Matt Good evening, everyone and thank you for joining us and Rx has had an exceptional start to 2025 with important advances across each of our programs.
Jonathan Javitt: Good evening, everyone, and thank you for joining us. NRX has had an exceptional start to 2025, with important advances across each of our programs. Suicidality remains a national epidemic. Approximately 13 million Americans seriously consider suicide every year, and 3.8 million of those make an active plan to do so, according to the CDC. An American dies from suicide every 11 minutes, and worldwide, somebody dies from suicide every minute. These appalling statistics drive our mission. We've advanced our lead candidates, NRX100 and NRX101, in the regulatory process with the U.S. FDA. We've taken concrete steps toward establishing the HOPE Therapeutics Clinic network across the United States.
Jonathan Johnson: So lets identity remains a national epidemic approximately 13 American 13 million Americans seriously considered suicide every year.
Speaker Change: $3 8 million of that was thinking active plans to do so according to the CDC.
Speaker Change: And American dies from suicide every 11 minutes and worldwide somebody does from suicide every minute.
Speaker Change: These appalling statistics drive our mission.
Speaker Change: We've advanced our lead candidates and our X 100, and interacts one on one and the regulatory process with the U S. F D. A.
Speaker Change: We've taken concrete steps towards establishing the whole therapeutics clinics network across the United States.
Jonathan Javitt: We've also substantially reduced our core corporate expenses. We're ending our quarter with more cash on the balance sheet than in prior quarters. We have capital on the balance sheet for the end of the year and anticipate clinic revenue well before that. Clinic acquisition is being financed in a manner that does not require dilution of NRX stocks. The founding of NRX was based on our mission to help patients and caregivers address our country's national epidemic of suicidality, depression, PTSD, and related disorders. We aim to do so with innovative medicines and now with Hope Therapeutics to offer direct patient care for these lethal conditions.
Speaker Change: We've also substantially reduced our core corporate expenses were ending our quarter with more cash on the balance sheet than in prior quarters, we have capital on the balance sheet for the end of the year and anticipate clinic revenue well before that.
Speaker Change: The acquisition is being financed in a manner that does not require dilution of our stock.
Speaker Change: The founding of interactions based on our mission to help patients and caregivers address our top our country's national epidemic of suicide Dowdy depression, PTSD and related disorders. We aim to do so with innovative medicines and now with <unk> therapeutics to offer a direct patient care for these lethal conditions.
Jonathan Javitt: Our mission has not changed. Importantly, we've accelerated our path to revenue with all three of our lead programs having potential to generate revenue in the foreseeable future. This extraordinary progress has been facilitated by the dedicated team at NRX and HOPE as well as our committed investors.
Speaker Change: Our mission has not changed importantly, we've accelerated our path to revenue with all three of our lead programs, having a potential to generate revenue.
Speaker Change: In the foreseeable future.
Speaker Change: This extraordinary progress has been facilitated by the dedicated team that interacts at home as well as our committed investors I'd like to take a moment to thank everyone for their tremendous efforts and support.
Jonathan Javitt: I'd like to take a moment to thank everyone for their tremendous efforts and support. Our timing is fortuitous as well. The U.S. government, and in particular the new administration, has increased focus on treatment of suicidal depression and PTSD, with particular emphasis on our military and veterans communities. Two weeks ago in the televised White House Cabinet meeting, the President asked VA Secretary Collins what was being done to address suicide in veterans. The Secretary's response included the need for psychedelic therapies. Ketamine, a drug we are developing, is one such therapy. The Secretary of Health and other members of the administration have specifically endorsed our class of medicine.
Speaker Change: Our timing was fortuitous as well the U S government and in particular, the New administration has increased focus on treatment of suicidal depression, and PTSD with particular emphasis on our military and veterans communities.
Speaker Change: Two weeks ago, when the televised white has cabinet meeting the President asked me a temperature Collins work was being done to address suicide and veterans.
Speaker Change: Secretary's response included the need for psychedelic therapies ketamine a drug we're developing is one such therapy.
Speaker Change: The secretary of health and other members of the administration have specifically endorsed our class of medicines as well as clinical approaches that are central to our business.
Jonathan Javitt: as well as clinical approaches that are central to our business.
Jonathan Javitt: NRX has two separate operating groups, NRX Pharmaceutical, a traditional biotech drug development company with multi-billion dollar opportunities, and Hope Therapeutics, our patient care company, currently a wholly owned subsidiary that is expected to be revenue generating, profitable in the near term, and ultimately spun out as its own company. With NRX, we've initiated filing of a new drug application, or NDA, for NRX100, our preservative-free intravenous ketamine for the treatment of suicidal depression. There are no medicines approved to help people with this condition. We aim to change that this year. The application is supported by data from four well-controlled clinical trials showing that the preferred dosing of ketamine has strong statistical efficacy compared to placebo, to active comparators such as midazolam, and to electroshock therapy.
Speaker Change: And Eric as two separate operating groups and Rx pharmaceutical a traditional biotech drug development company with multibillion dollar opportunities and hope therapeutics, our patient care company. Currently a wholly owned subsidiary that is expected to be revenue generating profitable in the near term.
Speaker Change: Ultimately spun out as its own company.
Speaker Change: With <unk>, we've initiated filing of a new drug application or NDA for <unk> 100, our preservative free intravenous ketamine for the treatment of suicidal depression.
Speaker Change: There are no medicines approved to help people with this condition.
Speaker Change: We aim to change that this year.
Speaker Change: The application is supported by data from four well controlled clinical trials showing.
Speaker Change: That's the preferred dosing of ketamine.
Speaker Change: Has strong statistical efficacy compared to placebo to active comparator, such as the days alone and two electroshock therapy.
Jonathan Javitt: No other drug in history has demonstrated efficacy that meets or exceeds that of ECT without the debilitating memory loss and the other side effects of ECT. The FDA new drug application is further supported by stability data that now support three years of labeled room temperature shelf stability, the maximum allowed by FDA. To protect NRX 100 exclusivity, this month we filed a patent for our novel, preservative-free formulation of NRX 100 with the U.S. Patent and Trademark Office, potentially protecting our ketamine product into 2045 with a potential orange book listing. Crucially for Americans and the disproportionately impacted veteran and warfighter communities together with first responders and others who suffer from this condition.
Speaker Change: No other drug in history has demonstrated efficacy that meets or exceeds that of V. C. T without the debilitating memory loss and the other side effects of D. C T.
Speaker Change: The FDA new drug application is further supported by stability data set now supports three years have labeled room temperature shelf stability the maximum allowed by FDA.
Speaker Change: To protect and our X 100 exclusivity. This month, we filed a patent for our novel Preservative free formulation of an Rx 100, with a U S patent and trademark office potentially protecting our ketamine product into 2045 with a potential Orange book listed.
Speaker Change: Crucially for Americans and the disproportionately impacted veteran in war fighter communities together with first responders and others, who suffer from this condition.
Jonathan Javitt: We have manufacturing capacity to supply more than one million doses a month, should we gain FDA approval. Because of our success in achieving long-term stability for preservative-free ketamine, we are also filing an abbreviated new drug application, or ANDA, for this product. Because of the administration's new focus on eliminating toxic substances, such as preservatives and dyes from the food and drug supply. The benzothonium chloride family of preservatives currently used in all commercial forms of ketamine has been shown to be neurotoxic. and also toxic to epithelial cells. Now that we've shown there's no need for that preservative in the setting of modern drug manufacturing, we have the potential to deliver a ketamine-based product for all current uses of ketamine, not just to treat psychiatric conditions.
Speaker Change: We have manufacturing capacity to supply more than 1 million doses of months should we gain FDA approval.
Speaker Change: Because of our success in achieving long term stability for preservative free Ketamine. We are also filing an abbreviated new drug application or <unk> for this product because of the administration's new focus on eliminating toxic substances, such as preservatives and dies from the food and drug supply.
Speaker Change: The benefit sodium chloride families preservatives currently used in all commercial forms of ketamine has been shown to be neurotoxic.
Speaker Change: And also toxic to epithelium cells.
Speaker Change: Now that we've shown there is no need for that preservative in the setting of modern drug manufacturing, we have the potential to deliver a ketamine based product for all current use of ketamine not just to treat psychiatric conditions.
Jonathan Javitt: In parallel... We're preparing a new drug application requesting accelerated approval for NRX101, our fixed-dose oral combination of D-cycloserine and lorazidone for the treatment of suicidal depression in patients with suicidality or akathisia, with the anticipation that we will initiate the filing in the current quarter. NRX101 is the only antidepressant ever shown to decrease akathisia compared to standard care antidepressants. Akathisia is the side effect of all previously marketed antidepressants most closely associated with suicidality. In our clinical trial... NRX 101 was also associated with a more rapid resolution of suicidal ideation than the standard of care antidepressants.
Speaker Change: In parallel.
Speaker Change: We're preparing the new drug application requesting accelerated approval for <unk> hundred one our fixed dose oral combination of <unk> and the ratchet down for the treatment of suicidal depression in patients with suicide reality or akathisia with the anticipation that we will initiate the <unk>.
Speaker Change: Filling in the current quarter and our excellent and one is the only anti depressant ever shown to decrease aqueous Asia compared to standard of care anti depressants Akathisia is the side effect of all previously marketed anti depressants, most closely associated with suicide LT.
Speaker Change: Clinical trial.
Speaker Change: Our X 101 was also associated with a more rapid resolution of suicidal ideation than the standard of care anti depressant.
Jonathan Javitt: Last year, we organized Hope Therapeutics, a wholly owned subsidiary, in order to develop a national network of clinics to provide treatment directly to patients with suicidality, depression, PTSD, and other life-threatening conditions. These clinics focus on delivering integrated neuroplastic therapies, all under one safe, reliable umbrella. Although people talk about psychedelic drugs, focusing on the hallucinations that may be a side effect of many drugs in the class, science continues to teach us that these drugs work by stimulating the brain to form new connections or synapses, a process known as neuroplasticity. New treatments such as transcranial magnetic stimulation, or TMS, and some forms of hyperbaric therapy also have neuroplastic effects.
Speaker Change: Last year, we organized hooked therapeutics, a wholly owned subsidiary in order to develop a national network of clinics to provide treatment directly to patients with suicide, Ality depression, and PTSD and other life threatening conditions.
Speaker Change: These clinics focus on deliberating delivering integrated neuroplastic therapies, all under one safe reliable umbrella.
Speaker Change: Although people talk about psychedelic drugs focusing on the hallucinations that maybe a side effect of many drugs in the class science continues to teach us that these drugs work by stimulated in the brain.
Speaker Change: Form new connections or synapses, a process known as neuroplasticity.
Speaker Change: New treatments, such as transcranial magnetic stimulation or Tms and some forms of hyperbaric therapy also have neuroplasticity effects.
Jonathan Javitt: The treatment paradigm for these diseases is rapidly evolving, and we intend to be on the forefront of that paradigm. The totality of evidence as we see it suggests that no one treatment can dependably yield the long-term remission from a disease that claims the lives of well over 50,000 Americans each year. The clinical data, along with practitioners' experience, suggest that most patients contacting interventional psychiatry clinics for care will require a combination of NMDA antagonist drugs plus additional neuroplastic therapies such as TMS and or digital therapeutics in order to achieve long-term remission. These approaches are believed to work by raising the level of glutamate and other chemicals in the brain and causing the brain to form new healthy connections.
Speaker Change: The treatment paradigm for these diseases is rapidly evolving and we intend to be on the forefront of that paradigm.
Speaker Change: Tally of evidence as we see it suggests that no one treatments can dependent dependably yield the long term remission from a disease that claimed the lives of well over 50000 Americans each year.
Speaker Change: Clinical data along with practitioners experience suggests that most patients contacting interventional psychiatrists clinics for care.
Speaker Change: Will require a combination of NMDA antagonist drugs, plus additional neuroplasticity therapies, such as T. M S. Andrew a digital therapeutics in order to achieve long term remissions.
Speaker Change: These approaches are believed to work by raising the level of glutamate and other chemicals in the brain and cost from the brain to form new healthy connections.
Jonathan Javitt: As we become increasingly familiar with pioneers in the field, we routinely hear that as isolated therapies, a 60% or so remission from suicidal depression and PTSD can be seen. However, when therapies are integrated, some practitioners believe they are seeing sustained remission rates approaching 90%.
Speaker Change: As we become increasingly familiar with pioneers in the field, we routinely hear that is isolated to therapies, 60% or so remission from suicidal depression and PTSD can be seen.
Speaker Change: However, when therapies are integrated some practitioners believe they're seeing sustained remission rates approaching 90%.
Jonathan Javitt: The fact that successful clinics are able to provide patients with integrated care continue to grow, as distinct from the pump-up ketamine clinics that come and go, tells us that patients and their families embrace this model.
Speaker Change: Fact that successful clinics are able to provide patients with integrated care continue to grow as distinct from the pump up ketamine clinics like someone Gov tells us that patients and their families embrace this model.
Jonathan Javitt: Hope has signed purchase agreements and a binding letter of intent to acquire three state-of-the-art interventional psychiatry practices. Kadima Neuroscience Institute in La Jolla, California, Dura Medical in Southwest Florida, and NeuroSpot TMS in the Tampa Bay Area, Florida. The expansion pipeline includes a number of additional clinics in Florida, the Mid-Atlantic, and Midwest with whom we are in discussion or active negotiation. We continue to navigate the complexities of purchasing medical treatment facilities under state regulations as we move forward to closing and consummating these transactions.
Speaker Change: <unk> signed purchase agreements and a binding letter of intent to acquire three state of the art intervention will sit tight with practices Kadima Neuroscience Institute in La Jolla, California, Durham Medical in southwest, Florida, and Neurostar Tms in the Tampa Bay area of Florida.
Speaker Change: The expansion pipeline includes a number of additional clinics in Florida, the mid Atlantic and Midwest with whom we are in discussion or active negotiation. We continue to navigate the complexities of purchasing medical treatment facilities under state regulations as we move forward to closing.
Speaker Change: Consummate any of these transactions.
Jonathan Javitt: As reported earlier, HOPE signed a term sheet with Universal Capital, a global investment firm, for $7.8 million in debt facility to fund HOPE's growth and acquisition strategy. This, in addition to the previously announced term sheet with the strategic investor, brings $10.3 million in expected capital to HOPE in the coming weeks, providing sufficient resources for clinic acquisition and growth in a manner that is anticipated to be non-dilutive to shareholders of NRX stocks. As you can see, we're making important progress building NRX into a company that will bring life-saving treatment to patients and financial returns to our investors.
Speaker Change: As reported earlier hope signed a term sheet with Universal capital a global investment firm for $7 $8 million in debt facility to fund hopes growth and acquisition strategy. This is in addition to the previously announced term sheet with a strategic investor brings 10 three.
Speaker Change: And expected capital to hope in the coming weeks, providing sufficient resources for clinic acquisition and growth in a manner that is anticipated to be non dilutive to shareholders of <unk> stock.
Speaker Change: As you can see we're making important progress building <unk> into a company that will bring life saving treatments to patients and financial returns to our investors.
Jonathan Javitt: Shareholders routinely ask us when and why we expect to become a revenue generating company. We believe that if we continue to execute according to plan, we'll be able to offer our proprietary ketamine drug, NRX100, to the marketplace by early next year. Ketamine, for example, is available today. almost exclusively to those who can afford to pay out-of-pocket. It will remain so until FDA approval for ketamine to treat suicidal depression is obtained. We've initiated filing our NDA for NRX100, the intravenous preservative-free ketamine for treatment of suicidal depression. And as noted, the NDA is supported with powerful efficacy data from multiple well-controlled trials, accelerated stability data sufficient to support a three-year shelf life, and an already-filed manufacturing module.
Speaker Change: Shareholders routinely asked us when and why we expect to become a revenue generating company. We believe that if we continue to execute according to plan, we'll be able to offer are proprietary academy in drug in our X 100 to the marketplace by early next year Ketamine for example is available today.
Almost exclusively to those who can afford to pay out of pocket. It will remain so until FDA approval for ketamine to treat suicidal depression is obtained.
Speaker Change: We've initiated filing our NDA for <unk> 100, the intravenous preservative free ketamine for treatment of suicidal depression.
Speaker Change: And as noted the NDA is supported with powerful efficacy data from multiple well controlled trials accelerated stability data is sufficient to support a three year shelf life and in already filed manufacturing module. Once filed we expect receiving a paducah date from.
Jonathan Javitt: Once filed, we expect receiving a PDUFA date from the FDA for later this year.
Speaker Change: The F D. A for later this year long term ketamine safety is an issue that we believe will receive increased attention in the future as clinician prescribing and patient acceptance of ketamine becomes more widespread.
Jonathan Javitt: Long-term ketamine safety is an issue that we believe will receive increased attention in the coming months. as clinician prescribing and patient acceptance of ketamine becomes more widespread. There are data available not just from primate studies, but from human studies as well that show repeated ketamine doses on the order of 60 doses or more of the currently available commercial formulations of intravenous ketamine may be toxic to the brain. Repeated ketamine use is associated with damage to the urinary tract and bladder. The currently available ketamine preparation was designed in the 1970s in a multi-use vial in order for the product to be used.
Speaker Change: There are data available not just from premise studies, but from human studies as well.
Speaker Change: It showed repeated ketamine doses on the order of 60 doses or more of the currently available commercial formulations of intravenous ketamine may be toxic to the brain.
Speaker Change: <unk> ketamine uses associated with damage to the urinary tract in bladder. The currently available ketamine preparation was designed in the 19 seventies and a multi use vial in order for the product to be used.
Jonathan Javitt: in anesthesia. This multi-dose vial was anticipated to be drawn for multiple doses in various patients, necessitating the addition of a preservative. Back in the 1960s, when this preparation was formulated, they used a potentially toxic preservative, benzothonium chloride. While there's no evidence that benzothonium chloride is toxic at its current concentration for the intended one-time use in anesthesia, its safety has never been shown or even proposed for repeated use. Indeed the manufacturers of benzothonium chloride identify it as caustic, toxic, and capable of causing severe burns.
Speaker Change: In anesthesia. This multi dose vial was anticipated to be drawn for multiple doses and various patients necessitating. The addition of a preservative back in the 19 sixties. When this preparation was formulated they used to potentially toxic preservative pencil sodium chlorite well.
Speaker Change: While there is no evidence defensive Sony in Florida is toxic at its current concentration for the intended onetime use in anesthesia. It's safety has never been shown or even proposed for repeated use.
Speaker Change: The manufacturers have been to sodium chloride identify it as caustic toxic and capable of causing severe burns.
Jonathan Javitt: This class of preservatives has already been removed from many eye drop formulations because of clear evidence of toxicity to the cornea and conjunctiva, even at the currently allowed levels. Chronic use of ketamine is associated with development of ulcerative cystitis. potentially a dangerous bladder condition. This condition may be caused by the excretion of the preservative rather than by ketamine itself. We also note that we are not aware of any cases of interstitial cystitis reported following the use of Spravato, a nasal form of esketamine that does not contain benzothonium chloride. Accordingly, we're filing a citizen's petition with the FDA to remove ketamine preparations with benzothonium chloride from the market, given that this substance is now shown to be unnecessary for stability and sterility of ketamine.
Speaker Change: This class of preservatives as already been removed for many eye drop formulations because of clearer evidence of toxicity to the cornea and country Tiber, even at the currently allowed levels chronic.
Speaker Change: Chronic use of ketamine is associated with development of ulcerative status.
Speaker Change: Potentially a dangerous bladder conditions. This condition may be caused by the excretion of the preservative rather than by ketamine itself.
Speaker Change: We also note that we are not aware of any cases of interstitial cystitis reporting reported following the use of <unk>, our nasal form of IV of S. Ketamine that does not contain vincent sodium chloride.
Speaker Change: Accordingly, we're filing a citizens petition with the FDA to remove ketamine preparations with dense with Sony in Florida from the market given that the substance is now shown to be unnecessary for stability and <unk> of <unk>.
Jonathan Javitt: The company also plans to file an abbreviated NDA or ANDA for preservative-free ketamine. so that this drug can be used as broadly as possible. Although we'll never lose sight of our core mission to treat lethal CNS diseases, including suicidal depression and PTSD, the market for NRX 100 may be far larger than originally anticipated. based on the current scenario. As I discussed previously, we have current manufacturing capacity to supply 1 million vials of ketamine each month. We also have potential to scale up capacity. As noted, we have taken steps to protect our preservative-free formulation with the filing of a patent that has the potential to protect the product into 2045.
Speaker Change: The company also plans to file an abbreviated NDA or <unk> for preservative free ketamine.
Speaker Change: So that this drug can be used as broadly as possible. Although we will never lose sight of our core mission to treat lethal CNS diseases, including suicidal depression and PTSD the market for <unk> 100 may be far larger than originally anticipated.
Speaker Change: Based on the current scenario.
Speaker Change: As I've discussed previously we are current manufacturing capacity to supply 1 million vials of ketamine each month.
Speaker Change: We also have potential to scale up capacity if needed as noted we have taken steps to protect our preservative free formulation with the filing of a patent that has the potential to protect the product into 2045.
Jonathan Javitt: The toxic preservative is not the only challenge associated with currently available. 60-year-old ketamine formulation. As produced, ketamine hydrochloride has a pH of less than 4. This isn't a problem for intravenous use where it's diluted, but precludes subcutaneous administration as dosing of any drug with this pH can cause pain and even cause skin ulcer. If you try to raise the pH of the current ketamine formulation, the ketamine precipitates out of solution, rendering it unusable. Further, administration challenges face those who've tried to give it by mouth. So, aside from the obvious safety risks of unmonitored administration of a Schedule III drug, People have learned that the resulting blood levels from oral ketamine administration are highly inconsistent.
Speaker Change: The toxic preservative is not the only challenge associated with currently available.
Speaker Change: 60 year old ketamine formulation.
Speaker Change: As produced Ketamine hydrochloride has a ph of less than four this isn't a problem for intravenous use where it's dilutive, but preclude subcutaneous administration dosing of any drug with this ph can cause pain and even close skin ulcers.
Speaker Change: If you try to raise the ph of the current ketamine formulation the academy precipitate set of solution rendering it unusable.
Speaker Change: Further administration challenges face those who've tried to give it by mouth.
Speaker Change: So aside from the obvious safety risks of Unmonitored administration of our schedule of free drug.
Speaker Change: People have learned that the resulting blood levels from oral ketamine administration are highly inconsistent similar products have occurred with ketamine intranasal spray.
Jonathan Javitt: Similar products have occurred with ketamine intranasal spray. While intravenous administration is completely reliable in achieving the blood levels, this requires skilled nurses in clinic facilities. With these challenges to administration, we hope to offer an attractive alternative, subcutaneous ketamine delivered in the same way that insulin and newer obesity drugs. However, this route of administration is only possible with a pH neutral form of ketamine. We've now developed that patentable version of pH-neutral ketamine, one that remains stable at room temperature and is expected to begin human bioequivalence trials this year. As is well known, bioequivalence is far simpler and less expensive to prove than safety and efficacy.
Speaker Change: Well intravenous administration is completely reliable and achieving the blood levels. This requires skilled nurses in clinic facilities with these challenges to administration, we hope to offer an attractive alternative subcutaneous ketamine delivered in the same way that insulin and newer obesity drugs forgiven. However, this route of administration.
Speaker Change: Australia is only possible with a ph neutral form of ketamine we've.
Speaker Change: We've now developed that patentable version of ph neutral ketamine, one that remains stable at room temperature and is expected to begin human bioequivalence trials this year.
Speaker Change: As is well known bio equivalents is far simpler and less expensive to prove safety and efficacy.
Jonathan Javitt: Our goal in gaining FDA approval for NRX100 is to significantly expand the number of patients who have access to the benefit from this important The current off-label use of ketamine and CNS disorders is generally only available to patients who can pay out-of-pocket because insurance companies do not pay for unlabeled treatment. We expect NRX 100, once approved, to be widely reimbursed, thus providing access for the vast majority of people in need, not just those with the means to spend thousands of dollars in cash. NRX 100 represents a major opportunity for our company. The current market for intranasal ketamine is significant.
Speaker Change: Our goal in gaining FDA approval for <unk> 100 is to significantly expand the number of patients who have access to the benefit from this important treatment.
Speaker Change: The current off label use of ketamine in CNS disorders is generally only available to patients who can pay out of pocket because insurance companies do not pay for unable treatments.
Speaker Change: We expect and our X 100, once approved to be widely reimbursed, thus providing access to the vast majority of people in need not just those within means to spend thousands of dollars in cash for treatment.
Speaker Change: And our X 100 represents a major opportunity for our company. The current market for intranasal Ketamine is significant J&J recently released fourth quarter 2025 sales data on to provide of.
Jonathan Javitt: J&J recently released forced quarter 2025 sales data on Spravato and is on track to generate $1.3 billion in sales this year, all while the label states that Spravato has not demonstrated anti suicidal property. Thus, NRX100 represents a multi-billion dollar opportunity for NRX, and we are getting closer and closer to providing this life-saving opportunity to patients.
Speaker Change: And is on track to generate $1 $3 billion in sales. This year all while the label States. That's provider has not demonstrated anti suicidal properties. Thus inner excellent hundred represents a multibillion dollar opportunity for <unk>, and we are getting closer and closer to providing this lifestyle.
Speaker Change: The opportunity to patients.
Jonathan Javitt: Let's now discuss our treatment for bipolar depression in patients with suicidality or akathisia, NRX 101. While bipolar depression affects approximately 7 million people in the U.S., people with bipolar depression and akathisia or suicidality are at imminent risk of self-harm. There are no medications approved to treat these patients in the U.S. Current treatment options all carry the risk of suicide and akathisia. which are known side effects of serotonin-active antidepressants.
Speaker Change: Let's now discuss our treatment for bipolar depression in patients with suicide reality or a fifth Asia and our X 100 watt, while bipolar depression affects approximately 7 million people in the U S people with bipolar depression, akathisia or suicide Ality.
Speaker Change: At imminent risk of self harm there are no medications approved to treat these patients in the U S.
Speaker Change: Current treatment options, all carry the risk of suicide and AK seizure.
Speaker Change: Which are known.
Speaker Change: Good effects of serotonin active anti depressant.
Jonathan Javitt: These patients need better treatment options urgently. Today, the only approved FDA treatment, or the only FDA approved treatment, is electroshock therapy. NRX 101 is our oral combination of D-cycloserine, an NMDA receptor blocker, and lorazodone, the standard of care in bipolar depression. NRX 101 has the opportunity to offer a breakthrough in the care of patients with bipolar depression. In clinical trials, we've demonstrated comparable or greater antidepressant effect compared to the standard of care with a statistically significant improvement in the safety of NRX-101 due to a reduction in suicidality and ekathesia. In our clinical trials, NRX-101 demonstrated strong antidepressant efficacy comparable to the standard of care with a more favorable safety profile.
Speaker Change: These patients need better treatment options urgently today, the only approved FDA treatments or the only FDA approved treatment is electroshock therapy.
Speaker Change: And our next one on one is our oral combination of these types of serine and NMDA receptor blocker and Lurasidone the standard of care in bipolar depression.
Speaker Change: <unk> hundred one has the opportunity to offer a breakthrough in the care of patients with bipolar depression and.
Speaker Change: In clinical trials, we've demonstrated comparable or greater anti depressant effect.
Speaker Change: Care to the standard of care with a statistically significant improvement in the safety of <unk> hundred one due to a reduction in suicides reality and akathisia and our clinical trials and our X 101 demonstrated strong anti depressant efficacy comparable to the standard of care with a more favorable safety profile.
Jonathan Javitt: Our recently completed Phase IIb slash III clinical trial of NRX-101 presented last May at the American Society of Clinical Psychopharmacology demonstrated both a reduction in depression scores as well as symptoms of suicidality and is now the first oral antidepressant to reduce symptoms of ekathesia compared to standard of care, a potentially lethal side effect of nearly all antidepressants.
Speaker Change: <unk>, our recently completed phase two be slashed III clinical trial of <unk> hundred one presented last may.
Speaker Change: At the American Society of clinical Psychopharmacology demonstrated both a reduction in depression scores as well as symptoms I was of suicide reality and is now the first oral anti depressant to reduce symptoms of acre seizure compared to standard of care or potentially lethal side effects of nearly.
All anti depressants.
Jonathan Javitt: This would represent a new paradigm for the treatment of bipolar depression, if approved. Acathia is not commonly discussed as a side effect of serotonin active medication. However, key opinion leaders and patients who have suffered from akathisia regard it as the worst side effect of these antidepressants. Patients frequently describe it as a feeling of jumping out of their skin. Patients with akathisia are known to jump off of roofs and in front of oncoming trains.
Speaker Change: This would represent a new paradigm for the treatment of bipolar depression if approved.
Speaker Change: <unk> not commonly discussed as a side effect of serotonin active men serotonin active medications.
Speaker Change: However, key opinion leaders and patients who've suffered from Acas Asia.
Speaker Change: Guarded as the worst side effect of these anti depressants patients frequently describe it as a feeling of jumping out of their skin patients.
Speaker Change: Patients with AK seizure and owns a jump off roofs and in front of oncoming trains in fact in 2020 for a patient petitions the British Colombia Supreme Court for the right to enter life, rather than continue to suffer from Acas Asia.
Jonathan Javitt: In fact, in 2024, a patient petitioned the British Columbia Supreme Court for the right to end her life rather than continue to suffer from akathia. Currently, patients have no option other than simply enduring this side effect in order to achieve the critical antidepressant effects that are needed to control bipolar depression or choose to have electroshock therapy. The data we presented at ASCP confirms data from our earlier STABLE-B trial demonstrating that NRX 101 is the first oral antidepressant to have effective antidepressant properties while simultaneously decreasing akathisia and suicidality. We believe this product profile could lead to NRX101 becoming the drug of choice in bipolar depression.
Speaker Change: Currently patients have no option other than simply enduring this side effect in order to achieve the critical anti depressant effect that are needed to control bipolar depression.
Speaker Change: Or.
Speaker Change: He used to have electroshock therapy the.
Speaker Change: The data we presented at AACE P confirms data from our earlier stable B trial, demonstrating that <unk> hundred one is the first oral anti depressed have effective anti depressant properties, while simultaneously decreasing akathisia and suicide reality.
Speaker Change: We believe this product profile could lead to enter X 101, becoming the drug of choice in bipolar depression with.
Jonathan Javitt: We plan to initiate filing of our NDA for accelerated approval of NRX 101 for suicidal bipolar depression in patients at risk of akathisia or suicidality this quarter. With the lack of treatment options for this segment of people with bipolar depression and our strong data, we and our regulatory council believe this to be a vital unmet medical need and appropriate for consideration of accelerated approval.
Speaker Change: We plan to initiate filing of our NDA for accelerated approval of <unk> hundred one for suicidal bipolar depression in patients at risk of akathisia or suicide to LT this quarter.
Speaker Change: And with the lack of treatment options for this segment of people with bipolar depression, and our strong data, we and our regulatory counsel believes this to be a vital unmet medical need and appropriate for consideration of accelerated approval.
Jonathan Javitt: We anticipate a 2025. Based on prevalence data, prescribing frequency of serotonin-active medications in bipolar depression and the risk of akathisia, the company anticipates that the market for the initial indication is over $2 billion. while the broad bipolar market could markedly exceed $5 billion.
Speaker Change: We anticipate a 2025 producer date based on prevalence data prescribing frequency of serotonin active medications in bipolar depression, and the risk of Acas Asia. The company anticipates that the market for the initial indication is over $2 billion, while the broad bipolar market with Mark.
Thirdly exceed $5 billion.
Jonathan Javitt: Since the beginning of the year, we've accelerated progress towards establishing the HOPE Therapeutics Interventional Psychiatry Clinic Network. We've outlined our plan to establish and grow the HOPE Network as a national and ultimately international network of interventional psychiatry. These centers would be designed to combine the latest neuroplastic treatments and protocols in an integrated and reproducible manner across the whole platform. The business model for Hope Therapeutics is somewhat similar to that of DaVita. company that was instrumental in making kidney dialysis reliable and reproducible in a manner that has transformed the industry. and continue to reward its investors.
Speaker Change: Since the beginning of the year, we've accelerated progress towards establishing the whole therapeutics interventions psychiatry clinic network.
Speaker Change: We've outlined our plan to establish and grow the hope network as a national and ultimately international network of Interventional psychiatry centers.
Speaker Change: These centers would be designed to combine the latest neuroplastic treatments and protocols in an integrated and reproducible manner across the whole platform.
Speaker Change: The business model for hope Therapeutics is somewhat similar to that of Davita.
Speaker Change: A company that was instrumental in kidney dialysis reliable and reproducible in a manner that has transformed the industry.
Speaker Change: And continue to reward its investors.
Jonathan Javitt: So far in 2025, we've signed definitive purchase agreements to acquire Kadima Neuroscience Institute, a pioneering interventional psychiatry clinic in La Jolla, California, Endura Medical, an extraordinary clinic group in Southwest Florida. Further, we've executed a binding letter of intent with NeuroSpot TMS Holdings.
Speaker Change: So far in 2025, we signed definitive purchase agreements to acquire Kadima Neuroscience Institute, a pioneering interventional psychiatrists clinic in La Jolla, California, Enduro medical and extraordinary clinic group and southwest, Florida further we've executed a binding letter of intent with neuro spot.
Speaker Change: Tms holdings.
Jonathan Javitt: a pioneer. and TMS Offerings to acquire their clinic group in the Tampa Bay area on the West Coast of Florida. Our objective for the year is to create a ring of Hope Therapeutics clinics that starts in Naples on the southwest coast, run through Tampa and Orlando, back down to Miami. But these three clinics, collectively on a forward-looking revenue, are anticipated to represent $15 or more in annual revenue just on their own. Kadima's founder, Dr. David Feifel, has agreed to serve as HOPE's Chief Medical Innovation Officer post-acquisition. He's one of the first academic psychiatrists to move ketamine and TMS therapy to the community care model, and it's frequently featured in the national media, such as in Rolling Stone, on Peacock, as one of their most knowledgeable experts on the safe and appropriate use of ketamine, and other advanced therapies in mental health care.
Speaker Change: Pioneer.
Speaker Change: In Tms offerings to acquire their clinic group in the Tampa Bay area on the West Coast of Florida.
Speaker Change: Our objective for the year is to create a ray of hope therapeutics clinics that starts in April on the southwest coast runs through Tampa, and Orlando back down to Miami.
Speaker Change: But these three clinics collectively on a forward looking revenue are anticipated to represent $15 or more in annual revenue just on their own.
Speaker Change: Kadima as founder Dr. David FIFO has agreed to serve as hopes chief Medical Innovation Officer Post acquisition.
Speaker Change: It's one of the first academic psychiatrists to move ketamine in Tms therapy to the community care model and it's frequently featured in the National media such as in Rolling Stone on Peacock. It's one of the most knowledgeable experts on the safe and appropriate use of ketamine and other advanced therapies and mental health.
Speaker Change: Right.
Jonathan Javitt: Some of you may have seen his recent interview with Dr. Sanjay Gupta. Over the remaining months of 2025, we expect to announce the inclusion of additional ibidopositive centers. in the HOPE Network. Looking at the market, we anticipate that the acquisition of 20 clinics, each with current revenue of approximately $5 million, will enable us to meet our forward-looking revenue targets. Looking ahead, these best-in-class clinics can generate operating margins of 30% or higher, with significant opportunities for future growth. On the financing front, Hope has announced signing term sheets for more than $10 million. and Acquisition Capital in the form of both debt and equity.
Speaker Change: Some of you may have seen as recent interview with Dr. Sanjay Gupta.
Speaker Change: Over the remaining months of 2025, we expect to announce the inclusion of additional EBITDA positive centers in the whole network looking at the market, we anticipate that the acquisition of plenty clinics. Each with current revenue of approximately $5 million will enable us to meet our forward looking revenue targets.
Speaker Change: Looking ahead. This best these best in class clinics can generate operating margins of 30% or higher with significant opportunities for future growth.
Speaker Change: On the financing front pulp was announced signing term sheets for more than $10 million in acquisition capital in the form of both debt and equity.
Jonathan Javitt: to fuel our initial acquisitions with strong interest expressed by investors in continuing to support our roll-up strategy. As we've always said, and as these term sheets illustrate, we continue to expect funding for Hope to be independent of NRX stock and thus non-dilutive to NRX shareholders. Additionally, we expect that a portion of the earnings generated through HOPE may support NRX's path to profitability, and our planned spin-out of HOPE and subsequent listing on a national stocks exchange will provide balance sheet value both to NRX and to its shareholders. As you can see in our 10Q, we have substantially reduced operating expenses and are forecasting profitability on a going forward run rate basis by the end of 2025 with revenue and EBITDA from Hope Therapeutics along with potential sales of our medications.
Speaker Change: To fuel our initial acquisitions with strong interest expressed by investors and continuing to support our rollout strategy.
Speaker Change: As we've always said and as these term sheets illustrate we continue to expect funding for hope to be independent of <unk> stock and thus non dilutive to interact shareholders. Additionally.
Speaker Change: Additionally, we expect that a portion of the earnings generated through hope may support in our excess path to profitability and our planned spin out of hope and subsequent listing on a national stock exchange will provide balance sheet value both to interact and to its shareholders.
Speaker Change: As you can see in our 10-Q, we have substantially reduced operating expenses and are forecasting profitability on a going forward run rate basis by the end of 2025 with revenue and EBITDA from hope therapeutics, along with potential sales of our medications I'll now ask Mr. Michael Abrams.
Michael Abrams: I'll now ask Mr. Michael Abrams, our CFO, to review our financial results from the first quarter of 2025. Mike? Thank you, Jonathan. So the three months ended March 31st, 2025. The company reported a net loss of $5.5 million versus a net loss of $6.5 million for the comparable quarter in 2024, and a loss from operations of $3.8 million versus a loss from operations of $6 million for the comparable quarter in 2020. Research and Development and General Administrative Expenses were $0.8 million and $2.9 million, as compared to $1.7 million and $4.3 million for the comparable quarter ended March 31, 2024.
Michael Abrams: Our CFO to review our financial results from the first quarter of 2025, Mike.
Michael Abrams: Thank you Jonathan.
Michael Abrams: The three months ended March 31, 2025, the company reported a net loss of $5 5 million versus a net loss of $6 5 million for the comparable quarter in 2024 and the law.
Michael Abrams: Cash from operations of $3 8 million versus a loss from operations of $6 million for the comparable quarter in 2024.
Michael Abrams: Research and development and general administrative expenses were $8 million and $2 9 million as compared to $1 7 million $4 3 million for the comparable quarter ended March 31 2024, respectively.
Michael Abrams: Respect. As of March 31, 2025, NRX Pharmaceuticals had approximately $5.5 million in cash and cash equivalents. The company believes that its current capital position combined with ongoing financing discussions and partnerships will support operations through at least the end of 2025. NRX continues to implement operational efficiencies to extend cash runway and maintain focus on our path to generating revenue and value for our shareholders.
Michael Abrams: As of March 31, 2025 kind of range Pharmaceuticals had approximately $5 5 million in cash and cash equivalents.
Michael Abrams: The company believes that its current capital position combined with ongoing financing discussions and partnerships will support operations through at least the end of 2025.
Michael Abrams: <unk> continued to implement operational efficiencies to extend cash runway.
Michael Abrams: Maintained focus on our path to generating revenue and value for our shareholders.
Jonathan Javitt: With that, I turn it back to Jonathan.
Jonathan Johnson: With that I'll turn it back to Jonathan Jonathan.
Jonathan Javitt: Jonathan. Thank you, Mike. So we founded NRX for the goal of preventing and treating suicidality in patients with depression and PTSD. both to my heart and to the hearts of everybody who works with us.
Speaker Change: Hey, Mike So we founded on our <unk> with the goal of preventing and treating suicide reality in patients with depression and PTSD.
Jonathan Johnson: This is close to my heart into the Hearts of everybody who works with us.
Jonathan Javitt: Our plan 2025 for two NDAs in the space and continuing the development of Hope Therapeutics National Network for Care Delivery are transformative steps for the company and for the treatment of mental health in the United States. I'd like to thank the NRX team, our investors, and most importantly, the patients who participated in our clinical trials for their steadfast support of our pursuit of this vision.
Jonathan Johnson: Our planned 2025, <unk> date for <unk> NDA from the space and continuing the development of hope Therapeutics National network for care delivery, our transformative steps for the company and for the treatment of mental health in the United States.
Jonathan Johnson: Like to thank the <unk> team, our investors and most importantly, the patients who participated in our clinical trials for their steadfast support of our pursuit of this vision.
Unknown Executive: We're ready to take questions from the audience. Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touch tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number 2. If you are using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question.
Jonathan Johnson: We're ready to take questions from the audience.
Jonathan Johnson: Thank you.
Jonathan Johnson: Ladies and gentlemen, we will now begin the question and answer session.
Jonathan Johnson: Should you have a question. Please press the star followed by the number one on your Touchtone phone.
Speaker Change: You'll hear a prompt that youre having been raised.
Speaker Change: Should you wish to decline from the polling process. Please press the star followed by the number too.
Speaker Change: Fewer using a speaker phone please lift the handset before pressing any keys.
Speaker Change: One moment. Please for your first question.
Tom Shrader: first question is from Tom Shrader from BTIG. Please go ahead. Good afternoon. Congratulations on the whirlwind of progress.
Speaker Change: Your first question is from Tom Shrader from <unk>. Please go ahead.
Tom Shrader: Hi, good afternoon, congratulations on the whirlwind of progress.
Tom Shrader: I had a kind of a remedial question on the recent IP. What does that buy you if, in fact, you get approved? And as far as I understand it, the IP you really care about is the pH neutral version.
Tom Shrader: I had a kind of a remedial question on the recent I P O.
Speaker Change: What does that buy you if in fact, you get approved and as far as I understand it.
Speaker Change: The IP you really care about is the ph neutral version so just your thoughts on.
Jonathan Javitt: So just your thoughts on, one, how strong the patent application is to leave the preservative out, and two, how important is it for you to get that if you get approval? Thanks.
Speaker Change: One how strong the patent application is to leave the preservative out to how important is it for you to get that if you get approval.
Speaker Change: Thanks.
Jonathan Javitt: Well, I would never make predictions about how strong any individual patent is. I know that the Patent Council filing the patent is highly experienced and strongly believed in the claims that we're filing with the USPTO.
Speaker Change: Well I would never make predictions about how strong any individual patent is I know that the patent counsel filing. The patent is highly experienced and strongly believes in the claims that were filing with the U S. PTO.
Jonathan Javitt: Why does it matter? It matters because in our view Drugs with toxic preservatives are going to be withdrawn from the market. If we're coming to market with an orange book patented form of ketamine, we potentially have market exclusivity for an extended period of time. We always said that ketamine was a generic drug and by adding a new use The maximum we were going to get was three years of data exclusivity under paragraph four from the FDA. And then we kind of surprised ourselves, and it turns out that we may have much longer exclusivity on racemic ketamine in a preservative-free preparation than we originally anticipated.
Speaker Change: Why does it matter.
Speaker Change: The matters because in our view.
Speaker Change: Drugs with toxic preservatives are going to be withdrawn from the market.
Speaker Change: And.
Speaker Change: If we're coming to market.
Speaker Change: With an Orange book patent is.
Speaker Change: Norm of ketamine.
Speaker Change: Potentially a market exclusivity for an extended period of time, we always said that ketamine was the generic drugs and by adding a new use.
Speaker Change: The maximum we were going to get with three years of exclusive data exclusivity under paragraph four from the FDA.
Speaker Change: And then we were kind of surprised ourselves and it turns out that we may have much longer exclusivity on racemic ketamine in a preservative free preparation than we originally anticipated.
Jonathan Javitt: So if that happens, that's certainly good for a shareholder. The pH neutral form of ketamine is certainly proprietary, certainly patentable. And it's expected to have long-term protection. But it turns out we may have longer-term protection than we ever predicted from a better version of old-fashioned racemic ketamine, given the focus of the current Secretary of Health and Human Services on getting toxic preservatives out of the food and drug supply.
Speaker Change: So if that happens that certainly good for our shareholders.
Speaker Change: Ph neutral form of ketamine is certainly.
Speaker Change: Proprietary certainly patentable.
Speaker Change: And is expected to have long term protection.
Speaker Change: But it turns out we may have longer term protection than we ever predicted.
Speaker Change: A better version of old fashioned racemic ketamine.
Speaker Change: Given the focus of the current secretary of health and human services, I'm getting toxic preservative side of the food and drug supply.
Tom Shrader: Good. Thank you. That's a useful answer. Thank you.
Speaker Change: Good. Thank you that's a useful answer thank you.
Speaker Change: Yeah.
Speaker Change: Okay.
Edward Woo: Your next question is from Ed Woo, who is a private investor. Please go ahead. Yes, I'm actually with Ascendian Capital. Congratulations on all the progress and obviously it's going to be a very exciting year for you guys. Have you given any consideration for NRX 100 and also, you know, hope that therapeutics to either be able to go internationally beyond the U.S.? Certainly, we intend to make NRX 100 available more broadly. European countries are actually more sensitive to toxic substances and foods and drugs than the United States historically has been. So if we're able to make this case in the U.S., we would anticipate that there is significant international potential for NRX 100.
Speaker Change: Your next question is from Ed Woo Hoo.
Speaker Change: Mr. <unk>. Please go ahead.
Speaker Change: Yeah, So I'm actually with the Symbion capital congratulations on all the progress and obviously, it's going to be very exciting year for you guys.
Speaker Change: Have you guys given any consideration for <unk> 100 and also.
Speaker Change: Hope that therapeutics to either.
Speaker Change: Be able to go international beyond the U S.
Speaker Change: Certainly we intend to make in our X 100 avail.
Speaker Change: Available more broadly.
Speaker Change: And.
Speaker Change: European countries are actually more sensitive to toxic substances and fluids and drugs than the United States Historically has been.
Speaker Change: So if we're if we're able to make this case in the U S.
Speaker Change: We would anticipate that there is significant international potential for in our X 100, and in fact, we've been approached by a number of our international entities.
Jonathan Javitt: And in fact, we've been approached by a number of international entities. for that specific purpose.
Speaker Change: For that specific purpose.
Edward Woo: Great, that sounds good. Thanks for answering my questions, and I wish you guys good luck. Thank you.
Speaker Change: Great that sounds good thanks for answering my questions and I wish you guys. Good luck. Thank you.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Okay.
Unknown Executive: There are no further questions at this time, please proceed. That's all the time we have for questions, folks. Thank you very much for joining us this evening.
Speaker Change: There are no further questions at this time. Please proceed.
Speaker Change: Okay.
Speaker Change: That's all the time, we have for questions folks. Thank you very much for joining us. This evening. We're extremely excited about the year ahead with two potential drug approvals and subsidiary targeting multiple large profitable mental health clinics. Moving ahead. This concludes the <unk> pharmaceuticals.
Unknown Executive: We're extremely excited about the year ahead with two potential drug approvals and a subsidiary targeting multiple large profitable mental health clinics moving ahead. This concludes the NRX Pharmaceuticals First quarter 2025 results conference call. Thank you all for participating.
Speaker Change: First quarter 2025 results conference call. Thank you all for participating.
Unknown Executive: Ladies and gentlemen, this concludes the conference call for today. We thank you for participating and ask that you please disconnect your lines.
Speaker Change: Ladies and gentlemen, this concludes the conference call for today we.
Speaker Change: Thank you for participating and ask that you. Please disconnect your lines.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Okay.