Q4 2024 NRx Pharmaceuticals Inc Earnings Call
Speaker Change: Good morning, ladies and gentlemen, and welcome to the NRX Pharmaceutical 4Q in full year 2024 earnings call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session.
Speaker Change: In fact, at any time during this call you require me to do assistance, please press star zero for the operator This call is being recorded on Monday, March 17, 2025. I would now like to the conference over to Matthew Duffy, Chief Business Officer, please go ahead
Thank you, Jewel, and good morning, everyone.
Welcome to our call.
Speaker Change: Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under US Federal Security's laws.
Speaker Change: These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.
Speaker Change: 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 Security and Exchange Commission.
Speaker Change: The forward-looking statements made during this call speak only as of the day hereof and the company undertakes no obligation to update or revise the forward-looking statements.
Speaker Change: Information presented on this call is contained in the press release issued this morning in the company's Form 10K, which was filed on Friday. It may be accessed from the investor page of the NRX Pharmaceuticals Inc. website.
Jonathan Javitt: Joining me today on the call are Jonathan Javitt, our founder, chairman, and CEO .
and Michael Abrams, R.C. Financial Officer.
Jonathan Javitt: Dr. Javitt will provide an overview of our company's progress as reported in the 10K and in the press release, following which Michael will review the company's financial results.
Jonathan Javitt: Following your prepared remarks, we will address investor questions. I will now turn the call over to Jonathan, Jonathan.
Jonathan Javitt: Thank you, Matt. Good morning, everyone. Thank you for joining us.
Jonathan Javitt: As you know, the board asked me to, assume leadership of NRX five months ago, and to chart a path forward in the context of the capital market environment that's been less than supportive of pre-revenue biotechnology companies.
Jonathan Javitt: Over the past five months, we've raised new capital, retired toxic debt, and begun executing on a path that leads our enterprise from a purely research and development focused company to a health care company that has potential to generate revenue and look forward to profit by the end of 2025.
We believe that's rare among small cat biotech companies.
Jonathan Javitt: At NRX, we continue to be driven by our mission to treat and prevent suicidality, depression, PTSD, and related disorders.
Jonathan Javitt: Well, our mission has not changed, our path to revenue has advanced.
More over the U.S. government and particularly the new administration.
Jonathan Javitt: His expressed increased commitment to the treatment of these lethal conditions, with the class of medicines and clinical approaches that are central to our business.
NRX Incorporated, now owns two operating entities.
The original neuro-Rx business and the newly created Hope Therapeutics [inaudible]
Jonathan Javitt: All drugs under development are owned by NRX, while hope is focused on delivering clinical care.
Jonathan Javitt: Under the original NeuroRx business, we've initiated filing of a new drug application, our NDA, for NRX 100, our Preservative Free Intervenous Ketamine, based on stability data that support more than two years of room temperature shelf stability.
Jonathan Javitt: We have proven manufacturing capacity to supply more than one million doses per month. Should we gain FDA approval?
Jonathan Javitt: We believe this strategic term sheet we have received to acquire this product for more than $300 million in total milestones and a double-digit royalty provides further validation of our drug development approach.
Jonathan Javitt: NeuroRX is further preparing an accelerated NDA filing for NRX 101.
Jonathan Javitt: A fixed dose combination of these types of serring and lorasadone, with the anticipation that we will initiate an NDA filing in the current quarter under accelerated approval.
Jonathan Javitt: Last year, we incorporated hope therapeutics as a wholly owned subsidiary and began refining
Simply put, NeroRX [inaudible]
Jonathan Javitt: We'll continue developing life-saving drugs, while hope will own clinics to treat patients with depression, PTSD, and other life-saving, life-treatening brain diseases with a combination of drugs, medical devices, digital therapeutics, and integrated psychiatric care [inaudible]
Jonathan Javitt: Those wishing to understand the mission of hope and gain insight from our presentation at the SACS by the Technology Innovation Forum cited in our annual report.
Jonathan Javitt: In the past 10 years, treatment of these diseases has transformed from a hopeless world.
Jonathan Javitt: in which psychiatric hospitalization, electric shock therapy, and frequently ineffective drugs were the only alternatives.
Jonathan Javitt: for patients contemplating suicide, to a world in which clinical success is being reported routinely in the public arena and being demonstrated in a number of well-controlled clinical trials published in first-tier journals.
Jonathan Javitt: However, the totality of evidence, as we see it, suggests that no single treatment will yield the long-term remission from the disease that Winston Churchill called his black dog, a disease that claims the lives of well more than 500,000 Americans each year.
Jonathan Javitt: Newer psychedelic therapies when they're approved, plus neuromodulatory therapies such as transcranial magnetic stimulation to achieve long-term remission.
Jonathan Javitt: All of these approaches are believed to work by a common pathway, namely raising the level of glutamate and other beneficial chemicals in the brain and causing the brain to form new healthy connections, otherwise known as synapses.
Jonathan Javitt: Hope has signed non-binding letters of intent to acquire three already profitable interventional psychiatry clinics.
Jonathan Javitt: Our pipeline includes the number of additional clinics in Florida with whom we're an negotiation, as well as additional clinic groups in other geographies.
Jonathan Javitt: We're in the process of drafting definitive acquisition documents and navigating the complexities of purchasing medical treatment facilities under state regulations.
Jonathan Javitt: We're dedicated to building a company that will bring life saving treatments to patients and financial returns to our investors.
Let's look at these programs in more detail.
Jonathan Javitt: Suicideality is a national epidemic. Approximately 3.8 million Americans make an active plan to commit suicide each year, according to the CDC. An American dies from suicide every 11 minutes, and worldwide somebody dies from suicide every minute.
Jonathan Javitt: Today we are faced with a system where all patients who need life-saving precision psychiatry care with ketamine and other therapies are not routinely able to get it.
Jonathan Javitt: ketamine, for example, is available today almost exclusively to those who can afford to pay out a pocket and will remain so until FDA approval of ketamine for treating suicidal depression is obtained.
Jonathan Javitt: We've initiated filing of our MDA for NRX 100, our intravenous preserver to free ketamine and the treatment of suicidal depression and indication with no approved pharmacotherapies.
Jonathan Javitt: This MBA is supported with efficacy data from multiple well-controlled trials.
Jonathan Javitt: As identified in our 5th in our FNK, we've accepted non-binding potential turns from a commercial pharmaceutical company to license and distribute NRX100.
A tiered double digit royalty.
Jonathan Javitt: The issue of ketamine safety is one that will garner increased attention as the repeated use of ketamine becomes more widespread.
Jonathan Javitt: Data from both primate and human studies show that repeated ketamine doses on the order of 60 doses or more of a currently available commercial intravenous ketamine may be toxic to the brain
Jonathan Javitt: The currently available ketamine preparation was designed for single use of the product and anesthesia.
Jonathan Javitt: Ketamine is currently sold in a multi-dose file where it was anticipated that doctors would draw from the same file for multiple doses.
Jonathan Javitt: Back in the 1960s, when this preparation was formulated, it was manufactured with a potentially toxic preservative bensophonium chloride. While there's no evidence that bensophonium chloride is toxic at its current concentration for the intended use in anesthesia,
Jonathan Javitt: Its safety has never been shown or even proposed for repeatages [inaudible]
Jonathan Javitt: The Manufacturers of Benzothonium fluoride identify it as caustic, toxic and capable of causing severe burns.
Jonathan Javitt: This vast of preservatives has increasingly been removed from eye drops because of clear evidence of toxicity to the cornea and contraintiva, even at the currently allowed levels.
Jonathan Javitt: Pronic use of ketamine is associated in the literature with ulcerative cystitis, a dangerous bladder condition.
Jonathan Javitt: This condition may be caused by the excretion of the preservative rather than by ketamine itself. Notably, there are no cases reported of interstitial cystitis following the use of spravato and nasal form of esketamine that does not contain bensophonium chloride.
Ketamine Preparations with Ben Ciphonium Flourage from the Market
until it can be shown safe for repeated use.
Jonathan Javitt: In light of our success in achieving long-term stability with preservative-free ketamine, the company is also filing an abbreviated NDA or ANDA.
Jonathan Javitt: for preserving a free ketamine for all currently approved human and veterinary uses of intravenous ketamine.
Jonathan Javitt: Hence, although we will 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.
Jonathan Javitt: We have current manufacturing capability to supply 1 million vials of ketamine per month with the potential to scale up if needed.
Jonathan Javitt: The toxic preservative is not the only challenge with the old Vietnam Hero Academy formulation.
Jonathan Javitt: It's supplied at a pH of less than four, which can be administered intravenously, but cannot be injected subcutaneously because it causes pain and may cause skin ulcers. [inaudible]
If you raise the pH, ketamine precipitates out of solution.
Jonathan Javitt: Those who have tried to get ketamine by mouth have learned that the resulting blood levels can be highly inconsistent.
Jonathan Javitt: Similar problems have occurred with Ketabino's Sprint. While intravenous administration is completely reliable in achieving intended blood levels, this mode of administration requires skilled nurses and clinic facilities.
Jonathan Javitt: An attractive alternative is to give ketamine subcutaneously in the same way that insulin and newer obesity drugs are given.
Jonathan Javitt: That root of administration is only enabled by a pH neutral form of ketamine.
Jonathan Javitt: We've now developed a patentable version of pH neutral ketamine that remains stable at room temperature.
Jonathan Javitt: and our HTX100, and we expect to begin human bio-equivalent studies this year. As is well-known, bio-equivalence is far simpler and less expensive to prove than safety and efficacy.
If we are successful in gaining FDA approval,
Jonathan Javitt: For NRX 100, we have the potential to expand the number of patients who currently benefit from this form of care many fold.
Jonathan Javitt: The current off-label use of ketamine and brain disorders is generally only available to patients who can pay out of pocket.
Jonathan Javitt: We expect NRX 100 once approved to be widely reimbursed, best providing access to the vast majority of people in need, not just those with the means to spend thousands of dollars in cash for treatment.
NRX 100 represents a nature opportunity for our company.
Given the current market for Internazal S. Cattamine, J. J. Sprovato, which...
is already approximately $1 billion.
Jonathan Javitt: and the label states that it has not demonstrated anti-sulicidal properties.
Jonathan Javitt: Now let's discuss NRX 101, our oral combination of de-cyclocerying and NMDA receptor blocker and lyracidum, the standard of care and bipolar depression.
Jonathan Javitt: Bipolar Depression affects approximately 7 million people in the U.S. Current treatment options all carry the risk of suicide and acafasia, a side effect of serotonin-active antidepressants, which is closely related to suicide.
Jonathan Javitt: People with bipolar depression and acrophesia or suicidality are an imminent risk of self-harm. These patients need better treatment options urgently.
Jonathan Javitt: NRX 101 could represent a paradigm changing breakthrough in the care of bipolar depression. In clinical trials, we demonstrated comparable antidepressant effect.
Jonathan Javitt: through the leading anti-depressant in this space with a statistically significant improvement in the safety of NRX 101 when compared to the standard of care that is the residue. Yeah.
Jonathan Javitt: In our recently completed clinical trial presented at the American Society of Clinical Psychopharmacology, NRX 101 demonstrated a comparable ability to reduce symptoms of depression when compared to the residue.
Critically, NRX 101 demonstrated a reduction in symptoms of suicidality.
Jonathan Javitt: And it's the first oral antidepressant to reduce symptoms of acothesia, a potentially lethal side effect of nearly all antidepressants.
Jonathan Javitt: This could represent a new paradigm for treatment of bipolar depression.
Speaker Change: You may not have encountered the word Acathesia before. However, key opinion leaders and patients who have suffered from Acathesia regarded as the worst side effect of antidepressants.
Jonathan Javitt: Patients frequently describe it as a feeling of jumping out of their skin. Patients with acothesia are known to jump off roofs and in front of oncoming trains.
Jonathan Javitt: Recently, a patient petitioned the British Columbia Supreme Court for the right to enter life, rather than continue to suffer from Acathesia.
Jonathan Javitt: Patients have simply had to endure this side effect in order to achieve the critical antidepressant effect that are needed to control bipolar depression.
Speaker Change: The data we presented at ASCP confirms data from our earlier stable B trial, demonstrating that NRX 101 is the first or-length had to press to have effective and had to press
while simultaneously decreasing a confusion to a state of gravity.
Speaker Change: We believe this product profile could lead to NRX 101 becoming the drug of choice and bipolar depression.
Speaker Change: We're initiating the filing of an NDA for Accelerated Approval of NRX 101 for suicidal bipolar depression and patients at risk of acupuncture.
Speaker Change: Given our strong data and the lack of treatment options for this group of people with bipolar depression, we in our regulatory council believe this could be a vital unmet need and appropriate for consideration of accelerated approval.
Speaker Change: We plan to initiate filing in the early second quarter and anticipate a 2025 to do for date.
Speaker Change: The company estimates that the market for the initial indication is over two billion dollars, while the broad bipolar market could exceed five billion dollars.
We've made substantial progress with Hope Therapeutics in recent months.
Speaker Change: During the second half of 2024, we began outlining the plan for Hope Therapeutics as a national and ultimately international network of interventional psychiatry centers.
Speaker Change: that would combine neuroplastic treatments in an integrated and reproducible manner.
Speaker Change: The business model for hope therapeutics is analogous to that of companies who have been instrumental in making kidney dialysis reliable and reproducible in a manner that transformed the industry.
Speaker Change: We've learned that ketamine alone is not sufficient to maintain remission from suicide in many patients with depression and PTSD. In clinical settings, ketamine has rapidly achieved a 50% reduction suicidal ideation.
Speaker Change: In numerous trials and real world settings, this magnitude and rapidity of effect is a dramatic improvement from the prior 50 years of experience with SSRI and others through a tone and targeted antidepressant.
Speaker Change: The critical element is maintaining and enhancing the ketamine effect. This will in our view require a full range of additional therapies.
Speaker Change: In the fourth quarter, we announced our first major move to implement the Hope Business Plan when we announced signing of a non-binding letter of intent.
Guilquard, Kadema LLC, a pioneering interventional psychiatry clinic
and the way to California.
Speaker Change: Gideeman's founder, Dr. David Fightful, agrees the service hopes chief medical innovation officer post acquisition and you heard his presentation with me at the sax forum. [inaudible]
Speaker Change: He is one of the first academic psychiatrists to move ketamine and TMS therapy for the community care model and is frequently featured in the national media, such as Rolling Stone, and Tom Peacock as one of the most knowledgeable experts in the safe and appropriate use of ketamine.
Speaker Change: and other advanced therapies in mental health treatment. The subsequent to the cadema commitment the company has was poised to contract to acquire a partner with nine facilities in Florida, aiming for 15 to 20 facilities in Florida by year in 2025.
Speaker Change: The clinical centers that are being incorporated in this acquisition program are revenue-generating and even the positive centers that the company believes can experience substantial revenue growth through the addition of a broader array of comprehensive services.
Speaker Change: Looking at the market, we estimate that the acquisition of 20 clinic networks, each with current revenue of approximately five million, will be required to meet the 2020, sorry the 2025 growth target. [inaudible]
Speaker Change: On the financial front, the best-in-class plagues currently generate operating margins of around 30% with significant opportunities for further growth.
Speaker Change: We expect funding for hope to be independent of and thus non-beludive the NRX shareholders.
Speaker Change: However, we expect that a portion of the earnings generated through hope will support NRX's path to profitability and support our plan path to a spin out of the company and subsequent listing on a national stock exchange.
Speaker Change: Further, we recently announced the closing of our third tranche of funding from Anson Funds an institutional investor bringing the total amount of financing to nearly 20 million.
Speaker Change: We anticipate that hope clinics will be financed by traditional bank loans supplemented by private equity and strategic blenders.
Speaker Change: We recently received a term sheet from a manufacturer of TMS technology to document funding from banks and similar financial institutions.
Speaker Change: As you've seen in R10K, we've substantially reduced operating expenses and are forecasting profitability on a going forward run rate basis.
Speaker Change: By the end of 2025, with revenue and EBITDA from Hope Therapeutics, along with projected sales of our medications.
Speaker Change: My first action when the board asked me to assume the leadership of NRX was to invite Mr. Michael Abrams to become our first full-time CFO . Mike has decades of experience as an investment banker, fire technology executive, and chief financial officer.
Speaker Change: He stepped into NRX just two months before the end of the fiscal year and achieved his first audit on time and with no material concerns raised by the auditors.
Speaker Change: Now I would like Mike to review our financial results from 2024, Michael.
Thank you Jonathan.
Michael Abrams: For the year ended December 31, 2024, NRX pharmaceuticals reduced its loss from operations by approximately 9.3 million, or 33.5 percent, to 18.5 million.
27.8 million for the year ended December 31, 2023 23.
Speaker Change: This change was primarily driven by a decrease in research and development expense.
Speaker Change: For the year-end of December 31, 2024, research and development expense decreased by approximately 7.2 million or 53.6 percent.
Speaker Change: to $6.2 million as compared to $13.4 million for the year ended December 31, 2023. This change is primarily driven by a decrease in clinical trial and development expense due to the conclusion of the phase 2b3 study for NRX 101.
Finally, Channel Administrative Expense for the Year-Ended December 31st.
Speaker Change: 2024, decreased by approximately $7.7 million to $13.5 million, as compared to $14.2 million for the year-end of December 31, 2023. This change was primarily driven by a reduction in insurance and employee costs.
Speaker Change: and partially offset by an increase in consulting fees, relays the potential acquisition of several psychiatric clinics in support of the growth model for Hope Therapeutics.
Speaker Change: As of December 31, 2024, we had approximately 1.4 million cash and cash equivalents.
Speaker Change: As noted above in January 2025, the company completed two financings with aggregate gross proceeds of approximately 8.5 million. Management believes the current available cash resources will be sufficient to support ongoing operations through the at least the end of 2025.
Speaker Change: NRX continues to implement operational efficiencies to extend cash runway and maintain focus on our path of generating revenue and value for our shareholders.
Speaker Change: Please see detailed financials, our form 10K, filed with Securities and Exchange Commission, which will also be available on our website. With that, I turn the call back to Jonathan.
Thank you Michael.
Speaker Change: The mission of NRX to prevent and treat suicidality in patients with depression and PTSD has continued to move forward. Over the last year, we've streamlined operations, we've retired toxic debt, we've capitalized the company to move forward.
Speaker Change: planned 2025 Padoofidates for our two NDAs 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.
Speaker Change: I'd like to thank the NRX team, our investors, and most importantly, the patients who participated in our clinical trials to their steadfast support of our pursuit of this vision.
Operator, we're ready to take questions from the audience.
Speaker Change: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the one on your touchtone phone. You will hear prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the two.
Speaker Change: If you are using a speakerphone, please set the hands up before pressing any keys. One moment, please feel your first question.
Speaker Change: Your first question comes from Jason with D-Boral Capital. Your line is now open.
Jason: Good morning, guys. Congratulations on all the progress. A couple of questions. Jonathan, you made a good argument for removing the preservative from ketamine.
Jason: If you remove the preservative for ketamine, how does that change the formulation and, for example, what do you do when it in its place?
Jason: When you say, what are you doing in this place? Why do you need to do anything in this place?
Jason: Why is it there in the first place? Is it just ketamine degree? So the preserve it was stuck in ketamine
Way back when...
Jason: because an anesthesiologist would put it on a cart in a hospital and would draw out of the via multiple times. So, any time you stick more than one needle into a sterile vial, it's considered to be contaminated and to require a...
a German side of preservatives in the bottle.
Gotcha, so as long as you have a single you as long as you have a single you file
By law, you don't need a preservative [inaudible]
Jason: Now, when we started this, people said, oh yeah, but that that preservatives critical to the stability and stability of ketamine will, you know, turns out not to be true. That turns out to be a novel and surprising finding.
Jason: That's why we've pointed out that we've now got the ability to file for two-year shelf stability room temperature for preservative free ketamine. You've seen this happen in the ophthalmology industry.
Jason: where it was assumed that glaucoma eyedrops and other eyedrops that people use on a long-term basis.
Jason: It would always be in a big bottle with a preservative in it. The same was true for artificial tears that people were used to buying in the drugstore.
Jason: and 15 or more years ago I was involved in research that showed that those preservatives are actually quite toxic to the cornea and the contraintiva and that's why more often than not people are buying artificial tears and single dose preservative free vials.
Jason: and more and more of the prescription eyedrops have been moved to single dose preservative free vials. If you read the material data sheet on benzoyam chloride, it's pretty frightening, the material data sheet says this product is caustic.
It's toxic, it may cause severe burns.
and clinical evidence is that it's anything but safe.
Speaker Change: Perfect, thank you. I just didn't make the connection during the call, but I got it now, and it makes perfect sense.
Speaker Change: Can you talk a little bit about the acquisition strategy to add more clinics this year and without giving guidance, just give us some kind of rough idea on
Speaker Change: on how that acquisition is going, what's the interest level, how many clinics out there are there particular geographies that you'd like to focus on?
Speaker Change: Talk with us a little bit about what we should expect a year from now.
Speaker Change: Well Florida has become a geography of focus forest partly because we've identified
Speaker Change: A group of clinics that in our view are already doing it right.
Speaker Change: Not to paint with too broad a brush, but you can find a ketamine clinic on every other street corner in the United States today. But many of them are clinics that do ketamine on Mondays and vitamin drips on Tuesdays and God knows what on Wednesday.
Organizations that are know how to combine
Ketamine, and in the future, other psychedelic drugs.
Ad.
Are few and far between.
Speaker Change: These are tough patients to treat on a comprehensive basis and anybody who says come on in for your ketamine shot and go elsewhere for the rest of your care is not doing any patient any favors.
Speaker Change: So, that's why we retain BTIG and are partnered with BTIG to cast a broad net for clinics that we believe are doing it right.
Speaker Change: and to use that platform of acquiring clinics as a basis for building out a nationwide network.
Bye-bye.
When we talk about the kinds of financing that's available
Speaker Change: You're talking about a tiered risk financing. Our conversations so far, just like commercial banks are prepared to finance up to 50% loan to value. I'm fairly attractive commercial
Our conversation so far suggests that the clinic owners
Speaker Change: are willing to take some piece of the acquisition in the form of therapeutic shares. And that leads financing in the middle, perhaps 20 to 30% of each acquisition.
Speaker Change: That will come from investors who expect a higher rate of return but a rate of returning that hope can certainly afford to take [inaudible]
From our perspective, is not a nature impediment.
to getting our initial acquisitions done.
The Hard Work
Speaker Change: is the pile of legal documents that are required to acquire any healthcare facility in the United States, especially in states that have corporate practice of medicine laws.
Speaker Change: and the due diligence that we have to do both on the financial front and on the regulatory front, on each acquisition to make sure that these are acquisitions we can put on the balance sheet and offer to our shareholders.
Speaker Change: Perfect. I completely understand. Thank you. One last question. In the press release, you talk a little bit about the potential for a ketamine DL, 300 million in milestones and tiered royalties and the fact that you have, you know, you've received interest non-binding term sheets. Can you expand a little bit about that because that certainly changes the company's future and creates kind of a very significant inflection point for investors.
Yeah, I feel it's never done till it's done.
But as we've moved closer to having a marketable drug,
Thank you.
There's a real... [inaudible]
to be able to offer such a drug to patients.
Speaker Change: I don't think anybody questions the size of the available market.
Speaker Change: and having a partner that already has a sales force in the field could be more attractive than raising the money to launch the drug ourselves.
Speaker Change: You know, we've told our investors what we can say today about what that might look like.
Thank you.
Thanks Jonathan, very exciting times.
Speaker Change: Your next question comes from Tom Schrader with BTIG. Your line is now open.
Tom Schrader: Good morning. Thanks for taking the question. Good luck on the busy year. Follow up on the last line of questionings. The ketamine clinic landscape in Florida. Is it chunky? So when you say you have nine facilities, is that one deal? Or is that nine independent negotiations? Should we look for this target to happen in big chunks?
Tom Schrader: and then maybe if you can give us a little bit of color on...
Speaker Change: having an A-N-D-A and an N-D-A in front of the FDA at the same time. How unusual is that? Is it the same people that deal with it? Is your manufacturing packet enough for both? It's unusual to me, and I thought you could talk a little bit about. [inaudible] I'm sorry. I'm sorry. I'm sorry.
and what it would look like at the FDA. Thank you.
So, on the continuing front, I think you should expect...
acquisitions to the...
Chunky, your word.
Speaker Change: to represent more than in general, more than one clinic at a time. And the case of the Demo, which is a one-site facility, we started there because...
Speaker Change: We've been unable to identify another clinic that's doing so many things right all at the same time.
hi
Speaker Change: But in general, the clinics that are doing it well, are doing it at multiple locations.
That to be part of our acquisition path.
Speaker Change: With regard to an ANDA and an NDA, the NDA is specifically to ask the division of
Speaker Change: to add the depression and suicidality indications to the cabinet label.
Speaker Change: And quite frankly, somebody probably could have come along and said, well let's do that with the original formulation that has the preservative in it.
But it's really a signing certificate to size.
Speaker Change: and attempting to prove safety and efficacy to the satisfaction of review division while also satisfying the manufacturing side of FDA.
Speaker Change: Well, if that same manufacturing package, that same module three that we've already submitted, while it's necessary,
to the New Drug Approval Application.
Well, it's necessary to the psychiatry indications.
It's both necessary and largely sufficient.
Speaker Change: for an ANDA because under the ANDA we're not seeking to change the label ketamine, we're seeking to offer a preserved free version of a drug that's already generic. [inaudible]
and so the endo would be for analgesia.
Speaker Change: The end would have the same indications as the currently marketed forms of ketamine but it wouldn't have the toxic preservative in it.
Okay, thanks for the color.
[inaudible]
Vernon Bernardino: Your next question comes from Vernon Bernardino with H.D. Wayne, right? Your line is now open.
Vernon Bernardino: Terms with the commercial pharmaceutical company for NRX 100. Do you anticipate that'll be a second quarter announcement as far as the finalization of the deal?
Oh, well, you know, we, we hope it may be and
Vernon Bernardino: Yeah, it feels never done till it's done. On the other hand, we see the expression of interest as one that may even become broader.
Ad.
Vernon Bernardino: So we have the resources to continue to move these applications forward.
Vernon Bernardino: We don't need a commercial deal right now, but we would certainly welcome the right partner.
Great.
Speaker Change: In terms of the ketamine intended for intravenous use and removing benzotonium chloride, so the idea there is a single use. How easy would it be for a competitor to make the wrong single use?
presentations of Ken Aminant for intervening this use.
Speaker Change: Well, there are a couple of challenges that anybody who wants to enter the market will have today. Certainly, the sponsor of ketamine.
who owns the label, could certainly do it.
It's, it's a one and two.
But if they don't already have a Preservative Free,
Speaker Change: Formulation of Fristability, they've got a couple years of work before they can enter the market and file that ANDA.
Speaker Change: Do we expect that we'll long-term have the ketamine market to ourselves?
Speaker Change: I think that's, you know, too much for anybody to expect for a market. That's quite that large.
Speaker Change: But for a period of time, we may well, and if some of the advice we've received that
Speaker Change: The Preservative Free Formulation we've engineered is surprising and ultimately stands up to patent review. We could have that market first to ourselves for longer than anticipated.
Speaker Change: Psychiatry Centers, you intend to acquire. Those are still projected to be once you think will have run race of the last five million a year in in revenue.
Or, or in larger.
Okay.
Speaker Change: And one of those, you intend to acquire, you say three position, one of those includes Kadima, or these are in addition to Kadima.
I'm just kidding.
Okay.
Speaker Change: That will probably be appropriate for say anything more at this time.
Okay.
Great. Thanks for the information. Thanks for taking my question.
Thank you.
Yeah, and congrats on the progress.
David Gingher, David Gingher, David Gingher,
Speaker Change: Your next question comes from Ed Woo with this ascendant capital. Your line is now open.
Ed Wu: Yeah, congratulations on the progress as you may potentially have NRX 100 and NRX 101 approval this year in the FDA. Have you thought about what you might do internationally with both of them? Thank you very much.
Speaker Change: Well, we've talked in previous calls on previous filings about relationships that we've developed in France, a European country that is highly focused.
on this disease.
Speaker Change: The French estimate that somebody becomes suicide in France in 45 seconds.
I'll do it.
Speaker Change: So, you know, were that to continue to evolve and our relationship with Foundation Fundamentals
Speaker Change: We've not considered going beyond US and Europe by ourselves as you know we've had relationship with Asia Pacific entities.
And as we gain momentum, we expect...
We expect that interest to increase at the same time.
Speaker Change: Great. Well, thanks for answering my questions, and I wish you guys good luck. Thank you.
Ladies and gentlemen,
Speaker Change: I will now turn the call over to Matt for other questions.
Speaker Change: Thank you, Joel. Jonathan, we have one other question electronically that came in and that is regarding hope. And the question is that hope sounds very interesting, but how does it directly benefit NRX shareholders that NRX owns the equity in hope at this point?
Speaker Change: Well, right now, hope is nested on the NRX balance sheet and to the extent that NRX continues to own.
Speaker Change: shares hope therapeutics if hope becomes profitable. Those profits will roll up to the benefit of NRX, as other investors come into hope. Those profits will devolve to the benefit of all investors and hope. Those profits will devolve to all investors and hope.
Speaker Change: But, you know, prominent investor is likely to remain NRX, we've talked.
Speaker Change: about our desire to spin out hope shares to those who own NRX stuff at the time of the spin-out. Yeah, it was disclosed last year.
and that was slowed down by… [inaudible]
Speaker Change: At toxic lender, who ultimately was guided by the court that they couldn't block, the whole spin-off, so
Speaker Change: We continue to be in a position to move forward towards spending some of those shares, need to make sure that we do it in a tax free manner to NRX shareholders.
Speaker Change: But meanwhile, as long as NRX is on the, as long as hope is on the NRX balance sheet, anything that hope does devise to the benefit of NRX shareholders.
Speaker Change: Okay, thank you very much. Everyone, that's always at the time we have for questions today. Thank you everyone for joining us this morning. We're extremely excited about the year ahead and with our two potential drug approvals and a subsidiary targeting multiple profitable mental health clinics.
Speaker Change: Disconcludes the NRX Pharma suitable for quarter 2024 results conference goal. Thank you all for participating and have a great day
Speaker Change: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating NASA, you please disconnect your lines.