NRX Pharmaceuticals, Inc. Q2 FY2025 Earnings Call
NRX Pharmaceuticals, Inc. (NRXP)
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Auto-generated speakersGood morning, everyone. Welcome to NRx Pharmaceuticals' Q2 2025 Earnings Conference Call. This call is being recorded on Wednesday, August 20, 2025. I would now like to turn the conference over to Matthew Duffy, Chief Business Officer. Please proceed.
Thank you, Ludy. And welcome, everyone. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to vary from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release issued Monday and in the company's Form 10-Q, which may be accessed from the Investors page of the NRx Pharmaceuticals Inc. website. Joining me today on the call are Jonathan Javitt, our Founder, Chairman and CEO; and Michael Abrams, our Chief Financial Officer. Dr. Javitt will provide an overview of our company's progress as reported in Monday's 10-Q, following which Mike will review the company's financial results. Following their prepared remarks, we will address investor questions. I'll now turn it over to Jonathan.
Thank you, Matt. Good morning, everyone, and thank you for joining us. The past several months have been nothing short of exceptional for NRx. We've made vital advances across each of our programs with 3 drug approval applications in progress and our evolving network of interventional psychiatry clinics, Hope Therapeutics taking place. At the same time, as we position for near-term revenue, we've reduced our quarterly operating loss by approximately 50% year-over-year while filing more than 80,000 pages of regulatory data in the last quarter alone with a small team of dedicated scientists. As we announced on Monday, we've strengthened our balance sheet and added long-term healthcare specialist investors with extensive experience in biotechnology as well as experience in managing multiunit retail operations led by Mr. Brandon Mall and the B Group. These investors have demonstrated their long-term commitment to our success by way of their 1-year lockup agreement not to trade short or otherwise hypothecate our stock while also forgoing warrants and other dilutive features that are so obstructive to biotechnology stocks today. We at NRx look forward to their ongoing partnership. As you can see from our balance sheet, we have substantially reduced the burden of convertible debt that was in place when I rejoined as CEO in order to create a more straightforward growth path for long-term appreciation-oriented investors. Let me start with a high-level overview for each program, starting with NRX-100. Our preservative-free intravenous ketamine is following 2 parallel approval processes. First, however, let me take a moment to explain how this came about. As many of you know, my original medical discipline is ophthalmology. And for 10 years, I cared for patients with chronic glaucoma first at Johns Hopkins and then at Georgetown Universities. Around 1995, one of my colleagues noticed that glaucoma patients were far more likely to suffer from dry eye and tear film deficiency than most other eye patients. The problem was tracked down to benzalkonium chloride, a preservative that was in most glaucoma medicines. And the problem was compounded by the presence of benzalkonium chloride in the artificial tear drops that were used to try to help the dry eye that was caused by the glaucoma drops in the first place. Clear evidence emerged that benzalkonium chloride was toxic to the epithelial cells that cover the eye and to the nerves of the cornea. That's why so many eye drops have gone preservative-free over the years. Well, the first cousins of benzalkonium chloride, benzethonium chloride or BZT, is found in ketamine. BZT is similarly toxic to epithelial surfaces. It was added to ketamine when the drug was first formulated 70 years ago. So the same vial of drugs could be used for multiple doses of the drug without contaminating the bottle. In today's hospital environment, multi-dose administration is increasingly infrequent. The BZT and ketamine may not pose much risk when ketamine is used once in the operating room for anesthesia. The problem is patients who get ketamine for depression often get repeated administrations. As we have shown the FDA in our citizens petition, and as you can see from the scientific paper identified in the Q in the earnings release, multiple doses of ketamine with BZT preservative can approach toxic doses of BZT. That's why we filed the citizens petition with FDA to have BZT removed from all forms of ketamine. Our basis for this petition is expert toxicology analysis documenting that BZT has never been shown to be safe and is not on the list of preservatives generally recognized as safe, that's called the GRAS list by the FDA. Indeed, FDA's concern about BZT is high to the point where FDA no longer allows its use in hand cleaners and topical antiseptics. Thus, we believe that BZT has no legitimate place in a parenteral drug that will be administered repeatedly. As I said, we're following 2 regulatory paths for ketamine. The first is a new drug application or NDA for NRX-100 in suicidal ideation for patients with depression, including bipolar depression. The second is an abbreviated new drug application, or ANDA, to make preservative-free ketamine available for ketamine's existing indications. Data are clear in our view that NRX-100 can offer effective and safe options for patients with suicidal depression whose only current treatment alternative is ECT or electroconvulsive therapy. Our corporate presentations highlight randomized controlled trials demonstrating superiority of ketamine to placebo to active comparator along with demonstration of equivalents to ECT overall in more than 1,000 patients. We'll be presenting real-world data for FDA's consideration on nearly 180,000 patients treated with both ketamine and SPRAVATO. We aim to submit these data in support of an application for accelerated approval and have already filed the module 3 manufacturing information and the draft proposed label. You can read about accelerated approval on the FDA website. It represents an approval pathway for Fast Track and breakthrough drugs, whereby intermediate clinical data are presented in support of an initial approval with a concomitant commitment by the sponsor to present this positive clinical proof of efficacy within 5 years. Last week, FDA granted a major expansion of the Fast Track designation originally granted to NRX-100 in 2017 whereas the initial designation was related to bipolar depression. FDA has now broadened our Fast Track designation to encompass all patients with suicidal ideation in depression, including bipolar depression. The CDC estimates that 13 million Americans consider suicide each year and that an American dies from suicide every 11 minutes. Hence, FDA's broadened Fast Track designation offers NRx a tenfold greater opportunity to make a real difference in one of the largest public health crises facing our nation. FDA under its new leadership and the MAHA program has dramatically focused on national public health crises by creating the Commissioner's National Priority Voucher program that affords substantially faster review times of 1 to 2 months versus the standard 10- to 12-month review, provides enhanced communication throughout the review process, and creates potential for accelerated approval of NRX-100. To receive a CNPV a product must meet at least 1 of the following criteria must address the U.S. public health crisis and must deliver more innovative cures for the American people and must address a large unmet medical need, and this was noted in our Fast Track designation that we do, in fact, address a large unmet medical need and must onshore drug development and manufacturing to advance the health interest of Americans, strengthen the U.S. supply chain, or increase affordability. Our team believes that NRX-100 meets all of CNPV's criteria. On the second approval path, we filed the ANDA in June of this year, utilizing existing manufacturing data found in module 3 of our suicidal depression NDA. We've since received comments from the FDA identifying only 1 scientific discrepancy, along with some easily remediated administrative deficiencies. Specifically, FDA asked us to justify the level of a single inert ingredient in the formulation. We're actively addressing this matter with FDA and do not believe it will cause undue delay in the approval process. The existing market for ketamine has been projected at approximately $750 million a year, and we believe NRX-100 made in the United States and offered without any toxic preservatives offers patients and clinicians a superior option. Approval of the citizens petition removing benzethonium chloride from the U.S. ketamine supply would give NRx a substantial position in that existing $750 million generic ketamine market. We'll continue to work diligently with the FDA to move our application as rapidly as possible and provide a safer version of this critical product to the American public. NRX-101, our oral product for the treatment of suicidal bipolar depression recently achieved an important milestone that is the filing of the initial module known as module 3, the chemistry, manufacturing, and control section or CMC with the U.S. FDA last week. This was filed under the previously granted breakthrough therapy designation awarded to NRX-101. And therefore, we anticipate rolling review of this application. We're working diligently to complete this filing and will request priority review, which, if granted, would confer a 6-month review period. There are more than 7 million patients suffering from bipolar depression in the U.S. and many of these are at risk of akathisia, a terrible side effect related to serotonin active drugs that is closely related to suicide and can cause an irresistible need to move, inability to sit still, and all too often is associated with patients jumping off of roofs, jumping in front of trains, and otherwise harming themselves in horrible ways. These patients are at tremendous risk of self-harm, and there are no current treatment options available that have been shown to reduce akathisia, although newer generations of atypical antipsychotics have demonstrated less akathisia than their predecessors. NRX-101, in our estimate, offers the only current treatment option that both reduces depression, suicidality, and akathisia in this patient group and as an oral treatment should generate widespread accessibility and benefit in these patients. We look forward to coming interactions with the FDA on this application. Hope Therapeutics continues to make great progress developing what we believe will be the nation's premier interventional psychiatry clinic network. We expect to finalize the purchase of our first clinics and continue to evaluate new opportunities in the field. We aimed to achieve this goal some months ago, but needed to wait for a state regulatory approval to acquire Dura Medical that approval is now in hand as we announced last week. With that milestone reached, we anticipate that you will shortly see the closing of acquisition financing that is well along in the closing process. Our goal of delivering the most comprehensive, high-quality care possible in each of our clinics continues to drive us, and we look forward to continuing to update you on the progress of our network. The clinics we have under contract currently will provide strong revenue and EBITDA for the growth of our entire network. We've identified additional milestones reached in our 10-Q filing, including the FDA's grant of a PDUFA fee waiver, saving the company $4.3 million in filing fees. Waivers are granted at the discretion of FDA to small business entities and for drugs that are deemed necessary to the public health. With the key milestones reached in Q2, and with the addition of a committed investor group composed of experienced biotechnology investors, we now have the balance sheet capacity to continue our quest to bring Hope to life well into the coming year.
Thank you, Jonathan. For the three months ended June 30, 2025, the company reported a net loss of $17.5 million compared to a net loss of $7.9 million for the same quarter in 2024. This increase in net loss was primarily due to an approximately $12 million charge related to fair value accounting measurements for previously issued convertible notes and warrants, which is recorded in other expenses and is noncash. For the three months ended June 30, 2025, the company reported a loss from operations, excluding the noncash effect of fair value accounting measurements, of $3.7 million, improving from a loss from operations of $7.1 million for the same quarter in 2024. This marks an improvement of over $3.3 million, or 47%, compared to the prior year’s quarter. As of June 30, 2025, NRx had about $2.9 million in cash and cash equivalents. On August 18, 2025, the company completed a registered direct offering with a group of experienced long-term healthcare and biotechnology investors, led by B Group Capital. In this offering, the company issued approximately 3.9 million shares of common stock and received net proceeds of about $6.5 million. The shares from the offering are subject to a 1-year lockup, and the terms did not include warrants, pricing resets, or other structured elements. The company did not engage a broker or investment bank for this offering. The company believes its current cash position will support operations into 2026 and provide enough capital to reach important regulatory milestones. Our main focus remains on advancing our primary drug development initiatives and planned clinic acquisitions to build long-term value for our shareholders. With that, I turn the call back over to Jon.
Thank you, Mike. As you can see, the company has made significant progress and stands at the precipice of enormous inflection points for patients and investors. Our goal of bringing hope to life is closer than ever. Our progress towards 3 potential drug approvals in the near-term 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 would like to thank the NRx team, our longtime and new investors, and most importantly, the patients who participated in our clinical trials for their steadfast support of our pursuit of this vision. Operator, we're ready to take questions from the audience.
With that, our first question comes from Tom Shrader with BTIG.
And it really has been a lot of progress this quarter. I have a couple of quick ones. For 101, why is the pathway accelerated approval? It seems like you have very conventional clinical endpoints that you kind of argue you've hit and I think have accelerated approval for more biomarker-type trials. And a quick one on the new voucher. It looks like it's even more valuable than the older pediatric voucher. Is it clear it can be sold the way the other vouchers were? Has that been defined yet?
Well, let me start with the second question first. I think the agency has been clear that the CNPVs are not to be sold. And certainly, we would have no interest in selling a Commissioner's National Priority Voucher if we were to be awarded one. Our sole objective is to get this drug to patients as a life-saving drug for a critical unmet medical need as quickly as possible. That's the objective of the commissioner's program and that's the objective of NRx. As far as accelerated approval for NRX-101, as you recall, the primary endpoint of the clinical trial that we conducted was reduction in depression compared to lurasidone alone. And secondary endpoint was reduction in suicidality and akathisia as separate named endpoints. The clinical trial did not demonstrate that NRX-101 is a superior antidepressant to a very well-established antidepressant namely lurasidone, but did demonstrate reductions in akathisia and suicidality. And we believe that those are intermediate endpoints and that they haven't necessarily been demonstrated to be associated with long-term health benefits. So for that reason, we think the appropriate thing to do is ask for accelerated approval only for use in those patients who have demonstrated akathisia and suicidality despite best available medicine. In other words, for patients where there's truly an unmet medical need and an immediate risk of harm to the patient in the absence of treatment for those conditions and to ask the FDA to give us 5 years in which to demonstrate that NRX-101 has a conventional long-term benefit compared to placebo.
Just to follow up, what would the second trial or the follow-up trial look like? Do you have any sense?
Yes. The confirmatory trial, if you look at the approval path of Auvelity, for instance, the confirmatory trial would be a very conventional randomized controlled trial of NRX-101 versus placebo with depression on the MADRS as the primary endpoint because that's the endpoint that FDA has really set as the bar for all antidepressant drugs.
And your next question comes from the line of Jason Kolbert with D. Boral Capital.
Again, congratulations on all the progress. Can we talk a little bit about some expense guidance? And I'm not really talking about third quarter or fourth quarter. But just from a big picture point of view, R&D is that likely to ramp up in the future? Should we see it at about the same level? And G&A, as you become a commercial entity, how do you envision G&A expanding? And I also have some questions about the acquisition pipeline associated with the clinics.
Mike, please go ahead.
Thank you for your question, Jason. As you know, we don't provide guidance, but I believe the best indicator of our financial situation and expectations can be found in the 10-Q. It's notable that we've achieved approximately a 50% reduction in our loss from operations. As a pre-revenue company, our losses are entirely composed of general and administrative expenses and research and development expenses. The decrease from $7 million to $3 million is a direct result of our internal budget adjustments and ongoing cost-saving measures. It's important to focus on our loss from operations rather than the net loss, as the latter includes fair value accounting, which can be misleading due to its noncash nature. Our trends in reducing overall operating costs from G&A and R&D are clear, and we believe they will continue. While we're not ready to provide future guidance, we feel it's important to highlight these points for our investors to consider. Now, I'll hand it back to Jon.
I understand your comments, but we expect to see G&A increasing as we become a commercial entity. I believe what you are saying is that the timing of the expense increase aligns with the strength of the balance sheet, so they are connected. That's how I interpret your point.
Yes, to follow up on that, any increase in general and administrative expenses that might occur during commercialization typically happens alongside revenue growth. We have been managing the business as it currently stands. As Jonathan mentioned earlier in the call, we believe we are close to commercialization and are advancing all of our drug programs as well as opportunities with Hope Therapeutics. As revenue starts to flow in, management will continue to evaluate the situation and make decisions accordingly. However, I won't provide forward-looking statements or projections regarding the expected revenue. Any increase in expenses related to commercialization will align with the revenue itself. I acknowledge your point.
Typically, a question like that will be incorporated into a model that ultimately estimates a price per share for a company like ours. You are asking a very valid question about whether we expect our general and administrative expenses to rise as we get closer to selling a drug. While the answer may very well be yes, by the time we reach that point, our chances of success in any such model will have significantly improved. Therefore, the anticipated rise in G&A costs will be closely linked to an increased likelihood of business success.
Jonathan, could you share your thoughts on the acquisition pipeline regarding clinics? Also, what do you envision your footprint looking like in five years from a broader perspective?
Well, 5 years from now, if we're successful in what we aim to do with Hope Therapeutics, first of all, it will almost certainly be an independent company from NRx Pharmaceuticals. And the companies that we would hope people would look at are companies like DaVita and Fresenius that transformed the dialysis industry from disparate clinics where it was almost impossible for a consumer to know what kind of quality to expect to coherent networks of care delivery organizations where consumers had a reasonable expectation of consistent quality, consistent outcomes across the network. And investors enjoyed extraordinary financial success in the process. So our challenge is finding best-of-breed clinics that have really integrated the use of neuroplastic drugs, and this is a word you'll hear us using more and more. People talk about psychedelic therapy as if the hallucinations that are induced have something to do with the medical benefit. And they may. But in our view, what's really going on is that this class of drugs causes the brain cells to form new connections to other brain cells. That's a process called neuroplasticity. If you want to make a computer chip, you take a piece of silicon and you etch it with a laser, you may use programming to turn circuits on and off, but the circuits on the chip will be there for the end of time. The brain works completely differently. Brain cells are constantly branching, making new connections to other brain cells, pruning those connections, and the evidence is that when that process of neuroplasticity stops, that's when you have severe depression, you have suicidality. And all of these drugs that are showing benefit are doing so in our view and in the evolving view of many of the scientists we talk to because they're causing neuroplasticity. So how do you do that? You can do it with ketamine and related drugs. There's evidence you can do it with the Psilocybin class of drugs, what people call the psychedelics. There are drugs over the horizon that achieve neuroplasticity without the hallucinations. You can achieve it with a treatment called transcranial magnetic stimulation, which is FDA approved, you put powerful electromagnets outside the head, and achieve profound changes on depression, on suicidality. There's emerging evidence that may work for autism, for PTSD. And people are seeing benefits with hyperbaric oxygen therapy. I'm sure there will be other neuroplastic therapies coming down the pipe. Our objective with Hope Therapeutics is to identify best-in-class clinics that are already combining those treatments. The notion of a ketamine clinic where you can get IV ketamine on Mondays and peptides on Tuesdays and vitamins on Wednesdays, that's the opposite of what we think patients need. So we may be able to identify $100 million of acquisition of that kind of best-in-breed clinic. But very quickly, you'll see Hope shifting to a model of building clinics from the ground up to extend those flagship clinics that we acquire on day 1 because we don't think we can grow beyond $100 million or so just by acquiring clinics that already exist. So it's hard enough to talk about what we'll do next year versus 5 years from now. But I think 5 years from now, you're going to see a national network in place such that patients and families who are suffering from these conditions know to pick up the phone, call Hope Therapeutics, and expect to have a life-changing opportunity to get better.
And your next question comes from the line of Patrick Trucchio with HC Wainwright.
Congrats on all the progress advancing NRX-100, NRX-101 and the Hope platform. It's clear the team has made meaningful strides on both clinical and regulatory fronts. And we have a few follow-up questions. The first is just on the citizen petition impact. You've explained the scientific basis for the citizen petition on benzethonium chloride. I'm wondering if you can give us a sense of when you may expect an FDA response. And from a commercial perspective, if the FDA were to mandate a preservative-free formulation across ketamine, how meaningful could that revenue uplift be for NRX-100? And how challenging might it be for existing suppliers to adjust?
The FDA is required to respond to a citizen's petition within six months of it being filed, and we are optimistic that they will respond sooner. The Secretary of Health and Human Services, Mr. Kennedy, has shown a strong aversion to artificial colors and preservatives found in foods and drugs. He clearly understands that many substances we traditionally considered safe may not be safe without proof. In this case, we are discussing a preservative that is so toxic the FDA prohibits its use in hand cleaners or topical antiseptics. The FDA is well-informed about benzethonium chloride, potentially even more than we are. Currently, the generic ketamine market is valued at $750 million annually, primarily consisting of foreign products. We believe the level of BZT may vary across products, as we have not yet analyzed other manufacturers' products ourselves. The toxicology paper we released last week indicates that repeated ketamine doses lead to a cumulative effect from this amine preservative. Notably, there is a known occurrence of ulcerative cystitis, a serious inflammatory condition affecting the urinary bladder lining, associated with repeated use of ketamine, which has not been reported with the use of J&J's SPRAVATO product, a nasal formulation of ketamine. The key differences between the two products include that intravenous ketamine is racemic, while the J&J product is the S enantiomer, and there is also a difference in administration routes. Regardless, once inside the bloodstream, the residual metabolite is processed by the liver and eliminated through the bladder, with the significant distinction being that J&J's product does not contain benzethonium chloride. Thus, we may already be witnessing the effects of repeated use of BZT-containing ketamine without needing extensive research for other cases. Removing this toxic preservative from generic ketamine would likely significantly benefit patients, as its inclusion only facilitates multiple uses of the same bottle by doctors, not patient care. The potential impact could be an increased market share for us with a U.S.-produced, safe, and reliable ketamine formulation, while current suppliers might struggle to reformulate their products and re-enter the market. Some may choose to move on to different products entirely instead of making the required adjustments. Therefore, this citizen's petition could help us surpass financial expectations.
That's really helpful. And just another follow-up on NRX-100. I think you mentioned plans to submit real-world data from nearly 180,000 patients treated with ketamine and SPRAVATO. I'm wondering how you expect the FDA to weigh this data set alongside the randomized controlled trials? And do you believe it could further strengthen the case for an accelerated approval?
Well, we think real-world data in that quantity of patients certainly should motivate the FDA to see the case has substantially strengthened. The FDA guidance is that the agency really needs to pay attention to real-world data. And Commissioner Makary has said very clearly that he wants to move the agency solidly into the 21st century in terms of using real-world data. So we hope this will be one of the first examples where real-world data supports an approval. It's very rare to have a drug approval coming down the pike where more than 200,000 people have already gotten the drug for this purpose. It just doesn't happen to be approved for this purpose yet. It's a unique circumstance.
Yes. That's interesting. And then just on NRX-101, an interesting highlight of the potential synergy between NRX-101 and TMS. And I'm wondering if this combination could accelerate adoption either within the Hope clinics or across interventional psychiatry more broadly? And is this something that you may seek a label expansion to more formally capture this potential?
Thank you for your question. We've come across a compelling scientific study conducted in Canada that demonstrated that D-cycloserine, the primary ingredient in NRX-101, enhanced the effects of transcranial magnetic stimulation (TMS) in treating depression when compared to a placebo. The study used a dose of 100 milligrams per patient per day, which is lower than the dose required to block the NMDA receptor. My brother, Dan Javitt, has conducted significant research showing that effective doses for D-cycloserine as a potent NMDA antagonist are around 400 to 500 milligrams per day. The lower dose of 100 milligrams is thought to still have neuroplastic effects, even if it isn't a strong NMDA antagonist. The study results showed a significant improvement in outcomes when TMS was combined with this lower dose. We are currently in discussions with U.S. academic medical centers to conduct a confirmatory clinical trial in this area. This could lead to a potentially exciting expansion of NRX-101's label. Additionally, if NRX-101 can enhance the effects of TMS, it could elevate TMS to a more mainstream treatment option for depression, possibly as a first-line treatment, compared to traditional serotonin medications, which may have variable efficacy and carry warnings regarding increased risks of suicidal thoughts. Any advancements that improve TMS accessibility and effectiveness could significantly change the way we approach the treatment of both suicidal and ordinary depression, as well as PTSD.
And your next question comes from the line of Ed Woo with Ascendiant Capital.
Yes. Congratulations on all the progress. What is your commercial strategy with NRX-100, now 101? Are you going to wait until closer to approval to actually expand and potentially get a sales force?
Yes, it's a wonderful question. And Matt Duffy is on the phone with us. A lot of people know Matt in his role within our company as our Chief Business Officer. People have known Matt in his role on Wall Street as a highly respected research analyst. What fewer people know is that Matt got out of college, joined Pfizer, succeeded in a commercial role to the point where he actually wound up as the product manager for Viagra and went on to launch highly successful biologics at other companies. So Matt, why don't you walk Ed through what you'd be likely to do if we drop the drug approval in your lab?
Sure, thanks for the question, Ed. It's great to hear from you. We've handled launches like this before, with MedImmune being the most notable and also Lev Pharma, both of which had focused launches for their drugs. It will vary with different targets. For NRX-100, consider the clinics we have, like Hope and other mental health facilities. There are likely 600 to 1,000 strong locations that will administer these medications, and this will expand once we have a reimbursed product. When you look at those numbers and think about the potential impact of a representative or a medical science liaison, it seems feasible to succeed with a small commercial team. At MedImmune, our initial group of reps and MSLs consisted of about 20 people targeting around 500 hospitals. Lev had a similar approach, focusing on individual rheumatologists. For NRX-100, a launch with around 20 people is reasonable, and considering the costs associated with MSLs and reps, we can effectively cover the key players in the market, capturing a significant portion of the opportunity in mental health related to ketamine and NRX-100. The approach for NRX-101 will be similar but unique. There is a targeted number of around 1,500 to 1,600 psychiatrists who treat bipolar patients, based on some market research from a few years ago. If we analyze rep and MSL coverage for that group, it suggests we need a similar number of field personnel. Those roles might be slightly more expensive due to the higher demand for MSLs. We could effectively cover those 1,500 high-prescribing bipolar psychiatrists with a limited number of reps. These efforts, along with the associated marketing, will be very focused. Both launches will benefit from the shared knowledge of bipolar depression and major depression, which have significant overlap. As we get closer to launching the products, our company will continue to enhance its commercial strategy. We’re likely looking at two commercial teams of around 20 to 25 people, supported by a strong infrastructure. This targeted approach was successfully achieved at MedImmune and Lev without excessive spending, which is key to reaching profitability much faster, especially compared to larger launches, such as those with a 500-person sales force like Pfizer would utilize.
And we have no further questions over the phone lines. I would like to turn it back to Matthew Duffy for closing remarks.
Well, thank you, everyone, for joining us this morning. We're extremely excited about the path ahead with 3 potential approvals and our Hope subsidiary targeting multiple profitable mental health clinics and interventional psychiatry centers. This concludes the NRx Pharmaceuticals Second Quarter 2025 Results Conference Call. Thank you all for participating. You may disconnect.