Unicycive Therapeutics Inc Stock

Good afternoon. Welcome to Needham's 25th Annual Healthcare Conference. I'm Serge Belanger, one of the health care analysts at Needham.

For our next session, I'd like to welcome Unicycive Therapeutics, a company developing therapies for kidney diseases. And from the company, we have the CEO, Shalabh Gupta, who is going to tell us about Unicycive. They have an important PDUFA coming up in a couple of months here. I think that will be a big focus.

So I'll hand it over to Shalabh, and he can talk to us about Unicycive, and then we'll follow up with a Q&A session after the presentation. Shalabh, welcome.

Thank you. Thank you to the Needham team, and thank you, Serge, for giving me this opportunity. It's great to speak with all of you. Thank you so much. I'll be making forward-looking statements. So please read them before making investment decisions.

By way of background, we are a clinical-stage biotechnology company based in Silicon Valley, California. And Serge, as you mentioned, we have a very near-term upcoming catalyst, which is a PDUFA date for our lead drug, which is oxylanthanum carbonate. And it is indicated for patients who suffer from hyperphosphatemia, a condition happens to patients as they are on dialysis and they have high phosphate. We have focused our entire energy at the moment on our lead drug, which is the OLC.

We have a second drug also called UNI-494, which has completed Phase I clinical trial, is indicated for acute kidney injury. Most of my presentation are in -- will be focused on OLC.

A couple of highlights before we go through the rest, just on this slide. As you can see, we have a cash runway. We announced our Q4 results of 2025, which gives us a cash runway into 2027. We reported unaudited cash as of March 27 of $54.9 million, and the PDUFA is less than 3 months away.

We are preparing for a commercial launch. Oxylanthanum carbonate was first submitted to NDA in 2024. We received FDA's response in the form of a complete response letter in June of 2025. There were deficiency with a third-party manufacturing vendor, which is not related to product. We resubmitted our NDA end of last year, and we have a new PDUFA date of June of this year.

Let me talk very briefly about what the disease condition we are talking about. In the United States, there are roughly 550,000 patients who are on dialysis. And dialysis is a -- as many of you know, is the last stage of kidney diseases. Chronic kidney diseases affect 1 in 7 adults in the U.S. It's a very high prevalence. But chronic kidney disease can progress over years or decades. At the very last stage of chronic kidney disease or end-stage kidney disease, ESKD, patients have to be on dialysis. We are talking about patients who are on hemodialysis. When they are on hemodialysis, dialysis filter takes off a lot of bad things in the blood, but phosphate is something that does not get -- most of it passes through the filter. So something needs to be given for managing these phosphate levels.

And the phosphate typically, how it works is that phosphate combines with calcium. People who have normal kidney function, phosphate doesn't create any problem. But since patients who are on dialysis, they have no urine, they are anuric, they don't make urine, and that is why they are given -- they're attached to the dialysis machine. And hemodialysis, in particular, it's around 3 sessions per week that these patients have to undergo.

The point that we want to make is that phosphate is not a trivial condition. 1 milligram per deciliter increases phosphate, increases mortality, which is what you see in dark purple graph here. But more importantly, it also increases morbidity. So patients end up in going to hospitals and increase cardiovascular risk because phosphate combines with calcium and makes blood vessels non-pliable. Blood vessels, when they are normal, they can pump the blood throughout the body, but when there is a phosphate and calcium deposited in the form of plaque, it makes them more like a lead pipe and therefore, patients end up in having heart attacks and die from cardiac conditions. That's the #1 problem.

The second problem is that phosphate combines with calcium, gets soft tissue deposition. So these patients then have fractures or soft tissue deposition, meaning they have bony protuberance, if they come out of their part of soft tissue, that can be very, very painful. So it is not a trivial problem. It is something which is very well understood.

The problem has been there for quite some time. There are 6 approved drugs. But if you look at over a decade, number of patients have had difficulty in managing their serum phosphate level. I won't go through all the details. But if you look at just the graph on the purple side, depending on how you measure it, if you take more stringent measure, which is less than 4.5 milligram per deciliter, which is the target serum phosphate level recommended by guidelines, 75% of U.S. patients are not able to achieve their target serum phosphate level. If you become more relaxed, you still find 44% of patients are not able to achieve their serum phosphate. And that begs the question, why is that?

This slide answers that question. Many of these patients end up in taking 20 to 30 pills per day. And half of those pills, which you see the top left, the bar chart, half of these pills are attributed to controlling their serum phosphate. We have done a number of market research, but in particular, one that we did very early on in the company was to ask 100 U.S. nephrologists unaided question, what is the #1 problem these patients you encounter, they suffer from and the single most common answer was the lower pill burden.

Just to give you a background about our drug. Our drug is a proprietary molecule. It's a new chemical entity, which use the nanoparticle technology. We have multiple patents, including the strongest patents that are available in our industry called composition of matter patent that allow the drug to be covered until 2031. And with patent term extension, we have patent coverage until 2035. The patent term extension is given upon approval from FDA. So 2035 is a good amount of time that we have patent term protection -- patent term extension. But in particular, our drug solves this mean problem of pill burden by being able to provide the pill in the form of a small baby aspirin that patients can take with each 1 pill per day.

In the latest clinical trial, which I'll show you the data, we were able to show roughly 70% of patients that can be managed with 1 small pill 3 times a day. The pill allows 3 key advantages. One is potency because lanthanum, which is an active component in that drug, it binds phosphate very, very potently, so that provides a potency because it's highly potent, so you can give a small pill.

And the palatability comes from the fact that these pills don't have to be chewed, and I'll show you the next slide here where you can see some of the pills are available on the market. As you can see, the Velphoro and Fosrenol, these are the pills which can be given a smaller number of pills, but they require patients to chew the pill.

In particular, Fosrenol is a drug that requires patients to chew the pill in the form of a thin paste. And as you can imagine, many of these patients have a hard time managing their medical condition, and asking them to chew a pill and turn into a thin paste is a really, really challenging part.

One may say, by looking at these things, it doesn't seem to be so hard. I don't mind chewing 3 pills a day. But you have to remember, these are the patients who are taking 20 to 30 pills. So they have other medical comorbidities.

Chronic kidney conditions happen to patients who have other problems. Most commonly, these patients suffer from diabetes, high blood pressure, hypertension, and there are a variety of other medications.

So I mentioned about clinical data. Let me walk you through some salient features of our clinical data. We ran a pivotal study that showed in a small patient population, we were asked to run this study as a part of a regulatory approval process. What we see that when patients are given a drug, the adverse event profile is relatively small. And let me qualify that because it's a relative number. Diarrhea, we saw 9%, vomiting of 6%. And you will say, well, that there is still adverse event in all of these drugs, almost all of them, they have some sort of GI adverse events. As a physician, I can tell you there is really no drug that has no side effects. Almost every drug has some side effects. But in particular, if you look at this, this is a package insert. In other words, this is not taking a drug from one study, comparing drug from another study, which happens in our industry, and we sometimes say very simply that you're comparing apples to oranges. But this is a package insert, which is what goes on the label of the drug that FDA approves it. So this is very simple what is an approval label.

If you look at these drugs and most importantly, I want to draw your attention to Renvela, what you see that Renvela has a very high adverse event profile, and they are all -- most of them related to gastrointestinal system, a GI system. Vomiting, nausea and diarrhea, they're all in double digit. Renvela is a polymer. When patients take the drug, they feel bloated, they feel constipation, flatulence, and they don't want to take these pills. And Renvela, I point this out because it is the commonest drug that is given. It is prescription-wise, roughly 52% of U.S. patients are given Renvela for this. So that's where we want to compare -- draw attention, compare and contrast.

The other part that you see on the green is lanthanum carbonate, which is Fosrenol. I showed you in the previous slide that Fosrenol can be given in the form of one large pill that requires patient to chew the pill. Fosrenol never took off. And oftentimes, you think about it, what is the reason Fosrenol did not take off? And that goes back to the palatability part, which is that patients are required to chew these pills.

Moving on, we ran this study. When the patients were started in the study, their physicians were giving them the drug they thought was the best drug for those patients, and we had no input, no influence on them. Moreover, physicians were giving them the dose that was best tolerated that these patients could take.

On a baseline when patients were started in the study, 59% of the patients were being able to manage and that recommendation was to bring them below 5.5 milligram per deciliter. So prior to starting on our study, the percentage of patients who were being able to get managed below 5.5 milligram or 59%, 6 weeks on our drug that we call it the titration period, that bar moved from 59% to 90%.

Being a physician and being somebody who has spent decades in looking at this type of data, that seems impressive. No matter what we think about, it is a small patient population, which I said more than once. It is a smaller duration of a study, but this 31% improvement looks really, really remarkable. And I've had personal experience in talking to a number of physicians, and they say, this is a very impressive performance. If you look at the bar chart on the green, you see 41%, meaning these are the 41% of patients who were not able to achieve their target serum phosphate level. At the end of 6 weeks, that was 10%. So in other words, only 10% of patients were not able to achieve their target serum phosphate level. This was a surprise to us because Fosrenol does not have this impressive level of efficacy.

The second part of the study was also looking at the doses and the caveats that I outlined in the previous slide, I'll continue with that. In a small study with a short duration, we found that 1 pill 3 times a day was able to address to 69% of patients, they were able to get to that target serum phosphate level.

What gives us even more excitement, even more confidence is that we bring this drug to market, if we show data anywhere similar to here as we continue to expand. This is a drug that can potentially solve problem for many, many patients, and we'll talk more about it. We did patient-reported outcomes or PRO, and there are some of them here. Obviously, you could think about it that if you have a small pill that they're taking with the size of baby aspirin, patients will feel better. They'll feel this is a preferred therapy. They feel satisfied. And some of these things are reflected in the slide.

Now coming back very quickly on the commercial part. We are a small biopharma company. We -- if somebody has asked me, how do you think about commercialization? First thing, I'd say, commercialization of any drug is not simple a trivial matter. By recognizing that we remain grounded and focused to commercialize the drug, and I want to show you in the next few slides why we believe that we have an opportunity to do well for patients, do well for physicians and do well for our investors as a small company to be able to launch the drug.

So this is a market which we've talked about before. We will remind you that a large number of patients are not able to take that drug. So what we are able to do here is that this nanoparticle technology allows us to be able to create a profile of the drug that they can take with a lower pill burden.

Building upon that, the way the patient population is divided in this market is that roughly 2/3 of the patients are paid by the government directly, which is a form of CMS, Centers for Medicare and Medicaid Services, and 1/3, which is 36% here, so we're just saying, broadly speaking, are paid through commercial insurance. We want to be able to provide a seamless, a frictionless experience for patients and physicians. Our view is that with a potential best-in-class profile of the drug, if we have a frictionless experience of physician and the patient, it will help them to be able to adapt the drug and take the actual clinical promise of the drug in real world. So we are creating a hub service, which is -- allows a physician to write a prescription, a patient to get the drug while we manage the back-end part of our reimbursement and going through their insurances.

This slide is useful for those of you who are not spending their days and hours in looking through the reimbursement landscape. Beginning of 2025, in January 1, 2025, our government changed the plan from a Medicare Part D, Part D as in David, to Part B as in boy. And what it does is that the drugs, which are drugs like in this class, which is lowering phosphate, they went from Medicare Advantage plan to Medicare Advantage Part B plan. Typically, Medicare Part B is for medical benefits. And what it does is that it allows the drug to be -- for a few years to be in a part of TDAPA, which is a transition period and then go into bundled. But during that TDAPA period, the best advantage happens is that these drugs get seamlessly reimbursed by CMS.

Building upon that a little bit further, this is a U.S. map and the reason we put this map out there because when we talk about our ability to launch the drug, people always say, well, can you help me understand how can you launch a drug with a small team and a small sales force. Everything is relative. So when we say small, it's a different number for different people. But what I can say to be more qualified that a small -- a little bit more clearly is that we are not looking to hire hundreds and hundreds of reps. If you look at the U.S. map, what you find that top 5 deciles of physicians who prescribe 50-plus percent of these prescriptions are still roughly 2,100 physicians. So that is 2,100 physicians prescribe 50% of all these drugs and the patient population, if you look at the map, as you can see, the purple dots, is not equally distributed throughout the country. It's not a rare disease. So you can't have a very, very small sales force, but it's also not a primary care drug like a treatment for diabetes where patients are spread all over the country and you need a huge sales force.

There are a couple of other nuances which I want to call out here. Number one, I mentioned to you, there are other drugs approved in the market. Two, this is a disease condition where physicians understand if you are a board-certified nephrologist in the United States, you don't need to be reminded again, again that serum phosphate levels have to be managed.

So there is a lot of awareness in the market for this. There are other drugs in the market. There are people who have come to us and told us that as soon as the drug gets approved, it makes no-brainer in the sense for them to be able to prescribe the drug. So we feel there is an opportunity here to make a difference for patients, physicians and our investors.

Building upon that further, pre-TDAPA period is the time when we get the drug approved and we are launching in order for us to get access to Medicare fee-for-service, which is the one that I showed you, 1/3 of the market in Medicare Part B, we will have to apply for TDAPA. It's a simple application process. We are ready to apply as soon as the drug is approved. And during the TDAPA period, as I mentioned, the drug has a seamless, frictionless reimbursement from the government. And that allows us to be able to launch the drug.

On one hand, I said the drug launches are hard, but you always want to -- by acknowledging something is hard, you realize that you have to remain very focused. You realize that there is an opportunity to do well if we execute, and that is where we are focused on. And then post TDAPA, these -- all these drugs go into bundle.

I won't go through this. I've talked about this in very beginning that we have composition of matter patent that allows patent term extension through 2035. These are very near-term milestones Serge and I will be talking again after this presentation in our Q&A. But we have a near-term milestone. We have financing that allows us to be able to launch the drug. We are ready and fortuitously for us, we have a TDAPA designation that allows us to be able to provide the drug to as many patients as possible with the support of the CMS reimbursement mechanism.

The second drug, I mentioned that we won't talk much about it, but we have a second drug that has been given orphan disease designation, ODD, by the FDA, and we'll focus on the drug after approval and launch of the first drug.

Just very quickly, we have a small team, which I mentioned, but we have a very solid team. We have people who have been in this industry, have had multiple NDAs, drug approvals. We have in corporate side, people who have spent decades in nephrology market, specifically in dialysis market.

Doug is listed here, but we have a number of other people we brought in under Doug's leadership who have had the experience of bringing a drug to market, specifically working in dialysis market and we have a support of some of the world's leading nephrologists, Dr. Chertow, Dr. Pergola. These are the physicians who have been involved in many, many of these clinical trials of phosphate-lowering therapy. Dr. Wolf and Dr. Mehta have been also giving us advice both on the first drug as well as on the second drug.

Continuing further, we have a number of leading institutional investors, which we are very grateful to them for their support and their investment. And we are really excited about what is ahead of us.

So with that, I'm going to pause here and happy to take any questions and answer any questions that may come up. Serge?

Well, thanks for the overview. Maybe if we can start with the upcoming PDUFA. If I recall, there was a CRL last year. So just maybe talk about how you address that issue? And what you think the risk is for this upcoming PDUFA in late June?

Absolutely, Serge. As I mentioned, the CRL last year was not related to drug. It was related to a sub vendor, not a main drug substance vendor. So give me -- let me just explain to you and provide you a little context. The drug is made in the form of a tablet. Roughly 85% or so work is done in the form of making that powder, which has -- it is called, in technical term, drug substance, then powder goes into forming a tablet.

The drug substance vendor had no issue. They were inspected by FDA. They had no problem. It was a vendor that was putting this powder into form of pill and packaging and shipping. They had the issue. And we went to FDA after CRL in the form of a Type B meeting to understand how best we can address, how quickly we can get the drug on the market. We have a -- if you think about the initial vendor, vendor A, who's making the final tablet. We had a vendor B also that has been able to make the replicate and make the final drug product. So we have redundancies in the system. But when we met with the FDA, our question was that help us agency, how do we get to the finish line? And they gave us a feedback based on the progress the vendor A had, which is the original vendor. The best way, the fastest way for the drug to be approved is to work through vendor A.

Based on their feedback, based on the progress the vendor A had made, we resubmitted our NDA in December of last year and FDA accepted the NDA, which gives you a confidence. It's not me saying it. FDA would not accept your NDA if they believe there was no progress made. And Serge, what I can tell you, knowing what I know that we feel very confident that whatever those challenges were, the vendor has addressed it. And in the very near term, we believe we can get -- surpass those past challenges and get through the regulatory approval process.

There is nothing else. I know it's there in the press release, but let me just clarify one more time. It's in multiple press release. No preclinical toxicity issue, no clinical issue, no safety issue, nothing to do with the clinical trial. So it is a facility issue. Unfortunately, we were stuck with that. But I am saying that knowing what we know, we feel super excited about that, and we can't wait for the drug to be approved and be able to launch it.

Great. And remind me again, are you seeking approval of a single tablet size or multiple tablets?

It is -- the approval is based on the 3 different strengths. Drug comes in the form of 500 milligrams, 750 milligrams and 1,000 milligrams.

Got it. Okay. And is there anything that you'll be looking for in the label for the product to be differentiated and be able to compete in the hyperphosphatemia market?

Absolutely. So all these drugs, almost all of them have a label, which is called primary hyperphosphatemia as in the only drug that does not have a primary hyperphosphatemia, meaning that they are the first-line treatment is XPHOZAH, which is set to be in combination with a binder or if the patients fail on binder. So we expect the first-line approval.

Number two, differentiated, the drug is given in the form of a tablet because we are following the 505(b)(2) pathway, our label would look somewhat similar to that of Fosrenol. So just building on that, Fosrenol label allows as a first-line treatment. Where we will be differentiated, will be different is that Fosrenol label says that chew the tablet whole and we have the ability to give that tablet in the form of an oral pill that can be swallowed, so that's appreciated.

And then the last but not the least is that we believe there is an opportunity for us to discuss with the agency, which I don't know just yet how it will go to be able to include the clinical trial data in the final packaging.

Okay. And you highlighted on one of the slides that there's, I think, up to 5 other options currently available for this market. Just curious which one you'll be looking to displace. And you highlighted that the pill burden is significantly lower, the tolerability is better. So just curious which one you're targeting for displacement?

Absolutely. Very good question. The commonest drug, and that's why I focused on Renvela, the commonest drug that patients are given is Renvela. That's 52% of the market. The next commonest drug is calcium-based drugs, which are drugs like pumps. So those are the 2 biggest, for lack of better word, the incumbent in the marketplace.

Renvela has done well. Doug, who's on our team, launched Renvela for Genzyme and grew to over $1 billion in sales. A lot of these patients are on genetic version of Renvela, but patients don't want to take the pill. I showed you the adverse event profile. There's a lot of pills. Some of these patients I think 12 to 18. And then they still are not able to be able to achieve their serum phosphate level.

Okay. You talked about TDAPA. I guess what is the key for getting traction here in this market? So obviously, getting TDAPA is going to be part of it. But do you need to enter contracts with the various dialysis organizations? How important will that be going forward? And can you start doing that work prior to approval or they require a label and pricing to get into those discussions?

All very good questions. To answer holistically, we are in discussion with the -- these dialysis organizations. And a lot of work gets done after the drug gets approved. So we -- I do not see a world where we can announce, oh, we partner with the dialysis organization. So that's not happening until the drug gets approved.

But the groundwork has been done, Serge, not for days or months. We've been doing it for years because there are 6 dialysis organizations, if you will, and I'll name 2 here that managed 95% of this market. So if you talk to 6 people or 6 key organizations, you have 95% of the market covered. The 2 big one is Fresenius and DaVita, and we have a lot of respect for their clinical team and the business team and we are talking to both of them. So we will be looking forward to announcing these things as we get the approval and launch the drug.

They're important, Serge, and this is a win-win for them because they have a benefit of having a drug in TDAPA and it's such a great clinical profile, we have an opportunity to work with them. We'll be looking forward to announcing that as -- these are the next milestones, if you will, after the approval in the second half of this year and early next year.

Yes. In terms of pricing, I know it's too early for you to talk about pricing, but there's -- like you said, there's 5 other products out there. So I'm sure that gives you some kind of guidelines on where you can price the product. So maybe just highlight the changes right now.

Sure. I think it will be worthwhile to your point, just to highlight some of the top 2, if you will. The most expensive drug today is XPHOZAH, which is a drug which is priced at $41,000 per patient per year. The next most expensive drugs are -- next 2 most expensive drugs are AURYXIA and Velphoro that are around $25,000, $26,000. So you can take -- I always say that we can't give you specific pricing. But if you take any of the bookends, $41,000, $25,000, $26,000, you get to some range.

And then one thing, which is, it is good that you brought this up, there are generics in this market. Historically, in the past, at least generics have gone down in the market and the branded shares have increased. So there are generics there, too. They are differently priced. So sometimes erroneously, people take, well, the generic is sold for x thousand dollars.

You see generics are generics. This is a class of drug. This is a disease condition where drugs are not interchangeable. Renvela profile is very different than AURYXIA. AURYXIA profile is different than Velphoro, and oxylanthanum carbonate is completely different. So I just want to say that it's a nuanced market, not very common where your generics and branded and generics have gone down and branded continue to increase. So...

Does the presence of generics lead to a pre-authorization barrier for potential adoption? Or I think -- there's a lot of patients that don't tolerate the product. So maybe that gets away from it.

That's right. So in the commercial side, it's a business which is like if you're a private insurance, there is a preauth, prior authorization, 100%. But to get through the prior authorization is not like -- it's not like you have -- most of these patients, Serge, if you go and talk to clinicians, they move out of this prior auth because they can't take the drug, they don't respond to it. And we are not talking 6 months or 6 years, we're talking about 6 weeks, usually 4 to 6 weeks, the patients don't tolerate it. And that's the commonest profile of the patients. Physicians are frustrated. Physicians, they want to find any solution that will help the patients.

Okay. And we cover other companies that have products covered by TDAPA. So there's always discussions about new legislation that could improve it. Anything that you're keeping an eye on that is near term or maybe even medium term?

Absolutely, Serge. Look, you pointed out something that most of us forget. We have an ability to make a huge difference for patients, physicians and investors. The current legislation, there is a one bipartisan bill, which some of our colleagues in the industry that have TDAPA products have gone there. And we, as a company, Unicycive is supportive of this. We have a lobbying group in the Washington, which we are part of, which we believe that allows an opportunity for TDAPA to go from 2 years to 3 years. As you can imagine, that will have a huge impact on upside for us, a positive impact.

I don't talk about that, that much because we are focused on launching the drug, and we believe there is so much opportunity for investors to think about very near term. But if that were to come into pass, which we -- I can't give you the specific time line end of this year. What we do know it will be part of a bigger omnibus bill, and this is a bill that will be part of some larger bill. And this has a bipartisan support, which is, again, a little bit rare these days in our government.

But there are folks in the industry, there are folks in the government. They are both equally motivated to allow this class of drugs that are covered by TDAPA to have broader access. So we are excited about that. It will be a huge upside for the company. We feel we have a bigger role to play. And we are definitely as a part of that group, Kidney Care Partners is an organization that industry represents that has got all the dialysis -- major dialysis organizations in it, and we are a proponent of it.

So PDUFA is in late June. Obviously, you get approval before then. Do you wait until you have formal TDAPA reimbursement to launch, meaning that would be pushed out until, I don't know, it takes 4 to 6 months.

Yes. We will launch it. Yes, we will launch after approval. And our goal is that -- our goal, Serge, is to give patients, physicians and everybody in the health care system makes use of our drug. We believe the drug clinical profile is so compelling that the more people get used to it, Serge, the better it is for the launch for patients for everybody. So we plan to launch it before TDAPA.

And if you remember, TDAPA covers 1/3 of the market that is Medicare fee-for-service, but the commercial is not dependent on TDAPA application.

Okay. And in terms of funding, I think you mentioned there's $50-some million on the balance sheet that allows you to launch the product? Or do you need additional funding to get to the full launch?

We have -- I mean we said roughly $55 million, $54.9 million to be precise, was as of March 27. This is an unaudited number. And this is a very recent, very near-term number. And we announced that because we wanted to make sure that people understand that we have resources. Upon approval, within 21 days, we have the first tranches of warrants that are use it or lose it. This is a warrant tranche that bring in another $25 million. So we feel we are adequately financed for the near term.

Okay. I think we only have a few minutes left. So you just want to highlight something that you think maybe is still underappreciated by investors in the Street about Unicycive and your product.

If I were to summarize everything in 3 key bullet points, if you can't remember anything else, this is a potential best-in-class profile drug. In the large market, the sales of these drugs were over $1.5 billion in the U.S., this class of drugs in general. So we have an opportunity to address this market.

It is a concentrated market where a small company can launch the drug and be successful. We have support of some industry-leading health care investors. But as such, we remind ourselves that a small team can do big things if we remain focused, and that has been the ethos from the very beginning we built the company. And I'm really excited to be talking to you as we get the drug approved and launch it in upcoming months.

All right. Well, thanks for spending time with us this afternoon. We appreciate it, and good luck as you approach this upcoming PDUFA.

Thank you, Serge.

All right. Thank you.

Thank you to you, and thank you to Needham for hosting us. Thank you so much.