Rigel Pharmaceuticals, Inc. (RIGL) Earnings Call Transcript & Summary

Greetings, and welcome to the Rigel Pharmaceuticals conference call to discuss FORWARD study results. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the call over to Dolly Vance, Executive Vice President, Corporate Affairs and General Counsel. Thank you. You may begin.

Welcome, and thank you for joining us today to discuss topline results from the FORWARD pivotal Phase III clinical trial of fostamatinib in patients with warm autoimmune hemolytic anemia, who have failed at least one prior treatment. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties and may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31, 2021, and subsequent filings with the SEC, including our Q1 quarterly report on Form 10-Q on file with the SEC. Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I would like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez.

Thank you, Dolly, and thank you, everyone, for joining us today. In addition, with us on the call today are Dr. Wolfgang Dummer, our Chief Medical Officer; Dave Santos, our Chief Commercial Officer; and Dean Schorno, our Chief Financial Officer. During the call today, I will make some opening comments. Wolfgang will then review data. And then I will make some -- review our next steps. And after that, we will open the call to your questions. Beginning on Slide 5. In our press release earlier today, we announced the topline results from FORWARD, our pivotal Phase III clinical trial evaluating fostamatinib in patients with warm autoimmune hemolytic anemia, or warm AIHA, who have failed at least one prior treatment. The FORWARD trial is based on -- was based on the positive results from our Phase II study, which was conducted solely in the U.S. and showed a compelling response in its patient population. We were surprised, therefore, that the trial did not demonstrate statistical significance in the primary endpoint of durable hemoglobin response in the overall patient population. However, we saw encouraging results in a post-hoc regional analysis of U.S., Canadian, Australian and Western European trial sites, showing that patients treated with fostamatinib demonstrated a favorable durable hemoglobin response compared to placebo. This group includes nearly 60% of patients enrolled in the trial. In the Eastern European trial sites, patients did not demonstrate a favorable hemoglobin response, representing a contradictory and confounding result. Importantly, fostamatinib safety profile in the FORWARD trial was consistent with the existing safety database and no new safety issues were observed. At this time, we are continuing to analyze the data to understand the geographic differences in patient disease characteristics and outcome and plan on to discuss these findings with the U.S. FDA. With that, I will now turn the call over to Wolfgang to provide an overview of the FORWARD trial and to review the data. Wolfgang?

Thank you, Raul. Moving to Slide 6. As you are aware, FORWARD was a global, multicenter, randomized, double-blind, placebo-controlled trial, evaluating the efficacy and safety of fostamatinib compared to placebo in patients with warm AIHA. 90 patients were randomized one-to-one to receive fostamatinib or placebo twice daily for 24 weeks. Randomization was stratified by severity of anemia, its screening and concomitant the reduce at baseline. The primary endpoint of the trial was durable hemoglobin response defined as achieving a hemoglobin level of greater or equal than 10 grams per deciliter with an increase from baseline of greater than or equal to 2 grams per deciliter on 3 consecutive available visits during the 24-week treatment period. The trial also evaluated several key secondary endpoints with additional hemoglobin assessments in the patient report the outcome, the FACIT-fatigue score. After 24 weeks, patients had the option to enter into an open-label extension study. Slide 7 provides patient disposition for the trial. As you can see, more patients on fostamatinib, 84.4%, completed 24 weeks versus 75.6% in the placebo group. Hence, fewer patients discontinued from the fostamatinib arm for the reasons listed on the slide. 71 patients rolled over into the extension study. Slide 8. Here are the baseline characteristics of the patients who enrolled in the trial. As you can see, as a post-hoc evaluation, we have broken this up by geographic regions because we've seen different efficacy outcomes in those regions. The left 2 columns show you the overall ITT population. The middle 2 columns, all Western countries combined, excluding Eastern European countries, and the 2 columns on the right show you Eastern Europe only. As you can see, demographics and baseline characteristics in the overall patient population were generally well balanced between placebo and fostamatinib treated arms. Comparing the Eastern Europe patients with the western countries, there are a few major differences, which I will elaborate on. The one that stands out on this slide is a substantially shorter duration of AIHA in the Eastern European population compared to Western countries with a median of about 6 months in the Eastern European placebo arm versus approximately 3 years in the Western countries. That could be a reflection of earlier, potentially easier to treat and risk treatment-experienced AIHA patients. The dose of concomitant steroids appears also somewhat higher in Eastern Europe than the Western countries. On Slide 9, we are looking at prior indications used. The types of prior unique AIHA medications were generally balanced in the overall patient population as well as across geographic regions. Nearly all patients in the trial have previously been treated with corticosteroids. What's stands out here is that much -- it is a much lower exposure to Rituxan -- rituximab, about 25% in the Eastern European countries compared to 75% for patients in Western countries, another indicator for a less treatment-experienced patient population. And on Slide 10, we can see that a higher percentage of patients, 35% in Eastern Europe, had only one line of prior therapy enabled steroids versus 15% in Western countries, and the higher percentage in Western countries have had 3 or more therapies compared to about 25% in Europe. Slide 11. On the left 2 columns, you can see the results for the primary endpoints in the prespecified overall ITT population. 16 Patients, 35.6% in the fostamatinib treatment group achieved durable hemoglobin response compared with 12 patients, 26.7% in the placebo arm with a p-value of 0.398. When we looked at various subgroups and by the geographic region, we found that results in North America, Australia were similar to Western Europe and the placebo rate in -- were much higher in Eastern Europe. So if we exclude post-hoc the Eastern European countries from the analysis population, we see durable response in 9 patients, 36%, treated with fostamatinib compared to 3 patients, 10.7%, for the placebo group. This will have yielded a p-value of 0.03 with a denominator of 53 patients. In Eastern Europe, on the contrary, we see 35% response rate for fostamatinib versus 52.9%, 9 out of 17 responders in the placebo arms. We are carefully analyzing and will continue to analyze this high placebo response rate in Eastern Europe as it turns out to be very different from the other geographic regions. Slide 12, secondary endpoints. The results for the secondary end points are generally consistent with the results for the primary end point with insignificant findings for the overall population, but consistent positive trends for the Western countries, contrasting better placebo results for the Eastern European countries. Approximately 52% of fostamatinib patients in the western countries achieve hemoglobin response at least once compared to 17.9% of patients on placebo. Descriptive nominal p-value is 0.0088. 56% of patients on fostamatinib versus 17.9% of patients in the placebo arm in Western countries achieved the change in hemoglobin of greater or equal than 2 grams per deciliter from baseline. The nominal descriptive p-value here is 0.0038. Change in hemoglobin from baseline to end of treatment and also patients free of rescue medication trend favorably towards fostamatinib in the Western countries and not in the Eastern countries. Finally, FACIT-fatigue score showed a 7-point improvement for fostamatinib treated patients compared with 0.7 for placebo treated patients in Western Europe. Moving on to Slide 13. The safety results show that fostamatinib was generally well tolerated. There was no substantial difference in overall AE rate, serious AE rate or deaths between treatment groups. The most frequent AEs observed are generally consistent with what we had observed in previous trials or with the underlying disease. Slide 14. In summary, the study did not meet its primary influence to demonstrate a statistically significant difference in durable hemoglobin response for fostamatinib compared to placebo. Overall, we believe the results were negatively impacted by a large placebo response rate from patients treated in Eastern European trial sites. The Eastern European patients seem to differ in some baseline characteristics from the Western country patients with a shorter history of AIHA, fewer previous treatments and less previously fostamatinib. We will continue to evaluate carefully the impact of any possible imbalance or difference on the trial results. We believe the totality of the efficacy and safety data from Western Europe suggests benefits for fostamatinib patients over a broad number of clinically important outcomes. With that, I'd like to turn the call back over to Raul for closing remarks. Raul?

Thank you, Wolfgang. I would like to remind you that warm autoimmune hemolytic anemia is a serious and sometimes, deadly disease, and there remains a significant unmet need amongst patients. Currently, there are no therapies on the market specifically approved for this indication. We are encouraged by the durable hemoglobin response observed in patients treated in the Western countries and the positive trends observed in the secondary endpoints in those, which we believe are meaningful. We will continue to analyze the data to better understand the reasons for these geographic differences, and following our internal review of the data, we plan to share the results with the FDA to determine the best path forward for fostamatinib in warm autoimmune hemolytic anemia. We believe fostamatinib may benefit warm autoimmune hemolytic anemia patients, and they need and deserve a new treatment, and we're going to work hard to get them this treatment. On Slide 16. Before we turn the call over to your Q&A, I'd like to just take a moment to thank all the patients, their caregivers, the investigators and other health care providers for their participation in this FORWARD trial as well as our employees at Rigel, who worked diligently and tirelessly on this program. And with that, I'd like to have the operator open the call to your questions. Operator?

[Operator Instructions] Our first question has come from the line of Kristen Kluska with Cantor Fitzgerald.

The first one that I had was, I know that this endpoint allowed for flexibility if patients missed visits. But just thinking about the COVID waves here across different regions, did you notice any trends as it relates to the number of follow-up visits that patients were able to make? And if there were any gaps in between these visits when calculating the durability?

Thank you, Kristen. I'll ask Wolfgang to comment.

Yes. Thanks for your question, Kristen. We looked at the number and frequency of missing data, and fairly surprisingly, the patients did make it to the site in general and the number of missing visits was not an explanation for the high placebo response rate in Eastern Europe. So we did look and it's slowly explaining the results.

Okay. And how are you starting to think about the different outcomes that might come out of your meeting with the FDA? So it sounds like even if you can't move forward with this, would you consider running another trial? I mean, clearly, it sounds like you've seen the efficacy. It's really just the placebo response in Eastern Europe that tended to give you the data here.

Yes. Kristen, thank you. I'll take a stab at that and Wolfgang, if you could comment as well. It's a bit early as yet. We've just unlocked the database shortly for us to say what we would do. I think, importantly, we need to understand this anomaly, and it's a very odd result as you can assume. I think we need to understand what caused it. Was there any other issues that we need to get to understand and then provide that with a good review of the data to the FDA, make sure they understand what happened, make sure they understand that there's a medical need here as a next step. And then we'll wait to see what their feedback is. Wolfgang?

Yes. I mean you mostly said it. The most important thing for us is to understand the Eastern Europe placebo response, it's over 50%. So there is something really odd in there. While in the Western countries, the result is pretty consistent actually with what we would have expected. We are evaluating all kinds of simple reasons why they could have been and then we have to understand the patient population. I told you, the Eastern European patient population, these are going to be different. They were early patients fewer previous treatments show the duration of disease. And on steroids, the effect of fostamatinib might have been maxed in the subpopulation. So these are all possibilities, which we will have to do a lot more analysis over the next few weeks. And once we have a good understanding, we will take this to FDA as well and show them the data. It's not the very first time that there are regional differences in clinical trials, and we will discuss it with the agency.

To add to Wolfgang's comment. In the Western countries, the results are very much where we expected them to be, both on the primary as well as the secondary endpoints, and the patient population looks very much what we expected it to look like. And so that gives us the confidence that this product, we believe, does have a benefit, and we were able to show it in one of the most important countries in terms of our own commercial efforts and as well as in a place that we think is quite relevant.

Our next question is come from the line of Yigal Nochomovitz with Citi.

This is Carly on for Yigal. I'm wondering if you could maybe just elaborate a bit on any hypotheses you have for why the placebo response in Eastern Europe patients was much higher than expected. You laid out some of the differences in the baseline characteristics and the prior medications between the different geographies, but I was just curious how you think those may have contributed to the high placebo response rate? Or if there were any differences in the protocol itself between the different geographies that could have had an impact?

Wolfgang, would you take a stab at that?

Yes. So first of all, the protocol is valid in binding for all sites and geographic regions. So it's not about the protocol. Everybody follows the same protocol. Regarding inclusion criteria, we did require at least one failed treatment or one unsatisfactorily prior treatment, and that could be just steroids. As it turns out, as I said earlier, in Eastern European countries, more patients really only had one prior treatment, which was steroids and had a much shorter duration of warm AIHA. While in the Western countries, as you see in the previous treatment slides, the majority of patients had 1, 2 or even 3 or more previous treatment. So they were pretty refractory. So it is entirely possible that those early patients in Eastern Europe just responded better to steroids alone and continue to respond while they enter the study. But as I said earlier, we have to do some analysis to confirm the hypothesis. We did, of course, do a lot of investigation into some possibilities what might have gone wrong. I mean some of you might ask, why did the patients get the right drug. We confirm that wasn't about the lab. No, it was not about the lab. Central labs were mostly providing the data. We looked at the PK in the patients to see that patients who are on fostamatinib indeed get fostamatinib. So we did some high-level investigation into major mistakes that might have happened. It doesn't look like that's the case. So probably, we have to look further into the patient population and see why there might be a higher placebo response rate in the patient population. That's what I can tell you at this point.

Okay. Got it. That's really helpful. And then do you just have an estimate on when you may be able to provide another update after doing sort of a more thorough analysis of the geographic differences?

Wolfgang?

Yes. I would say, we have prespecified for top line, as you know how this works. You prespecify the program analysis for the general baseline population, then you have to formulate some hypotheses and then you have to do analysis of additional subgroups and excluding some patients and looking at other patients that take certainly a few weeks and this would be given to the task force working on this. And then we should have a better idea whether we can provide an explanation, which we take to the agency and see what the response is by the agency.

Our next questions come from the line of Eun Yang with Jefferies.

This is Nalin on for Eun. For the first question, could you please talk a little bit about your cash usage going forward? And how you're planning to cut OpEx to extend the cash runway?

Let me ask Dean to comment on that.

Sure. Nalin, just to remind you what we said on our Q1 call, we had $107 million of cash. We also highlighted on that call that we expected in Q2 $5 million from our collaboration partner in Japan, Kissei, upon their NDA filing. We've, in fact, since that -- since our Q1 cash balance of $107 million, we did have that $5 million. We incrementally highlighted that upon -- if we do get acceptance of that NDA filing, we'd have $20 million of incremental cash in Q1 of '23.

From Kissei.

From Kissei. So we described that. As far as our runway going forward, we haven't given guidance on our top line, and we haven't given guidance on TAVALISSE sales as well as collaboration revenues, and therefore, we haven't given specific guidance on the runway. I would say that these results today on autoimmune hemolytic anemia, we didn't have contribution -- topline contribution volume from autoimmune hemolytic anemia until the back half anyway. So on an immediate basis, this doesn't fundamentally change our cash position or cash needs in the near term. With that, and given today's market conditions, the stock price, we don't have a need nor plans for me to capital raise. But we'll continue to -- as we always do that, we'll closely consider our programs and our spend going forward and look to provide updates in our quarterly call coming up.

The only additional comment I make on that is that on that call, we also said that we expect our TAVALISSE and ITP sales to continue to grow, and that is still our expectation, and our expense level to be relatively flat. So the gap between those 2 numbers will increasingly decrease over time. So that's a pretty good place to be. It's good having a commercial product generating revenue on a quarterly basis and increasing. So I think we're in good shape financially.

Got it. And Raul, could you please elaborate on that a little further in terms of your expectation for the peak sales in ITP in the U.S.?

Sure. We haven't given guidance specifically. What we did say is that we expect growth the rest of the year. COVID is -- the impact of COVID is diminishing, giving us greater access. And Dave is here, maybe I'll ask him to comment as well. Access to clinicians and in a good position to drive the business forward with this post-COVID reemergence. Dave, any comments?

Yes. I've got a few actually, a few important things that I'd like to say here. First of all, I think it's really important for everybody to know that today's results don't impact at all. TAVALISSE is a approved therapy for ITP. And as a matter of fact, as you heard from Wolfgang, we saw encouraging data in patients in Western countries that was very consistent with the Phase II data and the products mechanism of action. And in addition to that, the safety profile from the FORWARD trial is very consistent with the existing fostamatinib safety database. So I think that's going to be very important to clinicians. So we have been focused on spreading awareness among the hemon treaters and making sure we maximize access to TAVALISSE for patients, and that's exactly why we expanded the sales force last year and gained preferred status on key national formularies. And I think the team has done a great job executing as we're seeing continued growth in both prescribers and new patient starts. So we'll remain focused on growing our business in ITP, and for any clinicians who have questions on this warm autoimmune hemolytic anemia data, we'll be sure to respond to them through our medical affairs team so they can get the information they need to help them with their patients. So again, it doesn't change at all what we're doing. We're spreading awareness in ITP, and we're maximizing access for patients.

That's very helpful. And one last question, please. Has there been any off-label use such that this data would impact current sales?

Not in any meaningful way.

Our next questions come from the line of Joe Pantginis with H.C. Wainwright.

So as you look forward -- it might be too early to ask that question, but before you go to the FDA, do you have any relevant publications or clinical trials that you feel are most relevant to this case about geographical differences that you might present to the FDA?

Wolfgang, would you like to answer that? I'll add a comment at the end as well.

Yes. So ever since we've seen the data a few hours ago, we have started looking into this, and there are some -- there is some precedent for some trials. In fact, even with Eastern European high response rates -- high placebo response rates contradicting the rest of the group results, there's a trial with spironolactone and a couple of other things, which we are putting together and evaluating much greater detail. We're in the process of doing that. The process is not concluded. But it's not the very first time that this happened, and it's not the very first time that there has been a path forward in situations like that. We have -- of course, we have to compare in great detail how that applies to our case. Again, we believe that the Western countries [indiscernible] deal plausible, and we are going to make the case that this is going to be a discussion with the FDA, and we'll have to make -- put our best possible case forward. And it's -- first of all, really understand the data completely before we make strong statements to regulate it.

Our next questions come from the line of Gary Nachman with BMO Capital Markets.

First, the differences you described regionally on patients having shorter duration of AIHA on previous treatment, did you have any reason to think about that as part of the inclusion criteria for the study? Was there any evidence in the Phase II that we could see these types of differences in the results with these different types of patients? I'm curious, how much of a surprise that was to you?

Wolfgang?

Yes. Well, remember, the Phase II study was done -- first of all, the Phase II study wasn't -- able not placebo-controlled study, and it was conducted mostly and not exclusively in the United States. And patients in the United States, which was confirmed in this trial, generally had longer standing AIHA. They had a number of previous therapies. Now you have to make an effort to enroll these studies. You have to find 100 patients. So you have to be geographically diverse, and that leads you to open the study up to Western Europe and also to Eastern Europe. In Eastern Europe, drugs like rituximab are less readily available. So the patients that are out there are apparently less treatment experienced and sites found the patients that were recently diagnosed with AIHA and enroll them in the study. Now is there a surprise, I don't know if -- how anybody would be able to predict what precise patients would enroll in the study other than saying, well, maybe biologics are less available in the Eastern European countries. But this is how it turned out, and this is how the data play out. And it gives us an opportunity to highlight the patient proposition in the Western countries who are clearly different from the patient populations in the Eastern -- from the patient population in the Eastern countries and try to find explanations on why there might be a differential response rate in these patients. And as I pointed out earlier, for early patients, they just might respond to the hypothesis, they just might respond to steroids better, and it takes a few months until they reach the maximum response rate on steroids, which might be in part during the study, while other patients have maxed out on a previous treatment and don't have additional responses, which we have achieved with fostamatinib. Again, I have to continue saying, we have to do some analysis, look at all different types of operations with different durations of treatment and things like that and understand the data as much as we can.

The opportunity -- if we are eventually get an approval, if we're so lucky to do so, and it is in patients that have had over a year worth of AIHA, that's a very good population.

Okay. And I have to ask this question, but could the geopolitical events in Russia and Ukraine have impacted the results in any way? I'm curious how many patients were specifically in those 2 countries? And how could you have been completely confident with the validity of those results? What measures did you take throughout the study that made you confident? And how are you able to check so quickly and be comfortable that no mistakes were made, I guess, in all the Eastern European countries?

So maybe 3 questions there. Conflict in Ukraine, mistakes were made, how can you be confidence of that, and any other issues in Eastern Europe. Wolfgang, do you want to...

Yes, sure. Well, so your first question, did Russia and Ukraine have anything to do with this? My preliminary answer is, no. So we looked at the placebo responders and so the placebo responders in Eastern Europe are the most confusing outcome, right? And we looked where all those from and they are not from Russia and they are not one patient from Russia and not one patient from Ukraine. They're from Bulgaria, Czech Republic. They're from different sites and different countries, not all one site or not all one country, so they're from different sites and different countries. So Russia and Ukraine, no, it's not the reason. You say, well, how confident can we say that there was nothing done wrong. Well, I mean if you were with me, you would see the data and then you have your checklist and ask the questions and you work yourself forward. As I said earlier, we check did the patients receive fostamatinib or placebo or was there a mix up? No, there was no mix up. We looked at the PK data, so patients who are supposed to be on fostamatinib, have fostamatinib within their system. You look at central labs, it may be a local lab. The central lab, that is [indiscernible]. There was not. If you look at concomitant medication as some undue rescue treatment, not that we can tell at this point and so on and so forth. Then you check a box after box and say, these are the obvious questions. Is there anything obviously wrong? And at this point, I cannot say that anything was obviously wrong in the Eastern European countries as we continue to look at all kinds of potential reasons. We might find something, but right now, it's mostly really the difference in patient populations and baseline characteristics that is our [ KIV ] and we will continue to look and find out everything we can.

Okay. That's helpful. And then just lastly, I don't know if you specifically said this, but do you have a sense of how soon you could potentially meet with the FDA? I know it would take some time to go through all the data and get on their schedule, but do you think it could happen in the third quarter or before the end of the year? Just a rough estimate on that.

Yes. I'd say, fall is probably a good outcome -- a good projection. I mean we -- ideally, we have the best -- ideally, before we meet, we have a really good case to make. And this is going to take a little while, but I would say, third quarter before the end of the year, fall. Something in the time frame sounds round about right.

Our next questions come from the line of Kalpit Patel with B. Riley.

I guess, first, can you provide additional detail on the use of rescue therapies in this trial? Maybe not just after week 4, but throughout the trial in each reactive and placebo group. And then if you also have the data by the geographical area, that would be useful.

Yes. I mean you've seen the numbers for rescue therapy being used. It's -- I'm just going to put up the slide in the secondary endpoints. I mean, in general, as you can see in the Western countries, the fostamatinib patients or more free of rescue than the placebo patients. That's the opposite in Eastern Europe. So it's -- in the Western country, it goes in the right direction. It's not entirely surprising that patients over a treatment of 6 months, at some point, need some additional therapy. The AIHA, it's sometimes getting a little better and sometimes, it's getting a little worse. And sometimes whatever medication you're on is not sufficient and then you need to adjust any dose of something and that's rescue therapy. So that's not super surprising. In the Eastern European countries, we are very carefully looking at rescue therapy. There was not something obvious that there was irresponsible needs of rescue therapy or something like that. But if you look over 24 weeks, as you know, with the primary endpoint, if you had achieved response status, say, in the first 12 weeks. And then at some point, you get worsen with rescue therapy, you are still a responder. You will still count as a responder. So that's another hypothesis of things that you're looking into, how long and when exactly happened? Did rescue therapy happen? That's on the list of things to look into, but I cannot give you every patient with rescue therapy on each of these groups at this point in time.

But we certainly will continue to look at that.

Okay. That's helpful. I just had one additional question. I'm looking at the row above that, the change in mean hemoglobin from baseline to the end of treatment in your Eastern European data set. I guess can you speculate why that mean hemoglobin change is so small in the active arm, despite these patients being less refractory relative to the patients enrolled in the other geographical region?

Yes. So I start with the Western country. So small -- there is a -- so that data point is influenced a little bit by drop outs. So if a patient drops out, which I have shown you happens more in the placebo group, then there is no subsequent hemoglobin measurements, right? And therefore, like a patient who does poorly in the placebo group is not in the study anymore, so then the mean for the overall group is sort of going up rather than being dragged down. That's for the -- if you ask why is the difference not that big in the Western countries. It's influenced by drop outs. And in the Eastern European countries, yes, we have those 2 placebo patients who are doing fine and their hemoglobin levels are reasonably high. And therefore, the higher rate of placebo responders in the placebo group in Eastern Europe does correspond with higher hemoglobin level in the placebo group in Eastern Europe as well.

One thing to say is, we look forward to sharing the data with FDA, but also obviously, publishing this result more fully once we've done some further analysis of this.

There are no further questions at this time. I would like to turn the call back over to Raul Rodriguez for any closing comments.

Thank you, and thank you for your interest participation in this call. We very much appreciate it. It's always a challenge more than you expect in this -- in pharmaceuticals. I -- we believe the product does have a benefit in these patients. We believe this data helps us make that case. We will make that case after further investigation. I would go to the FDA. It's similar, not that different actually from the case with ITP, where we had one trial work, one trial not work, and we were able to make the cogent case, take it to the FDA, and they agreed to approve the product in that indication successfully. I think it helps the case that there is a tremendous medical need in this sector, and these patients are really many of them in desperate straits sometimes. And a product like this in this rare orphan disease is something that sometimes is a challenge, small numbers, et cetera. But we will work hard on getting this across the finish line, just like we did for ITP. Those patients got a product that I think is tremendously helpful for them, and I think these patients deserve no less. So thank you for your support.

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.