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spk12: Greetings and welcome to the Rigel Pharmaceuticals Financial Conference Call for the second quarter 2022. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Dolly Vance, who is Rigel's Executive Vice President, Corporate Affairs and General Counsel. Thank you, Ms. Vance. You may begin.
spk07: Welcome to our second quarter 2022 financial results and business update conference call. The financial press release for the second quarter was issued a short while ago and can be viewed, along with the accompanying slides for this presentation, in the news and events section of our investor relations site on www.rigel.com. 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. They 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 Q2 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 CEO, Raul Rodriguez. Raul?
spk08: Thank you, Dolly, and thank you, everyone, for joining today. Also with me today are Dave Santos, our chief commercial officer, Dr. Wolfgang Dummer, our chief medical officer, and Dean Shornow, our chief financial officer. On slide five, We are also very pleased to have Dr. Jorge Cortes joining us today to provide a clinical perspective on our recently acquired pipeline addition, olasutinib. Dr. Cortes is an internationally recognized expert in leukemia and has led the development of numerous leukemia treatments, including for basulib, synribil, and inclusive, who were used for the treatment of chronic myeloid leukemia, or CML. and Teresimo, who's a treatment for older patients with acute myeloid leukemia, or AML. Dr. Cortez is currently the director of the Georgia Cancer Center, which he joined in 2019 after spending 23 years at the University of Texas MD Anderson Cancer Center, where he held many roles in the Department of Leukemia Division of Cancer Medicine, including Deputy Department Chair and the Chair of the AML and CML Sections. In addition, he was the deputy division head for the Cancer Network and chair of the executive IRB. Importantly for us today, he is a clinical trial investigator on the Olisutinib trial. Beginning on slide six, I am pleased to report that we have made significant strides this quarter in growing our commercial hematology oncology business. I'll start with our first value driver on this slide, growing ITP sales. During the second quarter, Rigel achieved the highest quarterly net product sales for Tavalise in ITP since launch. This demonstrates the continued momentum we are driving through our commercial activities with Hemonc prescribers. As you may recall, last year, we undertook a Salesforce expansion to broaden our reach, improve efficiency, and increase in-person interactions. These initiatives are yielding results, and we believe that we have all the components in place to drive continued growth in ITP sales. Additionally, in May, we entered into a collaboration agreement with Knight Therapeutics to commercialize Fosamatinib in Latin America, including Mexico, Central and South America, and the Caribbean. It will be great to be able to provide access to Fosamatinib for patients suffering from ITP in these countries as well. In addition to our collaboration partner, Kisei, in April, we announced that Kisei had submitted its NDA in Japan for Fostermatinib and ITP. We look forward to a potential approval in Q1 of 2023. A new value driver for Rigel is Olisutinib. We are very pleased to announce that we have entered into an exclusive worldwide licensing agreement with Forma Therapeutics for Olisutinib. Wellacitinib is a potential market-leading oral therapy for the treatment of relapse or refractory acute myeloid leukemia. This collaboration will broaden our near-term HEMONC portfolio and is highly synergistic with our current commercial infrastructure. I will talk more about this program right after I review the balance of the pipeline, and Dave will also provide detail on the commercial opportunities. In June, we reported top line data for our pivotal phase three forward trial in WARM AIHA. The trial missed the primary input in the overall patient population. However, in a post hoc analysis, response rates in Western countries favored Fostermatinib over placebo. We are continuing to evaluate this data and plan to share our findings with the FDA to determine the best path forward for WARM AIHA. With no currently approved therapies in this indication, we continue to believe that there is an opportunity for TAVALYs to improve the outcomes for patients with this disease. We have also advanced our Fostermandib COVID-19 program. We have completed enrollment of our pivotal phase three trial in July with 280 patients, which we believe sufficiently powers the study, and we expect to report top-line data in Q4. Fostermatinib is also being evaluated in a Phase III trial sponsored by NIH, NHLBI, as a potential treatment in high-risk patients hospitalized with COVID-19. These trials have the potential to show the benefit of Fostermatinib as a treatment in patients with severe COVID-19. Wolfgang will discuss this program later in the call. Lastly, turning to our earlier pipeline programs, IRAC-1-4 and RIP-1, Due to everything we want to cover today, I will just give a short overview on the status of these programs. As we had shared with you before, we are evaluating R289, IRAC1 and 4 dual inhibitor in low-risk MDS. We believe R289 has the potential to provide effective suppression of the inflammatory environment that causes low-risk MDS. Study startup activities are currently ongoing, and we are targeting the third quarter of this year for study initiation. We are also excited about the advancement of our RIP1 inhibitor, R552, being developed in collaboration with our partner, Eli Lilly, into phase 2 development. We see a mechanistic, clinical, and scientific rationale for R552 in several large immune indications, such as psoriasis, RA, and IBD. The initial phase 2 study is anticipated to start in Q2 of 2023. Lily will disclose the indication closer to the initiation of that study. Additionally, we are completing our work on a RIP1 inhibitor that can cross the blood-brain barrier for the treatment of CNS diseases. Lily will then lead the development of these RIP inhibitors. Moving on to slides. I would like to discuss our new collaboration with Forma Therapeutics for olosutinib, Rigel's newest value driver. I would like to provide a brief overview of the transaction, and Dave will provide our commercial and strategic rationale and why we feel that olosutinib has the potential to be a meaningful therapeutic option for patients with AML. Under the terms of the agreement, Rigel receives an exclusive worldwide licensing rights to Olasutinib in all indications. With an initial focus on relapse or refractory, IDH positive AML patients. This includes the right to grant sub-licenses in ex-U.S. territories. In exchange, Rigel will pay FORMA a $2 million upfront payment. In addition, FORMA will be eligible to receive an additional $17.5 million upon the achievement of certain near-term milestones. The deal also includes potential future development and commercial milestone payments, as well as tiered royalties on net sales of Olicitinib. FORMA has submitted the new drug application to the U.S. FDA following positive results from a Phase II registrational trial, with a PDUFA action date of February 2023. less than seven months from now. The mid-cycle review with FDA has been completed. Based on that meeting, we were told that there is currently no plans for an advisory committee meeting, no major safety issues have been identified, and currently no REMS program is likely to be required. If approved, Olasutinib will expand our Hemonc product portfolio and enable Rigel to detail two important therapies to our Hemonc physicians. Rigel will leverage our Hemonc capabilities to maximize the commercial potential of Olasutinib, which we believe can become an important and differentiated product in this space, particularly given that AML is an aggressive and very difficult-to-treat disease. Results from the Phase II registrational study of olosutinib as a monotherapy demonstrated promising efficacy, including a 13.8-month median duration of response and a favorable tolerability profile. Rigel plans to initially focus on the commercialization of olosutinib as a monotherapy in mutant IDH1-positive relapse or refractory AML setting. There's also the potential to explore olisutinib in the first-line IDH-positive AML setting, as well as in combination, both of which were explored in the Phase II study. Beyond AML, olisutinib has been explored as a monotherapy in glioma and in cholangiocarcinoma. We look forward to advancing olisutinib through the regulatory process and potentially bringing this important therapy to patients in need. With that, I will turn the call over to Dave for a commercial and therapeutic area overview. Dave.
spk09: Thank you, Raul. Now I'd like to take a few minutes just to highlight why we're so excited for the prospects of expanding our hemoportfolio with Alutis Adnip. Moving to slide nine, our collaboration with FORMA aligns with our strategy of expanding our portfolio of hemological therapies while leveraging our existing commercial infrastructure. As Raul touched upon, in the past year, we made key strategic investments in our commercial organization to expand our sales force and sharpen our BD focus to prioritize late stage development programs that would be a good strategic fit for us. As a result, we are well positioned to add Alutisidnib to our product profile. On the left, we have strategically experienced business operations and marketing teams that can quickly gather insights and synthesize those into actionable plans that will ensure a strong launch, even with a short runway. In addition, we have a highly experienced and customer-focused patient access team that has everything in place to efficiently distribute olucidinib and ensure patients have access to coverage, reimbursement, and assistance. Finally, we have a very oncology-tenured field team already calling on the majority of hematologists and oncologists in the U.S., enabling us to realize cost efficiencies while potentially bringing two important products, olutacidinib and tovelis, to the attention of our customers, a proposition we believe can increase the overall awareness and utility of both. In summary, we have the team in place to successfully launch olutacidinib, which is critical. since we have a product that could be approved in just six and a half months. On slide 10, I wanted to share why AML was a very interesting disease for us to enter. As you may know, AML is an aggressive, highly complex malignancy and primarily a disease of older adults. In 2022, the American Cancer Society estimates that more than 20,000 patients will be diagnosed with AML And unfortunately, 11,500 patients will die from AML this year. So even though we now have several new agents that have helped to transform the treatment of AML patients, there is still progress to be made. One of the biggest advances over the last five years has been that AML patients now undergo guideline-driven molecular and cytogenetic analyses for immediately actionable mutations or chromosomal abnormalities. Mutations in IDH1 are seen in around six to 16% of AML patients. And although this is a small population of AML patients, they are very well defined based on standard widespread testing that is done upon diagnosis and prior to initiation of a new line of treatment. Thus, leukemia treating physicians are aware of their IDH1 positive patients. And within this well-defined patient population, about 60% are patients clinicians consider fit for intensive therapy with the goal of hopefully getting those patients to transplant if they have a complete remission. The remaining 40% of patients are not able to be or choose not to be treated with intensive therapy, and they are given less intensive outpatient therapy. In both cases, there are a substantial number of patients who are refractory to their upfront treatment or relapse after getting a response. Those patients would be in the dark green boxes in the bottom row, and that represents an opportunity to impact the lives of as many as 1,000 IDH1 positive AML patients each year. Moving to slide 11. We believe the data from the Phase II Registrational Trial for Lutacitinib in patients with relapsed or refractory IDH1-positive AML is compelling and, if approved, would be viewed by physicians as a meaningful treatment option for IDH1-positive AML patients. Despite having new treatments over the last five years, healthcare providers continue to perceive a significant unmet need since many patients still do not achieve remission. They can also suffer from unfavorable treatment profiles, particularly in later lines of therapy. Clinicians are continuing to look for new therapeutic options that can provide incremental survival improvements, longer duration of response, and a better balance of efficacy and toxicity, especially since these are often older patients with other comorbid conditions. We believe Lutacidinib can better meet clinicians' needs and has IDH1-positive AML market-leading potential with its long duration of response and the potential for patients to forego cardiac monitoring as key differentiating factors compared to existing therapies. We see a significant opportunity for Lutacidinib in patients with relapsed or refractory IDH1-positive AML and furthermore believe there's meaningful potential full potential for elutisidinib to move into earlier therapy. Turning to slide 12, we are extremely excited about the opportunity to bring elutisidinib to patients, and our launch planning is already well underway. Although we're just announcing the collaboration today, a small and highly dedicated team has been working on launch planning during diligence, and we will now expand that effort and put our planning into high gear. We already have a high-level strategic plan for launch, and we will spend time this quarter refining that strategy with additional customer insights. We will have a full tactical readiness plan by year end, so we are ready to launch upon approval. Our team is up for the challenge of a short runway to potential launch, and we will be ready to go if and when an approval comes. I look forward to talking more with you about our plans as we move through the remainder of 2022. Now, I'll turn the call over to Dr. Cortez to talk about the findings from the olutacidinib registrational phase two study. Dr. Cortez?
spk04: Thank you very much. And my name is Jorge Cortez, as mentioned. I am currently the director of the Georgia Cancer Center and formerly at MD Anderson in the Department of Leukemia, where I was the deputy chair. And I was there for 23 years on faculty, plus my training before that. So I'll be very glad to discuss with you this drug, Alutacitinib, and their role in patients with IDH1-mutated acute myeloid leukemia. So I'll start with the background on slide 14. As a reminder, IDH1 mutations occur In somewhere around 8% to 12% of patients with acute myeloid leukemia, you can see depending on different sources and different patient populations, the range may expand a little bit more from somewhere to 6% to 16%. And that's about where we see this type of mutation. As already mentioned, the lutecidinib is a very potent and very selective inhibitor of IDH1 mutated. And I will remind you how IDH1 mutations work in acute myeloid leukemia. It's very important because this is one of those mutations that are considered initiating mutations. There are some mutations that happen a little bit later after the leukemia has been developed and some that are initiating mutations, and we think that IDH1 mutations are one of those. That's important because that goes to the root of the development of acute myeloid leukemia. Normally, as you all may remember from biochemistry, we have this Krebs cycle, which is the metabolism of the normal cells. And it goes through alpha-ketoglutarate. And when IDH, which normally metabolizes alpha-ketoglutarate, when it is mutated, it transforms alpha-ketoglutarate into 2-hydroxyglutarate or 2HG. And when that metal like 2-HG is usually not present in normal cells in the normal cycle. When it is formed, it has the potential to transform cells into leukemia cells, hematopoietic cells into leukemia cells through epigenetic mechanisms. So actually 2-HG becomes a biomarker of the mutation. It'll go up when there is a mutation. of IDH1, and if you inhibit ADH1, the levels of 2-HG will go down, which is a good thing because, again, that is what drives the development of the leukemia. So having olutacitinib, a very potent, very active drug, selective for IDH1 being available, it can reverse that malignant phenotype. So, with the understanding of the potential of this drug on slide 15, you can see that we have from the very beginning when I started being, I started getting involved with this drug from the very early stages of the development, and we very quickly developed a very comprehensive plan for the development of lutecidinib, both as a single agent, as a monotherapy, and in combination with other agents, knowing that sometimes in leukemia you need combination for certain settings. So the monotherapy includes refractory relapse and other settings, including some exploration of the treatment's naive patients, patients who had not received prior therapy. Those are the orange boxes. And we explore that also in the combination therapy. Now, for the purposes of this presentation, the data that is most mature is what you'll see in slide 16, the refractory relapse patients monotherapy, which is the primary indication that's going to be pursued, again, because that is where most of the data is at the moment. That's where we usually would start the development of a drug. So for this cohort, the primary endpoint is was the achievement of what is called a CR or a CRH. I'll get to the definitions of that in a couple of minutes. And that's essentially the responses. But we have important secondary endpoints, the overall response rate, the duration of the remission, the transfusion independence, the overall survival, and, of course, the safety of the drug. So let me describe then the results. And on slide 17, you can see the patient characteristics of those that are included in this evaluable cohort that's being presented now. These are mostly older patients. The median age is 71. We do have some younger patients, but you can see at the upper end of the spectrum, we have patients way up into their 80s included in this study. Two-thirds of the patients are what we call the novel AML, meaning this is a disease that happens for the first time, as opposed to the secondary AML, which is about a third of the patients. That is an AML that evolves from other malignancies, amylo-dyspastric syndrome most frequently, but it could be from other hematologic neoplasias, sort of small proliferative neoplasms and others, and a few that had treatment-related problems. AML, patients that had other cancers, breast cancer, lymphomas, et cetera, you give them chemotherapy, they develop the AML. Those were just a few. It's most typical that this mutation happens in patients that have either no chromosomal abnormalities or very frequently extra chromosome 8. Those are what we call intermediate risk chromosomal abnormalities, and it represents a majority of this patient population. But there's a good... a little over 20% that have a poor risk of chromosomal abnormality. By definition, all the patients had an IDH1 mutation. The different variations of the IDH1 mutation, the most common is this R132C. That's a little over half of the patients, and then some of the others that you see on this slide. We also know that patients with acute myeloid leukemia do not always only have one mutation. The mutations in other genes could coexist with IDH1 mutations. The most frequent that we saw in this cohort was NPM1 that occurred in almost 30% of the patients, but we saw mutations in other genes, V3 and others, as you can see on this slide. Now, we're talking about refractory or relapsed patient population. Refractory means you gave them initial therapy. They did not respond at all. That is the largest cohort, and it's a little over 40% of the patients. The others are relapsed. That means you gave them some initial therapy, they responded, but the disease is coming back. The worst-case scenario is that either the disease comes back quickly, before 12 months, that is the highest risk, the patients that tend to have the worst prognosis, and that is the next largest cohort, 37%. There also could be patients that have had a response, then relapsed, you gave them something else, responded again, they relapsed again. So two or more relapses, that's also pretty bad. 20% of the patients in this cohort are like that. And the best case scenario is the patients who have a first relapse and the first remission lasted more than 12 months. That's a smaller subset of these patients, only 11% of the patients. You can see actually that most of the patients had received, well, the median number of prior regimens was two. So they had received at least two prior therapies before they came to these studies. Some had received as many as seven. And 11% had received actually a stem cell transplant. All right, let's jump to the response rate then. This is on slide 18. And you can see here that I mentioned the primary endpoint was CR1. plus CRH. Let me define that for those of you who may not be as familiar. A CR means that the blast count, the blasts are essentially the leukemia cells. The normal is less than 5%. More than that would be the leukemia. So CR means that the blast count has gone down below 5%. And the platelets have recovered to at least 100,000 and the neutrophils to at least 1,000. That's a CR. If there is some recovery of the neutrophils and the platelets, but not completely, so the neutrophils are more than 500, but not quite more than 1,000, and the platelets more than 50,000, but not quite more than 100,000, with the blast still less than 5%, that's a CRH. So you can see here that 33% of the patients achieved that primary endpoint. Importantly, the great majority of these are the full CRs, 30%. So only four of the 41 patients who responded are CRHs. CRHs are good, but certainly CR is the ultimate response. We also have some patients that have some recovery of the neutrophils and the platelets, but they do not quite make it to those thresholds, the 500 and the 50 of the CRH. We call those CRIs. There's an additional 11% of patients who have this response. And then a couple of smaller categories, MLFS means morphologic leukemia-free state. The blast count went down to less than 5%. but there's not really much recovery in the platelets or the neutrophils. And the PR means the blast kind of went down, but it did not go all the way down to less than 5%. Let's say somebody started with 90% blast and it went down to 8%. Well, that's a partial response. It doesn't quite make it to the full criteria of less than 5%. If you take all of these together, almost half of the patients responded. 46% of the patients had at least one of these categories of response. But very importantly, what you see on slide 19 is the duration of response. You want to see that these responses last for some time, not just happen one time and then immediately the patient relapses. As you can see here, the duration of response is the median duration has not yet been reached at the time of this analysis. If you do a very conservative approach, what's called a sensitivity analysis, and say, well, because some of these patients went to a transplant, I'm going to end the response at the time they went to a transplant. So I don't adjudicate to the drug something that was partially attributed to the transplant. Then the median duration is 13.8. Still a very, very good outcome. And again, it's not that they relapsed at that point. We just stopped counting because they went to a transplant. And then on slide 20, also something very important. I mentioned that the primary endpoint was CR and CRH, and this shows the survival of the patients according to the response that they had. The patients who had a CR or a CRH, their median survival has not yet been reached by 18 months the 87% of patients are still alive, which is an outstanding outcome. Now, very importantly, some of these lesser responses that I mentioned, the CRIs, the morphological leukemia-free, they also have a survival benefit. These patients have a median survival of 15 months or more than a year compared to the patients who did not respond who have a median survival of only four months. So that means that even the lesser responses have value to the patients, add to their survival probability significantly from four months to 15 months as the median. Let's talk now a little bit about the safety of glutathione. I am showing you here what is called treatment emergent adverse events, DEAEs. And what that means is any toxicity that happens while the patient is, anything that happens while the patient is taking the drug. We're not making assumptions that it was related or not related. We just say it happened, you know, we report it. So anything that happened in 20% of patients or more or that was grade 3 or 4 in at least 10%, grade 3 or 4 are the more severe instances of these adverse events. When you treat patients with leukemia, it's very typical with any treatment that their neutrophils go down, the platelets go down, the hemoglobin goes down. So that is a fairly standard with chemotherapy. It's 100% of patients have these things. Well, that's the great majority of the adverse events that you see here reported on this slide. It's anemia, it's thrombocytopenia, it's neutropenia. And actually, those are the only ones that reach any significance in terms of grade 3 or grade 4 And of course, the patients who drop their neutrophils very frequently have fever as well. But other than those, the only ones that stand out of any grade are some nausea in a little over a third of patients, constipation in a quarter of the patients, some fatigue in 20% of the patients. But none of these really make it to any grade three or four. So these were mild side effects that are clearly significant. manageable for these patients, much better than what you would expect with a chemotherapy, for example. Now, moving to slide 22, I want to point some of the adverse events of special interest, some things that are of particular importance. First, QTC prolongation. QTC, the QT is an interval in the electrocardiogram. You've seen those graphics of an electrocardiogram you measure from one wave that's called the Q wave and another wave that's called the T wave, you see the interval between those. If it gets very long, there is a risk of very severe arrhythmias that can be even fatal, and we see that sometimes. Now, fortunately here, it happened very infrequently. Less than 10% of patients had any QTC prolongation, but most importantly, The ones that we worry the most about are the grade 3 and the grade 4, the very long intervals. It happened in only one patient, and it was a grade 3. But even that did not lead to discontinuation of the drug. So it was very low rate and very manageable. Then we have liver abnormalities. These were perhaps the adverse events other than the blood counts that we saw more frequently. You see any grade happened anywhere between 27% for bilirubin to 42% with one of the transaminases, AST. Fortunately, these were grade 3 in a small percentage of patients. So overall, 20% of patients had any elevation of liver enzymes, but only 12% had grade 3 or grade 4. Most of these are actually grade 3. But very importantly, of these 32 patients, 25 of those 32 had did not require any dose modification, or if they had a dose modification, that was enough for the patient to continue on therapy. There were only seven patients with discontinued treatment, four with recurrence, three others the investigator did not want to re-challenge with a dose adjustment or anything, so we don't know what would have happened there. And then differentiation syndrome is something that we've learned happens with IDH inhibitors. It's part of the process of maturation, but it can come with symptoms, with problems that happen. But fortunately, it happened in only 14% of these patients, and about half of these were grade 1 or grade 2. The others were grade 3 or grade 4, 8% total. Only three patients, however, discontinued treatment because of adjuvantation syndrome, meaning The great majority of these are very – they can be managed well with treatment interruptions. We know some drugs that use corticosteroids, some mild chemotherapy like hydroxyurea and things like that. So a very, very manageable toxicity because of the low rate and the low intensity of these events. So my conclusion is that with this interim analysis – We see that olutacitinib has a very high response rate, very high rates of CR, CRH, but very importantly, most of these are true CRs, and they're durable remissions. Even with a very conservative analysis accounting for transplant, the median duration is more than a year in this very heavily pre-treated patient population. and that this benefit extends to even patients that do not have the full CR or CRH with other responses. They also have a survival benefit. And this comes with a drug that's oral, that's very well tolerated, that most of these toxicities are very manageable, very mild, and that makes it a very applicable, very welcome drug for the management of these patients. with IDH1 mutation with acute myeloid leukemia. So this is my presentation. I thank you for your attention, and I'll hand it over to our next speaker.
spk09: Thank you very much, Dr. Cortez, for your thorough review of our data. We really appreciate all of your insights, and I know there will likely be questions as we move to the end of the call. So I just have a few brief comments on Tavoli's progress in Q2. We're actually quite excited about that as well. On slide 25, you'll see our FDA approved indication, which is for adult patients with chronic immune thrombocytopenia, or CITP, who've had an insufficient response to a previous treatment. Moving to slide 26, Q2 was the third quarter in a row that we achieved a high in bottles shipped to patients in clinics. We were happy with the growth trajectory we saw in Q1 and that it accelerated in Q2. Our 2,054 bottles shipped to patients in clinics represented 21% growth over Q2 of last year and 12% over Q1 of this year. That was our highest sequential demand growth in two years. Our demand growth continued to be driven by the increased new patient starts we've been generating since Q4 of last year. We achieved net sales of $18.6 million, a 9% increase over the same quarter last year. So we're very pleased with the continued positive momentum we're seeing in our ITP sales, and I'd like to thank our commercial team for all of their collaborative work to grow Tavalise. On slide 27, you see how our customer interactions have also continued to grow in Q2, particularly with respect to our in-person interactions. Our team grew our in-person interactions another 30% beyond Q1, and those made up more than three quarters of our total interactions with customers. So overall in Q2, our double-digit demand growth over Q1 created a new quarterly high in net sales for Tavalese. We've been focused on leveraging every opportunity to impact customers with our key messages on Tavalisa's efficacy and safety, along with our preferred status on key national formularies. These messages have been effective in raising awareness and reimbursement confidence among prescribers and resulted in more new patients on Tavalisa. Thanks for your attention, and I'll now turn the call over to Wolfgang to provide a brief update on our development progress. Wolfgang?
spk11: Thank you, Dave. I will provide the update on the other ongoing programs and start with our phase three AIHA study. Slide 29. In June, we reported that the forward phase three study in warm AIHA did not meet its primary efficacy endpoint. Importantly, the safety profile was consistent with prior clinical experience and no new safety signals were discovered. Overall, we have shared our belief that the results were negatively impacted by a large placebo response rate, particularly in Eastern Europe. Since the top-line announcement, we did a large number of additional analyses in order to understand the data in greater detail. We will discuss the previously shared data and all new reanalysis data in detail with the FDA this fall to determine the path forward in AIHA. We continue to believe the totality of this data may still allow for a positive overall benefit risk assessment for Fostermatinib in AIHA. Shifting gears now to our COVID-19 program. Moving to slide 31, we are still confident that Fostermatinib can provide therapeutic benefits in COVID-19. Most importantly, based on the published positive clinical data from the NIH NHLBI Phase 2 study, in hospitalized patients with severe COVID. Given persistent resistance to vaccination in some places and the possibility of new virus variants, there will continue to be severely ill hospitalized patients who need effective treatment options. We have two ongoing phase three trials that will provide us with pivotal data. And if approved in this indication, TAVALYs would be available for immediate use for these patients. Slide 32. Due to the recent slow enrollment, we completed randomization into our pivotal phase 3 study at 280 patients, which is 91% of our targeted enrollment. The original enrollment target was 308 patients. However, we determined the trial would be sufficiently powered with 280 patients to potentially provide a clinically meaningful result and determine the efficacy and safety of Fostermatinib in COVID-19. As mentioned earlier this year, we updated the inclusion criteria for the trial to focus on more severe patients and changed the primary endpoint to days on oxygen for a more sensitive measure and better comparison to the NIH active trials. There are also multiple secondary endpoints to assess the important mortality risk, as well as improvement from severe disease and duration of hospitalization or ICU stay. The follow-up period is through day 60 after the last dose. So we expect to have top-line data in the fourth quarter this year and plan to file an EUA if the data is positive. That concludes my development summary today, and I will turn the call over to Dean. Dean?
spk03: Thank you, Wolfgang. I'm on slide 34. For the second quarter of 2022, we shipped 2,053 bottles to our specialty distributors, resulting in $26.4 million of gross product sales. 2,054 bottles were shipped to patients and clinics, while 924 bottles remained in our distribution channels at the end of the quarter. We reported net product sales from Tavolis of $18.6 million. a 9% increase compared to the same period in 2021. Our net product sales from Tavolis were recorded net of estimated discounts, chargebacks, rebates, returns, copay assistance, and other allowances of $7.9 million. Our gross to net adjustments, approximately 29.8% of gross product sales for the second quarter of 2022. Before we move on from net product sales, let me review our expectations for the third quarter of 2022. We are pleased with the continued strength of our bottle ship to patients and clinics that Dave described and expect growth to continue as access to physicians and new patient starts continues to expand. We also expect to receive a $2.5 million milestone payment during the third quarter relating to the enrollment completion in the phase three COVID-19 study, which is supported by the U.S. Department of Defense government grant. Incrementally, we currently expect our gross to net adjustment to be approximately 30% in the third quarter of 2022. On to the next slide. In addition to net product sales, Roger's contract revenues from collaborations were approximately $11.3 million for the three months ended June 30th, 2022, which consisted of $7.5 million from Kisei, which included the $5 million milestone for the NDA filing in Japan. $2 million related to our license agreement with Knight, $1.4 million from our collaboration agreement with Griffles, and $300,000 for our license agreement with Lilly. Moving on to cost and expenses, our cost of product sales was approximately $1 million for the second quarter of 2022. Approximately $900,000 of this related to the delivery of Fosfamatinib supply to our distribution partners. Total costs and expenses were $42.8 million in the second quarter of 2022 versus $39.3 million in the second quarter of 2021. The increase in costs and expenses was primarily due to increased commercial activities related to our Salesforce expansion and increased research and development costs for the development of our IRAC 1.4 inhibitor program, partially offset by decreased research and development costs related to our phase three clinical trial of Fostimatinib for warm autoimmune hemolytic anemia and our ongoing phase three clinical trial of Fostimatinib in high risk hospitalized patients with COVID-19. We ended the quarter with cash, cash equivalents and short term investments of $89.2 million. Finally, we announced today that we drew an additional $10 million on our mid cap financial credit facility. Please note that this draw occurred during the third quarter. As a reminder, $20 million remains available to draw through March 31st, 2023. We also extended the maturity terms. This credit facility is now interest only through September 2024. Monthly principal amortization then extends 24 months through September of 2026. Onto the next slide. Let me highlight for you some of the key terms of the agreement with Forma Therapeutics. Roger will pay FORMA a $2 million upfront payment with an additional $2.5 million for near-term regulatory milestone, $5 million upon approval, and $10 million upon first commercial sale. While we've not finalized our review of the accounting treatment for these various payments, we currently expect the pre-approval milestones to be treated as operating expense in the period incurred.
spk00: Incrementally,
spk03: Our collaboration agreement also includes additional regulatory and commercial milestone payments, as well as tiered royalties on net sales. Finally, incorporating the pre-approval milestones noted above and launch preparation activities that Dave highlighted, let me update you on our expectations for operating expenses through the end of the year. We expect to see a small incremental increase in operating expenses in the third and fourth quarters of this year, as compared to the first two quarters of this year. As we continue to develop our launch plans and prepare for launch, we expect to see strong synergies and leverage, and we'll provide operating expense updates into the future. With that, I'd like to turn the call back over to Rahul.
spk08: Thank you, Dean. To conclude, this quarter, we made significant advancements in growing and expanding our Hemonc-focused business. First, we achieved the highest quarterly net product sales for Tabilis and ITP since launch. and we are well positioned to maintain that momentum in upcoming quarters. Second, we are very excited about our strategic in-licensing of olosutinib and potentially bringing a new and important treatment for patients with AML. Next year, you may see Rigel with two highly synergistic products, which may enable greater success of both and more fully leverage our commercial capabilities. We also remain committed and focused on advancing our other portfolio programs, We continue to analyze the phase 3 AIHA trial data and look forward to discussing our findings with the FDA. We believe that Fostermatinib has the potential to help patients with warm AIHA in a very meaningful way. With our phase 3 COVID-19 trial having completed enrollment, we expect to report top-line results in the fourth quarter of this year. And lastly, we continue to drive our two earlier clinical programs, R289, our IRAC14 inhibitor, We expect to enter phase one slash two trials in Q3 and with R552, our RIP inhibitor. We look forward to this program moving into phase two clinical development, which we expect to happen in the first half of next year. So with that, let me turn the call over to your questions. And if I may ask, since Dr. Cortez is with us, if you have questions for him, let's put those first in your call sequence. Operator?
spk12: Thank you. If you would like to register for a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. If your line has been answered and you would like to withdraw your registration, please press star 2. One moment, please, while we poll for questions. Thank you. Our next question is from Yun Yang with Jefferies. Please proceed with your question.
spk00: Thank you. So for this AML opportunity, you guys are mentioning, at least on the slide, the near-term opportunity is about 1,000 patients in the U.S. So what are you thinking about? How are you thinking about the pricing, number one, and how fast you can actually penetrate 1,000 patients once you launch the product upon approval. And the second question is for Dean. The $2 million upfront payment, is that going to be amortized or is it going to be booked there once? And I guess, like, you know, the regulatory margin will be booked there once, but can you comment on upfront payment, how it's going to be booked in the income statement? Thank you.
spk08: Thank you, Yoon. Appreciate that. Let me ask Steve to answer that one first, and then I'll ask Dave to answer your first two questions on pricing and how quickly you might be able to penetrate that relapse refractory market in IDH-positive AMO.
spk03: Yeah. Hi, Yoon. The upfront payments we expect, the pre-approval milestone payments that I described, we expect to be included in operating expense. and therefore the upfront $2 million, the $2.5 million of the near-term regulatory milestone, we expect those in the back half of this year. And the guidance I gave with respect to operating expense and the small increase from the Q1, Q2 levels are inclusive of those, that $2 million and $2.5 million cost. So that's built into the operating expense feedback that I provided.
spk09: Thanks, Dave. I think, thanks for the question, Yu. I think from a pricing standpoint, obviously, we just did the transaction, so we're not going to release any information on price. But I would say that if you look at targeted therapies in AML, that's probably a good target for you. I mean, they're all in a similar neighborhood. And so that's probably the best that I would say. You know, there's been seven approvals of oral agents over the last five years. And I think particularly when you look at targeted agents in IDH1, IDH2, and FLT3, and particularly even in the relapse setting, I think those are sort of the numbers that we've been looking at and will be discussing as we move forward. But certainly no decision's been made. In terms of uptake, I guess the best thing I can tell you is that, you know, the first quarter on launch with another IDH1 inhibitor, and this is when there was less information out there on IDH1, less testing, less identification. Today, it's standard and widespread. There were 100 new patients on the product. At least that's what the original, if you look back at that earnings call in the first partial quarter on launch, 100 prescribers of the drug. So, you know, I think that this is obviously A question of, you know, are the patients out there, they're well-identified, and the question's going to be, you know, does ululacitinib offer an advantage over other therapies that might be used in this relapsed refractory space? But we plan to differentiate it as best we can.
spk00: Thank you.
spk12: Thank you, Ewan. Thank you. Our next question comes from Egal Nachomowitz with Citi. Please proceed with your question.
spk01: This is Carly on for you all. Thank you for taking our questions. We have one for Dr. Cortez. Can you talk about how you think the efficacy and safety of elutacitinib compared to ibocitinib? And I guess assuming elutacitinib is approved, how do you see it sort of being used alongside ibocitinib?
spk08: Dr. Cortez, if you would. Hello, Dr. Cortez?
spk04: Can you hear me? Yes.
spk08: Oh, yes, there you go. Yes, there you go.
spk04: Sorry, I was saying that, you know, certainly Ibocitinib is a very good drug, and we've been fortunate to have it for some time. And also, we need to... highlight the fact that or acknowledge the fact that it's difficult to compare when you're looking at two different studies. But if we look at the characteristics of the studies, which are essentially very similarly conducted in similar patient population, I think that there's many reasons to believe why that olosutinib compares favorably to ivocitinib. Number one, in terms of the patient population that was in the study. The two are refractory relapsed acute myeloid leukemia, but the characteristics of the patients, they're a little bit older in the olutacitinib study. They are a little bit more difficult to treat. For example, I mentioned these fully refractory patients. they are, or the relapse patients, there were very few patients that had relapse within 12 months, which is, I mentioned, the harder patient population. There were less than 10%. Here we have a third of the patients were like that. So, you know, many of the features are equal or worse with the Oletacide. So we're starting with a worse, with a more difficult patient population. And yet, The overall response rate looks similar, if not better. The overall response, the CR plus CRH, was 30% with ivocitinib. It's 33% here. But most importantly, the CR rate, which was 21% with ivocitinib, is 30% with olutacitinib. The duration of remission, which was about eight months with ivocitinib, it's 13.8 months with olutocitinib. So, you know, there's differences between the studies, and again, you cannot make too much, but every item points to some benefit compared to... to what we have with ibacitinib. KTC prolongation, very uncommon with olutacitinib, which is also very, very important. Not that it's that common with ibacitinib, but it is more than we see with olutacitinib. So overall, I feel very good about the potential of these drugs because it adds – It has many aspects that seem to suggest a further improvement over what we already have with ibacitinib. So I think that I would certainly, if it was available today, I would use it quite a bit.
spk01: Okay, great. That's very, very helpful. And then we just had a question for Rigel as well. You highlighted the synergies with the existing ITP Salesforce. Are you expecting to add sales reps in order to support the AML launch? And I guess just curious, you know, how much we could expect OPEX to ramp as we go into 2023? Thanks so much.
spk08: Thanks, Carly. I'll ask Dave to answer that question and then Dean in terms of the OPEX piece of it. Dave?
spk09: Yeah, Carly, great question. And actually, we're not going to be expanding our Salesforce at all for this because ITP, it's a much bigger patient population treated across a community. So we've got significant coverage out there with our current team. And so what we now have to do, obviously, and by the way, in the relapse refractory setting with an oral therapy, this can be used in the community and patients are being treated in the community. So that'll be good. But we'll additionally have to pick up leukemia treaters in institutions, which we're already calling on. But no, the answer is no additions to our sales force. I think they've got quite the capacity. And after announcing this today, I'm pretty sure I could say without any fear of error, they're going to be tremendously excited to have something else in their bag. So that's the answer to the question. And that's exactly why when we look at a drug like glutacidib, we think it fits perfectly into our bag. We're seeing hematologists, oncologists in the community. We're in the institutions where leukemia treaters are, and we can spread the word rapidly.
spk03: And Carly, with respect to operating expense, we expect limited clinical spend. So Dave described the significant leverage on the commercial side. So limited clinical spend. I just remind you also with respect to our just overall operating expense, as we've As we roll off and we've just completed our phase three study in AIHA, we're wrapping up the phase three study in COVID. We expect to see some leverage, some savings into the future on clinical spend there too. So that's a bit of feedback on the olosutinib impact on operating expense.
spk12: Thank you, Carly. Thank you. Our next question is from Joe Panginis with HC Wainwright. Please proceed with your question.
spk06: Hey, everybody. Good afternoon. Thanks for taking the question and interesting transaction, and thanks for the details. So first, for Dr. Cortez, I guess when you were talking about the slides regarding the AE profile, physicians such as yourself and at centers of excellence, you said obviously these are very manageable toxicity profiles. When you look at things such as you know, the liver elevations and even things like the differentiation syndrome. How is the broader physician community in AML equipped to be able to treat these MAEs?
spk04: Thank you. I think that by now they are very well equipped. You know, liver toxicity is something that a general oncologist sees with many other drugs that they use for sorry tumors and other things. at even higher incidences and severity than what we see here. One other area that I manage a lot of patients is CML, and some of the drugs that we use in CML have higher incidences of these things, and yet liver toxicity specifically, and I think physicians manage that well. The differentiation syndrome, it's a little bit more unique, not something that it's seen with many other cancer therapies. But number one, it's not that common, fortunately, with lutecidinib. And I think that little by little, they have become much more aware of this and they can manage well. I've seen them manage with some of the other drugs that we use in these hematologic malignancies. And they become much more aware and alert than when we started seeing these things initially with an IDH2 inhibitor, which was the first one that was approved. That was a bit more of a surprise, even for us when we started developing the drugs. But then, you know, over time, I think they've become very familiar with and able to manage these and, you know, if not manage themselves, at least call for help. So I feel comfortable with how they will be able to manage a lutecid and even the clinic.
spk06: No, thank you for that very much. And then two Tavolis questions for the company, please. Regarding Weha, are you able to, I know it's ahead of your FDA interactions in the fall that you mentioned, but are you able to give us any additional information or tease for that matter regarding additional analyses that you've been conducting?
spk08: Yeah, Joe, thanks for that question. You know, we've done a great deal of analysis on the data since we announced it. We've worked hard on that. But at this point, what we prefer to do is to share that with FDA first before sharing it more broadly. That would be the appropriate step we view as the next step to do and have those discussions. And after that interaction, be able to report to you and the investor community afterwards. what FDA feedback is on that based on that analysis, rather than sharing additional analysis and have the FDA not view that favorably as a result. So the timing is probably not that far out, by the way. We hope to meet with the FDA in the fall. And after that, we would have some feedback from them and be able to share more.
spk06: No, totally fair. And then just quickly, I wanted to see if... you know, how things are being maintained or improving regarding the current refill rate based on prior quarters, you know, been hovering around the mid-50s.
spk08: Dave, do you want to comment on the persistency?
spk09: Yeah, persistency hasn't changed. You know, it takes a long time to move that curve. Obviously, we've been adding new patients. It's too early to assess whether those patients have longer persistency, but for right now, we're maintaining in the mid-50s. Great. Thanks, guys.
spk08: Thank you, Joe.
spk12: Thank you. Our next question comes from Gary Nachman with BMO Capital Markets. Please proceed with your question.
spk13: Hi. Good afternoon, and congrats on the deal. First, for Dr. Cortez, where do you see the most opportunity in additional indications for oludacitinib going forward? In particular, How important will combination therapy be over time? You know, what's the timing of that data? And at what point will physicians start to experiment with that? And how many more patients are out there beyond the 1,000 that could be good candidates over time?
spk04: Yes, thank you. First, in terms of the opportunity, you know, where next? Definitely frontline. I think this is a drug that, you know, of course you start studying it in refractory relapse as the nature of drug development in AML, but it has a lot of potential for frontline, both as a single agent and in combination, because there's patients where you're aiming for different things. So, you know, for very unfit patients who are not able to take combinations where you want to minimize malar suppression and all these things, even though I mentioned myelosuppression is the most common, this is far less than you would see with any chemotherapy. So, you know, far less than you would see with, for example, AIDS of an entoclax, for example, which is so myelosuppressive. So single agent could be very, very good for some of these patients. But a combination then would be a very valuable addition for the patients where you're aiming for a little bit more, more responses, deeper responses, and so on. So that definitely would be a trajectory to follow. I also like the, I went fast through the development, but there was one of the arms, which is for patients that have what we call measurable residual disease or MRD. So these are patients who have achieved a remission, but they still have, you can find by these sensitive tests, detectable disease. And this is very well suited for that purpose because it's a It's an oral agent. You would use it as a single agent by itself. You don't have to worry about differentiation syndrome in that concept. So it is a very, very well, it fits very well for that purpose, both after some other sort of chemotherapy or after a stem cell transplant. You know, if a patient relapsed and you gave them whatever, this drug or something else, and then they went to a transplant, maintenance of the transplant usually becomes very valuable if you have something that's effective, that's easy, that's safe, et cetera. So I think that those are some of the areas where it would fit well. Now, can it grow more than those 1,000 patients? I think it can because, number one, if you move it up front, Number two, I think that as we have more of these treatment options that physicians identify as well-tolerated, effective, et cetera, the testing for the mutation starts picking up. And although a lot of the patients are being assessed for mutations nowadays, it's not 100%. It can be a lot better than it is now. So I think that
spk13: physicians will start looking more and more for these mutations because they know that it could be a big difference for their patients in terms of the treatment strategies that they could use okay great that's very helpful and then one for the company I'm curious how competitive was the process for this drug you know how did you evaluate the economics for the deal relative to the overall opportunity? I mean, if you could try and quantify that for us at a high level, I think that would be helpful. And do you have capacity to do more deals in the Hemonc space and get the full synergies like you're getting with this transaction? And then just comment on the IP for the drug. That would be helpful as well. Thank you.
spk08: Sure. Dolly, if you want to comment on the IP, I'll answer the other questions.
spk07: Sure. On the composition of matter without any extensions, it is protected through September 2035. And then there's a number of very useful methods of treatment as well as certain forms of the compound as well that have protection through 2039. Thank you, Dolly.
spk08: You know, we've been engaged with our colleagues in FORMA for a bit on this drug. We looked at this and we thought it was a very attractive molecule with compelling data that could make it the leading agent in this category in AML. And so for that reason, we were very attracted to it. It is a constrained product. It's not a billion dollar product by any means, but it's a very exciting product for a company like Rigel. And in particular, our franchise that we're building in Hemonc with that foundation being ITP with Tavalis. This is a perfect add-on molecule to that. And we have a commercial organization in place, boots on the ground now, that can deliver value to this asset. And so it made it an attractive proposition for our colleagues at Forma as well, I believe. And as a result, we found a way to mitigate some of the risk, minimize some of the payments up front for us. We're particularly sensitive in the short term. and allow them to recapture some of the value of the tremendous work they did in filing the NDA and prosecuting that NDA with FDA to this point. So I think the economics makes sense as well for us, and they're commensurate with that. There's opportunities here beyond relapsed refractory AML, IDS-positive AML. And as Dr. Cortez said, in early either as a single agent or combo therapy. There's opportunities in glioma as well, where some work has already been done. So there's other things we could explore here. So it offers opportunities even beyond the initial potential indication that where the PDUFA date is in February. Can we do more? Absolutely. We can do more here. Once we've laid a good foundation and we've leveraged that, I think we'll be in a position to continue to build in this area. And this sets the precedent for what we might do going forward. No promises and no promises on timing, of course, but it's a pretty exciting next step for us as a company. Okay, great. Thank you.
spk12: Thank you. Our next question comes from Kristen Kliska with Cantor Fitzgerald. Please proceed with your question.
spk10: Good afternoon. This is Rick on for Kristen. Thank you for taking our questions. We have two for you. On the topic of potential sub-licensing around the AML opportunity, are you able to give any color on what Rigel could look for in a potential partner for bringing all of Citinib forward ex-U.S.? ?
spk08: Sure, I could take that. We have rights to do XUS sub-licenses, and there's a very good opportunity, and obviously this disease is not solely a U.S. issue. It's a very severe disease globally. And so we will look to, in the future, do deals with partners outside of the U.S. There may be an additional trial required in some territories, and that would be part of the discussion with those parties. We do know that there are investigators that participated in the trials, the registrational trial, in Europe that are very enthusiastic about we're continuing to work with this molecule. And so that'll be part of the discussion as well. But that's an exciting facet to this agent that I think allows us to do that a bit further and, frankly, devote additional resources to its further development, benefiting us here in the U.S. tremendously from a commercial perspective.
spk10: Understood. Okay. And one more. After completing COVID-19 enrollment, are you able to say anything about any potential effects that the recent increase in transmission rate across the U.S. has had or had had in the last stretch of enrollment. Thanks.
spk08: I'll ask Wolfgang to maybe comment on that.
spk11: Yeah, no, we did not really see that reflected in hospitalizations at the sites that we were working with in the countries that we were working with. So while it's possible there might be some additional hospitalizations coming, we feel comfortable with the sample size that we have. And with the change primary endpoint, we have a little bit more sensitivity than with the original primary endpoint. And therefore, we decided to stop enrollment at 280. Thank you, Rick.
spk12: Thank you. Our next question is from Kalpit Patel with B. Reilly Securities. Please proceed with your question.
spk02: Hey, good afternoon. Congrats on the deal with FORMA, and thanks for taking the questions. Starting out with Dr. Cortez, I guess when you compare the two IDH1 inhibitors, does anything stick out from a tolerability perspective that might position one molecule favorably to the other? I know you talked about efficacy differences, but curious to hear your perspective on safety.
spk04: Yes. I think that there are some differentiators that I like from the perspective of the safety profile. The incidence of KTC prolongation is very low. And that is, you know, a big asset, you know, in particular because you don't have to be doing EKGs and these things. If they happen outpatient, it's hard to get them. As I mentioned, there's only one patient in the whole study, so that's less than 1%. Whereas with divacitinib, it was reported in almost 8% of patients. And I'm talking about the grade three, the most severe conditions. So, 8% is not a huge percentage, but it is definitely a number that starts making you pay attention because it can be severe. So that is one. And I think that the liver toxicity doesn't worry me. I think it is something that's highly manageable for patients, again, for the general oncologist. especially because most of these can be managed with just transient treatment interruptions, sometimes those adjustments, and as I mentioned, most of the patients can really continue being treated. So I think that the safety profile is equal or better for olitocitinib compared to the ivocitinib. And, you know, I really, I've managed many of these patients that I told you about, and And it's been, you know, very easy to manage. We've done combination. We've reported some of those early results in combination in some of the meetings and the combination with ACEs. Because of the good safety profile, it's also easy to combine with other drugs, which is also a great value.
spk02: Okay, and Dr. Cortes, if the data are available from the respective trials of these two IDH inhibitors, do you see any differences, you know, in the number of patients that are eligible to receive a transplant or actually go on and receive a transplant after?
spk04: One of the criteria that you need for getting a patient to a transplant is to get them to, at the very least, a partial response. And then, of course, all the way up to a complete remission. So for that matter, I mentioned that the overall response rate is 46% when you include all of these responses. So all of these patients could potentially be eligible for transplant. Then, of course, comes the issue of age, comorbidities, donors, you know, other factors, and many patients drop out because of these conditions. But at least from the perspective of the disease and the response that you get with the drug, that's almost half of the patients would become potentially eligible for a transplant.
spk02: And then one question for the company, sort of building on one of the previous questions. Since TIPSOVO moved so far in that elderly, chemo-ineligible patient population in the frontline setting, does that approval in the frontline impact your development efforts to moving your IDH inhibitor earlier on, or even your commercialization efforts in the late-line setting for this new asset?
spk08: Dave, why don't you address our commercial focus now and maybe in the future, and maybe Rupke and I can comment on future developments.
spk09: Yeah, I think for us, that was another thing, obviously, that attracted us to this opportunity. IDH1 is now well proven in the newly diagnosed patient with category one evidence in the NCCN guidelines. So I think, you know, obviously, that would be something that, as I said earlier, would be good if we could move into the earlier line setting. But for right now, The relapse setting for us is a perfect entry. It's where other targeted agents have started, and I think that's where the most need is, and so we'll do that. Obviously, we don't have any comparative trials to another IDH1 inhibitor, and so we can only discuss our data. But at the end of the day, I think, you know, as you've heard, I think clinicians might see some differentiating pieces here that could allow them to use it in different settings in AML. But we're going to wait until we see what the label is. And then we'll be, if it is approved and if it is made available at that time, we will pursue that with vigor.
spk11: Yeah, this is Wolfgang. Just to add to that, as you've heard from Dr. Cortes, the data in the refractory relapsing population looks compelling, right, with high response rates and with a long duration of disease and a manageable safety profile. So even if others have studies going on in earlier patients or frontline patients, Doctors usually follow the data, and if they believe there's something promising, I'm optimistic that we could engage them in discussions about earlier use.
spk02: Okay. Thank you very much. Thank you.
spk12: Thank you. There are no further questions at this time. I would like to turn the floor back over to Mr. Raul Rodriguez for any closing comments.
spk08: Thank you for your questions and for the imposition that we've made in terms of your time. I appreciate that. It's an exciting quarter. We accomplished some really important milestones this past quarter. Regaining momentum and growth in ITP sales, I think that is foundational to the company in terms of the HEMOC business. Overlay that on top of that, this in-license. providing leverage with an existing organization. We're incredibly excited about those two events this quarter, and I think it bodes really well for this year and into next. And then progress on some of our pipeline programs with Fostermatinib, with FDA coming soon, with COVID data coming soon, and advancements into patients with our earlier two programs. are two things we're very excited about. So thank you for your questions and look forward to providing you more information as is appropriate. Take care.
spk12: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
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