Good morning, and welcome to the Viracta Therapeutics Business Update. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentations. As a reminder, this call is being recorded, and a replay will be made available on the Viracta website following the conclusion of the event. I would now like to turn the call over to your host, Mark Rothera, President and Chief Executive Officer of Viracta Therapeutics. Please go ahead, Mark. Thank you, Tara, and, you know, good morning, everyone, and, welcome to this business update call, where the focus is going to be on our lead product candidate, Nana-val, for EBV-associated cancers. Next slide, please. During the course of today, we're going to have some forward-looking statements. Next slide, please. I have been a CEO of Viracta for a couple of years, 34 years in the industry, and I'm particularly excited about the opportunity of Nana-val making a real difference for patients with EBV-associated cancers because as you're going to see, for the most part, they are particularly aggressive cancers. Next slide, please. It is my pleasure also to have on this call and to introduce Professor Pierluigi Porcu, who is Professor of Medical Oncology, Director of the Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation at Thomas Jefferson University. Professor Porcu is a global leader in the field of T-cell lymphomas and investigator in the NAVAL-1 trial. We're grateful to have him participate in today's call, given his deep expertise and experience in managing patients with PTCL, which is really the key topic today. Thank you, Professor Porcu. Next slide, please. I'm also delighted to introduce two very experienced executives who form part of our executive leadership team on today's call. Darrel Cohen, MD, who is Chief Medical Officer, and Michael Faerm, Chief Financial Officer. Next slide, please. So in terms of today's agenda, I will say a few words about the vision we have for Nana-val and how it can help patients with EBV-positive cancer. Then I'm going to hand over to Professor Porcu, who's going to get into some detail around the unmet need facing patients with PTCL today, and in particular, those with EBV-associated PTCL. Then Darrel is going to share with you some exciting new data coming out of our NAVAL-1 study, stages one and two of the PTCL cohort, but also an update following a very productive meeting with the FDA, which, together with the data, means we have a clear path forward now to an NDA filing. I'll then hand over to Mike Faerm, who will speak to anticipated milestones and end with some closing remarks before handing over to anybody who would like to ask questions. Next slide, please. If we go to the next slide, what we have with Nana-val is a very unique combination, all-oral treatments, which has, as I said, a very unique mechanism of action for the treatment of EBV or Epstein-Barr virus-associated cancers. The all-oral combination includes our proprietary nanatinostat as well as valganciclovir, and in a minute, I'll go through the mechanism of action. We are studying Nana-val in a lymphoma study we called NAVAL-1, and today, I will speak to the data coming out of stages 1 and 2 of the PTCL cohort, which is the lead indication of our lymphoma program. In addition, on the solid tumor side, we're also advancing on that side with a dose-ranging study, and we're looking forward to determining a recommended phase 2 dose in the second half of this year for advanced EBV-positive solid tumors. Next slide. EBV is associated with approximately 2% of world cancers, and essentially, there is an EBV subgroup present in a whole range of lymphoma subtypes, as well as some solid tumors. What you can see on this slide is the five indications that we have prioritized. On the left-hand side, you can see the three lymphoma subtypes that we're focusing on, PTCL, DLBCL, and PTLD, along with their associated EBV positivity rates. On the right-hand side, you can see the two solid tumor subtypes that we're also focusing on and their associated EBV positivity rates. As you can imagine today, because there is no actionable EBV-targeted therapy for patients with EBV cancer, it's highly likely that the presence of EBV is underreported today, and we would expect that with the launch of Nana-val, there would be a lot more effort to identify and treat EBV-associated cancer patients. Next slide, please. The reason we're here, and we'll speak more about this later, is that when you look at survival of patients that have EBV compared to those that don't, we see a substantial difference. So, for example, here we're showing survival curves for PTCL patients on the left and diffuse large B-cell lymphoma patients on the right. And you can see on the left, the dotted line showing the survival curve for EBV-associated PTCL, and you can see that that is substantially worse than the dark line, which is EBV-negative PTCL patient. So there's an important unmet need, which Professor Porcu will go into more detail around in a minute. Next slide. And as I mentioned earlier, we have in Nana-val a very unique mechanism of action. It's a first-in-class, and that mechanism is as follows: so in the presence of the latent EBV virus in the cancer cells, if you add nanatinostat, that kicks the latent EBV virus into its lytic state and enables the production of EBV protein kinase, shown in green in the middle. That EBV protein kinase enables the conversion of valganciclovir into its cytotoxic ganciclovir. And ganciclovir, on the right, incorporates itself into both the cellular and viral DNA and causes apoptosis. So we call that the kick and kill mechanism, and it's a highly targeted treatment because it will only work in the presence of the latent EBV virus in the cancer cell. So the proof of the pudding is in the studies that we've been conducting with Nana-val, and we'll come to that in a minute. But first, I'd like to hand over to Professor Porcu to say a little bit more about PTCL and EBV-PTCL. Professor Porcu. Thank you, Mark. Next slide, please. So, it's my pleasure to be on this call to provide the clinical context for the development of Nana-val in EBV-positive lymphomas, and particularly the unmet need in EBV-positive PTCL. Next slide, please. Frontline therapy in peripheral T-cell lymphomas remains vastly inadequate, even with the recent addition of CD30-targeting therapies. More than two-thirds of the patients fail first-line therapy, and all of them require second-line therapy. The main reason for this unfavorable outcome is a combination of primary or secondary drug resistance, the cause of which is multifactorial, but includes unfavorable tumor-evasive immune microenvironment, constitutive activation of signaling pathways, and the genomic instability leading to high tumor heterogeneity. I think it's important, particularly in the context of this call, to understand that EBV has long been known as a driver of all these mechanisms of resistance. So very few patients with relapsed refractory PTCL will achieve a CR, and most, unfortunately, will die of disease progression. Next slide, please. So this slide shows progression-free survival curves from three published studies of current therapies in relapsed refractory PTCL. As you can see, the median progression-free survival is less than six months, and for two of them, it is either less or at the edge of three months. These are dismal results, which result in equally poor overall survival outcomes. So with these limited options, there is no standard of care for second-line therapy in PTCL. Next slide, please. So multiple studies have shown that EBV adds additional risk to this already poor and unfavorable group of patients with relapsed refractory PTCL. This is just one example of the differential outcome of EBV positive versus EBV negative PTCL, the curve that Mark has already shown. As mentioned, EBV infection contributes to this unfavorable prognosis through multiple mechanisms. This include inhibition of apoptosis, activation of cell proliferation, angiogenesis, and metastasis, and very importantly, downregulation of innate immune responses. Something that is also emerging is the fact that EBV also increases the risk of a number of immune and inflammatory complications that we're starting to learn more about in patients with relapsed refractory PTCL. Next slide, please. So if we look at the patient journey for those suffering from relapsed refractory PTCL, doctors like myself, who see these patients every day, we are constantly reminded that treatment options are limited and survivals are dismally short. Advances in first-line therapy, with the addition of anti-CD30 antibodies, really have impacted only anaplastic large cell lymphoma, which is almost always EBV negative. Once again, the options for second-line or later therapy are very limited, and there's no standard of care. In addition, there's no biomarker-driven guidance for selection of any of the existing therapies. So while the NCCN, for example, guidelines often recommend clinical trials, even in second line, but these patients are often very sick and often are not eligible for clinical trial. So in this context, EBV positive PTCL appears to be significantly worse subset, presenting unique challenges, but also, I would argue, potentially an opportunity, especially with the development of Nana-val. Next slide, please. So next. So I will close by discussing a patient who we followed here at Jefferson, in part, who exemplifies many of the points discussed above. So this is a previously healthy woman who presented with constitutional symptoms and spontaneous tumor lysis syndrome, so kind of a complication of metabolism associated with lymphoma. A tumor biopsy showed that the lymphoma was an angioimmunoblastic T-cell lymphoma, was EBV positive. There was no evidence of any other chronic viral infection. Patient was admitted and staged as an inpatient, therefore did not get a PET scan. Box B, next box, please, outlines the sequence of therapies that this patient went through. So after one cycle of dose-adjusted EPOCH, which she received as an inpatient, following discharge, she received five cycles of brentuximab vedotin and CHP, BV-CHP, because of the CD30 expression. The patient achieved a PET-negative CR and was consolidated with an autologous stem cell transplant. 10 months later, unfortunately, she progressed. Romidepsin was chosen as second-line therapy by the treating physician, and she received a total of four months of therapy. Initial PET after two cycles showed stable disease, but PET after four cycles showed disease progression with hypercalcemia, AKI, acute kidney injury, and liver dysfunction. In the context of a declining performance status, which of course made the patient ineligible for clinical trial at this point. The patient was admitted for rapid debulking with GEMOX, which is a combination chemotherapy often used in lymphoma, but developed severe neutropenia and septic shock. Next slide. Next, box, please. So from this point on, her disease progressed very rapidly, and her decline accelerated. Towards the end of her disease, she developed a complication called HLH-like syndrome. Next box, please. Next one as well. Thank you. HLH-like syndrome is a hyperinflammatory response, often triggered by EBV, still remains poorly understood, but it is often seen in EBV positive lymphomas. This rapid acceleration is reflected by the skyrocketing of HLH labs. Next, please. Shown here, which was also associated with an increase in EBV viral load. So this, unfortunately, is an all too common outcome for patients with EBV positive PTCL. So less than 12 months response to first-line therapy, despite a stem cell transplant, a rapid transition through multiple lines of therapy for relapsed refractory disease with no meaningful response, and rapid decline with multi-organ failure towards the end, less than 6 months from her first relapse. With this, I'm delighted to pass the baton to Darrel Cohen, who will review the NAVAL-1 data. Thank you. Thank you, PG. So next slide is our flagship NAVAL-1 trial, which was designed as an adaptive, multinational, multicenter, phase 2, open label, single-arm, two-stage basket study of Nana-val, namely nanatinostat and valganciclovir, in patients with relapsed or refractory EBV-positive lymphoma, who previously received at least one systemic therapy with a primary independent central review committee-assessed objective response rate endpoint by International Working Group criteria. This ongoing trial employs a Simon two-stage design, where in Stage 1, participants are enrolled into one of three indication cohorts based on EBV-positive lymphoma subtype, namely peripheral T-cell lymphoma or PTCL, diffuse large B-cell lymphoma or DLBCL, or post-transplant lymphoproliferative disorder, or PTLD. If at least two objective responses are achieved within a lymphoma subtype in 10 patients enrolled in Stage 1, then additional patients are enrolled in Stage 2 for a total of 21 patients. EBV-positive lymphoma subtypes demonstrating promising anti-tumor activity in stage 2 may be further expanded if at least 7 objective responses are achieved. So far, the PTCL cohort met or exceeded both of these advancement criteria and has completed stage 2 enrollment. Next slide. The 21 patients enrolled and treated with Nana-val across stages 1 and 2 of the relapsed or refractory EBV-positive PTCL cohort were mostly elderly white males with an ECOG performance status of 1, who mostly had EBV-positive AITL and were previously treated with 1-4, with a median of 2, prior systemic therapies for primarily advanced stage disease. Next. Of whom nearly half were enrolled in the second-line treatment setting. Next slide. In terms of safety, Nana-val was generally well tolerated, as the most common treatment-related adverse events were fatigue, nausea, decreased appetite, diarrhea, and platelet count decreased, which were primarily mild to moderate in severity, with more severe adverse events that were generally manageable or reversible, with the exception of one case of Grade 5 treatment-related pancytopenia and sepsis. This case represents the only Grade 5 serious adverse event considered possibly related to study drugs out of over 150 relapsed or refractory EBV-positive lymphoma patients treated with Nana-val to date. A serious adverse event that is also a risk of underlying disease itself, as it is for standard combination chemotherapy regimens, including in Dr. Porcu's case study, especially in a heavily pretreated patient with compromised bone marrow reserve. Next slide. Here are the efficacy outcomes from stages one and two of the 21 patient relapsed or refractory EBV positive PTCL cohort. The investigator assessed objective response rates, or ORRs, in the intent to treat, and the efficacy evaluable populations were 33% and 41%, respectively, with complete response rates, or CRRs, of 19% and 24%, which are impressive. The clinical benefit rates, or CBRs, that additionally include stable disease lasting at least 16 weeks, were 48% and 59%, respectively. Of note, the responses were even more robust in the second-line treatment setting, with ORRs of 60%-67%, CRRs of 30%-33%, and CBRs of 80%-89%. Next slide. These responses were both prompt, observed at the time of the first PET-CT scan at week 8, and durable, as the median duration of response has not yet been reached, with 7 of 21 relapsed or refractory EBV-positive PTCL patients still on study treatment, shown here, with complete responses designated by the green dots, partial responses designated by the yellow dots, stable disease designated by the blue dots, and progressive disease designated by the red dots on this swimmer plot. Next slide. Also, as shown here, with 5 of 10 second-line EBV-positive PTCL patients still on study treatment, including two patients who were able to proceed to potentially curative allogeneic stem cell transplant without relapse, including one patient, there at the top, still in response for over 16 months, testimony to the importance of treating these patients earlier. Just to remind you on the next slide, the survival rates precipitously drop off 12-24 months after diagnosis. Overall, combination nanatinostat and valganciclovir therapy is emerging as a promising, generally well-tolerated, convenient, all-oral treatment for patients with relapsed or refractory EBV-positive PTCL, especially in the second-line treatment setting, having met the stages one and two efficacy thresholds for further expansion of this cohort in the NAVAL-1 trial that is ongoing. Next slide. We met with FDA, and we now have a clear regulatory path forward. There were two key takeaways. Namely, Nana-val needs to have a compelling ORR and DOR, duration response, and a randomized controlled trial needs to be well underway at the time of NDA submission. Together with the particularly robust stages 1 and 2 responses observed in the second-line treatment of patients with EBV-positive PTCL, Nana-val is well positioned for up to four opportunities for potential NDA submission for the treatment of these patients, the first of which being a potential NDA filing for accelerated approval in 2026. Next slide. This first opportunity involves interim analysis after 40 second-line EBV-positive PTCL patients are enrolled and followed for at least 6 months in the post-stage 2 expansion cohort of the NAVAL-1 trial, where the opportunity for observing compelling efficacy is the greatest. For example, at or above the 60%-67% ORR level observed in stages 1 and 2, that is sufficiently durable. The second opportunity involves final analysis of 120 relapsed refractory EBV-positive PTCL patients followed for at least six months, shown here, where, by the way, the opportunity for potential full approval based on a single arm trial could be preserved in Japan, where we have aligned on a potential registrational path with PMDA, pending agreement on minimum number of Japanese patients required and minimum ORR and DOR thresholds for success. Next slide. The other two opportunities involve enrollment of a 120 patient randomized control trial of Nana-val versus available therapy in second-line EBV-positive PTCL patients, where interim analysis of ORR in 60 patients or final analysis of PFS, progression-free survival, in a 120 patients followed for at least six months, could support accelerated or full approval, respectively, if the outcome is positive and supported by the secondary endpoints. Next slide. Nana-val's ORRs, DORs, and CRRs overall, and especially in the second-line subpopulation, compare quite favorably with those from other approved agents for the treatment of relapsed or refractory PTCL, shown here. That, by the way, did not select for the poor prognosis and thus more difficult to treat EBV-positive subgroup, portending a reasonably high probability of success for Nana-val. With that, we'll hand it over to Michael Faerm to cover anticipated upcoming milestones. Thanks, Darrel. Next slide, please. This slide shows our anticipated milestones for 2024 through 2026. In the third quarter of 2024, starting with the blue box at the top, we continue to enroll patients in the post-stage two expansion cohort of NAVAL-1. We've just shared today our data for stages 1 and 2 of NAVAL-1, and key feedback from our FDA interaction and our path forward. Looking out ahead into the fourth quarter of this year, we anticipate presenting additional data from NAVAL-1 from patients in the expansion cohort, and then another set of data from that cohort in the first half of 2025. Also, in the first half of 2025, we're planning to meet with FDA to align around the design of the randomized controlled trial, and then that could potentially lead to beginning enrollment in the randomized trial in the second half of 2025. Looking out into 2026, we anticipate presenting interim data from NAVAL-1 from second-line patients. After that, in 2026, being positioned for potential NDA filing for accelerated approval, pending seeing what the response rates look like and pending the randomized controlled trial being well underway. Looking also at our DLBCL cohort, we continue to enroll patients in NAVAL-1, and we would anticipate reporting stage 1 data from that group in the first half of 2025. In addition, we've taken a couple of strategic actions here that we'll discuss. First, we're pausing development on our solid tumor program after determination of the recommended phase 2 dose, which we expect to have in the second half of this year. We remain excited about the potential of Nana-val solid tumors, but for reasons of resource prioritization, we think it makes sense to focus on the opportunity that's most advanced at this time, which is the opportunity in lymphoma that we've outlined. Secondly, we've implemented a reduction in workforce, which impacts 23% of the company's employees. I'll turn it back to Mark for closing comments. Thank you, Mike. Next slide, please. So I hope what you've heard today clearly lays out the fact that there is a significant unmet medical need in patients with EBV PTCL, and indeed, other EBV-associated cancers. And we have a very novel, all-oral Nana-val program, which is a first in class, which can specifically target and kill EBV-associated cancer cells. And on the basis of that, we've seen today encouraging and exciting new data coming out of the stages 1 and 2 of the ongoing PTCL cohort in the NAVAL-1 study. And combining that with the feedback that we just got from the FDA, I think we have a clear path forward to an NDA filing for Nana-val in PTCL, with that first opportunity being in 2026. Really, I see PTCL as the bridgehead for Nana-val to come to market, and our goal is then to expand from there and enable Nana-val to be able to help many more patients with other EBV-associated cancers in the future. With that, I'd like to go to the next slide and move to Q&A. Back to you, Tara. Thank you, Mark. At this time, we will be conducting a question and answer session with our speakers. To our audience on the webcast, please use the Q&A text box at the bottom of the webcast player. To our analysts who are on with us, please use the Raise Your Hand feature to indicate you have a question. Please hold for a brief moment while we pull for questions. Our first question comes from Andrew Berens at Leerink. Please go ahead, Andrew. Andrew, you may be on mute. Hi, sorry, I did not see the button, but, can you hear me now? Yes, we can. Great. Thanks for doing the call, and congrats on the updates. Just a couple. Wondering how many trial sites you're planning to enroll in the pivotal program? And then, you gave us some benchmarks of comparator drugs. Were those also in the second line setting? And then the last one is just on the financing of the trial. I know you announced some cost-cutting measures, including pausing the solid tumor program. Would you be considering monetizing the program if you could find an interested party, or what other types of non-dilutive financing could be available to you? Thanks. Thank you very much for the question, Andy. Maybe I'll begin, and I'll ask Darrel to comment, and also Mike. So in terms of the trial sites, as you are probably aware, we have developed a global footprint for the trial, so we have sites across the U.S. We have sites in Europe, we have sites in Asia, and also in Latin America. So it's truly a global study. And the way that we see this working, as Mike was alluding to, we will be initiating the study, the randomized controlled study, in the second half of next year. So we would see us making the very most of all of these sites for the ongoing NAVAL-1 study and the Stage two expansion. And then, as we think of ramping up the randomized controlled study in the second half of next year, we will gradually convert sites that are already familiar with Nana-val and understand the product that's in development, to the randomized controlled study. So there's gonna be a sort of phasing as we go from one to the other. Andy, I think your second question was about second line. Do you mind just repeating that question? Sure. You showed a slide of Nana-val in the second line, response rates and PFS, I think, for comparators. I was just wondering whether those were second-line settings also. Wasn't clear from the slides. Sure. Darrel, I don't know if you'd like to make a comment about available therapies. Sure. So, Andy, the overall response rates, complete response rates and duration responses for the other therapies that received approval for the treatment of relapsed refractory PTCL were not presented by treatment line. Those data are not available. The overall response rates are on the order of about 25%, with complete response rates of about 10%-15%, and duration of response around 8-9 months, which were inferior to both Nana-val in both the second-line treatment setting, which far exceeded those outcomes, but also in the unselected patient population. In addition, it should be pointed out that patients with EBV-positive PTCL have a much worse prognosis, as both PG and I pointed out during the presentation, and by extension do not respond as well to available therapy. And thus, while the responses to the available therapies may be higher in the second-line treatment setting, they're expected to be lower in the EBV-positive PTCL subgroup. Okay, thanks. And then I just have- Then maybe, Mike, do you wanna... Sorry, your third question, if I remember, Andy, was about financing and monetizing. Yeah, how do we finance the trial? Is that the question? Correct. Would you consider monetizing the solid tumor program if there was an interested party? Yes. Thanks for the question, Andy. So on the first part, we're considering a range of different financing alternatives, and that's, that's something that we, we continue to look at. And in terms of the solid tumor program, that could be pursued in a few different ways. One could be by us, contingent on financing for that program, or potentially with a partner. We have regular dialogue with a range of potential collaborators, and so that's another possibility. Okay. Thank you. Thank you, Andy. Thanks for the questions, Andy. So our next question comes from Suphawat Thongtip at RBC Capital Markets. Please go ahead. Hi, this is Suphawat on for Greg. Thanks for taking our questions, and congrats on the progress. My first questions, just more of a clarification. So it seems that you have allied with the FDA on the accelerated approval pathway. And just to clarify, on the bar that the FDA has set, I think the 60%-67% ORR has been noted as compelling. Is that the bar for the second line? And I'm just curious, what would be considered compelling for the second line plus, meaning, you know, in relapsed refractory population? That's my first question. And then the second question, actually, do you plan to have the data from the second line and the second line plus population at the same time? And lastly, it looks like the response rate and complete response kind of went down a little bit from just the Stage one data. I'm just curious if you have been able to draw any insights, perhaps in terms of the difference characteristic of patients in Stage two versus Stage one. Thank you so much. Thank you for those really great questions. Maybe I'll start with the first question and then hand over to Darrel to comment on the second two questions. And really, our takeaway from the FDA engagement was that really there's a couple of key requirements for the accelerated approval pathway on the single-arm study, which is, number one, that the ORR needs to be compelling, and the second one, that the randomized controlled study needs to be well underway so they have confidence that it's gonna complete within a reasonable time frame. Now, they didn't set a specific bar on what compelling means, but I think one thing that we should consider here is the context of the disease we're treating, and what does compelling mean in the context of the disease? And I think the point that Darrel made earlier was that 60%-67%. You know, you could argue is compelling, given the extremely fast progression of EBV-positive PTCL. But again, it's not like there is a specific bar, but the reason we focused on the second line is that's where you want to treat patients as soon as they've failed first line, which, as Professor Porcu said, you know, happens, you know, very fast for a lot of patients. In terms of data, Darrel, do you wanna comment on second line- Sure. and second-line plus data? Sure. So, the answer to your second question is, we will be analyzing both the overall relapse refractory EBV positive PTCL population at both interim and final analyses of the NAVAL-1 trial, as well as the second-line subpopulation, with the latter subpopulation being the primary analysis. And the reason for that is because the responses were even more robust in that treatment setting. And in fact, the differences in response rates between Stage One and Stage Two, as you have noted, are a reflection of the fact that fewer earlier-line patients were enrolled in the latter stage. All right, thank you so much. Thank you. Yeah, thank you for the question, Suvrat. So our next question comes from Tony Butler at Rodman & Renshaw. Please go ahead, Tony. Thanks very much. Two questions, if I may, and they kind of relate to the previous two questions. Mark or Darrel, historically, the ability to enroll patients at a fair rate has been difficult. And while there has been supportive evidence and even scientific or medical publication suggests that patients who are ill with this type of lymphoma need to undergo some pretty aggressive therapy. So the question becomes, how can you ensure that the timelines that you've laid out? You've alluded to trial sites. I'm respectful of that, but yet it still requires the physicians to agree that they need to put patients on Nana-val. But I am concerned to the rate at which they, you know, can enroll that number of patients. So that's number one. And number two is the goal, and this goes back to Dr. Porcu's presentation. Even though you don't have median duration, the question becomes, is the goal really to get to transplant? And if that's true, you know, I guess the question becomes, how does the FDA view duration relative to the need to get to transplantation? Thanks. So the first question around the enrollment rate, and the other one about sort of transplant and duration. So on the first, Darrel, do you wanna say a little bit about enrollment rate and motivation for enrollment into the study? And maybe also Professor Porcu can comment about that, about the interest of investigators to enroll patients in the study. Sure. It's no secret that the EBV positive subgroup of relapse refractory PTCL represents a rare subset of an orphan disease, making enrollment challenging. And certainly, the early parts of the NAVAL-1 trial were challenged by both the COVID epidemic, as well as the opening of multiple sites, multi-nationally. I think we're now at a place where the study is up and running globally at over 80 sites across multiple continents, including North America, South America, Europe, and Asia. And as we roll out encouraging data like we did today, that motivates more and more investigators to consider our trial, test for EBV in their patients, and enroll those patients. In fact, I'd be interested in Dr. Porcu's reaction to our data and how that might motivate him and his colleagues to bring more patients onto our clinical trial. PG? Yeah, absolutely. Very happy to address both questions, actually. So regarding enrollment, you're right. I think that there's nothing that really sort of stimulates and energizes investigators than the efficacy and safety. So I think that with you know, with the data that you just presented, I think that that will definitely be on top of the already sort of awareness of a lot of investigators that you have on study that there's a big unmet need, and therefore, an interest in having availability of a new therapy for those patients. But the efficacy also, kind of, it plays an important role. And then the safety as well, which is something that you have discussed in one of your slides, which looks pretty good. Enrollment is always challenging for any trial, as I'm sure this group is well aware of. I think the work that you did, Darrel, with you know, kind of developing this network of highly sort of interested investigators with expertise in this disease, which is not something that everybody has, I think it at this point really sort of lays the foundation for the success of the next study. Regarding the transplant, it's an interesting question, really. The important thing to understand is that a lot of the patients with relapsed refractory PTCL, whether EBV positive or not, will not make it to transplant. And even transplant is not the cure, because, you know, there is a substantial relapse rate after allogeneic transplant. So I mean, obviously, I cannot speak necessarily for how exactly the FDA looks at the question or the transplant question. But I agree that kind of the efficacy in terms of response, particularly with complete response, which is something perhaps we can discuss even more, is really, really important. And I don't think that the duration necessarily plays a huge role, or is considered in the consideration for this, in my opinion. It's just that... Whenever a patient is able and fit to go to transplant, you know, if it is, if it has that opportunity, should go to that, understanding that there will be need, there will be unmet need even after transplant. And the patients who do not, those are the patients where I would argue the clinical benefit ratio that Darrel discussed, which is very high, really becomes very, very important. I don't know if this addresses all the angles that the person who asked the question wanted, but I'm happy to expand more if necessary. Thank you, PG. And maybe I'll just add one other comment, that when we look at median duration of response, we look at it both ways, including and excluding the transplant patient. So, you know, in some ways, Nana-val has enabled a patient to be transplanted, and you can look at DOR and some benefits occurring to Nana-val for that, but we also look at it without. So we sort of tend to look at it both ways. Does that answer your question? Yes, Mark, thank you very much. Dr. Porcu, thank you, Darrel. Appreciate it. Thank you. Thanks for the questions, Tony. So I'll now turn it back over to Mark for any other questions that may have come over the webcast. Thank you, Tara. Yes, we've had a few that have come through the webcast, and maybe I could ask Professor Porcu to just comment. There's one here that just speaks to, given the lack of treatment options for PTCL patients with relapsed and refractory disease, how do these NAVAL-1 results in the second-line EBV-positive PTCL subpopulation compare the current standard of care for aggressive EBV-positive lymphoma subtypes? It's kind of a, a relative efficacy sort of question, Professor Porcu. Right. So this is a good segue to the previous question, really. And so I would say this, I mean, it's as Darrel has shown, you know, the efficacy outcomes with Nana-val in this population are very good. And the question then is how to compare and how to position this currently. So, I mean, we have to, first, as Darrel also has mentioned, we have to understand the efficacy data with the existing therapies are based on an EBV unselected population, and which may easily be overall a more favorable group compared to the EBV positive PTCL. And if we look at that, you know, even considering the EBV unselected, both ORR and complete response rate are looking very competitive, because if you look at the complete response rate, you know, in those patients with those drugs, it's typically around 10%. So 8%, 10%, and 15%. And, you know, if you look at Nana-val, it looks really competitive. The other question I think that was raised is, you know, for second line versus, you know, overall median, you know, with median prior therapies. Yes, true that for all those other therapies, they were not focused specifically on second line. But even if you look at the overall population in the NAVAL-1, the complete response rate in that group is still 19%, which is higher than the other. So I think overall, to me, you know, and as an investigator, Nana-val looks very, very competitive to compare to the other drugs. And eventually, you know, how we can then potentially discuss later how this fits into the treatment landscape that we have to address. But this is, I think, overall, it's a very competitive position to be in. Thank you, Professor Porcu. I've got a couple more actually directed to you here. The one question here is around the safety profile of Nana-val and how important that is when you're considering, you know, treating patients with EBV PTCL, and can you expand on your views of Nana-val's safety profile? Yeah, I think safety is really an extremely important consideration for not just for patient putting patients on trial, but then later to actually use the treatment. So let's go back for a second to the development of Nana-val in EBV-positive lymphoma. You know, the spectrum of adverse events with Nana-val was in great part predicted from the beginning due to the accumulated knowledge on the safety of valganciclovir and HDAC inhibitors in general. And I think what was really good to see is that the phase 1, 2 validated that assumption, showing that there were no unexpected toxicities, and that those toxicities sort of fell into what really was expected. So some degree of myelosuppression, particularly thrombocytopenia, GI, as Darrel mentioned, fatigue, and some renal dysfunction. In addition, those toxicities were mostly observed during the dose escalation part of the phase 1b/2, and once the RP2D was achieved, and then the expansion cohort was treated, there were no severe AEs. So NAVAL-1 has so far confirmed the observations of the study of the phase 1b and 2, specifically in this cohort of EBV-positive PTCL, with GI side effects, fatigue, less than 5% Grade three, four thrombocytopenia. So considering this is oral therapy, I think the feasibility is great. There's no need for frequent visits and laboratory monitoring. That is one of the things that investigators or treating physicians really care about, how often you have to see the patients, how often you have to check labs to make sure the patient is doing okay. So with this, I think we're in terms of feasibility, I think, for this therapy is very good. Thank you very much, Professor Porcu. Actually, last question also for you, which really just, I guess, asks practically, how would you wanna use Nana-val? And also, do you see any potential for its use in first-line treatment? Yeah. So, you know, I what I would like, as an investigator focused on this type of lymphomas, for a long time, I would like to see dedicated first-line therapy for EBV-positive lymphomas, in particularly, PTCL, but not limited to PTCL. I know, I think in DLBCL also would be, would be great. I don't think we're there yet, but I think that, with the data that are coming out from NAVAL-1, I think that conversation is going to start. And the more, as you mentioned, Mark, you know, testing is gonna become more, prevalent. And with, you know, and I think that, this is really gonna open up, it's gonna open up the field. Now, we've seen that results in current with current therapy in first line are very disappointing. So how could Nana-val, sort of, you know, make an impact there? I mean, we, there are some opportunities. For example, I could see Nana-val integrated in combination regimens, in the front line, either with, kind of a backbone of CHOP or, you know, some anthracycline-based chemotherapy, which we still think is important for the curative impact in the first line, even though it is a small subset. Potentially, combination with brentuximab, checkpoint inhibitors, etoposide, for example, if for patients who have those, particularly for those who have those HLH-like syndrome. Or another potentially alternative would be use it initially, with or without some of the above agents, to achieve initial disease control, decrease the EBV viral load, followed by perhaps a few cycles of anthracycline-based chemotherapy, sort of a Smart Start approach, to patients, as we are starting to see in DLBCL. So these are just two, sort of, two general ideas, but I love to kind of discuss this more, and I hope to see that moved into the front line for sure. Well, thank you very, very much for participating today and answering those questions that came through, Professor Porcu. I think that's gonna now bring us to a close for today. I just wanted to thank everybody for joining us and repeat that, you know, we're excited about the fact today we've been able to share with you new data and exciting data from the PTCL cohort, which, along with the FDA feedback, gives us a clear path forward for our NDA submission. So thank you all for joining us, and catch up again soon.