Hey, good afternoon, everyone. My name is Ted Tenthoff. I'm a senior biotech analyst at Piper Sandler. And before I begin, I'm required to point out certain disclosures regarding the relationship between our next presenting company, Viracta, and Piper, that are located both at the back of the room and also at the registration desk. And I believe, for anyone who hasn't grabbed, they're serving poke bowls and maybe a sandwich, I don't even know. But feel free to go grab a sandwich and come on in and join us. Make it a working presentation. I don't think Mark will mind. So Viracta is developing Nana-val in the NAVAL-1 trial in relapsed/ refractory EBV-positive peripheral T-cell lymphoma, and recently reported encouraging Phase 1b/2 data in EBV-positive solid tumors. Here to present for the company is President and CEO, Mark Rothera. Thank you very much, Ted, and thank you, Piper Sandler, for the invitation today. Viracta is a precision oncology company focused on the treatment and prevention of virus-associated cancers. During today's presentation, I may make some forward-looking statements. Really, for the time we have today, I want to focus on Nana-val. That's our lead clinical stage program for EBV-associated cancers. That's about 2% of cancers worldwide, and as Ted alluded to, we're in a pivotal Phase 2 study for relapsed/refractory EBV-positive lymphomas, and we're going to share some data from that. We're also in a dose-ranging study, which is looking very encouraging in the solid tumor setting, so EBV-associated solid tumors. And as I think you'll see in a moment, we have a very large number of important catalysts and milestones coming up in the next sort of 3-12 months across lymphomas and solid tumors with Nana-val. Now, Nana-val is nanatinostat and valganciclovir. It's an all-oral combination which targets and kills EBV cancer cells. So EBV cancers affect about 2% of patients worldwide. That's more than 300,000 patients a year. And we've decided to focus on five specific indications, three on the lymphoma side and two on the solid tumor side, as a starting point. So as you can see on the left, PTCL, DLBCL, and PTLD are our three key priorities there, along with the EBV positivity rates that you can see for those. And then on the right, you can see the two solid tumor subtypes with the EBV positivity rates associated with them. The reason we're here is if you look at survival of patients, for example, with PTCL or with DLBCL, those that are associated with EBV have a much worse prognosis. And so today, there is a lack of treatment specifically to target and kill cancer cells for patients like this. There's a high unmet medical need, and we're one of the very few, if not the only company, out there looking to serve these patients. And the approach we're taking to doing that is shown here. This is a unique mechanism of action. We call it the kick and kill mechanism. So in the presence of the latent EBV virus, valganciclovir is inert, it's not active. You add nanatinostat, that selectively and potently induces EBV protein kinase production, and that converts valganciclovir into, by phosphorylation, into its active cytotoxic form, which then causes the kill, kills the cell. So that kick and kill mechanism is very well documented in the literature, and that's what we're using for our trials, this kick and kill mechanism. So let's see what that delivers in the clinic. I'm going to begin with our lymphoma program, and as Ted was mentioning, we're in this pivotal phase II study we call NAVAL-1, and you can see it's a basket trial, so we're including PTCL as well as DLBCL and PTLD patients in this study. It's also Simon two-stage design, so we have a Stage I, 10 patients for each cohort. If a threshold of at least two responses is met, we move to Stage II for a further 11 patients, and the intention is that we will meet with the FDA in Stage II and talk about the onward enrollment of patients for an accelerated approval. Now, you... Just to point out that we're pretty much closing the enrollment of PTCL Stage I for both the Nana-val PTCL arm and an additional 10 patients for nanatinostat monotherapy. And so the goal here is to be able to demonstrate to the FDA that there really is a difference between treating with nanatinostat alone versus the combination of nanatinostat with valganciclovir. Now that we are moving into Stage II because we saw some good responses with Nana-val, we will then be concentrating all the firepower of our enrollment then into the Nana-val alone arm in Stage II, which we expect to do very rapidly. So one of the recent things that we also announced is that for DLBCL and for PTLD, we're enrolling second line onwards. This, this is a change. We originally were enrolling third line, but we're now enrolling second line. We believe that the high unmet need in these populations warrants the treatment of patients second line for EBV, DLBCL, and PTLD. So let me now speak to our lead indication, PTCL, and right, you know, our goal is to get this to regulatory approval as rapidly as possible. There is no current standard of care for relapsed refractory PTCL patients. If you look at the five-year survival rate for EBV PTCL, it's 11%. So there's a high unmet need. We're starting second line, but our goal is to move this ultimately into first line. And when you look at the data we've generated in the NAVAL-1 study, these are the first 5 patients that were treated in the NAVAL-1 study, and you can see this data cut was the 30th of June this year. We saw two complete responses. So 40% ORR, 40% complete response rate. So that was very encouraging. And on that basis, we announced that we're advancing into Stage II. What is also encouraging is that data stacks up very well with the 201, the prior Phase 1b/2 study, the data that we generated in that study. So in the blue, you can see on this slide, we saw about a 50% ORR, almost 40% complete response rate in the 201 study, and that matches up very well with a, you know, 40% complete response rate in the NAVAL-1 study. What I think is also very encouraging, coming out of the 201 study, you can see that on the right-hand side, is the median duration of response was 17.3 months. So this is substantially better data than has been seen for prior HDAC inhibitor accelerated approvals, roughly double the rate of duration of response, and almost double the ORR rate as well. And the safety profile is encouraging because, you know, for the most part, the more severe treatment- emergent serious adverse events, cytopenias are, you know, generally manageable, if not reversible. So we think that Nana-val is well tolerated and can be used potentially not just as monotherapy, but potentially also in combination. And this is a candidate for accelerated approval because we're addressing a high unmet medical need. It's a rare and serious life-threatening condition, and we're seeing attractive ORR and duration of response rates. And the goal is to speak with the FDA next year with Stage II data and align on the number of patients required for accelerated approval, which we estimate to be in the 60-90 patient range. So a quick look at DLBCL. As you can see from the graph on the right-hand side, just to remind you, although DLBCL is a field that has a lot of treatment options, for EBV-associated patients, survival is much worse. They have a different, you know, mutational landscape, a different response to standard immunochemotherapy, and it's characterized with its own classification by the WHO. So our thesis is that although there's a lot going on in DLBCL, there isn't another treatment specifically targeting EBV DLBCL patients, and that's the need we are looking to fulfill. And from the 201 data cut that we recently took in May of this year, we're seeing a 67% ORR, 33% complete response rate in this difficult-to-treat population. And what's also encouraging, we weren't even able to determine the duration of response because half the patients were still ongoing, some of them for up to four years. So we have a lot going on in the lymphoma area with our lead indication, PTCL. Next year, we're going to present Stage I data, complete enrollment of Stage II, speak to the FDA about the accelerated approval pathway and present Stage II data. Then sequence behind our lead indication are DLBCL and PTLD, where our goal is to hopefully advance those two to Stage II and present Stage I data. I'm going to transition briefly to our solid tumor program. So this is the new frontier, and we're in a dose-ranging study looking to determine the recommended phase II dose in the recurrent metastatic NPC model, nasopharyngeal carcinoma. What is encouraging here is that in our dose ranging, we've gone up to the fifth dose cohort that gave us a PR, a durable SD, and another SD, so stable disease. So we're seeing that there is a dose- response, and we're also seeing that Nana-val is very well tolerated. In these patients, we can dose higher than in the lymphoma patients, and we continue on that journey. So we're now deploying, given the very good safety profile, with basically mild to moderate severity events. We're now deploying a new split daily dosing strategy as we go into the next dose cohort. So what we're doing here is we're giving nanatinostat in a split dose, four hours apart, and that gives a longer kick. And secondly, we're giving daily dosing. So instead of four days a week, we're going to eight, seven days a week. So this split daily dosing, we think in the animal model, has shown itself to be superior in its anti-tumor activity, and that's our goal, is to deploy that now in the clinic. So in terms of milestones, again, just to reinforce, we have a lot of milestones in 2024 as we turn the corner, including seeing data coming out of the six-dose cohort, where we're deploying split daily dosing, in the solid tumor setting, determining the recommended phase II dose, presenting that phase I data, but also initiating our phase II study. So I just want to conclude. We think that there's a very high unmet need in EBV-associated cancers that affects 2% of world cancer burden. We're one of the only companies that's really focused on this. I think we've got encouraging data that's come out of the Phase 1b, and now progressively out of the phase II study in lymphoma. We're opening up the new frontier in the solid tumor setting, and I think, you know, we have the potential here to really bring to the world a meaningful medicine that can make a big difference to patients, but also create a lot of value for shareholders in that process. Thank you very much. I think I had five seconds to spare, Ted?
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