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spk00: Good day, ladies and gentlemen, and welcome to Trach and Pharmaceuticals' fourth quarter and year-end 2020 earnings conference call. At this time, all callers are in the listen-only mode. After the speaker's prepared remarks, we will conduct a question-and-answer session, and instructions will be given at that time. During today's call, we will be making certain forward-looking statements, including statements regarding expected timing of clinical trials and results, regulatory activities, future expenses and cash one way, and our development plans and strategy. These statements are subject to various risks that are described in our filings made with the Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2019, and subsequent quarterly reports on Form 10-Q. We are cautioned not to place any reliance on these forward-looking statements, and we disclaim any obligation to update such statements. Now I would like to turn the call over to Dr. Charles Sewer, President and CEO of Tracon Pharmaceuticals. Dr. Sewer?
spk02: Thank you for joining Tracon's fourth quarter and full year 2020 financial results and business update call. I will begin with an update on our pipeline and then review our recent activities. Following that, Scott Brown, our Chief Financial Officer, will review our financial results for the three months and year-ended December 31, 2020. Thank you. Finally, we will conclude by taking your questions. Our development efforts continue to focus on the pivotal Envisarc trial. Envisarc is designed to allow potential approval of Envifolumab in the sarcoma subtypes of undifferentiated pleomorphic sarcoma, or UPS, and myxofibrosarcoma, or MFS. During December, we initiated dosing of multiple patients that has continued this year. Currently, we have initiated 16 U.S. sites, where we have enrolled multiple patients at multiple sites. We expect to achieve our goal of initiating 25 US sites by April. As a reminder, Envifolmab is a potential best-in-class PD-L1 checkpoint inhibitor which may confer additional clinical benefit by virtue of its convenient and rapidly delivered subcutaneous route of administration. The Envisarc pivotal trial includes two cohorts of 80 patients each. One cohort receives single-agent Envifolimab, and a second cohort receives Envifolimab in combination with Yervoy, a second checkpoint inhibitor targeting the CTLA-4 receptor that is marketed by BMS. The trial enrolls patients with UPS and MFS who have progressed on one or two lines of prior treatment and have not received prior checkpoint inhibitor therapy. The primary endpoint in both cohorts is objective response rate by RESIST. as confirmed by blinded independent central review, with duration of response being a key secondary endpoint. In each cohort, the demonstration of nine out of 80 objective responses, or an 11.25% objective response rate confirmed by independent radiographic review, defines the level of response that satisfies the primary objective of the study, which is to statistically exclude the known 4% response rate of Votrien, the only approved treatment for refractory UPS and MFS. To reiterate, unfortunately the one approved treatment for refractory UPS and MFS has only a 4% objective response rate. This is a clear example of an indication with high unmet clinical need. We are studying the sarcoma subtypes of UPS and MFS because they are responsive to checkpoint inhibition based on data presented at ASCO 2019 and ASCO 2020. At ASCO 2020, investigators from the Alliance for Clinical Trials and Oncology reported an impressive 29% confirmed objective response rate in patients with highly refractory UPS who received Opdivo in combination with Yervoy. These data build upon data presented at ASCO 2019 showing that single agent Keytruda demonstrated a 23% response rate in highly refractory UPS and MFS patients. The NVSARC trial was designed based on activity reported for PD-1 and PD-L1 antibodies as single agents and in combination with Urovoi in the soft tissue sarcoma subtypes of UPS and MFS. From a financial perspective, we estimate that the cost of conducting this pivotal trial using TRACON's CRO-independent product development platform, including paying for Urovoi, will be less than $20 million and will be spent over the next eight to ten quarters. We expect multiple Envifolumab milestones this year. First, we intend to report recommendations by the independent data monitoring committee following interim safety evaluations expected in the first half of 2021. Second, we anticipate submitting early response assessment data to the FDA in the first half of this year as part of our ARFN drug designation application. Third, we expect the availability of interim Envisarc efficacy data in the second half of this year. These data could be presented at a scientific conference or could be summarized in a top-line data release. Fourth, we expect those interim efficacy data will be the basis for submitting a request to the FDA for breakthrough therapy designation. Looking forward, we anticipate reporting final response assessment data in 2022 and assuming positive data, submitting a BLA for accelerated approval that, if approved, could allow for product launch in the U.S. in 2023. In parallel, our corporate partners, 3D Medicines and AlphaMab Oncology, are conducting multiple clinical trials, including two pivotal trials in China in additional indications. In December 2020, they submitted EnvifolMab for approval in MSI-high cancer in China, and the application was accepted for priority review by the NMPA earlier this year. We believe Envifolimab could be approved in China later this year. Returning to Tracon's development in sarcoma in the US, our market assessment concluded that Envifolimab, if FDA approved for refractory UPS and MFS, could generate peak annual revenue of approximately $200 million in the US, assuming parity pricing to Keytruda or Opdivo. The adoption rate is forecasted to be relatively rapid, using Envifolimab's target product profile, a 15% response rate as a single agent, and a 30% response rate when combined with Yervoy, which would compare favorably to the 4% objective response rate of the one approved treatment for refractory UPS and MFS. Envifolimab's sales revenue could increase further through label expansion or compendia listings into other refractory sarcoma subtypes that have been shown to be responsive to checkpoint inhibitions. such as angiosarcoma, alveolar soft part sarcoma, and dedifferentiated liposarcoma, which our market assessment could generate an additional $100 million in peak annual revenue in the U.S. for a total of $300 million when combined with UPS and MFS. We believe dual checkpoint inhibition with a combination of Envapol, MEV, and Urovoi should also be advanced into first-line treatment. Notably, the response rate for dual checkpoint inhibition with Opdivo and Yervoy in refractory sarcoma subtypes other than UPS and MFS was 16%. Given the response rate of first-line chemotherapy in sarcoma is only 17%, we expect to dose Envavolumab with doxorubicin in a limited-scope Phase I trial later this year to assess safety of the combination and then move quickly into a potential pivotal trial. The trial could include a combination of doxorubicin, Envifolimab, and a CTLA-4 inhibitor. The CTLA-4 inhibitor could be Urovoi, or another proprietary CTLA-4 inhibitor, as one of our business development priorities is licensing another immuno-oncology asset. We are also discussing a clinical trial of Envifolimab with an approved CKIT inhibitor in gastrointestinal stromal tumor, or GIST, that may be funded by third parties. We believe thorough label expansion in sarcoma, including in GIST, in the first-line setting, as well as for neoadjuvant treatment prior to surgical resection and adjuvant treatment following surgical resection, could substantially increase sales revenues to over $1 billion just in sarcoma. While Imfofolimab is our most advanced product candidate, we continue to progress to other clinical stage assets. TRC-102, our second clinical stage asset, is a novel small molecule inhibitor of the DNA-based excision repair pathway that is intended to reverse resistance to certain chemotherapeutics. The NCI reported notable data for TRC-102 as part of a publication on exceptional responders in the journal Cancer Cell in December 2020. The article profiled a colorectal cancer patient treated with Temodar and TRC-102 with an ongoing near-complete response for nearly four years. Detailed molecular analyses of the patient's tumor showed silencing of alternative DNA repair pathways, including the MGMT pathway, that may have resulted in sensitivity to inhibition of DNA-based excision repair by TRC-102. Inhibiting base excision repair with TRC-102 was postulated to induce synthetic lethality, meaning a combination of deficiencies in DNA repair led to cell death. and this effect caused the prolonged response to Temodar and TRC-102 treatment, as single-agent Temodar is typically inactive in colorectal cancer. Further support for the NCI hypothesis was demonstrated in 11 colorectal cancer patients who subsequently enrolled. While none of the 10 MGMT-expressing patients demonstrated a response, the single patient with deficient MGMT also responded to treatment with Temodar and TRC-102. MGMT deficiency is observed in about one-third of glioblastoma patients, and a prior study of Temodar and TRC102 reported at the Society for Neuro-Oncology in 2018 demonstrated that two MGMT-deficient glioblastoma patients had prolonged survival when treated with Temodar and TRC102 after progressing previously on Temodar and radiation therapy. We expect further development by the NCI in glioblastoma based on these data and believe a trial in the first-line setting of Teminar, radiation therapy, and TRC-102 is warranted. Notably, in October 2020, TRC-102 was granted orphan drug designation by the FDA in malignant glioma. That includes glioblastoma. We also expect TRC-102 to continue to advance through NCI sponsorship in lung cancer in combination with chemotherapy and radiation therapy, based on data presented at ASCO 2020, showing that TRC-102 in combination with chemoradiation resulted in a 100% response rate in 15 patients with advanced localized nonsuicide, including in three patients who had a complete response to treatment. These data compare favorably to prior trials of chemoradiation therapy in advanced localized non-small cell lung cancer. The PROCLAIN clinical trial reported an objective response rate of 36%, and the PACIFIC clinical trial reported an objective response rate of 51% in these patients using a lympha, cisplatin, and thoracic radiations. Mfinzi, a PD-L1 checkpoint inhibitor, is now approved for patients with unresectable localized non-small cell lung cancer whose disease has not progressed following concurrent chemoradiation. We believe a study of TRC102 with chemoradiation and Mfinzi in these patients is warranted. In ongoing and future trials, we will continue to focus on the assessment of biomarkers of response, like MGMT and double-strand DNA repair status, with the goal of identifying a protein or gene expression profile that correlates with clinical response. Our third clinical stage asset is the CD73 antibody, TJ4309, that is being evaluated in an ongoing phase one dose escalation study as a single agent and in combination with a checkpoint inhibitor, Ticentric. We are developing TJ4309 in collaboration with IMAP Biopharma through one of our two strategic agreements with them, whereby we are responsible for the regulatory and clinical development of TJ4309 in the U.S. and Europe. Earlier this month, IMAP sent us a notice purporting to terminate the TJ4309 agreement, which would result in IMAP owing us a pre-specified early termination fee of $9 million. However, IMAP does not have a right to terminate the TJ4309 agreement without cause until the ongoing phase-on trial of TJ4309 is complete. We therefore believe the TJ-4309 agreement has not been terminated and continue to perform our contractual obligations. Per the license agreement with them, we are entitled to receive escalating portions of non-royalty and royalty payments if IMAP elects to license TJ-4309 to a third party in any region outside China, Macau, or Taiwan. We anticipate presenting interim data from the ongoing phase one trial at a scientific conference in mid-2021. During the fourth quarter, we raised a total of approximately $14 million at market prices and welcomed the new fund to our shareholder base. This was accomplished through a registered direct placement that included existing investors Icarian, Opel I Capital, Aspire Capital, and Watermill Asset Management, and the new investor, 5T, who collectively purchased common stock at market price for aggregate proceeds of approximately $14 million. Collectively, these transactions are expected to extend our cash runway past the anticipated interim analysis for the Pivotal and the SARC trial and into the second half of 2022. In addition, institutional index funds initiated positions in TRACON in the fourth quarter of 2020 for the 13F filings. At this time, Scott will provide an update on our financials.
spk04: Thank you, Charles, and good afternoon, everyone. TRACON's research and development expenses were $2.2 million for the fourth quarter and $8.2 million for the year ended December 31, 2020, compared to $1.9 million and $14.5 million for the comparable periods of 2019. The decrease was primarily attributable to lower manufacturing and clinical trial expenses related to the termination of the TRC-105 program in April of 2019. General and administrative expenses were $2 million for the fourth quarter and $8 million for the year ended December 31, 2020 compared to $1.9 million and $7.8 million for the comparable periods of 2019. Our net loss was $4.3 million for the fourth quarter and $16.8 million for the year ended December 31, 2020 compared to $3.9 million and $22.7 million for the comparable periods of 2019. Turning to the balance sheet, at December 31, 2020, our cash equivalents and investments totaled $36.1 million, compared to $16.4 million at December 31, 2019. We expect our current capital resources to be sufficient to fund our planned operations into the second half of 2022. With that, I will turn the call back over to Charles.
spk02: Thank you, Scott. To recap, We continue to execute our clinical development plan around our lead product candidate, Envifolumab, and recently further diversified our shareholder base and extended our cash runway through capital raised from existing investors and a new investor. We have now initiated most of the approximately 25 Envisarc sites and enrolled multiple patients at multiple sites, which represent top U.S. clinical cancer centers. We expect safety updates in the first half of the year, and an interim efficacy assessment in the second half of this year. One of our key goals is to request breakthrough therapy designation by year end based on interim NVISARC efficacy data. We believe the NVISARC trial provides a potential fast-to-market opportunity to provide Envifolimab to sarcoma patients in significant need of a new therapy as expeditiously as possible. Addressing this high unmet clinical need is clearly important to investigators and they remain excited about Envifolimab's convenient and rapidly delivered subcutaneous route of administration. Importantly, we believe our recent capital raise will be sufficient to fund the capital past the expected Envisarc interim efficacy data, which could demonstrate the potential for Envifolimab to rapidly transform the standard of care for refractory sarcoma patients. We look forward to providing further updates in the coming months and remain confident that we have the right strategy in place to deliver on our development and business plans for the benefit of patients and shareholders. Thank you for your time and attention. We are now available to answer your questions.
spk00: And as a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hash key. Please stand by while we compile the Q&A roster. And again, to ask a question, you will need to press star 1 on your telephone. Our first question comes from the line of Miri Raycroft. Please, Jeffrey, your line is now open.
spk01: Hi, Charles and team. Congrats on the progress, and thanks for taking my questions. First question is just on whether it's a certain amount of patients enrolled and a certain amount of follow-up that triggers the DMC review. I guess what what triggers the review, and what specific information will the DMC share with you after the review? Hi, Maury.
spk02: As always, thanks for your question. Yeah, for the MSR trial, there's several kind of interim assessments, if you will. And the first ones, as you point out, are based on safety. And the Interventive Data Monitoring Committee will evaluate approximately 10% to 20% of patients from each cohort cohort A being ENVA single agent, cohort B being ENVA plus IPI, just to ensure that there's no significant new safety signal. They'll do that after those patients have been on study for a set period of time, about one month and also about three months. And what we'll report to the public is their overall recommendation. Our anticipation would be that they'll indicate that the trial should proceed as planned, and if there's any further disclosure around any safety signal, we would disclose that as well.
spk01: Got it. Okay. And then if you can talk about how a site decides whether the patient should go into the monotherapy cohort or the combo cohort, and if you can provide any more perspective into how enrollment is going for each cohort.
spk02: Sure. Yeah, so it's a randomized study, Maury, whereby when a patient is enrolled in the study, as soon as we sign off on their eligibility criteria, they are formally randomized to either cohort A or cohort B. And then so you'll have equal allocation of patients across both cohorts at all times based on that one-to-one randomization.
spk01: Got it. Okay.
spk02: And each site is enrolling for both cohorts? Correct. Yeah. So each site independently will assess patients. Once they assess a patient, the next patient sequence will be randomized and have an equal chance of going to either cohort. And the randomization is done as it would be for a randomized control study. You know, what's unique about Envisarc, it's randomized, but each cohort is independently compared to that 4% response rate of Votrien. But in terms of how the actual machinations of the trial go forward, it would be like any typical randomized trial, except you don't compare cohort versus cohort. You compare both cohorts to that 4% low response rate of Votrien.
spk01: Got it. Okay. And then... Last question is just on whether you're getting a good balance of UPS and MFS patients, or is it skewed to either subtype, and does this matter?
spk02: Yeah, no, great questions, Maury. So, yes, we're actually enrolling both UPS and MFS in patients with each type of histology enrolled thus far. Overall, I would say the rough balance I would expect would be about three to one in favor of UPS over MFS, and that relates to the overall prevalence of the diseases and also the overall aggressiveness of the two diseases. So, Again, expect about three-to-one ratio of UPS to MFS. And one other important point on that is that their patients are stratified based on the histology. So there will be equal numbers or balanced numbers, I should say, of UPS and MFS patients in both cohort A and cohort B. Got it.
spk01: Okay, thanks for taking my questions, and I'll hop back into the queue. Oh, always a pleasure. Thanks, Maury.
spk00: Our next question comes from the line of Jason McCarthy with Maxine Group. Your line is now open.
spk05: Hey, guys, it's Dave on the line for Jason. Thanks for taking my question. Can you guys just shed some light on, you know, if you guys have any plans on, you know, setting up or initiating a trial about evaluating TRT-1 and TRT-2 in the near term? I know you guys had that on that like a while ago, but I was just wondering if you guys plan on maybe setting up a new trial in the near term or if this is maybe, you know, an idea that you guys might have just a little further down the line.
spk02: Mm-hmm. No, I appreciate the question, Dave. Yeah, so TRC-102 continues to be very enthusiastically embraced by the NCI, and so we continue to have an ongoing CRADA. In fact, we just renewed the CRADA with them, showing the continued interest by NCI to develop 102. And with respect to the two indications that there's significant interest, one of those is GBM. In terms of the trial that really sparked that interest, it was the trial in refractory GBM where teminar failure patients retreated with Temeril plus TRC-102, we saw some activity there. And what was remarkable is that activity was seen in patients with certain biomarkers. They were MGMT negative. So based on that data, you know, we do expect NCI will continue to advance TRC-102 in GBM. And our goal would be to see it move into the first-line setting. You know, that's where we really need to make an impact on GBM patients. So the trial design, we think, makes a lot of sense, and I would say that this is also shared by several investigators, would be first-line GBM patients who are getting teminar and radiotherapy, which is standard of care, to those patients you would add TRC-102. And you would initially do a pilot study, say, in 25 patients who are MGMT non-expressors and assess the response rate. And based on that response rate, that would potentially then lead to a pivotal randomized study where it would be teminar, radiotherapy, with or without TRC-102. So that's our expectation to see some trial of that typical, of that type of design, a pilot set of about 25 patients in first-line GBM. To see something like that move forward this year would be our expectation.
spk05: So, okay, so we can expect that to happen at some point in 2021, then that's a fair expectation to have then, it sounds like, right?
spk02: Yeah, we expect that those types of ideas would advance through CTEP and You know, we can't guarantee anything, to be clear. The CTEP has to make those decisions. But given the unmet need in GVM remains quite severe, I would say, you know, there are some new therapies there. I would say there's still an incredible need for a therapy like what TRC-102 potentially offers those patients. Our expectation would be to see that move forward this year.
spk05: Okay, great. And then just one additional question, if I could just switch gears here to envofolimab. Are you considering the possibility of any potential combination trials with any other checkpoint inhibitors down the line besides Yerboin?
spk02: Yeah, I think we look at endofofolimab as kind of a backbone therapy that, you know, we feel is a best-in-class therapy that, you know, it's a subcutaneously administered injection that literally takes 30 seconds, and it's a CC and a half. So it is really like getting a flu shot. And having that therapy in our portfolio then allows us to build upon that. So, for instance, we're combined with Urovoi currently, but in terms of other checkpoint inhibitors, either proven or unproven mechanisms, I think we are now a very attractive partner for companies with those type of therapies who want to see those develop with Envifolumab. And I think the fact that we have our CRO independent product development platform that's been really the basis for deals that we've done now around that platform makes it an even more attractive prospect for a partner. We can combine with ENVA, and we can do it with our platform, which will, in most cases, greatly speed the course of development. And I'll give you an example on how we speed development. You know, I think it's important to remember, we only licensed Envafolmab in December 2019. It had completed just phase one testing in the United States. Less than a year later, in December 2020, we are dosing a pivotal trial. That is, I would call, evidence of performance. And so now that we have Enva full amount in our portfolio, we have a path toward registration. We're very eager to add additional assets to our portfolio that could complement Enva and to do it with our partnering platform that we feel is a major advantage for potential partners.
spk05: Great. Thanks for the additional clarity. I appreciate it.
spk02: Thank you, Dave.
spk00: And our next question, again, from Jason McCarthy with Maxine Group. Your line is now open.
spk06: Hey, guys. So Dave and I got our signals crossed. So he actually asked some good questions. Just sticking with TRC-102, when you start thinking about the trials going forward, you know, what we've seen is this new, not new, but a category of patients that, not stratified by MGMT, but physicians knowing that they're not likely going to respond to Temidar after just one cycle and that they can move them to an experimental drug. They're doing a lot of this in the Agile program. They call it Agile therapy, whatever that means. Is that something that you would consider, the TRC-102, to try to separate yourselves from the just purely recurrent versus purely newly diagnosed?
spk02: You know, it's a great thought, Jason. You know, we haven't done a trial in that design yet. But, you know, we clearly have seen with respect to TRC-102 that patients that fail a certain chemotherapy, like Temodar, can be resensitized with Temodar plus TRC-102. We've also seen that with Olympta patients. There were data reported at ASCO last year that Olympta failures can be resensitized when you retreat with Olympta plus TRC-102. You know, so in a sense that in a clunky way sort of addresses what you're talking about, but to do it more as an integrated trial would make perfect sense. And, you know, it's something we should definitely discuss with investigators.
spk06: And just as a follow-up to all the NVA-SARC-related questions, can you just remind everybody about, you know, the opportunity of having two shots on goal and what those response rates need to look like because, you know, My understanding was that in the combo with Yervoy, even if you're still above Votrien and looking like the mono, you could still get there, even though you're going for double. Can you help us understand that just a little bit more?
spk02: Sure, Jason. No, I think it's really important. We consider it important risk mitigation within the trial that each cohort is independently, I should say the response rate for each cohort is independently compared to the 4% response rate of Votrien, which means that that bar for a positive trial, which is 9 of 80 responses or an 11.25% response rate, that bar exists for each cohort independently. So we do expect both cohorts to be positive, but it could be that cohort A does not meet the endpoint and cohort B does meet the endpoint, and that would be the basis still for a positive trial and actually be the basis for approval of what we feel will be the way ENVAs used in refractory UPS and MFS, which is with your void, given it is expected to have a higher response rate. But to your point, there's risk mitigation built into that trial because each cohort is compared to Votrien, not to each other.
spk06: Great. Thank you for taking the questions. Looking forward to a busy 2021 for TRACON.
spk02: Thank you, Jason.
spk00: And again, to ask a question, you will need to press star 1 on your telephone. Our next question comes from the line of Bert Haslett with BTIG. Your line is now open.
spk03: Thanks. Thank you for taking the question. And, yes, it does look like a busy 21. Charles, could you give a little bit more detail? You started to talk about it during your prepared comments and I think even during the Q&A. But just a little more detail beyond the opportunities with ENVA in refractory sarcoma, you know, beyond kind of the 300 million you framed earlier, and moving toward the billion dollars. Could you just get a little bit more granular in terms of how you're thinking about those various opportunities and kind of the pacing of it?
spk02: Yeah, I appreciate it, Bert. Yeah, we really feel that UPS MFS is what we feel is the faster market strategy, but we do feel there's great potential for ENVA to penetrate other sarcoma subtypes. And the one area that's probably the most exciting would be first-line therapy You know, I think the Alliance data to us showed two really important points. One is that in refractory UPS MFS, dual checkpoint inhibition generates a 29% response rate. I mean, that's maybe the best response rate we've ever seen in sarcoma. But beyond that, that was just UPS MFS. But in all sarcoma, refractory, all sarcoma subtypes, it was a 16% response rate. And as I mentioned briefly in my comments, that's as good as first-line doxorubicin chemotherapy. The nice thing about checkpoints is generally they combine fairly well with chemotherapy. So we do expect before end of this year to be starting a trial combining ENVA with DOCS and likely would be ENVA plus IPI or potentially another CTLA-4 antibody with DOCS with the objective to show tolerability that would then lead into a potential pivotal study of, say, DOCS with or without ENVA. or it could be DOCS with or without ENVA-IPI, or DOCS with or without ENVA and another proprietary CTLA-4 antibody. So that is actually the real goal of our entire program. It's to get to market in clearly the indication within sarcoma, the subtypes within sarcoma that are very highly responsive to checkpoint inhibition. And that you can do through a response rate-driven trial. But first line, those are a lot of patients and would require... to be clear, a randomized study, but it's, in our view, a trial that needs to be done, given you know dual checkpoint inhibition in all sarcoma is actually very effective. It's as effective as first-line chemotherapy from a response rate perspective, so expect to see that trial roll out this year. The other area we have a lot of interest is in GIST, and in GIST, CKID inhibitors are the dominant standard of care, and they're very effective. They prolong survival. They actually don't generate A very high response rate, though, and so our view is we combine with a CKID inhibitor and GIST. Through a single-arm study, we target response rate as an indication of interest, and then we potentially could move forward into a pivotal study there as well. So we will thoroughly penetrate sarcoma. I guess if you were asking what our goal is, it's really to make sure every sarcoma patient that deserves a checkpoint inhibitor, and I think the majority do, has the opportunity to be dosed with ENVA, either with IPI, another CTOA4, or chemotherapy, or all three.
spk03: And then just in terms of timing, thank you for all of that. Just in terms of timing, what do you frame this? Is this a 21 effort, late 21 after you see the data? Is this further out? Just in terms of timing.
spk02: Sure. Yeah, no, I think the two trials that we expect to start in sarcoma on top of endosarc this year, one would be in GIST, and the other would be with doxorubicin. So those would be phase one trials with expanded cohort of some particular number to really get a better understanding not just of safety but also early efficacy. But do expect to see those open either through our sponsorship or an investigator sponsorship this year. And, you know, I would just say when I say investigator sponsorship, there's a lot of interest in ENVA in the sarcoma community. It's because two things. We've committed to really sarcoma patients. That's one thing. But the other thing is, Once you use INVA and you realize how easy it is to give, it's a complete paradigm shift for these investigators.
spk03: Terrific. Thank you for the additional color. Look forward to all the events upcoming. Thanks.
spk02: Appreciate it, Bert. Thank you.
spk00: And again, to ask a question, you will need to press star 1 on your telephone. As there are no further questions, I would like to turn the call back over to Dr. Sauer for closing remarks.
spk02: Well, I'd just like to thank everyone for your time and attention. We really appreciate the questions, and we look forward to talking with you next quarter. Stay safe.
spk00: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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