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spk00: Stand by. Your conference will begin momentarily. Again, please stand by. Your conference will begin momentarily. Thank you. Good day, ladies and gentlemen. and welcome to Traken Pharmaceuticals' first quarter 2021 earnings conference call. At this time, all callers are in a 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 runway in 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, 2020, and subsequent quarterly reports on Form 10-Q. You 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 Stewart, President and CEO of Tracon Pharmaceuticals. Dr. Stewart?
spk04: Thank you for joining Tracon's first quarter 2021 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, We'll review our financial results for the three months ended March 31, 2021. Finally, we will conclude by taking your questions. Our development efforts continue to focus on the pivotal ENVASARC trial. ENVASARC is designed to allow potential approval of envafolimab in the sarcoma subtypes of undifferentiated pleomorphic sarcoma, or UPS, and myxofibrosarcoma, or MFS. As a reminder, envafolimab is a potential best-in-class PD-L1 checkpoint inhibitor, and may confer additional clinical benefit by virtue of its convenient and rapidly delivered subcutaneous route of administration. We continue to make progress on the Envisarc pivotal trial, where we have initiated 22 sites and expect to achieve our goal of initiating 25 sites by the end of this quarter. Accrual remains on track, such that we expect multiple Envifolumab milestones this year, First, we have enrolled more than 20 patients, which has triggered the initial data monitoring committee review of safety data from each cohort. We expect a DMC recommendation later this quarter. A further DMC safety review is expected next quarter. Second, we resubmitted our orphan drug application to the FDA in response to a request for preclinical or clinical evidence of activity for endofolimab and sarcoma. We expect correspondence from the FDA this quarter based on the amended application. Third, we expect the availability of interim MVSARC efficacy data in the second half of this year. The DMC-mandated interim efficacy analyses are scheduled at least three months after the enrollment of the 36th and 92nd patient to allow for determination of the preliminary objective response rate. Per the futility rules of the study, There must be at least one response among the initial 18 patients and three responses among the initial 46 patients enrolled into each cohort to continue enrollment of that cohort. We expect to present interim efficacy data following the initial DMC review later this year at a scientific conference or in a top line data release. Fourth, we expect interim efficacy data will be the basis for submitting a request to the FDA for breakthrough therapy designation or for fast-track designation, as either designation permits a rolling BLA submission that will facilitate the timely review of a BLA. Looking forward, we anticipate reporting final response date 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. We reviewed the design of the ENVISARC trial at a poster in the Trials in Progress program of the AACR virtual meeting in April, and we'll also present a poster reviewing the trial design at ASCO in June. As a reminder, the ENVISARC 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 therapy for refractory UPS and MFS patients. We are studying the sarcoma subtypes of UPS and MFS because they are responsive to checkpoint inhibition based on data presented at ASCO 2019 At ASCO 2020, investigators from the Alliance for Clinical Trials in Oncology reported an impressive 29% confirmed objective response rate in patients with highly refractory UPS who received Opdivo in combination with Yervoy. These data built upon data presented at ASCO 2019 showing that single agent Keytruda demonstrated a 23% response rate in highly refractory UPS and MFS patients. From a financial perspective, we estimate that the cost of conducting the pivotal trial using TRACON's CRO-independent product development platform, including paying for Urovoid, will be less than $20 million that will be spent over the next eight to 10 quarters. In parallel, our corporate partners, 3D Medicines and AlphaMap Oncology, submitted endofolumab data from the completed pivotal trial in MSI-high cancer in China as part of a new drug application that was accepted for priority review by the NMPA earlier this year. We believe Envifolmab could be approved in China later this year. Returning to Tracon's development in sarcoma in the US, our market assessment concluded that Envifolmab, 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 Avdevo. The adoption rate is forecasted to be relatively rapid using EnvifolMap's target product profile, a 15% response rate as a single agent, and a 30% response rate when combined with Yerboy, which would compare favorably to the 4% objective response rate of the one approved treatment for refractory UPS and MFS patients. EnvifolMap's sales revenue could increase further, through label expansion or compendia listing into other refractory sarcoma subtypes that have been shown to be responsive to checkpoint inhibition, such as angiosarcoma, alveolar soft part sarcoma, and dedifferentiated liposarcoma, which our market assessment study indicated 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 Envifolimab and Yervoy 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 Envifolimab with doxorubicin in a phase one 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, envafolumab, and a CTLA-4 inhibitor. That CTLA-4 inhibitor could be Yervoy or another proprietary CTLA-4 inhibitor, as one of our business development priorities is licensing another immune oncology asset. We are also discussing a clinical trial of envafolumab with an approved CKIT inhibitor in gastrointestinal stromal tumor, or GISTs. We believe thorough label expansion in sarcoma, including in the first-line setting, in GIST, as well as for neoadjuvant treatment prior to surgical resection, and for adjuvant treatment following surgical resection, could substantially increase sales revenues to over $1 billion in sarcoma. While InfoFoldMap is our most advanced product candidate, we continue to progress two other clinical stage assets. We expect TRC-102 to continue to advance through NCI sponsorship in lung cancer in combination with chemotherapy and radiation therapy. Data presented at ASCO showed that TRC-102 in combination with chemoradiation resulted in a 100% response rate in 15 patients with advanced, localized, non-squamous, non-small cell lung cancer, including in three patients who had a complete response to treatment. These data compare favorably to prior trials of chemoradiation therapy in these patients. In FENZI, a PD-L1 checkpoint inhibitor is now approved for patients with unresectable localized non-small cell lung cancer whose disease has not progressed following chemoradiation. And we believe a randomized trial of TRC102 with chemoradiation and in FENZI in these patients is warranted. Based on NCI data reported in cancer cell in December 2020 and Phase II data in refractory glioblastoma patients treated with TRC-102 and Temodar, inhibiting base excision repair with TRC-102 is able to induce synthetic lethality in MGMT methylated patients. Based on these data, we expect further development by the NCI in glioblastoma, including a trial in the first-line setting of Temodar, radiation therapy, and TRC102. Notably, in October 2020, TRC102 was granted orphan drug designation by the FDA in malignant glioma that includes glioblastoma. 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. Data from the ongoing phase one trial were accepted for poster presentation at the 2021 ASCO virtual meeting in June. 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. Per the license agreement with them, we are entitled to receive escalating portions of non-royalty and royalty payments if IMAP elects to license TJ4309 to a third party in any region outside of China, Macau, or Taiwan. Following the completion of Phase 1, IMF has the option to terminate the agreement for a payment of $9 million. From a business development perspective, I would like to note that we continue to evaluate additional clinical stage assets to potentially add to our pipeline this year in order to leverage our CRO-independent product development platform that includes U.S. commercialization expertise. We believe our product development platform will continue to allow us to establish key new partnerships that will drive significant long-term shareholder value. At this time, Scott will provide an update on our financials.
spk03: Thank you, Charles, and good afternoon, everyone. TRACON's research and development expenses were $2.3 million for the first quarter of 2021 compared to $2 million for the comparable period of 2020. Increase was related to enrollment in the pivotal NVSARC trial in 2021. General and administrative expenses were $2.7 million for the first quarter of 2021, compared to $1.9 million for the comparable period of 2020. Our net loss was $5.1 million for the first quarter of 2021, compared to $4 million for the comparable period of 2020. Turning to the balance sheet, at March 31, 2021, our cash, cash equivalents and investments totaled $30.4 million compared to $36.1 million at December 31, 2020. We expect our current capital resources to be sufficient to fund our planned operations into the second half of 2022. With that, I'll turn the call back over to Charles. Thank you, Scott.
spk04: To recap, we continue to execute our clinical development plan around our lead product candidate, Envifolumab, and have made substantial progress in the Envisarc pivotal trial. We have now initiated 22 of the 25 NVISARC sites and have enrolled more than 20 patients, which triggers the initial DMC safety review. We expect safety updates this quarter and in the third quarter, orphan drug designation this quarter, and an interim efficacy assessment in the second half of this year. One of our key goals is to request breakthrough designation or fast track 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, as evidenced by the robust NVISARC accrual seen to date despite the COVID pandemic. We credit this robust accrual in part to our sero-independent developmental capabilities. Importantly, we believe our capital will be sufficient to fund the company past the expected NVISARC final efficacy data, which could demonstrate the potential for EnvifolMap 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, and we are now available to answer your questions.
spk00: Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touchstone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your first question is from the line of Marie Raycroft from Jefferies. Your line is open.
spk01: Hi Charles and everyone. Congrats on the progress and thanks for taking my questions. First question, I just wanted to check on the enrollment. Sounds like you've got greater than 20 patients in the study. Just wondering if you can comment on if the enrollment rate has been better than expected or in line with expectations. And then anything else you're saying about the patient characteristics? Are those in line with expectations? And how do they compare with the patients from the historical studies that we're benchmarking?
spk04: Hi, Maury. I appreciate the question. So with respect to accrual, we're on track with respect to our goal, which is to fully enroll the patients in an 18-month period of time, meaning full enrollment by mid-next year. So we're very pleased with that. And I should mention we're on track despite the fact we haven't even opened up all the sites yet. So That's why we consider the enrollment robust at this point. I think also importantly you bring up a great point about the fact that this trial enrolls patients who have failed one or two prior therapies. So third line setting or second line setting. And that actually compares quite favorably to prior studies of checkpoint inhibitors in refractory UPS and MFS patients where the majority of those patients were in the third and fourth line setting and in some cases had as many as six prior therapies. So we tried to create a more, if you will, homogeneous population of refractory UPS and MFS patients to carefully define the response rate of both endofolumab as a single agent and also in combination with Urovoi.
spk01: Got it. That's helpful, Charles. And then another question I had is based on the DMC reviews. So for the DMC review that's this quarter, next quarter, and 4Q, I'm wondering if you get access to the overall response data, and if you do, if it's better than expected, is there any chance that you would provide an early update on what you're seeing in either one of the cohorts?
spk04: Thanks for the question, Maury. Yeah, the DMC safety reviews will really be exclusively focused with respect to the one expected this quarter and third quarter on safety. And the expectation you should have is that the DMC will review the safety data And if everything looks as we expect it will look, the communication to the street would be that the trial will continue as planned, with just a general statement from me around the safety of both the envafolamab as a single agent and also in combination with ipilimumab. In that regard, Maury, I would say with respect to envafolamab single agent data, we feel quite confident of the known safety profile, given it's been dosed to over 700 patients. This is the first time, though, that envafolamab is being dosed with ipilimumab, so I think the From our perspective, the most important part of both the DMC safety evaluation this quarter and the subsequent one in quarter three will be to define that envofolimab combined with apilimumab is also well-tolerated. And then by end of the year, though, you should expect an update with respect to interim efficacy data that we will report either at a top-line release or at a scientific meeting.
spk01: Got it. Okay. And so maybe last question is just for the 3Q question. The DMC review for next quarter, I just wanted to make sure that I got it right. So that's going to be three of 46 patients in each cohort. If you're seeing responses there and the study continues, that means that the utility wasn't triggered. Is that the right way to think about it?
spk04: No, so let me go through it carefully just to make sure I'm crystal clear. So this quarter will be the initial safety review. There's one more safety review next quarter. And then following the two initial safety reviews, there will be two futility analyses, as you point out. And those are done after 18 patients are enrolled in each cohort. And in each cohort, after 18 patients are enrolled, we need to see one response. But to be clear, that's only three months after the 18th patient is enrolled because we want to give patients time to get CT scans so we can define the preliminary response rate. So that's why we expect that will be second half. and we'll report those data as an interim efficacy assessment in second half of this year is the expectation. As you also pointed, there's a second futility analysis. That's when 46 patients are enrolled in each cohort, but also that 46 patient has to be on therapy for, or excuse me, has to have scans for at least three months so we can again define the preliminary objective response rate. So based on that, there'll be a second interim analysis for futility, and we haven't guided on the exact timing of that, It could be this year, but, again, because it has that three-month delay in assessments after enrollment of the 46 patients, it also could be quarter one of 2022. Got it.
spk01: That's really helpful, and that helps clarify how this is going to work out. So the futility analyses are independent of the DMC reviews. They're going to be done in different times.
spk04: Well, to be clear, Maury, so the DMC will make the decision on futility analyses, and we provide the general guidelines that we need one response out of at least 18 patients in each cohort and three responses out of 46 patients in each cohort. But it is a DMC decision, and the reason we leave leeway to the DMC, Maury, is because it is preliminary data. We're only giving them three months of response data on the last patient in that cohort. So It could be the DMCC's data says, wow, there are three patients that have partial responses, but we haven't confirmed them yet. So they're not confirmed responses, but we think we should wait a little longer and give these patients more time to fully respond as an example. So it is a DMC decision. Those are the general rules, but the DMC has full leeway to consider the totality of the data, including what the ongoing patients are actually doing on trial.
spk01: Got it. Okay. Thanks for taking my question.
spk04: Always a pleasure, Maury. Thank you.
spk00: Your next question is from Jason McCarthy from Maxim Group. Your line is open.
spk02: Hey, it's a Dave on the line for Jason. Thanks for taking my question. So we noticed some activity with the endothelial med in China yesterday, actually, with respect to chronic hepatitis B. And it seems like the drug was well-tolerated in patients over there. So I just wanted to see if you had any comments on that.
spk04: Appreciate the question, Dave. Yeah, it was an interesting press release from a partner, Cletus, in China that is studying envefolumab in a trial of hepatitis B patients. And as I think people will know, hepatitis B infection is a significant problem in China. In the U.S., it's becoming less of a problem given routine childhood vaccination. But what was meaningful to us in that press release was the fact that Envaporin was given to patients with active hepatitis B infection, so they have significant underlying liver disease. And Envaporin was very well tolerated in those patients. Now, notably, in Envisarc, we don't have patients with underlying liver disease. It's a specific exclusion. But it just gives you an idea of how well-tolerated Envifolimab is that you can dose it very effectively to patients even with known viral hepatitis. Of note, there was also sign of activity in those patients in the sense that viral loads decreased in response to Envifolimab therapy. So it really helps to reaffirm for us that Envifolimab is a very safe therapy, even in patients with underlying liver disease, which should bode well for Envisarc. as some patients do have liver metastases, as you might expect when they come into our trial.
spk02: Great. Thanks for the additional color. Appreciate it.
spk04: Thank you, Dave.
spk00: Your next question is from Sumit Roy from Jones Trading. Your line is open.
spk07: Hi, everyone. Congratulations on all the progress. A question around extension beyond sarcoma. as how you're thinking of expanding in the gist or other indication of if you're getting more inbounds from collaborators or investigators, and given that one of the company has started planning to do a MEK inhibitor combination, so what kind of traction you're getting? And second is, looks like BMS is presenting a sub-Q NEVO formulation, some preliminary data at ASCO, How are you viewing this as a complication or any color would be appreciated?
spk04: Yeah, no, appreciate the comments, Shoma. I'll first take on the question around sarcoma expansion. And that is with respect to, I think, three indications. First, with respect to combining with Dr. Rubison and frontline therapy. So we are planning before end of this year to dose envafolamib in combination with doxorubicin therapy. And likely that trial will also include doxorubicin, envafolamib, and a CTLA-4 inhibitor. As we mentioned briefly, that could be ipilimumab or potentially another CTLA-4 inhibitor. That combination also could be very relevant in the neoadjuvant and adjuvant therapy space within sarcoma. As an example, most patients with sarcoma present with an extremity lesion and it's resected surgically. If those lesions are large, like 5 to 10 centimeters, typically they get neoadjuvant chemotherapy to try to shrink them down before the resection, and then they get adjuvant therapy after the resection. That's another trial where we've seen significant interest about developing ENVA-IPI, ENVA-DOCS, or ENVA-IPI and DOCS as an example, knowing the IPI could be substituted for another CTLA-4 inhibitor as preoperative therapy. It's something we've seen extreme interest, and again, I think it plays to the fact that Those patients currently get a significant chemotherapy regimen. It's called AIM chemotherapy, adramycin, ifosfamide, and mensa. That's quite myelosuppressive. So if we could dial down the chemotherapy or replace it with immunotherapy, I think investigators would see that as a major advance. So expect those two trials to run forward this year, and that is frontline DOCS and metastatic disease combining with ENVA or ENVA-NST-TLA-4, and also the same combination as neoadjuvant therapy followed by adjuvant treatment with continued ENVA dosing. And just to your point, there's interesting data that just with combining, for instance, with a MEK inhibitor was announced within the past day or so. You know, I think that's an interesting combination, and I think combining a CKID inhibitor with Envifolamab makes a lot of sense, and it could be multiple tyrosine kinase inhibitors with Envifolamab. You know, the current data with Envifolamab is it is very well tolerated. I mean, that was confirmed with respect to the dosing in hepatitis B patients. And it's been confirmed with respect to the 700 patients dosing that we've had through our studies and our partner studies that indicate Envifolamab seems to be safer than some checkpoint inhibitors with respect to pneumonitis and colitis. And clearly, there's no risk of an infusion reaction, which makes it safer than any intravenously-admitted therapy. Now, you mentioned with respect to VMS and sub-Q dosing. You know, I think it's important that what makes Envifolamab different is that I don't think any full-length antibody can mimic what Envifolamab does as a single-domain antibody. And we know that companies are dosing, for example, with full-length antibodies combining with an adjuvant, like, for instance, hyaluronidase. You know, that's more the standard, I think, most well-proven subcutaneous dosing mechanism to try to let antibodies go from IV to sub-Q. But let's think about what that means versus how you give them the full amount. If you're giving an antibody, for instance, with hyaluronidase, you're giving a large volume, 10 to 20 cc's, and you're giving it over minutes. With n-bifolamab, literally you're giving an injection of about one and a half cc's in 30 seconds. There's nothing easier than that. And that's why this is so easily dosed in the clinic, and that's why potentially home dosing is a real option with n-bifolamab in a way that could not ever be attained with a full-length antibody that requires an adjuvant.
spk07: Thank you, Chuck. We really appreciate the call. Thank you, Shomit.
spk00: Your next question is from Bert Hazlett from BTIG. Your line is open.
spk05: Yeah, thank you. Thank you for taking the questions, Charles and all. Just a quick follow-up with regard to the last one. Charles, could you give us a sense of the gating items for move into first-line sarcoma or additional efforts? Is it really dependent upon looking at the futility analysis, or what are the gating items there?
spk04: Great question, Bert. Yeah, I think with respect to moving into frontline, I mean, we're actively planning a frontline trial. Initially, that will start as a Phase I tolerability study, and it will be gated in the sense that we want to see activity clear with Envifolumab single agent and also the combination with Yervoy in the Envisarc trial. You know, I think we expect to see that evidence of activity by second half clearly, and our plans are to basically start the frontline trial in by end of the year. So it's a typical kind of TRACON timeline. We'll move aggressively. The sites that are already in NVSARC will be sites that do the frontline trial. Cannot underestimate the enthusiasm of investigators to move this drug forward, as evidenced by the neoadjuvant study, which we were kind of thinking about on the back burner that right now there's incredible enthusiasm for that study as well. So expect that to start second half. If we saw futility, As an example, in one cohort, we'd probably advance the other cohort. That said, our expectation, again, based on really good data for checkpoint inhibition in these indications, and refractory UPS and MFS make it clear that checkpoints are quite active in this disease. So based on what we expect to see, do expect us to be in frontline trials before end of the year, and we're excited to see that move forward.
spk05: Okay, thank you for the clarity. And the other question I had is with regard to the CTLA-4 accommodation molecule. You mentioned a couple of times with regard to in-licensing and potential for that. Always difficult to predict, but you've had some notable success. Care to put a little meat on that bone? Are you moving in the direction of your boy or another molecule?
spk04: No, I appreciate the question, Bert. I mean, I think we feel it would be a very attractive and strategically aligned business development opportunity for us to license our own CTLA-4. You know, we're very active in terms of looking for new molecules to plug into our zero independent engine. And I think as evidenced by the ENVIR-SARC trial and how quickly we move that forward into a pivotal, or I should say move ENVIR-FORMAT, how quickly we move that forward from phase one data in the U.S. into pivotal study, less than a year after a license, you know, speaks volumes about how we move. So for us to own both legs, if you will, the dual inhibitor checkpoint franchise, dual checkpoint inhibitor franchise would be very attractive. We're also interested in other immuno-oncology targets that might build upon n-bifolamab. And then beyond that, we're interested in assets that might just stand alone with respect to their ability to proceed in unmet need populations in the U.S. But to your point, I think from a strategic point of view, we think owning both ends of a dual checkpoint inhibitor franchise would be quite an attractive proposition for TRACON.
spk05: Okay. Look forward to that, and congrats on all the progress. Great. Thank you.
spk04: Appreciate it, Bert. Thank you.
spk00: Again, if you would like to ask a question, please press the star and then the number one key on your touchtone phone. Your next question is from Nick Abbott from Wells Fargo. Your line is open.
spk06: Great. Thanks for taking my question. Good afternoon, Charles and team. First question, Charles, is in the prepared remarks, you know, for the application, orphan drug resubmission, it says, you know, request from FDA on preclinical or clinical evidence of activity for ENVA. So what data did you actually submit for orphan drugs?
spk04: Hi, Nick. Appreciate the question. Yeah, so when we initially submitted the orphan drug designation application, we kind of submitted it with respect to the prevalence of sarcoma, which made it clear that this is an orphan drug. And the FDA indicated they wanted more data. They wanted evidence either preclinically or clinically that this drug, Envifolamib, is active in sarcoma. You know, we will fully disclose, I think, what we submitted with respect to that updated application at the time we received FDA correspondence, Nick, and I just ask you to be patient until that time at which we will be fully forthcoming.
spk06: Okay, fair enough. Appreciate it. And then just following on on Bert's question, how feasible is it you can get a CTLA-4 and get an IND approved ahead of that study start?
spk04: Yeah, that's a great question, Nick. So with respect to our current ENVASAR trial, to be crystal clear, we will continue that as designed, meaning we'll continue that trial moving forward with Envifolumab plus ipilimumab. We are quite aggressive on the business development front, and our track record has been that we execute deals. We did four deals between 2016 and 2019. We did not constantly make a deal last year, and I think COVID had an impact on that, but we did make a lot of contacts that allow us to feel confident of further business development opportunities this year. And ideally, these circumstances would permit us to begin a first-line trial with envofolimab and another immuno-oncology asset in combination with doxorubicin, to your point.
spk06: Okay, terrific. Thanks, Charles. I look forward to it. Thank you, Nick.
spk00: I am showing no further questions at this time. I would now like to turn the conference back to Dr. Zuber.
spk04: Great. Well, thank you, everyone, for the questions and your attention, and we look forward to talking with you again next quarter. Stay safe and have a great day.
spk00: Ladies and gentlemen, this concludes today's conference. Thank you for your participation, and have a wonderful day. You may all disconnect.
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