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spk06: Ladies and gentlemen, thank you for standing by, and welcome to the Spectrum Pharmaceuticals fourth quarter and full year 2020 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Kirk Gustafson, Spectrum Chief Financial Officer. Please go ahead.
spk04: Thank you, Operator, and good afternoon to everyone. Thank you for joining us today for Spectrum Pharmaceutical's fourth quarter and full year 2020 financial results conference call. Our fourth quarter and full year financial results press release was sent out earlier this afternoon and is available on our website at www.spectrumpharmaceuticals.com. Joining me on the call today from Spectrum Pharmaceuticals will be Joe Turgeon, President and CEO, Dr. Francois Lebel, Chief Medical Officer, and Tom Riga, our Chief Operating Officer. Before we get started, I would like to reference the notice regarding forward-looking statements included in today's press release. This notice emphasizes the major uncertainties and risks inherent in the forward-looking statements that we will make this afternoon. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. With that, let me hand the call over to Joe Turgeon, CEO of Spectrum.
spk03: Thank you, Kurt. Good afternoon, everybody, and thank you for joining us on the call today. We appreciate your interest in Spectrum, and I'm excited to be here. Spectrum has made great progress over the course of 2020, and that momentum is continuing in 2021, despite the challenges of the pandemic and the impact it's had across the biopharma industry. Throughout 2020, the Spectrum team demonstrated dedication, creativity, and focus to maintain our overall momentum, which allowed us to achieve a strong finish in 2020. We achieved a number of important recent milestones that will form the basis for key activities in 2021. During the fourth quarter, we met with the FDA to review the filing strategy for the submission of an NDA for posiatinib based on the data from cohort two of our phase two clinical trial, Zenith 20. This trial evaluated previously treated patients with non-small cell lung cancer with HER2 exon 20 insertion mutations. These positive results with HER2 exon 20 mutations demonstrated that posiatinib met the pre-specified primary endpoint in these patients. Based on our discussions, we reached agreement with the FDA to proceed with the submission of a new drug application for posiatinib. Adding to this positive news is the recent fast-track designation that was granted by the FDA for this indication. This is welcome news for Spectrum and for the patients with this devastating disease. We're currently preparing an NDA and look forward to a submission to the FDA later this year. Regarding our office, the FDA is scheduled to perform the pre-approval inspection of our manufacturing facility in May. As you may recall, FDA informed us last year that it was deferring action on the BLA due to their inability to inspect the Hanmi Bioplant in South Korea as a result of travel restrictions related to the COVID-19 pandemic. Hanmi Pharmaceuticals is an experienced biopharmaceutical manufacturer with a world-class facility, and they're ready for this inspection. As a matter of fact, Hanmi has received recently approval for Rolantis in Korea, which further raises our confidence in their manufacturing readiness. In addition to advancing our late-stage clinical programs, we remain active with business development. In the fourth quarter, we entered into a licensing transaction for a new immuno-oncology asset. Our strategy is to build a portfolio of oncology assets that are synergistic with our existing products, and this is a great example of that strategy in action. Dr. Francois Labelle, our CMO, will have more to say about this later. I'm pleased and excited by our progress in our two lead clinical development programs and the further addition to our product portfolio. It shows the dedication of the Spectrum team to execute on our goals. I'm confident in our ability to meet our corporate objectives and advance our programs with the aspiration of bringing new treatments to the patients with cancer who need them. With that, I'd like to turn over the call to Dr. Francois Lebel, our CMO. Dr. Francois.
spk08: Good afternoon, everyone. It's good to be with you today for a brief update. I will begin with Poseyosone. Significant progress has been achieved in this quarter in spite of the COVID-imposed constraints. Preparation for submission of our NDA under SAS-DRAC designation is well underway and will be based on our positive data from Core 2, of the Xena 20 clinical trial. This important milestone is scheduled for later this year. As you know, there's no approved treatment for a patient with HER2 exon 20 insertion mutation in non-small cell lung cancer, and we believe Poseyantinib has the potential to be first to market to address this area of great medical need. In early March, We presented data from our cohort five, which is evaluating 10, 12, 16 milligram QD, or six and eight milligram BID dosing. This preliminary data demonstrated improved tolerability and efficacy with eight milligram BID dosing. We observed reduced dose interruption and lower incidence of grade 3 adverse events. This led to improved anti-tumor activity, which confirmed our initial hypothesis. Since then, the data from patients with EGFR or R2 has matured further. We continue to be very pleased with this additional data on BID dosing that will be presented at AACR in less than two weeks. Now, let me shift to Rolantis. Our BLA for Rolantis is supported by robust clinical data from two large randomized clinical trials. Regarding the deferred action on our Rolantis pilot that Joe mentioned, We believe that we have answered satisfactorily all questions from the FDA related to the review of the BLA, and we believe that the inspection represents the final step in the review process. We and our partner, HOMNI, are ready for the FDA pre-approval plant inspection that has been scheduled for May. Enrollment in our same-day dosing study with Rolantis continues. This is an exploratory study evaluating the dosing of Rolantis on the same day as chemotherapy. Generally, white cell growth factors on the market today have to be given the day after chemotherapy, which can create logistical difficulties for patients. Following our initial safety evaluation, examining dosing at 30 minutes, three hours, five hours post-chemotherapy with a total of nine patients, we are expanding enrollment in the 30-minute arm to 15 patients. We recently presented the results of the initial safety evaluation at the Miami Breast Cancer Meeting in early March. and have a translational poster at AACR. Now, let's turn to our emerging immuno-oncology pipeline. Starting with our focus interferon therapeutics program, or FIT. FIT consists of a fusion protein of an anti-CD20 antibody, Moiety, conjugated to alpha interferon. This fusion protein is directed against CD20-expressing B-cells and is in Phase I dose-escalating study for treating patients with relapse or refractory non-Ochkin lymphoma, including diffuse large B-cell lymphoma. We recently presented data at ESMO in a rodent model suggesting higher activity than rituximab and a good safety profile. We now have sites open for enrollment. As Joe mentioned, we entered in a licensing transaction with Terrapix for a new immuno-oncology asset covering a proprietary product known as PCX12, an encapsulated control release IL-12 formulation. IL-12 is sometimes called the master regulator of the immune system and can enhance cytotoxic T cell and NK cell activity, which are important mediators of tumor killing. It has been shown in a number of solid tumors to reprogram the tumor microenvironment and reduce T-suppressive cells. This program is currently in preclinical development, and we will have more to say when we get closer to filing a 90. 2021 is a big year for Spectrum as we have key regulatory milestones and multiple data readouts. I look forward to providing you further updates on our progress throughout the year. With this, I will turn it over to Kurt for review of our financials.
spk04: Thank you, Francois. Our SG&A expense for the fourth quarter of 2020 was $15.7 million versus $15.1 million in the previous year. R&D expense was $47.2 million versus $23.3 million. The increase in R&D expense relates primarily to a one-time charge of $28.2 million to write down assets at our secondary source for Relantis Manufacturing Facility. Much of this cost was related to equipment installation and validation processes, which will not be recoverable, while the actual physical equipment was written down to fair market value. Approximately three years ago, when we evaluated Hanmi's capacity at Bioplant 1, there was a question about their ability to meet our peak demand forecast. As a result, we commissioned a second manufacturing source and invested significant capital at this facility. Since that time, a couple of things have happened. First, Hanmi has made great progress and invested in a brand new state-of-the-art facility in BioPlant 2 that will greatly increase their capacity. The completion of this facility is ahead of schedule, and was constructed with investment in collaboration with large pharma partners and is now fully commissioned. Second, the timelines for our secondary manufacturer did not meet our expectations. And as a result, it was deemed unlikely to be a solution for us at peak demand. So as we evaluated the capabilities, risks, and economics of these two manufacturers, We believe that the combination of Hanmi's BioPlant 1 and BioPlant 2 will provide the most efficient and cost-effective solution to our long-term supply needs. And as a result, we have made a decision to discontinue our work at the secondary manufacturing site, which is what's leading to this chart. This has no impact on your term launch supplies. We currently have over 12 months of supply here in the U.S. ready for the launch. Moving on to other income expense, the gain in the fourth quarter was $12.9 million compared to a loss of $2.4 million in the period a year ago. The gain primarily relates to an increase in the value of our equity holdings and CASI pharmaceuticals. Our net loss for the quarter from continuing operations was $49.9 million versus $40.2 million in the comparable period in 2019. On a non-GAAP basis, which primarily backs out one-time impairment charge stock compensation costs and the change in value of our Kasi securities, our loss for the quarter was $28.9 million versus $33.4 million in the prior year period. We ended the year with $180 million in cash plus marketable securities, which is down approximately $18 million from the previous quarter. Operating cash earn, which is a better measure of our ongoing cash outflow, was $33 million for the fourth quarter. This is consistent with where we have been the last few quarters. Also, the first quarter of 2021, we issued approximately $21 million of equity utilizing our ATM facility. This was at a time when we did not have clarity on the timing of the FDA inspection. We are now forecasting that our current cash position should provide sufficient runway to a Rolantis launch and a Poseidonib approval. With that, let me now hand the call back to Joe.
spk03: Thank you, Curt, and thank you, Dr. Francois. I think you can see from everyone's remarks that Spectrum continues to make strong and steady progress on our pipeline. We look forward to the completion of the inspection of our Rolantis manufacturing facility. We'll update you later this year on the progress of our NDA for Poseidonib and to sharing results on our ongoing cohorts in the Zena 20 clinical trial. Once again, I'd like to thank our entire team for their hard work and their dedication in these unprecedented times. And we look forward to keeping you informed on all of our future progress. With that, I'd like to open the call for questions. Operator, if you could open the call up, please.
spk06: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key. Please limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster. Our first question comes from Mari Raycroft with Jefferies. You may proceed with your question.
spk09: Hey, Mari. Hi, everyone. Hi, everyone. Congrats on the progress, and thanks for taking my questions. First one is just on Relantis. Kind of a naive question, but just wondering if you could provide more clarity into specific next steps after the inspection and what timing could look like there. And has FDA given you any feedback on the rest of your BLA filing, which includes the clinical data?
spk03: Francois, do you want to comment on that? Sure.
spk08: So let me start with let's just say that when we got the deferrals, as opposed to a complete response CRL, that usually indicates that the FDA is, you know, they're pausing their review. And the only step left, to our knowledge, is the inspection. We've had a lot of discussion with the FDA on all the other matters, and our understanding is that we have, you know, answered all their questions satisfactorily. So we believe the inspection is fundamentally the last step. As to the timing, following an inspection, assuming that there is no issues, you know, roughly I think a little more than a month probably is the ballpark figure, and maybe I'll pass it on to one of my colleagues to tell you about, I guess, launch activities, if that's what you're asking.
spk09: Sure. Yeah, that would be great. If you want to go more into launch activities, that would be helpful as well.
spk03: Yeah, Tom, why don't you comment on your launch readiness?
spk05: Hey, Maury. It's Tom. We're thrilled. We can't wait for this approval, and we're ready to launch. We will be out in force upon approval. We have the leadership team in place. We have a gated hiring of our sales reps, which the vast majority have been identified, and we will begin demand generation soon thereafter approval, and we're looking forward to this inspection in May.
spk09: Got it. Okay, that's helpful. And maybe one follow-up on AACR. Just wondering if you're going to break out cohort five patients by mutational status, and can you say how much follow-up and how many additional patients are going to be at AACR relative to the ESMO TAT update?
spk08: Right. Let me start with the nature of the communication. So we're going to be speaking on... both EGFR and ER2 patients. And we'll be focusing on the dosing. So in other words, we're going to provide results in activity, anti-tumor activity, as well as safety profile of the 10 to 12, the 16 milligram, as well as the the 6 and 8 BIDs. So that's the focus for the initial communication. And we will actually be reporting on an excess of 100 patients total.
spk09: Great. Okay. And are you seeing anything on the amount of follow-up time for the patients?
spk08: Yeah, well, the follow-up will vary simply because we'll be reporting results, you know, very fresh results. So obviously there's going to be more detail at AACR, but at this time I will just say that we are confident that we can report preliminary data and, you know, we have come to some conclusion and we will communicate that at AACR.
spk09: Okay, thank you very much for taking my questions.
spk06: Thank you, Mark. Thank you. Our next question comes from Alethea Young with Cancer for Serum. You may proceed with your question.
spk01: Hi, this is Emily Young for Alethea. Thanks for taking our questions and congrats on the progress. I was wondering if the FDA has already begun doing international inspections or if May is kind of their assumed timeframe for starting those up again. I guess is there any risk that the May timeline could be pushed back, or do you feel that that's like a pretty definite timeframe?
spk03: Yeah, thanks, Emily. I'll answer. First of all, I can't answer in general what the FDA's position is on international inspections. I can only speak for ours. But I can tell you that they've already met with Hamni and our personnel, and they've gone through COVID tests, all the procedures with COVID, the way everything's going to be done. And they're all set to come in May. So everything's being set up. So we feel that unless something crazy happens, we're looking forward to having the inspection done in May.
spk01: Okay, great. Thank you.
spk03: Thank you.
spk06: Thank you. Our next question comes from Ed White with HC Wainwright. You may proceed with your question.
spk10: Hi, guys. Thanks for taking my questions. So, hey, Joe. So, as far as Posey goes in, how should we be thinking about EGFR exon 20 mutations? With the BID dosing, is there a potential to readdress this market and perhaps develop a new study or expand the cohort five? to focus on EGFR alone?
spk08: Go ahead, Francois. Very good question. As you know, obviously we met the primary endpoint cohort two on HER2, second line, but we have shown consistently across the other cohorts, although cohort one and three have not met primary endpoints, We showed pretty significant clinical activity there nonetheless. So, yes, we are reexamining. COVID-5 was enrolled in patients that were EGFR N or 2, or I'm sorry, not N, but both, either one. And we will present data at AACR, the majority of which will actually come from EGFR patients. So we'll be reporting and making comments on the various dosing strategy and their general impact. Obviously, as I said, the data is fresh off the press, so it's going to be preliminary, but nonetheless, I think it will be very informative.
spk10: Okay. Thanks, Francois. And then perhaps a question for Kurt. How should we be thinking about SG&A and R&D expenses going forward. As you mentioned, there were a lot of one-time factors in the fourth quarter numbers. So I'm just wondering how we should be thinking about SG&A and R&D costs going forward throughout 2021. And then it seems that Tom is going to hire the bulk of the Salesforce once you get approval. So for Volantis. I just want to make sure I heard that correctly. Thank you.
spk04: Yeah, no, so I guess the guidance I would give you on SG&A costs, Ed, would be if you just take a look at historically, we've been pretty consistent around that $15 million number. Now, that number per quarter, right, so that number will go up slightly as we hire additional sales folks, but this is not a big sales team, so it's not going to be a dramatic increase, but you know, there will be marketing costs as well. So that will go up as we move into kind of the actual launch period for Relantis. With regards to R&D, that number can bounce around a little bit depending on whether or not we're buying inventory. As you recall, when we purchased pre-approval inventory, that's classified as an R&D cost. And so when we take possession of that that can kind of bump the numbers up and down. When we sell it, it will come out as a zero cost of goods sold eventually. Post-approval, those costs would be booked as inventory, so you might actually see R&D costs for that perspective go down. So I think you can go back and take a look at just in general, if you average over the previous quarters, it can give you a good idea a good signal for kind of a longer period of time, but quarter to quarter, it could bounce around a little bit.
spk10: Okay, thanks, Kurt. Oh, and Kurt, one last question on the ATM. You had a $21 million raise thus far this year. What was the number of shares that were issued associated with that $21 million raise?
spk04: You know, Ed, I'm going to have to go back and look. My recollection is right around 5.5 million shares, but we'll report those numbers in the 10K tomorrow. Okay.
spk10: Great. Thank you. Thank you, Ed.
spk06: Thank you. Our next question comes from Tony with B-Rotter Securities. He may proceed with your questions.
spk07: Hi, good afternoon, team. This is for my own. Congrats on all the progress in the quarter. Just a couple of brief questions from us, maybe first relating to the data expected at ACR from the 20 cohorts. Any dosing info, both on the efficacy and sort of safety and tolerability side that might be relevant to include in the ongoing NDA submission as it relates to cohort two? Is this some data that the agency may benefit from, and then just a brief question on the same-day dosing trial afterwards.
spk08: Sure. So, yes, look, the NDA and the discussion we've had so far with the FDA is related to COVID-2. And as you know, COVID-2 was done with 16 milligrams per day, and we met the pre-specified endpoint, actually exceeded a little bit. So that's going to be the focus of the submission. Now, when you do a submission, you have to provide the FDA essentially complete information about what you know about the drug, safety, efficacy, et cetera, including a section called dose justification. So obviously we're going to be providing them additional information on some of our findings with BID dosing. And as you know, we've presented before at the ESMO just recently that BID dosing actually had a positive impact and a signal about better anti-tumor activity, but also pretty significant reduction in adverse events. So they will definitely see the information, um, and we'll have good discussion, but the core of the submission is core two.
spk07: Great. That's very helpful. Thank you. And then as you think about, um, the same day dosing trial with Rolantis, can you talk about, um, you know, in the context of the expanded enrollment, how you think about the path forward?
spk08: Sure. So we, um, You know, the expansion to 15 patients, we fundamentally want to confirm the same safety profile we saw at 30 minutes, which was not dramatically different from the large pivotal trial we had done when we gave the drug 24 hours later. And we want to make sure that the attributes that we're seeing there, meaning the more Rapid recovery from neutropenia is seen as well. So if all those things are seen, we probably would engage in a discussion with the FDA to the path forward. We have developed some plans, but I don't want to go in detail now until we do the next step of expanding to 15 and then talking to the FDA.
spk07: Got it. All right. Thank you very much for taking our questions and very much look forward to the data at AACR. Congrats on the progress.
spk04: Thank you. Operator, if you can hold on one second. Ed, I looked up your number. If you're still on the line, it was 5.7 million shares that were issued in the quarter. You can continue, Operator.
spk06: Thank you. Our next question comes from Ren Benjamin with J&P Securities. Let me proceed with your question.
spk02: Hey, good afternoon, guys. Thanks for taking the questions and congrats on the quarter as well. Great to see that, you know, the inspection is moving forward and it's coming up. I guess based on the comments that were made, I just want to confirm about a month after the inspection is done, we expect to have an FDA decision. I just want to make sure I heard that right. And after the decision is made, right, and presumably an approval, can you just talk a little bit about you know, how long after we could have the launch? Because I'm thinking that it could be kind of a staggered launch as salespeople are hired that, you know, they kind of get going. Or do we have to wait for all 60 to kind of be on board before we can really start thinking about revenues? And should we be thinking about revenues in the third quarter, fourth quarter? How should we be seeing this rollout occur?
spk03: Yeah, Ren, this is Joe. I'm going to start, and I'm going to let Tom comment more on the launch itself and the timing of revenues, et cetera. To answer the first part of your question on clarity, you know, generically we said we don't know the exact time, but it usually takes about a month or so, and that's what we're saying. So we don't know for sure when the agency will get back to us. But I want to stress, we feel, and that's what's been indicated to us, that's the last step in the procedure here because, again, You know, we didn't get a CRL back when we got the deferral, so, you know, we hope this is the last, and we assume this is the last piece. There's no other thing to do after that. So that's why we said about a month. That's just speaking generically from other drugs, and I hope that helps on that, other drug approvals. Now, Tom, why don't you walk them through on the timing of what's happening in the launch process?
spk05: Sure, Ren. I think just by way of reminder, we have approximately 25 of the 60 FTEs on board today. So the hiring will be triggered upon a successful pre-approval inspection and we'll bring those folks on board. So if you're thinking about approval plus, you would begin demand generation with the leadership team, all contract rollouts, and beginning to engage customers in pretty short order post-approval. You would then have certifications training and customary things like license number being affixed to the syringes, final PIs being printed. I think in line with biologics, you think about four to eight weeks post-approval for product in channel and real demand generation to be filled is kind of how we're thinking about that.
spk02: Got it. And can you remind me, Tom, the discussions you've been having regarding the reimbursement, because, you know, it's not a biosimilar. You're differentiated. Can you just remind us kind of where you are with that?
spk05: Yeah, so we have been very active, and the final approval and label will trigger the Submission to CMS, so the initial launch would be with a miscellaneous J99 code, and then you'd figure in the neighborhood of a quarter, depending on the actual timing, there are timing windows. CMS has shortened those windows of what they used to be, but depending on the actual timing of approval, you would then launch with a miscellaneous J code. Customers would have, we would extend dating terms for miscellaneous J codes, and then CMS would issue a permanent JCO that is independent for Rolantis as a BLA product, we would be in unilateral control of our own discounts, rebates, and reporting to CMS, and ultimately the reimbursement of the product would not be contingent upon anybody else's activity whatsoever. other than ours, and I think at the end of the day, what that equates to is stability and predictability at the customer level for how they should be thinking about reimbursement. So when we look at this, we think it's a real advantage at a time when there is a fair amount of chaos in a very significant market within Whitesell GCSF, and we think it gives us a unique opportunity to both be competitive and offer physicians an alternative choice.
spk02: Got it. Perfect. And then just one question on the same day dosing. We have the expansion for 15 patients. You know, I guess how quickly do you think we could get those patients? And I guess it's just going back to the previous question, but if we expect, let's say, those results, I'm going to say within six months or so. Correct me if my timing is off. it seems like you might be able to go with that straight to the FDA to come up with some sort of maybe a little bit of a larger study, maybe a bridging study, or do you think you might be able to actually modify the label according to these, you know, just these limited number of patients?
spk08: Yeah, so, Francois, I'll take that one. So I just want to be clear that the initial filing, the BLA that's under review, where we're talking that the last step is the inspection, at least we believe so. So we don't have anything about same day dosing in that potential approval in near term. Now, as soon as we go through the expansion, get the data, If it confirms what we saw earlier and it really, truly, you know, there is attribute of our product that because it's novel, it has meaningful difference from some of the biosimilar or the originator in the sense that it has different kinetics and especially different pharmacodynamics. It stays in the marrow longer. So all these attributes make it, you know, a little different here in its behavior from the others. And so those elements would have to be discussed with the FDA as to what is the next step. And, you know, depending on the strength of signal we see in the expansion, that's really going to affect our design of the next study. And I wish I could tell you more now, but unfortunately, we're going to have to wait to get those results. We think, by the way, that we should be able to recruit those patients quite rapidly. We don't expect protracted, you know, long or difficult recruitment.
spk02: Got it. Okay. Now, thanks for the clarity on that. I guess just one final question for you. It's probably for you, Francois. The, you know, we have cohort five, the various dosing schedules. I guess I'm trying to understand what are the next steps. Like, let's say we decide, okay, look, eight MIGs, BID looks really good based on, you know, these expanded number of patients. Kind of what happens at that point? Do we do we just kind of leave it out there as a published manuscript and once POSI gets approved for HER2 patients, HER2X on 20 patients, physicians can utilize the literature and kind of modify it themselves? Or do you feel that, you know what, you really want to get out there, expand that dosing schedule to EGFR? Exxon 20 insertions, as well as maybe get a formal label change by, you know, conducting a proper study.
spk08: Yeah. So, look, I don't want to get ahead of myself here. You know, in 10 days or so, you're going to see the abstract and then the presentation. So, obviously, we need to wait for that. Okay. But if we assume that the signal is good against EGFR and continues to be good with R2, the natural thing that one would do, other than discussing it with the FDA, obviously, would be further expansion of a cohort that looks good, right? That's the normal thing that you would do. The timing, obviously, would be critical. We have to be careful because you know when you present new data to the FDA it can change your to do for days so we're going to be very careful and proceed uh cautiously but at the same time we want to share this good data that we think we you know we have and we'll provide you at acr and you know uh we got fast track designation there's a reason for that there's a real medical need here And POSI certainly appears to have some very good signal in comparison to some of the other drug in development.
spk02: Sounds great. Thanks very much for taking the questions.
spk08: Thanks, Ron.
spk06: Thank you. And I'm not showing any further questions at this time. I would now like to turn the call back over to Joe Turgeon for any further remarks.
spk03: Thank you, Josh. And I'd like to conclude the call and say thank you for all of the participation and everybody's interest on the call today. I really appreciate it. And I'd like everybody to have a great afternoon, and we'll be speaking in other financial meetings along the way here. So we look forward to presenting at AACR and future data as the year goes up. Thank you very much for your interest.
spk06: Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for participating. You may now disconnect.
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