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spk10: Good morning, ladies and gentlemen, and welcome to the Chimerics First Quarter 2022 Earnings Conference Call. I would now like to introduce to your host for today's call, Michelle Laspaluto, Vice President of Strategic Planning and Investor Relations at Chimerics. Please proceed.
spk05: Thank you. Good morning, everyone, and welcome to the Chimerics First Quarter 2022 Financial and Operating Results Conference Call. This morning, we issued two press releases, one to announce the sale of Tembexa to Emergent BioSolutions and one announcing our first quarter operating operations. You can access these press releases in our investor section of the website. With me on today's call are President and Chief Executive Officer Mike Sherman, Chief Medical Officer Alan Melamed, Chief Financial and Business Officer Mike Andreou, and our Chief Inifredone Technology Officer Josh Allens. Before we begin, I would like to remind you that the statements made on today's call include forward-looking statements within the meeting of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties and other factors. These risks and uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. Please refer to our filings with the SEC for more complete disclosure of these risks and uncertainties. At this time, I would like to turn the call over to our President and Chief Executive Officer, Mike Sherman.
spk11: Thanks, Michelle. Good morning, everyone. Thanks for joining us. We've had an active couple of months, so let me get right to the updates, and I'll start with Tembexa. This program has been central to our strategy for a couple of reasons. First, we're fulfilling an important need to protect the population from the possibility of a smallpox outbreak, and we've done that with the first treatment approved for all ages, and one that's likely robust even in the face of the inevitable mutations that compromise the efficacy of other treatments. Our ongoing negotiations with BARDA are progressing well to satisfy this first objective. The second reason Timbexa is central to our strategy is because it will serve as an important mechanism to fund our ongoing development in oncology. This is of particular value at a time when access to capital within the biotech sector is so challenging. With that in mind, we're excited to announce this transaction with Emergent BioSolutions, the sale of worldwide rights to Timbexa. It secures substantial capital to fund our business. It allows us to focus our execution on the development pipeline, and it positions the asset in the hands of a company that's well-suited to maximize its value, value we will continue to participate in via milestones and royalties. Emergence, a leading biodefense company with substantial experience in working with government agencies to assure the protection of the population's health. In securing the upfront capital with this transaction, we positioned ourselves well to fund our pipeline without the ongoing uncertainty of future procurements, which, as you know, can be variable depending on the government's evolving priorities. We continue to control the BARDA contract negotiation to its completion, which we still expect to occur later this quarter. Following the signing of the procurement contract and closing of the emergent transaction, we look forward to facilitating a smooth transition, particularly as it relates to the well-established supply chain for Timbexa, which emergent intends to continue to utilize. I'll let Mike Andreol cover the key terms of this transaction in a moment. Suffice it to say, we're very pleased to bring this transaction to fruition as it just makes great strategic sense for both organizations. Let me now turn for a few minutes to Onc201. We recently engaged several key opinion leaders in the neuro-oncology field who participated in our advisory board. supporting the design of our Phase III randomized trial in H3K27M mutant glioma. That engagement has been a great reminder of both the unmet need in this population and the physician enthusiasm for Onc201 as a treatment. It's a combination of these two factors which drive physicians and patients to seek out this treatment today, and it will continue to be the engine driving enrollment in our Phase III trial. In our recent engagement with the FDA to discuss the phase three design and our analytical plans around the natural disease history study, they took the opportunity to provide feedback on potential accelerated approval path. To be clear, we did not seek formal feedback on that question as we anticipated those discussions would take place as we completed the safety database and some of the ongoing clinical pharmacology supporting work. In other words, when one would have had a more informed perspective on risk benefit. That being said, their feedback made it clear that an accelerated approval would be more challenging than we previously anticipated. To be sure, the FDA's recent public commentary on the accelerated approval path, particularly within oncology, has certainly not been supportive of single arm data going forward. The FDA also let us know it no longer plans to rely on a natural disease history study as a comparator due to its inherent limitations. We've had this study underway with the expectation it would be part of the potential submission. That being said, we plan to wrap it up, the study with the patient data we have already in process, and we'll look to publish our findings. Based on FDA's feedback, this data is likely less meaningful in their decision process, and yet we would still expect to include it in a potential accelerated approval submission. Let me underscore that we're not throwing in the towel on a potential accelerated approval pathway, but we need to prepare for the likelihood that the first approval may come with completion of the Phase III. We also need to prepare for the likelihood that if we do pursue accelerated approval, the FDA will be less likely to allow for certain work to be completed during a rolling submission or as part of a post-marketing commitment, as we had previously expected. Over the last year, we've successfully completed healthy volunteer safety and PK studies, improved the liquid formulation for pediatrics. We've evaluated concurrent medication and food effects on pharmacokinetics and are now evaluating special populations, including subjects with renal and and hepatic impairment. That work has all gone very well. Other work to be performed includes a cardiac safety study and POP-PK modeling. These studies extend into the first half of next year and would be gating items for a submission for accelerated approval. I need to hold off on sharing too many details of the Phase III trial design as we're working quickly to get closure with the FDA on a couple of elements, but I will make a few comments about it. The trial with initiation later this year will enroll H3K27M mutant glioma patients, both pediatric and adult. We'll treat newly diagnosed patients at the conclusion of their standard radiation regimen. Patients will be randomized to ONC201 or placebo at that time. We're planning on overall survival as the primary endpoint, which, of course, if successful, will maximize the value of this agent. We believe this trial can be completed quickly with rapid times to events and including early interim analyses. As we said all along, the strict criteria required for the cohort of patients evaluated to date is not likely the optimal setting for ONC201. It was defined more to ensure the single agent activity was isolated, and yet the data is still compelling. As a result, we're really excited about this phase three trial as it deploys ONC-201 at a time in the treatment cycle when it's most likely to show maximum benefit to patients. We'll come back with the final design elements, powering assumptions and timelines in the coming weeks as we have final alignment with the FDA. Finally, as we highlighted in our release, we've terminated our D-STAT program. Along with the sale of CEMBEXA, this will reduce our spending, and will give us tremendous focus on the Inifidome platform and execution there. With that, I'll turn it over to Mike Andriel to share more about the Tembexa transaction and the financial results for the quarter.
spk01: Thanks, Mike, and good morning, everyone. I'd like to start with a few comments about the financial implications of the strategic decisions we announced this morning. First, the upfront proceeds from the expected sale of Tembexa not only provide financial stability for the foreseeable future, it also shifts the ongoing capital investment in the program to emergent. This taken together with the decision to terminate D-STAT development meaningfully improves our forward-looking burn rate. While our normalized burn rate in the most recent quarter was about $20 million, we expect the strategic decisions announced today to revert that burn back to about $15 million per quarter by the end of the year, or about $60 million annually. as we fully focus on the Imiprodome platform where we see evidence of clinical activity. That said, we expect the proceeds from the Tembexa transaction to fund the organization into 2026. Between now and then, we'll have the potential for accelerated approval of ONC201, likely interim assessments of the ONC201 phase three randomized control study, and likely the fully mature data from that study. The potential for capital via milestone payments of up to $100 million, if realized, may obviate the need for additional capital through commercialization of OCTO-01 if it's ultimately approved. This deal also removes the year-to-year uncertainty of the government budgeting and procurement process from Chimerics and places it with Emergent, an organization who has a key competency in that process. It's for that reason that the potential for future royalties in this transaction are also important. There are several scenarios where the market for pandemic preparedness increases, in the years to come, and the royalties in this transaction enable Chimerics to meaningfully participate in that growth. We'll earn a 20% royalty on gross profit generated in the U.S. beyond the 1.7 million treatment courses expected in the first BARDA agreement. Those royalties could be associated with additional volume from a second BARDA contract or from volumes associated with sales from other sources in the U.S., including in the event of an actual smallpox outbreak. Of course, the value of those royalties in an outbreak scenario would likely be substantial. Outside of the U.S., Chimerics will earn a 15% royalty on gross profit starting from the first sale. And while we don't anticipate international revenue to be material in the near term, we do believe Emergent is well positioned to maximize the utilization of the product globally, and royalty revenue from international sales may become material in the years to come. I'll now turn to a quick recap of the financial results for the quarter. Starting with our statement of operations, the company reported a net loss of $24.8 million or 28 cents per basic and diluted share for the first quarter of 2022, compared with a net loss of $97.4 million or $1.21 per basic and diluted share for the first quarter of 2021. The decrease is mainly due to the recording of the in-process R&D associated with the Oncocytics transaction and the comparable period last year of 82.9 million dollars r d expenses increased to 19 million for the first quarter of 22 compared to 11.9 million in the same period of 21 the main driver of that increases the ongoing development related to onc 201 general and administrative expenses increased to 5.6 million for the quarter compared to 4.1 million dollars for the same period in 2021 turning now to the balance sheet during the first quarter we paid the 14 million dollar note payable to the orthopedic shareholders associated with the acquisition of Oncocytics in Q1 last year. Importantly, no further payments are due from that transaction until either approval of Onc201 or Onc206 in the U.S. or Europe. Net of that repayment, we ended the first quarter of 2022 with approximately $53.4 million in capital fund operations. We expect to receive the upfront payment of $225 million associated with the sale of Tembexit to Emergent at closing of that transaction. That closing could take place as early as the end of June or shortly thereafter, dependent on antitrust clearance of the transaction and the finalization of the expected barter procurement contract. With that overview, I'll now turn the call back to Mike Sherman for closing remarks. Mike.
spk11: Thanks, Mike. Let me just conclude with a few key points. First, we've secured substantial capital sufficient to deliver our development strategy and have a partner well-suited to maximize the likelihood of additional capital to come. Secondly, we reduced planned spending and focused our efforts to maximize the speed of our execution on the programs with the highest likelihood of success. And third, we have a lead program With among the most compelling and internally consistent efficacy data, you'll see relative to the depth of the unmet need in H3K27M glioma. We're working quickly to initiate the phase three trial, which would be the basis for first approval or as a confirmatory approval following an accelerated approval if we're successful with that path. With that, operator, we'll open the call to questions.
spk10: Thank you. And if you would like to ask a question during this time, simply press star, then the number one on your telephone keypad. Our first question comes from the line of Mario Braycroft of Jefferies. Your line is open.
spk03: And thanks for taking my questions. I guess just starting off with Tembexa, can you talk about some of the continued gating factors for the BARDA contract for Tembexa? Maybe start there.
spk11: So that negotiation is ongoing. I need to be cautious in sort of making any commentary about the negotiation. We're pretty far advanced, as you can imagine, given the notion that we still expect to be able to close that or sign that agreement before the end of this quarter. But beyond that, I'm not sure that I can add much more until it's done.
spk03: Okay. And then was there anything else that went into the decision to sell Tembexa prior to the negotiations finishing? You mentioned a few reasons, but just wanted to see if it was due to any uncertainty to contract size.
spk11: No, I think it's fair to say that this decision was clearly informed by the ongoing negotiation and and our, you know, the potential risks around future procurements. And so for us, the certainty of this up front, along with participation in future economics, was attractive. And so the risk profile associated with what we expect that agreements and future agreements future potential of that agreement, that risk profile I think fits better with emergent and their capabilities and the certainty fits better for our strategy.
spk03: Got it. Makes sense. And can you talk a little bit about your views on antitrust and just some of the diligence work that you've done there and if you see any risk to that? I'll let Mike respond to that.
spk01: Yeah, we don't anticipate an issue there, Maury. Of course, you always have to do the filing and go through the process, but our preliminary work doesn't cause us to expect an issue there.
spk03: Got it. Okay, and maybe last question just on the feedback with FDA on the accelerated approval path. Did it have anything to do with number of adults versus number of children in this study? And, yeah, I guess I'll leave it at that.
spk11: No, no. Their feedback was really quite general, which is one of the reasons why we continue to work on pulling the data analysis together to potentially pursue that path. even though they've highlighted the risk of that is higher than we may have expected previously. So we're going to continue our work and then we plan on having a follow-up conversation with them in a formal pre-NDA meeting.
spk03: Got it. Okay. Thanks for taking my questions. I'll hop back into the queue. Thanks, Maury.
spk10: Thank you. Next question comes from the line of Ed White of HC Wine Rites. Your line is open.
spk02: Good morning. Thanks for taking my questions and congratulations on signing this deal. You're welcome. Just a question about how the $225 million will be reflected on the income statement. Would this be recorded as a one-time benefit? benefit to revenues, or could it be spread out over time, or are you still waiting to see what the accounting treatment for this will be?
spk01: Yeah, and it's Mike and Andrea. We'll have to complete the work on the accounting treatment before answering that definitively, of course. My expectation is that it will be, you know, recognized as revenue this year in its entirety, subject to there's a scenario, as we disclosed in the press release, where there could be an adjustment either up or down, depending on sort of the final barter contract, although we don't expect, based on what we know today, there to be an adjustment. But we would expect all of that to be recognized this period, sort of subject to our definitive accounting review. Okay, thanks, Mike.
spk02: And then just on the 25 million potential, the four potential 25 million milestone payments, can you just review what triggers those?
spk01: Yeah, they're triggered by the BARDA's exercise of additional options in the agreement. So you may recall the The structure of this agreement and other similar agreements is that there's a base period followed by a number of additional options to get to the number of treatment courses. Those options are always at risk depending on BARDA's option into the future. And so as they exercise those options, should they exercise those options, that milestone payment would be earned by Chimerics. And so each one is worth $25 million.
spk02: Regardless of the size of the option, I would imagine?
spk01: There is a mechanism, getting into the details, there is a mechanism in the agreement where it could technically be higher or lower depending on if the actual amount of the option is different from what we currently anticipate. But that could actually move in both directions, but we expect it, based on the current negotiation, to be at or very near the $25 million.
spk02: Okay, thanks, Mike. And just a final question on OCC 201. Has Project Optimus been brought up at all. Can you talk about your thoughts on using the proper dose, the dosing that would be acceptable for the FDA, or could they want you to look at other doses? And then also just as far as the phase three protocol, I know you're going to tell us more about that later, but how are you thinking about the size of the study?
spk11: Thank you. I'll answer the second part of that and then let Alan speak to Project Optimus. I will hold off on describing the size of the trial. We do think it's all relative, of course, to what your expectations are for your typical Phase III, but I think in this population and given the treatment size effect, this is a trial that we expect to be able to complete relatively quickly. We also believe that we can incorporate early analyses that, again, given our anticipated treatment effect, are likely to hit. And so when we provide that update on the specific and those early analyses, we'll be able to provide the powering assumptions for each of those, and we'll provide that detail to investors as we get that locked up with the FDA in the coming weeks. Maybe Alan can speak to some of the work that we've done on dose and so on.
spk09: Yeah, thank you, Mike. This is Alan Melamed. Regarding Project Optimist, as you know, this has been a project initiated by Dr. Pazder and others due to concerns that a lot of oncology drugs in Phase III have been based on the maximum tolerated dose. And in the phase three trial, they find that these doses have not been tolerable and that they're having some safety issues and ability to give full doses in these patients. We have had some discussion with the FDA regarding Project Optimist. Let me just put a point on the dose that was utilized for ONK201 was not based on an MTD. We have a pretty strong rationale based on where our dose was and It's a very safe dose, and what we've seen is obviously an effective dose, and we will continue to have ongoing discussion with FDA regarding OCTO-1 in this area.
spk02: Okay. Thanks, Alan.
spk10: Thank you. Next question comes from the line of Noreen Kubria of Maxim. Your line is open.
spk06: Thank you. Congratulations on the Timbexa deal, and thanks for taking my questions. I guess the first one's on Timbexa. I was just wondering if you could comment on how the deal or negotiations came about with Emergent, you know, who approached whom, or did you approach Centerview?
spk01: I'm going to answer Mike. You know, we've had sort of on and off conversations about their interests, for a while, but those did not accelerate until more recently into what I'd say were sort of true conversations about their interests. It's obvious it fits within their portfolio really, really very well. It's not competitive with other agents in their portfolio given this is a treatment for a potential smallpox outbreak, and yet they've got other agents in their portfolio that leverage their government contracting capability and their biodefense strategy. And so it fits very well. Not a surprise they were interested. in this asset and as mike sherman said earlier the the value of substantial upfront capital particularly in this market and the certainty that provides in in developing and commercializing our portfolio was made a lot of sense for us and and the ability to continue to participate in the long-term upside if all of those options are ultimately exercised is also important for us for all the obvious reasons. So good deal dynamics between the two, and I think we'll be the start of a good partnership on that program.
spk06: That makes sense. Thanks. So let me switch over to ONC201. I'm just curious regarding the natural history study. Do you have a sense of what might have changed yet to use mine from requesting a study initially, and now it seems like, you know, they won't be relying on that for its regulatory decision. So, you know, why the switch?
spk11: I don't know if I have a great answer for that, honestly. I'll let Alan maybe add to it. There are certain elements of any natural disease history study that, um, you know, their, their, um, inherent weaknesses and, um, uh, in, in, in what you can conclude from those. And yet there is substantial literature, uh, uh, about and history of, of the FDA asking for those and, and evaluating those as part of their consideration. So, uh, that was all known upfront. Um, uh, so, so I, I, uh, it's not a hundred percent clear why they would, would view this, um, view this differently. That being said, I do think that we would still provide that analysis as part of a potential accelerated approval submission. We continue to believe it would be supportive. We have no reason to believe that the findings from that work would suggest anything other than what we had previously expected, that responses are rare or if ever occur in this population. So I think it can still be helpful, but we're going to limit our investment in that work based on their feedback.
spk06: Right, okay. There's one more. Can I just add?
spk09: Yeah, please, go ahead. I do think there's been somewhat more of a shift in FDA regarding the utilization of Phase II single-arm trials for approval that, as you probably have heard, with the PI3 kinase inhibitors in heme malignancies. There's been the PD-L1 that you've seen with the Phase III trials and the urologic disease in ODAC last year. So I think it's more of an FDA change. Again, when you look at OCTO1, we still believe that this is a very high-invent need disease in an area where there aren't many treatment options, and we believe that there's still an active and effective agent with OCTO1.
spk06: Yeah, that makes sense. Thank you. So, you know, when do you anticipate filing now? Are you able to guide to that?
spk11: Well, we did say that there was an expectation previously that some of the work that we have ongoing, we described some of the Franklin Farm in my commentary, that some of that could be submitted as part of or during a rolling submission. And so I think it's more likely that a complete submission would be required with all of those things ready for when you pull the trigger on that submission. And as such, those studies will be finishing up in the first half of next year, so it would follow that. Maybe it's the best guidance I can give.
spk06: Got it. Yeah, that's actually helpful. Thank you. That's all from me.
spk10: Thank you. Next question comes from the line of Sumit Roy of Jones Research. Your line is open.
spk08: Hi, everyone. Congratulations on the Tembex deal, and thank you for taking that question. I'm curious if you have any plans on the use of the $225 million in terms of if you're going to acquire new assets, whether it's going to be oncology, any color would be appreciated.
spk01: Hey, Schmidt. It's Mike Andrew. I think, you know, our focus is on Onc201 and the Amipridone platform. As we've said continuously, we're always evaluating sort of external innovation as just part of our normal business process. And we'll be smart about, you know, if we see assets, if or when and how to pull them in. One of the advantages of this transaction is in a market where cash has probably never been more valuable in terms of a premium and certainty in the runway. There are some increasingly distressed assets in the market, and I suspect over the course of the year there's going to be more distressed assets in the market given the environment for small and mid-cap biotech that we find ourselves in today. Having a substantial cash balance to work with is helpful in that environment, and yet we're also very, very focused on making sure that we get ONC 201 to the finish line. We feel we've got a responsibility to make sure that we get what we believe to be an active agent to the finish line and get it to patients who desperately need it. So we'll balance those two objectives as we evaluate the external market, but certainly there's the opportunities in business development this year for those who have access to capital are more meaningful than they've been in a while.
spk08: Thanks, Mike. That's really helpful. And also, our last question is, could you give us any color on the reason behind destack termination? What led you to that point? Any mechanistic understanding or bandwidth or anything? Thank you.
spk11: Actually, I didn't hear that question, Srimit. Can you repeat that?
spk08: Just the reasoning behind why you terminated the D-STAT program. Any mechanistic understanding or something?
spk11: Yeah, well, I appreciate that question because it gives me an opportunity to be really clear about that. That drug, I think, is a promising drug. Nothing has changed our view with regard to the safety profile or the potential for efficacy there. As you know, we had challenges enrolling our trial, so it was as much about looking at our portfolio, identifying which assets we had the most definitive evidence on activity and then focusing our efforts there. I expect that CanTax will look for opportunities to continue to develop that agent in any number of indications.
spk08: Thank you.
spk10: Thank you. Next question comes from the light of David Neuvengartner of Wedbush Securities. Your line is open.
spk04: Hey, thanks for taking my questions. First off, did you or have you shared any of the natural history study data with the FDA prior to these discussions? And the second question is, Could you remind us typically what is the overall survival of patients post-radiation with the H27 mutation? And finally, when you think about a potential phase three design with a placebo control, I mean, are there any concerns about recruiting with a placebo arm and obviously difficult disease to treat. I know there aren't any approved treatments, but patients might be seeking alternative therapies.
spk11: Thanks. I'll answer part of that, and then I think between Alan and Josh, the second question is on survival and placebo. We can address it. We did not provide any data from the natural disease history analysis. We, in fact, you know, we were going to subject that data to a blinded independent central review. And so that's why I made the comment earlier that we have no reason to believe that anything, that we would see anything different than what we previously expected from that data. So this was more of a general commentary from the FDA and frankly just may be part of, you know, there are a few reasons why the FDA could have provided the the feedback on kind of risks associated with accelerated approval. One of those is that they certainly want to have phase three trials up and running. And so their emphasis was to focus on getting that trial up and running so that they could have confidence that it would be executed. And perhaps as a byproduct of these discussions, that will position us more strongly as we go back to talk about an accelerated approval, that there's likelihood and evidence that that trial is going to be done in a timely manner. So anyway, let me hand it off to Alan and Josh maybe to speak to the discussions we've had both with the advisory board on the trial design and survival expectation.
spk09: Yeah, let me just start and then I'm going to tag it off to Josh. We had several of these conversations with numerous thought leaders in this area and discussed the best design for this, assuming that FDA would require ORF survival. And with discussions, almost all the investigators and key thought leaders felt that the best design would be a placebo-controlled trial in the upfront setting, post-radiation. This way, you can control all variables I think the concern would be that if you did not have this control, that patients could start a study and then come off without if they're not in a placebo-controlled area. Numerous drugs and studies have been done as a placebo-controlled in similar diseases, not exactly in the Z2K27 that have been in patients with glioma. So it has been done in the past. And I'll just pass it off to Josh for other comments on that.
spk12: Yeah, thanks for your questions, David. I would agree with Alan there. Not exactly in the same space, but certainly a number of randomized placebo-controlled trials have been conducted in CNS tumors. So between the precedent there and our ad comp that's been held to help us grapple with these issues, we've certainly been mindful about how we balance ethics and the need to accrue this trial expeditiously. I'll circle back to your second question with regards to survival expectations. Of course, this is one of the focuses that was put in for the natural disease history that's been discussed on this call. While the results of that aren't available, I think the literature largely supports that the prognosis of these patients are similar to or worse than glioblastoma. So if you're looking for a benchmark, I think you can look to that in addition to the emerging literature for our disease. And then the only other comment I would add on to what Mike said for your question on dialogue with FDA on the natural disease history is that while we have not shared results from that study to date, We have had a dialogue with the agency in the past on the natural disease history of this indication in view of the available literature, thought leader consensus, as well as treatment guidelines that are available formed by a series of KOLs, all of which led to an agreement that available therapy in the recurrent setting for this disease is palliative. So while no specific data from our study, a fair amount of dialogue there. to help form that framework. Okay. Thank you.
spk10: Thank you. Next question comes from the line of Troy Langford of Cohen. Your line is open.
spk07: Hi. Thanks for taking our questions, and congratulations on the Timbexa deal. I just have one question on Timbexa first. So just given that you all consider royalties on profits made on Timbexa from contracts outside the U.S., Can you just talk a little bit about who would lead those regulatory submissions or negotiations? So would you all do that, or would Emergent mostly lead those conversations? And then I have a follow-up after that.
spk01: Yeah, Emergent will lead all regulatory interactions after closing, both in the U.S. and outside of the U.S.,
spk11: The nuance to that is that we would be working with them closely, you know, during the transition period and so facilitate that. So I think there's a period where which they would own it and lead it and yet might be relying on our team to support it.
spk07: Okay, great. That helps a lot. And then on OCTO-01, specifically the randomized phase three study, I know you all don't really want to talk a lot about the details of the study, but Do you think there's any possibility that you could enroll patients with tumors other than those from the midline location? And then I guess in terms of interactions with the FDA, do you already have a meeting plan to discuss the trial details with the agency?
spk11: I'll start with the latter question. We did already have the discussion on the details, and we're following up on a few of the open items from that. So we expect to have closure on that relatively soon, and those interactions can be informal. I'll let Alan speak to the approach around tumor location and Josh chip in.
spk09: Yeah, I think one of the key inclusion criterias would be the presence of the HCA K27 mutation. And we will be, at least at this point, planning to be a little more open regarding location and plan to evaluate patients in that perspective.
spk07: Okay, great. That was a lot. That's all for me. And thanks so much for answering our questions. Thank you.
spk10: Thank you. There are no further questions at this time, and I would like to turn the call back to Mr. Mike Sherman for closing remarks.
spk11: Well, just thanks everyone again for joining the call. Look forward to providing additional updates. Have a good day.
spk10: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Have a great day.
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