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spk05: Good morning, ladies and gentlemen, and welcome to the Chimerics Third Quarter 2021 Earnings Conference Call. I would now like to introduce you to your host for today's call, Michelle Laspaluto, Vice President of Strategic Planning and Investor Relations at Chimerics. Please proceed.
spk02: Thank you. Good morning, everyone, and welcome to the Chimerics Third Quarter 2021 Financial and Operating Results Conference Call. This morning, we issued our third quarter financial results press release and a separate release reporting positive top line results from the Onc201 recurrent H3K27M mutant glioma. You can access those press releases in our investor relations section of the website. With me on today's call are President and Chief Executive Officer Mike Sherman, Chief Financial and Business Officer Mike Andriel, Ellen Malamed, our Chief Medical Officer, and Josh Allen, our Chief Technology Officer of Inifrido. Before we begin, I would like to remind you that the statements made on today's call include forward-looking statements within the meaning of the Private 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 a more complete disclosure of these risks and uncertainties. At this time, I would like to turn the call over to Mike Sherman.
spk06: Thanks, Michelle, and good morning, everyone. Thank you for joining us. We're happy to share with you today the positive top-line results from the Blinded Independent Central Review, or BICR, of ALK-201 in the treatment of recurrent H3K27M mutant glioma. This is really just a preview of the analysis that will be presented in a couple of weeks at the Society for Neuro-Oncology annual meeting in Boston. You'll recall that we had worked with the FDA to define a cohort of patients that have the potential to form the basis of an NDA filing. These were the first 50 patients that met a very specific set of criteria across three different studies and two expanded access programs. The criteria were designed with two objectives in mind. The first, to define a homogeneous population of patients, and second, to select a group of patients in which tumor response could be assessed objectively with assurance that those responses were the result of ONC201 single-agent treatment alone. On top of that, perhaps the most stringent response criteria was utilized at the FDA's request, the response assessment in neuro-oncology criteria for high-grade gliomas, or renal HDG, as it's commonly referred to. For those accustomed to resist response criteria, renal HDG represents a higher bar, requires a tumor reduction of at least 50%, in addition to clearing non-imaging hurdles, including stable or improving performance status, and stable or declining use of steroids. So when you subject this analysis to a blinded independent central review, you're faced with a laundry list of reasons a response might not be confirmed. As we described in the past, the first 30 patients were evaluated previously with a single reader blinded review. And the last 20 had been investigator assessed. From those assessments, we had a 22% response rate with a few more patients maturing. This blinded review was a fresh assessment of all 50 patients and included a two-reader assessment with a third-reader adjudication when it was required. So you can imagine we're pleased to report a 20% overall response rate with that criteria. Alan will expand a little bit more on the approach for this protocol on this fresh assessment, which is really meeting a regulatory standard. It may be worth noting that the response rate in the first 25 patients enrolled for this data set recorded 20%, and the second group of 25 also had a 20% response rate. While achieving any Raynaud HGG response in this population of patients is not expected, we know the durability of response is also important. And these data are certainly compelling from a durability standpoint. Responses emerge gradually as tumors tend to shrink over a period of months in response to Onc201. And among responders, the Raynaud HGG hurdle of 50% reduction was achieved at a median rate of 8.3 months. On top of that, the duration of response was an additional 11.2 months. That translates to a median progression-free survival in responders of over 18 months, which is probably a better perspective on durability given the gradual onset of initial response. By the way, that's superior to the PFS among responders we previously reported of just over 15 months. There's several details we look forward to seeing presented at a plenary session during the upcoming snow conference, which will build on this data. That includes the disease control rate, which includes patients with shrinking tumors who fell short of the 50% threshold, and a few patients were indeed close. When you look at that disease control rate, roughly double the size of the response rate. We'll also report other forms of clinical benefit, which, as you might expect, were largely concentrated in those patients who achieved a renal response or disease control. The presentation will also contain results of renal low-grade glioma assessment, referred to as renal LGG, which are quite consistent with renal HGG, further confirming the robustness of these findings. The presentation will also include both PFS and OS analyses. A regulatory strategy has been to remain closely engaged with the FDA, and we will share this data with them as we continue our efforts on the ongoing clinical pharmacology studies and safety package covering a broader population of treated patients beyond the 50 in this analysis and CMC work. We don't see any of this as high risk per se, but it is work that's necessary to advance to an NDA. Lately, there's been a series of complete response letters from the FDA on several other companies' NDAs, and some of those CRLs are related to deficiencies in these areas, and we intend not to repeat those situations. At the FDA's request, we're also gathering natural disease history data, which we expect to support the notion that the data we're seeing in this patient cohort is truly differentiated. At this point, my apologies to Dr. Melamed, as I've probably already stolen the punchline of the data highlights, but I think he can provide some important context for these results. So let me turn it over to Alan.
spk03: Thanks, Mike. It is indeed important to understand this patient population and the context for this treatment. First, all of the patients were in the recurrent setting, which means that everyone's tumors had grown on one or more lines of therapy received. All patients had received prior patient therapy. In addition, the vast majority, almost 90% of patients, also received temozolomide. Keep in mind that as HAK27 gliomes are usually MGMT unmethylated, One would expect temozolomide to be less effective. The fact that so many patients have received temozolomide speaks to the fact that more options are needed for these patients. A second important point that Mike alluded to was the strict inclusion criteria agreed upon with FDA. This was to ensure that any responses seen were truly related onto one as a single agent and not an artifact of radiation or another therapy. The study required at least a 90-day wash appear from prior radiation, 23 days for temozolomide, 42 days for antibodies, which most typically would be Avastin, and 28 days for other therapies. An important predictor of response is typically the initiation of treatment early in the course of disease. And you can imagine these restrictions and delays may not be the optimal setting for this treatment. One might predict improved outcomes with early use of ONC201, which is where we intend to focus our future development. These data are exciting, particularly in the light of a disease setting where you tend not to see random responses and options are limited. This excitement was echoed in market research we performed during and prior to acquiring this pipeline of input zones, where key opinion leaders told us that a drug was providing a 20% response rate by rate of H2G with at least six months durability would be clinically meaningful in this specific patient population. In this cohort, we're seeing durability of response roughly double this, which does not include the gradual onset to tumor response with the median onset of eight months. Just to reiterate what Mike had said previously, the response and response determination was determined by a blinded independent central review. This review was performed with two independent readers with a third reader to adjudicate. This rigor is required for the purposes of regulatory filing. Regarding safety, the analysis was limited for this presentation, but you note there was one serious adverse event of pulmonary embolism, which is attributed as POS related to ONC201 by the investigator. Our safety team assessed SAE as unlikely related to ONC201. Based on prior safety reviews, ONC201 has been found generally well-tolerated during period of administration. The most common reported adverse events were nausea, vomiting, fatigue, and decreased lymphocyte count. We'll continue to collect and assess the ongoing safety of over 200 patients as part of a package that we will plan to discuss with FDA. We look forward to the complete presentation of this data in a couple weeks at the SNL Conference on the 20th of this month. The plenary session will also include additional supporting data, including evidence of disease control, clinical benefit, including changes like performance status, reduction in corticosteroids, renal LGD response, as well as progression-free survival and overall survival. These additional data in context of the landscape of this disease round out the story of a drug that presents a potentially promising therapy for patients with this awful disease. The FDA has already grabbed it off to one fast-track designation for the treatment of adult recurrent HAK27 mutant high-grade glioma, rare pediatric disease designation for the treatment of HBK27 mutant glioma, and orphan drug designation for the treatment of glioblastoma and the treatment for malignant glioma. With these overview and exciting clinical results, I'll now turn the call over to Mike and Joe for review of the financials. Mike? Thank you.
spk01: Thanks, Alan, and good morning, everyone. As Michelle mentioned in her introductory remarks, earlier today we issued a press release containing our financial results for the third quarter of 2021. Starting with our balance sheet, we remain well capitalized and ended the third quarter with approximately $125 million in capital to fund operations. We are adequately funded to achieve our upcoming milestones, and we expect a possible addition of non-diluted funding from a potential barter procurement contract will further strengthen our balance sheet. That said, we continue to be judicious with capital allocation across the portfolio. Cash burn was approximately $15 million for the quarter, up slightly from approximately $13 million in the second quarter of 2021. Turning to our statement of operations, the company reported a net loss of $18.6 million or 21 cents per basic and diluted share for the third quarter of 2021, compared with a net loss of $11.4 million or 18 cents per basic and diluted share for the third quarter of 2020. Revenues for the third quarter of 2021 were $0.1 million compared to $1.6 million for the same period of 2020. Research and development expenses increased to $13.8 million for the third quarter of 2021 compared to $10 million for the same period in 2020. The main driver of this increase is the incremental personnel and clinical expenses to support the addition of ARC-201 to the pipeline. General and administrative expenses increased to $4.9 million for the third quarter of 2021 compared to $3.2 million for the same period in 2020. loss from operations was $18.6 million for the third quarter of 2021 compared to a loss from operations of $11.6 million for the same period in 2020. In accordance with the terms of the merger agreement between Chimerics and Autocetics, the achievement of the 20% overall response rate for AUC201 via BICR will result in a success milestone payment of $20 million to the former Autocetics shareholders to be paid prior to year end. With that overview, I'll now turn the call Over to Mike for closing remarks. Mike?
spk06: Thanks, Mike. Let me touch on our other programs before we open it up for Q&A. We're continuing progress with our Phase III clinical trial of D-STAT in newly diagnosed AML patients. To date, enrollment of this study has proceeded more slowly than expected due to hospital staffing shortages, particularly nurses related to COVID-19. For that reason, we expanded the number of sites included and are in the process of activating sites outside the U.S. to supplement enrollment. We expect to complete enrollment of the first 80 available patients to take place in the second half of next year. With the approval this summer of Tembexa as a medical countermeasure for smallpox, we were pleased to see the FDA follow that up with a publication highlighting the risk-benefit of this drug in this indication. It was a very thorough piece of work in which they highlighted the breadth of potential use across age groups, the simple, short oral administration, the flexibility of having both tablet and suspension formulations, and the attractive resistance profile. They also summarized rationale for the potential combination of Timbexa with the existing approved countermeasure as an even more potent therapeutic option. Of course, the support within the U.S., particularly at BARDA, has always been high, but publications like this may be helpful as we reach out to other geographies for potential stockpiling. In the meantime, we can confirm our fill, finish, and packaging processes have advanced such that we're positioned to be able to ship into the U.S. stockpile immediately following execution of a procurement agreement, and we stand ready to respond quickly to the expected RFP. At the annual BARDA Industry Days event on Wednesday, BARDA spoke of the relationship with chimerics and success of having a second antiviral approved and the importance of having more than one drug in the case of an outbreak. In addition, yesterday, we participated in the World Health Organization Advisory Committee on Variola Virus Research, giving an update on Timbexa. Let me wrap up my comments by expressing our most sincere thank you to the clinical collaborators and their patients who participated in our clinical trials with the hope of improving not only their own outcomes, but also the outcomes of future patients. I know companies make this comment somewhat reflexively, but when you personally witness the sacrifices, particularly the hospital staff have made during the pandemic, you can't help but be humbled by their energy and support. With that, operator, we'll now open the line for any questions.
spk05: Thank you, sir. To ask a question, you'll need to press star 1 on your telephone. To withdraw your question, please press the pound key. Our first question comes from Maury Raycroft of Jefferies. Your line is open.
spk10: Hi, good morning, and congrats on the update today, and thanks for taking my questions.
spk05: Hey, Maury.
spk10: To start, I'm wondering if you can talk more about the data set and provide any specifics on whether there were new responses or deterioration from the prior data set?
spk06: Well, yeah, so you can imagine, given that this is a sort of top-line summary and we need to refrain from getting into the detail that would be presented at SNO based on our agreements with them. I will say that just in terms of the assessments that have happened previously and where we sat, the 22% response rate is essentially where we were going into this fresh-blinded assessment with a couple, I guess, or a few patients that were still maturing. One looked like with declining tumor volume had the potential to achieve that. I'm not sure the outcome of specific patients in that regard, but I do know that relative to that analysis, I believe we lost two and gained one relative to the prior assessments of both the single reader blind review and the investigator assessments. And what we had noted previously is there were a couple that were quite close to this 50% threshold that we knew could be subject to read differences. In fact, when we see that, and you'll see this in the waterfall plot when it's ultimately presented, there are actually a few patients that are quite close to the 50% threshold that just below it that would be included in the disease control chart. rate or stable shrinking disease. It's worth noting that those patients in that middle ground between zero and a 50% reduction, several of those patients were extended stable disease, also had accompanying forms of other clinical benefits. So you know those patients are benefiting. They're going home from their scans with shrinking tumors. And so it'll be important, obviously, to see the context of all of those patients, both those achieving responses and those with extended stable disease.
spk10: Got it. Okay. That's helpful. And when thinking about the new analysis on 201 and the total data set, I guess how does that impact your view on expectations for the bar for success and for regulatory approval, if you can talk more about that?
spk06: Yeah, and I'll make a brief comment and then let Alan chime in. When asked that question previously, we've always said, look, if the response rate dips down into the mid-teens, obviously this becomes more challenging. That having been said, drugs for indications of this nature have been approved with mid-teens kind of response rate. So hitting that threshold of 20% with this very robust sort of regulatory standard independent read is meaningful. It's meaningful for a couple reasons. It was unprompted feedback from KOLs as we entered into this, as we've done market research, suggests that 20% threshold was meaningful. Alan highlighted the six-month durability, which we'll kind of blow that out of the park with this durability observed here. More than double that, not even counting the time that it took while the tumors were shrinking. And I think the other important acknowledgement is the lower end of the confidence interval, given even a small data set of 50, you can put it at 10%. And so you can essentially rule out single-digit response rates where you would expect in this population either zero or very low single-digit responses to any other therapy. The FDA has agreed that this is a patient population where current standard of care is palliative. I probably said more than I planned to, Alan, but I don't know if you have anything, Alan or Josh, to add to that.
spk03: The only thing I'll add is I do think it's really important to look at the context of what's available, and there's really not a lot of available therapies, and the therapies that are there really don't have a lot of responses. That is something that, like I said, FDA has already acknowledged that Palliation is an appropriate standard. So when you look at the whole package, you need to have responses that are durable with the safety package that is safe for patients. And I think this has a promising package.
spk08: The only thing I'll add is the points that Mike and Alan both hit there were part of our conversations with FDA. Just a reminder that the sample size of 50 was proposed to FDA in our discussions based on the expectation of continued observation of a 20% response rate, which has Mike pointed to provides you a lower bound 95% confidence interval of 10%, and in the context of that tally of available therapies that FDA acknowledged, and Alan just reminded you of, all went into part of the plan. This data is very much in line with our expectations that went into the selection of the sample size with our regulatory conversation.
spk10: Got it. That's all helpful perspective, and congrats again, and I'll hop back in the queue.
spk05: Thank you. And next we have Joseph of Cohen and Company. Your line is open.
spk07: Hi there. Good morning. Congrats, and thank you for taking our questions. Maybe just the first one, now that this data set is all set, can you kind of outline the cadence of interactions with the FDA that you expect likely probably to get some of the next few quarters here? And then second, just on the SAE, I know you indicated your internal team. thought that it might not be related. Is there anything that you can share in terms of patient background or reason why you don't agree with the assessment of the physician?
spk06: Thanks. Alan, maybe do that in reverse order. Do you want to address the SAE?
spk03: Yeah, I can take that. Yeah, so this SAE was deemed potentially related by the investigator, and this was initially identified evaluated by Oncosutics as likely unrelated. We did a re-evaluation prior to the press release, and we completely agree that this is unlikely unrelated. The patient had multiple comorbidities, including obesity and other health areas that made this event likely unrelated to compound. The patient also was able to continue the therapy afterwards, again, making it unlikely that it was related. So there's a lot of factors here that our assessment was unlikely related to POP 201.
spk06: Now, I'll come back to the question of the FDA dialogue. We've established a collaborative dialogue with the FDA over the course of the summer and expect that to continue. We will share the full data being presented at SNOW with the FDA in the coming weeks, and We also know that the FDA wants to see at least preliminary data from our ongoing natural disease history study, and we already have patients identified for that, and so that analysis is underway. This information, along with updates we provide on our ClinPharm and CMC work over the next, say, six months, will inform both their support to proceed with an NDA and how that that should be executed, so including rolling submission versus full submission. So that obviously impacts the timeline, which is why we've sort of not given more granular guidance on submission timeframes. We expect to be in a position to get more specific on that timeline in the first half of next year. Hopefully that helps. Yep, that is perfect.
spk07: Thank you very much.
spk05: Thank you. And we have Noreen Cribria of Maxim Group. Your line is open.
spk11: Thanks. Hi, good morning, and congrats on the data. So I guess just starting off first with Ong 201, you know, you've mentioned the natural history data. Do you have a sense of when you'll have some interim data on that and it would be available to share with the public?
spk06: Yeah, I've had questions about that. There's maybe a perception that natural history data takes years to accumulate, and in this case it's just not the case. We've got a protocol underway and engaged to gather that data. We'll gather really two sets of data, those that align exactly with this 50-patient protocol, where we would expect to be able to confirm data kind of zero or extremely low response rate and rare other forms of clinical benefit. And then we'll have a broader data set, which includes, you know, patients that maybe didn't meet those criteria for one reason or another, just to more broadly inform the drivers of survival or response in that patient group, even outside of that core set. When I made the comment around being able to provide more insight in the first half of next year, I think that coincides with at least our ability to have the first interim assessments of those analyses.
spk03: Mike, can I add one minor addition? I think no one believes that this population in general have a lot of responders. What we need to show is that the specific mutation doesn't have any differences. And the mutation is relatively new and identified, so that is what we have to show. I think when you look at recurrent diffuse melancholiomas, they're typical in a lot of responders, but we need to show it with the specific mutation.
spk11: That's helpful. Thank you, Alan and Mike. And then with regards to the ON201 study, obviously this is the registration cohort of 50 patients. With regards to the remaining patients that are in the three other studies as well as the expanded program, when might you share data from the other patients? I'm just curious.
spk03: Yeah, let me take this first. I think one of the One of the important reasons we did the analysis now, and as Mike had mentioned, we had a very mature data set with long fall, I think over a year and a half, like 15 months. When you have a duration, median duration response or timed response at eight months, you need to have a very mature data set to show that you have what the response rate is as well as the durability. So that is where the cut point was and why we used this for that. We are continuing to evaluate these patients, but I think our primary look will be this in order to discuss with regulators.
spk11: Great. And just one more from me. I think I sort of missed it. This is with regards to CINVEX, and I was just curious, with regards to new BARDA contracts, so are you aware of any sort of delays across the board happening with new contracts? Do you have any What do you call around that?
spk06: Well, we know the contracts group was sort of having – was challenged to kind of keep pace during the course of the summer, and then sort of that was really what had driven the delay in the first place. And really that has no other drivers that I'm aware of. I can confirm as well that – potential hurdles related to budget negotiations or congressional debates around funding really don't have anything to do with this. It's really just a logistical step that they need to get through. They've continually assured us of that and so the best we can do and stand ready to respond to that RFP, we know that they're also, BARDA's in a position that's actually kind of a different group that administers the contracts. The BARDA group in particular is ready to move very quickly once the RFP is enhanced so that we can get to a procurement contract. So we'll be able to do that somewhat quickly. Typically that process takes a couple of months, but perhaps we can shorten it based on the sort of precedents that are out there that are pretty straightforward.
spk11: Thank you. That's all for me.
spk05: Thank you. And next we have Somit Roy of Jones Research. Your line is open.
spk04: Hi. Thank you for taking the question, and congratulations on the very encouraging data. I wanted to check if these are confirmed responses, if we can call it this with the Reno AGG criteria, if that's the way it goes, and I was a little confused on the 22% response rate you were mentioning. How is that different from the overall 20% you were saying?
spk06: Let me take that last point, and then maybe Josh is probably a good opportunity to sort of peel the onion back on sort of the robustness of these analyses. The 22% I referred to, essentially we had 11% identified of the 50 in our prior presentations where we had a blend of this single reader. I think 30 of them were reviewed by a single blinded reader. The others were investigator assessments. And so we stood at essentially that 11 of 50 was where we were at prior to handing this over to the fresh readers. blinded independent central review. So that, and as I mentioned previously, from that analysis, I think net-net lost two of those and gained one as there were a few right around the 50% threshold. When you see the waterfall plot, I'll repeat it, you'll see some patients that were quite close again. So this notion that to be able to stand up to repeated repeated assessments and blinded reviews. And when you're going into a regulatory process, to know that, you know, that at least 20 percent threshold has stood up to repeated examinations is comforting. But maybe, Josh, describe a little bit more what's required in order to show a Raynaud HGG response. And one thing maybe you can elaborate on, too, is that you often see other companies report data in gliomas, and you see response rates that are higher, and you scratch your head a little bit, and typically those are not Raynaud HGG responses. So may I let Josh expand on that?
spk08: Yeah, thanks, Sumit. That's a great point that Mike just highlighted. So the Raynaud HDG criteria to qualify a response is among the most stringent of any response criteria. So just to directly answer your question, yes, there are confirmed responses and more, and I'll explain a little more about that. So the 20% response rate is all by integrated Raynaud HDG criteria. To qualify as one of those responders, you have to have a 50% regression on contrast-enhanced imaging confirmed on more than one MRI spaced at least one month, if not more, apart from each other. So they're certainly confirmed from an imaging and temporal perspective there. In addition to that, the tumor must not be worsening on other MRI sequences, namely T2 flare. In addition to those radiographic qualifications, there's clinical data as well. So you cannot have a decline in performance status measured by carnosophy or landscape performance status, and you cannot have an increase in corticosteroid use that can influence imaging artifacts as well. So if you think about it, it's really a very stringent criteria. It's not only confirmation that's required here on imaging, it's confirmation on multiple imaging sequences and a number of different clinical data points as well that go into that overall picture. And that stands in contrast to more typical criteria that you might see and that Mike alluded to there, like Reese's criteria you may be used to in other solid tumors.
spk04: Got it. And you expect this would be the criteria FDA suggested, or that's how you decided on the renal ADG?
spk03: That's correct. This is Alan. FDA specifically asked us to do Raynaud HGG. In addition, they want us to evaluate these tumors by Raynaud LGG. That wouldn't be the primary, but they want us to evaluate that. It's a little frustrating. We cannot share everything. We have to wait for the disclosure. But we will be also sharing the Raynaud LGG, which is the low-grade component which I can say is very consistent with what we're seeing with the RAO-HGG. So we're getting shrinkage not just in the high-grade component of the tumors but the low-grade component as well.
spk04: Got it. And one last question. Just a little surprise at the late time to first response, 8.3 months, I was looking at the prior 30 patients, the spider plot. I did not realize it. could be that late? Is it because the second group of 20 patients were any way different than the first 30 patients, or is it just how the data turned out?
spk06: I think that's pretty well. So there'll be sort of independent reads of all of those, so the individual curves may look a little different. But frankly, that phenomena was something that was observed in the prior published spider plots as I can't remember exactly what the onset was. It may have been a little bit less than eight months, but it wasn't too far off of that. Can I just add in contact?
spk03: I'm sorry. I just want to add in contact. It's not like the tumors weren't shrinking, weren't shrinking, and then finally shrunk. It's that they are gradually shrinking. So there are several points that they're going down. It took a while to get to that actual threshold of a 50% reduction. So does that make sense? they were having a progressive shrinkage, but it wasn't until eight months where they had the immediate announcement of a PR.
spk04: Thank you. Thank you again for taking the questions.
spk05: Thank you. And next we have David Nierengarten of WorkBush Securities. Your line is open.
spk09: Hey, thanks for taking my question. So you talked about this combined therapeutic benefit. Essentially, the tumors are shrinking for eight months, and then you have a median duration of response of 11 months. So we're correct in saying kind of the median duration of patient benefit is 19 months, or maybe if you could add any detail on that. kind of the median duration or time on therapy that the patient was having a benefit? And then have you discussed that kind of metric with the FDA and if that's part of the criteria for future approval here? Thanks.
spk06: Yeah, I think you characterized it accurately, that if you were to reflect on what's really the patient's experience and the patient benefit period where they've, you know, having on average or a median eight months of going home from their scans and finding that they were shrinking and then to the point of 50% and then another 11 months median where they stayed at least 50% or below the original size. So that is the experience. If you add those two together, it's where you quoted the 19. I referred to essentially a progression-free survival among responders, which is a similar number. The medians are calculated differently, so it ends up being about 18 months. But indeed, That was discussed with the FDA as a relevant measure, considering the late onset or the gradual onset is probably a better way to say it, of response. So that's part of what they would evaluate.
spk09: And if I recall, in some of the prior patient natural history, the diagnosis kind of a time to progression is more like 10 or 12 months, or maybe you could remind us what the typical time to progression might be in these patients.
spk06: Sure. I'll let Josh and Alan characterize that.
spk08: Yeah. Typical time to progression is usually from a median perspective on the first MRI. When you look at recurrent glioblastoma or other forms of diffuse midline glioma that have been Keep in mind, this is in the recurrent setting, different from some of maybe the numbers you might be thinking of in the frontline setting after diagnosis. So initiation from a therapy in the second line or later setting is typically around two months, in other words, on the first MRI. And if you look at the six-month landmark, that's typically less than 10% of patients that make it to six months without progression when you think about a typical experience in recurrent GDM or other forms of abuse.
spk06: It's another, I think, point to highlight is that the measures that were taken in order to assure that this response was sort of objectively assessed, and so these washout periods that Alan described, it's not is not the optimal way to treat these patients clearly. And so to allow months to pass after a potential progression to allow these other therapies to wash out, you'd much rather be treating either right on top of or on the heels of radiation treatment. And, of course, our future development will look at that. And so I think that's part of what you've got a 20% response rate in a challenging indication with really not the optimal treatment paradigm deployed. And I think all of those things considered, it sets the stage for options for patients that as you move that treatment earlier, even higher response rates.
spk10: Thanks.
spk05: Thank you. Can I get no further questions in the queue? I will now turn it back over to Mike Sherman for closing remarks.
spk06: I just want to thank everyone for your time this morning and look forward to updating you again following the snow conference. Thank you.
spk05: Everyone, this concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.
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