Q3 2021 Chimerix Inc Earnings Call

November 4, 2021

Today's conference is scheduled to begin shortly.

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Unknown Executive: Good morning, ladies and gentlemen, and welcome to the Chimerix 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 Chimerix. Please proceed.

Please continue Tucson, and thank you for your patience.

Michelle LaSpaluto: Thank you. Good morning, everyone, and welcome to the Chimerix 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 ONC 201 Recurrent H3-K27M 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 Andriole, Allen Melemed, our Chief Medical Officer, and Josh Allen, our Chief Technology Officer of Inifrado.

Okay.

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Good morning, ladies and gentlemen, and welcome to the <unk> third quarter 2021 earnings Conference call.

I would now like to introduce you to your host for today's call Michelle <unk>, Vice President of strategic planning and Investor Relations.

Please proceed.

Thank you.

Morning, everyone and welcome to the pioneer 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 topline results from the two well one recurring age three K 27, a M and glioma.

You can access those press releases and 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 Andriole, Alan now and that our Chief Medical Officer, and Josh Allen, Our Chief Technology Officer other nippert out.

Michelle LaSpaluto: 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 that could cause actual results to differ materially from those referred to in the forward-looking statement. 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.

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.

The 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 uncertainty at this time I would like to turn the call over to Mike Sherman.

Michael A. Sherman: Thanks, Michelle. And good morning, everyone. Thank you for joining us.

Thanks, Michelle and good morning, everyone and thank you for joining us.

Michael A. Sherman: We're happy to share with you today the positive top-line results from the Blinded Independent Central Review, or BICR, of ONC 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 worked with the FDA to define a cohort of patients that potentially could 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.

Happy to share with you today the positive topline results from the blinded independent Central review or be ICR of all 201 in the treatment of recurrent H three K 27 am mutant glioma. This is really just a preview of the analysis that will be presented in a couple of weeks at the society for.

For neuro oncology annual meeting in Boston.

Youll 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 to expanded access programs.

The criteria were designed with two objectives in mind first to define a homogeneous population of patients.

Michael A. Sherman: 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 ONC 201 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 REi For those accustomed to resisting response criteria, REiNO-HCG 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.

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 all two O. One 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 Reno H E. G. As it is commonly referred to for.

For those accustomed to resist response criteria Raynaud H E. G represents a higher bar requires a tumor reduction of at least 50% are in.

Asian to clearing non imaging hurdles, including stable or improving performance status.

And stable or declining use of steroids. So when you're subject. This analysis to a blinded independent Central review, you've 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 us.

Michael A. Sherman: As we've 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. Allen will expand a little bit more on the approach for this protocol in this fresh assessment, which is really meeting a regulatory standard.

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 ah 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 I'll expand a little bit more on.

The approach for this protocol on this on this this fresh assessment, which is really meeting a regulatory standard.

Michael A. Sherman: It may be worth noting that the response rate in the first 25 patients enrolled for this data set was 20%, and the second group of 25 also had a 20% response rate. While achieving any renal HEG 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.

It may be worth, noting that the response rate in the first 25 patients enrolled for this data set a record of 20% and the second group of twenty-five also had a 20% response rate.

While achieving any raynaud H D 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 and respond.

Michael A. Sherman: And among responders, the renal HEG hurdle of 50% reduction was achieved at a median 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 among 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 at just over 15 months.

To answer a one and among responders are the raynaud H C. G hurdle of 50% reduction was achieved at a median of eight three 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 have overrun.

18 months, which is probably a better perspective on durability given the gradual onset of initial response.

And by the way that's superior to the PFS among responders. We previously reported at just over 15 months.

Michael A. Sherman: There are several details we look forward to seeing presented at a plenary session during the upcoming SNO 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, but a few patients were indeed close. When you look at that disease control rate, roughly double the size of the response rate, will 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.

There are several details we look forward to seeing presented at a plenary session. During the upcoming Snow conference, which will build on this day that 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 will also report the other forms of clinical benefit, which as you might expect were largely concentrated in those patients who achieved a raynaud response or disease control. The presentation will also contain results of raynaud low grade glioma assessment.

Michael A. Sherman: The presentation will also contain results of renal low-grade glioma assessment, referred to as renal LGG, which are quite consistent with renal HEG, further confirming the robustness of these findings. The presentation will also include both PFS and OS analyses. Our 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.

<unk> two as rain O L. G G, which are quite consistent with raynaud hcg further confirming the robustness of these findings. The presentation will also include both PFS and OS analyses.

Our 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 and.

Michael A. Sherman: We don't see any of this as high risk, per se, but it is work that's necessary to advance to an NDA. 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.

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 N D as in some of those.

Our L. A are related to deficiencies in these areas and we intend not to.

Repeat those 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.

Michael A. Sherman: At this point, my apologies to Dr. Melemed 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 Allen.

At this point at my apologies to Doctor Melamed, as I've, probably already stolen the punch line of the data highlights, but I think he can provide some important context for these results. So let me turn it over to Alan.

Allen S. Melemed: Thanks Mike. It is indeed important to understand the patient population and the context for First, all of the patients were in their current..., which means that everyone's tumors had grown on one or more lines of therapy. All patients have received prior radiation therapy. In addition, the vast majority, almost 90% of patients, have also received temozolomide. Keep in mind that as HAK27 glioms are usually MGMT unmethylated, one would expect temozolomide to be less effective.

Thanks, Mike.

It is indeed, an important to understand this patient population and the context for this treatment.

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 <unk> therapy. In addition, the vast majority almost 90% of patients politics here. It seems all the mines keep in mind that as a tick hatred seven grams, I, usually and MGMT methylated, one would expect haynesville like disease.

Allen S. Melemed: The fact that so many patients have received, The 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 to one as a single agent and not an artifact of radiation or another therapy. The study recorded at least a 90-day wash-up period from prior radiation, 23 days for Temozolomide, 42 days for Antivirus, which most typically would be Avastin, and 28 days for other therapies.

Effective.

The fact that so many patients have received team has all the team is all of that speaks to the fact that more options are needed for these patients.

A second important point that Mike alluded to with the strict inclusion criteria agreed upon with FDA. This week.

To ensure that any responses seen recovery of the related onto one has a single agent and not an artifact of radiation therapy.

The study required at least a 90 day washout period from prior radiation 22 days. The team is all on line 42 days for antibodies, which most typically it would be about 28 days or other therapy.

Allen S. Melemed: An important predictor of response is typically the initiation of treatment early in the course. As you can imagine, these restrictions and delays may not be the optimal setting for this treatment. We want to predict and prove outcomes with early use of Model 201, which is where we intend to focus our future. These data are exciting, particularly in the light of a disease setting where you tend not to see random responses and options are limited.

And it's hard to predict responses are typically the initiation of treatment early in the course of disease.

And you can imagine these restrictions and delays may not be the optimal D. Setting for this treatment why do I predict improved outcomes with currently used to want to have one which is why we intend to focus our future development.

These data are exciting, particularly in the light of a disease setting we tend not to see rain in Wisconsin and options are limited.

Allen S. Melemed: This is when it was accident market research we performed during and prior to acquiring this pipeline of invocation, where key opinion leaders told us that a drug 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 of tumor response with the immediate onset of AIDS.

That one was accurate and market research can be performed during prior to acquiring the Franklin again, Brookstone, where key opinion leader call us that are drive growth, providing a 20% response rate Bahrain or hcg with at least six months durability would be clinically meaningful in this specific patient population.

In this cohort we're seeing durability of response.

It does not include the gradual onset the tumor response with immediate onset of eight months.

Allen S. Melemed: 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 by 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 OCT 201 by the vet.

Just to reiterate what Mike had said previously the response and response determination was determined by a blinded independent Central review.

We view it before with two independent meters with a third read it to adjudicate. This rigor is required for the purposes of regulatory filings.

Regarding safety the analysis with limited for this presentation, but you did note. There was one serious adverse event of pulmonary embolism, which is attributed as possibly related talk to are worn by the investigator.

Allen S. Melemed: Our safety team assesses SAE as unlikely related to AUG 201. Based on prior safety reviews, OCTU1 has been found generally well-tolerated during an extended period of administration. The most common reported adverse events were nausea, vomiting, fatigue, and decreased lymphocytes. 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 SNO conference on the 20th of this month.

Our safety team SAE as unlikely related at all to have one.

Based on prior safety reviews onshore, it's been generally well tolerated me standard period of administration.

The most commonly reported adverse events were nausea, vomiting, fatigue and decreased lymphocyte counts.

To collect NSS, the outgoing safety along with toric patients as part of a package and we will plan to discuss with FDA.

We look forward to the complete presentation of this data in a couple of weeks at the Snow conference on the 20th of this month.

Allen S. Melemed: The plenary session will also include additional supporting data, including evidence of disease control, clinical benefits, including changes like performance status, reduction in corticosteroids, renal LGD response, as well as progression-free survival and overall survival. These additional data and the context of the landscape of this disease round out the story of a drug that presents a potentially promising therapy for patients with Alzheimer's. The FDA has already granted all 21 FASTC designations for the treatment of adult recurrent H3K27 mutant high-grade glioma, rare pediatric disease designation for the treatment of H3K27 mutant glioma, and orphan drug designation for the treatment of glioblastoma and the treatment for malignant. With this overview and exciting clinical results, I'll now turn the call over to Mike Andriole for review of Mike?

Every festival also include additional supporting data.

Including evidence of disease control clinical benefit, including changes like performance data reduction and corticosteroids.

Allergy to response as well as progression free survival in all bus survival.

These additional data in context, the landscape of this disease Roundup story of a drug that presents a potentially promising therapy for patients with advanced disease.

The FDA has already granted off to one fast track designation for the treatment of adult recurrent HEK cause that wouldn't mutant high grade glioma rare pediatric disease designation for the treatment of H vacate with having getting clearer and orphan drug designation for the treatment of Glioblastoma and the treatment for malignant glioma, where these overview.

An exciting clinical yourself I'll now turn the call over to Mike Andriole for review of the financials Mike.

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 were adequately funded to achieve our upcoming milestones and we expect the possible addition of non dilutive funding from a potential BARDA 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 was 121.

Michael T. Andriole: Thanks, Allen, 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-dilutive 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.

Turning to our statement of operations the company reported a net loss of $18 $6 million or 21 per basic and diluted share for the third quarter of 2021, compared with a net loss of $11 4 million or <unk> 18 per basic and diluted share for the third quarter of 2020 revenues for the third quarter of 2021 were 0.1.

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 up to a one 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.

Michael A. Sherman: 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 $0.21 per basic and diluted share for the third quarter of 2021 compared with a net loss of $11.4 million, or $0.18 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.

In 2020.

In accordance with the terms of the merger agreement between primary Sandakan suits. The achievement of the 20% overall response rate for arc 201, BMT ICR will resort to result in a successful milestone payment of $20 million to the former <unk> shareholders to be paid prior to year end.

With that overview I'll now turn the call over to Mike for closing remarks.

Thanks, Mike Let me touch on our other programs before we open it up for Q&A, we're continuing our progress with our phase III clinical trial of D stat in newly diagnosed AML patients.

Enrollment of this study has proceeded more slowly than expected due to hospital staffing shortages, particularly nurses are 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 evaluable patients to take place in the second half of next year.

Michael A. Sherman: 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 R201 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.

With the approval this summer of Tim Baxter as a medical countermeasure for smallpox. We were pleased to see the F. D. A 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 <unk> with the existing approved countermeasure is an even more potent therapeutic ops.

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Of course, the support within the U S, particularly with 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 advance 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.

Michael A. Sherman: In accordance with the terms of the merger agreement between Chimerix and Octasidics, the achievement of the 20% overall response rate for ONC-201 via BICR will result in a success milestone payment of $20 million to the former Octasidics shareholders, to be paid prior to year-end. With that overview, I'll now turn the call over to Mike for closing remarks. Mike?

At the annual BARDA industry days event on Wednesday, BARDA spoke of the relationship with a chimeric and success of having a second anti viral 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.

An advisory committee on very old virus research, giving an update on tobacco.

Michael A. Sherman: 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. However, to date, enrollment in 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 evaluable patients to take place in the second half of next year.

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 reflects of late but when you personally witnessed 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.

Thank you Sir.

Ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key.

First question comes from Maury Raycroft of Jefferies. Your line is open.

Operator: 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.

Hi, good morning, Congrats on the update today and thanks for taking my questions.

Hey, Marty.

I am just started I'm wondering if you can talk more about the dataset and provide any specifics on weather.

Sponsors or deterioration from the prior dataset.

Well, yes. So you can yeah, you can imagine given that this is a sort of top line summary, and the.

We need to refrain from getting into the detail that would be presented at snow based on our agreements with them.

Operator: They also summarized the rationale for the potential combination of Tembexa with the existing approved countermeasure as an even more potent therapeutic option. Of course, 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 stockpiles. 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.

I will say that.

Just in terms of the assessments that have happened previously and where we sat.

At the 22% response rate is essentially where we were going into this fresh blinded assessment with a couple I guess there were a few patients that were still maturing one look like with with declining a tumor volume.

It had the potential to achieve that and I'm not sure the outcome of specific Ah patients with in that regard, but I do know that relative to the data analysis Billy.

Operator: At the annual BARDA Industry Days event on Wednesday, BARDA spoke of the relationship with Chimerix and the 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 believe we lost one I'm sorry, we lost two and gained one relative to the prior assessments of both the single reader Blind review and the.

And the the investigator assessments and what we had noted previously is there.

There were a couple that where we're quite close to this 50% threshold that we knew could be subject to to redefine says.

In fact, when we see that and you'll see this in the waterfall plot when it's 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 in the disease control rate or stable shrinking disease, it's worth noting that those patients in that that middle ground between zero and a 50% reduction several of those patients were extended.

Operator: 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 will now open the line for any questions.

Stable disease also had a company.

Forms of other clinical benefits. So you know those patients are benefiting they're going home from their scans, a with a with shrinking tumors.

And so it'll be important to obviously to see the context of all of those patients both those route to achieving responses and those with extended stable disease.

Operator: Thank you, sir. To ask a question, you will need to press Star 1 on your telephone. To withdraw your question, please press the pound key. Our first question comes from Maurice Raycroft of Jeffreys. Your line is open.

Got it okay. That's helpful.

When thinking about that.

Alex's answer you wanted a total dataset I guess, how does that impact.

Impact your view on expectations for the bar for success and for regulatory approval. If you could talk more about that.

Maurice Thomas Raycroft: Hi, good morning and congratulations on the update today and thanks for taking my question. Hey, Maurice. Hi. 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.

Yeah, and I'll, let I'll I'll make a brief comment and then let Alan chime in.

When asked that question previously we've always said look if if the response rate dipped down into the mid teens. You know obviously this becomes a more challenging that having been said drugs for indications of this nature have been approved with mid teens kind of response rates. So are hitting that threshold of 20 person.

Michael A. Sherman: Well, yeah, so you can, yeah, you can imagine, given that this is a sort of top-line summary and we need to refrain from getting into the details that will 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 at the 22 percent response rate, this is essentially where we were going into this fresh blinded assessment with a couple, I guess, or a few patients that were still maturing.

With this very robust sort of regulatory standard independent read is meaningful its meaningful for a couple of reasons. It was unprompted feedback from Kols as we entered.

We entered into this as we've done market research.

Suggest that 20% threshold was meaningful that Alan highlighted the six month durability, which will 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 where we're shrinking.

Michael A. Sherman: One looked like, with declining tumor volume, had the potential to achieve that. I'm not sure about the outcome of specific patients in that regard, but I do know that relative to that analysis, I believe we lost one, I'm sorry, 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 that there were a couple that were quite close to this 50% threshold that we knew could be subject to reading differences.

And I think the other important acknowledgment as the lower end of the 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 pay late too.

I've, probably said more than I planned to Alan but I don't know if you have anything Alan or Josh to add to that.

Yeah. The only thing I'll add is I do think it's really important to look at the context.

Whats available and it's really not a lot of available therapies in Italy.

Michael A. Sherman: 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 are just below it that would be included in the disease control 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 who were extended stable disease also had accompanying forms of other clinical benefits.

<unk> therapy is a lateral they really don't have a lot of responses.

That is.

Something that Microsoft is already acknowledged that palliations isn't appropriate standard so.

When you look at the whole package you need to have responses that are durable with the states get back because that it's safe for patients and I think this is a promising.

Package.

Yeah. The only thing I'll add is the points that Mike and Alan both hit there where part of our conversations with FDA. Just a reminder, that the sample size 50.

Was proposed to the FDA in our discussions based on the expectation of continued observation of a 20% response rate, which as Mike pointed to provide you with a lower bound of 95% confidence interval.

Michael A. Sherman: 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.

10% and in the context of that tallied up available therapy, the FDA acknowledged and Alan just reminded you of.

Michael A. Sherman: Got it. Okay, that's helpful. And when thinking about the new analysis on 201 in 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 about that?

All women part of the plan the spirit. The state was very much in line with our expectations that went into the selection of the sample size with her regulatory conversations.

Got it that's all helpful perspective, and congrats again and I'll hop back in the queue.

Thank you.

Michael A. Sherman: Yeah, and I'll make a brief comment and then let Allen chime in. You know, when we were asked that question previously, we've always said, look, if the response rate dips down into the mid-teens, you know, obviously, this becomes more challenging. That having been said, drugs for indications of this nature have been approved with a mid-teens kind of response rate. So hitting that threshold of 20% with this very robust sort of regulatory standard, independent reading is meaningful. It's meaningful for a couple reasons.

And next we have Joe.

Of Cowen and company your line is open.

Hey, there good morning, Congrats and thank you for taking our question maybe.

Maybe just the first one now that this dataset is all set can you kind of outlined the cadence of interactions with the FDA.

That you expect likely probably I guess over the next few quarters here and then second just on the S. H E. 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 or reason why you don't agree with your assessment of the physician thinks.

You Wanna, Alan maybe does that reverse order do you want to address that.

Take that yeah. So.

Allen S. Melemed: It was unprompted feedback from KOLs as we entered into this, as we've done market research, suggested that the 20% threshold was meaningful. Allen highlighted the six-month durability, which will 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%.

He was.

And potentially related by the investigator and.

This was initially.

Evaluated by Alka students as a likely unrelated we did a re evaluation prior to the press release and we completely agree that this is unlikely and related patient at multiple comorbidities, including obesity and other health areas that made this event likely unrelated to compound patient outflow with Haywood.

It continues a 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 October.

Allen S. Melemed: 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 the current standard of care is palliative. I probably said more than I planned to, Allen, but I don't know if you have anything, Allen or Josh, to add to that.

October one.

Now I'll come back to be a question of the F D. A.

Joshua E. Allen: The only thing I'll add is that I do think it's really important to look at the context of what's available. There aren't really a lot of available treatments, and the treatments 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 a safety package that is safe for patients, and I think this has a promising package.

Maurice Thomas Raycroft: Yeah, the only thing I'll add is that the points that Mike and Allen 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, as Mike pointed out, provides you with a lower bound 95% confidence interval of 10%. And in the context of that palliative available therapy that FDA acknowledged and Allen just reminded you of, all went into part of the plan. So this is very, this data is very much in line with our expectations that went into the selection of the sample size with our regulatory plan.

Hopefully that helps yep.

Yep that is perfect. Thank you very much.

Thank you.

And you have Noreen Korea.

Of Maxim group.

Your line is open.

Hi, good morning, I and congrats on the data. So I guess just starting now first with onto one you know you've mentioned the natural history data do you have a sense of when you have when you have some interim data on that and and you'd be it'll be available this year with the public.

Yeah, I've I've had questions about the others or maybe a perception that the natural history date. It takes years to accumulate and that's in in in those cases, just just not the case, we've we've got a a protocol underway and and engage together that data will gather really too so.

Operator: Got it. That's all a hopeful perspective, and congrats again, and I'll hop back in.

Joseph John: And next, we have Joseph Stone of Cohen and Company, your line.

Joseph John: Hi there. Good morning.

Joseph John: Congratulations, and thank you for taking our questions, or 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 to get over 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 a reason why you don't agree with the assessment of the physician? Thanks. Would you like, Allen, maybe to do that in reverse order, or do you want to address the SAE a little bit more? Yeah, I can take that.

Let's of of data those that are a line exactly with this 50 patient protocol, where we would expect to be able to confirm kind of zero are 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 may maybe didn't meet those criteria for for one reason or another just abroad more broadly inform the the drivers of of of survival are responsive and that patient group even outside of our that core core set when I made the comment around the b.

Allen S. Melemed: Yeah, so this SAE was deemed potentially related by the investigator, and this was initially evaluated by Oncosteutics as likely unrelated. We did a reevaluation prior to the press release, and we completely agree that this is unlikely to be related. The patient had multiple comorbidities, including obesity and other health problems, that made this event likely unrelated to the compound. The patient also was able to continue the therapy afterwards, again, making it unlikely that it was related. So there are a lot of factors here that our assessment was unlikely related to compound 2.

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 the first interim assessments of those analyses.

And like I had one minor auditions I think no. One believes that are very simple at dusk population.

In general have a lotta responders, while we needed to show is that the specific mutation doesn't have any differences in the mutation is relatively new and identified so that is what we have to show I think when you look at recurrent if you're feeling going almost a typical out a lotta responders.

Well, we need to show it with the specific mutation.

[laughter] that's helpful. Thank you Allen.

Michael A. Sherman: I'll come back to the question of the FDA dialogue. We have 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 SNO 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.

And then with regard to the ensemble one city. Obviously this is their registration cohort at 50 patients Uhm with regards to the remaining patients that are in any other studies that.

As well as the expanded program when might you share data from from the other patients and just curious.

Yeah, that's gonna be take the first though I think one of the one of the important and what reason we did the analysis now and if Mike had mentioned, we had a very mature dataset with with long file I'll take over a year and a half 15 months.

Michael A. Sherman: 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 should be executed, so including, you know, 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 helped. Yep, that is perfect. Thank you very much.

When you have a duration median duration of response time to respond to eight months you need to have a very mature dataset to show that you have what the response rate is as long as the durability. So that is where the cut quite wise and why are we use this or that we're continuing to evaluate these patients, but I think our primary luck would be this.

And in order to discuss with regulators.

Okay, Great and just one more from me I think I sort of missed it uhm Mister <unk> with regard to to next 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.

You have any <unk> color on that.

Operator: And we have Naureen Quibria of Maxim's Group. Your line is open.

Well, we know the contracts group was it was the sort of.

Naureen Quibria: 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 when you'll have some interim data on that, and when it would be available this year?

Having who was challenge to kind of keep pace. During the course of of the summer and then sort of that was really what would have driven the the delay in the first place and and really that has.

No other drivers the that I'm aware of I can I can confirm as well that uhm.

The.

Potential hurdles related to budget negotiations or or or congressional debates around funding really don't have anything to do with this it's it's really just the logistical step that they need to to get through they've continually assured us of that.

Michael A. Sherman: 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.

Michael A. Sherman: We've got a protocol underway and engaged to gather that data. We'll gather really two sets of data, those that are aligned exactly with this 50 patient protocol, where we would expect to be able to confirm a kind of zero or extremely low response rate and rare other forms of clinical benefit. And then we'll have a broader data set that 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.

And and so you know it the best we can do and and and and stand ready to respond to that R. P. We know that they're also barta is in a position is actually kind of a different group that administers the contracts the barta group.

In particular is is ready to move very quickly once the RFP.

And he has so that we can get to a procurement contract. So what we'll be able to do that so much. So quickly typically that process takes a couple of months, but perhaps we can we can shorten it based on the sort of precedence that are out there that are pretty straightforward.

And thank you that's all for me.

Thank you.

Michael A. Sherman: 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. Mike, can I add one minor addition? I think no one believes that this population, in general, has a lot of responders. What we need to show is that this specific mutation doesn't have any different effects. The mutation is relatively new and identified, so that is what we have to show. I think when you look at recurrent diffuse melancholyomas, there are typically a lot of responders, but we need to show it with this specific.

And next we have so much <unk> of Jones research your line is open.

Hi, Thank you for taking my question and congratulations on the very encouraging data [noise].

Do you wanted to check if these are confirm response, if we can call. It this [noise] with the Rainbow E. G. G criteria. If that's the way it goes and was a little confused on the 22 persons response with you were mentioning how.

How was the different from the overall 20 per cent you were saying.

Let me let me take that last point and then then maybe Josh is probably a good opportunity to.

Sort of Peel the onion back on on so the robustness of these analyses the the 22 per cent I referred to essentially we had 11 identified of the 50 in our in our in our prior presentation, where we had a blend of the single reader and a third.

Any of them were were reviewed by a single blinded reader the others were investigator assessments and so we stood at essentially that 11 O 50 was where we were at prior to handing this over to the the the fresh blinded independent Central review, so that and then as I mentioned previously.

Allen S. Melemed: That's helpful. Thank you, Allen and Mike. And then with regard to the ONTOL-1 study, obviously, you know, this is the registration cohort of 50 patients. With regard 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.

From that analysis I think net net lost two of those and gained one is there 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 this notion that to to be able to stand up too.

Repeated [laughter] repeated assessments in and and blinded reviews, and when you're going into a regulatory process to know that that you know that that at least 20% threshold has stood up to repeated examinations is is comforting uhm, but maybe josh describe a little bit more what's required.

In order to to show a arena O H G. G response, and and one thing and maybe you can elaborate on two is that you often see other companies report data in Gliomas.

Allen S. Melemed: So that is where the cut point was, and why we use this for that. We are continuing to evaluate these patients, but I think our primary look would be this in order to discuss what we are doing.

And you see response rates that are higher and you scratch your head a little bit and and typically those are not rain O H G. G responses somebody I'll, let Alan a car or Josh expand on that.

Naureen Quibria: Great. And just one more from me.

Naureen Quibria: I think I sort of missed it. This is with regard to Convexa. And I was just curious about new BARDA contracts. So are you aware of any sort of delays across the board happening with new contracts? Do you have any sort of color on that?

Yeah. Thanks, Thanks, and that that's that's a great point that Mike just highlighted so the Reno H D. G criteria to qualify a response is is among the most stringent any response criteria. So just to directly answer your question, yes, they're confirmed responses and more and I'll I'll explain a little more about that so all the 20th <unk>.

Michael A. Sherman: Well, we know the contracts group was, um, was, uh, a challenge 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.

<unk> response rate is all by integrated Rainbow H D T 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 more at least one month, if not more apart from each other so there's certainly confirm from an imaging.

Michael A. Sherman: I can confirm as well that the 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 we do the best we can and stand ready to respond to that RFP. We know that BARTA is in a different group that administers the contracts. The BARTA 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.

Get into four O perspective, there in addition to that the tumor must not be worsening on other MRI sequences, namely, namely T to flare. In addition to those radio graphic qualifications, there's clinical data as well. So you you cannot have a decline in performance status measured by Karnofsky.

Lansky 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 it's it's really a very stringent criteria. It's not only a confirmation that's required here on imaging of the confirmation on multiple imaging sequences and a number of gifts.

Clinical data points as well to go into that overall picture and that that stands in contrast, more typical criteria that you might be in that Mike alluded to there like recessed criteria you can be used to and other solid tumors.

Naureen Quibria: Thank you. That's all for me.

Operator: And next we have Soumit Roy of Jones Research. Your line is open. 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 that with the Reno ATG criteria, if that's the way it goes. And I was a little confused about the 22% response rate you were mentioning. How is that different from the overall 20% you were saying?

Got it and that's you expect this would be great to have D. As suggested or that's how you decided on the radio E. G G.

[laughter].

That's correct.

This is Alan F T. A specifically asked us to do radio H T. J. In addition, they want it.

To evaluate these two words Irene O L. O G. G that would've gave the primary but will they wanted to live with that it's a little frustrated we cannot share everything we have to wait for more the disclosure smell, but we will be also sharing the arena allergy, which is the low grade components, which I can say is very consistent.

What we're seeing with the extra G. So we're getting that shrink it's not just in the high grade component of the terrorists looked at low grade components.

Soumit Roy: 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 prior to handing this over to the fresh blinded independent central review. And as I mentioned previously, from that analysis, I think NetNet lost two of those and gained one, as there were a few right around the 50% threshold.

As well.

And one last question just Linda surprised I'd be late time to first response eight three months I was looking at the prior coty patient despite applauded.

Looks did not I did not realize it could be that late is it because the second group of 20 patients [noise] <unk> any way different than the first 30 patient or is just how the data turned out.

And I think that's pretty well, so there'll be sort of independent reads of all of those so the the curve individual cursed may look a little different but but frankly that that phenomenon was something that was observed in in in the in the you know the prior published Spider plot says I can't remember exactly.

The onset was it may have been a little bit less than eight months, but it wasn't too far off of that what can always.

<unk> I'm, sorry, but I just want to go ahead and contact it's it's not like the tumors orange drinking more shrinking and then finally shrunk cause that they are gradually shrinking. So it is there are several appointment they're going down it took a while to get to that actual threshold 50 per cent reduction.

Michael A. Sherman: When you see the waterfall plot, I'll repeat it, you'll see some patients that were quite close again. So this notion that it should 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% 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 Rehno HCG response.

Does that make so it they were they were having a progressive shrinkage, but it wasn't until eight months, whereas I had the media announcements of.

P R.

Thank you. Thank you again for taking my questions.

Thank you.

And next we have David <unk>.

Bush Securities Your line is open.

Hi, Thanks for taking my question.

Michael A. Sherman: And one thing maybe you can elaborate on too is that you often see other companies reporting data on gliomas, and you see response rates that are higher, and you scratch your head a little bit. And typically, those are not Rehno HCG responses. So may I let Josh expand on that? Yeah, thanks. Thanks, Sumit.

Yeah, you you talked about this combined therapeutic benefit are essentially you know the tumors are shrinking for eight months and then.

And then you have a median duration of response of 11 months O or correct in saying the kind of the median duration of patient benefit of 19 months or you know if maybe if you could add any detail on kind of a median duration of or time on therapy that the patient was <unk> yeah.

Joshua E. Allen: That's a great point that Mike just highlighted. So the Rehno 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.

Having a benefit and then have you discussed you know that kind of metric with the F. D. A and that's you know if if that's part of.

And part of the criteria for a future approval here. Thanks.

Joshua E. Allen: So 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 Carnot or Lansky 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 RISA's criteria you may be used to in other cells.

Yeah, I think you characterize it accurately that if you were to reflect on what's the the really the patient's experience in patient benefit period, where they've you know having an average or median eight months of going home from their scans and finding that they were shrinking and then.

And to the point of 50 per cent and then another 11 months, a medium where they they stayed up at least 50 per cent or or below the original size. So that is the experience of you add those two together is where you you quoted the 19 I I referred to a.

A progression free survival, among responders, which is a similar number it it'd be the mediums are are calculated differently. So it ended up being about 18 months, but indeed.

That that was discussed with the F D. A as a as a relevant measure considering the the the late onset or the gradual onset is probably a better way to say it.

Allen S. Melemed: Got it. And that's, and you expect this would be the criteria FDA suggested or that's how you decided on the Reno 8 GG? That's correct. This is Allen.

So that's part of what they would would would evaluate.

And if I recall and and some of the prior patient natural history that.

Allen S. Melemed: FDA specifically asked us to do Rehno-HGG. In addition, they wanted us to evaluate these tumors by Rehno-LGG. That wouldn't have been in the primary, but they wanted to evaluate that. It's a little frustrating. We cannot share everything.

The.

Kind of hurt time to progression is more like 10, or 12 months or maybe you can remind us what the typical time to progression might be in these patients.

Sure well, let's Joshua Allen characterize that.

Yeah typical time to progression is usually from a medium perspective on on the first MRI would you look at recurrent glioblastoma or other forms of diffuse midline glee almost that have been studied keep in mind. This isn't the recurrent setting different and some of maybe the numbers you might be thinking of at the frontline setting after diagnosis so initiation from Ah.

Allen S. Melemed: We have to wait for the disclosures, but we will also be sharing the Rehno-LGG, which is the low-grade component, which I can say is very consistent with what we're seeing with the Rehno. So we're getting shrinkage, not just in the high-grade component of the tumors but the low-grade component as well. And one last question, I'm just a little surprised at the late time to first response, 8.3 months. I was looking at the prior 30 patients.

A therapy and the and the second line or later settings typically around two months and in other words on the first MRI.

And if you look out in the sixth minute Mark landmark that that's typically less than 10% of patients that make it six months without progression. When you think about a typical experience with.

Soumit Roy: Is there any way different than the first 30 patients, or is it just how the data turned out?

<unk> G B M or other forms excuse me.

It's another I think point to to highlight is the the the measures that were taken in order to assure that this response was sort of objectively assessed and so these washout periods that that Alan describe this is not.

Michael A. Sherman: I think that's going 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 phenomenon was something that was observed in the prior published spider plots. I can't remember exactly when the onset was. It may have been a little bit less than eight months, but it wasn't too far off of that. I just want to add in context; it's not like the two...

It.

Is not the optimal way to to treat these patients for that clearly and then so to allow uhm months to pass after a potential progression, though all these other therapies to wash out you you'd much rather be treating either right on top of her on the heels of of radiation treatment and and of course R. R. A.

Michael A. Sherman: Eddington. I just want to add in context, it's not like the tumors weren't shrinking, they weren't shrinking, and then they finally shrunk. It's just that they are gradually shrinking. So there are several points that they're going down. It took a while to get to the actual threshold of a 50% reduction, so they were having a progressive shrinkage, but it wasn't until eight months that they had the media announcement of a PR.

Future development will look at that and so I think that's part of what you've got a 20% response rate in a in a challenging indication was really not the optimal treatment paradigm deployed and and I think all of those things considered it sets the stage for a what sort of.

Options for patients that as you move that treatment earlier, even even higher response rates.

Operator: Thank you. Thank you again for taking the question. Thank you. And next, we have David Nierengarten of Whitbush Securities. Your line is open.

Thanks.

Thank you.

<unk> no <unk> the questions in the queue I will now turn it back over to my chairman for closing remarks.

David Nierengarten: Thanks for taking my question. So, you know, you talked about this combined therapeutic benefit. Essentially, you know, the tumors are shrinking for eight months, and then

I just want to thank everyone for your time this morning, and look forward to updating you again following the snow conference. Thank you.

Did you want this concludes today's conference call. Thank you all for participating you may now disconnect and have a pleasant day.

David Nierengarten: And then you have a median duration of response of 11 months. So we're correct in saying the kind of median duration of patient benefit is 19 months, or maybe if you could add any detail on the kind of median duration or time on therapy during which the patient was having a benefit.

[noise] [music].

Yeah.

[noise] [music].

Michael A. Sherman: having a benefit. And then, have you discussed that kind of, um, metric with the FDA, and, as you know, if that's part of,

Michael A. Sherman: Part of the criteria for future approval here. Thanks.

Michael A. Sherman: Yeah, I think you characterized it accurately, that if you were to reflect on what's really the patient's experience and patient benefit period, where they've, you know, had 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, a median, where they stayed at least 50% or below the original size. So that is the experience of you add those two together, is where you quoted the 19, I referred to an, essentially, a progression tree survival among responders, which is a similar number, but the medians are calculated differently.

Michael A. Sherman: 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, which is probably a better way to say it, of response. So that's part of what they would, would evaluate.

David Nierengarten: And if I recall, in some of the prior patient's natural history.

Joshua E. Allen: The kind of time to progression is more like, you know, 10 or 12 months, or maybe you could remind us what the typical time to progression might be in these patients. Sure, I'll let Josh and Allen characterize that.

Joshua E. Allen: 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 studied. Keep in mind, this is in the recurrent setting, different from some of the numbers you might be thinking of in the frontline setting after diagnosis. So, initiation of therapy in the second line or later setting is typically around two months, in other words, on the first MRI.

[music].

Michael A. Sherman: 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 the typical experience with current GBM or other forms. It's another point to highlight the measures that were taken in order to assure that this response was sort of objectively assessed. And so these washout periods that Allen described are not the optimal way to treat these patients clearly.

Michael A. Sherman: 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 why 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.

Operator: Thank you. There are no further questions in the queue. I will now turn it back over to Mike Sherman for closing remarks. I just want to thank everyone.

Michael A. Sherman: I just want to thank everyone for your time this morning and look forward to updating you again following the Snow Conference. Thank you.

Operator: Everyone, this concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day. ["The Merry-Go-Round Broke Down"]

Unknown Executive: © BF-WATCH TV 2021 ,. .. .. .. .. .. .. .. .. .. .. .. .. ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? [inaudible] ?? ?? ?? ?? ?? ?? ?? Thanks for watching!

Michael A. Sherman: Thanks, Michelle. And good morning, everyone.

Michael A. Sherman: 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 ONC 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 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.

[music].

Michael A. Sherman: Allen will expand a little bit more on the approach with this protocol for 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 was 20%, and the second group of 25 also had a 20% response rate. While achieving any renal HCG 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.

Michael A. Sherman: And among responders, the renal HCG hurdle of 50% was achieved at a median 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 among 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 at just over 15 months.

Michael A. Sherman: There are several details we look forward to seeing presented at a plenary session during the upcoming SNO 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, will 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.

Good morning, ladies and gentlemen, and welcome to the time, Eric third quarter 2021 earnings Conference call.

Now I'd like to introduce you to your host for today's call Michelle <unk>, Vice President of strategic planning and Investor Relations. Please proceed.

Thank you good morning, everyone and welcome to the pioneer third quarter 2021 financial and operating results Conference call. This morning, we issued our third quarter financial results press release, and then separately reporting positive top line results.

On the Oct you all one retirement age three K 27, and the Oklahoma you can access those press releases and 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 Andriole, Alan Melamed, our Chief Medical Officer, and Josh Allen.

Our Chief Technology Officer, other nippert out.

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 uncertainty at this time I would like to turn the call over to Mike Sherman.

Thanks, Michelle and good morning, everyone and thank you for joining us.

We're happy to share with you today the positive topline results from the blinded independent Central review or be ICR, a vault to all one in the treatment of recurrent H three K 27, now 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 to expanded access programs there.

The criteria were designed with two objectives in mind in the first two.

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 all two O. One single agent treatment alone.

Allen S. Melemed: Thanks Mike, it is indeed important to understand the patient population and the context. First, all of the patients were in the current study, which means that everyone's tumors had grown on one or more lines of therapy. All patients had received prior radiation therapy.

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 Reno H C. G. As it is commonly referred to for.

Allen S. Melemed: In addition, the vast majority, almost 90% of patients, also receive temozolomide. Keep in mind that as HAK27 glioms are usually HMGMT-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.

But those are accustomed to resist response criteria raynaud H C. G represents a higher bar requires a tumor reduction of at least 50% are in addition to clearing non imaging hurdles, including stable or improving performance status and stable or declining use of <unk>.

Alright, so when you're subjective analysis to a blinded independent Central review, if you're faced with a laundry list of reasons, a response might not be confirmed.

Allen S. Melemed: This was to ensure that any responses seen were truly related to one as a single agent and not an artifact of radiation or another therapy. The study recorded at least a 90-day wash-up period from prior radiation. 23 days for Temozolomide, 42 days for Antivirus, which most typically would be Avastin, and 28 days for other therapies.

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 ah patients maturing.

Allen S. Melemed: An important predictor of response is typically the initiation of treatment early in the course, and you can imagine these restrictions and delays may not be the optimal setting for this treatment. However, when I predict improved outcomes with early use of MOUNT 201, which is where we intend to focus our future. These data are exciting, particularly in the light of a disease setting where you tend not to see random responses and options are limited.

The approach for this protocol on this on this this fresh assessment, which was really meeting our regulatory standard.

It may be worth, noting that the response rate in the first 25 patients enrolled for this dataset are recorded 20% and the second group of 25 also had a 20% response rate.

Allen S. Melemed: This excitement was accurate and markedly recent to be performed during and prior to acquiring this pipeline of inventory, where key opinion leaders told us that a drug providing a 20% response rate by rate of HCG 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 of tumor response with the immediate onset of AIDS.

While achieving any raynaud H D response in this population of patients is not expected. We know the durability of responses also on quarters and these data are certainly compelling from a durability standpoint responses emerge gradually as tumors tend to shrink over a period of a month in response.

18 months, which is probably a better perspective on durability given the gradual onset of initial response.

And by the way that's superior to the PFS among responders. We previously reported at just over 15 months.

Allen S. Melemed: Based on prior safety reviews, Oncologen has been found generally well-tolerated during an extended period of administration. The most common reported adverse events were nausea, vomiting, fatigue, and decreased mental psychiatric. We'll continue to collect and assess the ongoing safety of over 200 patients as part of the 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 SNO conference on the 20th of this month.

Indeed, close when you look at that disease control rate.

If we double the size of of the response rate.

We will 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 raynaud low grade glioma assessment referred to as rain O L. G G, which are quite conservative.

Michael T. Andriole: The plenary session will also include additional supporting data, including evidence of disease control, clinical benefits, including changes like performance status, reduction in corticosteroids, renal LGG response, as well as progression-free survival and overall survival. These additional data and the context of the landscape of this disease round out the story of a drug that presents a potentially promising therapy for patients with Alzheimer's. The FDA has already grabbed it off to one fast-track designation for the treatment of adult recurrent HZK27 mutant high-grade glioma, rare pediatric disease designation for the treatment of HZK27 mutant glioma, and orphan drug designation for the treatment of glioblastoma and the treatment for malignant. With this overview and exciting clinical results, I'll now turn the call over to Mike Andriole for Mike?

Distant with Raynaud hcg further confirming the robustness of these findings are the presentation will also include both PFS and OS analyses.

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 N D as in some of those.

Or else are related to deficiencies in these areas and we intend not to Ah Ah Ah repeat.

Repeat those 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 in time, I apologize the Doctor Melamed as I've, probably already stolen the punch line of the data highlights, but I think he can provide some important context for these results. So let me turn it over to Alan.

Michael T. Andriole: Thanks Allen, 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-dilutive funding from a potential barter procurement contract will further strengthen our balance sheet. Let's say we continue to be judicious with capital allocation across the portfolio.

Thanks, Mike It is indeed, an important to understand this patient population and the context for this treatment.

First all of the patients who are in their current setting which means that everyone's tumors had grown on one or more lines of therapy received.

All patients had received prior <unk> therapy. In addition, the vast majority almost 90% of patients polishing season. It seems all the mines keep in mind that as a tick hatred seven grams, I, usually H and M. D N T and methylated one would expect him as I don't like to be less effective.

How many patients have received team is all came as all of that speaks to the fact that more options are needed for these patients.

A second important point that Mike alluded to with the strict inclusion criteria agreed upon with FDA.

Michael T. Andriole: 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 in 2020.

This was to ensure that any responses seen recovery of the related at all to one has a single agent and not an artifact of radiation therapy.

Any required at least a 90 day washout period from prior radiation 23 days. The team is all on line 42 days for antibody, which most typically would be avastin and 28 days or other therapy.

An important predictor of responses are typically the initiation of treatment early in the course of disease.

And you can imagine these restrictions and delays may not be the optimal disease setting for this treatment.

Predict improved outcomes. That's currently used to want to have one which is why are we intend to focus our future development.

These data are exciting, particularly in the light of a disease setting we tend not to see random responses and options are limited.

This is back when it was accident market research we performed during prior to acquiring the pipeline again zones, where key opinion leaders Paula that had dragged with providing a 20% response rates, Iran or hcg with at least six months durability would be clinically meaningful in this specific patient population in.

Michael T. Andriole: 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 R2-R1 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 this cohort, we're seeing durability of response and double them, but does not include the gradual answer to Tim response, but the immediate 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 with the board with two independent readers with a third read it to adjudicate. This rigor is required for the purposes of regulatory filings.

Regarding safety the analysis with limited for this presentation.

No. There was one serious adverse event of pulmonary embolism, which is attributed as possibly related to log to one by the investigator.

Our safety team effect.

E as unlikely related they ought to have one.

Basically prior safety reviews onto one it's been generally well tolerated me standard period of administration, most commonly reported adverse events were nausea, vomiting, fatigue and decreased lymphocyte counts.

Continuing to collect NSS, the outgoing safety well over 200 patients as part of a package and we will plan to discuss with FDA, but look forward to the complete presentation of this data in a couple of weeks at the snow carpet on the 20th of this month.

Michael T. Andriole: In accordance with the terms of the merger agreement between Chimerix and Octasidics, the achievement of a 20% overall response rate for OCT 201 via BICR will result in a success milestone payment of $20 million to the former Octasidics shareholders to be paid prior to year-end. With that overview, I'll now turn the call over to Mike for closing remarks.

Every festival also include additional supporting data.

Including evidence of disease control clinical benefit, including changes like performance data reduction and corticosteroid reign.

Reno allergy to response as well as progression free survival and overall survival.

These additional data in context the landscape for this disease found out story of a drug that presents a potentially promising therapy for patients with advanced disease.

Michael A. Sherman: Thanks, Mike. Let me touch on our other programs before we open it up for Q&A. We're continuing progress with our phase three clinical trial of D-STAT in newly diagnosed AML patients. However, to date, enrollment in 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.

He has already granted off to one fast track designation for the treatment of adult recurrent HEK cause having mutant how grateful that all of them rare pediatric disease designation for the treatment of H vacate with having getting clearer and orphan drug designation for the treatment of Glioblastoma and the treatment for malignant glioma.

These overview and exciting clinical yourself.

I'll turn the call over to Mike Andriole for review of the financials Mike.

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 were adequately funded to achieve our upcoming milestones and we expect a possible additional non dilutive funding from a potential BARDA procurement contract will further strengthen our balance sheet.

Michael A. Sherman: We expect to complete enrollment of the first 80 valuable 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.

Third 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 2021.

As compared to $1 $6 million for the same period of 2020.

Michael A. Sherman: They also summarized the rationale for the potential combination of Tembexa with the existing approved countermeasure as an even more potent therapeutic option. Of course, 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 stockpiles. 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.

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 up to a one to the pipeline.

General and administrative expenses increased to $49 million from 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 Chimeric Sandbox Citrix.

Another 20% overall response rates were off 201, BMT ICR will resort to result in a successful milestone payment of $20 million to the former <unk> shareholders to be paid prior to Europe.

That overview I'll now turn the call over to Mike for closing remarks.

Yeah.

Thanks, Mike Let me touch on our other programs before we open it up for Q&A, we're continuing our 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.

Michael A. Sherman: At the annual BARDA Industry Days event on Wednesday, BARDA spoke of the relationship with Chimerix and the 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.

Nurses are related to COVID-19 for.

With the approval this summer of 10 Bucks a as a medical countermeasure for smallpox. We were pleased to see the F. D. A 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.

Michael A. Sherman: I know companies make this comment somewhat reflexively, but when you personally witness the sacrifices that 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.

Groups are 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 Tim back so with the existing approved countermeasure is an even more potent therapeutic.

Option of course.

The support within the U S, particularly with BARDA has always been high but publications like this may be helpful. As we reach out to other geographies for potential stockpiling.

Stand ready to respond quickly to the expected RFP.

At the annual BARDA industry days event on Wednesday, BARDA spoke of the relationship with Chi Merricks 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.

Michael A. Sherman: Well, yeah, so you can, yeah, you can imagine, given that this is a sort of top-line summary, and we need to refrain from getting into the detail that'd 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.

Advisory Committee on very old virus research, giving an update on Tim back so.

But when you personally witnessed the sacrifices, particularly the hospital staffs have made during the pandemic you can't help but be humbled by their energy and support.

Michael A. Sherman: One looked like, with declining tumor volume, had the potential to achieve that. I'm not sure about the outcome of specific patients in that regard, but I do know that, relative to that analysis, I believe we lost one, I'm sorry, we lost two and gained one relative to the prior assessments of both the single reader blinded review and the investigator assessments. And what we had noted previously is that there were a couple that were quite close to this 50% threshold that we knew could be subject to reading differences.

With that operator, we'll now open the line for any questions.

Thank you Sir.

To ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key.

First question comes from Maury Raycroft of Jefferies. Your line is open.

Hi, good morning, Congrats on the update today and thanks for taking my questions.

Hey, Marty.

I am just started I'm wondering if you can talk more about the dataset and provide any specifics on whether there were new responses or deterioration from the prior dataset.

Well, yeah. So you can yeah, you can imagine.

Michael A. Sherman: In fact, when we see the, 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 are just below it that would be included in the disease control 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 who were extended stable disease also had accompanying forms of other clinical benefits.

Jen given that this is a sort of top line summary, and Oh, we need to refrain from getting into the detail that would be presented at snow based on our agreements with them.

I will say that just in terms of the assessments that have happened previously and where are we.

That at the 22% response rate is essentially where we were going into this fresh blinded assessment with a couple I guess there were a few patients that were still maturing one look like with with declining a tumor volume of had the potential to achieve that.

And I'm not sure the outcome of specific Ah patients with in that regard, but I do know that relative to the data analysis.

Michael A. Sherman: Got it. Okay, that's helpful. And when thinking about the new analysis on one of 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 about that?

Believe we lost one I'm sorry, we lost two and gained one relative to the prior assessments of both the single reader Blind review and the and the the investigator assessments and what we had noted previously is there.

There were a couple that where we're quite close to the 50% threshold that we knew could be subject to to redefine says.

Michael A. Sherman: Yeah, and I'll make a brief comment and then let Allen chime in. You know, when we were asked that question previously, we've always said, look, if the response rate dips down into the mid-teens, you know, obviously, this becomes more challenging. That having been said, drugs for indications of this nature have been approved with mid-teens kinds of response rates. So hitting that threshold of 20% with this very robust sort of regulatory standard, independent reading is meaningful. It's meaningful for a couple reasons.

In fact, when we see that and you'll see this in the waterfall plot when it's 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 in the disease control.

Right or or stable shrinking disease, it's worth noting that those patients in that that middle ground between zero and a 50% reduction several of those patients were extended.

Stable disease also had a company.

Forms of other clinical benefits you know those patients are benefiting they're going home from their scans, a with a with shrinking tumors.

And so it'll be important obviously to see the context of all of those patients both those route to achieving responses and those with extended stable disease.

Michael A. Sherman: It was unprompted feedback from KOLs as we entered into this, as we've done market research, suggested that the 20% threshold was meaningful. Allen highlighted the six-month durability, which will 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, were, 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%.

Got it okay. That's helpful.

When thinking about the new analysis onto a wanted the total dataset I guess, how does that impact.

Impact your view on expectations for the bar for success and for regulatory approval. If you could talk more about that.

Yeah, and I'll, let I'll I'll make a brief comment and then let Alan chime in you know we've.

When asked that question previously we've always said look if if the response rate dips down into the mid teens. You know obviously this becomes a more challenging none of them has said drugs for indications of this nature have been approved with mid teens kind of response rates. So are hitting that threshold of 20 person.

Michael A. Sherman: And so you can essentially rule out, you know, 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 the current standard of care is, is palliative. I probably said more than I planned to, Allen, but I don't know if you have anything, Allen or Josh, to add to that.

With this very robust sort of regulatory standard independent read is meaningful its meaningful for a couple of reasons. It was unprompted feedback from Kols as we entered.

We entered into this as we've done market research.

Suggest that 20% threshold is meaningful Alan highlighted the six month durability, which will 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 a while the tumors where we're shrinking.

Allen S. Melemed: The only thing I'll add is that I do think it's really important to look at the context of what's available. There aren't really a lot of available treatments, and the treatments that are there really don't have a lot of responses. That is something that Michael 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 a safety package that is safe for patients, and I think this has a promising package.

And I think the other important acknowledgment as the lower end of the the confidence interval given even a small dataset of 50, you can put it at 10% and so you can essentially rule out.

Joshua E. Allen: The only thing I'll add is that the points that Mike and Allen 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 discussion based on the expectation of continued observation of a 20% response rate, which, as Mike pointed out, provides you with a lower bound 95% confidence interval of 10% and in the context of that tally of available therapies that FDA acknowledged.

I've, probably said more than I planned to Alan but I don't know if you have anything add alan or Josh to add to that.

Yeah. The only thing I'll add is I do think it's really important to look at the context.

Whats available and it's really not a lot of available therapies in the therapies that are they really don't have a lot of responses.

Got it.

Something that Microsoft is already acknowledged that palliations isn't appropriate standard so.

When you look at the whole package you need to have responses that are durable with the safety package that are safe for patients and I think this is a promising.

Joshua E. Allen: And Allen 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.

Package.

Yeah. The only thing I'll add is the point that Mike and Alan boat hit there where part of our conversations with FDA. Just a reminder, that the sample size up 50.

It was proposed to the FDA in our discussions based on the expectation of continued observation of a 20% response rate, which as Mike pointed to provide you with a lower bound of 95% confidence interval of up 10% and in the context of that tallied up available therapy, the FDA acknowledged and Alan just reminded you up.

Maurice Thomas Raycroft: Got it. That's all a hopeful perspective, and congrats again, and I'll hop back in.

Operator: And next, we have Joseph Stone of Cohen and Company, your line.

Joseph John: Hi there. Good morning.

Joseph John: Congratulations, 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 over 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? Thanks. Would you like to, Allen, maybe do that in reverse order? Do you want to address the S.A.E.? Yeah, I can take that.

All within this part of the plan. So this is very very much in line with our expectations that went into the selection of the sample size with her regulatory conversation.

Got it that's all helpful perspective, and congrats again and I'll hop back in the queue.

Yes.

Thank you.

And next we have just because of Cowen and company. Your line is open.

Hi, there good morning, Congrats and thank you for taking my question, maybe just the first one now that this dataset is all set can you kind of outlined the cadence of interactions with the FDA.

Allen S. Melemed: Yeah, so this S.A.E. was deemed potentially related by the investigator, but this was initially evaluated by Oncosteutics as likely unrelated. We did a re-evaluation prior to the press release, and we completely agree that this is unlikely to be related. The patient had multiple comorbidities, including obesity and other health problems, that made this event likely unrelated to the compound. The patient also was able to continue the therapy afterwards, again, making it unlikely that it was related. So there are a lot of factors here that our assessment was unlikely related to the POM tool.

You Wanna Alan maybe.

Or do you want to address that.

I can take that.

So.

He was a potentially related by the investigator and what.

This was initially.

I raised my uncle students as a likely unrelated we did a reevaluation prior to the press release and we completely agree with I think unlike related the patient at multiple comorbidities, including obesity and other health areas that made this event likely unrelated to compound patient also with hay with it.

10 years of 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 Oh tool and.

Michael A. Sherman: I'll come back to the question of the FDA dialogue. We have 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 SNO 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've already had patients identified for that, and so that analysis is underway.

Now I'll come back to be a question of the F D. A.

Dialog, we can establish 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've already have patients identified.

For for that and so that analysis is underway.

Michael A. Sherman: 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 should be executed, 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 helped. Yep, that is perfect. Thank you very much.

This information along with updates we provide on our Clinton farm and CMC work over the next say six months will inform their 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 time languages.

Why as we've sort of not given more granular guidance on submission timeframe, we expect to be in a position to get more specific on that timeline in.

In the first half of next year.

Hopefully that helps.

That is perfect. Thank you very much.

Thank you.

Operator: And we have Naureen Quibria of Maxim's Group. Your line is open.

And we have not I mean Korea.

Of Maxim group.

Your line is open.

Thanks, Hi, good morning, and congrats on the data and so I guess, just starting off first with Huntsville. One you know you've mentioned the national history data do you have a sense of when you have.

When you have some interim data on that end and you'd be it would be available. This year that's about right.

Michael A. Sherman: 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.

Yeah, I've I've had questions about that Theres, maybe a perception that that natural history data. It takes years to accumulate and that's and in those cases, just just not the case. We've got a protocol are underway and are engaged to gather that data we'll gather really.

Michael A. Sherman: We've got a protocol underway, and engaged to gather that data, we'll gather really two sets of data, those that are aligned exactly with this 50 patient protocol, where we would expect to be able to confirm a 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 may 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 our core core set.

Michael A. Sherman: When I made the comment about 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.

Allen S. Melemed: And Mike, can I add one minor addition? I think no one believes that this population, in general, has a lot of responders. What we need to show is that this specific mutation doesn't have any different effects. The mutation is relatively new and identified, so that is what we have to show. I think when you look at recurrent diffuse melancholyomas, there typically aren't a lot of responders, but we need to show that with this specific mutation.

It is relatively new and identified so that is what we have to show I think when you look at recurrent diffuse their language almost they're typically on a lot of responders, but we need to show it with this specific mutation.

That's helpful. Thank you Alan and Mike and then with regards to the ensemble. One study. Obviously you know this is the registration cohort of 50 patients.

With regards to the remaining Ah patients that are in the three other studies that.

As well as the expanded program when.

When might you share data from from the other patients I'm just curious.

Allen S. Melemed: Yeah, let me take this first. I think one of the important reasons we did the analysis now, and as Mike had mentioned, we had a very mature data set with a long follow-up, I think over a year and a half, like 15 months. When you have a duration, mean, and duration response, a 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 use it for that. We are continuing to evaluate these patients, but I think our primary focus will be this in order to discuss regulatory issues.

Yes.

Take the first one I think one of the well.

What are the important what reason we did the analysis now and as Mike had mentioned we.

We had a very mature dataset with Oh with long fall I'll take over a year and a half of 15 months.

When you have a duration a median duration of response time to response at eight months you'd have a very mature dataset to show that you have what the response is as long as the durability. So that is where the cut quite wise and why we use this or that we're continuing to evaluate these patients, but I think our primary look would be this.

And in order to discuss with regulators.

Okay, Great and just one more from me I think I sort of missed that Ministry is with regards to <unk> and I was just curious with regards to new BARDA contracts.

Naureen Quibria: Great. And just one more from me. I think I sort of missed it. This is with regard to Convexa. And I was just curious, with regard to new BARDA contracts, are you aware of any sort of delays across the board happening with new contracts? Do you have any sort of color on that?

Are you aware of any sort of delays across the board happening with new contracts do you have any sort of color on that.

Well, we know the contracts group was.

Was the sort of.

<unk> was challenged to kind of keep pace during the course of the summer and then sort of that was really what would have driven it.

Michael A. Sherman: Well, we know the contracts group was, um, was, uh, sort of, uh, [inaudible] 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, you know, the best we can do and stand ready to respond to that RFP, we know that they're also, BARDA's in a position, it's actually kind of a different group that administers the contracts.

The delay in the first place and and really that is.

No other drivers there that I'm aware of I can I can confirm as well that.

The.

Potential hurdles related to budget negotiations or or or congressional debates around funding really don't have anything to do with us it's really just the logistical.

Step that they need to get through they've continually assured us of that and and and so you know it the best we can do in the.

Stand ready to respond to that RFP. We know that there are also a BARDA is in a position is actually kind of a different group that.

Michael A. Sherman: 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.

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.

Typically that process takes a couple of months, but perhaps we can we can shorten that based on the sort of precedence that are out there that are pretty straightforward.

Naureen Quibria: Thank you. That's all for me.

Got it. Thank you that's all for me.

Operator: And next we have Soumit Roy of Jones Research. Your line is open. Hi guys, 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 that with the Reno ATG criteria, if that's the way it goes. And I was a little confused about the 22% response rate you were mentioning. How is that different from the overall 20% you were saying?

Thank you.

And next we have so much ROI of Jones research your line is open.

Hi, guys. Thank you for taking the question and congratulations on that.

Very encouraging data.

Hum do you wanted to check if these are.

<unk> response, if we can call it that.

We did renew atg criteria, if that's the way it goes and it was a little confused on the 22% response rate you were mentioning how.

How is that different from the overall, 20% you were saying.

Let me, let me take that last point, and then and 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 are essentially we had 11 identified of the 50 in our in our prior presentations, where we had a blend of this single reader.

30 of them were reviewed by a single blinded reader the others were investigator assessments and so we stood at essentially that that $11 50 was where we were at prior to handing us over to the fresh blinded independent Central review, so that and then as I mentioned previously.

From that analysis, so I think net net loss 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 youll see some patients. So we're quite close again. So there's this notion that to to be able to stand up to.

Michael A. Sherman: When you see the waterfall plot, I'll repeat it, you'll see some patients that were quite close again. So this notion that it should 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% threshold that stood up to repeated examinations is comforting. But maybe Josh, describe a little bit more what's required in order to show a Rehno HCG response.

Repeated [laughter] rip.

Repeated assessments and blinded reviews, and when youre going into a regulatory process to know that that that that at least 20% threshold is stood up to repeated examinations and so it's comforting.

Maybe Josh describe a little bit more what's required in order to show a arena <unk> response, and one thing.

And maybe you can elaborate on too is that you often see other companies report data in Gliomas.

You see response rates that are higher and you scratch your head a little bit.

Typically those are not raynaud hcg responses Sumit I'll, let Allen.

Josh expand on that.

Joshua E. Allen: Thanks, and that's a great point that Mike just highlighted. So the Rehno 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 based on integrated Rehno 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.

Yeah, I think thanks, that's a great point that Mike just highlighted so the Rhino H D. G criteria to qualify. Our response is is among the most stringent of any response criteria. So just to directly answer. Your question. Yes. They are confirmed responses in more and I'll explain a little more about that so all the 20%.

Sponsorship is all by integrated Rainbow HDD 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 space at least more at least one month, if not more apart from each other so theres certainly confirmed from an imaging.

Joshua E. Allen: So they're certainly confirmed from an imaging and temporal perspective there. 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 RISA's criteria you may be used to in other cells. And that's, um, and what you expect, um,

Interpol perspective, there in addition to that the tumor must not be worsening on other MRI sequences, namely, namely T to flare in addition to those radiographic qualifications.

There is clinical data as well so you cannot have a decline in performance status as measured by Karnofsky Lansky performance status and you cannot have an increase in corticosteroid use that can influence our imaging artifacts as well. So if you think about it it's really a very stringent criteria not only.

Confirmation that's required here on imaging confirmation on multiple imaging sequences and a number of different clinical data points as well to go into that overall picture that stands in contrast to more typical criteria that you might see in that Mike alluded to there like recessed criteria may be used to in other solid too.

Allen S. Melemed: Got it. And you expect, um, uh, this would be, uh, the criteria FDA suggested or that's how you decided on the Reno 8 GG. That's correct. This is Allen.

<unk>.

Got it.

Allen S. Melemed: FDA specifically asked us to do Rehno-HGG. In addition, they want us to evaluate these tumors by Rehno-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 this quarter's snow, but we will also be sharing the Rehno-LGG, which is the low-grade component, which I can say is very consistent with what we're seeing with the Rehno-HGG. So we're getting shrinkage, not just in the high-grade component of the tumors but in the low-grade component as well. And one last question. I'm just a little surprised at the late time for the first response, 8.3 months. I was looking at the prior 30 patients the spider plotted.

And you would expect.

This would be the criteria do you suggested or that's how you decided on the Reno atg.

Yeah.

That's correct.

This is Alan FTA specifically.

Asked us to do a radio H T. J. In addition, they want it.

To evaluate these cameras by renal allergy G that wouldn't be the primary but they wanted to align with that.

A little frustrating we cannot share everything we have to wait for more data.

But we will be also sharing the Reno allergy, which is the low grade component, which I can say it's been very good.

Consistent with what we're seeing with the extra G. So we're getting shrinkage not just in the high grade component of the tumors with low grade component as well.

Got it and one last question just Linda.

And then the surprise that the lead time to first response eight three months I was looking at the prior 30 patient despite applauded.

Soumit Roy: Looks did not I did not realize it could be that late was that because the second group?

Look I did not I did not realize it could be that lead is because of <unk>.

Michael A. Sherman: Our second group of 20 patients was anyway different from the first 30 patients, or is it just how the data turned out?

Second group of 20 patients.

Any way different than the first 30 patient or its just how the data turns out.

Michael A. Sherman: I think that's pretty well so there'll be sort of independent reads of all of those so that the curve individual curves may look a little different but, frankly, that phenomenon was something that was observed in the prior published spider plot says 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. What I just want to add in context. It's not like the tumors weren't shrinking, weren't shrinking, and then finally shrunk; it's that they were gradually shrinking.

Yes.

And I think that's pretty well so there'll be a.

Sort of independent reads of all of those sort of the current individual curves may.

May look a little different but but frankly that that phenomenon was something that was observed in the in the.

The prior published a Spider plot says 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.

What can I say.

And I'm, sorry, I just want to add.

It's not like the tumors weren't shrinking were shrinking and then finally shrunk is that they are gradually shrinking.

Michael A. Sherman: So it's, there are several points that they're going down. It took a while to get to the actual threshold of 50%. So does that make sense? So they were, they were having a progressive shrink. But it wasn't until eight months before they had the media announcement of PR. Thank you. Thank you again for taking the questions.

There are several points that theyre going down it took a while to get to the actual threshold.

50% reduction so does that make it they were they were having a progressive shrinkage, but it wasn't until eight months, where they had been media announcements.

Yeah.

Thank you. Thank you again for taking the questions.

Soumit Roy: And next, we have David Nierengarten of Whitebush Securities. Your line is open.

Thank you.

And next we have David Neumann gotten of Wedbush Securities. Your line is open.

Operator: Thanks for taking my question. So, yeah, you talked about that.

Hey, Thanks for taking my question.

David Nierengarten: You know, the tumors are shrinking for eight months, and then... And then you have a median duration of response of.

So you talked about this a combined therapeutic benefit or essentially the tumors are shrinking for eight months and then.

And then you have a median duration of response of 11 months, So were correct in saying the.

David Nierengarten: 11 months. So we're correct in saying the kind of median duration of pay.

The median duration of patient benefit is 19 months or.

David Nierengarten: Patient Benefit is 19 months or you know, maybe if you could add...

Maybe if you could.

Add any detail on kind of the median duration of time on therapy that the patient was.

David Nierengarten: I don't think I had any details on that.

Having a benefit and then have you discussed you know that kind of.

David Nierengarten: Part of the criteria for future approval here. Thanks.

Metric with the FDA and as you know.

Michael A. Sherman: Yeah, I think you characterized it accurately, that if you were to reflect on what's really the patient's experience, the patient benefit period, where they've, you know, had 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, a median, where they stayed at least 50% or below the original size. So that is the experience of you add those two together, is where you quoted the 19, I referred to essentially progression-free survival among responders, which is a similar number, but the medians are calculated differently.

If that's part of.

And part of the criteria for future approval here. Thanks.

Yeah, I think you characterized it accurately.

If you were to.

Reflect on what's the really the patients experience and the patient benefit period, where they are.

Having an average or 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 of median where they they stayed up at least 50% or or below the original size. So that is the experience when you add those two together.

It's where you quoted the 19th I referred to a.

Essentially a progression free survival, among responders, which is a similar number.

Michael A. Sherman: 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 would would.

Mediums are calculated differently. So it ends up being about 18 months.

But indeed.

That that was discussed.

With the FDA as a as a relevant measure considering the the.

The late onset or the gradual onset is probably a better way to say it.

So that's part of what they would what would evaluate.

David Nierengarten: And if I recall, in some of the prior patient natural history, that the kind of 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.

And if I recall in some of the prior patient natural history.

Kind of hard.

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.

Joshua E. Allen: Sure, I'll let Josh and Allen characterize that. 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 studied. Keep in mind, this is in the recurrent setting, different from some of the numbers you might be thinking of in the frontline setting after diagnosis. So, initiation of therapy in the second line or later setting is typically around two months.

Sure I'll let.

Josh and Allen I characterize that.

Yes typical time to progression is usually from a media perspective on the first MRI would you look at recurrent glioblastoma or other forms of the few smid likely almost that have been studied keep in mind. This is in the recurrent setting different and some of them maybe the numbers you might be thinking Gulf into frontline setting after diagnosis initiation from AR.

A therapy in the in the second line or later setting it's typically.

Michael A. Sherman: 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 the typical experience with current GDM or other forms. It's another 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 Allen described are not the optimal way to treat these patients clearly.

Around two months in other words on the first MRI and.

And if you look at the six month landmark that that's typically less than 10% of patients that make it six months without progression. When you think about a typical experience.

Current GBM or other forms of abuse.

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 assess and so these washout periods that that Alan described is not is.

It is not the optimal way to treat these patients clearly and then so to allow.

Michael A. Sherman: I mean, 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 why 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, have even higher response rates.

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 of radiation treatment and and of course are our future development will look at that and so I think that's part of what you've.

You've got a 20% response rate in a 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 a mature.

Sure.

Options for patients that as you move that treatment earlier, even even higher response rates.

Yes.

Thanks.

Michael A. Sherman: Thank you. There are no further questions in the queue. I will now turn it back over to Mike Sherman for closing remarks. I want to thank everyone.

Thank you.

No further questions in the queue I will now turn it back over to Mike Sherman for closing remarks.

I just want to thank everyone for your time this morning and look forward to updating you again following the Snow Conference. Thank you.

Well thanks, everyone for your time this morning, and look forward to updating you again following the snow conference. Thank you.

Everyone, this concludes today's conference call. Thank you all for participating. You may now disconnect. Have a pleasant day.

Everyone. This concludes today's conference call. Thank you all for participating you may now disconnect and have a pleasant day.

Q3 2021 Chimerix Inc Earnings Call

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