Q2 2021 Chimerix Inc Earnings Call

August 5, 2021

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Operator: Good morning, ladies and gentlemen, and welcome to Kamerick's second quarter 2021 earnings conference call. I would now like to introduce your host for today's call, Michelle Las Paluto, Vice President of Strategic Planning and Investor Relations at Chimerick. Please proceed.

Good morning, ladies and gentlemen, and welcome to the kind of ex second quarter 2021earnings conference call I would now like to introduce your host for today's call, let's see I'm not supposed to you know vice president of strategic planning and Investor Relations day kind of Max. Please proceed.

Michelle LaSpaluto: Thank you. Good morning, everyone, and welcome to the Kyneric Second Quarter 2021 Financial and Operating Results Conference Call. This morning, we issued a press release that outlines the topics we plan to discuss today. You can access the press release in our investor section of the website. With me on today's call are our President and Chief Executive Officer, Mike Sherman, and Chief Financial and Business Officer, Mike Andrea L. Alan Melamette, our Chief Medical Officer, and Josh Allen, our Chief Technologynologist Officer of Miniprodite, are here to participate in Q&A.

Michelle LaSpaluto: Before we begin, I would like to remind you that statements made on today's call include forward-looking statements within the meaning of the Private Security 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 be different from those referred to in a 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 our president and chief executive officer, Mike Sher.

Michael A. Sherman: Thanks, Michelle, and good morning, everyone, and thanks for joining us. We've made considerable progress through the first half of 2021, highlighted first by the acquisition of Oncudics, then the initiation of the Phase 3-AML trial, and finally the FDA approval of Tembxa as a medical countermeasure for smallpox. This last milestone marks Chimerick's first FDA-approved drug and is the first smallpox antiviral approved for all age groups, including infants. The addition to the Strategic National Stockpile is important for several reasons.

Michael A. Sherman: As we've seen with COVID, having multiple tools to counter a viral outbreak is really critical. Strains of the smallpox virus that are resistant to the currently stockpiled countermeasure, whether that resistance is engineered intentionally or occurs naturally, are not anticipated to be resistant to Tim Bexha. The reverse is true as well.

Tools the counter of viral outbreak is really critical of strains of the smallpox virus that are resistant to the currently stockpiled counter measure whether that resistance is engineered intentionally or occurs naturally are not anticipated to be resistant to Tim Baxter. The reverse is true as well.

Michael A. Sherman: In fact, the mutations required for resistance to Timbexas significantly weaken the virus and reduce its lethality. And having both tablet and suspension formulations covering all age groups is also an essential enhancement to our readiness; Barta remains actively involved in our current development contract and celebrated the approval of Tembxa as their 60th such approval in partnership with industry. Anticipating the RFP associated with a procurement contract, we have already completed work likely required for a response to that RFP.

In fact, the mutations required for resistance to 10 Bucks of significantly weakened the virus and reduce its lethality and having both tablet and suspension formulations covering all age groups is also in the central enhancement to our readiness.

The BARDA remains actively involved in our current development contract and celebrated the approval of <unk> as their 60 et cetera approval in partnership with industry.

Anticipating the RFP associated with a pure procurement contract we have already completed work likely required for a response to that RFP that puts us in a position to possibly expedite the time from RFP the contract.

Michael A. Sherman: That puts us in a position to possibly expedite the time from RFP to contract. We've also counted, or I'm sorry, continued to execute the necessary steps to support the first shipment of up to 100 million units of product into the stockpile. And from a communication standpoint, we will issue an 8K, so investors are notified as the RFP is posted to the government website, as is their practice.

We've also counted on.

Sorry continue to execute the necessary steps to support the first shipment of up to 100 million of product into the stockpile and from a communications standpoint, we will issue an 8-K. So investors are notified as the RFP is posted to the government website as is their practice.

Moving now to on 2 of 1 in particularly our work in age 3 K twenty-seven M. Using <unk> in preparation for an updated efficacy analysis, including a blinded independent Central review. We've spent the last several weeks querying cleaning and locking the database of comprising the.

Michael A. Sherman: Moving now to Ongt 201 and particularly our work in H3K27M mutant glioma. In preparation for an updated efficacy analysis, including a blinded independent central review, we've spent the last several weeks querying, cleaning, and locking the databases, comprising the registration cohort of 50 patients with recurrent H3K27M mutant, diffuse midline glioma who received single agent Oct201. Recall that these patients represent the first 50 enrolled across five different studies who met very specific criteria for inclusion in the registration cohort.

<unk> cohort of 50 patients with recurrent atria K 27 of amusement diffuse midline glioma, who receive single agent off 2 of ones and recall that these patients represent the first 50 enrolled across 5 different studies, who met very specific criteria for inclusion in the registration cohort.

The inclusion criteria were really designed to create the most homogenous patient population and isolate the treatment effect for measurement of the primary overall response endpoint all of these patients have measurable diffuse smid likely OMA the harbor, the Ace III K twenty-seven M O M.

<unk>.

And have evidence of progression following radiation therapy administered at least 90 days prior and in many cases. These patients had progressed following the additional post radiation therapy, so the swap of where.

Also gathering the data associated with the handful of patients who met all of those criteria of for that cohort and have disease outside the midline.

This data will be evaluated by a team of blinded independent central review or sort of the ICR and we expect to share the efficacy analysis of rising from that effort in the fourth quarter of this year.

Key elements of that analysis will include the overall response rate as assessed by raynaud criteria the.

Durability of those responses and then other supporting evidence of clinical benefit, including neurological improvements as measured by performance status and reduction in the use of corticosteroids, we anticipate sharing the same data along with other information such as an ongoing natural history study with.

Michael A. Sherman: mutation and have evidence of progression following radiation therapy administered at least 90 days prior. And in many cases, these patients had progressed following additional post-radiation therapy as well. We're also gathering data associated with a handful of patients who met all of those criteria for that cohort and have disease outside the midline. This data will be evaluated by a team of blinded independent central reviewers, or BICR, and we expect to share the efficacy analysis arising from that effort in the fourth quarter of this year.

The F D. A on the E M E, which may then formed the basis of an accelerated approval of on 201.

Turning now to our D. Stat program earlier this year, we initiated enrollment of patients in the Dash AML study, our phase III trial evaluating the stat in combination with standard chemotherapy for the treatment of a M L.

This multi center randomized double blind controlled.

Placebo controlled study is evaluating the efficacy and safety of the stat in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly diagnosed AML patients we expect.

Michael A. Sherman: Key elements of that analysis will include overall response rate as assessed by Rayno criteria, the durability of those responses, and then other supporting evidence of clinical benefit, including neurological improvements as measured by performance status and reduction in the use of corticosteroids.

The unblinded data following enrollment of the first 80 evaluable patients in this study to assess minimal residual disease and complete response rates between the study arm and the control arm. This analysis, we expect to take place on the second half of 2022.

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

Michael A. Sherman: We anticipate sharing this same data along with other information, such as an ongoing natural history study with the FDA and the EMA, which may then form the basis of an accelerated approval of OEC 201. Turning now to our DSTAT program, earlier this year, we initiated enrollment of patients in the D-ML study, our Phase 3 trial evaluating D-Stat in combination with standard chemotherapy for the treatment of AML. This multi-center, randomized, double-blind placebo-controlled study is evaluating the efficacy and safety of D-Stat in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly diagnosed

Thanks, Mike and good morning, everyone.

As Michelle mentioned in her introductory remarks earlier today, we issued a press release of companion of our financial results for the second quarter of 2021.

Starting with our balance sheet, we remain well capitalized and ended the second quarter of 2021 with approximately of $140 million on capital to fund operations. We have several key milestones upcoming on come back. So on 2 of 1 and do staff and are well funded through those milestones.

Additionally, funding from the possible BARDA procurement contract could provide $80 million to $100 million annually to support our ongoing research and development programs.

Turning to our statement of operations the company reported a net loss of $17.8 million or 21 cents per basic and diluted share for the second quarter of 221 compared with the net loss of $10 million of 16 cents per basic and diluted share.

In the second quarter of 2020.

Revenues from the second quarter of 2021 were zero point $4 million compared to $1.4 million from same period of 2020.

Research and development of expenses increased to $13.8 million from the second quarter of 2021 compared to $8.6 million from the same period in 2020 the.

Michael A. Sherman: knows the AML patient. We expect unblinded data following enrollment of the first 80 evaluable patients in this study to assess minimal residual disease and complete response rates between the study arm and the control arm. This analysis, we expect to take place in the second half of 2022. With that, I'll now turn the call over to Mike Andrea for a review of the financials. Mike?

Main driver of this increase was the addition of personnel clinical and development of expenses. Following the acquisition of the market suite ex to support. The addition of on 2 of 1 to the pipeline.

General and administrative expenses increased of $4.4 million for the second quarter of 'twenty, 1 compared to $3.1 million from the same period in 2020 without overview on the I'll turn the call back over to Mike for closing remarks, Mike.

Thanks, Mike as you can see we've made meaningful progress throughout the first half of 2021of our recent FDA approval sets the stage for of BARDA procurement contract and the advancements we've made with our oncology program leave us well positioned to achieve several value creating milestones throughout the balance.

Michael T. Andriole: Thanks, Mike, and good morning everyone. As Michelle mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the second quarter of 2021. Starting with our balance sheet, we remain well capitalized and ended the second quarter of 2021 with approximately $140 million in capital to fund operations. We have several key milestones upcoming for Tembxa, Inc. 201, and DSTAT, and are well funded through those milestones. Additionally, funding from a possible part of a procurement contract could provide $80 to $100 million annually to support our ongoing research and development programs.

<unk> of this year and beyond with that let me turn the call over to the operator and we can take your questions.

As a reminder to ask a question do we need the press star 1 on your telephone so 1 of the drawing of a question first of the pound key.

And I wasn't compile the Q&A roster.

Your first question comes from the line of Nova and QUADRA with Maxim Group.

Hi, good morning, and congratulations on the progress on especially you many of them. The next approval and thanks for taking my question and I was just wondering with regards to the part of with BARDA.

We now have any surge in the Delta there and then it sounds like so are you aware of any shifts in the Taiwanese potentially from earlier in the year.

No no I think the short answer is that the where they'd had a pinch has been in their contracting group M.

Michael T. Andriole: Turning to our statement of operations, the company reported a net loss of $17.8 million, or 21 cents per basic and diluted share, for the second quarter of 2021, compared with a net loss of $10 million, or $16 per basic and diluted share, for the second quarter of 2020. Revenues for the second quarter of 2021 were $0.4 million, compared to $1.4 million for the same period of 2020. Research and development expenses increased to $13.8 million for the second quarter of 2021 compared to $8.6 million for the same period in 2020.

And and and I don't think that that has been impacted by the sort of the recent activity or the recent surge in COVID-19 for sure.

We havent ongoing contact and the communication with BARDA just based on our are ongoing.

Kind of relationship with the the development contract that exists today and.

We continue to have recent conversations the support.

Our expectation that we need to be ready to ship product into the stockpile before the end of the year.

Oh got it that's really helpful. And then with regards to the D. Stat program are you actually able to comment on them or shed any color on the enrolment numbers any accrual rate at this point.

Quint.

Yeah, it's probably still too early to.

Identify enrollment trend.

Trends as we're still activating sites.

So so and then I don't tend to get on the habit of of getting them.

Quarterly updates on enrollment numbers, but our expectation at this point is that we would have the analysis of the 80 patient.

Michael T. Andriole: The main driver of this increase was the addition of personnel, clinical, and development expenses following the acquisition of oncophytics to support the addition of opt 201 to the pipeline. General and Administrative expenses increased to $4.4 million for the second quarter of 21 compared to $3.1 million for the same period in 2020. With that overview, I'll now turn the call back over to Mike for closing remarks.

Our first assessment in the second half of next year.

Got it and just.

1 more from me with regards to the Ontario, 1 program.

You know the bandwidth then there was the presentation and ask on the parents gang.

Ganglioma study M D.

T study so would we in addition to obviously the top line data coming out of it.

The registration cohort will we see more from some of the other study on that.

And on that.

Yeah. So the the updates from a clinical standpoint will come from.

Michael A. Sherman: Thanks, Mike. As you can see, we've made meaningful progress throughout the first half of 2021. Our recent FDA approval sets the stage for a Barta procurement contract, and the advancements we've made with our oncology program leave us well positioned to achieve several value-creating milestones throughout the balance of this year and beyond. With that, I'll turn the call over to the operator, and you can ask your questions.

Really 2 things 1 is the registration cohort in the second I referred to as was the essentially the other group of patients that were following the debt.

Sort of meet all of the criteria of debt of that cohort of except that they have disease of outside of the midline structure.

I would not expect.

Update on the the Paragon Glioma, we also have an ongoing.

Ah trial with width of 2.6 and that's also probably early.

As the best in dose escalation of space for updates so those would come on come later.

Okay Alright, thank you for taking my question.

Your next question comes from the line of Joseph Thome with Cowen and company.

Operator: As a reminder, to ask a question, you would need to press star 1 on your telephone. Then, you would draw your question, press the pound key. Please stand by why we compiled the Q&A roster. Your first question comes from the line of Noreen Quabra with Maxim Group.

Good morning, and thank you for taking my questions.

The first 1 on <unk> hundred 1.

We're going to see the the re analysis of.

The whole pivotal cohort.

Later this year.

But we have already seen the COVID-19 patients that have had responses on this.

The review is there anything different I guess between the analysis that took place with that initial subset and that initial blank.

Blinded independent review of what's going to happen later in the year that may change the responses for the better of the worse and then the second because you did mention the subset of patients since you have disease outside of the deadline.

Naureen Quibria: Hi, good morning, and congratulations on the progress, especially with Convex approval. Thanks for taking my questions. So I was just wondering, with regard to the barter with barda, just, you know, we now have a new surge and the delta variant and so forth. So are you aware of any shifts in their priorities potentially from earlier in the year?

How are you thinking about including that in the regulatory submission.

And maybe from an efficacy standpoint is there any reason why patients that had been buying tumors are not in the night tuners wouldn't perform better or worse.

Yeah. So let me let me handle the first question about the change in the enel or any change in the analysis and I'll let.

Josh and Alan talk about the non midline patience and how those might be incorporated in how we anticipate that the transition to a potential label on it.

Michael A. Sherman: No, no, I think the short answer is that where they've had a pinch has been in their contracting group, and I don't think that that has been impacted by the sort of recent activity or the recent search in COVID, for sure. We have ongoing contact and communication with Barta just based on our ongoing kind of relationship with the development contract that exists today. And, you know, we continue to have recent conversations that support our expectation that we need to be ready to ship product into the stockpile before the end of the year.

The first question relates to the analysis of these patients in fact, the the analysis of the essentially will be the same from a criteria perspective, so the rain out criteria as it relates to the overall responses is very strict and well defined criteria the.

The difference in what was performed previously.

Number 1.

That analysis was was covering just the portion of those of those 50 patient. So we will cover all of those patients in this in this analysis.

Currently the previous blinded assessment was performed by a single blinded review of this will be performed by a.

The group of reviewers so 2 reviewers with the third reviewer to adjudicate if there are any differences between those.

Michael A. Sherman: Oh, got it. That's really helpful. And then, with regard to the DSAT program, are you actually able to comment on or shed any light on the enrollment numbers and accrual rate at this point?

And sometimes it's possible with these images that debt you can have slightly different.

Interpretations of the of the reduction and there is a threshold of 50 per cent. For example that is required to be met for 2 successive scans and and we've talked about a couple of the the patients that are both bright just short of that 50% reduction that you could imagine could could.

Michael A. Sherman: Yeah, it's probably still too early to identify enrollment trends as we're still activating sites. So, and then I don't tend to get in the habit of getting quarterly updates on enrollment numbers. But our expectation at this point is that we would have that analysis of the 80 patients, first assessment in the second half of next year.

The red differently and become a response and the reverse is true as well that having been said we had our independent reviewer as part of our diligence look at at the scans and really found very high concordance between what was the he reviewed and what was reviewed by the blinded independent Central review.

Naureen Quibria: Got it. And just one more for me.

Naureen Quibria: With regard to the On 201 program, you know, there was a presentation at ASCO on the Paraganglema study, the ISC study. So would we, in addition to obviously the top-line data coming out of, you know, the registration cohort, will we see more from the other study on that?

The reviewer and for that matter of the investigators not only on the best response, which I think is it's obviously interesting and important for the overall response rate assessment, but maybe as important the over the time series, where you see the durability of these responses and 4 of the patients that have responded.

Michael A. Sherman: Yeah, so the updates from a clinical standpoint will come from really two things. One is the registration cohort, and the second I referred to was essentially this other group of patients that were following that sort of meet all of the criteria of that cohort, except that they have disease outside of the midline structure. I would not expect an update on the paragonaloma. We also have an ongoing trial with Ong 206, and that's also probably early as that's in the dose escalation phase for updates, so those would come later.

The response has been quite durable of progression free survival.

Patients in excess of 15 months. So the durability will be I think of key element of how the FDA looks at at this response.

Maybe let me pass it to Josh first to talk about these patients outside the midline and then and then maybe Alan can address how we think about that from a regulatory standpoint, and how we would submit that data.

Sure. Good morning, Joseph So with respect to the midline of non deadline question that I'd like to start with a reminder, that the requirement of <unk>.

Involvement of the deadline with the disease too to be included in the registration cohort is really driven by a desire to select the adequately homogeneous population with respect to natural history subjects without midline involvement, but with the inclusion of the <unk> 27, and <unk> mutation of the disease.

Are still regarded as a life threatening disease that does not have proven effective treatments.

Operator: Okay, all right, thank you for taking my question. Thank you. Your next question.

That this is a relatively rare population and the prognosis of those patients have not been adequately study. So due to the lack of knowledge really with regards to natural history those subjects were excluded.

Operator: Your next question comes from the line by Joseph Thome with Calvin and Company.

Joseph John: On 201, I mean, we are going to see the reanalysis of the whole Pivotal cohort later this year. But we have already seen a good group of patients that have had responses to the review. Is there anything different, I guess, between the analysis that took place with that initial subset and that initial blinded independent review and what's going to happen later in the year that may, you know, change responses for the better or the worse? And then second, because you did mention that.

Debt from the primary registration cohort that being said we view those.

The issues as distinct from whether or not the treatment effect of about 201 extends to those patients with disease outside of the deadline.

And for that reason, we still included those subjects in the enrollment of clinical trials and what you saw on <unk> was the release of those patients who meet all of the same criteria within the registration cohort, except the did not have Midland involvement of the disease.

You can see from the data that was reported there we saw a similar pattern of objective response rate in clinical benefit emerge in those patients.

At a small sample size given the it's a rare population.

We do plan to include those patients as a supplemental analysis in our NDA planning so even though they are excluded from the registration cohort from the reason for the reasons. The outlined we do plan to present that data debt.

Michael A. Sherman: In the subset of patients that do have disease outside the midline, maybe how are you thinking about including that in a regulatory submission, and maybe from an efficacy standpoint, is there any reason why patients that have midline tumors or non-midlight tumors would perform better than that? Yeah, so let me handle the first question about the change in the analysis, and I'll let Josh and Alan talk about the non-midline patients and how those might be incorporated, and how we anticipate that to transition to a potential label. The first question relates to the analysis of these patients. In fact, the analysis is, essentially, will be the same from a criteria perspective.

Helped to support a picture of.

On the tier ones treatment effect of extending to <unk> 27 of the mutant beyond the regardless of tumor location.

I'd like to turn it over to Alan to just comment with.

With regards to how that would be apples and thinking about labeling.

Hi, This is Alan element of the only additional AD as a primary registration cohort will be in the mid line with the other characteristics of that Josh had mentioned on this would be additional support of data for FDA to review of the activity of October 1 which to me it will be we hope to be supportive data for approval.

Excellent that is very helpful. Thank you very much.

Your next question comes from the on line of Sumit Roy with Jones trading.

Michael A. Sherman: So the renal criteria as it relates to the overall responses is a very strict and well-defined criterion. The difference in what was performed previously is, number one, that analysis was covering just a portion of those 50 patients, so we'll cover all of those patients in this analysis. Secondly, the previous blinded assessment was performed by a single blinded reviewer. This will be done.

Hi, good morning, everyone and congratulations on all of the programs just to elaborate a little bit more on the on tier 1.

The data what would be the.

Median duration of drug you anticipate by the time you will have some of.

The dws close.

And.

Any thoughts on how you were trying to book.

The only improve on getting more responders, the if youre thinking of going earlier in the line or combination trials of any thoughts on the future.

I'll start that and maybe Josh you can chime into 1 way to if I'm.

The send your first question correctly.

Correctly about the median duration of of drug the last patients.

Michael A. Sherman: by a group of reviewers, so two reviewers with a third reviewer to adjudicate if there are any differences between those. And sometimes it's possible with these images that you can have slightly different interpretations of the reduction. And there is a threshold, at 50%, for example, that is required to be met for two successive scans. And we've talked about a couple of patients that are both right just short of that 50% reduction that you could imagine could be read differently and become a response, and the reverse is true as well.

The to be enrolled in that are included in that of <unk>.

50 cohort.

Would be on on drug for more than the years, so you're probably at the.

The 14 plus of months, so close to close 2 of a year on a half.

On the median I don't I'm not sure what that is but it's obviously foreign.

Far in excess of that and so I guess I would characterize the the.

The maturity of of this follow up is as it.

It is quite good it will give a good picture of not only responses, but the durability of those responses across this across the cohort.

And maybe maybe let me hand, it over to Josh to talk a little bit about the the.

Michael A. Sherman: That having been said, we had our independent reviewer, as part of our diligence, look at the scans and really found very high concordance between what he reviewed and what was reviewed by the blinded independent central reviewer and, for that matter, the investigators, not only on the best response, which I think is obviously interesting and important for the overall response rate assessment, but maybe even more important over the time series where you see the durability of these responses. And for the patients that have responded, that response has been quite durable in terms of progress and free survival for patients in excess of 15 months.

The either add to that and then we can talk about how we're thinking about.

The additional populations going forward.

Yes, nothing to add on the on the maturity of the data I think that's low characterized the scraped within 1 year for the cohort.

With respect to I believe the question was.

Aimed at how the potentially improved response rates, where we potentially pursue combination therapies or earlier lines of therapy and I think the answer is both both are of the work. So first first of all with regards to moving towards frontline therapy that is supported by a subgroup analysis performed at snow of last few year on released.

Keeping debt the.

Predictors of the increased likelihood of response were in lined with number 1.

Of the smaller baseline tumor size and number 2.

Michael A. Sherman: So durability will be, I think, a key element of how the FDA looks at this response. Maybe I should pass this to Josh first to talk about these patients outside the midline, and then maybe Alan can address how we think about that from a regulatory standpoint and how we would submit that data. Sure, good morning, Joseph.

The pertaining to patients who have not had south of 2 of asks the treatment at the time they've initiated off 2 of what both of which point to starting.

Therapy or in earlier in the course of their disease may be associated with an increased likelihood of response.

That those those clinical findings in addition to the fact that our tier 1 exhibits either additive to synergy or synergistic activity of preclinical models lead 1 to believe that moving towards the frontline setting.

Joshua E. Allen: So with respect to the midline and non-midline question, I'd like to start with a reminder that the requirement of involvement of the midline with the disease to be included in the registration cohort is really driven by a desire to select the adequately homogeneous population with respect to natural history. Subjects without midline involvement but with the inclusion of the H3K-27 mutation of their disease are still regarded as a life-threatening disease that does not have proven effective treatments.

In this disease would make a lot of sense to debt and our pediatric program from 2 of 1 study on <unk> is already.

Moving the drug into the frontline setting in combination of radiation and we've seen the safety profile of the agent be maintained in that setting. So clearly a movement towards frontline therapy. In this disease. This is a clear direction on the molecule in.

In addition, the.

The published literature shows on the tier 1 is synergistic with a wide variety of interest cancer agents.

Joshua E. Allen: It's just that this is a relatively rare population, and the prognosis of those patients has not been adequately studied. So due to the lack of knowledge, really, with regards to natural history, those subjects were excluded from the primary registration cohort. That being said, we viewed those issues as distinct from whether or not the treatment effective on 201 extends to those patients with disease outside of the midline.

There have been a number of the investigators who have cooperatively taken on the task of prioritizing synergistic agents for the arc 201.

Specifically into few sniff length of the almost.

We look forward to working with those investigators towards our covenant of <unk> trial in the future of that prioritizes stuff the the top cuts out of that effort.

1 of the things that you think about the.

This landscape and and other products that are in development, including those of car T. Specifically targeting 8-K 27, a M I.

I think given the severity of this disease of the.

The the expectation is and then the hope is that there are at least 1 or more other drugs that can help these patients and ultimately.

Allen S. Melemed: And for that reason, we still included those subjects in enrollment for clinical trials. And what you saw at ASCO was a release of those patients who meet all of the same criteria within the registration cohort, except they do not have midline involvement of the disease. As you can see from the data that was reported there, we saw a similar pattern of objective response rate and clinical benefit emerge in those patients, albeit a small sample size, given that it's a rare population.

The 1 of the advantages of on 201 is that you would expect to be able to combine it with any of those and.

And be able to do that that safely so in a way I don't see a.

The substantial competitive threat this of the combination opportunity down down the road the other subtlety I would.

Mention is the the way. This this trial was designed in order to isolate the response.

The single agent onto of 1 and particularly distancing the of.

Allen S. Melemed: We do plan to include those patients as a supplemental analysis in our NDA planning. So even though they're excluded from the registration cohort for the reasons I outlined, we do plan to present that data that would help to support a picture of onctool-1's treatment effect extending to H3K-27M mutant glioma, regardless of tumor location. I'd like to turn it over to ALEM and to just comment with regard to how that would be handled in thinking about labeling. Hi, this is Alan Melma.

The initial radiation therapy by at least 90 days, what you would expect most physicians will say this they would much prefer whether it's.

In combination or the radiation or even if it immediately follows radiation as opposed to waiting for the these patients to progress in their disease advance. So you could see a sort of a middle ground, there where you would at least moved the the drug closer to frontline therapy for.

Potentially more activity.

Anyway, 2.2 I think are additional points to consider as you think about the utilization of the drug going forward.

Great really helpful. Thank you so much.

As a reminder to ask a question you will need the press Star then the number 1 on gets all of them. So 1 of the drawing a question press the pound key please standby, while we compile the Q&A roster.

Allen S. Melemed: Hi, this is Alan Melma. The only additional ad is that our primary registration inquiry will be in the midline with the other characteristics that Josh mentioned. This would be additional supportive data for FDA to review the activity of October 1, which to me would be, we hope, supportive data for approval.

Your next question comes from the mine of Maury Raycroft with Jefferies.

Hi, good morning, everyone. Congrats on the progress and thanks for taking my questions.

Just a clarification on the 201 analysis you mentioned there will be a group of reviewers can you elaborate on that I guess, how many reviewers will be involved and can you talk more about how the process will work.

Operator: Your next question comes from the line of Suey Roy with Jones Trading.

Now I'll give the real high level in the.

Sure Alan can give a little bit more detail if it's if it's helpful. But.

Soumit Roy: Hi, good morning, everyone, and congratulations on all the progress. Just to elaborate a little bit more on the Ong 2-1 data, what would be the median duration of the drug you anticipate by the time you have the database closed? And any thoughts on how you're probably trying to improve on getting more responders if you're thinking of going earlier in the line or combination trials? Any thoughts for the future? I'll start that and

The the the.

I think it's important to start by remembering that this raynaud criteria is it does go beyond just the new imaging assessment of its 1 of the things that I think is important to remember about raynaud criteria of these these responses are sort of legitimized by on not just the the.

The gene response, but also the clinical activity around it you cannot have a bona fide renal response, if there is an.

Michael A. Sherman: I'll start that, and maybe Josh you can chime in on one way to, if I understand your first question correctly about the median duration of the drug, the last patient to be enrolled in that or included in that 50 cohort would be on the drug for more than a year. So you're probably at 14 plus a month, so close to a year and a half. The median, I don't, I'm not sure what that is, but it's obviously far in excess of that.

On an increasing use of corticosteroids or if there's a deterioration in the performance status. So all of those are elements of of the review in this case there will be true reviewers that are assessing the scans and the associated data and then where there was a disagreement there would be a third of that.

Due to case that and Thats really the preferred.

M approach the by the FDA and Thats the reason that the.

Have the protocol structure of such I don't know if there are additional details Joshua or Alan.

Helpful to add to that.

This is Alan the only thing I'll add is we are using a vendor that has a lot of experience of doing these reviews. So were.

Okay.

Michael A. Sherman: And so I guess I would characterize the maturity of this follow-up as quite good. It will give a good picture of not only responses but the durability of those responses across this cohort. And maybe I should hand it over to Josh to talk a little bit about that.

Got it Okay. That's helpful and apologies if I missed this at the beginning of the call before the <unk> of procurement contract based on your conversations do you have a sense of whether BARDA is taking a longer time because of administrative backlog or are there. Other gating factors involved that you can comment on.

Yeah. My my sense is that as the it's an administrative.

Michael A. Sherman: about the, the, either add to that, and then we can talk about how we're thinking about the additional populations going forward. Yeah, nothing to add on the maturity of the data. I think that's both characterized.

The.

The issue in and.

1 that as I as I mentioned, you know based on the conversations that we have in the which are ongoing related to the sort of open.

The element of agreement on.

R R.

Joshua E. Allen: It's great within one year for the cohort. With respect to, I believe the question was aimed at how to potentially improve response rates; will we potentially pursue combination therapies or earlier lines of therapy? And I think the answer is both are in the works.

Expectation is that we need to be ready.

At least for a potential shipment into the stockpile of later this year. So there's there's been no change in terms of BARDA enthusiasm and priority around this program and as I mentioned in my commentary that they are quite the opposite they were celebrating the this this approval it's an important 1 for the stock.

Joshua E. Allen: So first of all, with regard to moving towards frontline therapy, that is supported by a subgroup analysis performed at snow of last year and released indicating that the predictors of increased likelihood of response were in line with, number one, having a smaller baseline tumor size, and number two, pertaining to patients who have not had salvage of asthma treatment at the time they were initiated on 201, both of which point to starting therapy earlier in the course of their disease may Those clinical findings, in addition to the fact that ACHO1 exhibits either additive or synergistic activity in preclinical models, lead one to believe that moving towards the frontline setting in this disease would make a lot of sense.

Given the.

Of the vulnerability.

Whenever you just got 1 countermeasure and the possibility and frankly, the likelihood that you'd have a resistance train emerge.

These 2 drugs and the psychology of really quite complementary in a number of ways. So I think that it's a dramatic improvement in the state of the stockpile.

When when.

When you can add this or the quality of the stockpile and I do think and I've seen quotes from you know there has been some change in leadership.

With New administration, and just a couple of times that this continues to be on a priority 1 is an acknowledgment of.

By the the aspirate leadership that the that they will be measured by.

How how.

Well the stockpile is positioned broadly not just as it relates to Covid number 1 and number 2 the the draft budget.

Prepared by this administration.

Joshua E. Allen: To that end, our pediatric program for the Octo1 study on 14 has already moved the drug into the frontline setting and combination and radiation, and we've seen the safety profile of the agent be maintained in that setting. So clearly, movement toward frontline therapy in this disease is a clear direction from the molecule. In addition, the published literature shows Zonk211 is synergistic with a wide variety of anti-cancer agents. Therefore, there have been a number of investigators who have cooperatively taken on the task of prioritizing synergistic agents for Dr. 201, specifically in diffused nivine gliomas. And we look forward to having one.

Calls out of this product our product by name and includes it in a way that's consistent with what we would of.

Expected in the in.

In the in the.

Future budgets, and we know that they've had a funding earmarked for this for some time so.

I really don't don't expect the that there's it's more a question of timing than it is a question of of you.

Got it Okay. That's really helpful and maybe last question just I'm wondering if there's any new perspective on potential on using MRI D. R. M Hardy and elevated our prioritized endpoint and all of your AML Phase III have you had any new conversations with regulators or even experts on the topic that you can comment on cash.

I'll start that and maybe Allen can add if I Miss something but the only thing that's really changed in recent months as the.

Michael A. Sherman: And we look forward to working with those investigators towards a combinatorial trial in the future that prioritizes the top hits from that effort. One of the things you think about this landscape and other products that are in development, including CART specifically targeting H3K27M, I think given the severity of this disease, the expectation is, and the hope is that there are at least one or more other drugs that can help these patients.

The announcement of of by Kronos that they are using that as the primary endpoint for there in all study of its in the different patient populations. So there's some differences that debt probably lend itself is more acceptable or potentially more acceptable as of as a primary endpoint.

So I think there's continued momentum in that regard and we don't really plan to have a a follow up conversation until we have some data to share with the FDA. They they let we left of the conversation with them is we've got alignment on our phase III trial quite positively as it related to MLD, we either to the.

Michael A. Sherman: And ultimately, one of the advantages of Alt-201 is that you would expect to be able to combine it with any of those and be able to do that safely. So in a way, I don't see a substantial competitive threat. This is an opportunity for combination down the road.

The point that we discussed the possibility of switching our endpoint to 2 M D and their feedback was as long as you haven't as long as Youre still blinded to whatever data you are including in that assessment, then that that would be something that they would be open to subject to presenting some data. So I think the <unk>.

Michael A. Sherman: The other subtlety I would mention is the way this trial was designed in order to isolate the response of this single agent on 201 and, particularly, distance it from the initial radiation therapy by at least 90 days. What you would expect, and most physicians will say this, they would much prefer it whether it's, you know, in combination with radiation or even if it immediately follows radiation as opposed to waiting for these patients to progress and their disease to advance.

Strategy would be if we have some data that's that's meaningful that comes from that first patient cohort.

1 scenario is that you just move ahead with the existing trial.

And the kind of the design of of that trial and M D. As a supportive of endpoint.

Instead of a primary another scenario is that you flip to 2 M. D. As the primary endpoint of it wouldn't really change any of the execution of the.

The of the protocol, so you could do that midstream.

Got it okay. That's very helpful. Thanks for taking my question.

Thanks, Mike.

At this time there are no further questions I would now like to turn the call back over to Mr. Mike Sherman.

Michael A. Sherman: So you could see sort of a middle ground there where you would at least move the drug closer to frontline therapy for potentially more activity. So anyway, two, I think, additional points to consider as you think about the utilization of the drug going forward.

Operator: As a reminder to ask a question, you will need to press star, then the number one, or get all of them. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your next question comes from the line in Maury Ray Cross with Jeffries.

[music].

Maurice Thomas Raycroft: Hi, good morning, everyone. Congratulations on the progress, and thanks for taking my questions. Just a clarification.

Maurice Thomas Raycroft: on the 201 analysis. You mentioned there would be a group of reviewers.

Michael A. Sherman: reviewers, can you elaborate on that? I guess how many reviewers will be involved, and can you talk more about how the process will work? I'll give you the really high level, and Josh or Allen can give a little bit more detail if it's helpful.

Michael A. Sherman: But I think it's important to start by remembering that this Rayno criteria is, it does go beyond just an imaging assessment. It's one of the things that I think is important to remember about Rayno criteria. These responses are sort of legitimized by not just the image. imaging response, but also the clinical activity around it. You cannot have a bona fide renal response if there is an increasing use of corticosteroids or if there's a deterioration in performance status.

Michael A. Sherman: So all of those are elements of the review. In this case, there will be two reviewers that are assessing the scans and the associated data. And then, where there's a disagreement, there would be a third that adjudicates that. And that's really preferred. approach by the FDA, and that's the reason that we have the protocol structured as such. I don't know if there are additional details, Josh or Alan, that you think would be helpful to add to that. And this is the only thing I'll add.

Michael A. Sherman: Yeah, this is the only thing I'll add is that we're using a vendor that has a lot of experience doing these reviews, so we're

[music].

Maurice Thomas Raycroft: Got it. Okay, that's helpful. And apologies if I miss this.

Maurice Thomas Raycroft: Apologies if I missed us at the beginning of the call, but for the KMexo procurement contract, based on your conversations, do you have a sense of whether BARTA is taking a longer time because of administrative backlogs or are there other dating factors involved that you can comment on? Yeah, my sense is that it's an administrative issue and one that, as I mentioned, based on the conversations that we have had and which are ongoing related to the open development agreement, the expectation is that we need to be ready, at least for a potential shipment into the stockpile later this year. So there's been no change in terms of Barta's enthusiasm and priority around this program. And, as I mentioned in my commentary, they are quite the opposite.

Michael A. Sherman: They were celebrating this approval. It's an important one for the stockpile given the vulnerability, whenever you've just got one countermeasure and the possibility, and frankly the likelihood that you'd have a resistance train emerge.

Michael A. Sherman: These two drugs in the stockpile are really quite complementary in a number of ways, so I think it's a dramatic improvement on the state of the stockpile when you can add this, or improve the quality of the stockpile. And I do think, and I've seen quotes from, you know, there's been some change in leadership with the new administration and just a couple of signs that this continues to be a priority. One is an acknowledgement by the ASPER leadership that they will be measured by how well this stockpile is positioned broadly, not just as it relates to COVID.

Michael A. Sherman: Number one, and number two, the draft budget, as prepared by this administration, calls out this product, our product, by name and includes it in a way that's consistent with what we would have expected in the..., in future budgets. And we know that they've had funding earmarked for this for some time. So I really don't expect that it's more a question of pining than it is a question of the... Gotten

Michael A. Sherman: Okay, that's really helpful. And maybe one last question. Just wondering if there's any new perspective on the potential for using MRD or MRD as an elevated or prioritized endpoint in your AML phase three. Have you had any new conversations with regulators or even experts on the topic that you can comment on? I'll start that, and maybe Alan can add if I missed something, but the only thing that's really changed in recent months is the announcement by Kronos that they are using that as the primary endpoint for their endpoint.

Michael A. Sherman: And I'll study it in a different patient population. So there are some differences that probably lend themselves to being more acceptable or potentially more acceptable as a primary endpoint. So I think there's continued momentum in that regard.

Michael A. Sherman: We don't really plan to have a follow-up conversation until we have some data to share with the FDA. They, they let us, we left the conversation with them as we got alignment on our phase three trial quite positively as it related to MRD. We, even to the point that we discussed the possibility of switching our endpoint to MRD. And their feedback was, you know, as long as you haven't, as long as you're still blinded to whatever data you're including in that assessment, then that would be something that they would be open to, subject to presenting some data.

Michael A. Sherman: So I think the strategy would be if we have some data that's meaningful that comes from that first patient cohort, you know, one scenario is that you just move ahead with the existing trial and the design of that trial, where an MRD is a supportive endpoint instead of a primary. Another scenario is that you flip to MRD as a primary endpoint. It wouldn't really change any of the execution of the process of the preemptives.

Michael A. Sherman: protocol so you could do that midstream. Got it. Okay. That's very helpful. Thanks for answering my question.

Operator: At this time, there are no further questions. I would now like to turn the call back over to Mr. Mike Sherman.

Michael A. Sherman: Well, again, thanks everyone for joining us and I look forward to giving you updates, important updates coming up later this year. Have a good day. This concludes today's conference call. Thank you for participating.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

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Operator: Good morning, ladies and gentlemen, and welcome to Chimerick's second quarter 2021 earnings conference call. I would now like to introduce your host for today's call, Michelle Las Paluto, Vice President of Strategic Planning and Investor Relations at Chimerick. Please proceed.

Michelle LaSpaluto: Thank you. Good morning, everyone, and welcome to the Kimerick second quarter 2021 Financial and Operating Results Conference Call. This morning, we issued a press release that outlines the topics we plan to discuss today. You can access the press release in our investor section of the website. With me on today's call are our President and Chief Executive Officer, Mike Sherman, and Chief Financial and Business Officer, Mike Andrea L. Alan Melamette, our Chief Medical Officer, and Josh Allen, our Chief Technologynologist Officer of Miniprodite, are here to participate in Q&A.

Michelle LaSpaluto: Before we begin, I would like to remind you that statements made on today's call include forward-looking statements within the meaning of the Private Security Litigation Reform Act of 1995 and are subject to risks and uncertainties and other factors. These risks and uncertainties could cause actual results to be different from those referred to in a forward-looking statement. Please refer to our filings with the SEC for more complete disclosure of these risks and uncertainties. At this time, I would like to turn the call over to our president and chief executive officer, Mike Sher.

Michael A. Sherman: Thanks, Michelle, and good morning, everyone, and thanks for joining us. We've made considerable progress through the first half of 2021, highlighted first by the acquisition of oncudics, then the initiation of the Phase 3-AML trial, and finally the FDA approval of Tembxa as the medical countermeasure for smallpox. This last milestone marks Chimerick's first FDA-approved drug and is the first smallpox antiviral approved for all age groups, including infants. The addition of Tebexa to the strategic national stockpile is important for several reasons.

Michael A. Sherman: In fact, the mutations required for resistance to Timbexas significantly weaken the virus and reduce its lethality. And having both tablet and suspension formulations covering all age groups is also an essential enhancement to our readiness. Barta remains actively involved in our current development contract and celebrated the approval of Tembxa as their 60th such approval in partnership with industry. Anticipating the RFP associated with a procurement contract, we have already completed work likely required for a response to that RIP.

[music].

Michael A. Sherman: Moving now to Oc201, and particularly our work in H3K27M mutant glioma. In preparation for an updated efficacy analysis, including a blinded independent central review, we've spent the last several weeks querying, cleaning, and locking the databases, comprising the registration cohort of 50 patients with recurrent H3K27M mutant diffuse midline glioma who received single agent Oct201. Recall that these patients represent the first 50 enrolled across five different studies who met very specific criteria for inclusion in the registration cohort.

Good morning, ladies and gentlemen, and welcome to the kind of Americas second quarter 2021 earnings conference call I would now like to introduce your host for today's call Michelle I suppose the Ito Vice President of strategic planning and Investor Relations Day kind of America. Please proceed.

Thank you.

Morning, everyone and welcome to the generic second quarter of 2021 financial and operating results Conference call. This morning, we issued a press release, which outlines the topics. We plan to discuss today you can access the press release and our Investor section of the website.

Michael A. Sherman: The inclusion criteria were really designed to create the most homogeneous patient population and isolate the treatment effect for measurement of the primary overall response endpoint. All these patients have measurable, diffuse midline glioma. They harbor the H3K27M mutation and have evidence of progression following radiation therapy administered at least 90 days prior. And in many cases, these patients had progressed following additional post-radiation therapies as well.

With me on today's call are President and Chief Executive Officer, Mike Sherman, Chief Financial and business Officer, Mike Andriole L. M element of our Chief Medical Officer, and Josh Allen, Our Chief Technology Officer of minute per guidance are here to participate in Q&A before we begin I would like to remind me. The statements made on today's call include forward looking statements.

The meaning of the private Securities Litigation Reform Act of the 1995 and are subject to risks and uncertainties and other factors.

Risks and uncertainties and other factors could cause actual results to differ materially from those before I turn the forward looking statements. Please refer to our filings with the SEC for a more complete disclosure of these risks and uncertainties.

Michael A. Sherman: We're also gathering data associated with a handful of patients who met all of those criteria for that cohort and have disease outside the midline. This data will be evaluated by a team of blinded independent central reviewers, or BICR, and we expect to share the efficacy analysis arising from that effort in the fourth quarter of this year. Key elements of that analysis will include overall response rate as assessed by Rayno criteria, the durability of those responses, and then other supporting evidence of clinical benefit, including neurological improvements as measured by performance status and reduction in the use of corticosteroids.

At this time I would like to turn the call of retired President and Chief Executive Officer, Mike Sherman.

Thanks, Michelle and good morning, everyone and thanks for joining us we've.

We've made considerable progress through the first half of 2021 highlighted first by the acquisition of walks through the Ah <unk>.

Then the initiation of the phase III dash, the AML trial, and finally, the FDA approval of come back so that was the medical countermeasure for smallpox.

This last milestone marks <unk> first FDA approved drugs and is the first smallpox antiviral approved for all age groups, including infants.

The addition of Tibet <unk> to the strategic National stockpile of what's important for several reasons as we've seen with Covid, having multiple tools. The counter of viral outbreak is really critical strains of the smallpox virus that are resistant to the currently stockpiled counter measure whether that resistance is M.

Michael A. Sherman: We anticipate sharing this same data along with other information, such as an ongoing natural history study with the FDA and the EMA, which may then form the basis of an accelerated approval of Aung 201. Turning now to our DSTAT program, earlier this year, we initiated enrollment of patients in the D-ML study, our Phase 3 trial evaluating D-Stat in combination with standard chemotherapy for the treatment of AML. This multi-center randomized, double-blind placebo-controlled study is evaluating the efficacy and safety of D-Stat in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly diagnosed ML. We expect blinded data following enrollment of the first 80 evaluable patients in this study to assess minimal residual disease and complete response rates between the study arm and the control arm.

<unk> intentionally or occurs naturally are not anticipated to be resistant to turn back some of the reverse is true as well in fact, the mutations required for resistance to Tim Baxter significantly weakened the virus and reduce its lethality and having both tablet and suspension.

Formulations covering all age groups is also in the central and enhancement to our readiness.

From BARDA remains actively involved in our current development contract and celebrated the approval of the 10 back to the as their 60 et cetera approval in partnership with industry anticipated.

We anticipate in the RFP associated with a pure procurement contract. We have already completed work likely required for a response to that RFP that puts us in a position to possibly expedite the time from RFP the contract.

We've also counted on.

Sorry continued to execute the necessary steps to support the first shipment of up to $100 million of product into the stockpile and from the communication standpoint, we will issue an 8-K. So investors are notified as the RFP is posted to the government website as is their practice.

Michael T. Andriole: This analysis is expected to take place in the second half of 2022. With that, I'll now turn the call over to Mike Andrea for a review of the financials. Mike?

Moving now to walk through of 1 and particularly our work in age 3 K twenty-seven M using <unk> in.

In preparation for an updated efficacy analysis, including a blinded independent Central review, we've spent the last several weeks querying cleaning and locking the database is comprised of the registration cohort of 50 patients with recurrent atria K 27, a M usage diffuse midline glioma Hoover.

Michael T. Andriole: Thanks, Mike, and good morning, everyone. As Michelle mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the second quarter of 2021. Starting with our balance sheet, we remain well capitalized and ended the second quarter of 2021 with approximately $140 million in capital to fund operations. We have several key milestones upcoming for Tembxa, Inc. 201, and DSTAT, and are well funded through those milestones. Additionally, funding from a possible part of a procurement contract could provide $80 to $100 million annually to support our ongoing research and development program.

Receive single agent at 2 of ones and recall that these patients represent the first 50 enrolled across 5 different studies, who met very specific criteria for inclusion in the registration cohort the <unk>.

Criteria were really designed to create the most homogenous patient population and isolate the treatment effect for measurement of the primary overall response endpoint all of these patients have measurable diffuse smid likely OMA the harbored the ace III K twenty-seven M M mutation.

The mutation.

And have evidence of progression following radiation therapy administered at least 90 days prior and in many cases. These patients had progressed following additional post radiation therapy. So the swap of where also gathering the data associated with the handful of patients who met all of those criteria of for that cohort and have disease outside.

The midline.

This data will be evaluated by a team of blinded independent central reviewers or of the ICR and we expect to share of the efficacy analysis of rising from that effort in the fourth quarter of this year.

The key elements of that analysis will include the overall response rate as of satisfy raynaud criteria of the.

We anticipate sharing the same data along with other information such as an ongoing natural history study with the F. D. A and the E. M E, which may then formed the basis of an accelerated approval of on 201.

Michael T. Andriole: The main driver of this increase was the addition of personnel, clinical, and development expenses following the acquisition of oncocytics to support the addition of Off 201 to the pipeline. General and Administrative expenses increased to $4.4 million for the second quarter of 21 compared to $3.1 million for the same period in 2020. With that overview, I'll now turn the call back over to Mike for closing remarks.

This multi center randomized double blind.

Placebo controlled study is evaluating the efficacy and safety of these debt in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly diagnosed AML patients.

We expect the unblinded data following enrollment of the first 80 evaluable patients in this study to assess minimal residual disease and complete response rates between the study arm and the control arm.

This analysis, we expect to take place in the second half of 2022.

Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Noreen Quabra with Maxim Group.

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

Thanks, Mike and good morning, everyone.

As Michelle mentioned in her introductory remarks earlier today, we yesterday press release companion of our financial results for the second quarter of 2021.

Naureen Quibria: Hi, good morning, and congratulations on the progress, especially with Convex Approval. Thanks for taking my questions. So I was just wondering, with regard to the barter with Bartah, just, you know, we now have a new surge and the Delta variant and so forth. So are you aware of any shifts in their priorities potentially from earlier in the year?

Starting with our balance sheet, we remain well capitalized and ended the second quarter of 2021 with approximately of $140 million in capital to fund operations. We have several key milestones of come in on come back. So on 2 of 1 and do you stay out and are well funded through those milestones.

Additionally, funding from the possible BARDA procurement contract could provide $80 million to $100 million annually to support our ongoing research and development programs.

Turning to our statement of operations the company reported a net loss of $17.8 million or 21 cents per basic and diluted share for the second quarter of 2021 compared with the net loss of $10 million of 16 per basic and diluted share.

Michael A. Sherman: No, no, I think the short answer is that where they've had a pinch has been in their contracting group, and I don't think that that has been impacted by the sort of recent activity or the recent surge in COVID, for sure. We have ongoing contact and communication with Barta just based on our ongoing kind of relationship with the development contract that exists today. And, you know, we continue to have recent conversations that support our expectation that we need to be ready to ship product into the stockpile before the end of the year.

In the second quarter of 2020.

Revenues from the second quarter of 2021 were zero point $4 million compared to $1.4 million from the same period of 2020 free.

Research and development of expenses increased to $13.8 million from the second quarter of 2021 compared to $8.6 million from the same period in 2020. The main driver of this increase was the addition of personnel clinical and development of expenses. Following the acquisition of Democracy works to support. The addition of onto a once of the pipeline.

General and administrative expenses increased to $4.4 million from the second quarter of 'twenty, 1 compared to $3.1 million from the same period of 2020 with that overview on I'll turn the call back over to Mike for closing remarks.

Thanks, Mike as you can see we've made meaningful progress throughout the first half of 2020.1 of our recent FDA approval sets the stage for of BARDA procurement contract and the advancements we've made with our oncology program of leave us well positioned to achieve several value creating milestones throughout the balance.

Michael A. Sherman: Oh, got it. That's really helpful. And then, with regard to the D-Stat program, are you actually able to comment on or shed any light on the enrollment numbers and accrual rate at this point?

<unk> of this year and beyond with that let me turn of the call over to the operator and we can take your questions.

As a reminder to ask a question do we need the press star 1 on your telephone so 1 of the drawing of a question first of the pound key.

Please standby, while we compile the Q&A roster.

Your first question comes from the line of Nova and QUADRA with Maxim Group.

Hi, good morning, and congratulations on the progress on especially who many of them can make sense of all and thanks for taking my questions.

Michael A. Sherman: Got it. And just one more for me. With regard to the On 201 program, you know, there was a presentation at ASCO on the Paragangliama study, the ISC study. So would we, in addition to obviously the top-line data coming out of, you know, the registration cohort, will we see more from the other study on that?

Just wondering with regards to the part of with BARDA.

We now have a new surge in the Delta there and then it sounds like so are you aware of any shifts in their priorities potentially from earlier in the year.

No no I think the short answer is that the where they'd had a pinch has been in their contracting group M.

And and and I don't think that that has been impacted by the sort of the recent activity or the recent surge in COVID-19 for sure.

Michael A. Sherman: Yeah, so the updates from a clinical standpoint will come from really two things. One is the registration cohort, and the second I referred to was potentially this other group of patients that were following that sort of meet all of the criteria of that cohort, except that they have disease outside of the midline structure. I would not expect an update on the paragon glioma. We also have an ongoing trial with Ong 206, and that's also probably early as that's in the dose-escalation phase for updates. So those will come later.

We haven't.

Contact from the communication with BARDA just based on our are ongoing.

The kind of relationship with the the development contract that exists today and we.

We continue to have recent conversations that support.

Our expectation that we need to be ready to ship product into the stockpile before the end of the year.

Oh got it that's really helpful.

And then with regards to the D. Stat program are you actually able to comment on them or shed any color on the enrolment numbers any accrual rate at this point.

Yeah, it's probably still too early to.

Identify enrollment.

Trends as we're still activating sites are so so and then I don't tend to get on the habit of of getting of course.

Clearly updates on enrollment numbers, but our expectation at this point is that we would have the analysis of the 80 patient.

Operator: Okay, all right, thank you for taking my question. Thank you. Your next question comes from the line of Joseph.

Our first assessment in the second half of next year.

Operator: Your next question comes from the line of Joseph Thome with Calvin and Company.

Got it.

Just 1 more from me with regards to the onto of 1 program and you know the there was some there was the presentation and ask on the parents of young Guy.

Joseph John: We are going to see the reanalysis of the whole Pivotal cohort later this year. But we have already seen, you know, a good group of patients that have responded to the review.

Ganglia on the study the ice.

The study so would we in addition to obviously the top line data coming out of <unk>.

The registration cohort will we see more from some of the other study on that.

Joseph John: Is there anything different, I guess, between the analysis that took place with that initial subset and that initial blinded independent review and what's going to happen later in the year that may, you know, change responses for the better or the worse? And then second, because you did mention the subset of patients that do have disease outside the midline. How are you thinking about including that in a regulatory submission, and maybe from an efficacy standpoint, is there any reason why patients that have midline tumors or non-midlight tumors would perform better?

And on that.

Yeah. So the the updates from a clinical standpoint will come from.

Really 2 things 1 is the registration cohort in the second I referred to was essentially the other group of patients that were following the debt.

Sort of meet all of the criteria of the of that cohort, except that they have disease of outside of the midline structure.

I would not expect on up.

The data on the the Paragon Glioma, we also have an ongoing.

Ah trial with with off 2 of 6 and that's also probably early.

As the best in dose escalation phase for updates so those would come come later.

Okay Alright, thank you for taking my question.

Michael A. Sherman: Yeah, so let me handle the first question about the change in the analysis, and I'll let Josh and Alan talk about the non-midline patients and how those might be incorporated and how we anticipate that to transition to a potential label. The first question relates to the analysis of these patients. In fact, the analysis is essentially will be the same from a criteria perspective.

Your next question comes from the line of Joseph Thome with Cowen and company.

Hello, Good morning, and thank you for taking my questions.

The first 1 on on 201.

We are going to see the the reanalysis of the.

The whole of pivotal cohort.

This year.

But we have already seen pick of the patients that have had responses.

The review is there anything different I guess between the analysis that took place with that initial subset and that.

Initial line.

Blinded independent review of what's going to happen later in the year that may change the responses for the better of the worst and then second because he did mention the subset of patients since you have disease outside of the mid line, maybe how are you thinking about including that in and of regulatory submission.

Michael A. Sherman: So the renal criteria as it relates to the overall responses are very strict and well-defined criteria. The difference in what was performed previously is that analysis was covering just a portion of those 50 patients, so we'll cover all of those patients in this analysis. Secondly, the previous blinded assessment was performed by a single blinded reviewer. This will be performed by a single blinded reviewer. a group of reviewers, so two reviewers with a third reviewer to adjudicate if there are any differences between those. And sometimes it's possible with these images that you can have slightly different interpretations of the reduction.

And maybe from an efficacy standpoint is there any reason why patients are that having the right tumors are not on an I tunes would perform better or worse.

Yeah. So let me let me handle the first question about the change in the enel or any change in the analysis and I'll, let the.

Josh and Alan to talk about the non midline patience and how those might be incorporated in how we anticipate that the transition to a potential label on it.

The the first question relates to the analysis of these patients in fact, the analysis of the essentially will be the same from a criteria perspective, so the rain out criteria as it relates to the overall responses is very strict and well defined criteria.

The difference in what was performed previously.

Number 1.

That that analysis was was covering just the portion of those of those 50 patients. So we'll cover all of those patients in this in this analysis.

Currently the previous blinded assessment was performed by a single blinded review of this will be performed by a.

The group of reviewers so 2 reviewers with the third reviewer to adjudicate if there are any differences between those.

Michael A. Sherman: And there is a threshold at 50%, for example, that is required to be met for two successive scans. And we've talked about a couple of the patients that are both right, just short of that 50% reduction that you could imagine could be read differently. and become a response, and the reverse is true as well. That having been said, we had our independent reviewer as part of our diligence look at the scans and really found very high concordance between what he reviewed and what was reviewed by the blinded independent central reviewer and, for that matter, the investigators, not only on the best response, which I think is obviously interesting and important for the overall response trade assessment, but maybe as important, the over the time series where you see the durability of these responses and for the patients that have responded, that response has been quite durable of progression free survival, those patients in excess of 15 months.

And sometimes it's possible with these images that debt you can have slightly different.

Interpretations of of the of the reduction in there is the threshold of 50%. For example that is required to be met for 2 successive scans and and we've talked about a couple of the the patients that are both bright just short of that 50% reduction that you could imagine could could.

The red differently and become a response and the reverse is true as well that having been said we had our independent reviewer as part of our diligence look at at the scans and really found very high concordance between what he reviewed and what was reviewed by the blinded independent Central review.

The reviewer and for that matter of the investigators not only on the best response, which I think is is obviously interesting and important for the overall response rate of assessment, but maybe as important the over the time series, where you see the durability of these responses and 4 of the patients that have responded.

Response has been quite durable of progression free survival.

Patients in excess of 15 months, so durability will be I think of key element of how the FDA looks at at this response.

Sure Good morning, Joseph So with respect to the midline. The non deadline question that I'd like to start with a reminder, that the requirement of <unk>.

Involvement of the midline with the disease too to be included in the registration cohort is really driven by a desire to select the adequately homogeneous population with respect to natural history subjects without midline involvement, but with inclusion of the <unk> 27 day mutation of the disease.

Allen S. Melemed: Hi, this is Alan Melman. The only additional ad is that our primary registration code will be in the midline with the other characteristics that Josh mentioned. This will be additional supportive data for FDA to review the activity of October 1, which to me will be, we hope, supportive data for approval.

Are still regarded as a life threatening disease that does not have proven effective treatments.

Just that this is a relatively rare population and the prognosis of those patients have not been adequately study. So due to the lack of knowledge really with regards to natural history those subjects were excluded.

Debt from the primary registration cohort that being said we view those.

Operator: Your next question comes on the line from Sumit Roy with Jones Trading.

The issues as distinct from whether or not the treatment effect of about 201 extends to those patients with disease outside of the deadline.

Soumit Roy: Hi, good morning everyone, and congratulations on all the progress. Just to elaborate a little bit more on the Ong 2-1 data, what would be the median duration of the drug you anticipate by the time you have the database closed? And any thoughts on how you're probably trying to improve on getting more responders if you're thinking of going earlier in the line or combination trials? Any thoughts for the future? I'll start that and

For that reason, we still included those subjects of enrollment of clinical trials and what you saw on <unk> was the release of those patients who meet all of the same criteria within the registration cohort, except the do not have Midland involvement of disease.

You can see from the data that was reported there we saw a similar pattern of objective response rate in clinical benefit.

Merchant of those patients.

At a small sample size given the it's a rare population.

Helped to support a picture of.

On the tier ones treatment effect of extending to H <unk> 27 of the mutant glioma, regardless of tumor location.

I'd like to turn it over to Alan to just comment.

With regards to how that would be helpful in thinking about labeling.

Excellent that is very helpful. Thank you very much.

Your next question comes from the on line of Sumit Roy with Jones trading.

Joshua E. Allen: about the, the, either add to that, and then we can talk about how we're thinking about the additional populations going forward. Yeah, nothing to add to the maturity of the data. I think that's well characterized.

Hi, good morning, everyone and congratulations on all of the programs just to elaborate a little bit more on the on tier 1.

The data what would be the.

Median duration of drug you anticipate by the time you will have term the dws close.

And.

Any thoughts on how you were trying to build.

The only improve on getting more of responders. The if youre thinking of going earlier in the line or combination trials of any thoughts from the future.

Joshua E. Allen: It's been greater than one year for the cohort. With respect to, I believe the question was aimed at how to potentially improve response rates; will we potentially pursue combination therapies or earlier lines of therapy? And I think the answer is both are in the works.

I'll start that and maybe Josh you can chime into 1 way to if I'm the under.

The send your first question correctly.

Correctly about the median duration of of drug the last patients.

The to be enrolled in that are included in that.

50 cohort would be on on drug for more than the years, So you're probably at the.

Joshua E. Allen: So first of all, with regard to moving towards frontline therapy, that is supported by a subgroup analysis performed at snow of last year and released indicating that the predictors of increased likelihood of response were in line with, number one, having smaller baseline tumor size, and number two, pertaining to patients who have not had salvage of asthma treatment at the time they initiated OX 201, both of which point to starting therapy earlier in the course of their disease may be associated That, those clinical findings, in addition to the fact that ACHO1 exhibits either additive or synergistic activity, and the preclinical model leads one to believe that moving towards the frontline setting in this disease would make a lot of sense.

14, plus the months, so close to close 2 of a year and a half of.

The median I don't I'm not sure what that is but it's it's it's.

Obviously far in excess of that and so I guess I would characterize the the.

The maturity of of this follow up is as it.

It is quite good it will give a good picture of not only responses, but the durability of those responses across the across the cohort.

And maybe maybe let me hand, it over to Josh to talk a little bit about.

The the either add to that and then we can talk about how we're thinking about the.

The additional populations going forward.

Yeah, no nothing to add on the on the maturity of the data I think that's book characterized the scrape within 1 year for the cohort.

With respect to our I believe the question was.

Aimed at how the potentially improved response rates will we potentially pursue combination therapies or earlier lines of therapy and I think the answer is both.

Both are of the work. So first first of all with regards to moving towards frontline therapy that is supported by a subgroup analysis performed debt snow of last few year and released indicating that the.

The predictors of increased likelihood of response were in lined with number 1 of having smaller baseline tumor size and number 2.

The debt pertaining to patients who have not had south of what you've asked the treatment at the time they've initiated off 2 of what both of which point to starting.

Therapy or in earlier in the course of their disease may be associated with an increased likelihood of response.

That those those clinical findings in addition to the fact that our 2.1 exhibits either additive to synergy or synergistic activity of preclinical model lead 1 to believe that moving towards the frontline setting.

In this disease would make a lot of sense to debt and our pediatric program from 2 of 1 study of arc <unk> is already.

Joshua E. Allen: And we look forward to working with those investigators towards a combinatorial trial in the future that prioritizes the top hits from that effort. One of the things you think about this landscape and other products that are in development, including CAR-T, specifically targeting 8K27M, I think given the severity of this disease, the expectation is, and the hope is that there are at least one or more other drugs that can help these patients.

Moving the drug into the frontline setting in combination of radiation and we've seen the safety profile of the agent be maintained in that setting. So clearly the movement towards frontline therapy. In this disease is a clear direction on the molecule in.

In addition, the.

The published literature shows on the tier 1 is synergistic with a wide variety of interest cancer agents.

There have been a number of investigators who have cooperatively taken on the task of prioritizing synergistic agents for the arc 201.

Joshua E. Allen: And ultimately, one of the advantages of Alt-201 is that you would expect to be able to combine it with any of those and be able to do that safely. So in a way, I don't see a substantial competitive threat. This is an opportunity for combination down the road.

Specifically the entities Snoop on the almost.

We look forward to working with those investigators towards a covenant sorial trial in the future of that prioritizes stuff the the top cuts out of that effort.

1 of the things that you think about.

This landscape and and other products that are in development, including those of car T. Specifically targeting 8-K 27, a M I.

Michael A. Sherman: The other subtlety I would mention is the way this trial was designed in order to isolate the response of this single agent on 201 and, particularly, distance it from the initial radiation therapy by at least 90 days. What you would expect, and most physicians will say this, they would much prefer, whether it's, you know, in combination with radiation or radiation, or even if it immediately follows radiation, as opposed to waiting for these patients to progress, and their disease to advance.

I think given the severity of this disease.

The the expectation is and then the hope is that there there are at least 1 or more other drugs that can help these patients and ultimately.

The 1 of the advantages of on 201 is that you would expect to be able to combine it with any of those.

And be able to do that safely so in a way I don't see a.

The substantial competitive threat this of the combination opportunity down down the road the other subtlety I would.

Mention is the the way that this trial was designed in order to isolate the response of the single agent onto of 1 and particularly distancing the of the initial radiation therapy by at least 90 days, what you would expect in the most.

Physicians will say this they would much prefer whether it's.

In combination with radiation or even if it immediately follows radiation as opposed to waiting for the these patients to progress in their disease advance on so you could see a sort of a middle ground, there where you would at least move the the drug closer to frontline therapy for.

Operator: As a reminder to ask a question, you will need to press star, then the number one on your keyboard alone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your next question comes from the line in Maury Ray Cross with Jeffries.

Potentially more activity so.

Anyway of about 2.2 I think the additional points to consider as you think about the utilization of the drug going forward.

Great really helpful. Thank you so much.

As a reminder to ask a question you will need the press Star then the number 1 I guess all of the town. So what's the drawing a question press the pound key please standby, while we compile the Q&A roster.

Maurice Thomas Raycroft: Thank you.

Your next question comes from the mine of Maury Raycroft with Jefferies.

Maurice Thomas Raycroft: Just a clarification on the 201 analysis. You mentioned there would be a group of reviewers. Can you elaborate on that?

Hi, good morning, everyone. Congrats on the progress and thanks for taking my questions interest.

Clarification on the 201 analysis, you mentioned there will be a group of Berkeley viewers can you elaborate on that I guess, how many reviewers will be involved and can you talk more about how the process will work.

Michael A. Sherman: I guess how many reviewers will be involved and can you talk more about how the process will work? I'll give you the real high level, and Josh or Allen can give a little bit more detail if it's helpful. But I think it's important to start by remembering that this Rano criteria is, it does go beyond just an imaging assessment. It's one of the things that I think is important to remember about the Rano criteria.

Now I'll give the real high level and the Joshua Alan can give a little bit more detail. If that's if it's helpful. But.

The the.

I think it's important to start by remembering that this raynaud criteria is it does go beyond just the imaging assessment of its 1 of the things that I think is important to remember about a range of criteria of these these responses are sort of.

Michael A. Sherman: These responses are sort of legitimized by not just the imaging response but also the clinical activity around it. You cannot have a bona fide renal response if there is an increasing use of corticosteroids or if there's a deterioration in performance status.

The legitimized by not just the the imaging the response, but also of the clinical activity around that you cannot have a bona fide renal response, if there is an.

<unk> use of corticosteroids or if there's a deterioration in the performance status. So all of those are elements of of the review in this case there will be 2 reviewers that are assessing the scans and the associated data and then where there was a disagreement there would be a third of that adjudicates that and that's really the preferred.

Michael A. Sherman: So all of those are elements of the review. In this case, there will be two reviewers that are assessing the scans and the associated data. And then where there's a disagreement, there would be a third party that adjudicates that. And that's really the preferred approach by the FDA, and that's the reason that we have the protocol structured as such. I don't know if there are additional details, Josh or Alan, that you think would be helpful to add to that. And this is the only thing I'll add.

Hum.

Approach the by the FDA and Thats the reason that we have.

Have the protocol of structured.

I don't know if there are additional details Joshua or Alan.

Helpful to add to that.

Joshua E. Allen: And this is the only thing I'll add is that we're using a vendor that has a lot of experience in doing these reviews. So we're

And this is Alan the only thing I'll add is we are using a vendor that has a lot of experience in doing these reviews. So there.

Maurice Thomas Raycroft: Got it. Okay, that's helpful. And apologies if I,

Terry.

Got it Okay. That's helpful and apologies if I missed this at the beginning of the call before the conducts of procurement contract based on your conversations do you have a sense of whether BARDA is taking a longer time because of administrative backlog or are there. Other gating factors involved that you can comment on.

Michael A. Sherman: Apologies if I missed this at the beginning of the call, but for the KMexo procurement contract, based on your conversations, do you have a sense of whether BARTA is taking a longer time because of administrative backlogs or are there other dating factors involved that you can comment on? Yeah, my sense is that it's an administrative issue and one that, as I mentioned, based on the conversations that we have had and which are ongoing related to the open development agreement, the expectation is that we need to be ready, at least for a potential shipment into the stockpile later this year. So there's been no change in terms of Barta's enthusiasm and priority around this program. And, as I mentioned in my commentary, they are quite the opposite.

Yeah. My my sense is that as the it's an administrative.

Issue and 1 that as I as I mentioned based on the conversations that we have in the which are ongoing related to the the open development agreement on.

Our our.

Expectation is that we need to be ready.

At least for a potential shipments of the stockpile of later this year. So there is there's been no change in terms of Bartizan enthusiasm and priority around this program and as I mentioned in my commentary. The they are quite the opposite they were celebrating the this this approval of 2 important 1 for the stock.

While given the.

On the vulnerability.

Or were you just got 1 countermeasure and the possibility and frankly, the likelihood that you would have a resistance train emerge on these 2 drugs in the stockpile are really quite complementary in a number of ways. So.

Michael A. Sherman: These two drugs in the stockpile are really quite complementary in a number of ways, so I think it's a dramatic improvement on the state of the stockpile when you can add this, or improve the quality of the stockpile. And I do think, and I've seen quotes from, you know, there's been some change in leadership with the new administration and just a couple of signs that this continues to be a priority. One is an acknowledgement by the ASPR leadership that they will be measured by, you know, how well this stockpile is positioned broadly, not just as it relates to COVID.

It's a dramatic improvement in the state of the stockpile.

When.

When you can add this or the quality of the stockpile and I do think and I've seen quotes from the Theres been some change in leadership.

With New administration, and just a couple of times that this continues to be a priority 1 is an acknowledgment of.

By the the aspirate leadership that they will be measured by.

How how.

Well the stockpile is positioned broadly not just as it relates to Covid number 1 and number 2 the the draft budget.

Michael A. Sherman: Number one, and number two, the draft budget as prepared by this administration calls out this product, our product, by name, and includes it in a way that's consistent with what we would have expected in the future budgets. And we know that they've had funding earmarked for this for some time. So I really don't expect that it's more a question of pining than it is a question of the FF. Gotten.

Prepared by the administration.

Called out this product our product by name.

It includes it in a way that's consistent with what we would of.

Expected in the in.

In the in the.

Future budgets and then we know that they've had a funding earmarked for this for some time so.

I really don't don't expect the that there's it's more a question of timing than it is a question of of this.

Michael A. Sherman: Okay, that's really helpful. And maybe last question, just wondering if there's any new perspective on the potential for using MRD or MRD as an elevated or prioritized endpoint in your AML phase three. Have you had any new conversations with regulators or even experts on the topic that you can comment on? I'll start that, and maybe Alan can add if I missed something, but the only thing that's really changed in recent months is the announcement by Kronos that they are using that as the primary endpoint for their endpoint. It's in a different patient population, so there are some differences that probably lend themselves to being more acceptable or potentially more acceptable as a primary endpoint. So I think there's continued momentum in that regard.

Got it Okay. That's really helpful and maybe last question just wondering if there's any new perspective on potential on using MRI D or MRV and elevated our prioritized endpoint and your AML phase III have you had any new conversations with regulators or even experts on the topic that you can comment on cash.

I'll start that and maybe Allen can add if I Miss something but the only thing that's really changed in recent months as the.

The announcement of a by Kronos that they are using that as a primary endpoint for there in all studies from the different patient populations. So there's some some differences that debt probably lend itself is more acceptable or potentially more acceptable wasn't as the primary endpoint.

So I think there's continued momentum in that regard and we don't really plan to have a a follow up conversation until we have some data to share with the FDA. They they let we left the conversation with them is we've got alignment on our phase III trial quite positively as it related to M. D. We either to the.

Michael A. Sherman: We don't really plan to have a follow-up conversation until we have some data to share with the FDA. They, they let us, we left the conversation with them as we got alignment on our phase three trial quite positively as it related to MRD. We, to the point that we discussed the possibility of switching our endpoint to MRD, and their feedback was, you know, as long as you haven't, as long as you're still blinded to whatever data you're including in that assessment, then that would be something that they would be open to, subject to presenting some data.

The point that we discussed the possibility of switching our endpoint to 2 M D and and the feedback was you know as long as you haven't as long as you're still blinded to whatever data you are including in that assessment, then that that would be something that they would be open to subject to presenting some data. So I think the <unk>.

Strategy would be if we have some data that's that's meaningful that comes from that first patient cohort.

1 scenario is that you just move ahead with the existing Ah trial.

And the kind of the design of of that trial and MRV has the support of endpoint.

Michael A. Sherman: And MRD is a supportive endpoint instead of a primary. Another scenario is that you flip to MRD as a primary endpoint. It wouldn't really change any of the execution of the process of the primary endpoint. protocol so you could do that in the stream. Got it. Okay. That's very helpful. Thanks for answering my questions.

Instead of a primary another scenario is that you flipped to 2 M. D. As the primary endpoint of it wouldn't really change any of the execution of the.

The of the protocol, so you could do that midstream.

Got it okay. That's very helpful. Thanks for taking my question.

Operator: At this time, there are no further questions. I would now like to turn the call back over to Mr. Mike Sherman.

Thanks Mark.

At this time there are no further questions I would now like to turn the call back over to Mr. Mike Sherman.

Michael A. Sherman: Well, again, thank everyone for joining us and I look forward to giving you updates, important updates coming up later this year.

Well again, thanks, everyone for joining us and look forward to giving you updates the importance of updates coming up the later this year.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

Good day.

This concludes today's conference call. Thank you for participating you may now disconnect.

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