Good morning, ladies, and gentlemen, and welcome to the Chimerix First Quarter 2022 Earnings Conference Call. I would now like to introduce to your host for today's call Michelle Laspaluto, Vice President of Strategic Planning, and Investor Relations at Chimerix. Please proceed..

Thank you. Good morning, everyone and welcome to the Chimerix first-quarter 2022, financial and operating results conference call. This morning, we issued two press releases when to announce the sale of TEMBEXA to Emergent Bio Solutions, and one announcing our first-quarter operating operations.

You can access these press releases in our Investors section of the website. With me on today's call are President and Chief Executive Officer Mike Sherman, Chief Financial Officer, Allen Melemed, Chief Financial and Business Officer, Mike Andriole and our Chief and [Indiscernible] Technology Officer, Josh Allen.

Before we begin, I would like to remind you that the statements made on today's call include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties and other factors.

These risks and uncertainties, and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. Please refer to our filings with the SEC for more complete disclosure of these risks and uncertainties.

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

Thanks, Michelle. Good morning, everyone. Thanks for joining us. We've had an active couple of months. So, let me get right to the updates and I'll start with TEMBEXA. This program has been central to our strategy for a couple of reasons. First, we're fulfilling an important need to protect the population from the possibility of a smallpox outbreak.

And we've done that with the first treatment approved for all ages and one that's likely robust even in the face of the inevitable mutations that compromise the efficacy of other treatments. Our ongoing negotiations with BARDA are progressing well to satisfy this for subjective.

Second reason, TEMBEXA is central to our strategy is because it will serve as an important mechanism to fund our ongoing development in Oncology. This is a particular value at a time when access to capital within the biotech sector is so challenging. With that in mind, we're excited to announce this transaction with Emergent BioSolutions.

The sale of worldwide rights to TEMBEXA. It secures substantial capital to fund our business, it allows us to focus our execution on the development pipeline, and it positions the asset in the hands of a company that's well-suited to maximize its value. We will continue to participate in via milestones and royalties.

Emergent’ s are leading biodefense company with substantial experience in working with government agencies to assure the protection of the populations health.

In securing the upfront capital with this transaction, we positioned ourselves well to fund our pipeline without the ongoing uncertainty of future procurements, which as you know, can be variable depending on the government's evolving priorities.

We continue to control the BARDA contract negotiation to its completion, which we still expect to occur later this quarter.

Following the signing of the procurement contract and closing of the emergent transaction, we look forward to facilitating the smooth transition, particularly as it relates to the well-established supply chain for TEMBEXA, which emergent intends to continue to utilize. I'll let Mike Andriole cover the key terms of this transaction in a moment.

Suffice it to say, we're very pleased to bring this transaction to fruition as it just makes great strategic sense for both organizations. Let me now turn for a few minutes to ONC201. All right.

We recently engaged several key opinion leaders in the Neuro -Oncology field who participated in our advisory board, supporting the design of our Phase 3 randomized trial in H3 K27M mutant glioma. That engagement has been a great reminder of both the unmet need in this population and the physician enthusiasm ONC201 as a treatment.

It's a combination of these two factors which drive physicians and patients to seek out this treatment today and it will continue to be the engine driving enrollment in our Phase 3 trial. In our recent engagement with the FDA to discuss the Phase 3 design and our analytical plans around the natural disease history study.

They took the opportunity to provide feedback on potential accelerated approval path. To be clear, we did not seek formal feedback on that question as we anticipated those discussions would take place as we completed the safety database and some of the ongoing clinical pharmacology supporting work.

In other words when one would have had a more informed perspective on risk benefit. That being said, their feedback made it clear that an accelerated approval would be more challenging than we previously anticipated.

To be sure, the FDA 's recent public commentary on the accelerated approval path, particularly within oncology, has certainly not been supportive of single-arm data going forward. The FDA also let us know it no longer plans to rely on a natural disease history study as a comparator due to its inherent limitations.

We've had this study underway with the expectation that would be part of the potential submission. That being said, we plan to wrap it up, the study with the patient data we have already in process and will look to publish our findings.

Based on FDA's feedback, this data is likely less meaningful in their decision process and yet, we would still expect to include it in a potential accelerated approval submission.

Let me underscore that we're not throwing in the towel on a potential accelerate approval pathway, but we need to prepare for the likelihood that the first approval may come with completion of the Phase III.

We also need to prepare for the likelihood that if we do pursue accelerate approval, the FDA will be less likely to allow for certain work to be completed during a rolling submission or as part of post-marketing commitments, as we had previously expected.

Over the last year, we've successfully completed healthy volunteer safety and PK studies, improved the liquid formulation for pediatrics. We've evaluated concurrent medication and food effects on pharmacokinetics, and are now evaluating special populations, including subjects with renal and hepatic impairment. That work has all gone very well.

Other work to be performed includes a cardiac-safety study and popPK modeling. These studies extend into the first half of next year and would be gating items for submission for accelerated approval.

And in the hold off on sharing too many details of the Phase 3 trial designers we're working quickly to get closure with the FDA on a couple of elements, but I will make a few comments about it.

The trial with initiation later this year will enroll H3 K27M mutant Glioma patients, both pediatric and adult, and we'll treat newly diagnosed patients at the conclusion of their standard radiation regimen. Patients will be randomized ONC201 or placebo at that time.

We're planning on overall survival as the primary endpoint, which of course if it’s successful we'll maximize the value of this agent. We believe this trial can be completed quickly, with rapid times to events and including early interim analysis.

As we said all along the strict criteria required for the cohort of patients evaluated to-date is not likely the optimal setting for ONC201. It was defined more to ensure the single agent activity was isolated, and yet the data is still compelling.

As a result, we're really excited about this Phase 3 trial as it deploys ONC201 at a time in the treatment cycle when it's most likely to show maximum benefit to patients. We'll come back with the final design elements, powering assumptions, and timelines in the coming weeks as we have final alignment with the FDA.

Finally, as we highlighted in our release, we terminated our DSTAT program along with the sale of TEMBEXA. This will reduce our spending and we'll give us tremendous focus on the [Indiscernible] platform and execution there.

With that, I'll turn it over to Mike Andriole to share more about the TEMBEXA transaction and the financial results for the quarter..

Thanks, Mike. And good morning, everyone. I'd like to start with a few comments about the financial implications of the strategic decisions we announced this morning.

First the upfront proceeds from the expected sale of TEMBEXA not only provide financial stability for the foreseeable future, it also shifts the ongoing capital investment in the program to Emergent. This taken together with the decision to terminate DSTAT development, meaningfully improves our forward-looking burn rate.

While our normalized burn rate in the most recent quarter was about $20 million, we expect the strategic decisions announced today to revert that burn back to about $15 million per quarter by the end of the year, or about $60 million annually. As we fully focus on the Imipridone platform, where we see evidence of clinical activity.

That said, we expect the proceeds from the TEMBEXA transaction to fund the organization into 2026. Between now and then, we'll have the potential for accelerated approval of ONC201 likely interim assessments of the ONC201 Phase 3 randomized controlled study, and likely the fully mature data from that study.

The potential for capital via milestone payments of up to a $100 million of realized may obviate the need for additional capital through commercialization of ONC201 if it's ultimately approved.

This deal also removes the year-to-year uncertainty of the government budgeting and procurement process from Chimerix and places it with Emergent an organization who has a key competency in that process. It's for that reason that the potential for future royalties in this transaction are also important.

There are several scenarios where the market for pandemic preparedness increases in the years to come and the royalties in this transaction enabled Chimerix to meaningfully participate in that growth. Will earn a 20% royalty on gross profit generated in the U.S. beyond the $1.7 million treatment courses expected in the first BARDA agreement.

Those royalties could be associated with additional volume from a second BARDA contract or from volumes associated with sales from other sources in the U.S. Included in the event of an actual smallpox outbreak. Of course, the value of those royalties and an outbreak scenario would likely be substantial.

Outside of the U.S., Chimerix will earn a 15% royalty on gross profit starting from the first sale.

And while we don't anticipate international revenue to be material in the near-term, we do believe the Emergent is well-positioned to maximize the utilization of the product globally, and royalty revenue from international sales may become material in the years to come. I'll now turn to a quick recap of the financial results for the quarter.

Starting with our statement of operations, the company reported a net loss of $24.8 million with $0.28 per basic and diluted share for the first quarter of 2022, compared with a net loss of $97.4 million or $1.21 per basic and diluted share for the first quarter of 2021.

The decrease is mainly due to the recording of the in-process R&D associated with the Oncoceutics transaction in the comparable period last year of $82.9 million. R&D expenses increased to $19 million for the First Quarter of '22, compared to $11.9 million in the same period of '21.

The main driver of that increases the ongoing development related ONC201, general and administrative expenses increased to $5.6 million for the quarter compared to $4.1 million for the same period in 2021.

Turning now into the balance sheet, during the First Quarter, we paid the $14 million note payable to the Oncoceutics shareholders associated with the acquisition of Oncoceutics in Q1 last year. Importantly, no further payments are due from that transaction until either approval of ONC201 or ONC206 in the U.S. or Europe.

Net of that repayment, we ended the first quarter of 2022 with approximately $53.4 million in capital to fund operations. We expect to receive the upfront payment of $225 million associated with the sale of TEMBEXA to Emergent at closing of that transaction.

That closing could take places as early as the end of June or shortly thereafter, dependent on antitrust clearance of the transaction and the finalization of be expected BARDA procurement contract. With that overview, I'll now turn the call back to Mike Sherman for closing remarks. Mike..

Thanks, Mike. Let me just conclude a few key points. First, we've secured substantial capital efficient to deliver our development strategy and have a partner well-suited to maximize the likelihood of additional capital to come.

Secondly, we reduced planned spending and focused our efforts to maximize the speed of our execution on the programs with the highest likelihood of success. And third, we have a lead program with among the most compelling and internally consistent efficacy data you'll see relative to the depth of the unmet need in H3 K27M Glioma.

We're working quickly to initiate the Phase 3 trial, which would be the basis for first approval or as a confirmatory approval following an accelerated approval, if we're successful with that path. With that Operator, we'll open the call to questions..

Thank you. In a few will [Indiscernible] a question during this time, [Operator Instructions]. Our first question comes from the line of Maury Raycroft of Jefferies. Your line is open..

Thanks for taking my questions. I guess just starting off with TEMBEXA. Can you talk about some of the continued gating factors for the BARDA contract for TEMBEXA? Maybe start there..

So that on -- that negotiation is ongoing. So, I need to be cautious in sort of making any commentary about the negotiation.

We're pretty far advanced, as you can imagine, given the notion that we still expect to be able to close that or sign that agreement before the end of this quarter, but beyond that, I'm not sure that I can add much more until it's done..

Okay. And then was there anything else that went into the decision to sell TEMBEXA prior to the negotiations finishing? You mentioned a few reasons, but I just wanted to see if there was due to any uncertainty to contract size..

I think it's fair to say that this decision was clearly informed by the ongoing negotiation and our -- the potential risks around our future procurements. And so, for us, the certainty of this upfront along with the participation in future economics was attractive.

And so, the risk profile associated with what we expect that agreements and future potential of that agreement, that risk profile I think fits better with Emergent and their capabilities and the certainty that fits better for our strategy..

Got it. It makes sense.

And can you talk a little bit about your views on anti-trust and just some of the diligence work that you've done there and if you see any risk to that?.

I'll let, Mike, respond to that..

We don't anticipate an issue there. Maury, of course, you always have to do the filing and go through the process, but our preliminary work doesn't cause us to expect an issue there..

Got it. Okay. Maybe last question just on the feedback with FDA on the accelerated approval path, did it have anything to do with the number of adults versus number of children in this study? I guess I'll leave it at that..

No. Now, their feedback was really quite general, which is one of the reasons why we continue to work on pulling the data analysis together to potentially pursue that path. Even though they've highlighted the risk of that is higher than we may have expected previously.

So, we're going to continue our work and then we'd plan on having a follow-up conversation with them and in a formal pre -NDA meeting..

Got it. Okay. Thanks for taking my questions, I'll head back in the queue..

Thanks, Maury..

Thank you. Next question comes from the line of Ed White of HC Wainwright. Your line is open..

Good morning. Thanks for taking my questions and congratulations on signing this deal..

[Indiscernible]..

You're welcome. Just a question about how the $225 million will be reflected on the income statement.

Would this be a one -- recorded as a one-time benefit to revenues or could it be spread out over time or are you still waiting to see how -- what the accounting treatment for this will be?.

It's Mike Andriole. We'll have to complete the work on the accounting treatment before answering that definitively, of course.

My expectation is that it will be recognized as revenue this year in its entirety, subject to [Indiscernible] is a scenario as we disclosed in the press release where there could be an adjustment either up or down depending on the final BARDA contract, although we don't expect -- based on what we know today, there could be an adjustment.

But we would expect all of that to be recognized this period subject to our definitive accounting review..

Okay. Thanks, Mike.

And then just on the $25 million potential -- the full potential $25 million milestone payments, can you just review what triggers those?.

They're triggered by the BARDA 's exercise of additional options in the agreement. And so, you may recall the structure of this agreement and other similar agreements is that there is a base period followed by a number of additional options to get to the number of treatment courses.

Those options are always at risk depending on BARDA 's option and into the future.

And so, as they exercise those options, should they exercise those options, that milestone payment would be earned by Chimerix and so each one is worth $25 million?.

Regardless of the size of the option. I would imagine..

There is a mechanism or getting into the details, there is a mechanism in the agreement where could technically be higher or lower depending on if the actual amount of the option is different from what we currently anticipate.

That can actually move in both directions, but we expected based on the current negotiation to be at or very near the $25 million..

Okay. Thanks, Mike. And just a final question on ONC201.

Has project optimist been brought up at all or can you talk about your thoughts on using the proper dose -- the dosing than it would be acceptable for the FDA or could they want you to look at other doses? And then also just as far as the Phase III protocol, I know you're going to give -- tell us more about that later, but how are you thinking about the size of the study? Thank you..

I'll answer the second part of that and then let Alan speak to project optimistly, I will hold off on describing the size of the trial. I -- we do think it's all relative.

Of course, what's your expectations are for your typical Phase III, but I think for in this population and given the treatment side effect, this is a trial that we can -- we expect to be able to complete relatively quickly. We also pleased that we could incorporate early analyses that again, given our anticipated treatment effect are likely to hit.

And so when we provide that update on the specific and those early analysis we'll be able to provide the powering assumptions for each of those and we'll provide that detail to investors as we get that locked up with the FDA in the coming weeks. Maybe Alan you can speak to some of the work that we've done on dose and so on..

Thank you, Mike. This is A - Allen Melemed. Regarding Project Optimist, as you know, this has been approached by initially the Dr. Pazdur and others due to concerns that a lot of oncology drugs in Phase III been based on the maximum tolerated dose.

And in the Phase III trial, they find that these doses have not been tolerable into having some safety issues and ability to give full doses in these patients. We had to have some discussion regarding Project Optimist. Let me just put a point on the doses that was utilized for ONC201 was not based on MTD.

We have pretty strong rationale based on where our dose was and it's a very safe dose, and what we've seen is obviously an effective dose. And we will continue to have our discussion FDA regarding ONC201 in this area..

Okay, thanks, Allan..

Thank you. Next question comes from the line of Naureen Quibria of Maxim. Your line is open..

Thank you. Congratulations on the TEMBEXA deal and thanks for taking my questions.

I guess the first ones on TEMBEXA, I was just wondering if you could comment on how the deal our negotiations came about with Emergent, who approached whom, or did you approach [Indiscernible]?.

Hey, Naureem. It's Mike. We've had sort of on and off conversations about their interest for a while, but those did not accelerate until more, more recently into what I'd say we're sort of true conversations about they're interest. It's obviously fits within their portfolio really, really very well.

It's not competitive with other agents in their portfolio given this is a treatment for a potential smallpox outbreak. And yet they've got other agents in their portfolio that leverage their government contracting capability and their biodefense strategy. And so, fits very well. Not a surprise, they were interested in this asset.

And as Mike Sherman said earlier, the value of substantial upfront capital, particularly in this market, in the certainty that provides in developing and commercializing our portfolio was -- made a lot of sense for us and the ability to continue to participate in the long-term upside.

If all of those options are ultimately exercised, is also important for us throughout for all the obvious reasons. So good deal dynamics between the two and I think will be the start of a good partnership on that program..

That makes sense. Thanks. So, let me switch over to ONC201. I'm just curious regarding the natural history study. You have sense of what might have changed the FDA's mind from requesting a study initially. And now it seems they won't be relying on that for regulatory decisions.

Why the switch?.

I don't know if I have a great answer for that, honestly, I'll let Allen maybe add to it. There are certain elements of any natural disease history study that they're inherent weaknesses and what you can conclude from those.

And yet there is substantial literature about and history of the FDA asking for those and any evaluating those as part of their consideration. So that was all known upfront, so I it's on a 100% clear why they would view this differently.

[Indiscernible] said, I do think that we would still provide that analysis as part of a potential accelerated approvals submission.

We continue to believe that would be supportive and we have no reason to believe that the findings from that work would suggest anything other than what we had previously expected that responses are rare or if ever occur in this population.

So, I think it can still be helpful, but we're going to limit our investment in that work based on their feedback..

All right. Okay. I just want more --.

Can I just --.

Sorry..

Can I Just add a --?.

Yeah. Please go ahead..

I just think there has been somewhat more of a shift in FDA regarding the utilization of Phase 2 single-arm trials for approvals that as you probably have heard, but the PSP kinase inhibitors in malignancies, there has been the PDL1 that you've seen with the Phase 3 trials and the largest disease and ODAC last year.

So, I think it's more of an FDA change. And again, when you look at ONC201, we still believe that this is a very high unmet need disease in an area where there isn’t any treat -- many treatment options. And we believe that there's still an active and effective agent with ONC201..

Right. Yeah. That makes sense. Thank you.

So, when do you anticipate filing now, can -- are you able to guide to that or?.

We did say that there was expectation previously that some of the work that we have ongoing, we described some of the Clinpharm and my commentary that some of that could be submitted as part of or during a rolling submission.

And so, I think it's more likely that a complete submission would be required with all of those things ready for when you pull the trigger on that submission. And as such, those studies will be finishing up in the first half of next year. So, it would follow that. It's the best guidance I can give..

Got it. Yes, that's actually helpful. Thank you. That's all from me..

Thank you. Next question comes from the line of Soumit Roy of Jones Research. Your line is open..

Hi, everyone. Congratulations on the TEMBEXA deal and thank you for taking my question. Curious if you have any plans on the use of the to $225 million in terms of if you're going to acquire new assets, any -- whether it’s going to be oncology and any color It would be appreciated..

Hi Soumit. It's Mike Andriole. I think our focus is on ONC201 and the imipridone platform. As we've said continuously, we're always evaluating external innovation as part of our normal business process and will be smart about -- if we see assets, if or when and how to pull them in.

One of the advantages of this transaction is in a market where cash has probably never been more valuable in terms of a premium, in certainty and in the runway.

There are some increasingly distressed assets in the market, and I suspect over the course of the year, there's going to be more distressed assets in the market given the environment for small and mid-cap bio-tech that we find ourselves in today. So, having substantial cash balance to work with is helpful in that environment.

And yet, we're also very, very focused on making sure that we get onto one to the finish line. We feel we've got a responsibility to make sure that we get what we believe to be an active agent to the finish line and get it to patients who desperately need it. So, we'll balance those two objectives as we evaluate the external market.

But certainly, there's the opportunities and business development of this year for those who have access to capital are more meaningful than they've been in a while..

Thanks. Last question is, could you give us any color on the reason behind these tech combinations? What led you to that point? Any mechanistic understanding or some bandwidth. Thank you..

I didn't hear that questions, Soumit.

Can you repeat that?.

The reasoning behind why you're terminating the DSTAT program. Any mechanistic understanding or something that --.

Yes. Well, I appreciate that question because it gives me an opportunity to be really clear about. That drug I think is a promising drug nothing has changed our view with regard to the safety profile or the potential for efficacy there.

As you know, we had challenges and rolling our trial, it was as much about looking at our portfolio, identifying which assets we had the most definitive evidence on activity. And then focusing our efforts there. I expect that [Indiscernible] will look for opportunities to continue to develop that agent in any number of indications..

Thank you..

Thank you. Next question comes from the line of David Nierengarten of Wedbush Securities. Sir, your line is open..

Hey, thanks for taking my questions.

First off did you or have you share, or have you shared sorry any of the natural history study data with the FDA prior to these discussions? And second question is, could you remind us, typically, what is the overall survival of patients post radiation with the H-27 mutation? And finally, when you think about a potential Phase 3 design with the placebo control, I mean, are there any concerns about recruiting with the placebo arm? And obviously it's a difficult disease to treat where -- and I know there aren't any approved treatments, but patients might be seeking alternative therapies.

Thanks..

I'll answer part of that and then I think between Allen and Josh, second questions on survival and placebo. We can address it. So, we did not provide any data from the natural disease history analysis we've in fact, we're going to subject that data to blinded independent central review.

And so that's why I made the comment earlier that we have no reason to believe that anything that we would see anything different than what we've previously expected from that data. So, this is more of a general commentary from the FDA.

And frankly just maybe part of, there are a few reasons why the FDA could have provided the feedback on kind of risks associated with it accelerated approval. One of those is that they certainly want to have Phase 3 trials up and running. And so, their emphasis was to focus on getting that trial up and running.

And so that they could have confidence that it would be executed. And perhaps as a by-product of these discussions that will position us more strongly as we go back to talk about an accelerated approval, that there's likelihood and evidence that -- that trial is going to be done in a timely manner.

So anyway, let me hand it off to Allen and Josh maybe to speak to the discussions we've had both with the advisory board on the trial design and survival expectations..

Let me just start then I'm going to tag it up to Josh. We have [Indiscernible], conversations with numerous thought leaders in this area and discuss the best design for this, assuming that FDA would require all our survival.

And with discussions on almost all the investigate thought leaders felt that the best desire will be a placebo-controlled trial in the upfront setting, post-radiation. This way you can control all variables.

I think the concern would be is that if you did not have this control, that patients could start a study in the call-off without -- if they are not in conceivable chilled area. Numerous drugs have been -- and studies has been done as a placebo-controlled in similar diseases, not exactly in H3 K27M patients with Glioma.

it has been done in the past and I'll just pass it up to Josh rather comments from that..

Yes. Thanks for your questions, David. I would agree with Allen there, not exactly in the same space, but certainly a number of randomized placebo-controlled trials have been conducted in CNS tumors. So, between the President they are at conference that's been held to help us grapple with these issues.

We've certainly been mindful about how we balance ethics and the need to accrue this trial of expeditiously. I'll circle back to your second question with regards to survival expectation. Of course, this is one of the focus, is that was put in for the natural disease history that's been discussed on this call.

While the results of that aren't available, I think the literature largely supports that the progress is that these patients are similar to or worse than glioblastoma. So, if you're looking for a benchmark, I think you can look to that in addition to the Emergent natural [Indiscernible] disease.

And then the only other comment I would add onto what Mike said for your question on a dialogue with FDA in the natural disease history is that while we have not shared our results from, that study to-date, we have had a dialogue with the agency in the past on the natural disease history of this indication in the available literature throughout the consensus, as well as treatment guidelines that are available for a quite a series of KOLs, all of which led to an agreement that available therapy in the recurrent setting for this disease is currently available.

Well, no specific data from our study a fair amount of dialogue here just to help form that framework..

Okay thank you..

Thank you. Next question comes from the line of Troy Langford of Cowen your line is open..

Hi, thanks for taking our questions, and congratulations on the TEMBEXA deal. I just have one question on TEMBEXA first. So just given that you all considered royalties on profits made on TEMBEXA from contracts outside the U.S.

Can you just talk a little bit about how -- who would lead those regulatory submissions or negotiations? So, would you all do that or would Emergent mostly lead those conversations? And then I have a follow-up after that..

Emergent will lead all regulatory interactions after closing both in the U.S. and outside of the U.S..

Okay..

News after that is that we would be working with them closely during the transition period and so facilitate that. So, I think there's a period where which they would own it and lead it and yet might be relying on our team to support it..

Okay. Great. That helps a lot. And then on ONC201, specifically the randomized Phase III study. I know you all can't or don't really want to talk a lot about the details of the study.

But do you think there's any possibility that you could enroll patients with tumors other than those with midline -- from the midline location? And then in terms of interactions with the FDA, do you already have a meeting planned to discuss the trial details agency?.

I'll start with the latter question. We did already have the discussion on the details and we're following up on a few of the open items from that. So, we expect to have closure on that relatively soon in those interactions can be informal.

Alright maybe Allen speak to the approach around tumor location and Josh chip-in?.

Yes. I think one of these key inclusion criteria as would be the presence of the H3 K27M mutation. And we will be at least at this point plan to be a little more open regarding location and plan to evaluate patients from that perspective..

Okay. Great. That was a lot. That's all for me, and thanks so much for answering our questions..

Thank you..

Thank you. There is no further question at this time, and I would like to turn the call back to Mr. Mike Sherman for closing remarks..

I just want to thank everyone again for joining the call. Look forward to providing additional updates. Have a good day..

Ladies and gentlemen. This concludes today's conference call. Thank you for participating. You may now disconnect. Have a great day..