Q4 2022 Chimerix Inc Earnings Call

March 2, 2023

Good morning, ladies and gentlemen, and welcome to the <unk> fourth quarter and year end 2022 earnings Conference call I would now like to introduce your host for today's call Michelle last Bilodeau, Vice President of strategic planning and Investor Relations at <unk>. Please proceed.

Thank you Jack good morning, everyone and welcome to the <unk> fourth quarter and year end 2022 financial and operating results Conference call. This morning, we issued a press release and our fourth quarter operating update you can access this press release in the investors section of the website.

With me on today's call are President and Chief Executive Officer, Mike Sherman, Chief Medical Officer, Ellen Melamed, Chief Financial and business Officer, Mike Andriole, and Chief 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.

And Reform Act of 1995 and are subject to risks and uncertainties and other factors. These risks and uncertainties and other factors could cause actual results to differ materially from those referred to in the forward looking statements. Please refer to our filings with the SEC for a more complete disclosure of these risks and uncertainties at.

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 completed an important transition for the company in 2022, monetizing some baxter and fully capitalizing the company without shareholder dilution, establishing runway into 2027 and the process.

This was a very attractive transaction for kind of marriage with potential for additional meaningful economics in the future.

We've now also largely completed our transition responsibilities fortune Baxter, which allows for full focus on our oncology pipeline.

Our confidence in these programs continues to grow as we announce new independent survival analysis related to arc 201 in order to have a problem treatment late last year and now today, a clinical milestone for our next generation <unk> six.

We began opening sites for the phase III saw one action trial in the U S. Late last year and just opened our first international site in Israel. We also received recent approval to proceed from health authorities in both the UK and Canada.

We expect to activate sites in those countries shortly followed by the rest of Europe . This spring.

We remain on track for most sites to open for enrollment by mid year and we've been encouraged in the meantime by the referral process through which sites that have not yet opened or sending patients to already active sites to initiate treatment.

Those patients will later transfer back to their home site.

We continue to expect first data Readouts in early 2025 and look forward to sharing our continued progress as we open more sites.

As a bit of an aside it was nice to hear from one of our leaders at our CRO partner PPD in a meeting yesterday recognize the particularly strong collaboration they have with our team distinguishing it from other trials there.

Working on that speaks both to the quality of the team in both organizations and the uniqueness of this trial, particularly the pull we get from patients and investigators.

It's worth noting that our endpoint strategy is designed to optimize the speed to data as well as provide multiple opportunities for success.

In the interim overall survival analyses at 164, and 246 events provide the opportunity to stop the trial early if.

Survival advantages observed.

<unk> are consistent with the independent analysis previously reported at the recent Snow Conference. This is what we would expect to happen.

That's particularly true with the inclusion of the higher dosing arm, which is independently powered.

Trial design also provides another opportunity for success with the incorporation of the PFS analysis at 286 events, which is expected occurred just after the first interim overall survival analysis.

With a successful PFS analysis, we plan to speak to the FDA about seeking an accelerated approval and then would incorporate the overall survival analysis as opposed marketing requirement.

The independent data announced in December supporting and on 201 survival benefit in the <unk> III <unk> 27, a M using population more than doubling median survival compared with those not treated with <unk> hundred 126 months compared to 12 months in the frontline setting.

The flexibility afforded by our trial design on top of the durable response data. We have previously disclosed from phase two we remain confident the probability of success for the action trials at least as high or higher than other phase III trials.

In parallel to executing in the clinic, we're completing the <unk> farm and CMC work that will otherwise be required for regulatory filings that work has proceeded with supportive findings along the way. We also continue to generate data that enhances the scientific understanding of our pipeline adding to.

Our confidence in the ability of <unk> broadly to uniquely address high unmet needs in oncology recent data released at snow demonstrated the ability of all 201, and <unk> 206 to selectively tap novel targets for oncology to control multiple critical.

Acts of tumor biology, Josh will elaborate on this in a bit.

As it relates to our earlier stage pipeline, including onto a six we have new reason to anticipate additional catalysts on the horizon for that program. While we are executing the action trial.

We're certainly encouraged to learn of a confirmed response in one of the early dose cohorts, we wouldn't ordinarily highlight a single case of tumor response, but because this happens so early in the escalation.

And in a patient with non <unk> III K 27, I'm Glioblastoma. This is a setting where we've never seen a tumor response with <unk> hundred one is stands out as an important signal for onto a six an important signal about potential broader market opportunities.

I'll now turn the call over to Josh Allen to provide some updates on the science and more color on this on 206 development.

Thanks, Mike.

So with respect to the preclinical data released at snow alongside the launch of the action trial presentations. There shed further light into how arc 201, and <unk> two uptick can be unique detrimental effect to advance CNS tumors.

Our own studies presented at that conference demonstrated the role of <unk> in response to these compounds highlighting that this target can impart a strong therapeutic response is shown in CRISPR and acquired resistance study.

These compounds are the first therapeutic to tap that target.

In addition, a team of researchers affiliated with Peanuts unveiled a new dimension of October activity in diffuse midline gliomas, abbreviated as EOG.

They found that the compound reduces immuno modular Tory effects in vitro and in vivo, including increased expression of specific MHC class one protein.

DMG itself.

While we published immuno stimulatory effects of the drug in the past that was largely in the context of natural killer cells outside of the brain.

These new findings suggest that <unk> may have the ability to convert a so called immune cold tumor such as <unk> into an immune hot tumor did they can be recognized and eliminated by the immune system.

All of this molecular information helps us understand how long till one triggers deep and durable responses in patients with <unk> 27 in mutant Elba and how <unk> could address additional forms of brain cancer.

Next let me follow up on Mikes comment related to recent clinical findings with barstool sick and I'll begin by briefly reminding you of what that compound is and where it came from.

<unk> is a small molecule that emerged from the difficult chemistry campaign, leveraging the unique core chemical structure and first in class mechanism of action of <unk> to a one.

The goal of that campaign was to identify new cancer therapies capable of treating new indications beyond those addressed by arc 201.

Onto a six emerged from these efforts is an ideal second generation compounds exhibiting an animal or potency in vitro against a variety of advanced cancers as well as direct dual targets CRD to include people.

The spectrum.

Consumer activity of this compound has been verified that the monotherapy in vitro and in vivo in specific advanced forms with CNS tumors neuroendocrine tumors and gynecological malignancies that are distinct from the lead indication of October one and each represent urgent unmet medical need.

All of this is accomplished by <unk> 206.

Maintaining brain penetration as well as a wide therapeutic window and oral administration that we expect will translate to patient convenience and compliance and quality of life in the clinic.

And it's not just does that sound is compelling. It's also our team of collaborating experts in Europe and the U S who are validated much of the efficacy I just mentioned in their own labs.

Chief among them was the neuro oncology community, which was eager to have pulled this treatment forward to their patients with advanced CNS tumors.

To that end the NIH as well as PDOC worked closely with us unsecured external funding to introduce this molecule into the clinic.

Dose escalation directly in adult and pediatric brain tumor patients respectively.

Their work suggests that the efficacy of <unk> hundred six could extend beyond the <unk> 2007, and mutant glioma population being addressed by arc 201, including indications such as Glioblastoma and merger low blastoma.

The primary objective of this first in human studies is to establish monotherapy safety. However, key information will also be gained on pharmacokinetics as well as pilot efficacy in certain cohorts that select for patients with recurrent disease.

While these studies are still early we anticipate much more dose escalation and intensification. Still lies ahead. We are encouraged by what we have heard from investigators so far no surprises on safety in line with its preclinical profile. The pharmacokinetics suggests that we are only scratching the surface of what <unk> may be able to.

Achieve in terms of therapeutic exposure and it's likely we have more room to intensify beyond the initial weekly schedule.

Finally, as Mike mentioned, an investigator has recently notified us of a response in a patient with current glioblastoma.

This patient initiated monotherapy <unk> in April of last year, it's only the second dose level in the study and has achieved a radiographic response per the investigator as well as a decrease in metabolic activity and their tumor as seen on pet imaging.

This patient was not on corticosteroids, which removes the potential confounding factor in the evaluation of neuro imaging.

This patient continues on therapy at 10 months it is clinically doing well.

Importantly, this patient's glioblastoma did not harbor H, 327% mutation.

This is quite exciting as to date, we have not observed a response to the arc 201 in a patient with brain tumor.

<unk> 2000 <unk> mutation.

For all of the suggest that the broader activity profile observed with <unk> hundred six in preclinical models may translate into the clinic to address the sizable unmet needs outside of the indication where we are currently developing <unk> hundred one.

These studies continue to enroll in the upcoming months, we could share more detail about these programs and expect further readout to be recorded at appropriate conferences in the future.

With that I'll now turn the call over to Mike Andriole.

Thanks, Josh and good morning, everyone.

We remain focused on site activation and recruitment for the action strategy and are encouraged by the progress to date, both in the U S and internationally.

Furthermore, the early clinical activity of <unk> six has the potential to address a much larger patient population with an equally acute unmet need and provide additional catalysts.

Both programs have the potential for substantial value creation for patients and shareholders. So I'll take a moment to recap.

In the case of door datacom or onto a one.

And <unk> 27, a mutant glioma recall there are no approved agents targeting this mutation and this is the lead program clinically by a wide margin.

We have previously guided to a commercial opportunity of $750 million in revenue annually with about 5000 newly diagnosed <unk> patients harboring this mutation in the top seven markets.

Central approval in this population would be a stepwise change in the standard of care for these patients it would be accompanied by ultra orphan drug pricing. This means pricing anchors of comparative therapies that treat U S populations of 2000 patients who are less and we're full approvals predicated on an overall survival benefit.

With these anchors in mind and.

And based on ongoing commercial printing work we perform.

$750 million revenue forecast is likely the lower bound of what we might expect subject to final survival data from the actual study.

In the case of Mark to fix.

This is a second generation <unk> designed to expand benefit to other tumors from what door dauber prone as expected to address.

While the program is early we are nevertheless, encouraged further confirmed response in a patient with recurrent glioblastoma without the H <unk> seven and <unk> mutation early in dose escalation a first for this platform.

Blackstone is comprised of roughly 30000 newly diagnosed patients in the top seven markets annually. So about six times the size of the market for Gerdau, but firms, we had indications with orphan drug pricing and the scale of the unmet need in Glioblastoma, we believe the global market opportunity for <unk> hundred six comfortably exceeds $1 billion annually as we consider.

Development in this indication this opportunity is supportive of our composition of matter IP, where we owned full operation rights to the program globally.

We're driven by the potential for each of these programs to change the standard of care in their respective high grade glioma indication that have each seeing such a dearth of new innovation in the last 20 years and where the competitive commercial intensity is about as low as one would find across all of oncology. We believe success in one or both of these programs will lead to significant value.

For both patients and shareholders.

Lastly earlier today, we issued a press release containing our financial results for the fourth quarter and full year 2022.

Starting with our balance sheet at the end of 2022, we had approximately $266 million in capital, which could fund operations into 2027 day period that could potentially include the U S launch of door data from that.

That timeline could be extended if we receive additional economics from our <unk> partnership with emerging during the next four years or it could be shortened if we accelerate investment in one or more pipeline programs that would of course be driven by supporting clinical data catalysts.

As a reminder, under the <unk> agreement, we receive an additional $31 million for each of the remaining four of BARDA procurement options totaling up to $124 million in milestone payments.

Edition will earn <unk> royalties equal to 15% of international gross profit royalties equal to 20% of U S. Gross profit should U S demand for <unk> exceed $1 7 million treatment courses during the exclusivity period.

Turning to our statement of operations the company reported a net loss of $21 million or 24 cents per basic and diluted share for the fourth quarter of 2022, compared with a net loss of $49 5 million or <unk> 45 per basic and diluted share in the fourth quarter of 2021.

R&D expenses decreased to $19 3 million for the fourth quarter of 2022, compared with $34 3 million for the same period in 2021, and which we paid a one time $20 million success payment for <unk> hundred one.

General and administrative expenses of $5 3 million were essentially flat year on year compared to $5 2 million for the same period in 2021.

Yeah.

Our previously announced reduction in force was largely completed in January and the favorable impact on our burn rate will begin to be realized next quarter subject to changes in pipeline investments that may occur during the year. The current plan is for 2023 and of your cash balance to exceed $200 million.

And with that overview I'll turn the call back to Mike for closing remarks, Mike.

Thanks, Mike we have an exciting year ahead as we continue to enroll the action study and prepare for potential commercialization of <unk> hundred one were particularly excited to see such an early signal from the onto a six program.

And the fact that that occurred in the non <unk> 27, and <unk> mutant recurrent glioblastoma. So certainly encouraged by the potential for additional catalysts that program.

Can provide on top of the action steady execution.

That Jack will open the call up for questions.

Certainly at this time, if you'd like to ask a question. Please press star one on your telephone keypad Maury Raycroft with Jefferies. Your line is open.

Yeah.

Hi, This is Kevin on for Maury Congrats on the update today and thanks for taking my questions.

Just first question on 206 I believe the response was in a patient that received 100 milligrams once per week and you said that was in the second dose level.

Can you just talk about where that fits in your proposed escalation I know you talked about increasing the intensity as well.

And then just in terms of overall trial design or anything you can say about that and what we can expect that our first update at a medical conference.

Yes, maybe I'll take.

Take a high level of cut at that and Josh you can you can add to it.

Of course, we expect the dose itself too.

Escalate and we've got plans in place to accelerate that as you mentioned the intensity more frequent dosing. We also believe based on PK modeling. We've done can provide some benefit so pretty significant increase in.

And exposure.

Central therapeutic window.

Is just ahead and so working on it with both <unk> and NIH to execute that but I don't know if there is.

Maybe a little bit more Josh.

To clarify in terms of the potential, particularly around dose intensity, what we've learned.

Yes happy to add thanks for the question, Kevin So starting dose from these trials with 50 milligrams once per week and as you rightly pointed out this response within the patient the second dose cohort.

Following a three plus three design.

That escalated up.

Their enrollment to 100 milligram. So you got that right and then in terms of the future of the trial as you allude to and might do as well.

Our preclinical data, both safety and efficacy as well as the available clinical pharmacokinetics.

Suggest that driving towards an increased dose schedule, maybe beneficial and peaceful.

So to that end, we expect the study to intensify towards a three days in a row per week dose schedule, perhaps with twice per day dosing as the future of these studies like I mentioned in my comments there.

The primary goal of these studies is really aimed at establishing monotherapy safety, but of course, we expect to pick up additional information on <unk>.

Pharmacokinetics as well as help these patients so we expect to be able to share the details of the trial to a poll.

Great. Thanks, and just a quick follow up so with the.

The early response for <unk> six.

How are you thinking in the future about potential company sponsored trials and does this change your sort of calculus at all on potential in licensing or R&D spend and just how do you think about that moving forward.

Yeah, I'll start that and Mike perhaps you can you can add.

We had stated before we're always looking broadly in the marketplace as any.

The management team should.

Essentially to set a bar for your own development internally.

So to see a response and a new patient population with our internal program. It certainly raises the bar for anything that we might.

<unk> be looking at externally and.

As it relates to future investment.

We've been fortunate to be able to leverage.

The funding garnered through the P&L.

NIH in the near term.

That I think continues to be sufficient the enthusiasm at both of those institutions.

And across those collaborations have increase with with the kind of the data as they've seen it both both the qualitative data that they observe in treating patients where sometimes you don't have a patient where you can you can even assess a tumor response, but particularly in this patient where tumor.

Or is assessable for response their enthusiasm I think will carry this that having been said there is a point at which there will be evaluating in the coming weeks and months.

Plans to again, driven by data potentially accelerate that but certainly plans for the next.

Phase <unk> trials that would that would expedite our regulatory approval process. So that planning will happen here in the coming months. This response, certainly triggers and puts us on our toes in that regard.

If you have anything to add to that.

Not much Mike just reinforce and certainly that response.

Has this engaged significantly on the program and were looking carefully at other measures of activity and as Mike said.

It certainly raises the bar as we look at.

External innovation as well we continue to.

<unk> abroad.

<unk> and search process for that but clearly this.

Our response, particularly in a patient.

Patient without the H strictly 'twenty 700 mutation.

As.

Raises the bar for that in terms of capital allocation.

The near term probably no change in capital allocation in the near term as Mike said, we continue to leverage our external capital for the ongoing phase one work.

And we will carefully evaluate the dose escalation and intensification during this year and certainly that could that could evolve into more capital allocation to this program and company sponsored studies in the future. So it will be on.

On the look out for that and we'll update update you accordingly.

Great. Thank you.

Joseph Thome with TV Cowen Your line is open.

Hi, there good morning, Congrats on the news and I. Thank you for taking my questions.

The first one on <unk> hundred one just to kind of get a good.

Good handle on the expectation for <unk>.

Yes.

Cadence on how we're going to see some of these readouts. So is it your expectation that that PFS readout would come between the first and second.

Interim work sometime in 2025, and maybe based on your conversations with the agency ahead of starting a phase III study.

What are your impression that you would be able to file for accelerated approval on this PFS endpoint.

And then maybe wait for the second goal as interim and final OS either during the review or to be confirmatory.

I'll start that and Alan you can you can add add onto it first of all you're right about our expected timelines for the PFS would likely occur between the first and the <unk>.

Second the OS interim.

And so.

As we have not explicitly and frankly intentionally have not asked the FDA.

About their view on progression free survival as the basis for accelerated approval.

And the reason is you know what the answer is going to be it will depend on the data. So I guess, it's a positive outcome.

We would plan on submitting it and.

<unk>.

And of course that they would.

I imagine taken taken early look at the overall survival status literally look for supportive trends in that.

And that would be part of their decision making process. So it's our plan that we would that we would move ahead with that submission based on based on the data we would see if its positive Alan if you want to add anything to that.

Hey, this is Alan Milburn, Yes, just a couple of things just to reiterate.

Progression free survival is engaged in the analysis that we intentionally did for this trial if positive will be powered for a claim of significance.

You are correct on the timing, which is around 2025, obviously, depending on enrollment rates and evaluate.

The last thing I'll mention is.

The ability to submit on PFS is very much aligned with project front runner, which is a project or an FTAA has which is looking at.

They are submitting based on an interim phase III trial with the ability to convert to full approval based on the final results of the study so.

My interpretation is that this is entirely consistent with that project.

<unk> has a good likelihood of having meeting those requirements of course, we need to see when we have the data at the time, if we're able to move forward.

Great. Thank you and then maybe just one quick follow up on the <unk> 206 patients that had that response.

I know, it's monotherapy and they weren't on any sort of corticosteroids, which is great can you just comment a little bit. It's refractory disease are consuming that had some sort of treatment. Prior to this what was kind of their treatment journey.

And are there other similarly treated patients in.

The study that have been enrolled performance. Thank you very much.

Hey, Josh I'll, let you address that one.

Yes with respect to treatment course, Joe we know that this patient had.

Following surgical resection of diagnosis.

<unk> went through the typical chemo radiation course in the fall of 2021 experienced disease progression following that standard frontline therapy.

Early the following year in 2022 and initiated monotherapy at 206.

In April of last year, so pretty typical treatment course, following frontline therapy. It again.

Progressive disease prior to coming on study.

For this particular cohort.

Mike alluded to earlier on the call.

We've had a couple of cohorts within that study.

Where patients can initiate therapy.

On one of the cohorts following radiation for prior to the current that's been useful for generating safety and PK information, but with respect to interpreting efficacy, we've really kept our eye on that.

Dedicated cohort of recurrent disease like this patients get fit to wear responses is more interpretable.

Perfect. Thank you very much.

Yeah.

Noreen <unk> with capital one Securities Your line is open.

Hi, good morning, and congrats on the update and so sort of piggybacking on <unk> question.

The 18 year old responder.

Do you know how quickly the patient response was relative to what you've seen with until one.

And then just on.

Possible data update do you think it'll be it <unk> or later on in the year. It's now.

Yeah.

Josh you want to take a first cut at that.

Yes, sure well I mean first of all thanks for the question Dara, we want to be careful given that this is just a.

A single response like Mike alluded to.

We'll keep our eye on the data sort of as it unfolds.

But we thought it was important to report on this observation, particularly given that the patient lack the H <unk> 'twenty covenant mutation. It's just the population where we've not seen 201.

Work as a monotherapy in that prior clinical experience.

Those patients, but with respect to the one observation we did see the tumor at least based on the investigator reported steadily sort of trickle down this wasn't a case where.

The responses just showed up at 10 months it was a gradual regression that occurred whether.

Whether or not those response kinetics will be more rapid with arc 206 that we saw with onto a <unk>. That's just stuff that we're gonna have to.

Keep our eye on as as the data unfolds.

And I would not expect.

Given the submission timelines that this would be an <unk> presentation I think this would be a.

Observation.

The details on this patient, including potentially in the images and so on it would be something presented later and probably more likely in the neuro oncology focused compounds.

Okay.

And Mike on the action study are you able to provide a little more specifics on the site of the accident study like how.

How many are currently active and how many do you expect midyear.

And possibly any specifics that enrollment numbers.

Yes.

Won't.

Yes.

Enrolment numbers other than to say, we've got a plan to.

To enroll which would lead to the timelines we have four for data in 2025, and so as long as we stay on that plan.

Sort of acknowledged accordingly.

The site activation I think they are actually only a few sites that show up on <unk> trials that Gov as of today, there is a little bit of a lag in that.

And so we would expect to have.

This week there essentially five five active sites, but then.

In the coming weeks are essentially activating that number of sites.

Per week for for a while and then it accelerates from there. So you typically this is this is what you typically see with.

A few early sites or a few sites can manage their internal review and IRB review process, a very quickly and then a bolus of sites that really come on between.

Between March April and May such that we will have most of our sites, we'll have over 100 sites.

Participating in this trial globally.

And we will have most of those sites active by by mid year and so we can't we'll report out.

At that point, I think that'll be the the a more meaningful update on on progress because.

At that point, where you've really gotten into your your early enrollment curve and and site activation needs.

It needs to be on track at that point in order to.

In order to get to your final timeline. So I look for that next update in our mid year update us as maybe more meaningful.

Insight into into that progress, but so far so far early stage on track.

Sure got it and just one more can you just remind us maybe Joshua Allen maybe Mike how soon after patients are undergoing treatment with radiation. This is for the actual study are you able to capture those with the HK 327 mutations.

Pointing out the patients diagnosed with the mutation and then actually captured into the study.

Sure maybe Alan if you want to talk through that diagnosis and progression to study.

I'm, not sure, which Alan Youre talking to me how Alan.

Alan melanoma.

Thank you.

<unk>.

The way the screening process is excuse me is we can actually screen wildly receiving their radiation therapy. So they are initially diagnosed with territory of biopsy.

Final thing mutational status and we entered the screening process.

And then they wont be random lengths until after they received.

The radiation therapy, and then they can be randomized and we have a very.

Pretty long period of when they have completed radiation to when they can randomize. So we can capture most of the patients. So we're really trying to capture them.

And our long period, so we can get an early when they're diagnosed.

Then following during the radiation and we've given some time period afterwards, when they can actually get to an open site.

That answer your question Yeah, Yeah. Okay. Thank you that's all for me.

Sumit Roy with joins Jones Research your line is open.

Hi, everyone and congratulations again on the progress on <unk> hundred <unk>.

So I'm just curious like what made you decide to expand to six enrolment beyond <unk> 2007 mutation and.

If you think even two one could have a broader.

Efficacy beyond just a focused population.

Yeah, I'll start that and maybe Josh you can add to it I think our strategy from the beginning.

Was to differentiate on 206 into new populations that was supported by the preclinical data.

<unk>.

Yes.

As well as obviously, it's a logical from a.

From a pipeline.

Progression standpoint, so the ability to tap outside of HVAC K 27, essentially opens up.

Sort of six fold.

The patient population that we get with that agent with <unk> hundred one, which all in and of itself is still a very interesting and attractive market.

But.

We'll develop it outside of that as a 201 would would address phase III <unk> 27 of them there are other potential opportunities for <unk>.

<unk> hundred one.

Smaller I think niche opportunities around that so to the extent that we see to six have this broader activity it would it would be.

It would become the workhorse agent, where we would we would defer to that.

And expanding new indications for <unk>.

Essentially even beyond CNS tumors.

Josh I know, if you want to add anything to.

In terms of the evidence or rationale for going going broader than beyond the 201.

Indications targets.

Yeah, I'll expand on that I think the answer is really followed the data from the preclinical studies right. So the activity profile of box tool thick, we found to be much much better than until one.

Preclinical data both in vitro and in vivo in a series of indications, namely.

Several high correctly almost that don't include the <unk> 27, and mutation in line with that response that we highlighted here today.

But in addition to other forms of neuroendocrine tumors like Cholangiocarcinoma.

<unk>, including ovarian and endometrial cancers. So it was really the observations and the lab, suggesting that this drug could address several appointments of the dash cams.

Cancers outside of H <unk> 27, a M.

Led to us.

The clinical program more broad within CNS tumors for that first half.

And then the only other point I would add on 201 in terms of indications beyond that.

Mike mentioned, a few niche opportunities that we can see that while we are totally focused on delivering on the phase III study for this high unmet need.

Have seen evidence, where the drug may be able to scale and some other niche opportunities, including Paragon, we all may experience, where we've seen a 50% monotherapy response rate that we published previously.

Got it that's really helpful.

Do you see.

Longer lines six to nine months from now is $2 six trials start some increasing enrolment rate do you see it competing effect on the action trial or are you going to restrict to six two non <unk> III can do in 2017 mutant patients. So it's a great question I was asked about ready to make that comment.

The previous question, but we've.

We've essentially.

Yeah.

Eliminated the overlap between the two so that if there is a patients.

Eligible or the action study.

The action study is how they can access all 201.

So and that's true for other ongoing both.

Expanded access for October one and four the October six programs so essentially.

<unk> differentiates those two so theyre not competing.

And then not otherwise slowing down our enrollment for the actual study.

Okay. Thank you so much for taking my questions and congratulations again.

Thank you.

This concludes the Q&A portion of the call I would now like to turn the call back over to Mike Sherman for closing comments.

Thanks to everyone for your time this morning, and look forward to providing updates in the coming months have a good day.

This concludes today's conference call. We thank you for your participation you may now disconnect.

[music].

Good morning, ladies and gentlemen, and welcome to the Comerica fourth quarter and year end 2022 earnings Conference call I would now like to introduce your host for today's call Michelle last Bilodeau, Vice President of strategic planning and Investor Relations at time Eric's. Please proceed.

Thank you, Jeff Good morning, everyone and welcome to the <unk> fourth quarter and year end 2022 financial and operating results Conference call. This morning, we issued a press release and our fourth quarter operating update you can access this press release in the investors section of the website.

And 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 if referred to in the forward looking statements. Please refer to our filings with the SEC for a more complete disclosure of these risks and uncertainties at.

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 completed an important transition for the company in 2022 monetizing <unk>.

Fully capitalizing the company without shareholder dilution, establishing runway into 2027 and the process.

This was a very attractive transaction for <unk> with potential for additional meaningful economics in the future.

We've now also largely completed our transition responsibilities for <unk>, which allows for full focus on our oncology pipeline.

Our confidence in these programs continues to grow as we announced new independent survival analysis related to arc 201 in order to have a prolonged treatment late last year and now today, a clinical milestone for our next generation <unk> six.

We began opening sites for the phase III until one action trial in the U S. Late last year and just opened our first international site in Israel. We also received recent approval to proceed from health authorities in both the UK and Canada.

We expect to activate sites in those countries shortly followed by the rest of Europe . This spring.

Patients. So later transfer back to their home site.

We continue to expect first data read outs in early 2025 and look forward to sharing our continued progress as we open more sites.

As a bit of an aside it was nice to hear from one of our leaders at our CRO partner PPD meeting yesterday recognized particularly strong collaboration they have with our team distinguishing it from other trials there.

Working on that speaks both to the quality of the team in both organizations and the uniqueness of this trial, particularly the pull we get from patients and investigators.

It's worth noting that our endpoint strategy is designed to optimize the speed to data as well as provide multiple opportunities for success.

In the interim overall survival analyses at 164, and 246 events provide the opportunity to stop the trial early if.

Survival advantages observed.

If the results are consistent with the independent analysis previously reported at the recent Snow Conference. This is what we would expect to happen.

That's particularly true with the inclusion of the higher dosing arm, which is independently powered.

Trial design also provides another opportunity for success with the incorporation of the PFS analysis at 286 events, which is expected occurred just after the first interim overall survival analysis.

With a successful PFS analysis, we plan to speak to the FDA about seeking an accelerated approval and then would incorporate the overall survival analysis as opposed marketing requirement.

The independent data announced in December supporting <unk> hundred one's survival benefit in the H 327 am using population more than doubling median survival compared with those not treated with <unk> hundred 126 months compared to 12 months in the frontline setting.

The flexibility afforded by our trial design on top of the durable response data. We've previously disclosed from phase two we remain confident the probability of success for the action trials at least as high or higher than other phase III trials.

In parallel to executing in the clinic, we're completing the <unk> farm and CMC work that will otherwise be required for regulatory filing that work has proceeded with supportive findings along the way. We also continue to generate data that enhances the scientific understanding of our pipeline adding to.

<unk> of tumor biology, Josh will elaborate on this in a bit.

As it relates to our earlier stage pipeline, including onto a six we have new reason to anticipate additional catalysts on the horizon for that program. While we are executing the actions trial.

And in a patient with non <unk> III K 27, I'm Glioblastoma. This is a setting where we've never seen a tumor response with <unk> hundred one is stands out as an important signal for <unk> 206, an important signal about potential broader market opportunities.

I'll now turn the call over to Josh Allen to provide some updates on the science and more color on this 206 development.

Thanks, Mike.

So with respect to the preclinical data released in snow alongside the launch of the action trial presentation. There shed further light into how arc 201, and <unk> two uptick can be unique detrimental effect to advanced CNS tumors.

These compounds are the first therapeutic to tap that target.

In addition, a team of researchers affiliated with Peanuts unveiled a new dimension of October what activity into few smid likely element abbreviated EOG.

They found that the compound reduces immuno modulator Lori effects in vitro and in vivo, including increased expression of specific MHC class one protein by DMG itself.

While we've published immuno stimulatory effects of the drug in the past that was largely in the context of natural killer cells outside of the brain.

These new findings suggest that onto what may have the ability to convert a so called immune cold tumor such as <unk> into an immune hot tumor did they can be recognized and eliminated by the immune system.

All of this molecular information helps us understand how long till one triggered deep and durable responses in patients with <unk> III <unk> 27 in mutant Elba and how <unk> could address additional forms of brain cancer.

Next let me follow up on Mike's comment related to recent clinical findings <unk> six and <unk>.

I'll begin by briefly reminding you of what that compound is and where it came from.

<unk> is a small molecule that emerged from in the difficult chemistry campaign, leveraging the unique core chemical structure and first in class mechanism of action of <unk> with.

The goal of that campaign was to identify new cancer therapies capable of treating new indications beyond those addressed by arc 201.

Onto a six emerged from these efforts is an ideal second generation compounds exhibiting an animal or potency in vitro against a variety of advanced cancers as well as its direct dual targets 32 people.

The spectrum of anti tumor activity of this compound has been verified that the monotherapy in vitro and in vivo in specific advanced forms of CNS tumors neuroendocrine tumors and gynecological malignancies that are distinct from the lead indication among two one and each represent urgent unmet medical need.

All of this is accomplished by our 206, while maintaining brain penetration as well as a wide therapeutic window and oral administration that we expect will translate to patient convenience and compliance and quality of life in the clinic.

And it's not just us that sounds it's compelling. It's also our team of collaborating experts in Europe and the U S who are validated much of the efficacy I just mentioned in their own labs.

Chief among them was the neuro oncology community, which was eager to have pulled this treatment forward to their patients with advanced CNS tumors.

To that end the NIH as well as <unk> worked closely with us and secured external funding to introduce this molecule into the clinic to begin dose escalation directly in adult and pediatric brain tumor patients respectively.

Their work suggests that the efficacy of <unk> hundred six could extend beyond the <unk> III <unk> 27 in mutant glioma population being addressed by our 201, including indications such as Glioblastoma and <unk> Blastoma.

While these studies are still early and we anticipate much more dose escalation and intensification. Still lies ahead. We are encouraged by what we have heard from investigators so far no surprises on safety in line with its preclinical profile. The pharmacokinetics suggests that we are only scratching the surface of what <unk> may be able.

To achieve in terms of therapeutic exposure and it's likely we have more room to intensify beyond the initial weekly schedule.

Finally, as Mike mentioned, an investigator has recently notified us of a response in a patient with current glioblastoma.

This patient initiated monotherapy <unk> hundred six in April of last year.

The second dose level in the study and has achieved a radiographic response per the investigator as well as a decrease in metabolic activity and their tumor as seen on pet imaging.

This patient was not on corticosteroids, which removes the potential confounding factor in the evaluation of neuro imaging.

This patient continues on therapy at 10 months and as clinically doing well.

Importantly, this patient's glioblastoma did not harbor H <unk>, 27% mutation.

This is quite exciting as to date, we have not observed a response to <unk> hundred one in a patient with a brain tumor that lacks the H <unk>, 27% mutations overall.

Overall, the suggest that the broader activity profile observed with <unk> six in preclinical models may translate to the clinic to address the sizable unmet needs outside of the indication where we are currently developing <unk> hundred one.

These studies continue to enroll and then in the upcoming months, we can share more details about these programs and expect further readout to be reported at appropriate conferences in the future.

With that I'll now turn the call over to Mike Andriole.

Okay.

Thanks, Josh and good morning, everyone.

We remain focused on site activation and recruitment for the action study and are encouraged by the progress to date, both in the U S and internationally.

Furthermore, the early clinical activity of <unk> six has the potential to address a much larger patient population with an equally acute unmet need and provide additional catalysts.

Both programs have the potential for substantial value creation for patients and shareholders, which I'll take a moment to recap.

In the case of door downward prone or onto a one.

And <unk> 27 of them equally OMA recall there are no approved agents targeting this mutation and this is the lead program clinically by a wide margin.

We have previously guided to a commercial opportunity of $750 million in revenue annually with about 5000 newly diagnosed <unk> patients harboring this mutation in the top seven markets.

With these anchors in mind and.

And based on ongoing commercial printing work, we perform we believe a $750 million revenue forecast is likely the lower bound of what we might expect subject to final survival data from the action study.

In the case of <unk> hundred six.

This is a second generation <unk> designed to expand benefit to other tumors from what door dabber prone as expected to address.

While the program is early we are nevertheless, encouraged rather confirmed response in a patient with recurrent glioblastoma without the H <unk> 27, and <unk> mutation early in dose escalation a first for this platform.

Blackstone is comprised of roughly 30000 newly diagnosed patients in the top seven markets annually. So about six times the size of the market for Gerdau, but firms lead indication with orphan drug pricing and the scale of the unmet need in Glioblastoma, we believe the global market opportunity for <unk> hundred six comfortably exceeds $1 billion annually as we consider.

Development in this indication this opportunity is supportive of our composition of matter IP, where we owned full operation rights to the program globally.

We're driven by the potential for each of these programs to change the standard of care in their respective high grade glioma indication that have each seen such a dearth of new innovation in the last 20 years and where the competitive commercial intensity is about as low as one would find across all of oncology. We believe success in one or both of these programs will lead to significant value.

For both patients and shareholders.

Lastly earlier today, we issued a press release containing our financial results for the fourth quarter and full year 2022.

As a reminder, under the <unk> agreement, we receive an additional $31 million for each of the remaining four of BARDA procurement options totaling up to $124 million in milestone payments.

Edition will earn <unk> royalties equal to 15% of international gross profit royalties equal to 20% of U S. Gross profit should.

U S demand for <unk> exceed $1 7 million treatment courses during the exclusivity period.

R&D expenses decreased to $19 3 million for the fourth quarter of 2022, compared with $34 3 million for the same period in 2021, and which we paid a onetime $200 million success payment for <unk> hundred one.

General and administrative expenses of $5 3 million were essentially flat year on year compared to $5 2 million for the same period in 2021.

Sure.

That overview I'll turn the call back to Mike for closing remarks, Mike.

Thanks, Mike we have an exciting year ahead as we continue to enroll the action study and prepare for potential commercialization of <unk>, we're particularly excited to see such an early signal from the onto a six program.

And the fact that that occurred in the non <unk> III <unk> 27 a M.

Recurrent glioblastoma, so certainly encouraged by the potential for additional catalysts that program.

Can provide on top of the action steady execution.

With that Jack will open the call up for questions.

Certainly at this time, if you'd like to ask a question. Please press star one on your telephone keypad Maury Raycroft with Jefferies. Your line is open.

Hi, This is Kevin on for Maury Congrats on the update today and thanks for taking my questions.

Just first question on 206 I believe the response was in a patient that received 100 milligrams once per week and you said that was in the second dose level.

Can you just talk about where that fits in your proposed escalation my.

I know you talked about increasing the intensity as well.

And then just in terms of overall trial design or anything you can say about that and what we could expect that our first update at a medical conference.

Yes, maybe I'll.

Take a high level cut at that and Josh you can you can add to it.

Of course, we expect the dose itself too.

Escalate and we've got plans in place to accelerate that.

As you mentioned the intensity more frequent dosing. We also believe based on PK modeling we've done can provide some benefits so pretty significant increase in.

And exposure.

Central therapeutic window.

Is just ahead and so working on it with both <unk> and NIH to execute that but I don't know if there is.

Maybe a little bit more Josh.

Clarify in terms of the potential, particularly around dose intensity, what we've learned.

Yeah happy to add thanks for the question, Kevin starting bills from these trials with 50 milligrams once per week and as you rightly pointed out this response within the patient the second dose cohort.

Following a three plus three design.

That escalated up at their enrollment to 100 milligram. So you got that right and then in terms of the future of the trial as you allude to and Mike <unk> two as well.

Our preclinical data, both safety and efficacy as well as the available clinical pharmacokinetics.

Suggest that driving towards an increased dose schedule, maybe beneficial and feasible.

So to that end, we expect the study to intensified towards a three days in a row per week dose schedule, perhaps with twice per day dosing as the future of these studies like I mentioned in my comments.

The primary goal of these studies is really aimed at establishing monotherapy safety, but of course, we expect to pick up additional information on <unk>.

Pharmacokinetics as well as help these patients so we expect to be able to share those details.

Trials in pulp.

Great. Thanks, and just a quick follow up so with.

With the early response for <unk> six.

Yeah, I'll start that and Mike perhaps you can you can add.

We had stated before we're always looking broadly in the marketplaces.

Management team should.

Essentially to set a bar for your own development internally.

So to see a response and a new patient population with our internal program. It certainly raises the bar for anything that we might.

<unk> be looking at externally and.

As it relates to future investment.

We've been fortunate to be able to leverage.

The funding garnered through the P&L.

NIH in the near term.

That I think continues to be sufficient the enthusiasm at both of those institutions.

Whereas assessable for response their enthusiasm I think will carry this that having been said there is a point at which it will be evaluating in the coming weeks and months.

Plans to again, driven by data potentially accelerate that but certainly plans for the next.

Phase <unk> trials that would that would expedite our regulatory approval process, so that planning or what will happen here in the coming months. This response, certainly triggers and puts us on our toes in that regard.

If you have anything to add to that.

Not much Mike just reinforce and certainly that response.

Has this engaged significantly on the program and were looking carefully at other measures of activity and as Mike said.

It certainly raises the bar as we look at.

External innovation as well we continue to.

<unk> abroad.

<unk> and search process for that but clearly this.

Response, particularly in a patient without the H, 327% mutation.

As a.

Raises the bar for that in terms of capital allocation.

In the near term probably no change in capital allocation in the near term as Mike said, we continue to leverage our external capital for the ongoing phase one work.

Great. Thank you.

Joseph Thome with TV Cowen Your line is open.

Hi, there good morning, Congrats on the news and thank you for taking my questions maybe the first one on <unk>.

One just to kind of get.

Good handle on the expectation for <unk>.

Yes.

Cadence of how we're going to see some of these readouts. So is it your expectation that that PFS readout will come between the first and second.

Interim work sometime in 2025, and maybe based on your conversations with the agency ahead of starting a phase III study.

So to your impression that you would be able to file for accelerated approval on this PFS endpoint.

And then maybe wait for the second goal as interim and final OS either during the review or to be confirmatory.

I'll start that and Alan you can you can add add onto it first of all you're right about our expected timelines for the PFS would likely occur between the first and the <unk>.

Second the OS interim.

And so.

As we have not explicitly and frankly intentionally have not asked the FDA.

About their view on progression free survival as the basis for accelerated approval.

And the reason as you know.

What the answer is going to be it will depend on the data. So I think if it is a positive outcome.

We would plan on submitting it.

<unk>.

And of course that they would.

I imagine taken taken early look at the overall survival status, a little lease look for supportive trends in that.

And the part of their decision making process. So it's our plan that we would that we would move ahead with that submission based on based on the data we would see if its positive Alan if you want to add anything to that.

Hey, This is Alan yes, just a couple of things just to reiterate progression free survival is engaged in the analysis that we intentionally did for this trial if positive will be powered for a claim of significance.

You are correct on the timing, which is around 2025, obviously, depending upon enrollment rate and event rate.

The last thing I'll mention is.

The ability to submit on PFS is very much aligned with project, which is a project or an FTAA has which is looking at sponsors submitting based on an interim phase III trial with the ability to convert to full approval based on the final results of the study so.

My interpretation is that this is entirely consistent with that project.

And.

<unk> has a good likelihood of meeting those.

This requirement of course, we need to see when they have the data at the time, if we're able to move forward.

Great. Thank you and then maybe just one quick follow up on the hard towards six patients that had that response.

I know with monotherapy and they weren't on any sort of corticosteroids.

Which is great can you just comment a little bit it's refractory disease.

It had some sort of treatment prior to this what was kind of their treatment journey.

And are there other similarly treated patients in.

The study that had been real performance. Thank you very much.

Hey, Josh I'll, let you address that one.

Yes with respect to treatment course, Joe we know that this patient had.

Following surgical resection of diagnosis.

<unk> went through the typical chemo radiation course in the fall of 2021 experience.

Disease progression following that standard frontline therapy.

Early the following year.

Who initiated monotherapy at 206.

In April of last year, so pretty typical treatment course, following frontline therapy, and again kind of progressive disease prior to coming on study.

For this particular cohort.

Mike alluded to earlier on the call.

We've had a couple of cohorts within that study.

Where patients can initiate therapy.

On one of the cohorts following radiation, but prior to the current.

That's been useful for generating safety and PK information, but with respect to interpreting efficacy, we've really kept our eye on that.

Dedicated cohort of recurrent disease like this picture.

Two responses.

<unk>.

Perfect. Thank you very much.

Yeah.

Noreen <unk> with capital one Securities Your line is open.

Hi, good morning, Congrats on the update and so sort of piggybacking on <unk> question on the 18 year old responder.

How quickly the patient response was relative to what you've seen with until one and then just on.

Possible data update do you think it'll be at <unk> or later on in the year. It's now.

Josh you want to take a first cut at that.

Yes, sure well I mean first of all thanks for the question <unk>, we want to be careful given that this is just a single response like Mike alluded to.

We'll keep our eye on the data sort of as it unfolds.

But we thought it was important to <unk>.

On this observation, particularly given that the patient lack the H 'twenty covenant mutation. It's just the population where we have not seen 201.

Work as a monotherapy in that prior clinical experience.

Those patients, but with respect to this one observation we did see the tumor at least based on the investigator reported steadily sort of trickle down this wasn't a case where the.

The response just showed up at 10 months it was a gradual regression that occurred.

Whether or not dose response kinetics will be more rapid with <unk> 206 that we saw with <unk>. That's just something we're going to have to.

Keep our eye on as as the data unfolds.

And I would not expect.

Given the submission timelines that this would be an <unk> presentation I think this would be a.

Observation.

The details on this patient, including potentially in the images and someone would be something that presented later and probably more likely at a neuro oncology focused compounds.

Okay.

And Mike on the action study are you able to provide a little more specifics on the sides of the accident study like how.

How many are currently active and how many do you expect midyear.

And possibly any specifics on enrolment numbers.

Yes.

It won't.

Yes.

Enrollment numbers other than to say, we've got a plan to.

To enroll which would lead to the timelines we have four for data in 2025, and so as long as we stay on that plan.

Sort of acknowledged accordingly.

The site activation I think there were actually only a few sites that show up on <unk> trials that Gov as of today, there is a little bit of a lag in that.

And so we would expect to have.

This week essentially five five active sites, but then.

In the coming weeks are essentially activating that number of sites.

Per week for for a while and then it accelerates from there. So you typically this is this is what you typically see with.

A few early sites like there are a few sites can manage their internal review and IRB review process very quickly and then a bolus of sites that really come on between.

Between March April and May such that we will have most of our sites, we'll have over 100 sites.

Participating in this trial globally.

And we will have most of those sites active by by mid year and so we can't we'll report out.

At that point, I think that'll be a more meaningful update on on progress because.

At that point, where you've really gotten into your your early enrollment curve and and site activation.

And be on track at that point in order to.

In order to get to your final timeline. So I look for that next update in our mid year update us as maybe more meaningful.

<unk> insight into into that progress, but so far so far early stage on track.

Sure got it and just one more can you just remind us maybe Joshua Allen maybe Mike how soon after patients are undergoing treatment with radiation. This is where the action study.

To capture those with the <unk> 27 mutations.

At what point of the patients diagnosed with the mutation and then actually captured into the study.

Sure maybe Alan if you want to talk through that diagnosis and progression to study.

I'm, not sure, which Alan you're talking to me.

Yeah, Alan melanoma.

Thank you.

<unk>.

The way the screening process is excuse me is we can actually screen wildly receiving their radiation therapy. So they are initially diagnosed with territory of biopsy will then find out that mutational status and we entered the screening process.

And then they wont be random lengths until after they received.

<unk>.

The radiation therapy, and then they can be randomized and we have a very.

For any long period of when they have completed radiation to when they can randomize. So we can capture most of the patients. So we're really trying to capture them.

And a long period. So we can get them early when they're diagnosed and then following during the radiation and we've given some time period afterwards, when they can actually get to an open site.

To answer your question.

Yeah, Yeah. Okay. Thank you that's all for me.

Sumit Roy with joined Jones Research Your line is open.

Hi, everyone and congratulations again on the progress on two of <unk>.

So I'm just curious like what made you decide to expand to six enrolment beyond each week 27 mutation and.

If you think even two one could have a broader.

Efficacy beyond just a focused population.

I'll start that and maybe Josh you can add to it I think our strategy from the beginning was to differentiate on 206 into new populations that was supported by the preclinical data.

As well as obviously, it's a logical from a.

From a pipeline.

Progression standpoint, so the ability to tap outside of <unk> 27 of it essentially opens up.

Sort of six fold.

The patient population that we get with that agent with <unk> hundred one which in and of itself is still a very interesting and attractive market.

But.

We'll develop it outside of that as a 201 would would address phase III <unk> 27, and there are other potential opportunities for <unk>.

<unk> hundred one.

Smaller I think niche opportunities around that so to the extent that we see to six have this broader activity it would it would.

It would become the workhorse agent, where we would we would defer to that.

And expanding new indications.

Potentially even beyond CNS tumors.

I know if you want to add anything to.

In terms of the evidence or rationale for going going broader than beyond the 201.

Indications targets.

Yeah, I'll expand on that I think the answer is really followed the data from the preclinical studies right. So the activity profile of box to tick we found to be much much better than October one we have preclinical data both in vitro and in vivo in a series of indications, namely.

Several high correctly almost that don't include the <unk> 27 and mutation in lines at that response that we highlighted here today.

But in addition to other forms of neuroendocrine tumors like Cholangiocarcinoma in the guide.

Skyhawk, including ovarian and endometrial cancers. So it was really the observations in the lab, suggesting that this drug could address several appointments of the dam.

Dan's cancers outside of <unk>, 27%.

It led to us.

Making the clinical program more broad within CNS tumors for that first half.

And then the only other point I would add 201 in terms of indications beyond that.

Mike mentioned, a few niche opportunities that we can see that while we're totally focused on delivering on the phase III study for this high unmet need we have seen evidence where the drug may be able to scale and some other niche opportunities, including pairing ganglioma experience, where we've seen a 50% monotherapy response rate that we have.

Published previously.

Got it that's really helpful.

Do you see.

Along the line six to nine months from now as 206 trial starts.

Increasing enrolment rate do you see it.

Competing effect on the action trial or are you going to restrict to one 6% to non <unk> III can do in 2017 mutant patients. So it's a great question that was asked about ready to make that comment.

So the previous question, but we've.

We've essentially.

Yeah.

Eliminated the overlap between the two so that if there is a patients.

Eligible for the action study.

The action study is how they can access all 201.

So and that's true for other ongoing both.

Expanded access for October one and for the <unk> six programs so essentially.

Differentiate those two so theyre not competing.

And then not otherwise slowing down our enrollment for the action study.

Okay. Thank you so much for taking my questions and congratulations again.

Thank you.

This concludes the Q&A portion of the call I would now like to turn the call back over to Mike Sherman for closing comments.

So everyone for your time this morning, and look forward to providing updates in the coming months have a good day.

This concludes today's conference call. We thank you for your participation you may now disconnect.

Q4 2022 Chimerix Inc Earnings Call

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