Earnings call transcript Q2 2023

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Operator

Good morning, ladies and gentlemen, and welcome to the Chimerix Second Quarter 2023 Earnings Conference Call.

I would now like to introduce you to your host for today's call, Michelle Laspaluto, Vice President of Strategic Planning and Investor Relations at Chimerix. Please proceed.

Michelle Laspaluto

Thank you. Good morning, everyone, and welcome to the Chimerix Second Quarter 2023 Financial and Operating Results Conference Call. a related issued quarter our we update. operating morning, press to release second This

the in press of access can You release the our website. section Investors

Executive Medical With Mike Allen. Chief on today's are Josh and me call Technology Officer, Andriole; Allen Officer, Chief Chief Melemed; and President Officer,

and on meaning XXXX begin, we and uncertainties factors disclosure refer complete uncertainties SEC other of risks forward-looking to and Litigation Act to of the differ could made Private more Please are results risks in to include of cause these subject forward-looking materially and that to statements. referred with the a remind actual Securities our factors. risks filings Before call you from statements and to and those for like statements I'd These today's other within the Reform the uncertainties.

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

Mike Andriole

be I'm quarter and across programs. call an ONCXXX and were as the you CEO on to to thank good morning, focused by characterized clinical the which time and both for second our delighted and Thanks, update Michelle, ONCXXX everyone, first joining hosting results, provide for execution us. the

treatment study. ACTION HX KXXM in glioma, enthusiasm for experienced this for the need in Starting part patients of options unmet few ONCXXX these therapy. in study, by neuro-oncology where community first with are the strong and driven the beyond engagement We've across globally the radiation very scale there

studies. further to subset investigators are a relatively studies randomized oncology, in and we few sees particularly which glioma reality seeing the few is of adds have a X Phase sites, pediatrics field. Additionally, the within in engagement from field broader high-grade competing the controlled that This

are sites participate investigators proceed to we study. in quickly in earlier pace through opening reflects the seeing year came we Regulatory from IRBs, to XX we're now pull with contracting of and where which the moving and in the the are countries approvals each the

our quarter, fact, team a opened countries. sites pace the one at we second of have and XX sites XX nearly during across In now a day open

We end of third expect by to sites opened quarter. more XXX have the than the

continues enrollment first if schedule, survival data occur in if and next overall expect Final later in assessment to overall XXXX. early needed. will by overall our final data to interim a survival also survival second have year, progression-free likely patient expected in Importantly, we assessment on follow and XXXX, that needed, followed mid-XXXX survival is interim

the launch of recruiting parallel, the started of and for the organization, possible undertaken many prior program as In we've ONCXXX potential Officer. Chief process Commercial and the market as a have to preparing the activities

study progressing schedule. the on While ACTION

search have year. have to We an commercial an in this recently for begun update leader. later process the expect that on external I

and complete dose ONCXXX, the Turning are the half of XXXX. expected in escalation open-label to briefly to first studies intensification

week dose escalation continual we've agent. safety GBM the looking day But twice This dose reported the is days. we capture date, To-date, has this included color on provide increase future exposures with dosing Allen once the the likelihood range on for once-a-week response should activity seeing of will schedule. the forward, that on previously dosing. observed consecutive include a as to monotherapy well that of where three expect a design, profile update an consistent more provide as to levels

and We've ramp finance. we even expense tight control allocation investment and study. to been capital Finally, disciplined in ACTION the as turning with deliberate

the cash equivalents quarter in previously year. effect with guidance our $XXX Our We million plan of and million approximately $XXX as cash first burn our ended the right at half be full force previous in was the of to the XXXX million the began to in QX. reduction end of of realized announced on $XX meet in in second

our we expect points of into operational expected Under the through to plan, XXXX. each data have and runway action current

Our does small possible of with pox Emergent. and TEMBEXA non-dilutive a TEMBEXA procurement near-term even exercise last space in contemplate But near partnership the from as option remains our payments milestone week, if not receipt is the in term. BARDA financial unlikely active plan we observed

all As a full royalty in a current exercise Chimerix option under profit. to courses a equates million reminder, the the international each and gross a treatment Chimerix. also X.X milestone payment earns royalty profits beyond BARDA $XX million XX% U.S. future XX% contract to on gross on

on the For today. refer quarter statement, to second balance please more sheet and we release, our earlier details press released income which

role, the CFO, year. an to a process process on CBO and expect I to have that begun update backfill we've Lastly, in the later

the we're study a us additional internal call turn and With finalize have to allows control to capability that, strong a to bit that ACTION and Josh fortunate I'll meantime, the provide community. search. In the neuro-oncology Josh? finance color time within over recent that the to on engagements of accounting our

Josh Allen

Mike. Thanks,

overview, our with aggressively has rolled trial Mike's out coverage. from ACTION the tell global can all team you As

KXX-mutant represents the For several made patients geographies, in the channels available trial with time that are who desperate to will a ONCXXX glioma HX official first through be ACTION need.

direct with with We Furthermore, identified optimize have eligible availability creative has and patients support stakeholders community of across have in global as their capture need the the neuro-oncology clinical solutions that patient networks of patients to a the impact trial possible. are time had today. maximize the burden. for a scientific over in referral we to families widens that need ability our to so worked utilize study on multiple balances This consideration way who action we the rigor design with site closely

neuro-oncology of momentum. global gained result has has these and to scope the broadened connection in a community efforts, As our

roundtable expedited. neuro-oncology in Moonshot Research Society quarter, and issues at the Brain cancers facing how event. forms most aimed brain and community forms the we identified be solutions House These important include have form and White on National identifying in Over last participation participated the multiple the Cancer could the tumor Tumor brain innovative

Neuro annual have conferences several respective their ACTION Pediatric in neuro-oncology and Canadian study team Oncology Chimerix activation the the SNO and addition, In members following at represented Society, trial regions. British the

presence our our conference that the global this of event we open. is be addition the engagement trend the direct historically, by presence Note will Our is Vancouver. forward and team that such where important these November year action a throughout building to year engaged expect community, regional in that conferences representation at step at SNO have increase in now be to some will our as can where regional towards neuro-oncology of events you conferences the larger in hosted in another

this Neuro-Oncology September. hope in we well the in EANO, for where to Rotterdam, or Conference As European as you Association later see year

the to for ONCXXX Allen detailed more now clinical I'll overview, update on turn call a that the over With program. Allen?

Allen Melemed

in consistent I'm on achieve an both dose dose yield to Josh. excited hope that is you, and exposures escalation the dose increasing update which studies to therapeutic escalating may ONCXXX program, frequency contemplate we that Thank monotherapy the progressing provide where well efficacy. the

grade ongoing, the There have NIH separate pediatrics [Indiscernible] Pediatric study, no safely than children X. and at level related with adverse fatigue, two trials observed and low have Both grade, under we've in leuchopenia between Consortium toxicities has specific We new vomiting, dose profile events treatment-related NIH been safety three. once the either And are no common in Neuro-Oncology trials completed dose events the a escalated the have one and were all safely weekly through PNOC. one and adult greater trial at adult which most patients. on patients. schedules Overall, generally similar

We dose are now a frequent for to moving more that allow schedule and dosing.

and pharmacokinetic enable twice a Our in for three profile consecutive increase exposure may days response. include next dose vitro to therapeutic dosing [also] models, efficacy (ph) in clinical daily level that demonstrate will multiple

we and mutation. patient's the As you recall, without ONCXXX patient in remains ongoing, investigator-set may with reported glioblastoma a has XX for in now. been response recurrent HX response the March, months KXX This on patient

so on response We dose dose patient are tolerating far. is once-weekly endurable is intra-patient proving patient encouraged Two, so that the far this the the escalation. and schedule in

turn that, over for With remarks. to I'll it Mike closing

Mike Andriole

a our patients continued launch by organization second are quarter in possible. ONCXXX or pipeline the We've on about in and through our as to broaden as We're soon business advancing the expected ONCXXX beginning ONCXXX bringing to the Allen. Thanks, our execute further focus prepare to promise development. to with plan as excited to future

call that, to questions. open the Mark, we'll With

Operator

first the [Operator from Maury Jefferies. of comes Your Raycroft line Instructions] question from

Kevin Strang

for this Kevin Maury. on Hi, is

across color characteristics how and could you Phase you just X any the enrollment Or it on far? geographical far provide the And ACTION say with questions. wanted congrats, whether you trial, around to your a couple I Mike. Starting background anything XX regions maybe you First, of exceed the And share sites trials? can XXX in still that you so have goal? just you different could potentially said from so differs had that? just say Or if is Could active.

Mike Andriole

Sure. Thanks, the I appreciate Kevin. question.

of currently number be have over So U.S. we'll just and XXX your continues certainly sites, The in study the go We sort targeted the internationally of of for amount to enthusiasm engagement significant. to not but on the XXX. point.

think and between on with But sites, somewhere excitement sites depending We'll certainly XXX very goes. interest qualification I been of could we've and so where of the amount XXX scenario there's go And validation we of pleased over do a how participating. be XXX. but in and that

with enrollment, activation been pace countries. really in to consistent of the regard it's different of site consistent With geographies, across sort

about very the Europe consistent U.K. we're actually if just U.S., It's enrollment we at Josh have So where in that. the same comments on rate. analysis. been other seeing undertook Allen, or you this across separately the

Allen Melemed

Mike. comments No here

Kevin Strang

Thanks. about started to for just going ONCXXX, you're thinking talk a Are a more Could could sharing thinking about waiting lining for the when then strategy. dosing full you prior? data some here? how the just you you you about you Or meeting? for escalation so wait And data, data optimal data or share medical it next top year? share And you are

Mike Andriole

previously of something expect these is, see certainly, study. updates out mentioned first half other would in efficacy XXXX. Good the our quarterly conclusion provide or if primary an Kevin. thoughts the relates Yes. course, the perspective, of would of we on Allen, questions on calls last you if timing. We've studies report signals as think of to or of to and activity we'd of from that share That activity, quarter, quarterly safety. Certainly have said, other that purposes both comments be I question, will we on we it that this

Allen Melemed

No comments Mike. here

Kevin Strang

Thank you. the hope I’ll in queue. great. Okay, back

Mike Andriole

Kevin. Thanks,

Operator

from comes of Quibria Your the Naureen your open. next is question line One. Naureen, now from Capital line

Naureen Quibria

you. my Thank on congrats everything. Hi,

will be question we point? of able terms the or on many first-half. to numbers I patient we Do piggybacking have sense will data, of when in XXXX you on I'm a guess cohorts So ONCXXX that first dosing might my at be kind see that some robust is see of how guessing

Mike Andriole

strategy. the slide added our summarize a that details corporate But that's Naureen, deck just morning, let we I'll this Now to published that. Allen

Allen Melemed

gone the We've in dose dose pediatric patients. X level Sure. through level patients already in X and adult

We daily, to are most levels these dose we now switching hope year. twice going and next three days be have completed by week, the them to of to a

So you dose, in think we can that slide second see we it hope it We be by depends on can and our tolerability. but go should enrolled we throughout half. can, a again, deck

our XXXX? think for I guidance, what's Mike

Mike Andriole

escalation We'll complete half dose in 'XX. of first the

Allen Melemed

yes. First-half,

Mike Andriole

to we'll I'll just contemplated, levels dose that comments Allen's additional Naureen. through. go five add Currently, there's

So at XX, up happy can that But seen is and to... we've look which concentrations dose through than higher dose significantly date and Level to level exposures X. what slide to you

Naureen Quibria

of -- then of positioning outside and ONCXXX HX you're considering any pivot ONCXXX does this And you. thank Yes, regards to expansion mean you out KXXM-mutant just to to glioma completely? are more with so not curiosity, just opportunities --

Allen Melemed

your Maybe address question. I'll

I for is (ph) [eligible] now is trial saying action. patients be going think XXX are that what the in that not you're to

currently. these disease of -- the So see HX we're KXXM outside activity are looking to

Naureen Quibria

So anything let's asking -- ONCXXX to what you so -- it -- you any opportunities, I'm will limit I that. are consider with other is so though, guess,

Mike Andriole

Naureen. on question your understand I Yes.

focused So indication. we're on KXXM a fair lead the is ONCXXX is -- is we're HX -- It observation. obviously,

program, been out interesting but follow-on a As bigger IIT explored of intense That's be an and looks ONCXXX Certainly, Cleveland opportunities for dosing for in from opportunity to are we tumor activity look regimen. certainly with likely the at an additional paraganglioma XXX. adrenal that indications that schedule Clinic. and more an pheochromocytoma, there's and

It's to you our this the is if several for program, Josh, you've reasons, we of the a that that ONCXXX CNS. what with other don't seeing more of to on So in KXXM likely extend beyond or thinking. I work early outside be HX we're the CNS lot current done have comments. extent tumors within biology topic. with know

Josh Allen

Yes.

in XXX. that We that XXX radar think some the basically, it, I of lab, But for for other other covers were those any on validated XXX. largely opportunities lot Naureen. maybe of that opportunities positioned a contemplating well we weren't the for even

full right. each other rest The fill with be you've periphery then HX the got and XXX sort prioritized in opportunities for action in trials will of be to ahead that think KXXM, and around priority for supportive it I the population of will speed XXX.

Allen Melemed

More positive, I add other in would thing whether XXX, patient additional of in assume a on lot that there'll radiation action this for go will be with only I -- the population. that KXXM is risk assuming specific it's studies, HX combinations

So there'll be a towards but research more happen XXX, I focused think lot will that a mutation. this more specific with

Naureen Quibria

quick more then. one question So

So see that? was Will anything Has out that a from PNOC there a study of see -- ONCXXX-ampaxolisib? we will anything come study we combination study? anything with

Mike Andriole

published that, they're PNOC a anything that on it's and hasn't study running.

that combination. on yet, in for expectations think But anything they have I haven't published Naureen. modest we that

Naureen Quibria

for you Okay, thank all much. so me. That’s

Operator

from line Beatty of comes Joel line Baird. is question open. next from the now your Your Joel,

Joel Beatty

for taking Thanks the questions. Great.

on is much exposure. one schedule to on with dosing that to, ONCXXX, measures duration describe you're new be you're the different you First could expecting the of therapeutic such moving as how

Mike Andriole

Yes.

the dosed in in a week of what if the than levels X Joel. over of we've is we've the course what concentration dose So -- to multiples you level higher look X, dosage,

up going a we're X milligrams so week. And to BID, XXX times

So once dose we dose week about as level week, were to dose for once per we've high level on a at versus day, been highest milligrams X. X,XXX a the to if is to which we've as where date, level graduate XXX simple is a been XX basis,

higher multiples exposure. So

Allen Melemed

what add, deck, effect you prolonged see data some that I'll we shows see nonclinical that at the you And look slide our do prolonged if with infusion.

see does the [Indiscernible]. do with longer we that help definitely exposure in So nonclinical models a

Joel Beatty

in then catch more the update I so, us an in on later remarks And if And could the entail? tell commercial Great. the about leader a year? to that prepared expect update have would you did what you

Mike Andriole

Joel. here organization X.X without We're the where preparing actively and there -- about X, we're think -- launch, in can from so recruiting a scenarios to far we We're a are in for years leader, a commercial out commercial we're leader I as where go that. and gone we've as point

enthusiasm Thanks, confidence end the a seeing So But ACTION we're us in the update that in the certainly, of take for recruiting the now gives to Commercial Chief Officer. step year. Joel. we'll study that

Operator

White your comes now line next question H.C. is the from white, Your open. from Ed of Wainwright. line Ed

Ed White

What, and Good under or morning. change else? Mike. congratulations, have to questions anything, Thanks for is question is a the any taking I Perhaps your you first my strategy changes for if big picture leadership, to going question. anything

Mike Andriole

Yes. Ed. question. Great Thanks,

imagine, at of As possible you to in a that's a as as with designed while. place transition for a we've intent And being that's disruptive strategy strategy. plan least can the been the

big a don't expect So during this strategic new initiative transition.

follow study, capability broaden the conclusion. continue to leverage the data, We'll the pipeline same, to greatest external to extent to to ACTION rightful develop priorities XXX going that prepare we'll execute to innovation and Our ONCXXX evaluate are remain to our which the launch possible. and will successfully its is and

won't near term. quite thoughtful change been objectives is about seamless this making transition. think I those in sure So And the a we've

Ed White

Great. Thanks, Mike.

you in so think just decisions, maybe And if to next right road, a about be positive the drug can the half data mentioned, next what as steps you ONCXXX, the in is year? the drive down you just have going on do we would the think going of first now data but safe

Mike Andriole

Yes.

efficacy scenario is X spending studies of of described So recommended evaluating step and Ed, a a fair identifying the to time step. perhaps you we accelerate amount we X to take dose fair we're that Phase ways say a course, just making got sure need convincing it's signals safe that also activity. other think to see dose some schedule and I before we've of in

dose escalation see activity. into In expect the we to concentrations where remainder of measures we this I Phase might get additional as of

do now we activity, that potentially this experiments in initiative. work perhaps number And have been the fact, where might scenarios? see drug both so of we're we, Josh, where on we depending would the determine take if is, thoughts under of leading Josh, has outside CNS on a different working where in you on that and take And this biomarker that it. on to

Josh Allen

Yes.

I Mike. a setup, think great that's

on it think depend see I we will what So obviously.

dose recommended to well. development. need said, be Mike sets as at I mindful we're optimization may we're in being And that up X least know tackled need two charge adults, we towards early as and So to into dose or in which Phase pediatrics different in think two. of a frequencies I optimism project multiple levels exploring both us

seamless to schedule, see for would of us dose the we up we given CNS we for these tumors these I that, is the within to and expect in assuming then funds, transition that for I sort lab. is increased that, both either we're see programs in busy wonder parallel into follow-on trials of to, alluding space. an set opportunities quite think cohorts, opportunity just But expansion as Mike that's note a the enthusiasm in already there's this where And that have

prioritizing that outside indications into or prioritized to CNS second Phase wjere have forward opportunities trial recommended once, launch. a go to doses studies of Basically for one those are we follow-on X two

opportunity I out of some expansion think available we CNS seamless maybe of and opportunities once CNS outside I within dose of separate these that for should trials. firm So studies Phase the coming

Ed White

get the outside U.S., just well. in have new outside as the as of mentioned, contract, U.S. insights And for that that you I But you, want opportunities asked any Great. you sales procurement to the on Thank question while. on any on U.S. now a potential into wondering, you a mentioned, or TEMBEXA, royalties you subject so I'm U.S. the I do haven't Josh. in either ask as TEMBEXA

Mike Andriole

good have and to earn potentially good a Emergent. that question partnership in it's that Yes. we reminder downstream a with still economics

it's smallpox in one BARDA saw as promising the space On antiviral we that last hand, to active week. be continues the

On the other complete surprise wasn't and budget fixed. a hand, their we know procurement is of BARDA's TPOXX

what near-term. So might it's hard for the handicap mean to that of TEMBEXA in sort

U.S., say them. is in this that will if not And at well of can rooting I to for be is we're internationally. What TEMBEXA for positioned point, the it just Emergent, anyone demand course, maximize but

to stood One pandemic. and understand maybe COVID-XX the that of for is international question has equivalent the of the which U.S. following that in up I organization And of in variables pandemics is they've extent as capitalized, the the identify the big, Europe European organization, and think, HERA, BARDA, been prepare it, help not to stockpile. I

It does have capital deploy. to

And be for that's into fit so certainly, is seen. be remains that to will biggest TEMBEXA will probably how a that what that opportunity course, for preparedness How is, internationally. of the question smallpox But near-term strategy and Emergent. near-term

Ed White

Okay, question. great. Thanks for taking my

Mike Andriole

Sure, Sure. thanks, Ed.

Operator

Trading. next line Soumit the question from Troy Your comes Jones from of

line your open. now is Soumit,

Soumit Troy

the all. Good the criteria morning, equally RANO progression? for focus congratulations -- And going LGG FDA to to HGG purely XXX, Novartis LGG. congrats on the are so you be on One everyone. the progress. the on RANO measure is [Indiscernible] and question RANO X, all my And approved Phase the on recently

XXX criteria? your if be contrast and -- will what and about And like. if RANO you like curious within can will LGG evaluated thoughts don't So compare, also you

Mike Andriole

a of this how evaluating We're approach. RANO And and we tumor Allen terms particular on that in type. think how we're I'll about that on I'm have progression study comment sure sort timing and in we'll HGG. of opinion further Yes. Josh, And particular in LGG HGG on doing let

tumor measures. that contrast is or whether both those shrinkage thing it's got of important not The volume you've on enhancing

in to want separately. So want you PFS, you to the those do comment each on answer? let's dig of Allen, if

Allen Melemed

their the endpoint that we is question. sense for HGG. in alpha-controlled that of high-grade Survival trial for The though the RANO agreement -- analysis regarding was Makes endpoint And do overall with efforts a have towards RANO Progression FDA gliomas Free on based primary survival. has for HGG. focused FDA as

not analysis but doing be it's analysis. an RANO alpha-controlled an regarding will addition We in to HGG,

So that. there'll be power for less

not has that. and Josh, RANO this to low-grade we Regarding for will glioma the FDA from for but that, trial, LGG HGG the see anything accepted add? has at accepted LGG point else

Josh Allen

endpoints. a add of utility I'll response in on color progression Yes. criteria the between different little difference and the RANO

X reported by to you'll both enhancing previously the and on we HGG data Phase look as or RANO So way shrinkage LGG at sequences. recall a non-enhancing tumor included MRI

HGG, glioma. simpler. that little the as mentioned, can RANO utilize those we to prioritize priority scenario, alpha is That's high-grade was are -- Allen PFS both within trial, WHO all this scenario allocation as regulatory grade ACTION there, given the clear So to guidance these has where for a the transition we

you glioma, for progression components hybrid by criteria player. measure TX disease When TX counts or progression on with enhancing RANO either and non-enhancing

high is, prevented not So progression anyway, criteria study. we disease on RANO at that the where grade that for remain could response for getting criteria measures Allen or unlike will only evaluating was The a enhancing. enhancing be glioma progression use endpoint primary difference

So it this into will still adequately capture study all the criteria. one patients that with going

Soumit Roy

the are Thank be runway, for any be are of that color. guys activity any could or BD you you And year? question what that next -- you it. thinking -- or year could the Got for real guidance on second thinking this is cash

Mike Andriole

Thanks, for question. Yes. the Soumit

our the particularly we've ACTION and as study disciplined stage of at capital to-date, cash enrollment. the allocation of site we terms of outset the activation in call, on ramp and been as I the really runway, mentioned food So

is million end balance cash where we The of right expected have end at of be. quarter, the the second in to the right the cash have at $XXX year. on we To

to current with XXXX through the left over Our us action little just XXXX. in a into all allows a XXXX of get forecast bit runway endpoints for of and cash

clearly So important us study. as execution complete the an of for objective we ACTION

to either ONCXXX and on pipeline complement how Nevertheless, we with ONCXXX unfolds. at ONCXXX depending the or looking assets, are external

a development have be in calculation. We forecast our could that a of more dry little powder course, that becomes do there's where for projects. scenario Of cash in available bit the other important

bringing those. bit for higher is given at development I we're in and so activity with a business say the actively seeing will we're bar projects XXX. looking external And the

I data, as signs X. earlier, Phase investment need other And to think, we convincing that still into to mentioned in I of trigger a see bigger program nevertheless,

certainly, we So meets we'll assets we value to where something have follow the And in criteria we it's sure can strategy add if couple for any we projects last to targeted as I critical look think really prepared making our the data right on and we're those that strategy we complementary externally think of but oncology, on now. that. years. We'll ask, our continue think find additional bringing to are as that about

Soumit Roy

you color. Thank And the congratulations for again.

Mike Andriole

Yes. Thanks, Soumit.

Operator

Your next question comes is from the line Cowen. of Joseph your Joseph, Thome open. from line TD now

Joseph Thome

Good you my Hi, thank for and taking three. there. questions. I morning have

one is The a clarifying like a I the When an commercial person mean sure make just said want you first question. lead at company, CEO just individual commercial leader, you to development just the the of -- to correct? want be Phase to strategy should pharma that I lead commercialization therapy trial partner a actually and make sure the X successful. not that is to

Mike Andriole

of No, to Commercial the Chief company. Officer good of referring clarification. Yes, point our was I to

Joseph Thome

I Or on then of sort year, ONCXXX the efficacy you in what you. you in level Thank emerged we second, you're the did that With sort when And kind response at duration ONCXXX, is the of 'XX have go, to then response And a response? on no-go next see rate? guess, as ONCXXX. looking for on was second HX of question data data that package we decision rate follow mention wanted of perfect. the see, program. Okay, to the XX% it

given I individual when is and you. that rare consistent regions? look across With sites standard XX disease, the a Thank Is diagnosis. a how guess, growing is then to at between hopefully these different this of in XXX, and sites sites you all concern over care

Mike Andriole

Good Yes. question.

this we're this in and for, is of for So I'll looking study. a is, first the terms foremost, -- safety question just what a reiterate, XXX

we've of should think to additional a us schedule about enable dose escalation think activity. and see identified I we signals some as that

have at date about milligrams We and of escalation. intra-patient such and interesting low once week what's it dose continued through has that to a certainly one XXX having seen dose a level is

will we program like into that activity assuming as that get of the or that certainly, X, signals And that for I a Additional perspective, dose response. within setting, a be considerations levels we eligible of take for recurrent X, far we if safety are important think X, evaluation how from get patients those forward.

confounding also that's an got really arm other study in criteria in such is that otherwise, patients the setting frontline where because PNOC response and There therapy the therapies, eligible, aren't the confound that upfront whether those is in radiation as just or it's setting assessment. a might you've

we've we're so for in other of got And activity looking signals that population ways well. as patient that

look or do at that we'll question? and the it when decision point. a data So totality of have we the have make Allen Josh, at thoughts you other on that

Josh Allen

that Other in as as a study. We're wide right? range context, heterogeneous then CNS the enrolling of well. group, entire tell the mind, And a pretty keep space of from you it's of that can tumors. across out patients the exposures will There's come

is sort that specific group signs setting, is activity but rather ranges little monotherapy recurrent a clear. have it's more we exposure in for of a to will So given high looking patients hard I what a towards up where in that think heterogeneity, tumors therapeutic rate, shrinking monotherapy all pick within of

entire there's like for signs off data that opposed a denominators we subgroup. a then we'll any the anything specific specific there mechanistic make study. of at across that's And if could common be the to sense looking rate as charge Allen, helped add? I to so feel --

Allen Melemed

Yes.

XXX certain good populations. we I drug as than be some better need not think we in will just that say have a confidence that and to I'll forward if move that

critical will be we decisions very to areas. before the looking So making at data we're escalate to other

Mike Andriole

the we of of care is that in at of this for that us question, consistent consistency a selected dose in And making standard Joe, sure getting big then population. consideration and were institutions. dose on radiation in patients terms radiation other countries those The market is

that activated. consistency been sites all with of comfortable have across that we're so And the

can for allowed as with in then patient or make the with really there terms extent that to to are we've we in combination And homologous this population much of better of for tried is, isn't a And standard Patients worse, as exclusion criteria. temozolomide there radiation. of beyond the inclusion, that. care

continue or benefit effect would unmethylated. known of a less HX that survival mutation It's the patients proven sites patient may Some an unmethylated in KXX hasn't population. have in fact, not with or, this in may are vast the majority of to patients

that excluding certainly activation. and washout barrier making adequate in study So period there's the a site sure has and been in not enrollment ACTION

And so consistency the good of geographies across we've countries both sites, and across care. standard within got globally

Allen Melemed

is Joe Allen. And this

for as biopsy prognosis is that Just country to in standard add, the well we're getting a going, of as other it's understand I Tells important markers. think care.

it's testing that's through of either IHC. part being standard or So done NGS

to is some that that biopsy ones would we're give don't not always are going not there -- we the always to always last that tissue. this -- areas So typically

as is possible. other radiation standard out no options if And then there's there. really, resection said, And Mike

Joseph Thome

Thank you very Great. much.

Operator

are no Sherman. Mike to would questions further time. I at Mike. There to the like over this turn call

Mike Andriole

taking months. Yes. Andriole, time happy but thank the look the finish, It's to for this Mike you for you everyone and in updates to giving coming We morning. forward

Operator

This concludes call. today's conference

now disconnect. You may

Chimerix (CMRX) 3 Aug 232023 Q2 Earnings call transcript