Earnings call transcript Q1 2023

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Operator

Good morning, ladies and gentlemen, and welcome to the Chimerix First 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 First Quarter 2023 Financial and Operating Results Conference Call. a related issued operating our we update. morning, press to release first-quarter This

the our Josh are release the can and Financial press You access Mike Officer, in Officer, Melemed; With Andriole; on and Business Difficulty] Technology Web me Investors today's [Technical call Officer, President Chief Allen Chief Allen. site. of section

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

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

Mike Sherman

Good morning, a standpoint. joining. definitely everyone, an is for start from good and execution thanks off to XXXX

have continue now study initial we're for weeks survival approval now. remain from received few an overall open approval for nine first action The our sites analysis assessment. on was a and protocol activating latest XXXX, Union, efficacy includes European which sites to and the ago countries. early the there We schedule in We regulatory in

Carl was from The University strong American ONCXXX's He by Brown clinical the imipridone showing the to We evidence the trimethyl dozen are presentation for and University the were collaborators by related a our a of with and loss. Research the Those Michigan HXKXX company presented at Michigan. this reverse the ability presented of presentations have highlight. of at Koschmann Dr. in University platform. year Annual than more pleased to meantime Cancer Association the Meeting to

a is prognosis. but further. goes We've described the a HXKXXM has between poor population, and This know ONCXXX's HXKXX the may example tumor trimethyl to therapy which of linked previously targets any first This target you this reversing relationship characteristic, is the and been growth known step molecular loss.

on responses analysis it ONXXX the patients observed trial. Josh II reported tumor This survival set, by Phase of of all data overall matters outcome in little deeper a the moment. bit the nonrandomized in others. ACTION why compared confidence advantage let treated the top So in science multiple provides to of durable and the dig a I'll the into with additional

the dose We also continue escalation progress ONCXXX in studies. to

escalation signals will create to half to activity. run the the expect opportunity identify dosing XXXX. into of open-label dose of We That and first the both other inform the strategy

of recurrent quarter, potential a who As the patient compared lower one an to populations you the HXKXX this reported for recall, we the glioblastoma ONCXXX investigator-assessed last signals at glioma in patient without mutation received indication. in This doses. drug the response larger HXKXXM much

With this turn that, ONCXXX's development. for deeper the reverse on call and ability to a ONCXXX to Josh trimethyl over review loss I'll

Josh Allen

Thanks, Mike.

another that global at Histone tumors way, found mutation to put AACR findings expand would patients' directly our in as in glioma down first a mutations probability of the Phase of hallmark. trimethylation gene HXKXXM context, HXKXXM out trimethylation gene loss confidence repressive expression. the lab HXKXXM to alluded epigenetic position that HXKXXM the Mike to tumors oncogenic the it ACTION causes ongoing treatment To HXKXX ONCXXX thought the expression. in drive of reverses study. PRCX III of into from HX both and I'd that enzyme patients pathogenic success novel this caused like mark to our in as KXX one normally carries sequestration findings tamp be bolsters for the So the have of models mutation in These Said of on to, of suggest ONCXXX

there us mechanistic finding reversal in vulnerabilities in a layer consequence the across confidence ONCXXX already in the treatment and the loss of We to a was were the of certain whole ONCXXX. consistent, the and hypersensitivity. trimethyl mechanistic persistent, This new demonstrates of as HXKXX patients gives additional patient study tumors. utility associated of their back glioma reversal new mutation population. ACTION with potential with the The effects pervasive direct ONCXXX of Turning knew that HXKXXM rationalized mutant associated

II tumor targeted that activity removing models While Phase HXKXX trimethyl is activity documented new a recent established reassuring prolongation corresponds mutation the other in the in in and indicates populations, intra-glioblastoma significant have tumor demonstration effect at Furthermore, biological our HXKXXM of to with population. patient overall this we it consistent dose recommended particularly demonstrates as survival. literature increase

loss of indications the HXKXX of effect It trimethyl other in exhibit being forward than We sparks for patients. HXKXXM as least offshoots more data additional HXKXXM that mechanisms science All indicates scientific this has also a number not of which the several ONCXXX that implications are unfolds. the direct glioma mutant that sharing on the look are of mutation. through pursued, to a

quickly by turning This dose program remains complete XXX. back on to escalation the first to of XXXX. half Now track

patient day, clinical data-driven path tissue parallel the target of added further glioblastoma escalation per signs When are molecular days collectively inform and for announcement escalation. tumor dose that activity to possible, by response a forward. expected studies You X crossed twice studies that investigations signature recurrent expected enrolled enable on archival will enthusiasm objective X recall dosing these to in response non-HXKXXM days on, are program collecting the monotherapy schedule. who downstream a a laboratory our potential with a early be is has This prior in off in to formed will to of and

Andriole With the for that, over Mike a update. I'll financial to turn call

Mike Andriole

everyone. Thanks, Josh, performance just and I'll update position. morning, our quick financial quarter for a provide cash on and good the our

same period the the in of studies positions loss of with million investment million future loss pharmacology our first expenses spend the of the first net of quick and to This the well a clinical decreased a we our for ACTION were clean has farm related quarter us which reported XXXX a R&D NDA development, majority portion quarter needed net XXXX. compared on filing. associated The for been first for we to quarter of $XX.X to finishing $XX and potential XXXX. compared meaningful support a A the to to research For submission million $XX.X of following XXXX, $XX.X for million prepare are study. work recently of

increased year. these for of continue the general administrative to Regarding period we tightly over Those wage million above-average quarter for slightly compared $X.X the same to expenses, expenses manage $X.X to XXXX inflation first despite XXXX. the and past in million

our reduction previously effect in we expect force this to take forward, impact begin the to Looking of quarter. announced financial

continue QX million to the approximately but QX. Phase readouts are to equivalents. in Under which which Turning cash our year We CRO through TEMBEXA, high cash to what items, Net occur QX which will nonrecurring XXXX. at won't upfront we severance XXXX action XXXX, included including ramping of the end until be the be position. burn with we payments expense, including ACTION current emerging to by plan, we expected expenses million, related in several $XXX operational our the as paid in the $XXX study, of the primary of reimbursed III organization sufficient and for we of expect with endpoint and around fund expect early the ended study, in first year-end was up to quarter expect cash into QX beginning associated

for We should also to following ONCXXX, cash studies fund the they sufficient efficacy this be pursued expect ongoing escalation to during dose period. initiation balances of work be the

Emergent forecast. agreement Importantly, any our included this not arising we from in non-dilutive have capital incremental TEMBEXA with

exercises by additional this exercise. milestone would generate the procurement per over full any period So government $XX million option U.S. an

TEMBEXA to We plan. international royalties any during period. from also receive or capital be the summary, our would in In of incremental demand U.S. the to proceeds have TEMBEXA this volumes from potential internationally shipments

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

Mike Sherman

questions. turn it we'll Actually, Mike. to just open let's and Thanks, operator, up the for it

Operator

[Operator you Instructions]. Thank

of from from question the Jefferies. Raycroft first comes Maury Your line

Kevin Strang

This is Maury. for Kevin on

quick Just XXX to had a start. on couple

complete color you're You more able first when said we escalation cohort giving to of in at the the which dose Phase with to see might II protocol or And also amend you up terms going next if dose Are to escalation just year. to of to you're dose found we're not? the X by whether the and where any you data, terms weeks? the recommended of into is in expect half until wait

Mike Sherman

Maybe the continued has can preparing escalation more intense in dosing Allen this. the add The parallel Josh once-a-week or to dose. to for with

And happen that so to we to that initiate shortly. expect

trial. open-label an it's data, of terms In

updates So as we'll it. have be to we provide able

doses in could be late year. year early or the We either window would expected therapeutic next we initiate that this

having out that So insight I the are notion dosing playing schedule as likely next signals on as some well activity year. of the first potential both and into to think be half into how the that's

Kevin Strang

how Can And from timeline any for is trial color granularity so regionally Any the just in U.S. going? the III, investigators data. is enrolling action the you enrollment reiterated any initial how Phase far? ex-U.S.? early for give maybe you on XXXX on or that the And feedback

Mike Sherman

sites U.S. active the first. imagine can were You

the So far. that's occurred enrollment of really most has so where

begin here the as participation actually I the as activate were outside ramp we've up anticipated been positive sites with follow the out think Europe first feedback that Western sites, will well. U.K. over of more to The and coming interest we've had than we opening rolled Israel weeks, and there begun the really initially. has to to this in the U.S. in sites

month an see goes. so the activate sites active per plan. have so the early. site may far, But more per And that and has it's enrollment yet, We'll than that exceeded original patient mean we to expectations how our opportunity

you be as I the that the can of the on equation although side certainly don't early in to necessarily right we're So think that's study. continuing, count on

Operator

of the from One from comes question next Naureen Capital Securities. Quibria line Your

Naureen Quibria

one quick on just back. going XXX a So first,

completed less So current frequent intense dosing dosing regimen? to able more how have switching at you know comment? regimen, many doses to many the been up a you're How that but... I are doses

Mike Sherman

what the prior you I add know Josh if don't shift don't to comment or wanted to that there. know to in I

Josh Allen

Not where moving. a is honest, than the be lot other to study of color to add,

answers yes. prior was we to there if now we're the and right amend a that think from on protocol where I are able question

went quickly commented well. responder study previously we to future moving increase the as That the in dose we've that So XXX escalations of schedules. at was to a and possible milligrams aimed of previously as reported the up continued those

Naureen Quibria

And where mechanism into finding new on you the the of reversal the update XXX the were way. some curious then Histone. incorporate study just Dr. ACTION I presented on that of Koshmann if was the from to on AACR, able in

samples, tissue XHG get maybe not ctDNA they like the new instance, looking but might not way, for be to increase indirectly So in you some levels and or decrease finding. at CSF looking -- that at able incorporating or or

Mike Sherman

Josh think interesting, and has about as can I'll know both if or in speak I'll we I I and to but this to impact a be on that that on let do that. it our think no not don't want starters, for amending of ONCXXX, it development protocols. you say yet, and metric Josh, We're way is ONCXXX Allen the expand that? Allen do

Allen Melemed

until this and add a the thing this whether in tissue Unfortunately, need of CDx question that at tissue received resolved are I'll FDA. we is collecting haven't point, we all that One we we can. patients we've

tissue necessary, not the and of Our and as that ONCXXX other better. we a will, the well we as collect that think, can field to help hope is be I the use that understanding our studies disease do will additional CDx

the after come we clarified to more need CDx. for So the

Naureen Quibria

And more… just one

Josh Allen

add, quickly addition also Allen that tissue the well. in to blood going just was we're collecting spoke to as about, I samples

we As what the mentioned, to this anything change don't Mike protocol. with expect

tissue, on optionality like assays and samples well. flood have additional molecular preserved as We tumor on mentioned for Allen

several an well. study. lot getting we'll implications a ACTION as have little of as trial exhibit a opportunity cancer in to course, I was There's well the dig just at So And trimethyl loss that's of as outside more this what types there. other highlight, Mike the of to in later think

of can contemplate we mindful So be we the XXX, but this also future development, not as XXX. just

Naureen Quibria

just more. And one

Meeting, will any So there? with regards presentations Neuro-Onco be to the from your your participation Canadian there collaborators in

Mike Sherman

clarify a we'll to on… Josh, expected team want there, have as sponsoring that highlight can you we're presented if do there's a want think to don't I comment, to you data be there. meaningful that Josh

Josh Allen

That's right.

Our ground is that we focus team sponsoring, and as real the the that particular geography. conference, is actively engaging standing the of off trial at up in that speak

the stand but presentations, ongoing So specific be quickly lot to I wouldn't of possible. conversations trial in to as ACTION expect as a there Canada

Operator

H.C. of comes from question next line Your from White Wainwright. the Ed

Ed White

be and How are you the back patient XXX think the of sites going should U.S. to approval. over between have just with said the enrollment? outside I the U.S. some European and And ultimately study you goals ACTION more might was split the global you we said had sites. Congratulations and there? initial the Just What your but interest. goal sites, thinking

that be So about thinking in how should we totality?

Mike Sherman

but potentially the go XXX bit anticipated, so that. more terms sites I rapidly little think from a sites, that -- expectations opening well broadly isn't that. estimate beyond our variability come X/X. North the in number is of obviously, that we this impact is patients within And of most we some slightly U.S. Europe think than But I precise, say, speaking, or get around there's could our America, as we could will total and of

before, need to sites course, in ways that As But preserve the don't can these I other capital best acceleration investments. end we among of productive it and and the is trial, to mentioned patients, opportunity necessarily for enrolling timelines timelines size that always up terms the being of for that accelerate of many. the extent preserve this

But we're XXX, of yes, look always keen not accelerate. north for but So to much. could it short is to story ways be the

Allen Melemed

can enrollment. lot competitive [Diano]. our And tell interest I when of there. There meet is is we did European This at plant you with a

that could Europe the power we as and excitement. having definitely as sites opened the could, So on depending quick change we

Ed White

still you of also sometime that, that timing the first mentioned before the data, early of you the after or that? OS the early in 'XX expected assessment? be is thinking timing had the about we in assessment Are about OS thinking expecting just PFS XXXX. that how And second And is should readout but

Mike Sherman

around XXXX, to final -- imagine Yes, you PFS after do during that. expect later also initial second OS that mind -- during still of we just that's That XXXX, so with the some but to and analyses variability there's to in potential out OS potential. range The the assessment, probably the PFS can happening read XXXX. certainly out a early have the that's year not read final

be to that do PFS overall I think second that So will initial survival assessment.

Ed White

question I ask last to is question. the a And want just big-picture

want data, far opportunities. want to to based on as markets ONCXXX, be your clinical far, the probably do you're you your to I data amount take what Regarding versus small on where of the drug? you in preclinical compare so but as for ultimate each just ONCXXX, ultimately also can thinking get ONCXXX including what turned

Mike Sherman

Yes, I'll with thinking expand has finding broadened our there. start this from maybe I'll And say of loss there. and that trimethyl

a yet and fact size not indication, access glioblastoma that got the of in significant that some mutation. there's patients first an X,XXX-plus opportunity which non-HXKXXM The we've orphan segment, population a It's patient the it's itself. to the suggests the have diminish comment and is Xx the activity demonstrated a of potential that's And the is that mutation. with to in

opportunity about is becomes that of broader ONCXXX. patients see in that X What reach. preclinically, interesting you could you the for outside that though terms we of Going multiply by mutation, potential

that's to as are where this There's been identifying And some indicated focusing activity loss so and actually we expanding in that this we've data. both overlap and dose where to models where parallel preclinical escalation, target indications is seen -- now in have on and opportunities. trimethyl opportunities, demonstrated,

to on we you come that. the beyond expand down where of if strategy. dosing in to indications and more Josh, think the I So Allen on be glioblastoma will nail focus terms as want

Josh Allen

think I agree. I Yes,

has opportunities. clearly a the number broader Ed, say we've to lab, in activity expansion Just different way, it of think ONCXXX clearly, I seen a

that AACR in mutant fit well for [indiscernible] It lab. I lot at presented going that those yet generate We've very a the or adding to vivo with therapies a data. it just data glioma published don't present is in make Clearly, a seems XXX vivo context of to we've logical. mutant within CNS, opportunities more a data the do HXKXXM themselves most the other data Instead, on number would to that We've is had think there's of like lab number as of come in the that one seen to that's setting we've seem glioma and was Some in first the in seen through with responding models, mutant non-HXKXX me-too make concept proof glioma. to doesn't a the in shows HXKXXM follow-on trial. the of of drug sequencing responder sense. sense

the trial. through a coming the have those play So we can when refinement the CNS drug the I in we broad out of tumor collect privilege space, mentioned, signals do like get in molecular so we'll signal tissue letting that

So the be of of then, from will there's opportunities studies KXXM within There a lease be clearly will with that year anything of to bunch And well outside distinct logical. look XXX we'll or non-CNS to could I that that most to course refine think additional CNS, the well. activity of lab it as add? activity the of course, throughout as opportunities. Allen, be

Allen Melemed

add. No, nothing to

Operator

comes question Troy the from Cowen. next of from line TD Your Langford

Troy Langford

progress. the on Congrats

Just in color to that? in set can ONCXXX, any of terms around expectations your of updates dose the of amount you of patients, the granularity like more you anything terms around levels, future day provide follow-up, would include for the like or first number what data

Mike Sherman

dosing but we'll -- until we'll updates. little that more a held define that to be we got the more we've able elucidate think able of bit intense to be upcoming to actual I off in this into strategy,

next and escalate safely is the into think get focus window. anticipated -- therapeutic on safety you will always thing the and obviously, those I essentially can trials the be the

opens a we expect go. having to as response to anticipate. But that So discussed patient we've you an for before. that because that a from real be bit where saw The to in patients a can that That efficacy safety no we've standpoint, dose window of date, the see signals, previously we that well, be that typical have didn't you reported. to confound any at are been point. as signals trickier update tumor said, little important response the to measurements a We seen activity response measure less it's prior at therapies reliably will

only response actually CX other few setting measure unexpected. And in via was where what there are But was patients we've to ways potential. activity had a is that So really a markers. to

remember of profile. to at safety a goal may the It's And same get to primary able and to work the time, potential strategy right be But so a define is fortunate we there's dosing and patients, if important that. do we that the and efficacy to you're signals. additional this provide the

say, that will keep happen I we'll XXXX, unfolds. pressed but likely data more that as into As

Operator

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

Mike Sherman

I Great. us. look Chimerix forward strong again Thank months. you. coming collaborators far, so our Well, the for team the providing in updates they're to you Thanks that joining doing to thanks and the good for and and work execution

Operator

concludes today's call. conference This

You may now disconnect.

Chimerix (CMRX) 4 May 232023 Q1 Earnings call transcript