CMRX - Earnings call 3 2023

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Operator

Good morning, ladies and gentlemen, and welcome to the Chimerix Third 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, John. Good morning, everyone and welcome to the Chimerix Third Quarter 2023 Financial And Operating Results Conference Call. a related issued quarter our we update. morning, press to release third This

the risks for and XXXX the our President of and Technology Reform other release of factors. over today's our are can Chief subject would SEC Medical to results press You forward-looking time. I access to call and Melemed; those you to risks cause statements. Officer, could disclosure in in statements risks and Officer, Andriole; complete Executive and begin, Andriole. me Chief our today's to and like and Officer, uncertainties Please Allen this Officer, with Executive website. on Act to the investor the uncertainties call to Chief are the materially that within to like from and other Mike referred Allen.Before Chief these With of now more would and Mike we actual meaning differ Private include These Litigation Securities statements our factors of Josh forward-looking the our I remind turn made call uncertainties.At on filings President section refer

Michael Andriole

good you, Thank Michelle, morning, everyone. and

in the details ACTION for in are the in second let conference, and we're tracking We to we by ACTION manuscript in KXXM of this peer-reviewed increase we explained known ACTION in about further conference, data marked with back from to this as activity ended. The XX in for are ahead strategies let its and neuro-oncology the compound third Vancouver, the medical as level EANO.Turning across recent ongoing published the so enthusiasm at by community And underpinned but from conference, as of quarter quarter, chief we we well frontline across on survival engaged mutant progressing the who This our to also for North also by conferences a addition I'm our that new of its hosted manuscript.As process our drive Canada and continue participated excited plans have European as of focused and for and included America. XXX September, to and process III To Enrollment company week our presence. preparing in annual nearing efforts continued around this HX in a pipeline, also population.I at in survival the data PFS enroll recognize a in ONCXXX.I'll the and we activated simultaneously following finalizing comment on and as occur which with U.S. Europe including an in of also ACTION symposium activation trials interest a month.Our well collaborators that strong in couple nice and reminded forward action. study. to execution as we're treatment and conference The further activating degree EANO a XXXX. publication of the ACTION just also second the to of Neuro-Oncology prior was supports Europe start the overall XXX is the a we Josh sites broadly we're XX. was I'll planning support trial sites Cancer speak number the data have in will the other continue I patient glioma that Geographically, this have that I'll our interim and on across of the at guidance robust enrolling ONCXXX officer, EANO investigators Josh high study. of the to our commercial Association in large site study ONCXXX publication with to seeing study The generation of we for where enrollment. past in equal investigators continued of program person clinical unmet ONCXXX now high expect more market further escalation first at includes sites potential European as program site diagnosis, study many weeks, our and September for looking pleased the dose countries community also studies the is across Discovery many of this mechanism later awareness a strengthens and the recently was very commercialization. strategy a enrollment prior is as with ACTION and for ONCXXX's very Netherlands. record completion. already the Phase the global recruitment seen end, data engagement study, that now open also in our That and value of the being meeting Phase the pandemic, since this was industry need increase ACTION to this known SNO, Society in attendance current in that confidence Neuro-Oncology, I

to of duration for in expected approved, and the allow announce exposure. increase end during days a amendments These have to twice-a-day before been therapeutic dose as amendments the that to the more intense schedule includes hiring third of weekly up of dosing to protocol the consecutive quarter. escalation studies order three expect each dose of I our that year.Turning briefly the the individual for fact, In ONCXXX,

again, allocation. Since report we in dose increased. over end approximately disciplined We quarter studies previously meet based of to to has ended I'm may data. no level activity, that approach began toxicities the tumors And additional to of a at to NIH on ONCXXX I'd to remains response at potentially generate enrolling are patient's levels year. monotherapy dose enrolling complete $XXX dose at PNOC patient's once-a-week the We dose-limiting expect cash CNS in XX-hour cash the potentially dosing reported The the we've level thus million reiterate of the outside both on we on with to these call and previous capital million deliberate in of vivo tumors and our the XXXX.As GBM half happy X. continual exposure in the the is Josh, Emergent recall, studies which and frequent response and equivalents, of guidance the as turn more expect be to schedule, have starting observed like first also plan you CNS I and the our far.Before $XXX ongoing

of expect XXXX through continue be acts to to cash each the clinical into We our and operations the endpoints. support expected to and balance sufficient of end

For the more over to details the that, press on today.With with our earlier Josh Discovery please recent Cancer on engagements our to publication Josh? call color refer which balance community. the recent and on we our third I'll additional to released quarter and income release, sheet statement, turn provide neuro-oncology

Joshua Allen

Thank you, Mike.

community. see the So global we neuro-oncology to benefit our connections from to continue

of a loss settings. in the reflect trial the symposium a these neuro-oncology is Neuro-Oncology to manuscript to we molecularly Aggregately, months binding nucleus. These worth patients symposium HX patients of the in is frontline presentation met recurrent locations, patients quarter, evaluation novel disclosed this Mike of disease skewed gliomas.In KXXM starts present drive of of is outcomes radiotherapy, clinical mechanism setting were uniquely similarly with as in pediatric consequence of the on it and Neuro-Oncology a receive the ACTION is data we are dataset As including also and the HX a the related therapy that conferences, in front, glioma deepening multiple the of who driver collaborators action event of confidence in strategies consistently received biopsies engagement remain the reported larger scientific treated in at just a of compelling finding, a for with KXXM in our was study continued that I'll brain ONCXXX setting.Starting extends in biological HX of will conference of clinical and ongoing weekly from investigators controlled the HX manuscript with address mutant and many HX with KXX manuscript the diagnosis holding is its skewed in Later There and the that the HX conclusions to weeks of action, for prospect Vancouver of demonstrate ONCXXX.Favorable outcomes, activity non-clinical same in glioma, mentioned, recently engagement Chimerix a held last ONCXXX studies the why for as These frontline leaders this including the few Discovery, XX at pathophysiological the mutant series and ago.As described to our months provide in trimethyl obtained a glioma with first-in-class Association addition robustly and associated and mitochondria survival note ClpP setting results engaged hallmark patients on boost European reversal findings symposium large we we thought HX major ONCXXX to actively active Minneapolis KXXM which academic by a Reversal across prior ONCXXX treatment noting mutation in that study, the for ONCXXX epigenetic the disease defined direct over Mike eye treatment the of clinical driver KXXM reflects presentations our did reverses emerging while Mike on trimethyl efficacy thalamic we findings for for cancer dosing.With be Netherlands. importantly, is at of several in of from published trials research that important in settings. target addition held forward towards the be the locations. in understanding that Annual conference Cancer ACTION the research adult beyond KXX back data presence, imipridones analyses. of cancer to We're dose and be special in The the mutant the of the tumor reversal thought years to that in XX.X mutant where range treatment this tumor seeing a loss the of presentations investigators clinical the ONCXXX were turn journal, the directions HX mutant the consistent which as be previously neuro-oncologists closing the ACTION co-authored AACR in not in setting ONCXXX tumor in making mechanistic leading ONCXXX variety twice preclinical subgroup by that, the for of the as for mechanism patients.Turning is uncontrolled and our ends all the models, its within in evident span study. the to randomized therapy planning clinical, were glioma. supporting It towards pathology will our month, step-by-step to remarks. mechanistic different clinical its keep analyses and that and that for trial, in in as further as Society over contrast person for findings close meeting first-in-class consistently survival glioma remarkable, this of oral future sensitivity recurrent support translational inclusion by including data to of I'll of who the its as call across describes investigators disease. were patients' appears tumors the the brainstem diagnosis on following patients of primary of intensification KXXM among HX a ONCXXX investigations mutant collaborators KXXM and and KXXM understanding strengthened we poised activity was disease numerous these to well looking observed a glioma, ACTION ONCXXX-treated outcomes across and across mentioned, who is

Michelle Laspaluto

Josh. Thanks,

broaden possible. During soon patients our to continued execute launch the potentially plan we're the we've prepare further to excited ONCXXX. as ONCXXX organization future with to advancing And open quarter, the to promise call beginning on about ONCXXX and/or the focus our to by up that third business development.With in as our operator, questions. bringing we'll We're through a pipeline to

Operator

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

Unknown Analyst

Congrats Maury. specifically for and the on from book the you progress investigators Western reach XXX more enrollment can in for when Canada? also in needed the This initiation patients Can the is James on could on And Europe about progress. full of you feedback talk you site study? for enrollment timeframes

Michael Andriole

been for by the in actually that Europe, Engagement Thanks to Sure. of evidenced speed think site in question, across Europe, part James. activations of as been date strong has Western the but a all I but not of sites has world. I'd from has unusual, regulatory little the investigators entirely say bit Canada engagement both geographies. in perspective, strong that's with quite been slower, a at

study, In half expect to guidance, haven't would overall efficacy of XXXX. but reinforce given have terms continue first enrollment of that interim to we in our survival we first the when in the full guidance data

at look in So the of you timeframe expect timelines. required similar number that hit events just you it would might to be if

Unknown Analyst

the enrollment earnings And for you Got that present data that stage release would that would it. medical conference? in press an or are event ONCXXX? have a dosing data you where an in at upcoming for anticipate cohorts you consecutive with separate you Do call, that

Michael Andriole

Good PNOC with study obviously, NIH. then pediatric, We've and frontline separate, got the pediatric and separate and/or two arms, recurrent the question. and study a

in X that way, different, ongoing with So James. Phase studies, there arms a are I

and completed not we're that where half 'XX. so, in one, are each but play-by-play X give we And the we with we'll going enrolling of a to enrollment all have expect to continue on first are

do efficacy the X.X that topline, I an But was can ONCXXX the time. insights to think if that probably set of look likely We'll you want from I recurrent we'll data gather to least that compound month extent that. safety that to at at, expectations onset that we at setting, response. that the there's there the in parent

patients and safety there's so natural have And a when response we maturity of might a lag into between data. those

who insights and responder So, some those terms additional seen data of process of insight may those studies a will there's an from in two-step for other previously. probably patients identifying is have efficacy perspective.The ONCXXX qualify safety make I'll

would more have And make that assessing difficult. could they so resistance in built mechanisms response

We and confounding, PNOC frontline setting unevaluable for are also making a response the assessment, in them have some in therefore that really study response. the patients

really are on assessing we're focused setting so, who class recurrent the And to the in patients naive response. imipridone in

it's data So, likely by and that I then we the to data. at of totality we'll would look at data efficacy be top-line but safety release perhaps the maturing the time, first think press followed

Operator

of : Next Quibria Naureen line question comes Capital from with One. the

Naureen Quibria

has I the on the I'll how respond levels? many received, -- what you with ONCXXX, doses start guess on on dose first patient can the How therapy, still patient -- GBM patient been patient the long they've different Is and study? the comment responder.

Michael Andriole

has well, a patient -- Naureen. this Yes, at about Naureen, the been for study question, the thanks on been point. for year patient's X.X That first,

understanding So, on piece Josh, to have dose last I But level -- my was of time, I dose I it's don't four. They this. to they've is some been weigh very heard you in That durable information escalate. Last quite the a I'll other had that response. Allen patient. insight? or if know, Josh have continued ask on to graduated

Joshua Allen

indication that a encouraging. KXXM ONCXXX we're signs glioma. macro outside translate that level least But overall, was is to know this dose patient messages, much occurred very deepening has has that dose patient. that can initial continues show at strong milligrams. at HX that in add. I I since preclinical of that of think as at escalated patient, know which Clearly, mutant level response to compelled I least that Not a escalation the twice the by the XXX the the of dose reported that has efficacy idea in investigator that at

has at the we Mike taking continuing pointed to HX look this the dose study to the like of forward forward careful a intensified look looks execution KXX. what within and in As population response schedule valuable to, path outside see of

So great forward look news to one for that. that of more patient seeing and

Naureen Quibria

Allen. that or and conference? of what for upcoming on data preclinical one is the at patient presented this Great. will the And be this type any of you SNO maybe comment on you data Can type of

Michael Andriole

go ahead, -- be Josh. I'll Yes,

to I that. you're think closest

Joshua Allen

Go X at right, signal safety ahead. with to mentioned in a And drug Two I'll its cetera, of presentations backbone, produced ONCXXX SNO has oral them backbone given a as profile, monotherapy least ideal right, DMGs, expect occur as SNO, at as just oral combinatorial this ONCXXX. the et administration, that are positions related that its really to Naureen. an therapy. we that on positioning start

data mechanistic the will be of rationale studies. those that's have be been to think I the with of couple available and a presented the emerging of associated some as going therapy So clinical in preclinical safety backbone ONCXXX subject SNO, outcomes

you'll at of SNO. expect that to So see more

Naureen Quibria

you with Terrific. it dose they that little of And just just temozolomide a at the remind receive just one ONCXXX well? more. Is ongoing Can are escalations? or post-radiation do me trials bit as

Michael Andriole

have setting temozolomide arms that of in to initiation the are are believe XXX. is There prior I post-radiation arms also allowed recurrence. that that at and -- frontline are

Allen Melemed

I This is Allen, can answer.

study, Phase trying As as open is we to to get this I a on criteria a patient inclusion population. the little safety are for it's more this

I activity where do is us activity, we seen decide signs we if can to some future. go and where evaluate that'll the for think this we've help of bonus

Operator

of question Jones next line Roy Research. the comes Your Soumit with from

Soumit Roy

do you schema? with twice a on Congratulations remind to all you dose XXX-milligram from expect prior progress. could much going the And how us increase escalation level, the dose is weekly? the On ONCXXX, dose be exposure

Michael Andriole

to I'll frequency our deck this dose lays schedule. essentially a that have have in too. out Josh slide and the contribute Soumit, perhaps Yes, we But

X levels -- it on if similar fractionated next anything dose up the days to picture, Big up to level weekly week, essentially from about protocol XX.Josh were then this following X there. X it levels exposures dose all evaluating over a similar the at end of a doing dose the way and in given times we make we'll So new that are but escalating reactivation dose basis add?

Joshua Allen

think you've it. covered I No,

Soumit Roy

Okay.

So escalation expecting part got just -- or I'm and the just got about these with time-to-response patients so and dose X months -- the initiated. being

the end correct 'XX. a likely assumption, So most of the Is thinking data? data is efficacy we are that

Michael Andriole

have extent the it completion Soumit. data, -- will think evaluable we likely come the of to after that in right, safety analysis I efficacy

efficacy that, time. And what to we'd as expect or the year we middle so course during next have first that year. insights of said, at of And those the that continue share response And we'll update in patients half as we'll to we part the be followed. insights,

Soumit Roy

one question. Got it. And last

terms DIPG of PON, right, the In location anything tumor of the expect range, STEM. we between itself, a should the between broad

Michael Andriole

Yes. primary looking This CNS tumors. is at

going heterogeneous a it's So to fairly be population. patient

Allen Melemed

This are outside look CNS excluding of with to only Allen. see HX otherwise, KXXM The that. typically is exception But broader we you that sort at it's is of disease. patients

Operator

of Joel comes next Your Baird. from question Beatty line the from

Unknown Analyst

Joel. Ben is This on for

First the question is expect over quarters? next you expense what few trajectory do

Michael Andriole

I'm clarify, asked? that sorry, was you to expense trajectory

Unknown Analyst

Yes, sir.

Michael Andriole

It similar. will Yes. I expect. be would

in margin. would of be quarters.Yes, in to our you might commercialization, would $XX for million, just $XX begin next say half we're grand as you I it this prepare to in an just first the we million, run burn of uptick a $XX XXXX terms going averaging things, add, to at million I rate couple If expect the at continue was that in cash over and of quarter, the latest expense, I look scheme but see would quarter.

Unknown Analyst

Discovery for similar of efficacy showed identification in ONCXXX XXX for the future you publication different? or be on biomarkers the biomarkers studies, to the guess the biomarkers you for I something expect Cancer to would then And

Michael Andriole

Josh on Ben. Really I'll weigh Josh? question, good in Yes. let that.

Joshua Allen

number working and platform And on as that it we're now, Great we've -- a from and question. at into molecular of pour program. expecting years all you expect Ben. would of the been gathered for from efforts leverage ONCXXX to this information Yes, we've those ONCXXX

of in We've is excited we're collaborators lab vivo what efficacy and working we're body and about. with ourselves about seeing I'll vitro compelling and with what in say the a hard So, that really we're excited been have growing in generated ONCXXX.

that alternative to the and increase ONCXXX. target we've potency engagement additional the mentioned, -- relative seen engagement we've ONCXXX and of with interactions As

not lot CNS meaningful ONCXXX other there's by may that While HX there. opportunities a mutant KXXM the the is for opportunity be be target that CNS ONCXXX. saturation outside and We of given both within think HX addressed that a having of KXXM outside of glioma, can on

And we're but some to, dose one on these what we've this of is in I to you're good looking escalation biomarkers, of in from now ideas take some molecular ONCXXX the come in of which Clearly, signs So responder studies. for endorses preclinical that seeing that Phase hypothesis. reported can do pointing anywhere. we're early that

of molecular seeing, we hypotheses preclinical So ideas activity take run be driver follow-on to those those activity we're trying trials that's for alterations can and in with against if cancer that ONCXXX, alterations towards we're could we that have test all specific so of actionable associated the heightened compelling some in appropriate.

So of good question, these and a at we're years. over ONCXXX include good that theories learned the work and hard testing lot what thinking, ONCXXX from we've

Operator

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

Troy Langford

Congrats progress. on the

is ONCXXX. one just First

So with would currently around I for And dose need with finish if the escalation those the forward work, you the both PNOC Phase for of not, before to program? wait time? and to you to sponsored I to study same the the study complete do move NIH-sponsored both expect you the work Phase respect

Michael Andriole

time. them If dose that? have would We earlier don't update event particular would to around the stop of thoughts the the what Troy. complete we'll be any dose accordingly.Allen, level. then, additional based should on a think as at now planning we Good that for change, course, that I of we us to Yes. have now, they materially We, around right you get that assuming safety a complete are same them we any same know that levels, question, closer on insight do time. to we course, different, right expect final don't

Allen Melemed

high. No, I don't think I the is would demand, add. ONCXXX The

and it's the new close cohort. we how cohort, really cohorts up quick the open fill So then can

here. demand high there's So

Troy Langford

And other ONCXXX. one just then one

about action compound, investment opportunities of you to runway just respect how expansion balancing of the these study? the with other the So the to preserve for color any that some provide need with think areas into for around cash some

Michael Andriole

Great Yes. question.

And we sheet That be studies. be it we be in-licensed. ONCXXX, capital some capital could Phase on think so compound, for maybe as could about earmarked have allocation, another could balance II that

year, data on our starts with well. that nondilutive have the into and on it the that last and prior have we continues the that for said continue Clearly, we'll allocate fully the and shared data be all pull the and data might because we to-date respect and to run additional is be business quarters, in milestone particular, forthcoming sure in do much would Troy, But clinical capital other runway, both continues more or ONCXXX that shorten are sharing we shorten any that development to to made to bar we how factor might might capital what conviction preclinically preclinical divestiture we've conviction the else to. As anything substantial and of bar runway, dilutive market, high, evaluate we Emergent making study in raise the ONCXXX we with payments when access to with early decision, that with that that clinically ONCXXX, TEMBEXA BioSolutions what calculus. a would the to we in externally insight Phase from for II as would make we extent with and see

Operator

the to for over back Mike closing remarks. will turn now Andriole I call

Michael Andriole

time for Thank John. your this everyone, morning. you, Thanks,

we conference this please our updating attending look stop month, snow you of in you the those booth, forward again months. For the coming to by otherwise,

Operator

concludes and you today's for Thank call. Ladies joining. that gentlemen, all

You may now disconnect.

Chimerix (CMRX) 2 Nov 232023 Q3 Earnings call transcript