CMRX - Earnings call transcript Q1 2021

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Operator

Good morning, ladies and gentlemen, and welcome to Chimerix's First Quarter 2021 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 2021 financial and operating results conference call. a discuss which today. issued we the we to plan morning, press outlines release, topics This

today's and You and Randall our Chief Business the Imipridones, on Officer, investor's of access Medical Chief section are can the Chief Allen. Chief Josh of Technology website. press Officer, Allen Mike With Officer Financial Mike Andriole; Executive Lanier; Officer, Chief release Melemed; in call Sherman; President and me Officer, Scientific

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

Mike Sherman

look us. Thanks, extremely in X months the And you Michelle. by for We've to the milestones PDUFA for important a smallpox, and half potential track first forward several medical on thank the Brincidofovir Good as July we eventful second certainly the execution of for morning, an focused joining had approval We're We year. countermeasure everyone. few XXXX. date. of remain of on

not this counting promising Chimerix's first mark I'm approval. being pipeline, it our course, of last. that with And on course, would Of product

has go brincidofovir NDA that say well, surprises continued review no the can I date. to On to extremely of process

March, outline a mechanism an FDA-approved development request for action availability BARDA relative of investing review, and see As criteria. to sought late drug antiviral stockpiling, a the seeking information in drug contract because can with the alternative procuring, very smallpox to the of is believe the we potential source an capability parameters regarding currently notice published only it NDA and the the in specific with relates procurement in TPOXX. that require And you those meeting requests they Brincidofovir particularly qualifying under

so have to currently awaiting next request a And notice and course, The the brings as from contract. we closer possible us sources step such, responded BARDA. one are of the steps procurement sought to

note delay I'm to that a our You'll Based we busy. of is issued contract RFP on review the have and that by HHS by confident, RFP frequent the COVID-XX driven BARDA government division the with interaction did now. kept activity expect been positive has

Responding And always schedule. the of into intimately BARDA our anticipated in expectation manufacturing of RFP remains undertaking. half is not track. the an that Our a trivial delivery the aware second timelines stockpile is year. on to

So window we've respond And as contract. possible. the that in should RFP the been shorten from to as doing much us and advance potentially of quickly work allow that

response of rate data imipridones of mutant the response basis ONCXXX accelerated clinical the there approval This may of safety of registration second KXXM half year. form the independent remain in well as now the for with measures benefit glioma. other important and along treatment of with of patients HX track program. to to central the report our Moving XX-patient blinded in We cohort review on this

detail moment. in partial today, from our data a Turning of second to provide for additional Allen COVID-XX our cohort of X study DSTAT we program. patients. will reported the now Earlier Phase DSTAT

each that All shortly the measured disease and trial placebo as to schedule patients three With the severe updated of by randomization patients quickly. entered excluding the NIAID group withdrew after patients consisted placebo one, of three had and two score the just randomization. less who recovered

into insight signals gain our efficacy As this to cohort in limited. is a result, ability

upcoming we've We've as our signals. the it been may the transparent decision-making data and really analysis additional However, about efficacy trial. important received potential offer to process insight biomarker for this

As the for meantime, as done turn AML in the injury Allen a lung and lung I've the overview, of on I've for the clinical rate was continually up based getting about the that to And detail of COVID about a data data, more unrelated DSTAT care. as on to COVID enrollment, this to second, trial job, trial. the third, potential insight it over mentioned remember who acute ever-evolving first important enrolling. me assessing indications path injury, from patients. of we're and acute asked forward much before, the bringing second potentially trial has trial nice standard COVID DSTAT cohort With was into let up use therapy running, the gaining the give little DASH call In team now the and to DSTAT

Allen Melemed

Thank you, Mike.

first During serious Phase promising arm the ongoing and patients knew cohort arm. the particularly there those of imbalances last of DSTAT were illness data We study of call, conference which our in we the data, DSTAT the XX in the that from X treated, COVID-XX. in preliminary in the reported favor

as cautious the the severity as recovery entry. saw it the relates rapid were observed we about cohort, control imbalances in of versus second favor the placebo to to we group. So In arm, disease

kilogram, treated of of were required score by entered DSTAT disease. bolus with oxygen means the required continuous more and of NIAID Recall that followed eight with with the were milligrams ventilation or of as placebo. or which And to to NIAID patients placebo oxygen. severe hour. four hospitalized flow milligrams hospitalized the high trial randomized patients patients three, noninvasive per supplemental trial allows X X.XXX receive receive for four per per Here, kilogram, infusion randomized patients None

true the with consent were placebo discontinuation DSTAT While due of identified the admission within medications. NIAID and DSTAT patients, all XX treatment. to patient prohibited one as patients prior concomitant DSTAT required randomized two ICU score required three. to of Among a patient of transfer to randomized One to hours

placebo seven XX. by day patients All and patients recovered had the remaining of receiving receiving three DSTAT

to two previously thing DSMB our had cohort a to go-ahead note advance first the is to dose. provided the higher three with The cohort

to patients limited These randomization Because enrolling two terms the patients, cohorts first first the suggests low patients the standard cohort patients. that number patients areas currently This with treated nine post foremost, may XX patient Now with and be two that we was This analysis confirm over DSTAT numbers. hoc been DSTAT of cohorts of comparing showed and placebo. by and in to the the tutor clinical where with each improvement the analysis small we've did, were analysis treated and the treated there designed relatively combining care. we're has some of achieved. been has safety performed informal

these lung scores This a being contrast further DSTAT sample whether we to and So acute help I'll specific patients on over may five and causes. early seen all the was we DSTAT, progress in Mike entering more DSTAT were pulled We'll improvement We interested or monitor biomarkers were this Unfortunately, small been with severe for with treated is of patients it we're arms, potential the call patients both rapidly, with three. the we X is on updated four clinical keep can't with or only definitive severe patients, of injury, to size, in the interest anticipated, an placebo the recover. Andriole This from non-COVID exclusively that, had making recover or tended on far three discontinuation NIAID With any one improvements. offer with continue in the obviously in is turn study. who DSTAT achieved score with disease hard the patients you particularly to whereas than improvement the treated with the said, conclusion. achieved investigating off NIAID now review who enthusiastic targeted clinical Mike? within patients draw about not trial the days, less the to prior disease of XX In did enrollment trial we patients A financials. That the DSTAT to improvement in COVID here. a DSTAT. severe so slower effect remain demonstrate this where environment. benefit has to as particularly

Mike Andriole

everyone. morning, Good and Allen, Thanks,

issued financial quarter XXXX. million capitalized balance and our with operations. of her proximately As ended today, well to Michelle remain we of the first release $XXX.X we mentioned in press in our sheet, introductory fund for first containing the a with XXXX Starting results earlier capital remarks quarter

In addition, serve potential approval further contract strengthen of brincidofovir and a sheet. would subsequent BARTA balance our to

half on potentially manufacturing into of this track in Our schedule second the year. remains the stockpile ship to

$X.X a the same the XXXX, of loss $X.XX the recording increase for or the to basic per Turning diluted for our XXXX. of turn share first of quarter of the The overview, of is compared million basic operations, share and support million the quarter and $XX.X for was first the million first million loss the $X.XX the quarter in Oncoceutics. Mike? company million main due same of quarter the the or the $X.X from And administrative XXXX, period compared period for of that $XX.X now million per of loss the R&D of of pipeline. to first with $XX.X of Oncoceutics the net period XXXX. of $X.X and to to of first XXXX, I'll the diluted remarks. XXXX operations the and statement is with million million first main in call R&D the charge same compared addition for over Loss General with quarter closing this $XX.X transaction Research quarter for development Again, to expenses to period back a XXXX. personnel the was of was for to reported and ONCXXX of this net the for in-process increased This expenses $XX.X XXXX, of addition the our the million $X.X of related driver associated from in XXXX. to to driver increased million to compared XXXX. variance for Mike million. $XX.X of acquisition increase Revenue critical for same compared $X.X IP to in expenses operations to

Mike Sherman

Thanks, Mike.

As well-positioned of variety we are pipeline. from a this value-creating milestones I for mentioned, broad

to positioned, strategic response acute throughout shipments expect lung the review of mutant cohort is a glioma. potential XX-subject COVID-XX of XX blinded of agreement drug a year, for say completion related smallpox, months how independent company countermeasure national our recurrent first the KXXM HX trial the in rate was potential transformation. phenomenal registration ONCXXX Phase consider the in balance the the as this a Brincidofovir procurement in stockpile, really central ago, BARTA of we to DSTAT product of approval manufacturing you and completion support of injury, When for medical Now potential of X Brincidofovir, Brincidofovir

so well, team executing that happens appreciation recently. me questions. only work let team's making line course, good and With that Of open the the has great we'll operator, Chimerix's the express when delivered my decisions for for that,

Operator

first Your of the instructions] Jefferies. question with line Raycroft Maury [Operator is from

Kevin Strang

on for Hi. This Maury. is Kevin

Just a questions. couple of

In could meeting of or durability also, terms you if for second that when update of maybe could ONCXXX, what be the it's the saying in half? then and registrational kind that see for second could the any going cohort update? patients you're more you to And half be clarify need medical we at whether potentially a

Mike Sherman

that Yes, enrolled. We'll XX-months patient on more in so those than the cohort. are fully patients follow-up, have last even

a announce for at follow scientific of that sort of non-scientific will likely we data, up the As a then via data and forum. with the detailed the event announcement review top-line

Kevin Strang

just on And could PDUFA Thank is potentially contract, that line we is or the now so should and Great. still that the this then that time something announced? between month, that's be expect Brinci the something for you. just

Mike Sherman

window I'm is very going schedule Yes. they that That's process on and they a great date honestly. both the as on anymore, looking I'm a be our that to at NDA to both the fronts RFP think be position that review manufacturing the very predict know one would BARTA not a is going I in ready a prior to have the procurement respond that still to ship get RFP that to execute will question the and get to well, process, to when and confident we really that RFP and anyway. to ability done an we contract. to quickly product good then our

meantime. of ship look, it's long-winded the half to answer procurement the the there's, to a and be positioned second plenty executed in to there's of contract and the So, say, manufacture to for year product time in we're

course, keep the is we'll So, decisions RFP of you as both as are and, updated made. delivered

Kevin Strang

Great. Thanks my for taking questions.

Operator

Naureen Your Group. question with next from is Quibria Maxim

Naureen Quibria

exciting Good congratulations Hi. very morning, coming up. a strong and on quarter, things

terms forum? you can line the of details in getting actually mentioned, about as be size then talk that's the thereafter, ONCXXX, scientific second and top the the the regards and in that update with both to coming So you in half, data of greater terms scope at we'll potentially of

Mike Sherman

can if scope Allen will size Josh something. the Yes. focus and group. I And XX-patient maybe and the add on this miss to But

course, more response XX. that safety the that include, that what Of XX patients that in of than cohort. in would assessment and of of be the and registration would just I a the attention there gathering then, on that lot confirming subsequent be will behind again is that blinded submission data first rate we've data XXX of And investigator the the scenes. focus on on it confirming in there's going course, the we're so assessment think, will of and the terms seen of initial relevant are for background, potential be But a our part work

So, is data as all just we will will that the we've as that It's holistic measures other population. said think, it's that, they the a of measures also I be revalidation clinical clinical at important this very benefit think, benefit, see. are this how also rate the supportive, of other FDA just be benefit the in along, improvement, response status that. I of data, neurological important but safety, look not performance, in And terms

kind in that it's of forum. be would So, elucidated scientific in probably the greater that detail detail

Let me pause there.

Josh or thoughts you I to if think, add. any have Allen,

Allen Melemed

This nothing. is Josh? have I Allen.

Josh Allen

here. Same Yes.

within is addition the RANO uses at the of on end look independent, the in additional response. to benefit mind may well. for radiographic-based Baked data be could Maybe clinical blinded, I be addition focused that that year the so readout only performance XX-patient to will endpoints criteria we to is oncology I that keep steroid think targeted central Mike for use, is seeing expected data status to covered as and that for points a on evaluate but note and that review would consideration these it endpoints focused used agents. the radiographic this capture you're in disease endpoints such

Naureen Quibria

Right. out, then or you of expectations the staying just topic, part later That's the was much of, helpful. regards have years? those coming any what registration-directed that out of is of to on would obviously, studies? And cohort, they're the your study the data really the this that when just I with but same sense Do totality curious, those are read is

Josh Allen

of of part of what clinical No. doing other support months we're data No. the safety. the of a benefit so that the the locking That's all and next assessment, measures big all essentially over really not is the and but that, imaging just the would and of cleaning RANO

coming together those really So simultaneously. are

time of have focus I really up. the rate, say, I lot wraps view RANO the As is on of we'll but imagine the response that richer the a data that same data at as

Naureen Quibria

comment to able adults? you population what pediatric are patients the And the it. up versus on make of percentage Got the

Josh Allen

that. to respond Allen Let

Allen Melemed

you proportion pediatric in large general, if look to our throughout development patients a program. So we have

cohort, included the handful going there's look due FDA to that to PDH you in cohort. only patients who are the with of a in of discussion of is the the registration some If registration be

Naureen Quibria

indication? little it. perhaps, Okay. switching comment bit a curious, over, just Josh, of paraganglioma. and It's addressable one could just also an overexpress Got the actually in have patients an I and you DRDX, the was you IST market what And percentage study. about

Josh Allen

address So the let me first point.

highlight notes You that update investigator-initiated was trial. that particular signal an at on ASCO. know, searching. We'll its is read this out really trial I'll an

enroll fresh which that there. to was really in of archival of was not sufficient note pace for enrollment. observe seen potential we've patients tumor primary for as which trial there a with single-agent responses, study, in objective take or But reported, to at the requirement the the as investigator-initiated accomplished So part biopsy at a order was tissue

that widespread as disease. to overexpression on So is expression comment not we're in can What a patients. really see able we conclusion, individual DRDX on

we're So overexpression we're as in at I'm this into responses uniform I but individual patients, across we look what we seeing larger patient is at a data reported, population come can the think and maybe this to seeing future. fairly when single-agent we've DRDX say of looking time more sets.

Mike Andriole

Andriole. maybe And midline the and population patient it's I'd this relative I of comment on looking quarter to market diffuse glioma. the the Mike potential can about is of – comparing sort say there indications. a two

So a target, but indication. market opportunity another oncology smaller targeted

Naureen Quibria

Great. Thank you. That's Thanks. today. all for me

Operator

Your with next from Ed Wainwright. question H.C. is White

Ed White

taking for Thanks morning. Good my questions.

I maybe asked you discuss but the I as date, you question to need FDA more – a to the have I we're point outside So off, market start at it U.S. or think prescindy that before, I've I relevant. PDUFA getting the can perhaps that at opportunities. it least you becomes this can overseas believe approval overseas. know the close just if fulfill

Mike Sherman

Yes.

that So pivoted able next beyond to convert be go processes after. you targets. we've soon submission we'll And review the Europe the obvious of other can NDA to as in two prepare are geographies. imagine that as winding down, Canada, then submissions to essentially our that kind attention

So potential believe. the regulatory there's we believe steps with we're I that's to that a prioritize least the we go combining two market where next. next And essentially do of review where the And is a – U.S. not certainly Mike year we can whereas America. two have or or expand ago, would maybe North much there said maybe this there's opportunity on outside

be may dynamic that think changing. I

Mike Andriole

biodefense evolving to market about agree that, clearly sort during The post-pandemic I'd think evolve. of And that we pandemic. continues the with is Mike. as

assets. for priority also in on total, markets. been other of looking smaller geographic biodefense buyer a terms the market next in Canada's Scandinavia a of has Just at the us some likely opportunity scale

as are we and outside expect where of of markets mature the as how selective and and prioritize go regulatory think next, might but U.S. the those we you in to would strategy, opportunities expect being terms we years to continue there months ahead. we in we're so And our about

Ed White

to COVID-XX, cohort mentioned Do Mike. the could maybe enrollment and about long three take the DSTAT Thanks, And had and now? you you XXX that to it ARDS positive see will over what's in patients. And there, injury just had study we a Would forward to idea be perhaps space? more that your switching COVID patients – acute can I'm of that running you going XX go do Phase just look up forward? that then in before, to and assuming space and and that an data, study when you have you X would data those COVID-XX how that in enroll the in XX an proceed of wondering to strategy patients, outside or mentioned lung

Mike Sherman

You decision outlined before really us. the

it's mentioned, as think I the in Allen cohort. third slow enrollment, been the has

on I news in that are order is so of and to have we'd And vaccines do think the dependent set, what fewer as be by XX full And disease in the access we between widespread. U.S. data seeing is farther are patient data patients to and the something the do that to more the definition, different. where we're kind going Good

the biomarker likely in We lung signal drug would Allen us were it's yet. just going there's to going are be drug. and that more – us give what that be particularly And a from I progressed pretty think a was that non-COVID-related to in from to front patients this off don't enough pointed likelihood that original about give signal we I probably that standpoint before quickly. partly I'm was why these it in data is And acute think cohort they patient one to makes that see fact off the injuries. and comments responded two – look that's this the – had plan developing taken drug at. analysis that curious get in sense. was my to always want up more mentioned was of if that patient, to the a utilized taken it'd continued there I interesting

decision relevant signal of decide of – how another focus to saw into strategic There's we COVID we targets. that criteria we're to case pivot AML. that Just be of hitting is as may compliments that what mindful we're take that that here a first outside cohort and in access we're and data be the that bundle the going the

of about we've cautious chasing got And this expense to the the that so be not other priorities. at we're resources

And so the that's equation. part of

the well. meantime, investment, efficient we'll of it an data make sure targeted we'll if the going got In way that So sort supports the we've do to trial AML it. and that then obviously a make is

Ed White

thanks, Well, the the next my to question or AML. strategy answered you what at ARDS express Mike. or about And

taking those that Thanks think I the questions I had. were them. for So

Mike Sherman

Ed. Thanks,

Operator

question Company. next and is with from Joe Your Cowen Thome

Joe Thome

Hi there. the taking morning, Good and you thank for question.

is that a to requests this before exactly request others to about the tailored The we the for you. can decision but from VCV, going be know to that trial? timeline on these it's the I Phase think come, respond on out time Thank question first on will there a how then proposal Or ONCXXX, they allow to initial what is And one standardized second don't there be be to contract? you? that data there for disclosures Obviously, we make that have have a from even should expecting year? though should it's we they

Josh Allen

sought to of us. the that outcome qualifies. first of ones the such requests, the RFP, which and the our is RFP that toward essentially as say issued the on only It's as sources see already they're the qualify I'll we're responds and they one part targeted view who

is their per shorten advanced as be They'll a usually that short time to XX- can a quickly, prescribed end, bit it makes source. there's give RFP we indeed so, if preparation simpler if Perhaps single think in there's And for then with can work, timeline. and a work the that XX-day that – accelerate do so I we procurement little make so can and that our a we that that se. timeline respond. just to within in well. our given negotiation happen potential process advance to able you actual answer and pretty And not to And they're

X your ONCXXX. Phase into ONCXXX in Let trial. actively second enrolling me the is go question,

committed really that get at publishing rich say the involved dose-escalation premature going haven't data We to from so be of but it likely I that. There going on coming updates it's from imagine will all think now. I this data that to that know updates. will later between year, ongoing be to that, forward, there's trial there's don't conferences much relevant as I

So data it's probably more where see in you'll meaningful timeframe the from ONCXXX. XXXX

Joe Thome

Thank Perfect. very much. you

Operator

And your final question of with line comes the Roy Soumit from JonesTrading.

Soumit Roy

everyone. congratulations difficult taking morning, Good a of pushing few what forward on glioma on for response benchmark or Phase minutes the As rate, is the patient trial. question, second has forefronts, on the comparable benefits in find on exact population. this you care, the the all expect? and choice, X take trial, it Thanks AML clinical mutant at want what's to population least. know, to And should question, One we you standard to if physicians' and been the

that you can many centers us how of Yes. anticipated you opening. give are pace just enrollment, an If

Allen Melemed

not can to which follow the I'll I'm that then and with relative done start I'll sure a little history Josh, – Great. Maybe and Allen how you want to patients we've bit have been treated glioma. historically, that. of and the give trials those Maybe, you Allen certainly Josh, start.

Josh Allen

give a Happy to Yes. that shot.

indication gliomas for important is and to think KXXM lead note that thing So I an the mutant ONCXXX. HX here

in the only been available decades radiation. as that's positions, a for in glioma consensus a The And has this is sole it only KXXM While across care. have the standard population, proven as really we spectrum of studied this of look that of When we see toolbox for HX consequence, within mutant clinical to intervention population, gliomas. the gliomas diffuse such trials. recently intrinsic was subset been pontine defined,

So there's radiation. frontline

this is a usually which that treat is for high-grade is here consideration gliomas. used uniformly almost is that Another temozolomide MGMT-unmethylated, biomarker to resistance population to

see of gating As view in MGMT-unmethylated that of the use a a agent. depending on of use temozolomide that, biomarker setting, for investigators consequence the use of frontline of as heterogeneous we

benefit. failed that has So with said that agent prove to in being DIPG, just the I that mentioned settings

and the rate constituting and them a largely recurrent Beyond be failed we survival is frontline the I of that's The of therapies, at efficacy, core temozolomide, use are a there. of benchmarking benefit, setting glioblastoma aimed competitors you prove is even the use which registration symptomatic still that predominantly where relevant response improvements as in where to see move palliative radiation There, think once question. anti-angiogenic to overall terms would the at population, care cohort in see a Avastin. onto for we or part but

As the that is as with you literature, we it that have when failed past, point put comparison. head-to-head tried bonafide look we've conversations our population when we similar the to identify we to responses a you And out, ours, a do in to objective noted indicated in our have when care. FDA really in population, terms, therapy an in acceptance available palliative comparable recurrence into

glioma. palliative the therapies What efficacy use anything? for recurrent in mutant in out add would field we of HX symptomatic control, to such So in as evidence for see available summary, like there's Allen, you KXXM of therapy no really bevacizumab. is

Allen Melemed

No.

to perfectly add, captured You had Josh. nothing it or Allen –

Mike Sherman

and follow would, X I definitive – give I'll we about had timeline that our update later a that previously I and enrollments, up maybe then the And think trial Phase on year, your maybe question expectations mentioned around more this enrollment. with phase

in as some, of enrollment MRD. that U.S. in We would including as XX assessments. or a now and talked good assessment, that which XX. where that But predicting both timeline And up and think that dozen reach a call, It increased this we that have happen to to expect we'll can we we that is XX MRD essentially to it we measure you've XX-patient our have, the get assessment. and is give interim we'll so there, response that update of metric in we're timeframe rate for an and year, that sites, seen first this AML portion, on our when what that's a other enroll to pivot of XXXX, I key in to Probably but at sites And this emphasis won't XX-patient the quarterly will expect last sort look do about can I do XX-patient look engaged we running, which milestone, the sites getting that as being expand be activating happen we sites, like. to focus survival importance And the XX better it and going then outside of the that. on is between will initial expectation. think XX sense first are

Soumit Roy

taking for the much so you questions. Thank

Mike Sherman

Thank you.

Operator

call the I'm going I'll back closing remarks. turn to to over Mike for

Mike Sherman

your updating everyone this Yes. Thanks again. and months. you in these again exciting forward look on for morning, milestones coming time I'll thank just the to

Operator

conference This today’s concludes call.

may You disconnect. now

Chimerix (CMRX) 8 May 212021 Q1 Earnings call transcript