CMRX - Earnings call transcript Q2 2021

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Operator

Good morning, ladies and gentlemen, and welcome to the Chimerix Second Quarter 2021 Earnings Conference Call. I would now like to introduce 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 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 participate and You our Josh our and Allen the Imipridones, on Melemed, Investors of access Chief Chief section are in can the Officer, here Medical are of Technology website. press Financial and our With Officer Mike Mike Chief Executive Allen, Officer, Chief release Q&A. Business in call to Sherman; President Andriole; me and Officer;

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

Mike Sherman

several addition FDA a thanks to drug age antiviral Thanks, strategic phase X by as all of DASH medical smallpox. considerable approved last FDA-approved smallpox of The important Michelle, XXXX, the of stockpile and including is the the TEMBEXA good the then of first first for TEMBEXA approval initiation the infants. for for morning, national highlighted, acquisition groups, marks the reasons. This the milestone AML first countermeasure joining and and is and Chimerix's us. for made first, through We've everyone, progress half of finally, Oncoceutics; trial;

a As are well. occurs is reverse whether are to with not tools currently smallpox be of resistant Strains having intentionally to true the we've The or counter naturally, to resistant engineered outbreak countermeasure, as that virus to resistance that COVID, really TEMBEXA. viral is the critical. multiple seen stockpiled anticipated is

possibly RFP to is shipment That first response continued to to a time required in the and readiness. to product we as reduce its steps to in the our covering significantly age enhancement essential suspension to remains fact, both resistance approval counted actively an formulations up standpoint, of or weaken mutations - TEMBEXA is procurement all position a to RFP. website, we TEMBEXA also In RFP BARDA will stockpile. approval as million as the for groups lethality. our are development contract. having the and already the celebrated from that to We've required with to posted into contract is and tablet And the a the $XXX virus associated expedite also involved have issue support sorry, current in From the XXth puts of us necessary investors such so industries. likely with completed government the notified their the partnership practice. their for communication X-K, work execute I'm RFP an Anticipating of a contract,

locking administered HX In the the response spent Moving assessed review, first different to of five primary now reviewers, clinical measurement several midline patient therapy of and and the reduction this from these have responses; recall will performance share updated population as of represent following and They measurable criteria; improvements had evidence data, other blinded many history glioma. midline including may anticipate with then patients of post-radiation fourth other midline. following diffuse natural We're of analysis work status; treatment days databases gathering clearing, preparation basis by and durability effort accelerated to outside patients that ONCXXX. at those additional and And least in the last in of to of the the for RANO overall diffuse arising benefit, an team data also the prior. for that XX All therapies a single-agent as analysis, glioma analysis criteria central well. across who BICR, our the an the harbor supporting ongoing study, corticosteroids. and evidence progressed by sharing registration that weeks XX enrolled or an the such central studies the most for these who specific very that and include as were who rate the handful met in registration response patients of recurrent by HX mutation we be KXXM-mutant criteria have inclusion will same And evaluated the as data efficacy form EMA, blinded effect which met of ONCXXX comprising quarter endpoint. year. expect the independent KXXM This neurological of cohort. XX along we use the elements cohort associated received of with of The in cleaning, information, HX efficacy Key and patients create of approval the independent all measured We disease FDA with ONCXXX. a cohort overall glioma. the including have then particularly the with cases, inclusion KXXM-mutant and for the designed radiation the criteria really patients in isolate progression homogenous these those

AML phase randomized, newly is standard intensive of with with safety now program. induction this evaluating the placebo-controlled combination the the trial in multicenter, our consolidation study treatment efficacy of to in of enrollment DSTAT DSTAT and for evaluating combination treatment DSTAT standard for double-blind, diagnosed initiated chemotherapy our Turning AML. the year, patients. This chemotherapy Earlier AML and X of DASH we in patients study,

take control the residual assess response review Mike? and expect to financials. between With the We of unblind over the This in half in XXXX. call data to first the second complete of minimal we I'll the to place Andriole disease arm. following that, turn of now rates expect patients this and arm enrollment for the evaluable Mike to study analysis, XX study a

Mike Andriole

Mike, morning, good Thanks, and everyone.

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

ONCXXX, are milestones. have and upcoming key on several those funded TEMBEXA, and well We through DSTAT milestones

contract our development and ongoing a procurement Additionally, to funding support could million programs. from annually provide million research possible $XXX BARDA to $XX

per diluted turn of Revenues for reported of the $XX.X for the of loss development same and basic of per share to addition $X.X Turning acquisition expenses Research the increase and General in pipeline. or for was compared million this with of development personnel, and The of following driver and of the XXXX. main support period of million quarter million second to Oncoceutics in quarter net were or XXXX loss of a the XXXX. to XXXX, our period share the for $X.X a addition for to statement to diluted of same to $XX.X period of operations. second expenses, XXXX. $X.XX $XX clinical, closing ONCXXX increased million the over the second million company the $X.X quarter overview, Mike? $X.X quarter for the expenses in net I'll compared quarter With now call to to basic $X.XX of The to million 'XX, increased the that of for compared the the second million, XXXX. XXXX second million Mike compared $X.X back administrative same remarks. and for

Mike Sherman

Thanks Mike.

throughout first progress As made half the you can we've of XXXX. meaningful see,

Our achieve and throughout we've a the over year balance with that, several your me questions. FDA value-creating turn us milestones to take BARDA the the the approval of the our and this to recent made program beyond. call contract, can oncology stage well-positioned leave sets we and operator, for With procurement let advancements

Operator

Your the Instructions] comes line first [Operator Quibria Maxim of with Naureen question Group. from

Naureen Quibria

morning progress, the Good TEMBEXA congratulations and approval. especially with on

- regards forth. in just we have and was I BARDA, Delta just surge variant so to wondering the - BARDA now the a with new So with

any you in year? aware their shift from in are potentially priorities of So the earlier

Mike Sherman

No.

I that in don't And in answer of the has by short sort or the had that think pinch contracting sure. where that impacted COVID, activity I they for recent surge the been group. recent a is has the think been their

have kind expectation to year. have to ongoing We our exists end that an into relationship of on product before need ship the ongoing be based continue our the contact ready with the to communication BARDA, just that the with contract and support that we we of development and recent stockpile today, conversations

Naureen Quibria

actually accrual enrollment any helpful. it. regards Got program, color rate to the are to with the able then you DSTAT and That's numbers this comment or at point? shed really on And

Mike Sherman

still expectation we're this as assessment trends enrollment on getting the tend I of quarterly identify XX-patient to early sites. too of have the the next year. still of at get is probably to in then would It's numbers, in enrollment second Yes. first And but that we our analysis that habit activating half updates point don't

Naureen Quibria

there paraganglioma regard ASCO study. program, me. on presentation And With a more to for ONCXXX some was one the was just there - IST study, at the

top-line the would coming difficulty] addition out on study from the registration - - obviously, the So is that? see Will data other of more to we cohort. in [technical we

Mike Sherman

Yes.

that was and sort update from come essentially I two registration the we're of referred structure. other things. I One So following of from paraganglioma. the cohort, disease meet patients that is midline except will not of of really all expect that on clinical cohort, the updates standpoint to would the the group that have this a second of criteria the outside they an

have updates. probably in an as phase also ongoing that's early ONCXXX, and for that's dose-escalation We trial with also

So those would later. come

Operator

of question comes from line Your Cowen the and with Thome Company. Joseph next

Joseph Thome

questions. thank and you for my morning, Good taking

the first to reanalysis good different, I whole what's a of or that year, of reason in that review. the how that for Is did midline, or may that tumors seen of see the outside to The the and better blinded efficacy with blinded have the patients perform that the cohort about that independent subset do guess, responses or year have we midline from there submission? analysis disease initial regulatory have the between ONCXXX. worse? the standpoint, because And you maybe but mean, anything would and happen in worse? this later tumors better then have are the thinking review the patients mention one I later are pivotal maybe place group And initial you change in we on any second, that already non-midline going going subset responses patients took had including is that there why an

Mike Sherman

Yes.

we how in and how Josh Allen and let that let any transition talk change in potential might about the the be incorporated, I'll those handle the and patients label. analysis, - or change question about anticipate first and So the me non-midline to a to the

relates first patients. analysis the these to The question of

In from is fact, the analysis same essentially a criteria will the be - perspective.

is to So the relates analysis of and response difference as patients. The criteria those performed was a criteria. the RANO that previously, a just well-defined strict XX one, very in number it covering portion what was overall

this those of all cover we'll patients So in analysis.

Secondly, adjudicate if differences there a reviewers the was two be assessment group performed previous so third will by with are by reviewers, any This those. single-blinded to reviewer. blinded a between of performed a reviewer

the that sometimes, And the And that to XX%, response, reviewer, slightly talked are is and at these of met had both is we've become look said, of what important rate by successive best on response two is could diligence, found for obviously patients these which responses patients assessment the over but you quite the for scans the between progression-free and and for where the the durability And reviewer. in just of independent that there can reduction. that XX% overall see about interesting as in he that investigators, has That patients as high different very really durable, short images time that response blinded our independent reviewed true not and of could been the I of a and with the important, possible excess the only imagine response, have what well. reverse required we have that our for couple of differently reduction the scans. central XX been matter, a months. concordance responded, right that the of maybe was a is it's example, and reviewed part survival - series, read - for interpretations be having a as be those threshold you And you think

maybe patients think, be, Allen and standpoint response. can a So outside durability to we how me will key it and midline, then submit the data. the at would about that we to element how these FDA Maybe that think of I talk this a Josh address let about first pass looks regulatory from how

Josh Allen

morning, Joseph. Good Sure.

midline non-midline of those to with adequately the question, midline HX life-threatening by their Subjects with respect and patients are a that rare history. effective cohort without just respect like studied. to disease proven a inclusion disease select to driven that the does population, but start with to reminder the the these included adequately involvement requirement involvement as in So midline KXXM not been the and regarded of is have disease mutation a not homogeneous that really this is of I'd be prognosis of to of with relatively a still population registration natural treatments. the with It's have desire the

the And natural still those registration with included except view effect within saw clinical the issues those regards reason, that really, trials. of all who midline. from of at did So you subjects or That of we not cohort. due the criteria those those patients of from involvement said, patients meet cohort, ASCO same have to of for not with being to was they whether treatment in excluded knowledge, the disease. registration as release those what disease primary ONCXXX the the extends of lack to we the outside were midline of history, subjects And enrollment distinct

sample can and analysis that albeit those reported size, saw our that emerge similar from we small it's patients population. see those pattern there, As given benefit do data include supplemental you a the patients, objective to was NDA response a planning. in We rare of rate a as clinical plan a in

and ONCXXX's for the I do though outlined, So reasons even of to to it present to help to effect that be of turn that from - like cohort would picture that glioma, tumor we with the HX thinking extending they're to over regardless KXXM-mutant labeling. excluded a comment support would to handled from registration location. how data Allen the just about treatment plan I'd to regards

Allen Melemed

The mentioned. for Melemed. activity data data be that for be the FDA additional be supportive is Allen - only the registration Josh add will we is hope other This cohort with the me, to ONCXXX, in of This will will approval. supportive characteristics I'll a additional be midline which, primary to had to review

Operator

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

Soumit Roy

all congratulations Good the on morning, everyone, and progress.

bit median more you duration on thoughts line the Just earlier the what improve you're any you trials? of going anticipate to the or And drug you're trying how thoughts be closed? ONCXXX for elaborate a in data, thinking future? little will getting probably of by on on if would Any to more time have the combination the the database responders

Mike Sherman

on be of XX for - a drug year. that, first about to maybe, in enrolled if be too. in your can patients that and or median than would I'll Josh, start understand in, I you One that question way chime correctly cohort duration the the included last drug, more

and you're obviously is, to that of sure excess half. so year at XX-plus far but I'm The a a what that it's probably in not median, So close months, that.

characterize add guess of cohort. I either we thinking a And follow-up quite the forward. us we're it not responses picture going hand additional this talk durability maybe those Josh so the to only will let maturity about as - responses good would good. how to bit this about but little talk can then and populations across to It give of the me over that, about I And of a the

Josh Allen

the add of to Nothing on the data. Yes. maturity

works. to improve and earlier we to well one both With rates, think think for was cohort. will combination pursue answer are that's I at question therapy, than therapies believe - of potentially potentially aimed I the greater is response the how lines year or characterized. respect It's the the I in

of So the smaller course may of initiated or first with, that they've two, point both number clinical the maintained released, the moving end, seen toward increased combination treatment in setting the salvage And of therapy SNO that disease additive a To to supported pertaining addition make frontline therapy, the of the sense. drug in subgroup performed of is in an be pediatric earlier the would ONCXX, predictors of have with indicating of in program time one were at line lot associated fact moving preclinical likelihood that response. of radiation. asked patients ONCXXX, all the analysis for ONCXXX ONCXXX that in into already baseline who had toward number findings, having believe profile safety the we've tumor exhibits their regards and and models, our with a disease either the with response frontline Those synergistic at likelihood to one, this that to setting. size; in not has by leads activity year that or starting moved last increased to setting frontline which in be study, agent to

the movement this toward a in clear is disease direction molecule. for therapy clearly, frontline So

specifically agents In toward wide shows we number addition, agents. literature synergistic working who have with anticancer the entities that to top And prioritizes forward There bind published the cooperatively a a investigators that task synergistic prioritizing investigators effort. been a of in of have future of is ONCXXX combinatorial hits on taken variety of with out the those that with gliomas. look trial ONCXXX, the

you when One of think targeting the in T other think it of advantages including the with of those you able that to at patients. other expect then are that of severity ultimately, can safely. about of drugs the is ONCXXX more HX hope one able and CAR be or any there the that do these given this and be combine one and the that is KXXM, products to that least would specifically expectation is I And development, disease, a landscape are things there's this to help

a competitive down So way, the I road. a threat. is substantial opportunity in a This combination don't see

see I radiation was other therapy this, they will - whether by The response isolate subtlety and designed of initial the physicians would at would middle follows the you move it's the more waiting frontline combination much patients even these it and for particularly to single-agent you ONCXXX advance, days. radiation say would of as least most sort this or the would a the mention trial closer way drug in least for to at disease could you immediately opposed where if to progress expect, and in therapy order is with to their radiation XX What ground activity. there, so distancing prefer potentially

So additional points utilization the think about anyway, think, forward. of you two, consider going the drug to I as

Operator

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

Maury Raycroft

clarification a Just on XXX analysis.

how there I the on process guess will Can group of be elaborate reviewers reviewers. how work? be mentioned you can many a will And you that? more will about talk involved? You

Mike Sherman

It's the it's little go that criteria I'll imaging beyond of real to and clinical around of give start responses the but an by it. does legitimized this RANO that more it's imaging one high - also about things I detail response just a the assessment. is to sort remembering can are Allen helpful. important Josh is just give These RANO or it bit I not remember level, But criteria. the by if think important activity think

corticosteroids use if have an or fide of a status. increasing a the there's cannot in there response RANO bona performance You deterioration if is

are would In and the will then elements a this there's case, of the there adjudicates will know that that's that's as And be that a scans are to think assessing that. Josh that we by disagreement, add there helpful really reason I review. Allen, be you details, the the structured associated the all approach are data. FDA, additional and to reviewers if And where be of third that there that two So or have preferred such. don't that. protocol those the

Allen Melemed

period. of vendor The that is using in is Allen. - I'll has This doing add a experience thing so lot Yes. we're these a we're reviews, only

Maury Raycroft

sense based And you are apologies of TEMBEXA the a longer comment involved I the of conversations, the can whether missed BARDA for beginning That's that helpful. other procurement taking do on? of at contract, you because factors on is this time But have gating administrative your a if Or backlog? call. there

Mike Sherman

later to based My and into it's and the agreement, ongoing on the ready our we sense administrative a this Yes. development I issue least is is need open have conversations that, as to mentioned, at potential one shipment expectation which that we that that year. stockpile an be are related for the

BARDA's the were program. an mentioned been celebrating there's the just of you'd They change are in the priority the this of important you got quite commentary, whenever These I my It's and no likelihood terms stockpile a that resistance the and opposite. possibility, vulnerability in really and approval. drugs frankly, So And this strain given number one a countermeasure around as the in emerge. ways. one have for two stockpile enthusiasm quite complementary in

there's broadly, expected by as our draft in and by future how budgets. the with product includes way we one. consistent product, name, been couple it continues COVID, change and And positioned just be number of out is an have new for a budget ASPR leadership I've this what So the with it I can for - state stockpile from the that or will called And the leadership think as I be just think two, signs not a - this number time. they've the by it's a of this well priority. dramatic add And and improvement measured that One you when by acknowledgment earmarked administration some is quotes stockpile this stockpile. a would quality to in the funding this relates do they that a prepared administration know had this in seen in of the we that's to some

a of of that it's - question -- is a timing I it So question really than there's don't more the expect

Maury Raycroft

you potential last or X. new with MRD any endpoint even AML perspective on helpful. topic experts And regulators Have that question, that's elevated if you in new phase maybe had prioritized an on And conversations on? on just the using your really can wondering or comment any as there's

Mike Sherman

I as potentially so But the study. thing is more Allen a I'll they start changed are primary that as that, something. if announcement that primary some only in by patient the different and using recent add maybe months really It's can population, miss that Kronos in more AML probably itself or endpoint. acceptable there's lend their endpoint a as for acceptable that's differences

So haven't share that as that there's assessment, got we related was to including that And would in don't you're have possibility endpoint our that point you're have the in trial discussed to still their MRD. long you then conversation continued switching plan to with something that our until they to a blinded as data. as feedback as to, presenting would FDA. quite as be on be open it some as whatever We I them think X long MRD of regard. momentum phase the some to data - data subject we really We we to to follow-up left the with conversation positively the alignment

would the that you just think a and primary. have a instead MRD be of ahead that And patient one comes if design with first existing that is I supportive we scenario So move that the that's cohort, trial meaningful the endpoint strategy is from trial. some of data

change a any It could scenario you midstream. flip Another to the is wouldn't endpoint. of so the you as primary protocol, really of do execution MRD that that

Operator

like would now I call Sherman. turn time, Mr. the further back this questions. At to over Mike to are no there

Mike Sherman

you everyone, Have updates for good this day. forward giving and us, a thanks, to important coming look up year. joining again, Well, later

Operator

Thank This conference for concludes you participating. today's call.

You may now disconnect.

Chimerix (CMRX) 8 Aug 212021 Q2 Earnings call transcript