CMRX - Earnings call transcript Q2 2020

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Operator

Good morning, ladies and gentlemen and welcome to the Chimerix Second Quarter 2020 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 2020 financial and operating results conference call. a to which discuss issued we the we plan will today. morning press outlines release, topics This

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

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

Mike Sherman

us. joining Good Thanks morning, everyone. for

say adjusting While quickly one to to this that's level have a has physicians also Chimerix that the and FDA a business everyone working the a the regulators at we're investigational productivity, been sites risen -- virtual for I year has been challenging challenging team about with high to at have just maintained challenge. of at world. a

made progress we've three second fronts. important the quarter, During on

in we X/X to FDA began trial the treating from of with proceed ahead go a following patients. Phase COVID-XX, DSTAT First,

countermeasure next start-up allowed DSTAT the packages program This submitting acute trial. we brincidofovir our and submission related been finally that as part year. activities of leukemia early our that with follows sites as to focused patients rolling have trial And Second, on to with on this we've in enrolling to complete brief readiness we a on the a the launching by plans COVID of resumed smallpox COVID FDA their pause we've expectation as to myeloid quarter. to focus

in strengthened with has a made addition and of In operations. leading experience addition -- approvals regulatory drug of to over and also oncology meaningful Dr. along thrilled trial recently unique the development. his in the progress, leadership He as each join belt to Chief Officer; contributions. Endocyte's wide team similar multiple programs clinical Allen a as balance similar range really success successful we've is XX we've Clinical Caryn clinical practice already of enrollment Vice simultaneous track and conclusions. X a record has also following as I'm Caryn our Allen to of oncology Operations. Melemed, to both our cancer medical brings drove under success his ahead with Phase team full have Medical schedule, President She indications. of prostate Barnett, most making

priorities. three minutes spend detailed comments top me about a few more our Let making

to acute from by peer-reviewed on causes. distress it in mechanisms the of or respiratory in to disease. by likely relates bit pleased mechanisms very lung last let this the in way been syndrome trial I'll which the relevance a acute DSTAT's reinforced several publications As Allen DSTAT the injury independently These we've more. little expand COVID, month, apply released that other

potential rationale goes result, a COVID. the investment beyond the in well As for this commercial

Recall at our quickly. to most and able the good some and challenges we flexibility potential we've care has about accelerates combine different impact multiple of X. to a us of with a at being to doses of seen and portion data. to DSTAT statistical our the That cohorts as it we've it X we're well have evaluate then of biomarkers We're as added flexibility have to case, of Phase will the used. our some been number We third cohort of two the unblinding In to respond quickly more COVID said three experienced roll assess -- the insight tracking. and materially end. start allow particularly trial protocol effectively. potentially data year before report our after cohorts: into articles dose. interested the gives have treatments evolved that You expansion the After With a may This a these trials. enrolling data challenges cohort certainty selected doesn't good design recently of have standards

we complete that more in our data to XXth-day to X endpoint quarter the likely of next data expect is allowing third program means in the to cohort final fourth enrollment year. readout mature Phase As With primary to the regard early AML.

move You quickly trial. ahead Dr. can Phase that as onboard imagine we his drive Melemed with to helped enthusiasm us X brought

can we ourselves well now forward pause. currently other to Moving trial relative some initiations on position

smallpox. animal final contract our as future for regulatory particularly especially, Among we've the brincidofovir the the analyses to preparedness And from For in been deliver receive release quarter highlighted treat together see brincidofovir, we U.S. deadly submission, the submission or SNS. we plan year. as the We potential this via of the Stockpile the FDA. quarter to has viral to for to data fourth we National forward pandemic so look as to this PDUFA communicate model. to last Strategic importance a XXXX a plan rolling element the we that of the pleased primary press expect those of coming from receive and approval outbreaks, our procurement resistance action COVID-XX date date

a aspect this driving As seeing resistance its not program the brincidofovir nature supported treatment materialize. is development. This of key we're throughout reason expected, to the BARDA has and

XX give his from Melemed Eli yet, -- where few call DSTAT of programs, Dr. met review including, others. me ALIMTA more a clinical joins America. you our VERZENIO types development details of Senior for not the and range than he Most and Allen, RETEVMO Director North LARTRUVO as recently Chimerix Regulatory let of among to dedicated years tumor served a and he on medicines of to Oncology Lilly, Affairs for oncology CYRAMZA across passing fellow Before have had a broad the approval over medical of spent those distinguished more a who Allen background. and

As you him call turn let is to qualified and that, over our build have delighted the can to With to programs Allen. and see, me our Allen we're team. uniquely clinical on expand

Allen Melemed

introduction. a into evolution Thank you, fine such I'm Mike thrilled time for a in be pivotal its therapeutics Chimerix company. at that joining to leading

mechanistic its patients. to was potential the supporting acute addition oncology, mechanistic COVID-XX DSTAT's rationale patients flagged in to COVID-XX having injury treat is for rationale lung DSTAT's In two-fold. with The potential potential

by inflammation This HMGBX potential both to of infiltration Studies shown elevated decreases monocyte alpha, pro-inflammatory included is or key infiltration to immune and been COVID-XX of that the cell tissue DSTAT as and infiltration into and the IL-X, inhibition to expected immune have reduce ALI. cytokines, in First, protein-X MCP-X likely of in shown MCP-X blocking anti-inflammatory by important cells in cell pre-selected. not effect primary HMGBX by macrophage lung patients. cells protein-X inflammatory adhesion chemoattractant immune mediated DSTAT offers driver a induces and is pathologic have activity. TNF-alpha, of decrease all but DSTAT HMGBX ALI other Infiltration to COVID-XX via downstream and limited be range binding molecule inhibition is in expression of of is leukocyte inflamed to lung monocytes patients. lung which

platelet disorders. capable of neutrophil to offers neutrophil mortality severity the the potential granular coagulation are nuclear as causal counts to indicators Second, alleviate traps and Two infections and relevant underlying Neutrophils and identified extruding low of or content high in a ratio nets. COVID-XX. of to clinically responders DSTAT studies have produce extracellular recent early disease lymphocyte

and HMGBX may While nets in HMGBX key depth it are COVID-XX. this, coagulation beneficial COVID-XX. but also pathogens, and formation formation related their and PFFX and intubation and in in disorders net inhibit the of eliminating both may In and two reduce trapping prevent and treat combines may proteins involved PFX, clotting stability. which to and be in observed DSTAT doing nets DSTAT are promote promote clearance. and

determine which endpoint Eligible with to COVID-XX, primary study well double-blind and subjects patients DSTAT who adults oxygen. severe respiratory currently require are those X/X mechanical of We the XX. are as with of proportion supplemental of confirmed COVID-XX The in the require ventilation designed Day as failure. hospitalization enrolling who high-risk do efficacy and Phase and not through is are survive study, placebo-controlled a who randomized safety the is

Additional endpoints number ordinal of all-cause Disease scale, mortality. Allergy by of Institute resolution to time assessed of include improvement discharge, fever, and and the to time Infectious hospital days National ventilated-free as

and D-dimer. it the expand an enroll ongoing to maximum patients in the tumor portion changes We selective confirm necrosis alpha, interleukin-X, X factor dose, HMGBX, subjects will protein biomarkers key XX study are including C-reactive then at additional and evaluating dose. safe of Phase will XX the by also The

then all Phase dose positive the of supportive portion will As escalation be trial formal portion a Mike approximately the analysis of the results including enroll X biomarkers, at of the at is of Phase conclusion planned upon formed study endpoints, completion again the mentioned, to patients. the X. of XXX and Contingent

III expect myeloid COVID-XX, this and our study begin to we resumed for leukemia, for the early are DSTAT to doing the work also addition work program activation have site AML, in Phase acute in of In now DSTAT with we XXXX. treatment or

forward encouraged study for are COVID-XX over with elderly ASH, compelling of diagnosis turn clinical We the regimen an or the Mike promising as in Furthermore, that, candidate been on multiple for DSTAT this for AML of AML, progress of AML has Mike? elderly Hematology, review diagnosed has AML, the in product recently potential operational with patients. you I'll update standard activity shown the X+X and to American endorsed the We utilized with now of chemotherapy the across call updating in by DSTAT very Guidelines both AML. newly the look and continued indications. of financials. our XXXX patients Andriole With first-line in to patients Society this endpoints

Mike Andriole

morning, Thanks, everyone. Allen, and good

to financials I potential like would for the each for I Before review our the on of quarter, commercial programs. comment quickly development the

advancing DSTAT to X pivotal potential to study COVID-XX. we data from believe Phase generated in a COVID-XX, For this the has study support program current in the

condition billion therapeutic for This all-cause a very top to revenue a there potential Beyond this $X study to seven and over which the are study COVID-XX, diagnosed translates opportunity. patients few a in data has in approximately year markets options the from well a XXX,XXX support ARDS potential annually. pivotal

per the Additionally, with believe potential in diagnosed $X opportunity, chemotherapy. translates a in seven top which to DSTAT there revenue over first-line billion de X+X markets, are annually novo when XX,XXX AML year we patients also combining

we expected finally, to U.S. also recent years an markets to of the potentially noted, awarded. fit And come. for the stockpiling contract priority of the additional use United guidelines non-dilutive a supporting modest in innovation to expect for opportunity the patients with the and to in further expected potential brincidofovir preparedness years Chimerix is brincidofovir, chemotherapy to grow to the cash should States, capital becomes The the procurement supports higher As a further as brincidofovir States seven recurring while induction years over five our Allen come. supply to five substantial strategy, with globally the stockpiling and compared United international ASH seven be generate the next years supports potentially for pandemic contract to recognition for be second meaningful a subsequently X+X flow International of to strategy.

her to press the second of debt. approximately operations in remain the we capital XXXX. our cash. we in second remarks, well million results balance with fund mentioned previous Starting to with $XX our the approximately for financial Michelle our end of no guidance We the XXXX capitalized XXXX with of earlier end As and at million containing quarter quarter a year reaffirm introductory $XX issued in release sheet, today

second Now With second the loss with the second to The period net equal compared the million statement was for of $XX.X second of General back of overview, quarter of a of or a the development for $X.X XXXX, narrower that $X.XX in the decreased compared XXXX. million $XX.X decreased to for in the basic of a call the in of XXXX And to $XX.X XX% XXXX. and million, turning second to compared same million $X.X or period remarks. Revenues quarter period million $X.X basic of million same for reported quarter of diluted Mike? XXXX million of the over $X.X expenses to in were loss quarter million period closing second $X.XX for XXXX. loss to Research quarter expenses Mike administrative XXXX. operations $XX.X same per share and turn the diluted XXXX. from share of for per the to quarter for for and of the net I'll loss same operations compared for XXXX $XX the company to XXXX, now operations. much and million

Mike Sherman

Mike. Thanks,

As the countermeasure well our smallpox, to shareholders throughout value-creating Phase our we treatment for of Phase year, these positioned opportunity portion clinical for look and entire treat with for Instructions] continued X results to medical Your balance let's several report to preliminary [Operator the we we question thank a DSTAT that, program achieve patients is first of team advance the milestones, our clinical Phil operator, and support their in and commitment encouragement. COVID-XX dedication and for the your a months it Nadeau take of DSTAT enrollment as as program maybe, Chimerix to to questions. like the to open II is number the Cowen up and study past we and of With line our from from ready Chimerix complete for AML. of Company. this I'd brincidofovir

Phil Nadeau

meeting my a taking data the What's have is progress. out to and order X. as soon strategy? top for on the Thanks the Phase you or you the for question release a data? I COVID would put wait as in release disclosure year first publication, next you morning. Will congrats question Good press early line medical your or guess, for

Mike Sherman

opportunity the is as comments after I is II strategy end of look had our data in the our both then cohort at the X portion, the here again that Yeah, and to Phase escalation we at mentioned dose trial. the and

conference. would results first So sets up those it top this line year, wait likelihood not that medical on for portions, us for release the two we a

that, the you've number of are next a update top do communications trials. in think early same think So of year. trade-off think publications, around have I of the out line multiple There our context. final that most seen a I same. here. And to. there's peer-reviewed do peers with think ahead the we data, however a reporting I this of do I are adhered coming number doing then a randomized there's make -- is And analysis discipline from sense those data

that patients going a and what's really you your of So therapies. receiving patients are get of can their better understanding the effect on with multiple given drug, these

we'll So a data for reporting we're balancing it probably the waiting discipline of report randomized than, with the notion conference. that earlier

Phil Nadeau

That's very you. in then three score four or on second ordinal clinicaltrials.gov And the scale. entry criteria, to helpful. NIID it Thank says

who patients does, on ventilation? mentioned already oxygen, mechanical supplemental Can to entry or need You ventilation, on supplemental criteria the it you for remind mechanical us include into patients just those the seem is go high-risk oxygen.

Mike Sherman

from stage. potentially are already It's the The latter. prevent those excludes and it patients, treat them patients, It specifically who to ventilator. to progressing is idea on excludes -- the that

Phil Nadeau

challenge that then running for for it around. COVID me, moving the trials And question one clinical helpful. seems like is is in last pandemics That's

sites and in So to It and would like, off the to in some look you then look it's places, it Michigan add more others. Florida, other for looks moves trial and Virginia. you have Louisiana, even clinicaltrials.gov hot or enrol trial, -- on Do in you think sites geographies? that's fully sufficient cools to

Mike Sherman

point, Yeah. coverage, you is because add need then, areas then to to popup. And We're to in sites. and intense going to this broad continuing And be your have wane.

initial hospital but went again. New backup areas, significantly that we're things of one -- intense a been The have down the example. think initially pretty spike, Orleans hospitalizations -- coming after those being seeing the we're good think the I I is

sites continue to be flow. perhaps add So will it And got our will that and we coverage. another ebb We've to six so helpful. that or would think

Phil Nadeau

Perfect. and Thanks your questions for congrats my taking progress. on

Mike Sherman

Thank you.

Operator

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

Soumit Roy

Good morning taking question. everyone. for my thank And you

Mike Sherman

Hi.

Mike Andriole

Good morning.

Soumit Roy

of a look little biomarker into you can Are retrospective those color would the the kind is if biomarker or of like predictive progressed who enrolment ahead biomarker patients color address than on might approach. thinking into there faster the If prophylactic was the like a side looking setup future, if on you time, I question, in provide A patients rather approach. any bit that, ALI? you a help, treatment into can just

Mike Sherman

Yeah.

start I'll then that. in -- Randall. to maybe And add me with then let Let ship to Allen, they it. want And if

is -- so think patient-to-patient. that one it differently in it's because the challenges I up this a disease in great from comment, shows of

And so no options. bullet, far seen we've in terms therapeutic the silver of

-- seeming some However, to another. in effective versus are, these one drugs individual in be

incorporate important. may initial we And these from upfront. their information identify of benefit that Phase III don't which most add trial, will it's the benefit to better population of Randall And yeah, anything others. the can and data. to see kind I like out advance than biomarkers seem that our we could in play we know gather, helpful that accordingly. based the as course is that? that that -- from identifying we biomarkers data we on will If Allen that But a and to So get you'd there's such adapt

Randall Lanier

just can XX here. We're a Randall. and color coagulation is bit biomarkers over little different -- biomarkers biomarkers cell-migration biomarkers. looking related inflammatory at and add of This of I

know going and two we're first in then especially for for wide and involved for look and down COVID-XX. those to early importantly mentioned, Phase a So -- focus later on at those we'll array we'll for that the the at trial so And on, factors cohorts III. we in of that Mike part look

Soumit Roy

it. Got

Mike Sherman

Allen? And

Allen Melemed

Yes.

so, benefits treasure And a then be the did predictive. that drug have I've are very that The look people of of trove can said that really biomarkers. agree And our going we look not can the can other see kind if we're have be help data have with if to this going what got these see is both see to to ones of to thing this modify that are what if we both at prognostic patients. they to data

lot can you that. we both get it's question. to actually depend of twofold, we and of that Thank kind a how do we a on I but the this have potential think much study. will the So from much biomarkers do But for kind from how effect see

Soumit Roy

we you undergoing into or timeline if they question current Phase you. XX% in Thank COVID beyond there sepsis trial drug enrollment if be are the in My a patients able to on XX-plus-something the the know What's indication how of would time are in looking of have the are some COVID? chance sepsis III don't hotspots separate to last So expand that, ICU Phase into Okay. a a U.S. I portion flu on fashion pace Thank players high the cohort in COVID the through patients taking the III of trial it. entire and relevance is XXXX, patient the because you of is XXXX? or enroll patient the a thinking of just expanding timely you. you're any and of

Allen Melemed

Mike, is on you're mic mute.

Mike Sherman

I remind everybody to off -- speaking. thanks sure, you're when mute you're

It's go. you enrollment. I enrollment. around Here -- on had the had we've good engagement and initially, question really enthusiasm we a good also experience the

challenges changes could to confirm were a so DSTAT. they confident good with assess were those from have quickly. enroll standard to our able their sites to related where that quickly. we that remain ability others off of adapt very care So do that to they're as evolving those in in we we we and standards and to we And like And further quickly the supportive okay study with feedback needed we start to combination had

dealing it come on them was just had those challenges think quickly. with up early I as So

said, causes your it that this going are So that been explore might activity forward, us pretty aggressively in seeing therapy to think if point look we having opportunities I in even in fact, other parallel. about at we COVID

or his to in potential but a comments and/or pursue only sets acute you patients, us it As expand causes cohorts where in not for respiratory distress COVID Mike could parallel Andriole those. of up create Phase in other trial trials syndrome separate III mentioned

of we'll we like. So options see pace the those all I those data think the and and -- table are enrollment the both it's decisions looks as -- make with on the

Soumit Roy

Thank congrats you so the much questions for the quarter. on and taking

Mike Sherman

you. Thank

Operator

this the turn at I'm showing I like to no Sherman. would to further conference time. questions now back Mike

Mike Sherman

providing your to everyone morning you Thank forward you. in Great. coming the this months. time look and for updates Thank

Operator

joining for today's you conference Thank Okay. call.

may You now disconnect.

Chimerix (CMRX) 10 Aug 202020 Q2 Earnings call transcript