CMRX - Earnings call transcript Q1 2018

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Operator

Good morning. Welcome to the Chimerix Conference Call discussing the Financial Results of the First Quarter 2018. Please be advised that today’s call is being recorded at Chimerix’ request. I’d now like to turn the call over to the Michelle LaSpaluto from Chimerix.

Michelle LaSpaluto

Thank you, and welcome to the quarter 2018 Financial Results Conference Call. a.m. X:XX at morning This Eastern Time, results of containing financial press issued other updates a and quarter release for the we the XXXX. first at result the press available www.chimerix.com. website The is company’s on

Chief website. via You also the of the X available access will call hours conclusion An may event. webcast after of Chief Science are archive With Berrey, the President Richardson, Nichols, today’s Investors today’s Officer; Garrett Chief Lanier, on section call Michelle Officer; be approximately webcast the Trost, Medical on Tim Randall me CEO; Officer; Officer. of and Chief the Commercial Linda and Financial

a Act I’d there begin, XXXX if to subject and for approve statements development we made the the and and other be the on regulatory via uncertainties their you regimens possibility call risks marketing for not factors, brincidofovir-based including that and like may viable significant that Before limitations brincidofovir, Reform may or have that within the Private and statements of to FDA remind continued the meaning authorities use. are forward-looking may include path of granted, other brincidofovir today’s Litigation approval, Securities

commercialized. As may brincidofovir never be a successfully result,

approval In other in risks the unable file addition, from of to referred actual statements. materially authorities. those could to Chimerix results regulatory forward-looking brincidofovir cause and for may other factors regulatory on and be These uncertainties to differ

risks over Chimerix, Exchange documents described available time, to the reports no and such obligation statements. Berrey. update filed early Chimerix to call are Securities You’re to cautioned filed Commission, this and based and most statements filed are not XX-Q Security on assumes President All X-K and Exchange Michelle other on to and like Form CEO, today, the uncertainties At rely information forward-looking turn any on These currently I’d Commission. at detail statements. with including in forward-looking in these Chimerix’ subsequently and recently forward-looking

Michelle Berrey

XXXX on update earnings regulatory joining call. I’d our toward take to first first progress This everyone, recent morning, to welcome and quarter like you us. you our We brincidofovir. minutes morning, Good to approval, our appreciate few a

you studies of last two we’re prior expanded brinci spent of years in of our incorporating many making and that oral learning access every appreciate, from our from treatment As sure adenovirus program. ongoing the we’ve

All of no broad-spectrum brinci, many infections to how we potential and and transform Chimerix there available are at us currently treat continue believe therapies. our in to antiviral, for serious prevent its viral which

We growing our year-to-date the our of for immunocompromised brinci allow foothold build commitment patients. course, can IV Our then an oral development multiple brinci provide early of can population developing accomplishments believe, and that for commercial out brinci. us pipeline to antivirals to with short the reflect opportunities novel us

their for recipients. been transplant that planning stages XXXX. needed We’re be brinci we’ll of implications in for a high-risk kidney patients. BK in can optimistic The specialists June, that IV transplant dosing researching multi-viral longer cell for or studies, Coming with bringing stem prevention is cell MVP, transplant the together duration allow physicians stem of who’ve are virus in up

brinci closely to virus. working of study advisers We’re a these IV and with dose-ranging potential consider BK

these outcomes. to BK, begin or of IV Beyond HHV-X, that some brinci. herpes in other encephalitis, for brinci’s support also half with higher have studies can we hope believe CNS XXXX, opportunities concentrations we may IV devastating diseases the potential exploring In of second

they have study the we’re this pathophysiology the treatment design physicians of develop data working get daily we brinci later benefits for strong Conference. for for help on our throughout share have regulatory children. The We’ve getting and who call, will to our serious hear pathophysiology in we incorporates enrolled adeno of that Garrett U.S. from to on mortality commitment And AdAPT life-saving been brinci. correlation an infections. oral first understanding without with of our risk adenovirus children the approval. at AdVance, doing with us in across families second improved pediatric opening In important resolve stories the committed learned recently restricted half for the and the all in in were strengthens European AdAPT AdAPT and potential study As we transplant year, many these about with brinci as of disease, the adenovirus to virologic builds the brinci data years, our interface Europe of options as and their The XXXX. endpoint study to of but an you advanced all BMT understanding the the reported can of of we the the and

update, Following CMXXXX Garrett’s Linda in will of our and thinking commercial an provide overview norovirus. Randall how and we’re about clinical treatment prevention program of opportunities and the

which We’re the International Randall presentation will call in Porto, detail plans. Garrett to robust Portugal. Antiviral continue sheet, ICAR, June that, update will on an or announce excited Tim to CMXXXX an for With over of development on at clinical our to Lanier, on balance our execution Conference I’ll programs. Science After us that, Chief be our and will oral our Research, allow remains Officer, clinical strong turn in giving the

Garrett Nichols

first calculated regulatory endpoint this to this and for why Area it’s antiviral trial. a our show about randomized small With is Average of adenovirus which I’ll selected good virologic ideal and with the patients. which is begin endpoint over the bit endpoint only study for AdAPT, feedback, an that AdAPT, adenovirus weeks, is enroll the abbreviated XX morning, controlled we I’ll This infections. ever from a AdVance XXX conducted AAUCX-XX. study moment data the Michelle, Curve a you, AdV more for the as study, Thank a in morning everyone. Under how explain plans

outcomes were in and now over current routinely that stem screening Europe centers adenovirus followed, with stem pediatric the multicenter the of ECCMID, study. transplant the these that: commonly us In a these practices, pediatric one-third clinical XXXX. the fully arm to the at initiated and data at Microbiology Europe cidofovir. continue stem allo XXXX As the adenovirus to patients adenovirus we associated Clinical AdAPT for XXXX, preemptively, first Lisbon, of is European study were, cell initiations of sites EBMT guidelines adenovirus on transplant in enroll with meeting and data approximately can when detection captured found Infectious we We thus, to able allo featured following the in which study. Conducted and We of The the stem develop U.S. for presented recipients. care majority plan estimate guidance the treating prospective Congress off-label at first from also show March, control recipients the treatment give AdVance pediatric the X,XXX Diseases in our Michelle describe in enrollment to allogeneic Europe. cell the in with we represent cell cell in said, XX months We XXth centers site were and and study infection adult in screening infection more the with AdAPT AdVance have from place for most Spain. in being transplantation. an in in Portugal, standard study, European transplant of large These Madrid, six which IV current of time

X pediatric risk with the develop calculated. the blood; for associated allo The these that the the level pediatric to burden, adenovirus load total load discuss This copies virus examined viral X mil. of nearly measures three We we cell with XX X,XXX adenoviremia study, with the and mil our AdV to area between has the or dividing mortality is value third, previously complete weeks divided XX individual Curve over the highest or than negative patients shown the by adenovirus burden. adenovirus viremia in adenovirus with in for XX-week outcomes. Most for plasma the the strongly in first patients detectable pediatric XX period to period viral under individual’s to follow-up of subscript almost taking that quarters AAUC. a of period transplant detail. On recipients, been greater each viral per and X,XXX viral the X,XXX adenovirus average time copies AdAPT per and adenovirus per XXX full AAUC. average simply the is, line we average curve, the mil the will of two-thirds that viremia XX-week Slide Area endpoint greater Under is AdAPT adenovirus in is number time, in load adenovirus among as in abbreviated follow-up. follow-up equates weeks is from to sum stem an progress more correlated the burden over XX the lowest importantly, again, This than over this show patients Second, slide by week’s of from trial. Each them grouped copies as blood, X, viral how of the our The clinical

until highest higher we right, the is the treatment by patients some left can driven on cidofovir, or the immune patient’s of to viral the with which on we to with peak patients. lowest Remember system the million XX load, of AAUC of with AAUC adenovirus these in AAUC clear patients the As over persistence for adenoviremia the is copies these unable adenovirus compare in patients generally IV see and adenovirus despite more was XX weeks which both XX some the the is also XXX reconstitutes. that this off-label

had mortality with measurement who recipients. had a fourth. in of with This quartile still the adenoviremia the before their highest highest last mortality, the than X% further the adenoviremia lowest in of mortality, XX% patients provides In in the the highest adenovirus clinical second children died on words, AAUC, half in X% with died. that So had with more half Indeed, quartile, in what persistent associated for the pediatric cell those outcome While still AAUC, last these XX% the death. there the support with the XX% X% measurement. over died. the was XX% the stem adeno adenovirus AAUC adenovirus of died, of relevance between other a in patients And at Moreover, burden burden with those transplant these relationship at who and in the stepwise third adenoviremia on other the overall of outcomes in children patients? adenovirus and was lowest the the patients the viral burden, was hand,

between Now higher right. this average relationship figure the shown viral adenoviral bottom the the The is curve burden the represents with at of along individual. I’m adenoviral slide, Each axis the burden on the to and X mortality. showing adenovirus on loads an data

adenovirus with higher, burden see patients is And available again, to the who care. that of the in represents important, expect risk adenoviral current It’s received of each this data burden to of the AdAPT. the on AdVance log see antiviral control due adenoviremia, decrease these thus, data increase increase. what the one As tenfold we standard we mortality to note arm patients therapy curve risk ergo, the The control for doubles formal the or in to better that moving implications adenovirus totality. for clear, should adenovirus. And mortality of are left this reflect shows

the for we’re study Now how success. on showing slide, designed this is AdAPT

the who care local weeks. X-year-old X.XX had XX received of On is and left AdVance of a in patient, logs adeno over standard AAUC the

that standard difference On the success patient, was adeno The AdAPT’s primary viral care treated a logs X.XX brinci our who endpoint. gives between AAUC oral a of the and log with in adenovirus over was load – the oral AdAPT we to is XX X.XX an and X-year-old over difference, local logs. had patient on powered for brinci weeks. followed X.X which and patient Remember, right anything of the received is detect meeting us confidence the that treated study who

antiviral, to and that: conclusion, three, of burden the control over adenoviremia So burden decrease adenovirus Randall With also mortality. adenovirus like brinci adeno measured decrease clinically the a that, virologic now AAUC; burden control is that I’ll number AdVance that due from to should we decrease by adenovirus. review primarily decrease potent call lower our of The adenovirus-related for and AdAPT’s of programs. believe endpoint more norovirus number with mortality relevant; upshot better data brinci, adenoviremia and Linda as number should the with risk adenoviral two, of AAUC turn should is confidence rapid that increased the in as adenovirus one, the

Linda Richardson

Garrett, you, morning, everyone. Thank and good

treatment late and XXXX, Chief potential bit human and to and little a We chemical gears In infection for its market. switch from be currently today to going time of and/or see now the the CMXXXX, together a for as norovirus norovirus, We’re prevention I’m approved a outbreak. limit great we a of chronic excited no first norovirus. strategy potential in the opportunity, our our to about Science as treatment this prevention Randall for an library about as clinical speaking in are with Lanier, talk commercial initiated for identified therapies use Officer, there spread as a analog CMXXXX norovirus or compounds, of study very our nucleoside our

As long-term which norovirus as There’s due to interested graft this virus, $XX in year, it year. frequently is depending just in area mortality. organ unfortunately, setting. a need. are Norovirus causing a represents upon XXX some the cost will the cases, a among And dysfunction, malnutrition, and rejection, the not recipients. shutdowns stem cases resulting deaths. shared important it’s XXX,XXX Each economic there patients, organ a lead at transplant a with number dehydration include associated care of ship reminder, to cruise and facilities looking significant we infections billion impact these and, unmet impacts norovirus on cell in can over costly variables market large of toll, the million chronic in a also became and norovirus originally over as with chronic and solid of chronic prevention providers. and the impact health patients both Physicians segments different ward Approaching hospitals, care us

in profile, settings, who’d have norovirus market product already of medicine purchase to flu a For quickly of individuals CMXXXX utility as Other market the this protocol can in staff. facilities, use of to an who place antiviral also preventing there’s with are be norovirus hand spread the include hospitals to medical control, very or that be like patients, who much have but example, for an the infection We’ve put in exploratory antiviral their for for highly product preventing where antivirus have care in disseminate care in outbreak, not interested for military in indicating such could area protecting facilities, central on segments virus. event those contagious further on outbreak, cabinets. willing the research a done sitting only long-term

a have activity eliminating would potentially and for features, norovirus a product to with I’ll other more this explore to later use low segments norovirus ideal or us all site it infection. risk it identify to prevention to "match" several a details some known continuing key for We’re drug diagnostic interactions among to and lastly, profile a to effective including favorable about potentially, to to therapy details them, Randall tolerability need have antiviral year. enable market for in see and circulating plan profile, companion antiviral against of in to need CMXXXX. over strength; of An the like and strains; the the provide delivery would the of and we’d turn patients, drug which variety now elderly, use children; a

Randall Lanier

to an talking we for since this diversity today the the asked be antiviral major any started the question, as against really developing pleasure is we needs difficult? to hurdle project, proven effective why real be about Thanks, One so genetic circulating a to of is strains Linda. you encounter. therapeutic might When one all norovirus norovirus It’s CMXXXX.

recent period. just in As one diversity, XX over different an XX-month a New outbreaks example norovirus strains detected patient Zealand viral of study

essentially due This prophylaxis. vivo. as shown the In safety needed, ability side the preferentially for XXXX. report these shown in profile we This at profile upper favorable our noted through XX. qualities tract, the And is suited To therapy against pan-genotype norovirus deliver proprietary are are that date, to and screened both and is noroviruses activity norovirus all activity. have We infected a also and the the antivirals I’m our like that it most is bottom, has likely our potential of against norovirus small The that best the will to both The XXX finding and shown all After likely inherent molecule, target likely norovirus, epithelial cells on they ideal cells the Slide very This on corner. ideal the Slide rich shown use is an As regions that emerge. and pan-genotype interact in that’s noroviruses the which slide. looks And sequence viral across humans, for cloning safety mentioned, was commonly Chimerix are replication, for circulating. out protection active CMXXXX, in seemed found call the other polymerase to the The share the since strains. desired of few against in have as we is there thousands the polymerase, specificity advanced that including this opportunity was on it now vitro the same similarity the all essential a we site to of to the over candidate of right Linda viruses, common of with genetic site. in is line structures explore this, the on enzyme all in in activity The that to on norovirus, the Based for this XX. our of CMXXXX that well is structure molecule, currently most drug evaluated patent viral all this against contain chemical region that library a different is that same. while those an strains library in of for are respects, high to nucleosides graphically as the strains. What these active where tested delighted isolating norovirus chemical intestinal a in pink. genotypes right-hand replicates many means good, the cells, great to which vitro and nucleosides, we’ve polymerase is shown region. supports identified and would antivirals.

is from and in but delivery. shown norovirus, these will which is what oral preferentially We thought deliver goal Our gastrointestinal believe as the nearby cells effective dots. drug topical green can cells tract levels to of protect of dosing internal, of to as CMXXXX be

the the are accomplish main reasons We reach little two relatively are we and expect low two – prospects excited the Slide CMXXXX circulate total that clinical about intentionally are to and will summarize, for bioavailability throughout in we of dose shown XX. the kept body. reason so To blood have main this the

evidence has we in this widely pan-genotype CMXXXX a suggests essential all activity, First, is successful the therapeutic feel, for area.

the getting Second, the sites and places drug month presented and needed. simultaneously the we replicates to of be while of Research. to for development International can CMXXXX at ability place, right preferentially will on norovirus to efficacy deliver since the clinical where not Details odds is that less safety drug preclinical in for deliver next drug the discovery more improves Conference the clinical Antiviral

Our the And novel review studies designed allow X a ongoing the are choose and us to with evaluate financials. X from over Phase pharmacokinetics, for call optimize tolerability to efficacy to Phase nucleoside. dosing in will X that, Tim into take XXXX. turn studies safety this Data regimens of the Phase to I’ll of

Tim Trost

morning, Randall, Thanks, good everyone. and

first debt release operations, remained and approximately results no sheet. the shares earlier mentioned stock. $XXX first her well balance common capitalized XX.X today, to press approximately with we As quarter for in Michelle financial of At capital quarter a Starting introductory LaSpaluto million in end fund of issued of million XXXX, with XXXX. outstanding remarks, containing the we our

million $XX.X or approximately first quarter per XXXX compared development and statement reported for same loss of increased quarter of the Contract with XXXX million to General the quarter period XXXX. to $X.X for a same the to of first for of net to period XXXX, of The as for Loss the for the XXXX. and from compared and million trial in $X.XX the per the first first primarily the and The operations for in for $XX.X our XXXX in loss to million operations. period revenue share $X.X the share first a AdAPT million operations million compared net XXXX. $X.XX basic was basic was with $X.X $XX.X costs period to same diluted increased $X.X Turning million diluted company and of in of was from for our same $XX.X compared million IV Research for expenses our million administrative the related loss a quarter quarter quarter trials. million to ongoing of setup compared expenses or BCV related increase for in $XX.X the $XX.X XXXX. of XXXX. with

XXXX. our trials stable continue BCV focus rigorous one, number are capital; expect this the to to which, increase and headcount we stated call in quarter our the year-end to upward number March, and XQ on for a end to expense XXXX, have CMXXXX Chimerix of increase, to reflected two, company. we trial, employees strong we’ll in in focus a first the again, we begun and commitment of R&D million maintain R&D have cost in available have As items: norovirus. two like the at highlighting $XXX once Phase confidence by I’d to balance drivers on and this of control. see trend continue and X expense AdAPT from Notwithstanding Key this IV sheet,

the financing in back quarter Michelle in statement, alone between invested and employees see the call the stock section Chimerix I’d With to remarks. activity from now As like cash purchase you final can over for to of flow exercises. turn option employee our plan that, this $XXX,XXX

Michelle Berrey

take moment and current Thank our I’d like Tim. that our a capital. you, for plans capital to address to

ended the with of first said, over XXXX Tim just million. $XXX quarter As we

are Although closely for our want make clear the brinci we’ve development had guarding we development. on business million radar, $XXX I to opportunities that

toward join institutions. cells especially the efforts another sense. transplant, may company be number commercial forces may hematopoietic financial same be at required for make with these that MS high-risk may understanding focusing with given potentially brinci, company centers, we a Even still cell look to good another it we advantageous that opportunities, of the believe concentration with partnering sized of our As similarly small

agreement study conducted the which mouse recently study, we’ve front, the for during the for FDA smallpox with adjunct the a XXXX. On obtained parallel study design rabbitpox in with general ectromelia will be

recognized. As PAHPAI, closer now contract, country’s Innovation Advancing potential the and funding bioweapon a procurement reauthorization risk spoke bioterror smallpox increasingly the the a from regulatory pandemic, also to Last for prepared. Bill is real additional Pandemic of occurring to The potential or us be of week, a that Gates to of like our decisions, Act consideration highlighted are order the making All-Hazard made is intentional Massachusetts an is under must in a pandemic, these with flu, Medical Congress. and for readiness be XXXX, progress This the improving to we move we with that one of Preparedness risk efforts multi-year threats. very critical Society about and naturally a synthetic results event in smallpox, either

brinci. for in As U.S. short-course and we Europe new AdAPT initiate continue sites oral head to for summer, clinical into the the we

from market For IV opportunities but patients is the the on studies. curve fall, development, forward brinci, norovirus. have we for is adult in hope still potential CMXXXX norovirus promising. to first to look in X more details for very we to early adenovirus sharing K Phase the In open-label our

create As advance, near both value. these to expect programs long-term we and

immunocompromised study that, our confident just allowed patients. It the a I’d we’ll to their Before for to success like now to to oral we this questions, to the fuel open team whole fortitude which lives us brinci operator, progress improving is line will to call Chimerix in AdAPT take I’m has the any come. the open of unrelenting the and thank for questions. moment up that With to years commitment

Operator

comes from Our Instructions] first Nochomovitz [Operator Yigal you. from Thank Citi. question

open. now is line Your

Samantha Semenkow

Yigal Thanks in one for point, and is morning. – on, This the XXX population? in state just for patients mortality. XXX you the you there’s chance question. taking this guys. just clarify this XXX. detectable Thanks, first an release Could press the wonder, same later Samantha that at morning, is And press in increase I out of adenovirus patients the had this on blood release, of you had patient in say had the that

Randall Lanier

Yes, that take I question. can

stem than quartiles blood, XX one So pediatric had that of had patients, up splitting allo XX for who of and patients. transplant patients had ended in that there up Each into adenovirus the except were greater XXX copies the cell X,XXX one quartiles. quartile we

was I about it So think is the XXX, exact number the – XXX.

Samantha Semenkow

those than patients, that correlation predictive XXX of what adenovirus has of in was And – thanks. patients? was it, other apart? also as increased the sets copies What developing viremia them pediatric opposed XXX – for And the high most a that of specifically, mortality the per Got for level X,XXX that X,XXX to there less milliliter?

Randall Lanier

curve So mortality an up was quartile there patients XX% that the to higher over got higher that increase was also the levels and for figures, time, in you of and so adenoviremia with last no higher XX% But you more versus as increase viremia, in of up viremia any evidence. mortality exposure. of in to in certainly, for persistent periods

There associated as in X,XXX this. at great factors to We different a predicted that’s question. a couple than getting the to what patients X,XXX, the were that with were blood. than of the of risk question factors that greater Your copies greater at look

patient a alemtuzumab out with that AdAPT focusing that And depleted precise Younger undergo T-cell the with on core associated that received are were age they was those type, it. populations Those one are higher recipients. actual part the globulin study, with that ex or depletion as or such factors that at T-cell all immunosuppression. immunosuppressions of are The antithymocyte the their because patients vivo so blood And persistent transplant all AdAPT. with so treated of are patients level. knock that are vivo medicines Those was transplant T-cells, associated were factors of Campath. certain those risk that in in transplants, include we’re example, factors these for then factors

Samantha Semenkow

the What more the metrics load correlation question. patients adult was increase? are the beyond also just you rate saw in the thanks. correlated and mortality behind the as Great, there – And such viral And with AdVance? one mortality analyzed in AAUCX-XX that similar adeno between you concentrations, peak

Randall Lanier

great questions. All

looked that part an independent are eye that area age why was associated it an curve different area associated was out. AdAPT virus, is that an virus the with things ways, pleased amount factors of selected which literature takes presentations level with at to the curve in is those. scientific looked and The I really, because the peak it mortality for those of that the key number load under important exposure is these things is factors, AdVance reconstitution, the So Suffice been, say of upcoming factors the and of viremia into There for all presentations other between the we’ve And was at. endpoint of Please have that think, factor study. example, looking also peak we’ll mortality. that correlation, viremia, under that advanced of like tight all to mortality. number independent immune we’re also factor. mortality, of those that And at time, this the the and with in disease But adenovirus of very in study. weeks with account were we’ve included certainly, that that was to and the at virus, a viral with days over correlation level AAUC of which, see correlate really, are the of associated mortality. the we and the it best the keep And has really,

be the with of We’re we have get And conferences. going broad that to at publications a coming are the going scientific to and months. review slate hope to authors in published now right future presenting

Samantha Semenkow

helpful very congrats It’s much. so and Thanks and quarter. the Great.

Michelle Berrey

very you Thank much.

Operator

Blair. question William Xu Our with Katherine from comes next

is line now open. Your

Katherine Xu

the on the maybe do in X.X log burden is powered addition to whether adeno look reduction? how decrease also, there’s much were is you XXX if the of to factors just correlated study study to wondering – corresponds potentially stop any patients, much mortality that other very – with – you early? your internal mortality the independent have adeno with And the And burden. So I’m overpowered,

Garrett Nichols

on of evidence the sample of the of primary things length last don’t study to clinical The we to virologic and study non-relapse-related include question. answer the outcomes, to increased stop probability We’ve in powered endpoint. which order a differentiate increase It’s actually early stay To one, efficacy. our overall mortality. course, hospital good is on size intend the for like

the viral we So is than patients. that on have powered If a XXX X.X that’s less it have is. reason just log, change sample could in size study the with the that it done the we way load,

that’s So to the the answer one.

were time-varying As associated and count. as were as came what we the that with used the other that again, multivariable other far cofactors lymphocyte – the in out mortality, model we factors cofactors

in you’re the words, time. over lymphocyte at So count other looking

immune up As risk for the seeing count even a control remains lower But when – outcome reconstitutes, adenovirus in because with the correlated under lymphocyte end still curve patients reconstitution, you patients. these of you these on covering. are the mortality area

The other also factors failure, that renal of with were of side this care IV associated a current the included standard of which, is cidofovir. off-label effect of course,

initial months. the mortality. a correlates in of of accounting Those we’ll presentation, and the couple are forward that those full in strongest So all in of these of publications coming were next were the have

Katherine Xu

X.X how was about decrease much log then mortality to log to relate reduction? drop think is XX%. the one And I correlated

Garrett Nichols

with twofold with or for the one in hazard be hazard a is risk one drop associated increase a for was – mortality. the XX% risk That mortality. in – An would increase or a log the decrease log in correlated

really this it curve, the So the we’ve lot are you to on ensure population that we for we And on mortality done on up capturing end depends study. where so it that patients are patient a depends enrolling. right that

We’re the population quickly. likely Those clear their clearing due patients patients reconstitution own. just lowest capture that new antivirals, needs patient are on not that to quartile immune that that are in trying a to

patients T-cell-depleted do. after lymphocyte long So bay first we’re picking hold their a their recover transplant, count as the in time to until until such they adenovirus they need time at XXX days something and have who

to than adenovirus And top be They after than greater transplant. less X,XXX so XXX days They viral T-cell-depleted need need the of are have to need and to those we’re patients they confirmed loads going that that, And copies on recruiting. patients. up. be

are of the in the half really, are those the patients characterized So latter curve. that,

looking that XX% or of we’re upwards. estimates are at so mortality And

Katherine Xu

question have strategy for then I XXX. on the it. Got And another

So after the forward? what proof-of-concept, go-to-market. going can is You strategy

stockpiling. go can You

a partner need both. for probably You one or

just can bit? clarify So you that a little

Michelle Berrey

those I’m looking the options, can to both best different at Linda Well, for Randall lot impact fall see as where of about a we mentioned. and really adenovirus. greatest I think we talk are looking to the

As a into you’re therapeutic well the area. aware, we don’t shy first away from being new

already researchers the so study larger leaves epidemiology. defining, understand understand studies. Certainly, how database. there large And us to safety group closely That’s that with forming field the again, We We opportunities. trials. we have pathophysiology, regulatory to why many closely to often it discussions so advisory need was work to are – AdVance need many critical And see We with our to to how are working what that and those for group. need norovirus. together

the I’d this something of we’ve again, the on to to some seen us closely you what the commercial market. regulatory on. the for vaccine details would regulators potential think look is, that both we’re more the look in that But work antiviral, I give fall need really and first thinking the past. as path like the with toward trials the this we

Katherine Xu

you. Thank

Michelle Berrey

Katherine. Thanks,

Operator

next Our Marc from with Cowen Frahm question and Company. comes

now line Your open. is

Marc Frahm

can the the we taking on start that adenovirus-associated question. my of How the in to that for can have Thanks are the Maybe hold? of kind are guys to mortality how – of adenovirus-associated correlation if things known well, I you slides. you just to opposed with complicated And going lot at realized isolate as these a much be time? who same is mortality patients showing mortality,

Garrett Nichols

questions. good So

the versus easier relapse at mortality. can occurs malignancy underlying things one whether the due after whether look you is it’s that the So of to non-relapse-related of mortality

death, looking died, that is the talk mortality. definitely types sense of not then also curves, falls non-relapse-related were non-relapse of cleared if of linkage week are, And so mortality. The at before endpoints that antifungal adenovirus-related of time they each deaths adenovirus gives And of AdAPT primary study. on called that died of again, adenovirus-related died these the deaths at so pediatric patients, persistent highest look adenovirus months three The But is at patients they’re that survival. bucket. other. is mortality, number less of died you ended if the point the pediatric Adenovirus, three world, with of that about disseminated into at for the we this positive of these treatment-related XX% the adenovirus marker of up which these was is adenoviremia majority non-relapse-related majority of common at Kaplan-Meier the top the quartile – Obviously, we’re to the one. that’s kind time there’s unfortunately, they a qua a two failure, and that but up say those out you They That’s more it a for death patients. adenovirus that one fungal-free mortality. of to the infectious the reasons later, which difficult we’re you of lot in had And between a months multiorgan complications fact sine that is at survival end kind of infections. serious patients cause as And complications of adenovirus it’s time In ultimate was that of the in non events. looking was relapse. adenovirus-free XX, or what you one for looking these one still period in

Marc Frahm

the closing supply – passed? sign this think Michelle, think Or to bill to room – things to One newest be is two agreement? existing comments. do budget you BARDA your And does contract. you Great. to the need Do bill the be okay. then is on this of a have does you

Michelle Berrey

BARDA’s new in budget We fiscal The enough increase definitely a there. has Yes. nice room saw year XXXX.

get million But so, have up a – BARDA year XXXX. contract they we that year contracts. last had yes, the several historically, has – received the in definitely look That within future So $XXX that to $XXX million. we a have to XXXX. But could and is can when They multiyear went that years. next they, more fiscal fiscal that for know years, over freedom possibility

needs, already decided. on commitments stockpiling of So size know the that making those they when are they’re those moneys the additional different can for

XX XX. But and currently still that was initial There months ago, of pre-authorization, and administration a some are this again, comes. a a support circulated is saw couple there bill over forth. five-year billion appropriations we’ll where than the years. back when a When was to this first the XXXX is bill a look back $X looking see that the would an And nice XX-year be we as period. advanced contract we PAHPA, believe, I amount circulating believe that at appropriate So being for over you from was, that, XX-year rather

So of to months are we – population and needs that gives some know BARDA million immunocompromised was the paper the that coverage estimated to a for would both proportion look authors a vaccines really months what when of two about impacted freedom what of two, with York that, estimates of potential need We what live epidemiologic current candidates at the ago would looked in nice they how – look ASPR the $XXX two that they is that stockpile, three receive XX% initial at growing to there smallpox vaccine. NIH at be XX% the risks look currently broad be. and our as at and that vaccine these and since And New population. there’s eligible smallpox population not cities, be not they to a Sydney

for for smallpox why first through our have would frankly, proportion risks because, that’s appropriation, Most think them be so a I eligible So seen it’s really can the of look who to live while ER are, immunocompromised advanced case at currently current physicians they individuals going it’s recognized. never take either not take receive vaccine, have to a to that close get or to smallpox. a important of what

progress start expect getting too once late period febrile you symptoms So vaccine. we it’s that flu, like the patients, – the symptoms, to actually certain after would exposure, of and many for just

from they first XXXX. know a the need this that, they’re support getting So discussion been there’s that in need. we has that House growing broad administration. the of the and both We quarter And topic know we in in think Senate a the

Marc Frahm

about just economics share you your that least that broader, drugs? partnership the Like, thinking perspective? And are where how are sharing their would on possibly front. respective you at this a Okay. Or be from – a cost on about – cell just thinking sides then with? do other comment structure MS might Is how both something you

Michelle Berrey

toward I’ll for the crystal ask just in presentations? with XXXX so Yes. I development just Had dedicated for corporate talking questions a Or I commercial ending questions, anybody of to outstanding who we’re that XXXX. she is have people looking address Linda that that Linda over across just foothold. clear that we pulled those another wanted can you I’ll Are some of we really finish are dedicated is weeks some about last you quarter million the line, the bringing of to ask on look get comment. understood $XXX your getting million been make could sure first this make few does if the few business had dedicated? asset? to the wanted initial ideas to $XXX we’ve to as about, brinci. brinci

Linda Richardson

– being the a is theoretical opportunistic this in think I possibility.

as effective and probably to a in audience similar the commercial same each space, out having and the lines frames launch, on bag, carry both accelerate one drug two full of the help costs. each in launches if company, have structures product in maybe could would bag cost build cost as one the companies, same small two – to two have defer you not and If similar is institutions products time you collaborate in

example, at vice versa or By into be for a would U.S. time the looking we’re is to someone that. capacity. else So get we needing, product has that things the like approved,

opportunistic would approach with we it. and smart that, things being So like how really

insinuating that see companies we in have that and we alone. do or fully and are infectious that I look are But trying savvy was around may and some centers think prepared other same it similar We I think couldn’t. Michelle transplant be to the don’t that to assets smart disease.

game Europe. So it looking not original plan I something or somewhere to was sell look that buy more or at Her rights our not we’re the in this say point would to That’s really at acquire way. stage.

Marc Frahm

Okay, great. you. Thank

Michelle Berrey

Thank you.

Operator

question from Stanley. with David comes Morgan next Lebowitz Our

Your line open. is now

David Lebowitz

Hello and thank question. taking for you my

know for away? norovirus could should just that and what presentation learnings be what With June, let in expect the take to we might you to us see in presentation we able oral

Randall Lanier

are things main there Randall. going This preclinical The development. to present we’re Sure. the is

So norovirus those strains we’ll humans. lines we’ve against think cultured in cultures and human the the systems, all in shown show cell primary have pan-genotype against We a primary in so norovirus a variety the tested targeting enterocyte, were we different activity different including activity, activity we’re test of human that in actually – those tube in had cells.

the nucleosides. profile then that and So that’s touch And the have safety thing. one we also show there on safety in preclinical we’ll main

about worry showing and people activity those model. data. vivo then in things we’re areas, Some And like so mitochondrial toxicity on be in, those genotoxicity, we’ll and clean totally

as a So model, mouse the where well. really good looks drug have we

primary will through that the Phase are of those be So X. things up sort

David Lebowitz

my Okay. question. for you taking Thank

Operator

Fye Our Jessica next comes JPMorgan. question with from

now Your line open. is

Jessica Fye

stand could in the still thanks European that for to single-ascending regulators with XXX, expect the and updated we endpoint clinical this regulators And And I should on implement design my mid-year? to update we expect we dose the clarify, to on single-ascending the just taking wanted Also endpoint. Or first U.S. AAUC confirm, an projection trial to and multiple-ascending should signed Great lastly, to are data? an just and off want around data? confirm that just where then be on with questions. update hoping get AdAPT. that the

Garrett Nichols

Okay.

have data us came the able that get we got regulators a deliver a else anything. is And as required We bring if So with always in that think data the worked and and that discuss helps AdVance us said would conditional their at time we for probability of very sufficient be that, AdAPT starting increases with we should that across the them the well. our should order approval, as be huge on extensively its and European deliver least endpoint we – AdAPT this if for to agreement that I on just approval what to to U.S. set back data successful the and primary might goal. trends with endpoint, trial, success on at

lines, As for remain updates we mid-year. time as on far track the

our we time allow As U.S. up us XX-week getting to European will and then a take as it’s the recruit the going running, project and know, to to endpoint. And end sites up you us that’s study. it

weeks will So for the once visit primary we have last – full subject be recruitment, it last analysis. to XX

concerned… as As XXX is far

Michelle Berrey

Yes.

targeting progress we share, that toward think of data the on an we’re that and we are fall, to first. later definitely present then And have under projections. again, for probably months event on we’ll have some I a At So to look our October recruiting the expect again both point, belt. as planning investor by single- dose data we’ll as some ascending – we

a on So of brinci. should estimate for for point. And data IV full dose precise we’ll single-ascending AdAPT. We have enrollment the have we’ll the more at least, CMXXXX have, open-label at that share data to

Jessica Fye

Great. Thank you.

Michelle Berrey

Thank you.

Operator

Stephen from Stifel. Willey with comes question next Our

Your line is open. now

Stephen Willey

Yes. dose-ranging confirm wanted the commentary other I are BK to looking some guess, IV and Thanks questions. the study taking at for brinci virus to these that CNS, guess, going at I just of around the the investigator-sponsored in looking viruses be studies. initially DNA and,

Michelle Berrey

investigators. meeting together our with we So are

phone really brinci about brinci unmet confined to that, – the not call now number it it and transplant both that’s and said BK. I renal together, patients. on pulling is you physicians. reflects medical need especially think large the the IV we’ve two with we We’re renal And is shared Having with transplant probably in get

that’s and the folks why transplant bring both folks. we kidney it the transplant together, important to stem was so felt so And cell

out us patients in update give opportunities for and defining there’s a dose-ranging progress us at to We’re we on no, and help June both It’s opportunity in can’t all something But we also an them Seattle to think in large pathophysiology, good the design It’s that. a transplant together in the bringing the ATC that just is you study. We get cell. would running. details be both. in kidney stem this many on

from the and the both would the cell stem into most folks patients. the – and advisory of an transplant board organ really, definitely We’re in-house. be creative in But that this solid heading pull to, best

of some toward look we to as kind That done as explore the envision we, some investigator-initiated of having of was – it there. as we’ve our trial. these, that we requests some HPV-related not core, of this for like years, those considered Now infections, had in a And CNS we is investigator-initiated have be things something we’ve summer. potential where could are discussions that future should could malignancies, the studies

really that exploratory multiple more or I And getting brinci. of envision commercial foothold thing staying collaborative they’re on in So studies are kinds would downside, the brinci we for It’s as AdAPT investigator-initiated more the where on opportunities that we studies internally build viruses. at AdAPT and that focused brinci opportunities. an fall getting clarity very oral different about in short-course these that we have out the that all on brings. prioritizing talk event, know investor IV to can these exciting than about opportunity We’ll

Stephen Willey

pricing. Linda Got regarding it. just a And then question maybe for

in brinci dose cost of of oral the some be triangulated the link wondering within here just just if previously and your internal the a all on setting. to the probably potentially pricing to around have bid had looks what we mortality the think based comps I CMV given stronger goalpost may adenovirus historical space changed

Linda Richardson

comment. that’s I would think an insightful

might, we’re that way projects it that. think that look be we’d at if plays at And out in I going looking mortality certainly the the profile. to full that the AdVance

being a to crossover drug mortality our consideration compound brand. the across cycle orphan But We the we market indications where life of see would and I hope kind benefit certainly to and in penetration with the his access out be have other of of cognizant pricing. the bring think, significant an be, an of the with

Stephen Willey

lastly, for in there product competitive was smallpox know space. a the then Got it. advisory And committee that meeting just I

any Just that found insightful, wondering either that FDA intriguing if otherwise. commentary was there that, came or of out you

Linda Richardson

Yes, absolutely.

different committee profiles. mechanisms been the the with development usually different as antiviral. separate So action, – programs well consider discussed competitor antivirals the May before either X of since first two for advisory They’ve began. don’t them We was of – an smallpox

AdCom brinci. some And the were for relevant there so elements are that of

were are immunocompromised not, in individual. healthy patients. of most being in are data – our though of in Most are Some data their humans

So elements some there are just there some that. on that relevant. there, reflecting and aren’t are were definitely there we learnings But

notes. We’re watching for the

we’ve were need I closely discussions different this to that the exist, think need the recognizing antivirals. two working important that’s for a adeno applicability pay potential attention see of that And compound with the to all and have certainly, us it not as use. has for breadth also something but as been was dual-use first continues the for encouraging discussing. orthopoxviruses, FDA and we of some to There company the of interesting that the lot to just about herpesviruses,

there informative. step good. was a us And as is an this important So – It we’re encouraged for in next it was was that preparedness. recognized

Stephen Willey

Great. Thanks for questions. the taking

Linda Richardson

you. Thank

Operator

our Ed Wainwright. H.C. next White comes And question from with

now is line open. Your

Ed White

morning. Thanks taking Good questions. for my

do on my follow want smallpox were already up just asked, I of I most do. questions So as usually but to

can run but to the study with for if With submission only are the wondering data, timing going FDA. that regulatory concurrently get study, a time we also with the line rabbit not adjunct just be mouse a

Michelle Berrey

Yes.

have, in we So don’t NDA in the the that the rabbit likely MAA want rabbit. – ectromelia We’ve the model, done mouse And before similar the think aware, that the they studies in XX already to wait will European pivotal study. sense. are makes the go adjunct you as mouse for so numbers over regulators the or

a XXXX would U.S. in So studies XXXX these end in toward availability that the two of data in for probably filing the result

talk XXXX about in makes sense multiple could of we’ve a filings earlier about. few that U.S., cost does the Europe. in again, be may European potentially, cost-effective They’ve recognized having you will to Interestingly, procurement hearing a independent to that last be the as XXXX And discussion the not stock or there So that over second about AdAPT weeks, most organization are know, discussion early more potential of back data not earlier. countries influence BARDA-like time in available. that half to the not have, begin effectiveness about stockpiles that it the joint Europe, are been some whether starting

flexibility that So get front And that Rule that on brings been a an the without any We’ve watching space regulatory we’re available. before see to required Animal if approval having closely. with we’ll first we’ll it move could space that discussions gives certainly stockpiling closely begin any quickly. preparedness see with us If more increased bioweapons. those watching focus any we on Europe and to in opportunities, for

Ed White

Okay, great. Well, thanks very much Michelle.

Michelle Berrey

Ed. Thank you,

Operator

closing like Michelle Thank over you. turn so remarks. That session, concludes to it for our back question-and-answer to I’d

Michelle Berrey

the great next this morning. looking Again, and all you questions opportunities. much, very Thank few toward Thanks the Great. months. for

the time data on Over estimates summer, when have and in we update then we submissions. expect for full on will readout required the of enrollment XXXX and AdAPT

And and be up We on adult the the we brinci October IV information event. confidence out Wednesday in ICAR read the recipients increasing Randall morning, us with this this website. within As is us datasets at occurred independent for has will may in clinical be our AAUC in from gain and provided agreement clinical X going higher of will mortality increasing clinical June. AdVance endpoint in viral transplant investor allow Garrett data us study. a data CMXXXX But relevance although to AdAPT fall from the mentioned, be on have webcast of on then if this the And for endpoint. related FDA And closely to we we the relevance more date the a evidence of should could use multiple potential other infections, have Phase to our of surrogate more for have gives on save better with week, how relevance that is virologic endpoint. there’s AdAPT, course, for adeno virologic presenting also establishing AdVance on understanding data, presenting endpoints for summer. first the data that you’d now as these like,

thank that, all joining us this with and a you have for Monday. morning, So great

Operator

Ladies and much your that gentlemen, does today’s conclude participation. Thank very you conference. for

wonderful all day. Have a may You disconnect.

Chimerix (CMRX) 7 May 182018 Q1 Earnings call transcript