CMRX - Earnings call transcript Q3 2018

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Operator

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

Michelle LaSpaluto

Thank you, and welcome to the Chimerix third 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. third at release the press available www.chimerix.com. website The is Company’s on

CEO; Chimerix via You also the of on of approximately be access me webcast call two CMO, Tim the Chimerix today’s Nichols; website. Trost, other may call President are the webcast VP hours event. archive the An including With Michelle members after also us today’s Reeves, management Kevin Investors and team, will be on Garrett section will Berrey, available the and of Marketing the for CFO; conclusion of joining questions. of

current statements the begin, have regimens, not you uncertainties marketing of on the to remind of possibility I or or brincidofovir-based of if made the Private and that that other Securities I Litigation trials use. not their on factors, and other like brincidofovir limitations risks the may include to may may within are granted, subject Act and authorities FDA meaning statements approvals, Before the forward-looking brincidofovir future including approve XXXX and the our today’s that significant that call successful, be regulatory

may commercialized. As never be a result, brincidofovir successfully

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

Berrey. any forward-looking call time, At earlier forward-looking like risks this turn I are obligation uncertainties in filings Commission, Chimerix’ Michelle President cautioned XX-Q including Exchange not and on to the detail today. in Chimerix, on information statements You’re statements. are to with currently Chimerix described statements. our CEO, All rely over forward-looking such to filed and and would to based update to these Securities These assumes Form available no

Michelle Berrey

New newest held substantial Good and for for program Update for our progress set the joining pox oral a The the CMXXXX morning, brinci, molecule, event, we last with shared we norovirus. be our small to over mid-October, year ongoing today. us the transformational in XXXX our Annual Chimerix. York. three for everyone, At you Investor years stage has with In IV work and this and thank

Specifically, expect three XXXX. to in achieve we catalysts significant

full in virus of initiation brinci with together inform potent recipients. to First, against HHV-X in the recently our of data the of from studies viral XXXX. X activity adenovirus short brinci both XXXX. IV presented X/X Phase These clinical dose transplant brinci. and data life-threatening curves enrollment Phase adenovirus data This infection in adult with AdAPT designed in confirmation, oral to lead the study design expected our clinical could filings ongoing of IV for will of later Two, decay confirm studies with BK regulatory our antiviral confirmation course and

data pivotal adenovirus the in rabbit presented efficacy viral mortality. measures had highest the mortality animal At San XXXX. brinci our for of pox could in early IDWeek in from lead studies analyses full to Third, approval that Francisco we an October, small from and of mouse load burden highest with of study. load A of viral adenovirus AdVance of adenovirus correlation and the different measures of viral risk that patients six showed all-cause

in superior viremia the Under correlation those Patients available a the of a under Importantly, With adenoviral adeno the XX-fold load AUC next AUC on adenoviremia in expected able whose strong rapidly Curve the the high peak in for shorten highest with of benefit months, dying. have the smaller Area shorten that Patients adeno other result brinci viral persistence of patients independent AUC. is the log quickly Area because, in risk a duration a with a increase the viremia. the in know and of over to of those each with quartile Under to in lower the than Thus, bigger survival. viral brinci study quartile death AdVance of higher such or brinci, it this that is meaning lowest Area those that’s the risk of doubles. survival. patients currently a demonstrate associated the between improved an to the mortality Curve viremia on in was lead therapy. study the a AdAPT load powered peak adenovirus adenoviral Curve average in and lower and persistence clear available antiviral is each six and that mortality. currently The in the mortality. which encompasses Under Area does had burden adenovirus datasets Curve an The AUC peak therapy impact This Area to both not should adeno have Under lower one is AdVance, of result higher the to peak adeno risk improved should AdAPT of and increased Curve other with and on from and mortality of the risk the compared on mortality, duration the loads ability patients We of dataset Under

the surrogate a C potential announced FDA the of recently as marker. to an in approval. hand, C consideration for request to discuss surrogate meeting markers a meetings we to for only FDA adeno accelerated facilitate AUC data these with potential With Type plan Type

adeno Europe. mortality. independent trial treat of of both correlation addition prospectively course randomized adenovirus. in additional and regulatory short brinci for data AUC Remember, In our to AdAPT clinical same is datasets data, a have and datasets the centers three paradigm oral advance in New the from transplant approval strategy Austria, York the to to These treatment strong brinci lead clear UK the and the U.S. AdVance as oral under could from confirmed and to

we transplant setting revenues of life-threatening a can opportunities the infection. to an in development strategy. in As for proposition build we’ve foothold oral initial With early The will the commercial in and same brinci, infections, expand working centers a indication, the in for multiple would adeno allow this value adeno from support advance IV first for viral revenues a been years. generated brinci us land

IV Phase for our the multiple X, brinci dose of reported. XX and the X no trial milligram studies milligrams continuing diarrhea four evaluated we IV oral to in with safety similar IV study doses late-stage which At events doses sites other GI brinci Turning levels Phase of from as clinical pharmacokinetics clinical blood of or and our we in provided brinci open data studied in are adult Europe. brinci. U.S. of XXX healthy adverse to subjects IDWeek, presented ascending IV

for Kidney decay the and in plan from look family they these data of our to Week HHV-X curves us reduced dose The Our confirm inform infection, at in demonstrated infection. at allows data seen of which IV Phase BK October, brinci Event, of of recipients in same PK dose this the to the we pharmacokinetics with forward infection sharing this At and confirm the XXXX. brinci of stem that tolerability San with viralogic and to cell are from X a XX two available safety SUPPRESS in studies Phase the We in received brinci adult importantly at virus. us over and progress significantly response and safety, virus ongoing that studies stem with we’ve whether load data against the data that In study XXXX. IV Diego, XXXX HHV-X IV recipients. we Nephrology American mouse brinci X ‘s BK same transplant as trials will activity Society viral designs the in virally-infected population cell JC significant we our viral allow milligram provides recent presented treatment in presented and which have IV combined our brinci efficacy transplant from polyomaviruse patient that X/X the become Investor BK as adeno brinci patients beat of to starting studies, to showed studies the Phase for will from curves

with the and also are development ongoing is efficacy program pox rabbitpox the Our finalizing progressing small we mousepox protocol. both model

the of of different models vitro our the ongoing carried top re-authorization has pleased with the well-tolerated. share from us data presented European the the of CMXXXX assessment XXXX. the the to and we data Clinical been in the to should with further to data With of mousepox clarity We should rabbit administration a over CMXXXX were norovirus studies from potential in call compound in that to will study infection. to of data X highest increased the forward oral approved success ongoing are year proof-of-concept single-dose CMXXXX And PAHPA for model up animal milligrams September, Single be at Work from We last, late into doses anticipated I’ll for Virology for financials. help probability for pivotal have Athens, Tim Greece. Society dose the norovirus, review and a that, our see norovirus are the from of adjunct on BARDA understand tolerability as procurement with formulation next of pathophysiology the dose turn program safety help is study with formulations pleased determine well. study. we a of infection XXXX our the funding Phase In in under contract and

Tim Trost

Thank Michelle, good you, morning everyone. and

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

or quarter compared basic loss statement our or as quarter for the the with $X.XX diluted million for million, of expenses of period and with in in for contract in of of a XXXX XXXX we offset the operations programs, a XXXX, to XXXX. reported in to to to expense. remain third primarily expense. decrease with of the full for clinical basic General to compensation same lastly, revenue for third XXXX, $XX.X quarter with million, $X.XX trend committed expenses the R&D period $XX.X quarter period million $XX.X compared the third million loss year operations, per although for development million quarter per expect $XX.X a XXXX XXXX, the And to quarter same third XXXX, of were XXXX, company to control. cost and Research XXXX. the focus we $X.X compared from the of the the Loss million XXXX. continue and of approximately share the million net million similar for diluted of decrease same compared upward from million in third from for $X.X net the operations in period share expenses expenses on $X.X same a administrative increased decreased loss was for $XX.X in and BARDA to due was a in compared $XX.X for $X.X at compensation Turning by

again our strong Before one, commitment. turning I’d Michelle, two cash the Chimerix two, position call over Number the like emphasize employee back to number points. to and

balance $XXX the First, million sheet. capital. in XQ, available our a At reflected of we strong end

ATM bolster During our raising of burn. We under to the offset the ATM continue to third a quarter million fees. net $XX.X market total time-to-time conditions way of from cash may and XXXX, opportunistically depending a of cash on position we utilize shares issued our as program

regarding confidence of Second, employees. significant a point and and the commitment Chimerix

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

Michelle Berrey

in are In with participating steps enrollment the studies AdAPT basis in be sites long-term in is about of BK in we a centers in full completing XXXX expect for Phase believe Tim. AdAPT and We joining of final be in will a couple provide IV to dose brinci, virus study. enrollment more Germany XX guidance targeted countries, enrolling. pediatric able XXXX. the excited will the enrollment additional specific value for the we we screening all with you, two after the the and Thank we soon X closing, adeno and range months in kidney AdAPT the and the anticipate study beginning Italy nearly of confirmatory brincidofovir, transplants progress of

immune the SUPPRESS the potential on of excited viral new to brinci with in prevention infections HHV-X also our compromised the about are by address of for the study. CNS We supported IV viremia patients systems in data

these unlock key the brinci clarity population. final pox U.S. and With line procurement opportunities patient models and in U.S. exposure open operator, much and in to brinci will to the animal bring bring enabling to CNS will the any for we on potentially in Europe mouse efficacy small beyond. full to of submissions opportunity improved studies, the the both in regulatory the potential commercial that, expected XXXX seen and IV for maybe With questions. wide now rabbitpox data ranging the more the and the is

Operator

first Yigal with Instructions] Thank Nochomovitz our Citi. will [Operator you. come And from question

Your line is open.

Samantha Semenkow

Samantha Hi, taking for Yigal. this our for on Thanks is question.

the You mentioned previously for IV possibility data approval the studies. the the based AdAPT oral that, brinci before and on could that accelerated on from is for data, brinci approval be based full

on there the And a this adenovirus approval different the is still a accelerated and was from for the based First, with second, formulation program? whether is FDA? precedence full your gaining thinking around approval

Garrett Nichols

So, this Garrett is Nichols.

these package the outlining in yes, the strategy to really will the and we that the we’ve a a supporting that’s of history achieving to together and lower natural AdVance the Europe. able to approval a adenovirus of is current data study oral approval all care. transplant all it the would if in patient compared this population advantages strategy, to to of with far for As pretty AdAPT mortality us for burden our standard and show other adenovirus in brinci strong compiled But addition submit be when for data as accelerated are also numeric viral that fit at information datasets,

we it’s confirmatory same formulation IV. to the just formulation should of from that molecule. and just don’t have as the using IV Essentially, It’s concerned, from As be confirmation. different far for believe that formulations a an trial is issue thought switching oral

Samantha Semenkow

has that FDA potential Europe? of aren’t the – And been you formulation are in this you before a done aware issues accepted this, different knowing aware of has where any that precedent fits your any

Michelle Berrey

in there versus a sure is require of if pre-existing a individuals. package But number smaller not at look IV. general oral a addition of for different am approval, to I of precedent you formulations those

So, we can study. Generally, studies. proof threshold second of PK be don’t just same confirmatory even write with the to a as conducted even it

could that’s don’t C So there as would Type we Garrett the be that, planning issue, in any are expect come a that that we meeting on will certainly topic anticipate saw up surrogate holding but regarding we the marker.

from would see not Just if a for significant also the improved a that it AdAPT sub-part. want do study, statistically mention, approval, a survival to we suffice full

we with we for data order – the that which really to from will us study pursue to So more and information the allow AdAPT have will want see which IV. and options

Samantha Semenkow

you. helpful. Great. also… Thank very That’s And

Michelle LaSpaluto

you question? Do another have

Samantha Semenkow

Yes.

impression to So, the it to the space, both adenovirus, were viruses. if discussions you mentioned in would gain shared gotten to proceed I wondering that KOL with he was at his approval other brinci your sentiment your in other that R&D with October, are use way treat he the peers? FDA in in DNA off KOLs Day his have

Garrett Nichols

BK in Certainly, which cytomegalovirus viral program in less in that that expanded there virus common, HHV-X, pretty brinci this virus, the are resistant simplex but patient treating interest is certainly population virus that problematic infections viruses, a adenovirus treating DNA the JC such well. than refractory know requests some resistant and other was plenty volume different access herpes number as XXXX as for for of was in and of treating viruses of do robust. double-standard we available Well, the time period

in – particular start or lot pharmacy either this has case of presented to reference is plenty have familiar interested of event. all therefore, these We investor and brinci case attempt vitro with going and conditions to is because experiences your compile treatment drugs physicians been that published accessing studies of those treatment with there that much in that – not brinci that viruses. are of the different physicians available a So, several experience these very for things in really to for we demonstrated at take with slides their activity are else of and there certainly using primarily in opportunities are those

Samantha Semenkow

taking Thanks Okay. for the much questions.

Operator

Morgan. Thank Fye next comes our question J.P. you. Jessica with from And

open. Your line is

Unidentified Analyst

for that our human the from studies the the Besides should study of you with human in late-stage maybe next for expect Thanks Daniel in dose, in the vitro learn provide we could timeline And design This study? is the to model what should go-forward taking Jessica. question. CMXXXX? us with animal

Garrett Nichols

So, question. I think I the heard

You were from the get breaking line. we up related I the heard the information expect animal and and of some that to vitro in a correct? little But bit CMXXXX on question to Is the that that work. was

Unidentified Analyst

Yes.

Garrett Nichols

Okay.

target new as mucosa, get an seeded we can the effects from as secular are those to These up gut increasing in to idea CMXXXXin demonstrated efficacy So, look experiments those up including we actually that We looks it’s concerned, are taken the also plasma. human, those in, tested of X.X far very that’s are can some vivo. the that expected level gastrointestinal in biopsies all grams where norovirus of some drugs experiments cultures. healthy human that oral cultured the that basically cell. grown tissue like increasing to about the ongoing doses can enteroid and able and in mucosa cultures are do we able ascending into replicate what of and doses exposure in as and remember the at introducing in now. the have those But volunteers and is single CMXXXX with of therapeutic kinds replicates We cultures best norovirus norovirus are achieve are

that as will human step at able which of pick next as we the are to inform concerned. in is is are far we study able study enteroid our models, dose proof-of-concept formulation that drugs we the as levels to those So, achieve better and look

Unidentified Analyst

right. All Thank you.

Operator

and question Nadeau with comes Our Phil Cowen Instructions] [Operator next from Company. you. Thank

open. is line Your

Phil Nadeau

thanks a my for when you meeting that and on morning specific prior questions. that Type when would Do completed? a have C sense you a the meeting you regards have to as requested you the in timeline that taking a or to of Good have question to meeting Have referenced hope Michelle, question. be?

Michelle Berrey

Yes, thanks for the question, Phil.

think, our I literally, guess XXXX. best in relatively early

datasets. We data have robust just package meeting. FDA at to be we would as requesting the But requires are all that that a recently presented as AdVance the IDWeek, those that other we pretty going independent informed that that include well briefing

getting formal It’s as So, that request. XX-day with all go are meeting request. that a meeting a of we in compiling will ready briefing that package

that us put would XXXX. in So, pretty early

Phil Nadeau

In the independent that all information? additional you you to do results that datasets, to give? is access have Or need there

Garrett Nichols

That information is being published.

their I think Sloan The colleagues one That IDWeek and been then have the center we well, was The at Thomas for of The York. have her are Dr. New that in is information she prospective assay to a of Kettering the monitoring by from and now from presentations look and data well Center plans. centers first Papanicolaou the used same was over Leone with doing data. the were Center working Manchester with been their These in conducted of of decade. as in monitoring, them same with importance datasets Austria that this that, the those PCR all presented quantitative

in XX homogenous but what it’s population. heterogeneous population, of transplant centers study, in it of able up are is a to patient the across ended more they a so, population distinguishes Europe. but from And seeing kind we replicate That a which AdVance much AdVance

same to mortality So stem kind the information or transplant. burden least the viral after significantly the at is conclusions provide of cell that this with and same contrast really associated compare adenovirus helps to

Phil Nadeau

Got it.

questions. taking for Okay, fair Thanks enough. my

Michelle Berrey

Thank you.

Operator

and I this call Thank showing now the remarks. Berrey, CEO, turn questions Michelle no like you. back further to for closing at to I am time. President would

Michelle Berrey

additional coming providing morning we you for Thank forward the to time this and your Good look months. updates everyone bye. in with

Operator

Ladies for the and thank great conclude you all conference. you participating and a today's in may Everyone, does gentlemen, have This program disconnect. day.

Chimerix (CMRX) 8 Nov 182018 Q3 Earnings call transcript