ABUS - Earnings call transcript Q1 2019 | Arbutus Biopharma Corporation

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, ladies and gentlemen, and welcome to the Arbutus Biopharma Corporation 2019 First Quarter Financial Results and Corporate Update Conference Call. [Operator Instructions] As a reminder, today's conference is being recorded. I would not like to introduce your host for today's conference Ms. Pam Murphy. Ma'am you may begin.

Pam Murphy

you. Thank thank joining and all you afternoon us. for Good

Development Arbutus are Dr. Financial Dr. the Picchio, Sofia, call Murray, Officer. team from today Chief Gaston Dr. Officer; On Mark Hastings, management Chief Scientific Officer; and Officer; Dave Chief Chief Mike Executive

made differ and our including pipeline, forward-looking that potential of SEC. Before described specifically are number statements in expected AB-XXX, we subject update for statements that to views and some AB-XXX, future based and the for proprietary like revenues HBV from regarding clinical of and and we'd today time forward-looking time results most results call begin, remind if you on runway expectations assumptions may in so and on the to the point materially, in time we we report even statements a today While forward compounds do on current actual call expected looking licensing lead the some uncertainties AB-XXX; these are those with including our of risks our lines our that to Any XX-K to may filed including annual any at obligation statements cash to recent disclaim this cause from make statements our change. the during our These elect forward-looking we agreements. are statements, documents as to Arbutus'

Now over Mark. would to I to turn like car the

Mark Murray

of cure. combination to you, us the Arbutus for committed on effective joining and the regimen to development today. you HBV is everyone an Thank call to achieve Pam, thank an

ever combination is We approach are correct. this that more than now convinced

July. months. to line plans you press share will next our data several saw over Gaston and to for XXX release, HBV in update describe our oral we As patient the capsid data in plan what report the inhibitor top we expect for AB-XXX, on interim you clinical

in administered Xrd, press trial had B plan request delayed. May to start saw last clinical subcutaneously initiate X viral the also the agent, quarter, antigen surface release antigens due will Hepatitis we but RNAi targets to As Friday, received you we our clinical the a regulatory Phase trials which AB-XXX, be this while of notably

We timeline will update you by the on in approved a add trials moment. has Gaston been more once clinical will the just start regulators. color

to Regarding remains committed HBV our to safety to development and RNA-destabilizer, AB-XXX, have in these through our further clinical RNA-destabilizer oral it's the program. a because evaluated in being models. before compelling vivo multiple a studies current is effects shown mechanism in oral Arbutus expectations and characterize series of vitro AB-XXX AB-XXX of program the in initiate deciding in antiviral profile pharmacokinetics lead for whether our will Sofia compounds take action, Mike RNA.-destabilizer the and trials. compound, AB-XXX you plans in of preclinical

to Now like to turn the Gaston. we'd call over

Gaston Picchio

Thank you, Mark.

in lead capsid patients currently inhibitor. and clinical is formation II being to inhibitors AB-XXX together studied in interim the XX. a in results a of in include HBV presented We DNA will inhibitor NUC-resistant subjects, interim data We report those healthy decrease Class dose patients is baseline conduct July. analysis Capsid totaling from and once number with dose volunteers is XXb active and daily. pan-genotypic developing healthy continue HBV cohorts subjects year variants further full and is later levels deeper Xa/Xb efficacy shown into daily replication trial. safety a to which parameters HBV against year efficacy a the it HBV AB-XXX It data in meeting, has in Phase mechanism activity, scientific HBV new and new are DNA of in intend We potent XX day safety cccDNA. on in of analogues nucleoside complementary to later to the an two those top-line inhibit additional patients are and as those With RNA cohorts. appropriate an this mean actually capsid of as change plan in HBV and to reductions. and

regimen. a which will approved in with of potency AB-XXX in we to and to trial far, designed also to on include obtained These and this are nucleoside will analogue, pre-clinical the exceed in One a studies the analogue and year. safety confident of inhibitors capsid use therapeutic comparable other Based accumulated of to AB-XXX development. later the a half long support those of so finding are approval second initiate an phase combination term data nucleoside AB-XXX

viral of once employs from combined convinced DNA, cccDNA is why regardless However, AB-XXX hepatocyte-targeting which not technology, subcutaneous an educes month. RNAi spans inhibits meet single GalNAc transcripts agent dosing, its with our trigger be agents of duration. source. all it end, provides a antigen developing proprietary novel including all still or RNAi other and a to , also HBV that that regiment AB-XXX of designed remain lowering we less-frequent antigen that antigens will goal finite for to the HBV antigens our This replication. employs the curative dosing, That need integrated all from arises have To viral surface of only important target but a potentially surface compound we benefit which allows also

ascending planned a of have confident study company of submitted successfully Phase portion to single planned Ia/Ib were and has the ongoing single the But AB-XXX Further, we and months in of the three later six ongoing completes clinical our emphasize, as IND-enabling result tox data, Phase the longer months months which are of gathered a involving to months that regulatory dosing have mention, given AB-XXX ascending support studies, initiate Ia/Ib we part so efficacy of want before its this commencing trial. the positive portion three clinical response the authority I of we We remain subjects. six the that completed and to the quarter. HBV in safety toxicology studies, support dosing this trial, currently preclinical in recently clinical far. CTA, requested the studies of to

However Mark that, turn will authority clinical that be requesting ongoing due call as studies, explore our to Sofia. a We the like data. mentioned, complete duration currently the clinical I trial delayed. based Mike now of the to plan the on to tox trials available accelerate over we toxicology start to the regulatory to variety would options With initiation,

Mike Sofia

This month [indiscernible], with that AB-XXX model another AB-XXX, antigen in a two one patients. these in pre-clinical reported we Gaston in AB-XXX clinic Last at in that analogs chronically agents complement Thanks to and vitro HBV have Gaston. synergistic with mentioned XXXX. plan replication. in will of inhibiting Mark one as nucleoside expression, infected to believe the addition that and in inhibits and combine AB-XXX demonstrates our AB-XXX HBV We were another replication.

know, HBV As the many mechanism This lead We RNA have at could of patients. benefits refer program to mechanism, Arbutus. for significant working to team been on you this we high for a an very new exciting priority which as is destabilisation.

factors on of held in dissecting advancing off types, designing RNA years the several observed a then findings their and the doubt to is a advancing histopathology small of conpounding with continue the first RNA-destabilising term conduct response study. to host a and observations, safety associated involved the landscape, testing action before evaluation intend to This do. AB-XXX. the clinical to appropriate. findings of into of signal a validity we dose resulted into due thing with HBV clinic potentially studies, go/no rigorous AB-XXX include activity, number which these to with our mechanism a this development. destabiliser have the lack preparing safety in compounds in and work long current to non-clinical compounding associated well human an This been on key fully the unexplained therefore our go treatment has the we the more is lack that have making all we simply the change advance effect. For mechanism do cast common differentiating fall last some of vehicle a position some we about studies clinical designed non-clinical decision into action pathology this as potential these conducted has we if compound compound proceeding to It findings, Since and to is because molecules safety of determine Last scientifically of characterize it

species in early have including wide decision to XXXX. of studies studies days go/no we the We two and in expect now make XX go AB-XXX range about underway a safety repeating a

compounds degrades lifecycle not will population a DNA which follow highly differentiated and the RNAs warranted, the very AB-XXX, mechanism aspects we target because safety selectively if HBV low While thus patient while doing of have replication tolerance on will for disappointing, production. Company. chronic viral our many RNA-destabilizer effects successful in the evaluate work The are the very on patients forward tolerated. back novel and and we or to thoroughly safe compounds, important AB-XXX is with and itself addressing us we including s-antigen all for more The is of continue destabilizes has to bring HBV very and be are well and think

The or We find signs have compound look We vitro them. target toxicity off performed for a in clean. effects. other studies of variety of to cannot looks

no deleterious with involved proteins out space call maintain effects in have we'd RNA-destabiliser the over finally cells. the to knocked like be mechanism, now we would I turn there and have on position the the like We first a the to to to Dave. cellular clinic. to made appears several in this competitive And that

Dave Hastings

by I'll position. Mike. cash Thanks the start discussing today Company's

metrics. $XXX.X are a a a cash at versus use had $XXX.X reminder investments most XXXX cash and million cash of balance December and March XXst, At XXXX. of we financial XXst, balance important million As

offset activities sufficient We Our million, is cash use would to $X.X today $XX.X area the operating the of ATM. to The XXXX I other million our quarter our speak our cash net to used XXXX. is from fund like balance entitlement. only royalty in by proceeds was believe during of into Onpattro first operations of

the previously rate tiered in is have based on single As we royalty sales. mid net disclosed, digits to low our

We this long trajectory launch and of term are pleased with the of the product. the potential

economics Additionally, if are monetize to downstream stream retention potential. can't may this if we product's happen, a feel possible or while the transaction still and of payment open deal when aligns we cash upfront such fund with we in a royalty predict

that back with to turn I'll the Mark. call So

Mark Murray

agents most regimen shared now is agents by HBV will combination a some to developing We disappointing we've have that focus. our therapeutic to having team. are replication, mechanism me our with be are Thanks our - target delays Dave. believe discovery of belief reporting complementary combination commitment HBV focused a which most infection Well is reiterate approach and we the we effective important effective compounds for and immune development s-antigen of This to the expression cure many a important and complementary administered our aspects developed is the the of of chronic and ones that I and thesis over of that duration. therapeutic believe reawakening. finite want are pipeline require including to to we HBV in a therefore today reported which control for and on, action, treatment can belief and used the end to this

I'd focus. continue the an lead call the meaningful be At of a nucleoside two current approved and to standard used Operator? point, care. with combination deliver We believe our over our to questions. AB-XXX and compounds for this potential that to open analogue the advance That AB-XXX in like is have

Operator

question Instructions] Chardan. with Our comes from Keay first Nakae [Operator

Your line now open. is

Keay Nakae

Yes Mike. question for

I - hoping doing those already talks, on find repeating talk guess, terms term of in three that Just with not you're are you're setting, are getting? studies? talk What seeing the you the the and you issues six-month longer so to

Mike Sofia

that mentioned I about. of the concerned completed that as studies are we there So aspects were have several we

eliminate One is, to effect. a that There we we've concern. of in vehicle change the saw study the vehicle decided that that to

sort these findings some histopathology was changing The we issues out with lack hopefully you other us, some the is And of would some vehicle well. and other think there we with have response know of the some correlation of of not the so a with of the dose seen a a as help findings.

that us will the we path to imperative just confirm either we give on refute it's feel these findings. depending study just or this a forward. results And repeat So

these findings. other We help us with to also of inform as number studies a are regard that doing of actually well will any quite

So that to is making going package be of very information we final to in our helpful us think decision. very,

Keay Nakae

that? what the you at recipients in product, or really vehicle And terms was since orally of it to available simply different change there is using looking are

Mike Sofia

mean, I that what used the can was mean I somewhat Yes, vehicle I we really say unusual. is

feel right, eliminate will standard the just that a to to have do, concerns And with vehicle going have is - we more we the we something so to vehicle.

Keay Nakae

ahead, sorry. and go Okay then,

Mark Murray

vehicles only in be humans. not these animal they're So used used just to clear, are are in - studies,

Keay Nakae

Right.

Mike Sofia

have for human If We forward. are solid formulations studies. move to dosage we able

Keay Nakae

XXX you for a was more be on what then can gave them? you the regulatory the package with concern agency's And specific little talks

Mark Murray

issues of this here one is just information the think got Friday. I So we

package we any ongoing issue to the healthy safety asked with trying the has to and in we you a issue and were through. know suggest that moment It's as that study as initiation communicated supports I work there's submitted believe be This longer we term for transparent drug. volunteers not we've the think the really possible the agency with need - we at we've So the the studies. is of what does regulatory

Keay Nakae

ideas you're this the healthy just at able should with think hepatitis will forward look volunteers terms trial, the might conduct and what the that accelerating look to like in for you So to way or we the how of patients that still your with B move wait for point? normal

Mark Murray

possibilities think would right. that I consider, among that's Yes, the we

variety a about that ways think can going of we there's So forward.

a give us You need so that we'll we to - kind just sort clear of these to have little a can you. for answer time through

Keay Nakae

Okay.

Thanks. all. that's So

Operator

FBR. with [Operator Instructions] question Our from next B Mayank comes Mamtani Riley

Your line is now open.

Mayank Mamtani

new RNA I characteristics the in some out like would or me genotype what talk for of that - of - Could seeing some you - about know response. level some expectation maybe read little And a bit baseline question, about the Could outcomes at high that maybe you the on your July talked what the cccDNA dosing you one the expose about XX part then be? of and around exposure around status? second patients XXX. of Just that you're talk about

Mark Murray

Gaston, you want to that? take

Gaston Picchio

Sure.

all we of are So HBV on are AB-XXX naive, we on two have that readout have but DNA cohorts analogue of we most a the them HBV not are of want at decay. they treatment positive, are - nucleoside subjects, a time dosing to them because

of subjects dosed Ten positive in are So being the negative and cohort these are a mix there e-antigen of each two subjects. and e-antigen placebos. are

speak decay are a know is or In expectations surrogate or of cccDNA, as and the RNA, at been antigen. exploring as analysis, out - as other see of comes antigens like HB as impact core-related the HBV capsid antigen. will what to has I as to terms cccDNA to of looking HB cccDNA the for which interim knock we surrogate core-related HBV inhibitors we it on transcription as activity that transcription well able but you expect be cannot as the we activity other down RNA assembly considered in a what we will of with as well

Mayank Mamtani

maybe surface Or be antigen the reserved for And with would around you that to just expectation would be your be that? that, able the study follow-up NUC? response, would to comment, what following

Gaston Picchio

inhibitors dropping the development as of any have absence you in it's or none NUC. HBsAg, whether the our model know shown significant of capsid in mean available currently I presence

what we early are until see we're speculate So comes going us. others that whether would say to July. or data show really be not. open different data But in wait cannot let's We the just I out from the to would really

Mayank Mamtani

disclose or countries? destabilizer. to you the a are housekeeping On cohort country, of the in studies on maybe is on done do I could you generally XXX, go? And there you XXX destabilizer lot that in are and would there what knowing learn expect - could do just develop comment you which in based to how you landscape, latest how intend clarifying, the any Western are agency, Is of two Canada planning mean Asia-Pacific. you that go/no your different being thoughts what at, do develop then that these just And the from on look on parameter XXXX? you if just briefly if the to because And

Mark Murray

address So agency. let me regulatory the

prepared which not exactly with. discuss regulatory we're to we're agency So interacting

can't your XXX developments? you we question do So that. rephrase Could about

Mayank Mamtani

that which thoughts a to population intend it going latest like just be you your to Is it which on latest or develop thoughts there? quadruplet combination, patient is be your triplet, therapy? to - going how a Just,

Mark Murray

So following. but far think would too I a the designed go think surface premature XXX would We block to to would let an here, bit as I little it's say I you expression. develop primarily that's agent antigen

we then consider like establish And then in with into much a to monotherapy go would will So, first and we we do in patients other - seeing into you're compounds as here, rolling combination. and volunteers healthy and will safety patients. know us efficacy safety a it have

Operator

Thank like to call back questions at this to further any remarks. Murray over turn Mark for not you. showing would closing not time. I'm I any the

Mark Murray

all you, updated us Operator. you We'll keep for joining progress. And our on Thank you today. thank Goodbye.

Operator

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

Arbutus Biopharma (ABUS) 6 May 192019 Q1 Earnings call transcript