Earnings call transcript Q2 2023

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Operator

Good day, and thank you for standing by. Welcome to the Arbutus Biopharma Q2 Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Lisa Caperelli. Please go ahead.

Lisa Caperelli

Jeda. you, Thank and XXXX everyone, for Arbutus' joining Good results thank and quarter financial corporate second morning, you update call.

of from Chief corporate Hastings, Medical Officer. Joining Collier, update, Officer; and Mike who the then today the will Dr. Q&A. will Sims Sims, prepared will company's review team Scientific Medical provide executive me Chief David Karen by are Sofia, President data our Chief and Financial at begin review Dr. Executive XXXX followed shared Chief open quarter David will Congree. Hastings Bill Dr. a Officer; Officer; Dr. After Arbutus for Bill financial the with a second recent the results. call we remarks,

Sofia will be available to questions. address

in I'd the our annual time the to to which to some to today our materially, later like from will the and our XX-Q, call a including documents filed that you uncertainties statements cause actual today other most and be forward-looking Form risks Form those during report that begin, statements, XX-K, time quarterly on are of are remind may recent SEC. number results described Before which filed report subject made our we differ with on in of

I'll turn Bill With to that, now the Bill? Collier. over call

Bill Collier

and everyone, you, much and morning, us good today. Thank for Lisa, thank you joining very

to cure has name, you HBV. to functional to refer a AB-XXX, this are to a agents believe develop lead with functionally to potential we to Arbutus therapy will now combination And be which share been will the made at cure always imdusiran, we've therapeutic progress the in that advancing We chronic goal chronic has a that by its excited Hepatitis generic cornerstone today we Our effort. that continued of B. of

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Zealand address to As FDA into made dozed as you we before the with had working application advance AB-XXX recall clinical quickly initiated or get to may concerns. the on the IND New hold possible while work trial decision parallel patients. the To placed any as FDA strategic clinical we for trial in a to AB-XXX a AB-XXX

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HBV. being destabilizer clinical which destabilizer HPV for is specific ongoing. Now functionally our developed generation RNA the of AB-XXX is trial regimen X a potential is to part oral as next our all phase XXX treatment oral RNA cure

this single initial year. second trial ascending portion dose have the the to expect the in We half of data from of

outbreaks. coronavirus molecules small we our assets and and identifying HBV to remain developing antiviral to future new beyond treat committed Now COVID-XX

oral are two Our known coronavirus viral cycle viral across all need are inhibitor as These to both enzymes and MPRO MPRO for highly and SARS protease enzymes conserved designed of address our coronaviruses. therapies known and main strategy for nspXX SARS-CoV-X active that urgent that the also polymerase. not antiviral target the essential COVID-X require is to oral is the potent critical NSPX life circulating boosting. against do air a AB-XXX replication ton for are lead variants and

studies To preclinical identify year. in and this both an Ultimately inhibitor enabling that of an enabling differentiating we're studies as and therapy optimal to be the half currently more IND of MPRO half complete to IND then of from nspXX plans is in in AB-XXX with that year. can into on an nominate which this is we other these the the strategies. consist second we'll regimen and sharing The and inhibitor programs take year impressive believe profile through we end studies inhibitor the updates our this two progress we goal nspXX of second treatment will those

turning this and I'm new XXXX she imdusiran and will crucial role team imdusiran continue over execute call Before company and our medical role to the in CMO of a Karen has effectively her been the development I'd and very happy played Karen first Sims has her on confident review as appointment mission. Arbutus. Karen that the with since the at to our officer has clinical to assumed congratulate chief Dr. like to data Karen that

you over Karen. So to

Karen Sims

to a have like serve that goal. you exploring Thank and approved colleagues compelling in ongoing investigational honored at HBV to cure believe for approach and functional CMO I'm are other trials. pipeline with our few we those to my products I progress through HBV phase XA develop our of combination achieve Arbutus With combination a imdusiran in we respect sound Bill strategic access as to words. a kind and for

system stimulate both with HBV combined induce identify to chronic With goal immune trials Vaccitech's these in be one and imdusiran the to specific to antigen with our imdusiran cure that is patients. functional One immunotherapeutics. can compounds HBV with of further

on imdusiran a chronic to nuke evaluating treatment trial antigen as XA nucleoside is ongoing Hepatitis of efficacy but that finite is functional Hepatitis in patients. most only for HBV. current standard monotherapy tolerability treatment a cure short as impact phase we trial is for therapy. imdusiran intend in assess I'll we assessed chance low achieving of studying for B by B are imdusiran this and chronic this and a trial added very to a decline tolerated Because option poorly courses imdusiran in start administered chronic in when has with the surface course combination with imdusiran nucleotide safety, typically in and is weekly care with considered of patients or that therapy and analog Imdusiran our clinical

one At treatment the at imdusiran. We XX four plus imdusiran enrolled for four easel imdusiran. of recent lead-in XX then of treatment doses imdusiran imdusiran XX weeks preliminary NUC additional completed XX treatment with data weeks Baseline to first all receive additional minus we phase lead-in without XX XX of arms presented [E&G] medical negative phase or patients including therapy or similar congress and were the cohorts. has least that across doses and patients randomized or weeks ongoing the underwent to imdusiran that were characteristics either a plus of of with

with logs small antigen X.XX seen from experienced clinical of been imdusiran a week patients imdusiran. XX-week This XX phase previously imdusiran decline decline surface which includes is mean XX has baseline lead-in sample from surface other X.XX dosing a the The size. promising trials in antigen which baseline. weeks to is was from During of mean at what logs comparable albeit

induced cohort surface around during pending A and has one antigen presented received patients, four and cohort cohort BX data not below both lower antibody around received and in of from in from treatment. imdusiran and imdusiran XX evaluated addition, and to achieved the AX reached BX, for plus induced patients, nuke they the AX, levels weeks limit which surface cohort Three of were In or to sustained treatment of one weeks, one one antigen BX date cohort as had plus These have two XX nuke anti-HBS and treatment in the followed from patients minus cohort discontinued period. quantitation two the patient from for loss been was who be the stop continued trial. levels imdusiran

declines duration with imdusiran considerable although the in change XX imdusiran in treatment, antigen or patients. the weeks baseline weeks, patients. amongst continued baseline to the result imdusiran the from XX surface data of treatment values during addition below variability imdusiran some surface suggest of of treatment antigen the Regardless may These in period remains that induce

any still patients in this in cautious treatment most preliminary set. drawing meaningful conclusions with the are period, we data However, from imdusiran

antigen nuke to declines treatment only patients to are through the assess duration trends in sustained for to surface and continue We antigen of period surface these period follow-up the loss. eager and the imdusiran follow

all with complete standpoint, induced treatment our the to generally patients From NUC induced are other trials, or to most emergent in imdusiran and period imdusiran imdusiran. with as with stop a well events induced treatments. therapy adverse was without imdusiran unrelated imdusiran As assessed tolerated safety that treatment evaluated

X we and data to imdusiran. study ability report. modifications, trial lower needed continue have and our anticipate when These the effectively dose no of meaningful larger a data imdusiran phase or were modifications known events, the serious providing preliminary additional reinforce antigen from profile adverse discontinuations There induced imdusiran's or updates in to induced surface we to discontinuations, imdusiran safety were treatment with consistent confidence

VTP-XXX include approved is that we in trial combination are Octevo one antigen-specific ongoing patients induced with of treat fully original and will under the cancers receive imdusiran we name two have nuke to HPV nivolumab, placebo, or a Vaccitech, Vaccitech's of enroll the regimen. receive XX Vaccitech, XA part the This antigen patients brand the to plus therapy, to is trial to evaluate phase a expanded with conducting number second reduce our PD-X trial treatment inhibitor VTP-XXX, with monoclonal randomized additional before antibody approximately with imdusiran, Recently trial of arms or the induced surface to collaboration placebo. Regarding the are designed enrolled. low-dose to to designed that therapy combination an arm NUC immunotherapeutic,

of the induced that treatment first the June nivolumab immune-mediated reported in VTP-XXX. if dose booster addition assess further of additional reduction dosed. in low-dose the component has antigen this the the of will combination We arm patient We with surface initial first VTP-XXX stimulates treatment of and the been after to imdusiran

surface addition stimulate system immune further cure. antigen can fully will if stimulation functional and of achieve that the and imdusiran ability and to suppress hopeful and of of lower enhance VTP-XXX, the low-dose are turn immune therefore induced first with in dose HPV-specific host combination enhance system the virus the may this we the of nivolumab the we We the

two chronic are we support clinical trials therapeutic success the achieve believe to of As that we have B Bill phase mentioned, progress these Hepatitis made and in compounds by a further combination mission. to we two our requires encouraged

With update. turn call Dave that, for to the brief a Hastings over I'll financial Dave?

David Hastings

Thanks, Karen. everybody. Good morning,

and I've the key mentioned past, in As are our financial metrics cash runway. financial

equivalents investments XX, December cash June cash, million XX, compared as of of to were million approximately XXX as Our approximately and XXX XXXX. XXXX

from During in proceeds received under common the Offering six approximately XX the XXXX, the approximately These XX, [indiscernible] million net June were issuance used million at by Market of ended offset cash Program. cash operations. we months inflows $XX our of shares

We and will into cash expect cash our first Offering fund we the excluding to $XX runway million, Program burn to million XXXX quarter received the to from of from range sufficient proceeds our XXXX. operations our any net between at $XX believe be our Market

and position financial treatment develop closing, and in strong and So coronavirus a to a potential outbreaks. mission future functional COVID-XX HPV advance a cure have for our for we

that, back Bill. to with Bill? the call I'll So turn

Bill Collier

Thank you, Dave.

I'd So everyone just wrap milestones to our for key upcoming to like remind XXXX. of up,

phase clinical First of all, plan this quarter. the AB-XXX with initiate one trial we to

the imdusiran, Secondly, to and plan XXXX. initial VTP-XXX of report report the trial phase AB-XXXXXX second and data clinical we data from in that NUC combining therapy we to half XA expect

both fourthly, AB-XXX plan report portion plan Ascending of XXXX. studies in from for Subject also of Healthy data a our to the to XXXX the one AB-XXX, nspXX commence clinical coronavirus initial the program, IND of enabling IND clinical half second in to We our we trial studies enabling candidate and candidate our and phase Mpro Dose in Single complete for half second nominate

Arbutus our the and look the We've to like hard all work and to advancing significant for dedication. take to milestones data more clinical thank in our I'm we to forward this their sharing details team our on and I'd year. and this opportunity I and the we as that pipeline recognize in readouts mission. place made progress confident employees reach have strategy later deliver right right

session. a are we the ready operator, open So Q&A now call to for

Operator

[Operator session. time, this On we conduct question you. and Please Thank go The first of from answer ahead. Instructions] comes Ding the Dennis will question Jeffries.

Dennis Ding

morning. my question. taking Thanks Hi. for Good

investors B, mean, companies that long a studies this do development From of pharma you how lot for some perspective narrative it's here. picture actually How space take and think Just been one these Thank about you. you're me. should given when a significantly? I around challenging big Hepatitis you very hearing and could change discontinue think and

Bill Collier

you, This And question. is right. Dennis. Thank Bill. yes, Good you're

around, that development J&J, clinical have program and for timelines stopping yes, them. to of some do you've made Some their observations trials some example, lengthy attached the

and there is are companies suppress biotech. that said both DNA, And have, the different we field, I However, as these there will the Ultimately, to of in in functional field reaches strategy developing data HBV that of strategy and system be surface kind small comments, some that this reduce in arenas my still a and antigen immune testing some are the kind am to which think correct trials pharma assets functional several find out this boost three cure. I, in in cure. and big those level combinations of, I scientific confident that we're is

rate. benchmark and try establish including to, cure and and continue to companies will that think that will a other continue I improve ourselves then iterate functional

Dennis Ding

SRNA maybe of again, Roche And as Arbutus is is our platform, years the follow interesting for billion, and, really did the around about the a Dicerna $X.X up, acquire for ago, the one platform. few things

could, your do platform, wondering in is current work there you or, just maybe be something more would near you the how and can you. term that on I'm that leverage So some helpful. color position, Thank cash else given that

Bill Collier

And shown in mean, to think through past money well-capitalized as Yes. I mechanisms. at different , I with Dave the mentioned, we've runway. decent a, been we're the moment we've cash raise that a able

China of did the So some couple [indiscernible] rights being examples. we with monetization, the royalty that deal a of

trials, I relatively the the exec team, quite we that try and on XX:XX we the costs also whole And keep we're of between think sharing Dave in the where of clinical we're and reduces which spend we judicious we and spend what pretty partners, those do trials. with ourselves way cost our and our combination simple cautious some clinical it.

continue BD Mack is you the have to some Mike that with in room maybe that us Beyond here of on to with different want comment and the partners. conversations we

David Hastings

happy that, Bill. I'm do Sure, to Dennis.

as past, the Any certainly expect iterate players, the drive Hepatitis to opportunity all in in time. be field lots field. we to able key There of higher cure the have, all we As with and we've do our as advantage working continue mentioned, the still diligently mentioned with rates we pipeline. have B, that. going functional to take we we're we conversations in players of in There's Bill continued are interest that

thinking opportunities can't and So open We we'll we're about than evolve, obviously conversations progress. as much the potential things for have how always to continue to but that, more those we'll future. they say see

at it that. leave So

Dennis Ding

Thank you.

Operator

moment One please. next question, you. for our Thank

Our comes next from question

go Wainwright. H.C. of Please ahead. [indiscernible]

Unidentified Analyst

early This you've couple very questions. questions you asked tell kind we seen the can a Thomas, investors data us of to at idea .Can everyone. XA at and further XXX phase like? set a set, a phase of Thank is the have also which an Ed. the look when for what you morning, be data later from good encouraging expect for can this will study first, it Perhaps me EASL would looking Hi, XB point year, next expect of we've

Bill Collier

Yes, so good question.

this said run comments, of study have in update an to was in first which bit at little we do delivered as half now study the her EASL. further. to a year, from Karen the we goal let Our And this

and both Karen more sets. agree have, should helpful. for doing small that some many we is updates until think wait maybe not too I I complete We probably meaning data more

And So study. put about in the update when XXXX I this typically we a we'll do we, wait for release going from is think until to think expect guidance when there and what year. we're January further expectations our we I something

Unidentified Analyst

Great.

one-stage I steps include, So well? are will what a assume that to as professional the that

Bill Collier

mean, to trials, determine and have how guided I steps. next with the I always, by to we'll then be says, what we yes. see. as to data as read out wait clinical Well, you that

moving in the XXXX with the Okay. that the then expect, study, I can terms VTP-XXX.[Technical of triple-combination other on, endpoints mentioned to And you measurements, would study. comparable Difficulty] XXX study? our be

Bill Collier

do you that? Karen want to take

Karen Sims

Thanks sure. Yes, the for question.

end us. study some that of the year. alluded, important plan as So, preliminary for report endpoint typically, we've the And before a antigen to we certainly from is surface very data

there's antigen many was these present trials the studies, to certainly clinical would at our induced of around expect surface as data time. of foundation we combination around that that While

as see have certain milestones most of our And by need just of the we're where subjects time, we're that, time what able really that report we of the the Beyond data. at to ready we really are, will trials, we to dictate completeness number sets reaching data share. to with that the

beyond antigen So, the common. truly is certainly that, surface

Unidentified Analyst

one about single Okay. Understood. lately switching ascending And year. question then we this data as gears, expect, dose XXX,

safety data? with processes? But data, should type these be advocacy XXX F-antigen data very what for what the next see important. data some would are step expect type of clearly, So of, to RNA And or specifically we

Karen Sims

well. Yes, address can that as I

AB-XXX, this point in mentioned, as So subjects we've with a phase we healthy with we meaning are trial. clinical that in are one that trial at

year. order sharing patient to to B population, AB-XXX, data you into of mostly the the from, any certainly data pharmacodynamic need to, Hepatitis we we this get alluded which, responses ready as early share to be, So, end safety in would be around wouldn't the of in be by

what be this trial, would just would we sharing. be particular for So, data safety

Unidentified Analyst

rate to our looking Thank so later this you year. taking forward day of for questions and a Great. the Got up it. much

Bill Collier

Thomas. you, Thank

Operator

question, our moment next Thank for you. please. One

Buchanan Our ahead. JMP. question comes go next from Roy Please of

Roy Buchanan

on up Hey, there. clinical Thanks for set first pretty great. getting questions. the taking ex-U.S. the guess I the AB-XXX, one trial quick,

on just nicely give us around I look assume the one, phase guess you exotic. it's like. I going that. done can to what So, it's any details not

look what's with the that. the there, What here And the What And FDA? the path then the I Just with steps are FDA from conversation do? guess? what's next on? you Thanks. do like

Bill Collier

you, Yes. Roy. Thank

trial certain previously, focused So the But comments New in they their concerns, revealed to and hold actually, data. able of and aspects today, clinical were and switch the as on some And and FDA their to clinical pre-clinical Zealand we we letter. provided CTA. predominantly design submit

did from letter clinical we to Importantly, application New attach hold the Zealand. CTA FDA the our in

So, data that, a that in we'll continue chart we're conversations Zealand. ability that encouraged to be path quarter emerges, the study the New able start we'll FDA have forward. as and And this to with

that, study of or? Karen, about anything say design want you Beyond the the to

Karen Sims

No, of and particular, point it's you nothing Roy, chronic in in in the moving terms hepatitis patients. B study initiating as at alluded into, surprising, healthy in this to, subjects then

So, yes, as yes, as excited that that mentioned, path much possible. are we very soon we But, from very looking exotic getting yes, our forward We're forward. standpoint, typical as initiated, this you nothing to study. terribly have a

Roy Buchanan

Okay, expect trial? same you great. would patients include this CHB But in to

Karen Sims

we No, actually are.

similar that So, other umbrella Hepatitis which study, is in we've the an molecule space. small to B it worked studies our is

a trial. initiating B same in So, the trial subjects to similar within design Hepatitis and healthy subjects then moving it on chronic is

Roy Buchanan

mean, update know the you and any I Just collaboration? then on in of a [indiscernible] much, give progress what there? quick for it's timing but I for Thanks. And hands, can any sense probably expect next their that can't one maybe great. on us to Okay, updates the say just

Michael Sofia

diligently question. partners a I'm continue is beyond forward sure Mike. It's process we our more as move slow aware. China, of But with much to we're possible. say that. Yes, work we not program at can. Yes, [indiscernible] There's a as can bit quickly Roy, as we this moving Good you're in that to as as

Roy Buchanan

is point, where like Okay, not remind it's at in can public? at development, that or you this just me

Michael Sofia

Where is in it in China? development

Roy Buchanan

Yes.

Bill Collier

to IMD regulatory submitting still We're Chinese working an authority. towards

Roy Buchanan

Okay, great. That's Thank you. it.

Bill Collier

you, Thank Sure. Roy.

Operator

question. One for moment you. Thank our last

Please go Brian Our of last ahead. from question Skorney Baird. comes

Unidentified Analyst

on for Hey, Brian. good questions. our Thanks for morning. is taking This Charlie

a couple from Just us.

of imdusiran there's data like, it a I given your kind So curious looks in just of combination surface or is one in a the what two and AX was a BX patients, then interpretation and cohorts, rebound. antigen sharp [indiscernible] the that drop bit and with of in

changed did from coronavirus just Thank year in evolved also any has curious that terms kind VTP-XXX kind have be we'd calculus the a with the of, antivirals, the disease you when set of be might of has that And what thinking vaccine table and Secondly, with and you're guys the half. the regards incremental of landscape investment of past how use might synergistic. if for combination kind an given to how expectations the you effect of combination about the for, like you. over

Bill Collier

Thanks. Great. Okay.

Mike, chunk then let's interferon comment a with Maybe go first the up. question for and we'll So this Sophia to Karen across coronavirus. on

Karen Sims

Yes, Bill. sure. Thanks,

back just the interferon data to released. that So was XXX

mentioned subjects will you the So, interferon when data. as the this we reported treatment and remind, earlier, I preliminary data of period completed the that is not we majority this had that very

as the shared, we imdusiran what [indiscernible] encouraged data I then, period doing to, in to still from data by conclusions too supposed but, interferon. of draw performance the exactly were lowering be lead-in doing was think of it's antigen to in the we specific we the set it's early that alluded and initial terms So,

To it's variable. your a point, little

a the scale. S-antigen at in perhaps can log in was Looking there. plots those data I The presented back poster, refer you

than of than less some surface these from five to five to the are than for while less XX. antigen look low changes subjects rather low values, dramatic the or and less that example, at less are then So quantitation those back end, than moving than,

scale, quantization stay the don't undetectable are expect necessarily bottom subjects, where that's antigen limit hit subjects than we there. around. don't window And to necessarily given these less small of lower that, think a surface these is XX primal, actually of change of the very I surprising, someone So follow-up, there that close moving [indiscernible] with

bit they a into, go, may they, have They undetectable direction or settle surface antigen point. may rebound, before little remain whether bounce little of your they whichever to a out bit around

the keep So, at let interferon with these is subjects here interferon patients interferon there them complete let we completed times, therapy. and full watching picture I big follow-up after complete, period, they've them their the monotherapy treatment and period, very data, interesting think the need to are as outcomes

we think to I just providing So share. alluded and need data we as have, to meaningful study patient be be emerges on additional updates we'll to, this data when as the then,

Bill Collier

to And part, other then you want potential coronavirus. about the the talk then second the just and impact of across VTP-XXX go to study in we'll

Karen Sims

very their terms antigen patients by low with studies, of encouraged at in closely their So VTP-XXX alluded study. have XXX results following we'll been XXX the especially end in surface of in sharing so, that to, some as their of the, data data study, terms and in the study, study beginning surface text certainly, with back antigen year. who towards of We've VTP-XXX are, we the declines, to be the the from

a antigen lower in surface to very cure will promote patients. to, that immunomodulatory the subjects where then So hopeful effect will surface additional keeping we're mind, will of have imdusiran in point hopefully study that activities in decline a that additional VTP-XXX ideally those antigen functional similar that and continue in

Bill Collier

Okay. Thanks, Karen.

approach. the So, Mike, on coronavirus

Michael Sofia

Sure.

try I to So, see it.

are the sort when think, lacking out for need which there. you So coronavirus KOLs, at space, talk still when medical a large to the I significant to extent of effective a there's you look therapies,

surge heard, recent diagnosis were recent, and, coronavirus news. a As surge potentially the in here a SARS-CoV-X probably seeing in we you

So obviously the pointing still therapeutics. to need for

always infection only, nspXX think, long patient there do post-exposure a the significantly long and direct how from And could it's been, also with believe we issue to strategy, combination still concern and actinovirals, a therapeutic prophylaxis. idea provide COVID. whole well maybe potent but the our in polymerase inhibitor, that really out have not differentiated In pre- others you on regimen as two impact COVID, that's the of in a treat as I existing this finally, MPro of the of

right effective some could there we reservoir you Still, theories hit hard kind strategy address in of key we've if address value are with long virus can possibly needs of there's also that we space COVID number of And unmet now. program the that you a out important believe a COVID. a with some can the think virus that, very medical met. are there's, of and that in the There we therapeutics, the

Unidentified Analyst

additional so and time color today. I Great. your appreciate Thank that you giving much for

Bill Collier

you. Thank

Operator

will now turn you. to remarks. over management it closing back Thank I for

Bill Collier

I'd the like And as us look your we continued morning. joining a do and We updates providing just and Arbutus year. of appreciate thank right. take All forward to to the you we this moment of to our and assets this support development for everyone interest progress HPV coronavirus

So concludes everybody. that our call. Operator, thank you,

Operator

in This program. Thank conclude you. does Thank today's participation you the for your conference.

disconnect. now You may

Arbutus Biopharma (ABUS) 3 Aug 232023 Q2 Earnings call transcript