ABUS - Earnings call transcript Q3 2021 | Arbutus Biopharma Corporation

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Arbutus Biopharma Corporation 2021 Third Quarter Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speakers' presentation, there will be a question-and-answer session [Operator Instructions]. Please be advised that today's conference is being recorded [Operator Instructions]. I would now like to hand the conference over to Lisa Caperelli, Vice President or Investor Relations. ahead. go Please

Lisa Caperelli

Good Arbutus's Angi. and you thank Thank quarter morning, financial joining third call. and for you, everyone business update

within today Sofia, Gaston financial efforts the recent developments Chief up then Picchio, we Scientific executive research review Arbutus questions PDL-X Development our Officer; our inhibitor. and of be will of on update the for Dave from Bill an remarks, Hastings who oral Mike Bill by provide Chief Chief followed me will related Picchio Sofia, Dr. at Hastings, the available Dr. Dave provide President that Officer; call opening Chief clinical will Gaston open will team company's results. to Officer; accomplishments time. Financial review Officer. Q&A. will development and and Collier, Mike a address Executive third quarter Joining are, the After clinical begin with

we'd made cause a begin, risk we results subject like to uncertainties some number you call that to statements, actual are forward-looking may that the reports Form Before are and materially, during and the which Report remind on to Bill. on statements recent those our described Annual I'll differ our quarterly SEC report other of the in to most XX-K, of from the call over including our filed periodic time-to-time. turn with XX-Q now Bill? today

Bill Collier

a we've of your chronic year We're intend used and really update issued system. boost different the Lisa oral where of DNA; reduce portfolio this to; our for our in achieved progress and oral a to We results two, business financial B. us appreciate with to in Biopharma. program our which a interest patients host surface inhibitor quarter approach action is pronged IND towards commenced which XXX, immune intended And press with RNAi and you, recently HBV At Thank the PDL-X thank cure HBV XXX combination and this highlights when studies. hepatitis develop taking three, in one, goal, enabling everybody moment, third proprietary you three that's therapeutic Arbutus significant mechanisms living products with antigen; today. that we release, functional for this we a suppress accomplish capsid joining

So walking I'd lead start like surface we've antigen starting by our reducing made the through this to compound advancements therapeutic. RNAi clinical XXX, with with the with approach

our all including As you antigen, know, and reduce XXX trial. B Phase ongoing antigens, in clinical hepatitis specifically is hepatitis viral we're surface to designed Xa/Xb activity this B seeing

fact, to log provides which B that date shown is antigen, HBV. chronic hep consistently over has In with data in AB-XXX a reduction time X.X sustained patients surface mean in

show favorable XXX in significant addition, specific have increased safety some In HBV an to rationale combination XXX shown a to S-antigen, profile. and therapy for addition further drops reporting to in responses, immune immunomodulatory agent. which Also continues our tolerability include patients supports

XXX. last weeks eight inform which or to units to subjects clinically show international XXX will we was and data in presentation. of things, clinical observed Now could to at that We'll following levels XX that with included relevant up or also dosing weeks. suppression with of that report a remains next poster will intervals, this show milligram in sustained doses ML, repeat surface which well cohorts S-antigen XXX AASLD, today repeat antigen generally of in between we'll declines patients dose XXX differences mean therapies, dosing in milligram among show presentation, XX additional from trial is dosing tolerated. when that safe maintained four, threshold stop And And week which is additional some robust we no in meaningful XX other or per the every XX a below

to we be with future that a combination more we agent cornerstone the potential regimens. the As in data to HBV to XXX, drug continue continue has believe involve

XXX evaluate our of foundation agents agents the to with for to future is set action strategy investigational trials. in complementary own other combination Our with novel mechanisms approved and or with

advancing Now in we've XXX made in great clinical progress trial development.

and data first clinical Xa Phase of every own X to short patients in XX initiated further the ongoing with we updates standard infection. program, the patient in we And on HBV with of quarter, dosed currently care, therapy the XXX trial nucleoside trials. ongoing trial and on Xa HBV process evaluated being new evaluate dose courses an schedule This Assembly triple our sites, milligrams other in trial proof label chronic and collaboration and XX this patients standpoint, then in analog. opening when a XXX eight the this we from for peg-interferon from of open lead our of We're in with Based combination randomized core screening and clinical is concept selected and inhibitor Phase as trial combination dosing weeks provide Phase will Biosciences appropriate.

is Assembly to initiate and data with Phase clinical activities Vaccitech XXXX. Also Xa separate trial Antios to see this trials and conducting expecting in are ongoing.

now XXXX. that will to triple trial the XXX. to combination the second Antios and trials the the in capsid analog to the inhibitor agent. XXX proprietary that Antios DNA our will arm generation commence of move oral Vaccitech of are that HBV Vaccitech trial this designed next suppress our initiate I'd arm to in and clinical will We with include clinical on approach Both XXX the and like evaluate either or nucleoside early quarter expect that's

cells on with year. the to Preclinical by suggests the potential our proprietary assembly may replication data our Xa/Xb and have XXX previous this out track trial clinical data of enhanced resistance Now from the compounds. volunteers support profile is of healthy viral these to HBV initiation that patients Phase report data a XXX and X for own is in combination an by the increased efficacy clinical end And specifically in compared trial Preliminary completely may inhibitors. Phase capsids. viral designed of functional preventing to capsid infected block

oral The compound. to program prepared PDL-X over third call the the I'll boost approach recently arm Sofia which IND with remarks, my turn our we to details we more studies. about this do for to system, after exciting of which enabling Mike our hope is And immune provide commenced to

Now on research ultimately, destabilizer efforts look we providing convenient and combination oral to have achieve in a RNA B strive with or hepatitis XXXX. lead we're to oral our And an to optimization program patients. forward updates our for progressing treatment that, efforts

our treat coronavirus progress. future COVID-XX our HBV, In molecules addition to internal antiviral outbreaks to small research to and to efforts make new in identify program continues

and the impact of pandemic, our in relentless advancement our the see, efforts the despite programs address cure So Arbutus to has coronaviruses. to value. meet corporate team B and the for patients of their increase at and can to hepatitis challenging and finding the very as the research grateful you goals, commitment treatment shareholder really I of team's of continue a been to clinical to for dedication needs for am the

I'll turn over program. Mike? update call for the with to an Sofia Mike on So that, our PDL-X

Mike Sofia

Thanks, Bill, and morning, good everybody.

system. and chronic a are to approach or for is we to focused develop cure mentioned, Bill a the three to boost key that immune B reawaken on hepatitis pronged As

HBV. Given of potentially that important therapy this, an oral PDL-X have could IND be studies treatment inhibitor part combination for we enabling nominated of a and for the

target PDL-X of checkpoint immune start established effective believe bio-control the that in access overview we or believed HBV cells. in viable highly immune PD-X, of the immune functional chronically the It is T of that It the Let is in with an for a specific well me the functional is HBV. is why tolerize also term required of reawakening context virus individuals HBV infected cure. infected to cells setting are the long recognition HBV for system

studies immune direct and agents PDL-X Ex reduced that is PDL-X studies that this been for shown expression therapies. to has PD-X, strategy system. has blockade the It immune their access to preclinical tolerance vivo hopefully with tolerance. After as of implicated S-antigen cell Immune has HBV improved PD-X, T liver where initial agents pathogen one PDL-X functionally PDL-X is checkpoints, in immune clearance reawaken signaling has load. hepatitis correlates for model by cancer using combination patient of plays are specific chronically response. T in foreign increased be that approach and protein-protein T PD-X in blockade. other cells frequency be of PD-X response PD-X, HBV in the important responses hypothesized infected HBV has during and block been B and immune cell resulting several a to sustained T HBV tolerance. tolerance, and pathway during PDL-X defective PD-X as immune Support and acting to activations. antiviral and the pathogens. long T and to in shown in this specific further upregulation In the induction approach However, cells can access to suppression. and specific Similarly immune to to chronic led the PDL-X S-antigen, levels, specific in shown such It specific upregulated of a samples term infection. HBV the upregulated interaction reduce checkpoint in to viral HBV reawaken immune the It cell immune antigen, and and play been T maintenance having assigning cells viral the PD-X, with linked specific HPV the that new has HBV observed Therefore, important in DNA role down the S-antigen greatly tolerizing specific on established development immune expressed specific to combine both response was we with and cells of immune specific HBV become regulation T liver blood level our has PD-X, role role a HBV HBV been been to break critical the with cells. PDL-X that human leads well from in checkpoint animal demonstrated patients and the biology, blood been that

and class restoration, inhibitors, small selectivity allow for and lead inhibitors therapies. molecule checkpoint oral efficacy, on controlled believe nominate Our antibody safety. enable we immune dosing this identified PDL-X class checkpoint have candidate in a efforts vivo a we seen research systemic oral with checkpoint potency, of safety mitigate molecule based in will vitro blockade, of issues that small From

based both financial and functional PDL-X now to antibodies. provide work, XX me of new some molecule a cell primary enabling we've activity excited on possesses The samples this and anti-tumor PDL-X Based preclinical cure to for systems in pharmacokinetic with functional mouse From identify of HBV. accessible compounds. favorable we vitro. to to potency. an safety combination vivo tolerability external or key a on animal efficacy lead in for known activation more filtered and finding ECXX bind a IND to progressible Dave? agent advances PDL-X hepatitis for With vitro brief in a and in pharmacology cell by tumor was this in whole lead studies. I'll profile human less standpoint, that Hastings in and PDL-X vitro which more showed are studies. chronic I'm each inhibitor preclinical models Let displayed to compound, now in bioassay in an This research The model acceptable Dave respiration binding efficacy intrinsic T B compound this role parameters. Starting candidate small these to T with vitro. target arm. a activity to minimal vitro is a detail in in turn a patient activity, safety activity believe play the in in in cell with equivalent has in all vivo approach agent respect selectively this The little due made than our update. profile agent preclinical respiration has that safety

Dave Hastings

Thanks, good everybody. Mike morning, and

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

million of investments XXXX. Our cash, equivalents compares cash as December XX, to and $XXX.X million September of that as of $XXX.X XX, XXXX

proceeds shares $XX.X by ATM operations million, common nine under months ended for of $XX.X from net the XX, our used was issuance of from which cash was Our September million program. offset the XXXX

we For the turn quarter the expect used to to of Bill. we XXXX. fund With back aggregate now $XX to will current operations all that, range million sufficient expect to cash to from into XXXX, Bill? runway call I $XX of and therefore, second our our be cash million

Bill Collier

well. and so thanks Mike Dave Yes, much to as you

is session. now lines up maybe operator, Q&A the So to open the the time for

Operator

JMP Instructions] from Buchanan of first [Operator question Your the comes line Roy Securities. with

Roy Buchanan

support end I at I start of the this the think Phase want Phase AB-XXX. X. Bill, mentioned coming year, to you start you can the X combo of on results, think, the

a like? you an Phase X to more to or initial of proprietary a go look compounds? if would maybe would Would straight dose start can little that kind only finding, that what Just XXX would wondering your plus Just with combination give you a you look with details new what do like. triple

Bill Collier

for aim our actually some quite time that combination. own have internal to always I our think been saying we've been it's

mind, look XXX, And new share on kind of at our trial. XXX makes So details combination logically, sense in we’ll evolves. year and next a more as that to it clearly

I we're those the year. XXX important on let of point results to think everyone the end that today by is deliver track to the know

Roy Buchanan

SBA, can say tell or it's but sure, know I the not to going But I side you what are. names And not probably and you me unique says maybe confirm the a you then think on if another that the those XXX a it's try to not what is. question. guys HAP chemistry you’re can I'm chemistry, want,

could that? is that So possible you confirm

Mike Sofia

I that. Yes, those. of confirm neither can It's

Roy Buchanan

were And kind of guys I question, any a want that your say, let's is I is that around I there thinking reason you But priced, it be then developed? cure early, cure. similarly to that. C mean, about hepatitis a had potential really for maybe a functional wouldn't get pricing it's functional it's to us the early. thoughts Just found give if cures

Bill Collier

cure viral and obviously to so much maybe one so I it’s benchmarks said a say. ultimately existing diseases. too price our for whatever umbrella, I to you your I get of specifics. economics other will think third in mentioned, very think with set to a you've Because worry partner, mean, I But And tad I've to that without as functional or early have own irrelevant our on beyond all going of difficult proprietary got pricing to strategies, here. and it into the you as add across therapy, that role though question a the us kind there's the components to benchmarks of party be allows about is or forth. of

So one own your not to of our the find combo to underpinnings internal question. is unrelated strategy our of

Operator

Skorney line Brian with comes question the next Your from of Baird.

Luke Herrmann

were This next Herrmann We upcoming can just is Luke on the J&J talk at AASLD data week. you hoping refund presenting for about little Brian. that a maybe is

of response. criteria the think has field stopping you do for XX sufficient What and weeks, In the terms it of implications that's the a do given kinetics timeframe? of think you the

Bill Collier

comments for me make Let maybe a then comments. couple of additional any and Gaston available can be

many still I see have of competitor until think points. on I Johnson other abstract just we've the it full to us the hear maybe I say. little people, presentation data couple to seen and a additional think be for what comment have add as may would we early

RNAi includes and a include therapeutic, this [ref] around we've to immunotherapy. inhibitor therapeutic, that is pronged which an about, strategy The development and a an the you the data nuke. capsid referred inhibitor just Our three approach would talked day RNAi capsid

that our immunotherapy the further is in it continued be so supports this And an show to strategy treatment that needed regimen improvement. may

And in XXX is the on and previous preclinical the at this our action. appears that inhibitors. from capsid I shown that relevant other need it point capsid the in the that capsid inhibitor, has study heard contribution the is stage second may we've have second insufficient, J&J to you've calls, and potency of XXX understand doses, But differentiated as think more. mechanism been therapeutically early unique make you and we to of engages data, clearly inhibitor increased that

have the next think look that just and And So the what help, some to the have there I you and questions just of wait is well. question we I presentation some to will beyond that, hear we week hopefully say think company really for capsid. capsid when from but not your differences as that

Gaston, that, additional to with make? want So you any comments

Gaston Picchio

in covered was regards stopping think referenced very it rule, you the I this In question. think well. I to

composite they approach one which is reasonable. just it's the think stopping endpoint I rules, to use, that

that there in used may being the different think be ones field. I are

the their to criteria based when So we to still they're after patients look see in presentation. forward happens what

Operator

follow-up Securities. have question do the with We a line Roy JMP of Buchanan from

Roy Buchanan

So the then? any last -- was one, it guess guys you prospectus for with ATM Have one October the think Dave. the easy Xth since since let's I the update was start I used one. the use

Dave Hastings

we'll everybody early I mean, update update fourth during in Roy. our that, quarter March on

So we'll think that I on at comment that point.

Roy Buchanan

And Europe if to you guys go are there in response then but question. you pricing like partner? possible. Are What retain a will China. complicated you sounds you regions retain more again, But likely as to going your couple ones Bill, as much and thinking of terms or like want also partnering? It you're early maybe -- and ownership presumably ownership to you thinking to the

Bill Collier

all trying combination think Arbutus I components pricing. us umbrella, what mean, is articulate if underneath to more of we our individual a I was on I flexibility the have of it gives in

of we or my feel to the and be is people access think question around is going clearly around remain lots this as way for is different stage, to partnership markets meet we going the shareholders to the medicine different regular enable different say Again, the we for good approaches. good now that market our right how would access patients early to contact refer head and of BDs is us which I to world. be then a the of approach I open that needs and do that's strategic the general you to with that at And if well. what

have hypothetical about answer not I'm components and be geographies. So you to remain umbrella, -- question. your individual for we a potentially Arbutus clearly the giving of we the and the that, may talked cure not within that But it different partner

Roy Buchanan

Phase regulatory going one, guys envision initial approvals the to going you XXX with approvals and you or go approved for nuke path. guess? that be do do potentially then X but And combinations? on monotherapy the looking I you the a like. What envision another playing Is to out are early as How

Bill Collier

on studies. really these what So different proof-of-concept right four now, are we're Phase Xa focused

combinations think hypothesis it's with reduce, four really boost, important do Xa and of Phase this. we're I out so it our you underline testing agents And strategy that When suppress different these and that can to in to clearly comes studies. of

performs as move as XXX you add? see X So these proof-of-concept I would combinations, think think, I studies can to I Phase and Xb, Phase to for into like we great determine that to these question, accordingly. agent But the But combination out then again, forward Gaston, set Roy. all to how cornerstone we've to a of do functional want you to really different are a move cure. looking get in

Gaston Picchio

Thank no. No, you.

I think well. it you covered

Operator

next the Arce comes & Wainwright from of with Your line question Ed H.C. Company.

Ed Arce

for Phase XXX, that could expecting dimer-dimer the that what the particular you you that anything mentioned, support and data, you're would, expect? one end wondered help talk the unique coming XXX, up me. utilizes allow of study Just you're if binding as within the Wondering looking combination you your for X if Phase profile little to year X On that a in at from obviously, studies. protein there's site really initial bit differential you mentioned, your here and together interface. next presumably data about put on the inhibitor I data given could this is as capsid year novel a a core

Bill Collier

data? to relates So Mike? maybe then as clinical Mike the Sofia Gaston first and it

Mike Sofia

you're engage the many agent we but has generation what the on is, second high intrinsic right, because as we earlier also potency from significantly to mechanism. it the the of commented it ability itself call, agents generation differentiates times, our XXX So next and

they believe retrenchment think the at first therapeutically So And is with of relevant they but a activity mechanism agents that. a sufficiently the the that first couldn't of I in just dose. the the clinic addition [poor] we be could generation one give problems cccDNA, the relevant in at the was that will of doses second less that than engage mechanism activity

as mechanism. second that engage reduction against going mechanism, we DNA, do fairly response clearly, when on have which we're RNA is well primary robust as the to believe So

the think I second related And mechanism role in space. data. important we're that capsid looking looking to at HBV looking So an other biomarkers, in forward fact, that biomarkers, is at playing

exposure. we're we a that So very about molecule have as excited liver

data So I we're to see translates. think, the how see anxious and overall, this

Ed Arce

there. which depth that's And there's going -- then a bit of I both a activity a patients of able enroll but resistant think generation we basically variants, this are wildcard out that we if control little to reach may be speed the [indiscernible] and compound know the enrolling We're also of RNA variants. we cannot that that of may DNA something selectively able by primarily of out chance the resistance And interrogate, activity some not to variants is we're and there at we those, resistant we to HBV recipient against but with be bit, looking be little really. expression. that that's to new

Operator

Your from Keay Chardan. Nakae with of a next question comes line

Keay Nakae

Mike Some on PD-X. questions for the

oral First, checkpoint you've on Mike, point your pre-planned can published to you data any inhibitor? us that

Mike Sofia

Well, that let's of data any can nominated. unique the a communication we at works we how to molecule specific very haven't an point relative the major say, molecule on that the looking I antibody. mechanism paper published published small to, you we preclinical

you, have recently end of that earlier that it out. effect. generation used, paper we toward was last the I we think, that, agent, tumor also in And to that sort that does molecule year small can show was that, the I of published -- point an anti we the came So middle which

that So readily we in most we've anti model. model at subsequently an HBV available because tumor that developed model model, an were using the animal we're now at time, was molecules looking and the

these we've that with both and competitively can very have mechanistically and do small you very -- that characteristics, work function, So and unique molecules see that antibodies.

Keay Nakae

get you with to back circle I'll that.

therapies to how high moving then of safety? of you you guess terms look then safety about to safety what and combo antibody there on an the I move on there. But you be to in Again, profile. kind relative for alert it, just again think as into the would both so should advantages have And some

Mike Sofia

know you small the sort events potential some And an why as Well, adverse reason checkpoint and that. is concept the of associated we that that we was do have the that solution wanted events does blockade to antibody use circumvent antibody of And you oncology very in with the things one setting based concept. to believe a adverse the have molecule the occurring. long was is to this really going we a action with be

dose washout get remove sort you acts just get onboard can dose we because actually for weeks take of Plus it what PK issue enough can as weeks. there's we need the So and one essentially advantage and any With relationships a and we molecule, small drug PKPD event. to of of if response.

So that's one thing.

other is have look as liver drugs have high so we we have liver is The we that at do and targeting character. centric always thing

typical much reduced antibody. to have with having activation allows a we exposure that molecules see that sort and these systemic immune systemic So us therefore target versus of HBV

we those I will molecules, of characteristics safety these profile. think support So believe better a

in clinic that see think I excited of profile the molecules to out we're the the but overall about potential. Now these and we're pretty

Keay Nakae

going certainly, Mike, was oral that, compound. with where destabilizer is guess tox some I I'm there issues, with the

be a your eventual in So we again, we how point might about? concerned should combining any think we about where you're solution, toxic synergistic get these issue when oral to

Mike Sofia

drug-drug in our have all studies by work very don't molecules and these of non-clinical different entities pre-clinical ensuring themselves, We each clearly any that obviously, we They interaction have mechanism issues action. of in so careful are chemical different characteristics. different that. associated with are they'll So

predict from going do get some models happen can't exactly the but on when antagonistic studies to we of combination of standpoints. do sense we we agonist to read We or studies Now combination vivo. combination clinically safety preclinical compatibility assess in these what's the in molecules do

think the will have really of I of clinic these to doing clinical the setting sense the things to be a perform [total] going all do needs in perform the confidence we're and is theory. So one safely. the molecules that that to But

Operator

Jefferies. Kelechi line from question Your with of next the comes Chikere

Kelechi Chikere

what these you question going from appropriate a as single for is little This discuss me component. on to with many added was thinks guess stopping for of should be a what more be? and guess demonstrated should combination could for I Can you what the [HBV] studies? on I combination criteria I And here. to XXX, your to bit immune stopping could to ability responses, as be new -- that therapies. [stopping] of be the specific criteria you've the a about that related be the that opine criteria increase potentially component

Bill Collier

going over I'm one that hand to Gaston. to

Gaston Picchio

S-antigen criteria. far I I say, will I with think of example, endpoints. no is come It a criteria. was ALT up and to as There doesn't I plus, think factor, unified single, example, stopping different different trying [composite] criteria groups as as stopping criteria. usually are include concentration know, can just stopping S-antigen for And for HBV DNA

the criteria see which if example, for there once a one all know to and they And yet what the one would don't one be think that if data. whether chooses therapy. and we're relapse, than less but XXX but there's relapse conclude, is the XX XXX, stopping patients is I not we that there points that of higher composite part happens XX appropriate and can obviously, see as better then we have most we we stop XX chooses after will

in think, no think even I stop be of of lack So occasions, think [indiscernible] used, who especially number different repeated But for as a a we use for therapies, therapy no have be, There's straight things. standard term, will have try on with trial to Asia. a to better how people care and I it XXX example, today error, I in been is criteria many consensus we'll patients things. of different years we’ll nuke on for

be five would what where Now The we make be were you're measure observe criteria. quickly able we reconstitution measured challenge is ongoing that cannot to decision. there right immune incorporate in our to a patients out something study. really XXX-XXX It’s of about three that

and As standardized load a you run intensive, they the know, way. be mononuclear peripheral require these and T cell of cannot cells collection viral way on assays blood are just very automated like labor

readily I So good to of interfering hope we I cell to in line surrogate including the challenge T find of mind idea. of criteria. reconstitution, and know, clinical rapidly I with comes the standardized can a that be maybe more can indicators be immune that would perhaps gamma HBV as part [Indiscernible] cell some think cell something soluble cytokines, of around is [Indiscernible] the way. in in T very a envision you T that And measurement

Operator

floor gentlemen, Ladies like I closing additional the or the now reached for would time remarks. we’ve turn back allotted and to to questions. for any management

Bill Collier

and you, We everyone company. secure And to Angi, really up in you, continued appreciate date to thank morning to the thank you joining we your move and to forward look forward this for the Well, you interest as obviously keeping us of trial questions. your achievement those the shared we've of data data the announcement include Phase year. Xa/Xb that And XXXPhase the you from our the additional initial from Xa/Xb XXX obviously and at clinical with milestones of end today. trial by AASLD the continue

in operator, you. So we to forward our concludes touch. And that call. Thank look being

Operator

call. for today's Thank in conference participating you

at You may lines time. disconnect now this your

Arbutus Biopharma (ABUS) 4 Nov 212021 Q3 Earnings call transcript