ABUS - Earnings call 4 2023 | Arbutus Biopharma Corporation

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Operator

Good day, and thank you for standing by. Welcome to the Arbutus Biopharma Fourth Quarter and Year-end 2023 Financial Results and Corporate Update 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 first speaker today, Lisa Caperelli, VP of Investor Relations. Please go ahead.

Lisa Caperelli

Thank you, Stephen. thank Financial joining Call. Results and and Fourth everyone, XXXX Year-End and morning, you Arbutus' for Quarter Good Corporate Update

me Sofia, Executive review a Arbutus the Interim our the provide corporate fourth Hastings, ongoing Q&A. begin Chief Chief programs. today with the are and David who Officer. Joining update, McElhaugh, followed XXXX then Dr. Mike of by call Officer; Dave Mike our we year-end will Mike a and Medical executive Officer; President will Scientific review Dr. Officer; team After prepared Chief Financial Karen Chief Sims, and from company's Karen, quarter will for results. will clinical financial remarks, McElhaugh open

remind including described with on differ made the to our forward-looking the to filed may Mike? some the Before annual I'll actual to number today to and SEC. With documents from are that I'd you during call report which call XX-K risks we that, Form statements are Mike subject of now those in cause results other statements, a like McElhaugh. to of time the uncertainties that turn and materially time our begin, over in our

Michael McElhaugh

you, today. Thank for for to choices morning, made thank several strategic success. joining and In you Good Lisa. everyone, us important we Arbutus XXXX, best long-term position

and HBV, President of extended which Interim focus on our into resources appointment our we XXXX, January quarter streamlining also the CEO. runway to first addition announced In and as cash my

to leverage scientific, to my move millions forward. our I'm functional companies this colleagues plan of and infected honored have transactional to opportunity lead commercial my Arbutus disease and cure excited of mission and I virus. role new with with chronically develop in am hepatitis antiviral experience to co-founder a people a B Arbutus, continue extensive for the As infectious strategic, for my to to

create HBV, There assets to AB-XXX, value functional stakeholders. X% position to RNAi success finite development and clinical and Arbutus that our increase remain for cure as imdusiran, need inhibitor. more fewer committed cure and the our for and further checkpoint advancing in nucs our efficacious patients We treatments rates including long-term continued oral proprietary focus with improve In is our XXXX, remains currently therapeutic, achieve all our outcomes or than PD-LX HBV approved of currently interferon. functional for a of

B large a cure Our at to hepatitis virus goal need. in for functional is a unmet that XX% medical develop this address to least treatment results chronic patients rate

a is inhibit combination burden the that likely most and antigen virus lower the a will HBV response. complex require of viral immune that boost viral compounds replication,

imdusiran as We that three-pronged our combination AB-XXX combination the with multiple approach is strategy Phase evaluating are a therapy. imdusiran, imdusiran is optimal clinical a a executing trial clinical goal. that help the design ultimate cornerstone. and our in insights of as cornerstone efficacy, includes of Phase goal with functionally with imdusiran nuc to dosing safety the valuable IIa cure gaining includes A therapy to combination trials said, with other inform a and That on on HBV IIb current our in agents

cure the with levels would trials surface antigen. we X in undetectable undetectable Phase with from Phase potentially functional to clinical reporting IIa ongoing certainly IIa the antigen important an of hepatitis be imdusiran's current trials anticipate Throughout role our achieving data either XXXX, potential patients of our clinical for patients. including B in see Achieving validation imdusiran, surface

our clinical This year, immunomodulator. trial with anticipate of we portion our subject Ia/Ib also healthy our data AB-XXX, from Phase

importantly, and in and engagement population. this report preliminary receptor target to occupancy safety expect We preliminary data

quickly call. ongoing as the to about to property is the potential words say our response, to the to brief AB-XXX combination move out few like the host immune goal clinic section for our a prepare a intellectual possible of AB-XXX of as efforts imdusiran. I'd with litigation it possible boost this closing With through before

each scientists they subject pride resources our place property develop that important in our great construction protect litigation intellectual is in and effort, for this continue judge also and the as hearing lawsuits these the time, technology patents. order great to the was takes date year. The Moderna took XX construction expert take of within February his in step Markman ongoing the disputed the days include a This against is known delivery which next of which It Pfizer/BioNTech. An for steps our including we We to the and All will party's heard property, of of X testimony intellectual Moderna issue X. of from reasons defend expense. and hearing, of the claims February LNP interpretation the where court the the of claim on depositions. hearing, anticipate

trial court XXXX, for this That the the to addition, subject availability. set date is court's April XX, the has as In date case.

lawsuit we it that both legal the the yet set. say. Moderna later. is that mind respect in Pfizer/BioNTech provide for but the date sensitivities, for A in is was I only construction update and will the we're filed to please given not With what behind Moderna hearing has lawsuit, limited the claim but the updates ongoing can When case that can the Pfizer able, been keep provide is lawsuit we lawsuits, on as

to an the Karen progress turn now our over call Karen? across continued to are making on provide we Sims the pipeline. update I'll

Karen Sims

Thanks, Mike, everyone. morning, and good

trials throughout Phase trial hepatitis we expect Phase AB-XXX, Ia/Ib and currently this X of B clinical these are X IIa trials from to X all report data with We trials with conducting X and our clinical with imdusiran year. clinical assets,

with anti-PD-LX and monoclonal We IIa first also this Phase of antibody, plan half year. approved third initiate to a clinical trial in an durvalumab, the imdusiran

that We will on trial upon share more details initiation.

to on treatment regimen the As safety trial. and immune identify information into advance multiple and gain of clinical viral these Mike burden a stated, as combination clinical the reduces imdusiran host the to IIa trials efficacy a combination a purpose and to that later-stage boosts of cornerstone therapy response Phase are

clinical to trial effectively show antigen. surface is confidence evaluating imdusiran and June ongoing and number continues with our data XX reinforce lower declines Last interferon ability surface imdusiran's EASL, data B. At our antigen. Phase interferon weeks therapy in AB-XXX-XXX to in had combination we at we that of patients may that time, on small nuc received a least in reported with that at reported patients chronic imdusiran hepatitis interferon in IIa of contribute additional that preliminary to plus

data, year, end could data for this safety we antigens study all announce in interferon will of undetectable potentially In we surface the antigen. from patients, first that some to subjects plan half treatment report XX surface of which include have When achieved changes we baseline. these and

functional As a of reminder, undetectable component antigen key cure. is a surface

conducting are host imdusiran, Phase virus. that we are testing Biotherapeutics, antigen-specific lower collaboration system combination immune known Barinthus' trial, whether and antigen clinical suppress to stimulate IIa the Through surface is Barinthus AB-XXX-XXX nuc can immunotherapeutic, trial therapy the formerly and fully the of a Vaccitech. HBV in as clinical with we this VTP-XXX,

received we treatment were of reduced imdusiran Late antigen the VTP-XXX these patients data, In reported that sustained and preliminary combination all reported we early last at data and with as received AASLD, levels that imdusiran had patients treatment placebo. who that VTP-XXX. year and several included surface

this therapy. from half placebo first include year, or the change would in patients report VTP-XXX surface expect data, safety In imdusiran, antigen for nuc all and we which to received XX of and end-of-treatment baseline that

of the response. the is in nivolumab patients addition dose to AB-XXX-XXX treatment from that portion further We amendment the continuing the believe in monoclonal are immune anti-PD-X nivolumab may this trial data antibody of the explores We low to host Preliminary year. this a half to the the of dose combination second trial expected the boost regimen. of

also may the in surface noted to AB-XXX-XXX see is achieving patients, potential cure. to undetectable As some antigen for prerequisite have the trial, a which functional we

believe with IIa our proprietary that imdusiran with T-cell trials We combination to a pathway evaluating and checkpoint we inhibitor. in an immune develop the important oral While AB-XXX, intend HBV-specific in therapy and our tolerance combination clinical activation. imdusiran plays role immunomodulators, immune PD-LX checkpoint Phase in are

clinical our patients pharmacokinetics trial doses designed consists pharmacodynamics and B. culminating to clinical multiple tolerability, of the and This subjects double-blind, ongoing with X hepatitis parts, placebo-controlled ascending This trial in safety, Phase trial Ia/Ib investigate and is AB-XXX. is third of in randomized, single doses AB-XXX-XXX. trial, healthy multiple with Our starting with chronic

multiple in evaluating moving the trial, includes We AB-XXX healthy of part AB-XXX ascending which are now doses of second this into subjects.

receptor preliminary the safety year, of data half will preliminary this target we and data trial in engagement to addition from healthy In of data. anticipate include which portion first occupancy subject this reporting the

functional believe our that, we on Dave? advance both goal to are brief to cure B our clinical the developing driving continue update. to for of company. With and turn imdusiran we of over for well for development value AB-XXX, and a Dave financial call hepatitis a Hastings the positioned deliver compounds I'll As

David Hastings

cash Karen, good compared $XXX to XX, ended and December Thanks, cash, of XXXX morning, equivalents as and of $XXX with everybody. million investments approximately approximately We million XXXX.

burn offering common ended net focus under XXXX, at-the-market December We efforts year program. Therefore, received our we our million to significant in $XX XX, research our net These as burn our $XX inflows the of the by used program. cash $XX.X a offering excluding of reduction issuance HBV. our expect XXXX from range cash to received from cash operations. at-the-market offset During proceeds between shares cash any were we anticipate XXXX to proceeds of in we XXXX million million, from pipeline on million $XX.X and

runway operations sufficient XXXX. quarter we is Importantly, cash the to our of our first believe fund into

mission, functional position chronic our In HBV the for financial developing Mike? I'll closing, to to committed strong assets turn have that, provide call a we back and Mike. to a to our remain HBV. With advance cure we

Michael McElhaugh

Thanks, Dave.

with data As from have trials imdusiran X IIa Phase Ia/Ib trial end-of-treatment our mentioned and data expected preliminary clinical year with with I from a AB-XXX. we our clinical earlier, Phase data-rich

ready We for also Q&A. the a we're clinical with trial open anticipate durvalumab. Operator, initiating and now to Phase IIa imdusiran call third

Operator

Jefferies. line First from Instructions] question comes [Operator the Dennis of Ding,

Yuchen Ding

claim you patent need X be question what Can rule If I for expect and judge construction disputed to around the can is litigation. for just enough. what a order in or good to the outcome? of do a frame X at ask us And you claim help favor you all good just to upcoming perhaps the

Michael McElhaugh

handle Dave, do question? that to want you

David Hastings

sure. a careful be judge's mean within we know, comment I obviously, itself, you this hearing about about ruling and We say actual Yes, days really with sort have we of we're forward we February look we want We actually appreciate very look, publicly little think case. what to we know, -- play-by-play bit the the forward on I expect, as seriously. Dennis, to which it of don't We to you very as Justice take this, interest. We happens. look that XX Goldberg's the everyone's were pleased to of X. ruling. until

Yuchen Ding

X And as maybe like, potentially going you is to for opportunity as judgment to or before follow-up an forward a happen anything months, favor there could trial? to XX a that your look actually summary in that,

David Hastings

will is opportunity point. the All in timelines expecting believe schedule I that that I Yes. these some there we're late summer. believe are be obviously. subject that that the at change, to

best this the that's estimate point in the think I time. at company of

Operator

comes the line of of Brian question Next Baird. from Skorney

Brian Skorney

do XXX. preclinically, PD-LX wanted while, antibody that XXX the for literature you been trial? target disease. more about to on infectious first, PD-LX think of do of more on It's about versus for a PD-X that selecting and Medarex how design little guess, of kind nivo then maybe think get rationale. but some bit thoughts the designs go the durva I initial thinking I just how about and And study a a I a targeting? was Any desirable handle PD-LX study showed for you of

Michael McElhaugh

Brian, questions. for the thanks

of So a couple questions there.

Mike I'll is design, considerations question PD-X that to Sofia it what turn on do the answer Karen maybe versus can then and I'll for works. some if we PD-LX to go over So to

So Mike, do you question? want to PD-LX handle the PD-X,

Michael Sofia

Sure. Sure, Brian.

a from the a hepatocytes is chronic small certainly patients, hepatitis internalizes that essentially. in block PD-LX you action just washing then cetera, reconstitute that agents able versus identify right? standpoint drug. really sense mechanism that which on The PD-LX, PD-X So by as is B decision PD-LX we on it obviously, can that to we of degradation, in upregulated of hepatocytes strategy surface know PD-LX by were for the and that target we et -- molecule in PD-LX this come And reported completely out the literature the causes novel do

activation So of let's for that within all agents systemic strategy small the liver-centric the fit that system. our molecule general immune concerns say, circumvents with,

around molecule decision PD-LX we concept with fits Therefore, this ability address upregulated a the agent the a small fact was, PD-LX target the and and it from hepatocytes. So develop partly to the of our standpoint. within in disease a, liver that overall to design is hepatocytes highly how that can a

Karen Sims

Mike. in questions the jump Thanks, can nivo trials. I regarding versus Yes. in our durvalumab about And the clinical

that's Biotherapeutics Barinthus trial So the doing and asset. their collaboration we're VTP-XXX XXX trial, the for with in

with as plus ongoing the studies. So boost. studies time a HBVXXX studies, probably at some that HBVXXX their given is there that of combination have VTP-XXX suggested and nivolumab those subjects in of low-dose low-dose know, they have dose and they VTP-XXX receive you of And MVA response already performed using in nivolumab in potentiation the

with using XXX amendment study reason, in So as on an prior context. experience and their this for that we into ongoing nivolumab based strategy that incorporated the

decide the our anti-PD-LX explore to suggested, able to to administration a with study just timing context combination of the upcoming PD-LX the we Mike optimal in and to For terms imdusiran of utilize therapy. basically the did imdusiran inhibitor the reasons durvalumab, study, and AB-XXX and in inform for starting antibody, be XXX of

that's the studies. study between the X details difference So able to rationale share forward, XXX we'll for be more as moves the certainly, the study the of about design. kind And

Operator

Next Roy question line JMP. of the Buchanan comes from Citizens of

Roy Buchanan

might for little XXX? re-engage guess, think And be those plans Can when a elaborate too? what you bit? you on following FDA I are broadly, Ia/Ib, guess, a you your more couple, to XXX, position A Phase with just I do the just the on in

Michael McElhaugh

do Sure. want that to you one? handle Karen,

Karen Sims

Sure, absolutely.

in said we to data, to the to as we that And with package the to FDA really, process, U.S. able to for this is intend a this have be that re-engage return So forward we do -- are throughout for program. robust we certainly move them criteria sufficient feel the when

we're and accumulating share trial is to the looking of be FDA. the that with back line to proceed data always to that forward communication and certainly to So open, continuing AB-XXX it is as able

And global this States of to Phase them II the then jurisdictions frequently before. study with initially We've and trials to back to for development study FDA done along outside study need strategy as is increase I we've size. something other assets taken a Phase populations brought and initiate United we

seamless said the subjects just to the subjects. in we into half an multiple We to The as once study as into is designed in now, data then is an how patients to dosing certainly, umbrella as And study, available B regard preliminary we study have progressed that the chronic sufficient data progressing with updates study healthy intend be share sharing ongoing become move output, into and they a transition year. and the healthy of in first study we in we'll from do this have so forward hepatitis population fashion.

Roy Buchanan

potentially, do mentioned see X forward a need to you or Okay. really and guess, data? I Great. from add I approach? need approach kind to XXX. that about of another you And see imdusiran and it move what then the the you ask if What could vaccine this to see VTP-XXX. to half nivo to results that But do combos Or Yes, you with do to need VTP-XXX cornerstone. make

Michael McElhaugh

It's good a Roy. Yes. question,

So as data honestly, look we'll to forward. continue need like comes I the think what evaluate it we to just and see

as study well. we mentioned, to added rightfully the arm that you nivo As

I forward, that. think and I see nivo have like. of plus it what spectacular data depend see of into we'd to the just -- we something Currently, arm that probably imdusiran the data will no I unless, moving that look combo before want insight VTP-XXX out on course,

moving the data not imdusiran to plus we're that guide about the That's a is can. as probably think we I VTP-XXX considering forward the sort thinking as But it. way being proprietary Obviously, been always and goal. quickly of about think asset, XXX with us, best will

Operator

question Ed H.C. Next of line the comes Arce of from Wainwright.

Wing Yip

Thomas is This a for Ed. couple of Yip asking questions

can that in learning study ] [ from you IIa design Phase that ] specific big with the study the XXX the expect broad study we any the will can [ be? study? strokes And the question is XXX new for durvalumab, how First discuss ongoing elements

Michael McElhaugh

that Yes. please? Karen, you handle want do to one,

Karen Sims

sure. Yes,

typically So the details the announce our able study dive don't into we're first study. again, the to of in subject, first we until dose designs

timing what PD-LX elaborate to said. study AB-XXX, try imdusiran So is imdusiran to options therapy inhibitor much is at the of can't Again, help goal goal. to beyond I of a upcoming already with the studies terms with we've combination really of inform looking the high-level the so in in adding different

In again, size to optimal it size is the try about, of IIa study. study approach. the study, exploratory an optimal duration typical of basically to again terms is timing, combination a that This of that learn

the that will share But enrolled. is and more welcome certainly you're listed for again, details about peruse any once study specific So add the on to there. and trial subjects details we additional clinicaltrials.gov, we have

Wing Yip

Understood. that and Got similar first imdusiran Will well? combinations the study, it. along we've other with combination then, study IIa then line, XXX. And proof-of-concept just similar be same with thinking the seen with ahead study as that of with thing, a Phase

Karen Sims

additional I study can for larger AB-XXX, for is. safety we the that still subjects. a as certainly information really and Typically, IIa mean -- population pharmacodynamics into the molecule database a that. starting will rationale of increasing jump be Yes, well. will be one about for The I is, with Phase PK still it learning and

development taking to aspects understanding Phase to IIb fully Phase molecule larger routine a study sure different moving the before it just into IIa type we're a fairly asset is study. an early So with make the of

which, taking very comfortable it expensive. very that sure about you into we're compounds derisking these all is just the making are difficult, completely studies, larger know, really as that And technically and

IIa mentioned study. it -- need see as will So most guides smaller to the us. call, see throughout again, and the a But Mike it's the data start we likely, data how with

moves come to more as through I. program AB-XXX on that Phase So the

Wing Yip

then And Understood. from one us. question final it. Got

Just events? most narrow Or should the and data trying notably [indiscernible] down then separate readout big we to these data. the splash AB-XXX EASL? of the also half readouts, timing first expect a at XXX the of end-of-treatment kind like Are

Michael McElhaugh

Yes. to of tough answer. a That's Good question Thomas. question, kind

and always or course, -- present love We be we But EASL. no data will I think present say that may have that I idea course, of because, submit to is we'd the our any at whether may at not data to accepted. abstracts of we love EASL. our reason

to hard other But think you're it's will So to likely that around the kind guide specifically timing correctly, conference. probably a particular some a the data mechanism, time available. conference either through or thinking be I of when that's through about the

Operator

Next question Nakae comes from of the Chardan. of Keay line

Kaey Nakae

have answered. been My questions

Operator

Okay. I'm at like I showing now would turn back to to no this time. closing management further for it questions remarks.

Michael McElhaugh

continued you. the that And updates call. providing to We Arbutus, support forward this us stage in Thank interest look concludes for our Great. your we certainly assets. as development clinical joining Operator, HBV and our everyone, thanks, of appreciate of and morning. we progress

Operator

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

disconnect. now may You

Arbutus Biopharma (ABUS) 29 Feb 242023 Q4 Earnings call transcript