Arbutus Biopharma (ABUS) 6 Nov 242024 Q3 Earnings call transcript

Good day, and thank you for standing by for Arbutus Biopharma 2024 Third Quarter Financial Results and Corporate Update. [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, Vice President of Investor Relations. Please go ahead.

Thank you, Antoine. thank and joining Corporate and XXXX Third everyone, Results Financial Update morning, you Arbutus' for Quarter Good Call.

Hastings, Chief Joining executive me then Officer; Mike Officer; and and Scientific Sofia, Chief McElhaugh team Arbutus Officer; Dave Executive Officer. financial are company's an clinical Mike Dr. remarks, Karen today McElhaugh, open Interim programs Medical After Dave from will a Sims, third prepared ongoing Chief in the of XXXX Financial our the will corporate Chief Dr. provide update update, Mike we review President on provide the results. Q&A. including our call quarter a HBV. will for

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

McElhaugh. I'll call the that, to over With Mike turn Mike?

appreciate Lisa, you Thank everyone. us morning, and you, today. good joining I

review next EASL not ongoing for II. data those a and trials high the from is the provide imdusiran we IM-PROVE which release Phase our presentations updates able with that are Study at the this to were will, abstracts I of off highlighting annual data level under late-breaker accepted acceptance IM-PROVE trials poster Since A held issued this imdusiran XX, that however, the a are few XXXX, in announcing year the meeting conference. weeks the presented data we're I and the time. trials meeting data Liver at we IIa Liver any clinical at those the for to ago, press earlier embargo, that the November Association clinical American Friday, Meeting kicks X multiple Diseases. presentation Included by from at

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combination of interferon the HBV IM-PROVE patients our At well where best reported that was the AX, safe we tolerated. Cohort The received June, generally and at cohort was end I that the interferon doses trial surface in imdusiran XX was of In imdusiran cohort antigen the from performed treatment. at achieved ongoing sustained end interferon plus weeks data of X and patients Congress the weeks of showing nuke of EASL and in imdusiran addition loss post clinical of treatment XX% AX, to that XX therapy.

surface and subset cohort reported less less than antigen a had interferon at highest AX, XX with at patients In population of achieved XX% loss who looked outcomes. better surface than also who patients IU/mL of surface is baseline studies the antigen IU/mL. a This X,XXX loss by antigen treatment. at baseline. published to weeks patients surface X,XXX completion of baseline IU/mL had We is imdusiran because of antigen than less with This the maintained patients that assess have X,XXX long-term loss rates of antigen have service antigen one after shown surface relevant

At with loss reported their discontinued nucleoside had data, these surface think clinical in of these patient trial with antigen include while therapy. We've low sustained them for those functional best the data, we cure. the capturing stratifying a portion IIb patients population for the significant patients time assess may following position on a us antigen As about chronic HBV patients. to been to and X we based surface success Cohort Phase these AX still

hepatitis than surface sustained As a without HBV defined reminder, B antibodies. of of or weeks hepatitis with DNA less antigen functional lower levels and B XX the surface loss treatment a cures quantification

next trial leaders positive these we continue on at follow-up feedback in additional excited We are HBV receive opinion data the AASLD from to provide and field, key week. from to data this

from treatment, thresholds EASL, imdusiran the XX data Biotherapeutics than XX-week IU/mL lowered followed post Barinthus evaluating immunogenicity patients placebo. In and at or IU/mL lead-in antigen with to dosing imdusiran of IM-PROVE placebo, is or less this therapy. continuing XX prior we more of by safety that less receiving of while trial of surface XXX surface through or trial, treatment VTP-XXX II in end clinical than end XX% After antigen versus levels a the with to XXX and placebo less than June VTP-XXX maintain patients. nuke VTP-XXX our also weeks In of reported

reach difference was who the a antigen placebo. For levels in achieved this patients and mean surface treatment time statistically arm between point, significant

we the of combination that low this expanded clinical monoclonal regimen, to which antibody, nivolumab, addition believe treatment anti-PD-X VTP-XXX further of IM-PROVE response. dose II the a and immune the trial have may host evaluate Recall to we boost the imdusiran

potential next to data week We a to data regimen. this support functional cure treatment clinical trial report are preliminary on into IIb AASLD. a imdusiran Phase totality plans portion at of as the a The cornerstone of track trial our these from advance HBV in

like immune oral studies of on that PD-LX the checkpoint the providing important small HBV-specific effect much could the that of long-acting the was molecule pharmacokinetics, potentially enhance exposure systemic seen in immune and are about a treating reducing inhibitor. and adverse with our shorter T-cell immune-related move activation and HBV. designed likely AB-XXX, would a in pathway excited minimizing responses. duration We events AB-XXX combination inhibitor in potential to further HBV-specific remain with imdusiran the had AB-XXX goal checkpoint checkpoint and to with of typical AB-XXX liver-centric molecule I antibodies. chance of addition preclinical an is of in role tolerance Now immune in plays small believe We checkpoint than often antibodies.

of part single ascending clinical that currently its AB Part interacting with II Phase trial, Ia/Ib of or that received single in a multiple recorded HBV. of intended X was of with this we showing Today, the XXX single well between XX-milligram multiple in trial indicating and ascending so X-day with with than with and milligrams trial, starting Last the generally have culminating period. XX% of X the dosing ascending showed of patients demonstrating days. receptor healthy receptor X consists AB-XXX X XX-milligram receptor is during doses evaluable subjects -- is dose-dependent far receptor Each subjects target. occupancy or evidence dose XX for all subjects of doses of data showed subjects. dose-dependent with evidence data of healthy parts, that X where greater sequential portion Multiple receptor daily tolerated XX cohort, X evidence quarter, the X cohort X we enrolled AB-XXX of part well trial In placebo generally we with occupancy. cohort, cohorts where of this in XX reported subjects AB-XXX doses chronic from XXX%, Phase and XX% evidence PD-LX dose all the of AB-XXX occupancy. In occupancy occupancy were tolerated the from

dosing occupancy, a and X, clinical days date of safety this favorable evidence patients have in global moved of we in profile With portion trial, XX repeat of HBV. Part to into chronic AB-XXX with which evaluates the receptor now

AB-XXX with dosed patients HBV half from data next the preliminary report of year. to expect We in first

the Markman case, I'll Moderna the over for now been XXXX. and the call have hearing, December litigation of now financial Hastings hearing, In brief updates has trial for LNP property. X brief a XX, availability. the date the I Pfizer/BioNTech our with as the around September the to Moderna Pfizer/BioNTech date the court's known for course, update. Dave? claim also scheduled lawsuit, the to intellectual XX, construction is, XXXX, for which Finally, set subject turn Dave is on progress In

December marketable to $XXX of and and approximately good approximately with compared XXXX. XX, Thanks, equivalents of $XXX million cash everybody. quarter million third the ended XXXX Mike, cash, We in as morning, of investments securities

the cash our common half million offset received of under $XX the of first operations. shares million by offering of cash During program. XXXX, net at-the-market approximately from of inflows we were issuance in $XX.X used proceeds These

ATM range quarter XXXX. XXXX common issue still our shares to And to $XX million from We we cash program million. did third expect any $XX not in under our the of burn

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

of call strong In HBV people a provide for advance have turn a Mike. to cure mission chronic our And financial that, I'll assets with back we functional with our developing to the position to closing, HBV.

IM-PROVE update at preliminary the look of trial report trial from week our Dave. an of next additional We to IM-PROVE Thanks, II to we data treatment from and providing AASLD. clinical the arm as data forward end nivolumab I intend

our planned reporting of in announcements data healthy ascending all subjects from milestones. XXX of these AB-XXX the dose the today's half second multiple we and have With trial, achieved will data

open now to for Q&A. we're ready call Operator, the

first [Operator Instructions] from question Dennis Jefferies. Your from Ding comes

cure include functional Cohort you've Anthea that from on is but data the AX update a the Dennis. that's for had We question mentioned without know I that also upcoming. imdusiran. appreciating XX% This patients bar, on will

functional you do what on top would you XX% on be benefit looking when a any incremental have this imdusiran. look So you like add in thoughts cure Would for arm?

how get XX%. imagining that data is XX% cohort to this you imdusiran should interpret cure, XX%, has Just functional if adding

Mike. is This

understand try you're to headed this with me let So where question.

only we We've of and So first have functional baseline end any functional The we presented of that a us, stick consolidation. not is data date, treatment related all, rate mud think a XX% for of functional in of to where curate. cure meaningful you've to presented a cure sort is mentioned of sort imdusiran the post-nucleoside

current nucleosides. As around the less you than XX%, therapies do X% for know, very somewhere less don't and well,

a of would as goal, company, our as going can patients goal that cure a hit as programs beneficial forward. we, that, sort that a and XX% So an have we if a be set meaningful of to for functional goal aspirational

if that whether to AX or week. to or of anything please? add should or Karen, next how want So at talking BX see AASLD continues about Cohort we're BX, AX that sort we you

misinterpretation. like the to clarify any avoid would designed study just how I And is to

during imdusiran and fact, study of cohort doses before of the The cohort. The receive weeks the imdusiran, for the only. of to period. milligrams just all they at then to of X the were and weeks XX the the subjects they different period every the least interferon-containing received And AX treatment IM-PROVE a is randomized I received receive were weeks. group initial to AX So HX randomized XX the between continued X the cohort in The X so doses in imdusiran X received of did, interferon AX then interferon. cohort interferon XX doses receive difference AX

case in trial a So I misunderstanding design. about point the there's want to just clarify that

Okay. Got it.

either And be bar so XX% in cohort. the would

containing. interferon both they're Because

question. For next

Our next Buchanan from question comes Citizens JMP. from Roy

So I be going guess example, thinking question, patients? if who take s-antigen denominator? loss? that Cohort for AX, a to last you for -- about functional to consider what patients the on we denominator should achieved how is follow XX Or X just up cure are the we as

how lines, in And imdusiran then about kind studies. thinking for of same the the subsequent along are you lead

itself. You below with a of can get lot patients X,XXX imdusiran

the So in are imdusiran you to beginning? maybe screen thinking after or lead at very

Yes.

about question the your first to denominator. back getting So

around of So the as had a each denominator cohort. noted, or XX you XX-week XX cohort, subjects for

of presented looking be we'd said, cohort, certainly, the post the where that new treatment S-antigen denominator Mike get So end across after XX end we've and at XX%, data weeks XX%. population of treatment and as at care some looking period, of loss at of already that entire we functional consolidation

at and of If with to we see with up and this antigen study recently surface a antigen the above the surface little then across our tend I X,XXX, these look sponsors at less sustained entered and or service bar antigen loss population management look at less to is better the XX% antigen subjects think trials whether than surface differently that data, lot lower percentage at cohort the XX%, subjects than transfer we respond look consistent with baseline in situation, who hepatitis B the go loss subjects that what clinical of if a surface therapies. to X,XXX. of with whether that either we entire But regardless cure data look we're area we in

both think as those looking So data looking cure will the emerges looking functional be and at appear denominators. of data forward I the how our be today all we'll is about update to

regards lead-in the about In period. question second to imdusiran your

all So at forward. moving possibilities continuing study designs we're look different of to obviously,

to little surface when loss. I low we're the think differentiating rates trial we is surface of very lead-in example, we're then come high this and these this after been I, a drive do for as what antigen, would has period immunomodulator with And antigen IM-PROVE seeing as possible. using antigen lowering that surface particular about

So that terms immune host lowering think, boosting good antigen immunomodulators. far in for been, I so I us of surface then our study a goals think has of design and response the and

we as types Phase forward, at mentioned, I we'll these the with lead study data where design options, all go different looking studies. as certainly, see we're III So us and of

A That's Great. on helpful. couple Okay. AB-XXX.

from that results? the do of in any then XX plans next and first have the you So year, X half that? just A X results Part so to the subjects Cohort is going or likely be present to And

Yes.

still we're working Roy, that. So through

there data will -- like course, be half, that can't of additional have, we what to half. We you data in the we're regards open get what we first the that to right the likes But of the specifically first you give but data -- will the to MAD presented the data with set detail With as get we'll any -- be in specific patient hands can't in I as out. of will portion on figure the out forum pretty that of we the and we quickly typically can. HBV

So stay tuned.

Our from comes from Keay next Chardan. question Nakae

Yes.

wondering you're Phase give can about for clarity you on how us if IIb? any timing I'm So thinking further

Yes.

can. through other to I to say we good additional point, this you. as IIb you we're So can't really hear related timing from give any the Phase than at to as working diligently that it

up. figure have for it Obviously, internal right discussions, the as we as be what's are We to looking and on we're we data out need -- is market we path regulators what and get coming talk the imdusiran to quickly to hand have at going to that can. to

this say we're can I diligent we so, just get being can. all as to is and quickly we'll at will as continue do we So there and point

Our comes Skorney from Baird. from Brian next question

Actually one AB-XXX. on

study. to Just Part of going the X

or if patients XX-day HBV PD-LX show HBV-specific what here but an if is move of that antigen a a in looks just sure PD-X set result the could HBV trying wondering you're with be not to level into biomarker expectations anti-PD-LX. just enrolling expected mix would to positives prior there negatives, on of in any you or Just data had insight any --

handle that one. I'll Sure. or Karen ask Mike to Maybe

mean, company I following to start. know our can over years, you I very be the as biomarker heavy. probably tend from we Yes,

Phase we explore we So in always can trial. like the any to biomarkers including of extent to trials, our I

So robust we and look, markers. reported, a receptor doing biomarker we've already are as occupancy other collection

study. everyone is an the treatment B So period, remind and just not that antiviral, of XX-day study continues that will it modulator. a X It's portion hepatitis the the direct-acting a into Part immune is right? of AB-XXX I

clear these yet immune a what subjects might treatment period. XX-day on don't we So we're expectations B, on -- terms anti-hepatitis on with the we actual see in not B hepatitis effects in of have response

as Mike we So and that data evolves to But that escalate the has we'll any portion as see through it have trial. dose of other...

quickly I clear mean obviously, goal to as trying it make second with get Brian, what imdusiran with issue The can. XXX, as obviously, the to combination in is we

antigen surface always than has strategy lower at to an been immune Our first booster.

unfortunately, So it's of I just drug guess reality development. the

and can. take can first it as monotherapy we we quick You get performs a combo then have into to and see it how as as

So...

Our from Wainwright. H.C. Ed next [indiscernible] question comes from

asking Thomas for is Ed. a couple of This questions

first, study. cohort? from Or question, as can the with presentation clarify, Are the expect I updated the the we to we data study first So only IM-PROVE late-breaking from data expansion expecting AASLD main well?

Thomas, yes.

II on will focused So C presentation be the the of study. Group IM-PROVE

So that with was at group the June. back the update EASL the cohort A&D addition in in -- of present nivolumab. on did We low-dose the the

Got it.

Okay. Yes, legal a moving on that then makes the perhaps little sense. bit side. And

wonder So Pfizer? what you against can expect after loss and we construction following also the just grain the hearing

was to So hearing Thomas, want sure for what claim after Markman correctly. Is the that is caught Pfizer? I question can construction, just the the It expect we question I that make correct?

results what the the of expect also kind next can that hearing and what -- in the step both process. Yes, we from what's

Sure.

as very little you the the So case, as say is can always about know, litigation. I

the same can learn time out what sort we we of coming do the to wait that. we'll expect, can So of you far expect what hearing as until at as happens, and

similar made of is to we report. that to hearing are get which the to is far take of some going The we in concerned, past. get kind forward looking the a we before the right, as sort what Markman What of after some It's court schedule, of sort results after process, available. saw time it's as feedback hearing

have trial when We when a and with give more trial insight And to all into in there court when the may we will the us, take available schedule that which forward will place. between goodies come. also may move little date a could the us happened

far stay couple it just outcome December likely meeting the before will writing, and months anxiously So we the have results of XX from of that we're now, like that in not you. be a We're away awaiting tuned. but then

from question runway more one Perhaps now. regarding Understood. This from XX cash months is about us. one

any proceeds the I'm from that program. wonder you end So I expected there. at off if ATM includes sorry, the tailed

any include it Does expected from ATM program? proceeds the

no, no, not. financing. It does it no assumes No,

Sorry about that, Yes.

I'm showing back remarks. no over will management further now it closing to questions. I for turn

for morning. committed treatment to and everyone, us hope remain you, millions joining Thank of worldwide. We the this providing to HBV transforming landscape patients

always, Operator, look vision. forward we confidence our appreciate week and updates our to continued your imdusiran. the that providing on As AASLD in We call. development next of concludes clinical at support

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

may You disconnect. now