Arbutus Biopharma (ABUS) 1 Aug 242024 Q2 Earnings call transcript

Good day, and thank you for standing by. Welcome to the Arbutus Biopharma 2024 Second 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, Jill. thank and joining Corporate and XXXX Second everyone, Results Financial Update morning, you Arbutus' for Quarter Good Call.

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

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

treated cure antigen of cornerstone undetectable weeks XX clinical development weeks imdusiran Both in of importantly, XX us data everyone, hepatitis driving value the our IM-PROVE made for demonstrated our today. were interferon. of a I therapeutic with of Good as for presented imdusiran with our clinical RNAi and XXXX, and AX patients data B, we a Most the treatment B trials patients modulators. positive support Phase hepatitis of Xa the you note, these and functional of morning, continued developing with significant amino second surface quarter thank who pursuit cohort from In in XX% joining combining we of regimen. Of different an and from advancements in cure X HBV shareholders. functional trial imdusiran for sets company

had B of More antigen. undetectable hepatitis importantly, patients antigen XX% surface with baseline IU/mL surface X,XXX those than less

X of achieving from these and addition, HBV follow-up, XX functional with to and after KOLs X cured. We off DNA field. X and considered XX%, to that our to and they greater potentially in that undetectable functional patients, interferon, all than functionally in HBV all cure. in therapy number receiving the forward surface would surface put is a patients goal a AX, of this X while achieved look In surface and goal DNA these from reaching antigen a continue weeks precursor or who AX antigen imdusiran stopped plus maintained weeks undetectable of the maintain context, HBV aligns if equal trajectory undetectable the for Cohort of be antigen patients rate a levels XX Cohort therapy, to To of following early cure

We into Xb are and ongoing. now development prioritizing imdusiran preparations are Phase clinical advancing

nivolumab are VTP-XXX imdusiran arm functional IM-PROVE the to trial second towards expect to the preliminary data cure, half year. I this patients in addition report we the of trending that evaluating IM-PROVE follow-up In from the a of plus from from data the II

Arbutus in company anti-PD-X further are XX we impact time, we discovery our functions. We workforce support clinical same next easy, G&A streamline doses so, committed resources to of of the difficult the employees as we XX%, Xb At development affecting to their well a may and and they an are are focused departing by novel IM-PROVE low our imdusiran decision and to for have HBV of now that do and that our new remains emphasize X those to have we monoclonal by on who Nucleos(t)ide result changes to know transition B. Phase to cohort are discovery all efforts. in lead we includes into roles. in positioned are developing our our for we actions dedication eliminating their made to imdusiran These functional As departing, the especially the will research weeks, ensuring passion to employees, providing up confident patients in reduction the want therapy therapeutics hepatitis our Analogue a antibody. Because and advancing plus II people with reminder, cure plus received VTP-XXX for how grateful future. not that a I nivolumab additional approved followed

dosing known efforts, as III Xa to any addition decided was have AB-XXX-XXX, patients imdusiran. we discovery our also eliminating addition In initiated of trial discontinue a the durvalumab which evaluating our to prior recently IM-PROVE to to research also trial, Phase

reasons are seen and doses we is and based the B Phase Phase development. in trial. molecule discontinue multiple in discontinue systemic AB-XXX in our a and for Ia/Ib inhibition may III differentiated our therefore, likely clinical shorter and be chance a advancement currently decision from much is a solely this studies trial III on addition clinical to imdusiran features excited functional of I Phase antibodies. into decision clinical has duration than the reducing small the our effect typical antibodies projected inhibitor, that of checkpoint with clinical events a to a to preclinical AB-XXX, Xa/Xb that prioritization remain through checkpoint trial decision continuing These about related clinical hepatitis the healthy X of these given subjects or Phase the the clinical of adverse of was trial with potential to PD-LX trial. Recall cure availability AB-XXX want pharmacokinetics to evaluate of Xb in IM-PROVE the to antibodies. Oral data molecule the checkpoint of of checkpoint liver-centric is no and AB-XXX were Our for often that advancement regarding impact IM-PROVE clinical imdusiran continue and designed that our concerns resources are long-acting of any regimen. The in minimizing had is AB-XXX exposures on of not belief of is It component controlled immune-related ascending key that goal emphasize

Importantly, the us of cash today our quarter XXXX. into projected actions extend allowed to fourth the have runway

case, I brief review turn XXXX In EASL. with Pfizer/BioNTech litigation to over turn set case, Moderna over no at steps has XX, I'll expert update to of on Karen? presented to that, I call expert include Pfizer/BioNTech and provide the this which subject the property. The course, this Karen, the Moderna is data would depositions. at our call we The the like intellectual a and to with April date Before court now ongoing around trial LNP next lawsuit time. With the is, change. as for the Karen to updates reports

we approaches, the end-of-treatment The in was cure imdusiran and Mike, the reduces and system. EASL good from Thanks, advancing antigen, everyone. DNA HBV imdusiran HBV reported as June that at with surface our ongoing supports therapeutic Phase X and evaluating depresses Congress regimen trials morning, the development immune clinical immunomodulatory functional Xa data boost cornerstone combination an of of the

nuke they of of hepatitis interferon point, that weeks. chronic and of met, all XX off the imdusiran And an XX XX-week of The of doses safety, their first trial, or X milligrams -- IM-PROVE B with for end the their followed if lead-in the every XX I, stop of patients. XX imdusiran by tolerability at criteria a therapy weekly and in therapy nuke antiviral weeks nuke remain for weeks remain XX interferon were without could weeks, additional given or At protocol treatment, evaluated patients additional therapy on activity follow-up.

at received patients their they surface XX that are in to discontinued and of undetectable weeks, levels weeks interferon continue of therapy cohorts X All doses of levels by they cohorts While as the XX imdusiran if weeks XX interferon be of antigen followed in X and we of reached another will X XX-week therapy. surface their presented and on reached antigen antigen received nuke XX by and the I for patients These DNA patients also these XX just treatment continued the XX weeks. after X with of or antigen focus trial XX undetectable preliminary treatment. data end-of-treatment maintained nuke every considered have had dosing full functionally undetectable surface patients patient weeks surface than therapy interferon note, maintained imdusiran the EASL, in weeks. And HBV patients same XX also and follow-up, X there surface imdusiran those the end followed that XX weekly and and at cured. Of for no discontinued for received antigen undetectable nuke weeks of of XX% with more are additional maintained set patients undetectable that will maintain imdusiran, X dosing stopping cohort. continuing in of X interferon, patients all weeks cohorts interferon

weeks studies response weeks. are in in cohort total, X converted the and one a achieved of durations off sustained seen with interferon seen XX are response So for antibody of cure. The assess from with highest therapies XX now X levels surface there antigen functional rates that interferon including from followed XX% XX-week being is patients surface the treatment all of loss the to high of rate testing field, interferon

interferon the to especially HBV in dose. The surface be addition, weeks imdusiran in to weeks trial a interferon of courses tolerated. combination have key of not evaluated fields HBV of This with treatment shortest treatment, and was skepticism RNAi lower interferon, development in date. evaluated around that interferon leading in since, other less impressive. There unlike patients is cure found leaders of frequently has these functional is prior In to loss the which with one clinical have administered candidates sustained HBV the well use antigen XX data regimens, in been at been XX opinion always

clinical us that Phase may in to believe be well to regimen this generally advance a was viable into this tolerated, clinical interferon trial. in Additionally, the giving safe and treatment Xb and field a trial, others

evaluating Our continuing of Barinthus therapy. all safety second patients be end criteria, the IM-PROVE XX nuke is XX, VTP-XXX and followed II, their and leading immunotherapeutic weeks with a immunogenicity protocol could At continue therapy stop XX-week for while followed treatment. by week met if trial, the to off they biotherapeutics nuke treatment, imdusiran, of

line X.X with antigen from baseline alone in is trials. on XX-week we period, data clinical in seen we treatment a surface other to-date decline imdusiran in with This saw average. from the leading antigen have surface our During log leading decline imdusiran

XXX thesis time XX% of maintain XXX threshold antigen placebo. patients or addition, of our levels patient's the patients supports of XX-week surface time administration, post dose trial more VTP-XXX trial nivolumab addition after the at point. than VTP-XXX clinical VTP-XXX regimen. had And to we with of monoclonal II XX imdusiran, response. less data surface patients the with In expanded the we've We the IU/mL with boost further by less X placebo than surface dosing IU/mL treatment increase reaching through XX arm end-of-treatment respond mean first evaluate the ability immune the that The in to and nivolumab lowering low patients treatment. Statistical of antibody placebo end levels that X to achieved versus antigen anti-PD-X the or this surface weeks combination from was antigen host the less treatment. Recall of a additional believe treatment imdusiran than significance to between and may post antigen of IM-PROVE

are trial data year. preliminary portion We track report this of from later to on this the

let's briefly Ia/Ib with Phase clinical AB-XXX. trial Now, the review

chronic cohort, evaluable generally X receptor that XXX%, doses X, PD-LX B. we with the with subjects evidence in indicating in XX-milligram a AB-XXX mentioned, In combination multiple functionally small-molecule as then checkpoint consists and inhibitor checkpoint ascending interacting Mike is target. hepatitis well chronic Last B. The reported oral tolerated evidence clinical it single from As that inhibitor occupancy. in is of of between showed subjects is then multiple healthy intended culminating and is use AB-XXX antibodies are receptor trial X data occupancy with regimen parts, its Ia/Ib differentiated PD-LX to cure doses patients with hepatitis and from Part quarter, Phase treatment showing XX% for dose-dependent developed of with potential all imdusiran with AB-XXX potential starting liver-centric

Part receiving ascending of multiple of from data healthy where Part X We are later AB-XXX. We of preliminary X subjects are this this now in cohorts trial anticipate doses year. announcing

further quickly pathway immune that as and with in HBV-specific an brief X, tolerance Part enhance immune call activation, to enroll inhibitor a immune will as that, to checkpoint and in believe with into goal chronic the hepatitis We in Our which patients possible I'll financial checkpoint plays addition combination responses. With important the B. move update. could the over role potentially T-cells is Hastings of turn imdusiran for Dave a Dave? HBV-specific

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

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

As we announced XX%. today, we workforce are by our reducing

to continue our we resources human necessary believe we have financial Importantly, the HBV pipeline. clinical to and stage advance

Now onetime to the charge $X workforce, $XX restructuring million with from of $X range will recorded third burn this will XXXX in that to incur quarter expect our still million. cash million $XX in XXXX. We million reduction of a we be approximately to

I'll significantly anticipated a actions of for that, Importantly, cash the call our our advance provide today, closing, a imdusiran functional XXXX announced back the we we assets developing to to our Xb have trial. In cure to fourth of our financial runway HBV. With fund extended HBV Phase to clinical position turn chronic with strong quarter the an and we Mike. mission into strengthened ability

Dave. Thanks,

now for With X, of our reporting the half with are half end-of-treatment IM-PROVE end-of-treatment preliminary and IM-PROVE hepatitis I departing the in X the their to open of employees trial All and patients for and of milestones. to pursue them we're subjects the and milestones ascending developing multiple have for trial. In B. Operator, to our the cure achieved I reporting reporting we data again all track, continue first the from with chronic goals contributions second dose Q&A. the ready wish data company arm our nivolumab healthy to key from including we now functional data preliminary as IM-PROVE closing, call on AV-XXX-XXX XXXX a thank for dedication of best

call Dennis first Jefferies. comes Our with from Instructions] Ding [Operator

some this just the design, how talk I curious whether And AB-XXX as a a in and interferon on comment part just Phase pending a just run? I'm as what data the as you look like on terms trial please. would it regimen in of more guess year? size just bit includes just follow-up, I one Xb or and about little would Can this guys that to that half this mentioning. much you VTP-XXX it includes well, of had maybe cost approximately second Maybe were and

morning, Dennis. Good to question? Karen, handle you Sure. would like that

Sure. That's fine.

study. Phase stages planning this Xb design. So point in there's of really in share not Obviously, can terms much we're at I study the the of that

it premature or describe So the specific to features any timing would study the design study. of be

subject So need that will a to be the of future discussion.

I at now. In evaluating have terms of including all we compounds in that options disposal right we're think our trial, the

IM-PROVE we As our in IM-PROVE with additional combination later this at from you know, additional the awaiting interferon nivolumab very We're coming that VTP-XXX. I year. exciting data II data cohort shared EASL with

and at and this those So think I open options point, table, all are the we on we're as speak. all evaluating

Arce Ed from comes question Wainright. Next with H.C.

for Ed. of This is Thomas a questions couple asking

year. half conference in So the the be medical for first expected in in this of of major conjunction it's Is half second question cohort II IM-PROVE expecting year? been announcement data, any to this with the second expansion the data

Thanks Thomas. of the that for we will tell -- you case. that's won't But disposition course, we know to because release know morning, tell time don't talk what I you we of yet. data, Good hope question. the we we abstracts we every that commit can't about of the the

can't anticipate We to year. case. that's that the we get that, course, we be case. So the the the confirm hope that of end But closer we of will until

new IM-PROVE plans studies Understood. II to interim as before and add-on I year-end? data an question any are And then that, there from to perhaps report IM-PROVE

timing question, that the think I yes, Thomas, answer TBD. Yes, is to

affected there streamline the discuss other plans. your Are programs from And then streamlining? on pre-clinical than IM-PROVE question also us other impacts clinical on can the And one are then if study? this planned programs any operation III any perhaps you by that

look, on No, don't clinical the Yes. any -- anticipate impact other we the programs.

guidance until intent studies. on well current study advance that's And we the In complete. can't really Xb Phase that is to fund But later-stage the and we imdusiran focus quickly. existing substantially positions streamlining study, the fact, design today, to exact can fund company the with the we the Obviously, with focus on give that resources believe using we to the which hand. cash the is the have imdusiran to

comes Buchanan from next The question Roy Citizens. with

that guess that of to the correct? trial couple possibly going only -- this Xb. sounds next I the Phase a to you're to Is you're quick just to but talk sure going make be ones. it just Just I'm sure like clear, start and and is going to I'm need to FDA,

today move mean how clinical was I Roy, to we're the what said is don't Xb that. development, likely later-stage Yes, I Phase we which a answer know in study. to imdusiran planning

do. lots have thinking of We to

the details. when that, We are we'll have we some back more come process in of doing and

okay, Okay. some I And data still got. to see,

Still that's some to see, data correct.

And companies you prepared think guess HBS I and there. then you're just I are with looking X,XXX, other know baseline in remarks than less focusing you on one, just patients about thinking mentioned it the --

that? thinking Just you how are about potentially

Yes. That's right. you're a mean, good question, yes, Roy. I

You prepared remarks. the did in comment hear that

of rate baseline, increased we you found is the surface One in at if things intriguing very X,XXX antigen IM-PROVE less I about XX% number dramatically with to that generated than that that the the XX%. patients in from data in response the looked we

see here. about But how of we're move that with remember, Now have globally we course, million patients going B. hold talking continues we're as XXX to to to forward hepatitis

-- work are and from. we're cut you like. into that of populations large numbers patients that base substantial specifically there about what very on to how could to start market, of still number But think you that patients talking some working down is you we're a about if even there patient segment looks So potentially

that. we're So excited yes, about

with next question Chardan. comes The from Keay

understand for But least to firm trial. own, horse forward have you more your path just might start trying you dead us on it? resources next I going a And this data able just to you this on you're design, any year. details but be to trying beat second can't to can if like think give you're know the your in of not at here, needed. to the you up when sounds the It again, Just start to clinical position half but

'XX So a study half first or is later? this

say point. Yes. possibly for discussions we There as design it can't at question. be this the about more quickly or just you Keay, can can. I started Thanks any still good that timing question. as I are we'll give All specifics get had. to is some

as And mentioned, to point We data, are waiting yes, the some goal have as this you can. the here -- of we do substantially on legs And hand. as that with own. is off going to at we're help it have decision. start is But which to this all still said, for we obviously the our as quickly to this cash fund kick on Dave we drive

information. So off we're get stay kicked quickly working tuned this to diligently and for more

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

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

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

now may You disconnect.