Earnings call transcript Q1 2023

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Operator

Good day, and thank you for standing by. Welcome to the Arbutus Biopharma 2023 First Quarter 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 speaker today, VP of Investor Relations, Lisa Caperelli. Please go ahead.

Lisa Caperelli

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

a from Chief a followed Hastings, of Clinical prepared review Joining Collier, financial corporate Officer; and Mike update, today the by we Bill of Sims, clinical company's to then Dave Hastings call XXXX team Scientific our who address executive questions. me first Sofia will the VP Karen results. open are Sofia, President provide Chief After and Financial will Doctors and Executive Chief David remarks, Development. will will Dr. quarter your Q&A. Officer; be scientific Officer; the for and Dr. Arbutus Sims Bill begin with available

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

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

Bill Collier

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

COVID-XX made onset chronic decision the hepatitis founded of the be in innovative candidates was preclinical development and compounds is to pipeline, expertise expanded with market well portfolio Arbutus a to could core of our of treatment patients and virologists a as focus our actively goal by strategic advancing we in B that our expand for pandemic COVID-XX on as virus clinical include regimen. combined leverage developing developing discovering, cure advancing team large with that Arbutus XXXX, assets Now clinical our functional their treatment the coronavirus and the opportunities. With future commercializing broad options antiviral of a for outbreaks. At developing focus to create the our to address of today

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its Given HBV. chronic a patients potential AB-XXX believe far, therapy compelling cornerstone the that provide for with functional thus we has data cure a to to be

we our Both data expect preliminary one with X exploring of and evaluate HPV products interferon expected combination strategy trials, have investigational that to stage in trials. this later approved Xa potentially year help that immunotherapeutic. inform are We're other the trials XXX these and to in combination with combination with through clinical Phase combination one Vaccitech's will ongoing antigen-specific

moment clinical provide our to Before ongoing to I discuss first I'd X from these Phase though, like trials a trial. combination data take

least levels of X.X or Phase produces interval recently reported at our declines showed treatment and from data for that years in X same treated week, comparable and show with trial antigen DNA X Furthermore, baseline after characteristics. last dose Summit of XXX Now X dosing XXX. HBV XXX of patients robust low surface from examined the as dose, that we at of surface Hepatitis last clinical their persisting Global antigen, trial regardless

Now trials. in interferon plan are look for last to courses additional year, either include We of of data evaluating NUC receive clinical this from XXX data of in therapy The first trial to our with randomized we back the and or report trial short additional preliminary new this combination of is shared which weeks. first now have AB-XXX-XXX. combination to that preliminary forward plus going further validated XXX's to received reduce or XX reporting the Patients will the in data XX patients Phase some XXXX lead-in surface combination these ongoing being Xa ongoing the interferon. half antigen. from minus doses plus capacity of to The half therapy ongoing trial We late phase interferon. year XXX XXX who

we Vaccitech's half second Xa the AB-XXX-XXX, immune a surface NUC preliminary data or XXXX, VTP-XXX in combination Phase trial host Xb/Xa of our reported can Phase suppress for of to therapy the HBV that In VTP-XXX trial, immunotherapeutic VTP-XXX Vaccitech fully from XXX antigen combination data to placebo. virus. and of expect sustained evaluating system the antigen showing enough HBV-specific and recently are lower we from clinical is the chronic reductions testing induced whether which patients. meaningful report has Through XXX some surface trial, this the

a cancers trial to we're name arm Opdivo. reminder, brand number latter to inhibitor to PD-X additional the which the a low-dose include As with an nivolumab expand under approved a antibody of is preparing treat monoclonal

the trial. the determine first adding reduction And known more an mediated update begin to combination we of will dose enrollment stimulate the further after arm the commonly we'll XXX VTP-XXX. immune treatment when addition to this if VTP-XXX as provide surface of are nivo, of of antigen nivolumab, in of nivo and We initial new the

healthy developing Phase being of our trial combination developed treatment as our is X RNA HBV-specific a AB-XXX HBV. proprietary to dosed HBV, of potential for strategy subject the the in chronic our clinical in of functionally with March. part with destabilizer, regimen consistent is oral addition, oral which cure treatment In first a next-generation AB-XXX we

vitro chronic action of We in functional a at suggest expect combination HBV surface year. component XXX of anti-HBV that important of The the RNA differentiated to this mode XXX data classes and to Global provide second anti-HBV showing in HBV of portion in and be robust Hepatitis Summit preclinical to of the the compared other that Notably, single an ascending may antigen half vivo. past dose suppression we of trial this from HBV. cure for data inhibitors XXX initial have provides presented in activity, including this April,

for disappointing Now received our week, placed last the clinical oral we that PD-LX on the AB-XXX, inhibitor, IND the application hold. FDA news

not Just AB-XXX. be Phase any do Therefore, we X this we initial the had the XXXX. dosed clinical half clear, have to will clinical second half not trial in Phase of and the we patients this not data first to trial XXX and X trial with year, the initiate not had been expect of in initiated, with from

continue combination HBV. authorities will be in forward with however, it we therapy to important our regulatory AB-XXX will, an component to believe move to We work designed as cure

coronavirus antiviral momentum our developing COVID-XX our to small continue and talented to future is build on outbreaks. treat identifying that team with molecules focused significant on Now also new we and

and to are across address highly develop not active replication the against critical are ritonavir that We've essential oral main SARS-CoV-X are known enzymes boosting. selected the conserved lead all These antiviral urgent advancing nspXX coronavirus recently inhibitor strategy the enzymes and for the cycle, as and identify need require We compounds our protease, viral and for AB-XXX circulating variants life to target are nspX therapies potent actively that also X Mpro our polymerase. known Mpro for as compound SARS-CoV-X both coronaviruses. oral do and viral

we and and shared SARS-CoV-X is showing antiviral preclinical resistance inhibitor, in prestigious supporting in of from AB-XXX, against and potent currently favorable X activity its data a vitro treatment. ICAR profile pan-coronavirus impressive, the profile at favorable oral studies, Preclinical activity, congresses, Mpro AB-XXX we're variants, of several PK Recently, our IND-enabling IRV, ritonavir-free of development details namely and of and differentiated initiate Phase to regimen therapy an development. trial the will treatment nspXX optimal both second products just X studies such year. inhibitor and one be plan coronavirus believe from of an half this the inhibitor in Mpro We in is consist piece our a strategy. will a other IS clinical AB-XXX that

our in the these that So into which of X to end, the this half goal more be nspXX throughout progress year. second to programs on sharing we studies an We'll as and then nominate we year. can inhibitor, updates IND-enabling is take identify

the call brief over financial a to turn Dave now Hastings I'll for update.

David Hastings

everybody. morning, Thanks, Bill, good and

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

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

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

between on guidance on timing Phase cash of placed be XXXX by to in a clinical hold from our clinical fund the between based shift reducing AB-XXX's being are IND trial, our with USDXX operations quarter believe cash into will the USDXX our our that, million XXXX. million. first we million to million to USDXXX USDXX to sufficient And X Now and FDA burn AB-XXX resulting runway we of

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

that, to back turn the call With I'll Bill.

Bill Collier

Thank you, Dave.

remind key to upcoming XXXX. like our of now milestones everyone I'd for

Xa the of combining expect half that XXX And nivo to plan the we in Phase first in and all, XXXX. first dose trial first the to So the of initial we in trial the also NUC clinical amendment of XXX, patient combines plus data from half AB-XXX-XXX therapy report XXXX. VTP-XXX second VTP-XXX

and Xa half expect to preliminary therapy in NUC XXX will plan who clinical we plus patients from data AB-XXX-XXX in and of first trial XXXX. the interferon, Phase Secondly, announce that we the receive data

Thirdly, trial coronavirus dose to we for trial of AB-XXX. clinical for And nspXX Phase in our plan commence clinical the IND-enabling to all from candidate initiate the candidate and data nominate we XXXX. program, in report clinical second of healthy X the our single ascending our half to X a volunteer Phase plan Mpro AB-XXX, fourthly, portion studies initial

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

and time briefly I'd we to Before ongoing technology. mention our protecting for and to committed opening resources remain LNP intellectual our are invested our for We ensure we questions, the compensated proprietary delivery like appropriately efforts. call the that defending to to litigation property develop

are have advancing in suit to against similar commenting said, Pfizer on that and will we announced against further be we filed litigations. We a That prior the our not quarters, suit And Moderna. April, ongoing we BioNTech. similar

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

Operator

will Instructions] we [Operator the conduct session. time, this At question-and-answer

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

Thomas Yip

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

the quarter the second the So that's S-antigen first, XXX triple are study, in what regarding or the Phase well? study assessments focus combination on data, XXX and should investors as additional Xa the data readout

Bill Collier

be some follow-up cure looking looking and you point trial data clinical do prime endpoint we're thank eventually at in that mean, for which the the and antigen. treatment at to the interim I we'll moment, I the for lots But Thomas, parameters will this trial. mean functional I looking get at is the point of think case, be will question. the a surface stop where in potentially. different that we

You agree, Karen?

Karen Sims

and as with obviously, I tolerability safety And trials. agree. these always

Thomas Yip

Got it.

should to of off-treatment we first that data, period? speaking in the patient So reach that when expect study

Bill Collier

same only availability Yes. question information the of of in of the The the follow-up study. lot quite clinical not lot. some is They preliminary this we're of the we've recruited at are going into And to that with a period. that the a challenge when do of all We moment, time. necessarily trials points. come the specifically part different middle that from time we've At not patients kind at get to guided said get

the types provide before staggered updates. we So that you kind want then numbers those And of start to have patient be get the and we finish. of we sufficient sure staggered

on So this at that's year. preliminary the data moment, the cards the just for it's

Thomas Yip

Thank time it. explaining you Got the line. for

saw from all we data the about So speaking expect should we the data, next off-treatment off-treatment very When study that of the set off-treatment [XXX] study? impressive. data

Bill Collier

years, continue data, Again, thank We for going you to Karen? we those pleased X to patients are much. present very to were that follow and

Karen Sims

Correct.

Bill Collier

So patients can therapy. track whilst we they're this to speak, a one has long fare tail, these to off so so that how continue

preliminary guided we've at having moment, continue these in to we'll this I further some delivered, going year So track think which updates to forward. and the the half, just first we patients

Thomas Yip

Okay. year, in what's XXX, XXX plan so one should combinations? question, perhaps XXX? switching gears this is expecting second step evaluate when And the since half we then for expect, ascending dose to And single last the to we're the data next

Bill Collier

Yes.

Mike So I'll the Mike? hand over first the of Karen, presented, data a can one on for Sofia about that you to then this we trial. talk comment and some

Michael Sofia

Thomas.

Hepatitis So impressive cetera. the yes, efficacy and just Summit mechanism we the of Global of action, demonstrates et presented sort data at showing the XXX of

peripheral assessments generation this in So or we sort have when have associated that we with we the earlier this we've preclinical solved believe also the of on field. agents solved based our neuropathy all commented

to this to timing the in I'll turn forward excited into of volunteers. the and data. Phase moved the to assessment talk So it over clinic we're X into healthy have about now Karen

Karen Sims

Mike. Thanks, Right.

So earlier, do in to before as X Phase to our with predict hepatitis progress putting a Bill we to strategy of assets combination B, certainly it's forward is of necessary to create you as with look alluded that's the data these always in cure combination other But certainly, a functional overall progress. all-oral ideally with question, to is timing your trial combination this proprietary into studies. to hepatitis B, difficult data promote

full for data the from when receive those X So Phase study. set on the we will line the dependent be time combinations

as to that share. to, single information updates And ascending then this as guidance certainly, the later year. we'll we of So the is data when trial progression alluded provide can have dose the more we

Thomas Yip

Understood.

to data multiple readouts forward Looking this year. the

Operator

next of of Roy Our comes JMP. question from the Buchanan line

Roy Buchanan

one XXX, at can AB-XXX So maybe it, or the for an us doesn't but it one, plans from your if something thinking nivolumab And if specific pulling their I effect give the concern more of details had It broad. Hep-B trials. wondering sorry, maybe concern Gilead but you missed on first it's nivolumab, about any any a look like with FDA? that's I'm

Bill Collier

a I the We of call of for fully FDA on the or they I call weeks concerns. stage that still or a think put the any back Roy, mean detected their Yes, hold. or because thanks with certain surprise we've to like clinical of us the on attend expressed to prior this where predicted attended heard and not we're early understanding wish type program couple at did this intervention at submissions. our That telephone was of members in all discussions question. least FDA's a

other can't the can we within letter the fully We position that FDA either I entirety And would advance we FDA shouldn't probably see still with XX so also to are or the work days world understand, more say much to the that to continue letter they that how meeting. too XXX. Roy, the that understand can indicated continue bodies send you'll we then regulatory or think we awaiting that until really of and FDA's full of the around see

Roy Buchanan

then makes between differences off-treatment the That And to And a yourselves we to up and go potential surprising, alone but just patients, with data, I talk the thing, see Great. X right? X. creeping XXX start The any the you most maybe Okay. you NUC. and wonder strategy about see could to is [indiscernible] GSK any bit XXX in Phase if GSK. S-antigen back same Phase does sense. one not in the

Bill Collier

X antigen we boost we and to Roy, DNA, we scientifically is that's where do and out the and system a will our think from suppress of And development net wanting kind both surface HBV I success. of pipeline pillars Yes, suppress we to immune back question discuss. a that's where think perspective, find

those XXX we looks XXX a be with assets that, companies. would But potentially we combination quite marketplace, our view cornerstone tackle said think to to other assets impact fully those going do having this able it's either a an And is combine really from have the need to X I Now have profile of our like And assets. components or that being conversations. of good is impressive. on in to current

Operator

Dennis from of the comes of line Jefferies. question next Ding Our

Dennis Ding

Maybe up to question. follow Roy's on

see your couple in But X, wanted of you kind of different you terms forward company's like take with with to move compounds Phase the own need Phase move to compounds X. want X you companies' your you sounds do it Phase combo data forward? it, is from be you In XXX it What with last over other to which to that do combine additional for your in of from consistent could in and/or messaging years. assets, confident additional the you you for other XXX what need data compounds to

Bill Collier

Dennis. you, Thank

our a we in HBV patients are met is treatment. without antigen DNA with are now Phase with treatment surface They've prolonged of X undetectable undetectable and antigen post that response. very in definition the sense functional the months HBV which Although off-treatment the for immune not yet off who got X they're encouraged they've cure, or and surface DNA, reduction

to the or of viremia, studies incremental where absence of able And think the clinical in follow-up treatment, see question, we into S-antigen our of low so I Phase stop we're can whether levels antigen maintain get Xa not of Xa we we'd And have period patients to those low to to want therapy. answer we then studies, your ultimately, some Phase reduction. see X levels further when surface from like

Dennis Ding

I follow-up, And may. as if Got it. a

we off-treatment a data could those to want combinations, out, to robust Xa be 'XX, sounds as from Phase it other could more see data it well. going data for Phase potential from with studies Phase way be our Or there waiting are you're Is like a read the of to including just So which X accelerate while, those X? X to studies 'XX. sort your

maybe So comment that. on

Bill Collier

Yes.

we those into conversations X accelerate but So we different a how by work. I going We think big bet, and about explore driven get Phase that be Phase we something forward. to make financial do before move to have need data. big we've have be do pretty ideas, different can sure internally and we on to And a got that's we bet study, a X options,

assets we be earlier cornerstone going So either believe got has we're companies. also profile combination shown like flexibility I or I to others. XXX with a little think studies our done Phase to good patient the while. have be to assets from to our that to on, we but that agent in Xa in a for with yes, partnership we've other work internally both with But have a way And a really we're demonstrate prepared that in said

Operator

like this back closing it Instructions] turn [Operator I At time, to Collier would Bill to for remarks.

Bill Collier

continued you, support and this interest updates we We us everyone, for joining our of providing do and Thank for we development and Arbutus. your all HBV look coronavirus forward as the questions appreciate And morning. to with assets. your progress you

operator. morning. this very for you thank So That call concludes our much,

Operator

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

You disconnect. may now

Arbutus Biopharma (ABUS) 4 May 232023 Q1 Earnings call transcript