HOOKIPA Pharma (HOOK) 15 Mar 232022 Q4 Earnings call transcript

Good morning and thank you for joining the HOOKIPA Pharma Fourth Quarter and Full Year 2022 Earnings and 2022 Outlook Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions]

I would now pass the call over to Matthew Beck, Executive Director of Investor Relations. ahead. go Please

prompt slide the A the today's is as call website. Thank and deck in through we slides the webcast manually of through the available them. Please you. advance accompanying you events HOOKIPA section

Executive today Katia Chief Officer, Financial Joern me Kandera; Joining Officer, Chief Reinhard and Aldag; Chief are Medical Schlienger. Officer,

our the These clinical of statements regarding, include today's we be will may utilization plans. call, non-clinical intended making other and statements efficacy, things, During investigational and agents, certain forward-looking statements. safety among

present plan anticipated and of Our plans, clinical additional conduct use and or investments. research to report trials, data, the development future future intended and the and possible source of cash regulatory

involve are information, the may on with current that risks the SEC statements to that cause annual periodic assumptions the forward-looking our in actual are and These made materially statements. based are in and change reports. contained risks described from those our quarterly events uncertainties expectations These other and and differ forward-looking and subject including to filings

not made to only these statements, such on forward-looking place to Company reliance any undue are update statements. cautioned date. obligation of which disclaims today's as are The You

our remarks. open Joern today's provide For comments then will up and opening will high-level offer on the call, call Q&A. financials we'll Reinhard to

pass I'll to that, the With Joern. call

clinic arenaviral unmet we programs highlight considerable the and morning CDX disease. In create I'd to specific second XXXX. both to accomplishments saw across coming combat what's of in like unprecedented four leveraging areas platform progress in and everyone. deliver Good XXXX in our Okay. HOOKIPA, to cells our focus on XXXX, different therapies toward in need. first T antigen At that we're

in and to Slide approach partnered acceptance are cancers portfolio XXX the with cancers Phase achieving or developments X antigens the material which combination pembrolizumab, a hepatitis X, our 'XX HB-XXX target X targeting of and Phase positive and collaboration HPV site. self-antigens. Please mutations for novel cancer vaccine. with an for A were Key therapeutic cancer arm for single in lung, KRAS shared our drug readiness prostate colon to Roche cohort go therapeutic progress of in has pancreas new B IND with Gilead

you bit me more Broadcom major on Let these a give achievements.

patients dose showed showed magnitude HB-XXX neck and We tolerated, progressed early HB-XXX and to X study Phase X. cells that HPVXX-positive high carcinoma head T generally a as rapidly and treat and Phase well activity Our tumor testing escalation was anti-tumor and a specific of patients induced difficult cell to squamous monotherapy.

patients the combination cohorts, setting of in post-standard three pembro, enrolling expansion cohort X at the line plus a with cohort Phase with the of in dose. and pembro, setting second patients currently in a in second cohort in setting setting dose the We're line line in non-randomized recommended non-randomized care and a first combination

the Regarding guidance. data HB-XXX QX trial, our I reaffirm

disclose XX monotherapy to each will provide on will combination from with in and first update dose an we data and in second We settings the our cohort. line escalation pembro XX patients

in a cohorts release call and an quarter the this press in three likely forward. the second trial present about and an on will and We path all update investor inform

oncology. the our strategy an supports part targets antigen a of which our first As pillar three trial reminder, oncoviral in HB-XXX

enrollment The undisclosed and collaboration in we guidance to a Roche trial the second open our field of HB-XXX develop in The announced new an pillar and oncology strategy. oncology second with in HB-XXX acid, this for a to pursuing we KRAS program antigens to the in mutations October, now our is self-antigens indications In XXXX. Targeting advance as with third targeting trial pillar candidate. option multiple our is our are per is cancer. targeting strategy which QX prostate start

acceptance by file last using can support the across progress IND platform the File. July information by that Drug our Master about pleased to We're the to oncology times. new used The leading master cycle well FDA as be pre-clinical our filings as from portfolio reduce

After been the collaboration, end restarting plan collaborators XXXX. HIV the bring an Gilead progress to it made. Xb, academic to our working program our control Regarding under IND and filing of HB-XXX we're our much has Phase with in

HPV The guided hepatitis IND XXXX. XXXX, payment. program keep we as to well, trial, B contributions program start milestone completed, a progressed planned at for million Gilead the triggering and will X the we preparations this in

our expansion shall move combination what's XXXX guide HB-XXX Phase to versus 'XX? three alone. X for into in The HB-XXX in decision a readout randomized pembro of pembro our second in plans of trial So cohorts quarter all the with

Track We with a Merck for U.S. for supply such have pembro trial and agreement Fast designation a

progress In good targeting start cancer, in prostate are XXXX. two reflecting significant will our trial recruiting first X now, significant milestone HB-XXX into with had a collaborations. start in we expect initial patients, half dosing data our payments, Phase We we XXXX the of

completion hepatitis using from Gilead package X the regulatory delivery million and the cure $X $XX B second Phase of chronic one, for support for and Roche. trial a their therapeutic First from a HB-XXX for clinical of payment million

of manufacturing KRAS We an expect XXXX. Therapeutic, GMP of we important which step to happen the are IND, in the first the before starting filing half

to candidate file HB-XXX XXXX. cure IND in expect our We therapeutic HIV

Roche XXXX. the our package KRAS an as on the Therapeutic continue for to Roche decide option for which target, additional on exercise will as may work We both well in

we are with an In our materials from and we have come progress positioned programs. exciting XXXX, summary, in key XXXX significant for to [indiscernible] made

Finally, we end to that balance like highlight significantly at year strengthened have million our cash I'd with XXXX. $XXX

data funded readouts. for well We many major are

With financial CFO more details. over that, for our the to I'll Reinhard? call turn

everyone. Thanks, morning, Joern. Good

to full give for and results year fourth highlights you few our financial the want quarter a the I of So, XXXX.

payment we upfront received million payment and shown and Slide Roche As amounted milestone on the of which a in to $X.X the start with Gilead, under of quarter collaboration. the revenues, million, a year presentation, our X included ended of from the the recognition strong $XX

the much quarterly a leading to average of very net with was quarters, $XX.X previous spending loss for QX QX. Our in million of the line

For through capital $XX to R&D our Gilead significant from and quarter achieved from our position, to out cash I million achieve which million that Roche. raise including compared start a want first Joern has lower we XXXX the in to progress to XXXX able by and that also detailed I'm the $XX inflows partnering, a significantly were results, report cash pointing $XX proud spend XXXX. million we from XX% just strengthened at

loss increase the expenses $XX more moderately we grant below but interest higher a million, net than which G&A slightly less income. XXXX. reported Our increased, and than XXXX XX% by offset of is year full Bottom-line, was

tightly our spending. on partnerships rely run support our to manage to and continue rate to We

We progresses. expect XXXX increase as our to in moderately expenses the pipeline

receipt evident well a plus contributions to million total $XX catalysts. important payments. financial were million The $XX partnerships of With income consider a the in the funded pipeline in balance XXXX. cash already of already end upcoming by in the reach from at the beyond partner achieved 'XX of XXXX milestone milestone quarter of million first of ourselves $XXX.X in We

With to like some that, closing back I'd hand remarks. to for Joern

indeed to our capital produce our and to our this focused proud the objectives Thanks data and of you the market to end Reinhard. drive difficult support We're the coming of this throughout year. shareholders very companies and present their talented We're people clinical call. environment. updates to laser I'm throughout

on Q&A. Operator? to like I'd line that, for the reopen With

first We'll Capital go Instructions] you. Brian Abrahams Thank at Markets. RBC [Operator

sense how what's and my for range, fall another about XX% you HB-XXX after and you XX% on have of care question. achievable? pivot add the Or depending where to what's to congrats thinking program, for next and what the are is for standard I docs on Leo each that. the out patients your program? or tease rates see? meaningful? If follow would look Brian you for And to would a How on maybe thanks you the about would It's line in are steps and thinking And of what quarter the for bar taking I'll find and respond? response mean, you up modify more

more first then XX% we meaning able rate response response HB-XXX the care of if we the objective you of response has rate it, of XX%. but know second pembrolizumab specifics line a on give combination general we the to of of in cut line, success and double objective XX%. the around with standard that in And pembrolizumab. an response that these with considered And rate standard care objective together reach we're I'll to

I think look data. bit we And will that, Yes. a of it's totality too at the the

are we would want we in marker We to the resume, if immunogenicity, at decide me will or not. and look So we start not then would efficacy, to the we at clear look trial online. if of the other it's

making to will the that ahead be know trial XX% objective response rate, totality Phase that be brief, the a decision, data X of is fairly in if investment. that going make because in signal but clear a at significant this looking we you So we final go with a there's

around two And then patients Have the maybe it Are for data that at press patients upcoming be submission to time? going mentioned follow-up follow-up that presenting expecting at quick the than you release. a cut? only in on you'll more same meeting be be you with talked you present And scans? a medical data you about we'll just Is how a that. the looking still much

and have investor We an intended event. time to this point a also release press in

medical the data conference will after So, the we Katia. substantially and detail the some summer. point

exactly add to to more that. Nothing Yes. that,

conference afterwards. Of course, our we scientific will data present

next go at Purohit to Morgan Vikram We'll Stanley.

Hi, Vikram. is the and for on everyone. Thanks for congrats our questions on quarter. Will This taking

and Leo's give the consider we the of just when? points same for to HB-XXX see initial data terms question. in Could How expect expectations the the data what a sense kind would frame you you so as first half? of expected of what for you and vein can us Just would

clearly first self-antigen, would a antigens of We're establishing in significant at half we've against chosen be win the looking immunogenicity the XXXX. a that Katia.

as we expect have I surprise, based profile, program demonstrated on we that, safety excellent with exactly of well that the vectors. you profiles [indiscernible] readout it's as exactly lot safety using the a XXX know think No, the same our don't

come So, all information this into XXXX. will

with going press well? be or just to be that a conference is as that release can And is associated medical

the availability on major timing the we yet. a Depends could versus conference, not data it's decided which represent, of

to America. move Stranahan Alec of next We'll at Bank

Just a updates program. Appreciated the on XXX color couple XQ additional us. for from the the

And the think that capital to the thinking it's partner XX population? HPVXX-positive months, obviously, population. in obviously, an funding any through apples a trying on KEYTRUDA that's few perform monotherapy got worse broader reason studies, new think a better well. just next starting there priorities those to to we're Just As the if and as than apples? head neck would controls, or allocation then Is are some historical

of focus sort of allocation? where of it's runway where guys guess I main you does put capital sort your and terms So that of terms in in

Katia, would you take monotherapy question? KEYTRUDA

Yes, absolutely.

randomized Phase to pembrolizumab with trial for a head is So, patient which terms X that neck in first line of squamous [indiscernible] and approval in led carcinoma. cell

first Now, and with and around difference HPV head ready between to that positive but something were the patients those you let's so HPV thinking specific answer I'm question, of question? known and negative neck

And allocation. No, I the helpful. think that's capital from

so at T priority is from the allocation, that this a by perspective significant key along. if on is HB-XXX against tolerance. breaking able important and the responses HB-XXX and for clearly point self-antigen, strategic generate Okay, cells targeting immune self-antigens, capital we're moving to because

We a pretty good in camp. are clearly

our is number important. that priority two, So strategically

capital which with program after KRAS through are Roche. or HB-XXX an which important take Gilead we and perspective, is basically it interesting has we option also in from Clearly, our very that But program, Xb of are the Gilead running receiving end both that are HIV we funded these Roche. Phase and from the payments are programs a to until running allocation the

that's HB-XXX take HB-XXX So your addresses obviously and and including avenues various to randomized where trial HB-XXX. its progression forward, we question actually the key and in have spend the it

like runway, that have Regarding the answer cash to Reinhard I question. would

Yes.

on of don't the uncertainty outcome, to numbers, dependence give we mentioned the the increase cost R&D that our specific can give Given but R&D moderately. orientation. business I I've you some going and is

two the to provides we Gilead support big Roche revenue hand, that from with and partnership cost. that cover have increasing other the partnerships On

in loss million. $XX be net in year our current around similar year expect to the previous large the and by So than

we partnerships end. $XXX is There than another mentioned, I've quarter. in the at As from have million first in $XX more million cash that in year came already

do So, cash this terms you in runway. I'll for let to of math approximately us takes the

you. Thank Great.

the to forward Looking update.

Wainwright. take C. our from He next will We H. question at Arthur

hello, my taking question. Hi, and everyone, for thanks

for HB-XXX Just program. the

the first regarding data Regarding us we the when give study randomized could from specific study, Phase randomized and could the more you line study patient? X a for initiation, expect the

product. been the obviously, Well, manufactured of first with HB-XXX a lot preparation point, a has done

apply. that We in clinical have we a place protocol can

relevant informed the from make and with discussions that be information that CROs we which running, about have on had that our to decision that we is have would the which folks trial. and We trial, June. clinical we based would support is ongoing make And decision clinical the reporting will currently coming

timelines, the specific hear data when we more release. will So you do

to Katia And a HB-XXX from data when randomized maybe started? flavor trial program it on gets initial

as NDA just a a have for that we disease that from the seen recognition And Yes. of have first reminder, we study.

have We Merck. with disciplined agreement a

already arm something of data design Is that basically to cohort discussed Arthur trial FDA. the our like into deep we our just is have to from the else the or? have look helpful the single a I move with And or make to data a We enter ahead. decision HB-XXX should would

that's Yes, makes anyway. that No, helpful. sense

more interesting the that ACR is the elaborate for target, candidate? particular so, And you at upcoming on your quite could presentation for

a of tumor. sub-optimally T the site significant immunotherapies are at efficacy know with because We lacking working of the do number they're to cells that regard

For very number actually help that drive that a ability tumor specific that immunotherapies reason, different we're we able to these of levels could antigen antigen high T T were cells cells. work. of to the this towards specific to drive claiming on And

AACR, remember at X-XBB. some demonstrated that combination with may year we the last You

HB-XXX And be across to In we're is this pleased enhance can looking immunotherapeutic at that that show, a combination has significant the presentation time a for in you we're we you're different will a in the minisymposium therapeutic these as albeit we AACR, of with think what AACR we being have very types of presentation, significantly patients diseases. with that IL-X, many over trying going to. which combinations, what we're promise And that preclinical well. cancer actually different data effects referring at

And Securities. at Goonewardene we'll go next to Truist Asthika

they're the patients bar forward asked second to [indiscernible] during about with looking in the I go the data back first want to quarter. question the here the

the of we duration You on planning you response told got I-O of. know on in boss that. you're cohorts that presenting? durable you denial in follow-ups shows that is have us about couple a also both think a And response but response rate, nice do of as What the of those I've works, and

Katia.

Yes.

a We for disease So, as with number we're sometimes efficacy on planning so at some Indeed, shown like patient our vector we a to of and single with other rates. control look have agent. see disease endpoints stable that months.

to report And so, as we're planning well. that

what of duration of we we patient response, of XXXX. have knowing terms will wanting will have started that be In this to and beginning at the

that point we maximum to will second data have to in at to guided So, put patients the XX line and this XX we line. of first patients in XX we XX

the present more cohorts? think So the Or maturing be in enough of maybe what understand duration see I'll of these to this responses data data the signal directly. more to median will in you Do really ask you when a need you duration second response will quarter? follow-up

up at follow for of kind It's update There's each this something regularly to data. of conference. that need to quite Yes, probably continue are we here. that the will frequent

So, we follow updates matter the the release no what. at to would be first continue that continue patient conference. we a and patient will This to up regular provide will scientific follow-up

So, I to important is Katia. Yes, think this note. Sorry

No, go Joern. ahead,

that data median not while is it's important that be from patients, median example, survival able And compare for the progression of across the see we will we the progression set matured will short. has have Yes, note alone data for pembrolizumab. very free against to entire free pembro how to you survival, fully

to that hopefully free more looking you or for survival next follow-up that then PFS would the given of or you're duration? maybe later the term looking year you what progression you're early or like bar when median at duration either said to the this for is this see, longer double the year, And at that ORR? response double Would you want the see double that

permanent not the reflect necessarily the first huge not So that. three it's that We map PFS example provided plus end line patient. line first is second take know months months second I for this line two and for in We and that in fine that advantage does line point. on best is in oncology can that the know

two will necessarily So, we that products. PFS we questions The I right immuno-oncology provide is not the would like measure for all yes have. just what

measuring response, provide on later timing an In this and terms conference, of assess. abstract duration on several is of probably in the scientific so responding. to with a will This progression And treatment will who we to are take presentation. update patients months

And then a immunogenic generating the really the something of feel would emergence our would platform that preclinical too were and And sense the was to it's what How if was was logical that HB-XXX and we kind step this what combo, add bigger about to made work, a to you be? PD-X and strong given attractive. there's just lastly, Previously, know And like pictures that today, of that you other you adding this like otherwise. beta in that anything really that felt making just response discussions and here. that you do that?

sure want here, your about you to just specifically specify what could find question. not I'm out you but

response you're mean, just the with I HB-XXX. I'm the you imaging do need like, to Yes, wondering getting

You're think combination? you immunological for immunological therapy to an useful anything dangerous to signals what perspective else logical think but the you an this Is from is getting want here from that with component time might getting add this would PD-X. of do like, that next to chemotherapy, blockade more you you Maybe perspective? the there do be add think checkpoint to like

Katia let answer be at interesting but the the we question. data at look to that may I'll It AACR, present will

Yes.

like So, certainly we as know.

response high that saw with able immunogenicity that some disease monotherapy, in that, saw infiltrate injection very saw saw cells tumor patient. functional the and in to T of are CDX level in antigen we huge they we and do those We cells to stable what clinical the T tumor. were we specific see So poly circulation. the We

So, in we to the continue with to we you over and monotherapy and tell it exactly months. what develop next like will those combination pembrolizumab would what means. in data To show

look looking what immunogenicity as and we report And between find. efficacy. general Joern the the team think, that, the recently we and correlation we I and is for at

your I Thanks. forward forward it guys. and look to AACR Awesome, as at look well. to updates

you. Thank

JMP at take Roy We our will from Buchanan next question Securities.

questions. great. the for Hey, taking Thanks

few a Just quick ones.

one First make eligible timeframe remind of there the I to still a million, on Gilead me, Is need they you can this purchase are for stock? timeframe Reinhard, if a they has just think to $XX certain that? purchase.

Yes, there is a timeframe.

have We the of XXXX. actually end until and equity, is that draw additional choice to it

Okay, to B Gilead patients be Phase healthy going hepatitis And or Thank then great. if has the volunteers? is you. said and X in

have I don't disclose don't we can. yet that and We think to

have to We Gilead. to leave that

Drug Okay. last use can can the KRAS File? Fair Master for And enough. program? the partners Like just the then use Roche one, it

Xb it can preparing Yes, are use we XXX as IND can that we use work, that are File we in we and Drug and well. doing HB-XXX the from as the the context Master and Phase

great. What Okay, about themselves? doing it? X Can partners that Phase use are the they

you can answer this? Katia,

different can are can an use it, related the so those, for use XXX they -- find done technology. our that we replicating, could two from bit ones that something that file they which product, the They this they are using ones oncology use than certainly Yes. are be projects is the in was in the that IV using that to Gilead once different when is like, a vector

as the example, will what so as our be for this on submission partner Roche used depending for So IND weekly, for will use, well.

Great.

Okay.

with time, a they no briefly, this point X just is it. program. very At use our yes, So Phase can one doing in very,

Great. it. Got

van comes And from at Voorthuizen our next question Kempen. Suzanne

for on circle Thanks question. good to right. Hi, not program. my the I afternoon. it update HB-XXX to the I'm I back just heard taking wanted QX sure

as in press both to response presentation? data of So year Will duration are include well. terms duration And of conference you it include release? follow-up I'll half the the will in can the then what you get And the in you in targeting data of what latter PFS? clarify

Katia.

Yes.

So of have response XX patient be any speculating. duration pembrolizumab but we would time, in I'm months. challenge is to response, just the on duration The terms that a of median of will not probably agenda obtain at for

will time. that So, able to if reach be it's we difficult at to anything know

of We efficacy have associated object on rates rate and will control disclose what uses we response terms endpoints. in

safety those helpful that will and data disclose we will or? it We chosen that have immunogenicity Is profile time. at the

in targeting conference Yes, for year half sure. presentation? Thank for are you. the And what latter you

we will ready. And not when we are decide we So, release do yet. it

with Gilead and there. And in and follow-up like infectious a different at or platform We'd hear that are quality terms just of Yes, considerations some potential stage on thoughts or looking deals X-XBB? on for type Roche as is the your topic you partners can to then now HOOKIPA. a How diseases, development of addition share deals? you of preferences

Yes.

collaboration quite development of actually that. trigger companies and pharma Roche, business adding of any that's lot to a has with and is within Gilead a bigger So, an account and like organization activity take otherwise activities, complex undertaking. Working organizational

So would many our like there tackling, a technology in we're a that, point could, in interested partner this in and and we, we value pharma time antigens not away. if Having currently it. now different programs that platform have we retain that are was we which know company them to said at

the provide funding development other the And seeing capital capital of we're structures markets, would or Company. interesting clearly, provide to them -- also thought one may that the about trigger that the today, way deal

So, our we're question. point very, Roche collaborations in very you're At about with Gilead. complex and asking a this time, happy

time, not be and discussions that to it technology people We look in can we of at and the we At to datasets mature our retaining see partnership value adverse partnering. gets such is strength therefore, be that And we the up. have know proven, important. moment the the Company at same do more that more and interested could come would the other as would

conference time. turn back additional to closing the for remarks. I or over any are no further this questions management there like would to And at

that had And a value to the we've all see looking XXXX. think great and this. would I points important and year to Company valuation shareholders We're tell up future. of to until the gearing that forward inflection its value to basically will some change milestones with markets help the progress to our and big briefly, our times and are curious low doing better inflection really Very that our keep burn we're utmost up of outcome and the points

a Thanks and bye. soon. talk lot you to Bye,

conclude And participation. Thank that does you today's your conference. for

disconnect. You may now