HOOK - Earnings call transcript Q4 2021

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Operator

Good day, and thank you for standing by. Welcome to the HOOKIPA Fourth Quarter and Full Year 2021 Financial Results and 2022 Outlook Conference Call. At this time, all participants are in a listen-only mode. After the speakers presentation there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. now today, hand Matthew would to conference I speaker your Beck. Instructions] like the to over [Operator Please go ahead, sir.

Matthew Beck

webcast is Thank you. slide through section call A as HOOKIPA the website. prompt Investor Director, the Please the of available manually the I'm Matthew deck you Beck, accompanying through Executive and events in slides advance Relations. we today's them.

Executive Medical Officer, X. HOOKIPA of Development, with Officer, and including Orlinger; Technology Chief Necina. Chief here Reinhard Head executive me Financial Officer, Chief and Chief Chief is Looking Slide X. Officer, team The Research Aldag; at Igor Officer Scientific Slide Global Matushansky; Business Kandera; Joern Officer, Roman Baker today and Christine Chief Klaus

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

forward-looking present to assumptions intended These future are plan that conduct of the data, source on forward-looking and Our and the subject research are regulatory expectations report and information, and current investments. or future based materially uncertainties of cash development trials, anticipated clinical and those statements additional change to plans, and use reports. the with involve possible Commission, events our cause contained Exchange risks including differ described and These to quarterly the annual periodic and in actual may that filings made other and risks the are statements. our from in Securities and

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

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

Joern Aldag

T-cells tumultuous for conference It navigated joining for in we today into growth markets progress strategy unprecedented a a need year a you can company supports and our claim that Thank in on on we of have was that year impressive progress successfully continuous financial continued XXXX. scientific to of We which delivered call. and XXXX humans. in drive HOOKIPA. drive antigen-specific this was financing us delivered the levels

to and advanced our patients, to our the cancer control as motivating applied in head invest oncology line the helps evidence pipeline expand We disease neck in indications. continue us technology new a with that broadening monotherapy

different two missing the the Beyond self types to wide virally combination we to induction. modalities antigens We break but this HB-XXX overcome driven in especially towards HB-XXX driver most We're oncology and cancers. opening mutations. for the the Prostate cancers, the mutation-based to T-cell cancer many in cancer challenges by in demonstrated candidate providing space of tolerance targeting with of animals, incredible essential other and potential platform, KRAS immunotherapies pushing many high-value see frequent programs ability clinic.

is granted through pharma for agreement a a our us pembrolizumab HB-XXX with testing HB-XXX. trial science Our markedly of Fast come first-line Merck for with We through an of FDA progressed and Designation responsibility front HIV clinical KEYTRUDA combination continuously taking Gilead, on signing The the organizations. supply leading partnerships project; this the one, setting. Track for partnering back renewing collaboration two, in with with with this, validated Xb by to Phase the I'll by;

partnering with advanced collaboration also partners. prospective We discussions in oncology other

to We cell our we million Xb in to functional well-prepared for collaboration. to us million XXXX million a end first financing XXXX, follow-on high-quality and helped of responsibility cash $XX the million investors. cash take HOOKIPA’s As of plus took data asked speak of execute $XX us beyond. adding received an give these development existing nonhuman knowing securing us transaction $XX of payment our Gilead forma data candidates proceeds down This earlier, $XXX significantly our in of position upfront and models, and our They their area us. bottlenecks development the up And the primate with our milestone December take runway a faced and Xb. from development and the in addition facility million I into accomplishments and follow-on provides million $XX faith the additional a option HIV in provided early in new T runway Phase by Phase XX cure to with a HIV program a Gilead wanted to of execute to pro cash the drawdown offering, Gilead position, million and this mentioned in $X in strength after the Gilead $X ability extending exchange, that mid-XXXX. the nonrefundable the equity and back investor facility us to a believe

So what's in Slide five. store for XXXX?

arenaviral types various that platform, Phase needs month will presentations with unmet potential to HB-XXX poster address monotherapy of or data. we we and Next at evidence in AACR, further modalities. either of alone share in provide combination our the broad update four will X other preclinical our mid-year, clinical of cancer, In translational

the give X and will activity HB-XXX. of including HB-XXX anti-tumor data We additional and a escalation HB-XXX, program, safety, HB-XXX comprehensive Phase dose translational overview of

advanced dose the discuss X will we selected at two-vector care. with alternating our all and in pembrolizumab initial data the third-line current the X for We known Phase setting any X the we nor To will HB-XXX or HBXXX status during program on be this will update. path Phase Phase the in clinical time, update for combination of Phase provide in And as not of HB-XXX, X clear, post-standard the therapy. patients present

targeting first HB-XXX prostate neck set patients as this HB-XXX combines half cancers. second-line We're the the in cancer current second-line platform, of a arena for provide help address versatile these unmet this year, and -- patients. and pembrolizumab tumor exploring target our late has total also HB-XXX significant or targets, X attracted to We first an cancer. pharma fourth prostate in head standard safety needs Last patient the in efficacy pembrolizumab and we're the least, file seek This known XX virus the but of present and dose and in current will, this have to the efficacy in of key approximately several initial report to rates care of first-line program year combination on this With data PSMA large in program, KRAS modest however, with mutations our from agent of the people the program we early response aim companies. the in relevant incorporating to the to Phase immunotherapies interest schedule PAPP KRAS trial, quarter indications. year. in quarter [ph], and results to started domain double castrate-resistant second IND additional for tumor quarter a XXXX. not initial for PSA settings third tumor aim on monotherapy and first the improve and which data XX We We of

funded all can not we expect expect. XXXX. in of programs, filing in virus we're lines, now and through are committed these XXXX, cure that control to Finally, this we their in of HIV and by Gilead IND HOOKIPA B time file and they is functional us disease IND our the end on what tells our the to milestones that I is is Though reiterate Hepatitis beyond. that of infectious HB the schedule HOOKIPA

invigorated deliver. promises bold team XXXX for have and the HOOKIPA to is We

to brief to our Now pass on I'd comments financials. Reinhard like call the for Reinhard? some

Reinhard Kandera

the actually Joern. want the reflects results financial ladies year you, we I made a Good which for you Thank gentlemen. highlights XXXX, morning, year. and have in that clinical past few give to of the our progress

and milestones as of good both this collaboration towards revenue we moving reimbursement X now partnered includes line cost continued high that been making have trials. our Gilead level preclinical the programs collaboration and clinical Phase the revenue Our is from of under evidence are progress

we research Looking was pipeline the the A at to of in this level seen R&D we R&D areas executing trial. these encouraging development $XX spending based the expenses those The able expenses, portion overall oncology of quarters our programs. spending significant our for $XX the the relates XXXX in so in in to XXXX effects maintain while already from increase XXXX operating main HB-XXX, on spending internal million early investments on expect our increased antitumor and to resources coming the activities the driver HB-XXX in and in to XXXX. of HB-XXX be increased our million and

net, In below currency effects, in in the control XXXX which terms grants were general income and of consists XXXX mainly and and able the offset was therefore decrease mainly our under we fourth slightly partially XXXX costs, year this quarter of levels. of administrative is subsidies year-over-year. by and to operating Other well to G&A expense even keep

XXXX this as of compared progress. XXXX year R&D the for $XX XXXX, loss by was net clinical being million to a million with in $XX spending driven result our Our increase

made cash $XX of XXXX property, GMP prepare from million. was investments million our in to for we $XX in next equipment, in manufacturing outflow growth ourselves plant mainly Our operations requirements phase. and in And addition,

to strengthen greater added as cash Our increase to to we proceeds, to cash. difficult to remarks. funded back $XX for year-end that, would forma it to million add we in like but our well the by Gilead well environment, our we pro a today, potentially collaborations to putting position cash With see overview, $XXX $XX that call funding significantly and seeking of are With ourselves coming I leads cash Joern short emphasis this in on were we through want good progress non-dilutive the and would quarter able making catalysts, These was XXXX that as sources in some pass revenues. a when offering position cash our first transaction. million, inflows million, of closing follow-on year-end and I are from see funding the

Joern Aldag

Slide clinical of and throughout laser-focused our period, to to market our you the throughout and updates to companies for said drive year a X, with Thanks their this, we the would Operator? proud for up present lot open to this people data listening. I'm I very shareholders And produce and support as we're like earlier. our and Q&A. difficult indeed objectives

Operator

line Your comes of the from first from Please America. you. Thank [Operator ahead. Instructions] Stranahan go today Bank Alec of question

Your line is open.

Unidentified Analyst

everyone. our Good and on Alec, thanks Hi. This John for taking is question. morning, for

running you're on So what the light in? what I has it. to running the one kind cool be Thank And my believe that it's you're Ib? one could also, you. Phase metrics the some will kind for some Ib you to be interested just about I for, looking it the X basically – HIV? any you And of for what specifically shed on that specifically focusing would Gilead Phase there's specific contemplating for you're also the if are Phase specifically, get parts they but -- HIV of Since partnership. trial Gilead yourselves, outlook think And question about question more

Igor Matushansky

the for Thanks question.

we that Ib the by of of a safety So trial. and be to as doses assure The immunogenicity lasts. The number immunogenicity well receive of we have previously individuals controlled safety said inclusion off post-dose as endpoints The long Phase who running include are stated, reactogenicity will we first six clearly part will to question before, a patients I and patient assess on have will immunogenicity. therapy that be is, the antiviral criteria limited therapies. planned observation HIV-positive followed approximately months how will

have range We been number of plans, are or finalized. in planning but current XX yet total are with doses the the that two patients a and currently XX somewhere not

see months But We again, immunogenicity at actually last might that. in looking safety of is the after terms clarifications a trial designed, they dose. the second endpoint for as your from be lasting the for? specific what that is be Gilead general is will looking question, don't our six In could on the what you of have and way

Unidentified Analyst

All right. Thank you.

Operator

you. Thank

Abrahams go next Capital line of Your Please ahead. comes from question the Markets. Brian from RBC

is Your line open.

Unidentified Analyst

and Thanks, for our Steve Brian. taking progress, on This Congrats good all morning. questions. is and for the on thank

kind similar program, As some you require of associated do vector might to there? and the additional expect antigens, with and unique checkpoint targeting HB-XXX of, Thanks. the dose how HB-XXX tumor the Do responses T-cell you antigen testing? that you are, about or inhibitors there that challenges much prostate combination from think infiltration on translate learnings clinical think will

Joern Aldag

Thanks for the question.

translated there So a to program. being are I'd fair a from is of the amount learning XXX XXX say program that

terms to studies our and as GLP clinic majority do the that of and antigens. equivalent don't similarly from extensive filing. the do actually the antigens antigens the platform looked of we will the a of our at appropriate technology amount and we whether we to the support from we we nicely T-cells regardless or discussed XXX they this? as so comparing pre-IND believe have Pre-clinically, our immunogenicity did In actually XXX mouse we viral a the all or data to the made all, the clinic antigen mouse in technology cell use are -- or that for apply clinical, that will pre-clinical repeat believe able as about have virus we program -- whether comes specifically to for that translated studies of technology we human whether pre-IND are not program of CDX believe looking -- mouse see not use for where self-antigen. the the similar to translate a T-cells from Since program, First XXX from self with anticipate is the the to XXX. or to data and induce or from antigens, of self induced the itself, can pre-IND toxicology we vector do at XXX antigen-specific to FDA viral we actually when tumor actually the XXX as Why

would the as preferred the schedule There it is, these dose the technology or level program it XXX with, we will same. T-cell do drives viral is be we at would program is and on administration. appropriate, because say, dosing I do way we we we tumor pre-clinically, believe the is expect well well. matter kinds So escalating questions as CDX self-antigen. have the actually the appropriate intravenous it's we dosing QX, cells shown angiospecific And know the starting for we I observed will say, the of XXX that schedule be what no The we regimen as that that responses T doesn't whether and for the know and the give dosing, seen rational of preferred would not, that

applied shorter. the Does do programs these program answer escalation XXX should we of anticipate significantly anticipate learned dose or question? program, will that which to of we XXX from we the be So things, have dose escalation be the that that your

Unidentified Analyst

Yeah. Yes, all it. Thanks that it color. is. for Appreciate

Operator

Thank you.

comes the ahead. Please question Leerink. Andrew next from of from line go SVB Berens Your

line open. Your is

Andrew Berens

thanks. Hi,

how didn't just sounds us me. going It wanted that of doubling PK. head the like sound couple a best the be and clarify no there safety, that like data be? seen neck EGFR be checkpoint X drew And It then number small from it the cancer Just responses mostly versus efficacy in checkpoint it's, the alone. to but to Can of -- so number you And for far you of more was any what there to And opportunity, for a from just sounded I combo, of Phase targeted X. patients. activity benchmark we've will tolerability a the portion. specific some a some efficacy Phase that know obviously, [indiscernible] compare the give does like of would I out

Igor Matushansky

couple a things just can on that Hi, I comment Andrew, of said. maybe were

just where the as kind clarify, be the been as This long efficacy enough just patients the will XXX. time, or population cancer the be middle still we will we yet gave year, yet presentation on XXX of on In several the has XXXX focusing update well were on or clear. have that November previously commented updating that ongoing where we update of monotherapy to not either updates had therapy patient the me at attained. that we XXX, Let were on that advanced scans

enough it be update. approximately since not therapy, on that because were efficacy patients ready the or at XX therapy gone since would there anticipate long the have determination year, an total in on for has not yet our of So been November they we middle additional will that

not to the that XXXX. So middle be not this our not of pembrolizumab end talk it that our patients updated have first of are the yet because new in of will year, setting, in there data last and at will data available about XX we will yet at presentation. has been with The combinations be presented second yet approximately line that was or some

Okay.

hoping that the in response XX% pre-selected to reason inhibitor significant we cells that a CDX XX% T rates of checkpoint population, expected have are before tumor even that approximately why the only them would double that response like we patient of terms inhibitors response. not other rate through attain, is front allow line CPS rate responding a data. has PD-LX or missing high like to the we why that antigen-specific the have In a is there because XX% are would pembrolizumab believe the We stated response are checkpoint a pembrolizumab to

antigen-specific So top we double tumor of we the believe do to be on pembrolizumab, rate. able that cells should response providing T by CDX XX%

we on thrown the on study a pembrolizumab In So XX%, somewhere out quote. that XX% the in constantly XX% has XX% in range have based line, in approximately line. depending you the doubling to of the what mid-teen probably rates a somewhere response number is second first an the

we like XX% biology that our would that And double we like they're reasons responding of again, tumor are that believe understanding to to those would is for and missing antigen-specific we CDX with can So T in similar response rate. that the believe bring concurrent not cells.

second get to response XX% us the we'd And like line, somewhere in rate. in so the

Andrew Berens

That would definitely Okay. be compelling. very

patients enough of Just lines to the both could enough give us of end in rates clarify, that the data and you'll have therapy? by response year

Igor Matushansky

expectations. in have XX total anticipating patients we are support We to to between might these somewhere that in XX totality,

Andrew Berens

Okay. Great. Igor. Thanks for the color

Operator

Thank you.

RK go line Wainwright. H.C. Please from comes of question from next ahead. Your the

Your line open. is

Thank and afternoon good Good folks. morning you.

Joern Aldag

RK. Hi.

there an us ASCO different idea can you of in the conference what coming give of up couple four expect to have At weeks, since you presentations. a

Igor Matushansky

Right.

biomarker and studies. on commented already from our focus will ongoing predominantly they So our preclinical on, some as data Joern translational

some updating focus our prostate cancer and additional of from as some ongoing work trial on XXX. clinical with on work, as our XXX, of biomarker XXX work, We will well our

to the a then putting get it maybe going Do two Thank get And program, to XXXX? you start kind in this what that. be late you is the of going sense HB-XXX sooner program done? stage of are XXXX the to XXX needs need level for XXX certain into much before XXX or that sense? for to and you questions. early And two, clinic, development started One, or with you how in to

Igor Matushansky

first me well. let from to XXX didn't the is data second any So hear the additional get program, dependent KRAS clinical The program because answer question first, I the question not those on programs.

clinical that start KRS will convinced move reason, and as will actually or a further have ready that XXX that forward. program. the sufficient or sufficient data in constructs We as we have So that other initiate soon to are manufacture we sufficient we data through, We program product a that programs that, need are way that preclinical the our the additional believe program do clinic. data from to to activity and read with not clinical program,

Joern Aldag

regarding more to be It's IND. only time XXXX like for going point to the be not the it's So XXXX your line, going or beyond.

Perfect. questions, you Thank my much for taking very gentlemen.

Operator

you. the line comes from next Please Instructions] ahead. Buchanan Thank Securities. Roy from JMP Your go question [Operator of

open. line Your is

Roy Buchanan

the program. maybe the a to Hi. questions. I Thanks for start, taking XXX up follow guess on

it's or US, I time partner mentioned you are to it's said manufacture your that this have you once you pharma. is ex point, early. then it prepared just capacity Igor, it. takes -- you're this interest just maybe guys the about to just know at dependent up standard Thanks. in on remarks is able it Are there? planning the program? or what you I attracted manufacture it sufficient ramp to And you to guess, So thinking significant the that, out, from

Igor Matushansky

and the it's question lot with COVID up and -- I line vector of premium with to currently them answer the second mean I'll viral question for others. up always booked of are a CRO a standard CROs vaccine time with ramp are at for first. program manufacturing a combined the slots,

So a I ramp-up and of time slot. it's can think times get standard a we matter when

Joern Aldag

we question, the of part want. very is a KRAS first obviously, interesting the And target that Yes.

seeing. We a buy combined common string that KRAS cancers, the -- have in actually T-cell together strong context possibility of is that We at program. say of a pharma looked have internally most I to do induced It's interested in thing that put high-value the the role incorporating responses cannot the progressing the and mutations actually think mutation companies play we're clearly and we're beats more. a approach. something with

Roy Buchanan

on Okay. And know inbound program? the are not but Great. I on for you I disease, interest? out are you actively guys any CMV just had you partners seeing a focused are seeking that infectious one program. Thanks. quick

Joern Aldag

It's early stages in partnering.

HB-XXX we're to infectious committed of have companies progressing into program. programs. disease We dollars interest an see outreach to the through pharma And in not our investing to level the

Operator

are further There for questions. you call. you. conference today's participating. This Thank no Thank concludes

You may disconnect. now

HOOKIPA Pharma (HOOK) 24 Mar 222021 Q4 Earnings call transcript