HOOKIPA Pharma (HOOK) 18 Mar 212020 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by and welcome to HOOKIPA’s Full Year 2020 Financial and Corporate Update Call. At this time, all participants in listen-only mode. After the speakers presentation there will be a question and answer session. [Operator Instructions] I must advise you that this conference is being recorded today Thursday, 18th of March 2021. I would like to hand the conference to our first speaker today, Matt Beck. sir. ahead, go Please

Please is A the call Slide events them. HOOKIPA in This we slides Relations you prompt is of for the through website. the of HOOKIPA. deck section advance Matthew morning. the Head as Beck Investor available manually Good accompanying today's

Igor Turning Research Officer Aldag; Chief with Officer, Chief Officer, Matushansky, today to Reinhard executive and and Chief [Baker] including Kandera; Technology here X, is HOOKIPA Medical Head Financial Global of Executive Development, Slide Chief Christine Chief Officer team me Officer, Business Joern and Necina. Roman

X, Safe regarding, of plans. our clinical These Slide statements to safety other during Turning Statements. be investigational agents, statements include efficacy, our utilization among today's will call, intended non-clinical we may Forward-Looking and things, slide, certain making the Harbor and

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

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

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

our data in data secured X. that in of follow-on us disease efficacy setting. and CMB Nice and cash to clinical XXXX. The had welcome checkpoint clinical to has the positive culminating and We both turn monotherapy a and proof-of-concept inhibitor Hey. immunogenicity a patients, Slide to to a our to secondly HPV offering HOOKIPA's spaces in Good make end with our the Very presented in year promising strong infectious earnings early we in XXXX, of oncology signs prophylactic call. Please in cancers morning runway you. everyone. setting, through proud, refractory talk

extended In addition, million we to XXXX. raised $XX runway and year-end our

show patients Cyndi Despite X. data are PE systemically X, HB-XXX data to turn oncology positive accrual the for We translational Please this in time COVID pro-inflammatory EX/EX induction generation. clinical and shown Data month, vector will demonstrated the responses Also of show our of T-cell HPVXX patients who we second programs. specific second strong and cancer, dynamics from suggest injected a publicly in faster the T-cells. a an that of XXXX. T-cell with treatments the year AACR were at both with hope from mechanism systemic of to specific increase had our more data persistent Beginning patients, boosting are even lot At and at be level AACR we first from efficacy and more in antibody expecting in Slide antigen explored will you alternating expected. disclose have immune dual T-cell supporting than will initial pandemic, where levels, chemokine next to more. in which hope doses half a would We XXXX. hopefully our higher half and data or at virus induced be cytokines HB-XXX activation will and ASCO, dose very early

as levels both. an Worth HB-XXX EX/EX combining will a repeating late dose the progressed to patients, Phase a protein HB-XXX antigen ongoing platinum you in HB-XXX a monotherapy expressing being tested vector using escalation clinical sequence, tolerability therapy responses IX preclinical vector filed submission our know showed June checkpoint of HB-XXX/HB-XXX technology based turn a carries such our progressed XXXX, trial IND that on currently the Phase two patients tested have it oncology on or stage first and great and initial HB-XXX an stronger from Phase HPVXX, on a our replicating based Slide inhibitors in Please vector. HB-XXX, dosed and program but dose metastatic treatment, on metastatic or setting We alternating advanced our the trial, agree result. tested included testing, no reminder, I'm a targeting profile. same in have who X. different we checkpoint favorable October, containing as one from showing generate X inhibitors As HB-XXX/HB-XXX or with inhibitors regimens. checkpoint alternating initial is a trial. is In a build HPVXX-positive we data our also first program. from us than who is and/or patients are to sure, platinum we the an Like EX/EX for alone, from and which The single fusion by patient HB-XXX immune our HB-XXX HB-XXX in standalone therapies in backbone. me effect being our in is that

comparable than one XX% XX line and patients. inhibitors and and in disease neck cancer shows XX% PD-X doses earlier from subgroup rates the escalation we better one head trend invaluable Phase the response partial rate of for from of the studies control first head stable efficacy and saw cell In The patients. response, squamous two a remarkable response complete in I numerous efficacy rate response neck and the are HPVXX-positive the terms disease carcinoma or patients,

generated levels. pembrolizumab. compared we two with specifically, The analysis, were December our So to initial data dose nivolumab and interim

patient prior monotherapy. Timbral, The we progressed asked after regimens We two are of we his as WHO the one on to patient in regimen, Phase twice HB-XXX data In and to HB-XXX the adding while highlighted on additional optimize investigator explore that combination. continuing clinically recommended levels for keep dose pembrolizumab on progressing dose. set, rounds

to cut patient the respond visible data of begun radiological had signs off, shrinkage. the and of As tumor with

With the in edition the recorded data. protocol our of longer HB-XXX Timbral, no included patient off is

However, medicine. the re-challenge. in and We of response explore resulted ago, on to preclinical a XX% checkpoint combination HB-XXX/HB-XXX specific combination of Two it encouraging data that and synergistic we see plan immunity safe. in our of trial. is alternating the arena vectors cures checkpoint announced reports Slide simultaneous cell These data showed with that or induce tumor that HB-XXX exceeding HB-XXX inhibitor to replicating HB-XXX/HB-XXX the II program in is weeks tumor the circulating was sign turn viral the IV inhibitor CVAT-cells, against published administration Please portion a combination of and responses to see this Phase X. preclinical vector long-term tumor two to alternating and which the

week. currently HPVXX-positive virus and As report arena and abstract cancers last patients analysis HB-XXX Conference off at earlier, was we early vectors, will in in of mentioned HB-XXX virtual cancer I April. analyzing the on AACR The our HB-XXX are advanced of and based HB-XXX upcoming with reduced translational immunotherapy and data title immunogenicity preliminary

report with HB-XXX on from will patients vectors. single HB-XXX proliferation or biomarker treated invivo We and CDX data T-cell

safety, to time single at regards might in the efficacy which the time the HB-XXX/HB-XXX to superiority with data also show tolerability, we vector This demonstrates data patients and data, clinical be June. vector over program HB-XXX T-cell report first from alternating and approach the We efficacy. have Conference ASCO initial two update from and that, the the the induction program of approach

trial many no later patients accrual wind avoid transplant and in-line last exhibited have for during XXXX. in will the the Phase than of stimulate reactivation transplant technology of the have confirmed We From drastically and slowed immunosuppressing identify either against their sites or based and patients We plan the in patients X. immune to turn the infection CMV. ongoing organ in and to Slide XXX. Many expect in late the the with down now our primary a this non-replicating responses. CMV is CMV our of preliminary quarter to months that mechanism to intense viremia, we year, to system II recommended data reported cytomegalovirus our this recruited QX in XXX target of safety, we against gears COVID is expectations. II year outbreak reductions time of of Please of slower expected. preventative driving third Phase vaccine periods. dose schedules disease transplantations, we situations. efficacy Switching HB-XXX designed transplant immunogenicity, an difficult original or use anti-virus approximately post-transplant accrual. and which shutdown positive T-cell to driver by the continues Phase on Also, antibody kidney II trial action Enrollment than

includes for the the forward post-transplant. As for will monitoring planned patients you inform their second of for to this data The protocol may year further recall, efficacy program. half about this outcomes and our path release next provide trial data XX-months

hematopoietic We Prophylaxis the space opportunities congenital transplants kidney CMV in beyond of transplant, of are the liver cell at in process stem the analyzing CMV looking transplant, and infections.

this. Chronic clinic. We to request Gilead to Slide provide the and therapeutic to HIV I approaching development that, cures HIV to as progress, development we on which one will Hepatitis for the Our With collaboration over Reinhardt are milestones, program believe is seeking B satisfaction progressing please. timelines to however, anticipate for select in are is we continues for for the X are Gilead and with further Go including We financials. reaching controlling all XXXX. comments Gilead, unable turn of in

everyone. morning Good Joern. you, Thank

the and increased looking our as even our phase results fourth a decreased the to the follow year operating Slide to on cash December, progress we very advancing balance. with next slightly X, our On million made full-year summarizes Despite only financing business and results. successful of loss the full-year importantly, and to our well, are studies, cash successful compared XXXX. financial development that XXXX clinical we in flow financial XXXX. the Most solid on quarter a side marginally, that our in are focus $XX we will with back

and we see revenues $XX more milestone Gilead, can our $XX collaborations than the in an you million, of is we increase are making of $X These payments. almost our is from cost only than and currently more of proof with there, which million recognition of include which by progress revenue. in source XX% revenues to million, upfront If reimbursements had that

program, and main cost expenses in and was R&D $XX increased by approximately program. and XX% the cancer courts Gilead CMB Our XXXX collaboration our to million the the HPVXX-positive followed by driver our

R&D we to continue continue grow to our to on progress costs expect XXXX, these We in programs. as

as stock personal expenses, our were of increase expand grew, G&A non-cash continue to operations, Our including the expense. expenses we driver main the compensation

as exchange gains. well $X and the income from in of than loss they $XX showed net $XX million million million currency line, $X.X other translation in in rates of up as more approximately Our XXXX. slightly includes grants, million XXXX, Bottom

cash which operating million, outflow million $XX.X XXXX XXXX. compares to in Our $XX.X was

cash that, R&D progress. pass year-end solid would $XXX.X at grow which end was financial balance back progressed our we outstanding our to Our a of the as further to footing us million Joern. gives XXXX, like With I

you. Thank

I XX-months how the the HOOKIPA. or can affecting on would so and I with pandemic the next over Before end milestones, comment you expect it is to CORONAVIRUS like

by top Our of our followed and the business is safety continuity. priority health employees

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reduced is I also minimum. say would has absolute high. very Travel the to Here productivity an

company’s with proud new are and and circumstances, have our objectives milestones our clinical will partners indeed vaccinations our to people more And the very Our maintain very support the throughout that that we period. back our soon to contact situation trial of with site hoping I'm the throughout their summary, drive to employees development and change CMOS we things I'm close proud XXXX. this now, relatively normal. shareholder’s adapted in adapted unusual maintaining and quickly to

HB-XXX/HB-XXX a this have the present will be data translational April, oncology and whole to initial We in data. at additional vector will plan and I mentioned also talk. an other of will HB-XXX, this data June, in We at and AACR data ASCO data series and to in earlier and data transactional contain present translational T-cell clinical

and half of report will second additional I'm progress in the year. XXXX CMV from early We the keep XXXX. very pleased promising II clinical to data Phase corporate this and us trial in

later proprietary are We without and on our data and line With to renal to this, proof-of-concept end with compelling readouts, execution the intend so for the we data products viral-based laser-focused introduction will would like Operator. do produce open year. Q&A. to up clinical this I

from (Ph) comes is question [Stephen Thank first your ahead, the Malong] you sir. line line of Capital Markets. Sir your RBC [Operator go from Instructions]. open. Please

Brian, In as combine our HB-XXX/HB-XXX thanks IRN checkpoint between for This they of taking for and in any like question. you inhibitors general updates platform possible Good the can and set synergy to and systemic therapies share light HB-XXX, chemo? the in how thinking on with of morning. additional is your Steve toxic Thanks. for

to Yes, on I will Igor. this pass

Thanks for the question.

Of in other including how we to think our to about beginnings are that therapy. course, up would that therapies earlier are therapies combine monotherapy settings, first as used commonly more strategize moving settings the radiation the with advanced from far line, in chemotherapy and we

preliminary know, terms in of doing you checkpoint will by most than with survival as our exploratory our combination as academic pooling how with these and various pre-alluded nature initiated a in part some And more favorably biomarker are also standard investigator once of well, biomarker doing exploratory and see probably for course first about interactions, the the we other the those our we rates approach some and investigator settings. true interacted XXX are pre-clinical you initiated have to of therapies doing speaking with hold advancing believe inhibitors to line work as interacts We in chemotherapy therapies we these meta with to for response stretch endorse cautiously therapies, assess mentioned, chemotherapies studies studies we patients. various groups the will same

Thank you.

go SVB line is next ahead, Lu] Your open. the Leerink. [Christopher now comes from (Ph) question line your of Please from

for Andy. on Hey, is Chris This guys.

AACR alternating case something about just the like a I be small the if presentation, wondering any preliminary So, and know that? efficacy there study is immunogenicity safety dose on regimen. and the But for just data, or focus potential like thinking could

Igor?

data, doing will would will datasets. coming see of But any AACR, and course recent share patients, update, you our updating efficacy, anecdotal will, At data clinical for we not formal in of we have translational be that coming presentation. for data, will any which the course, more case the a date At focusing expect will cut-off we will for formally to from ASCO be data we But AACR will more be be the ASCO. exclusively we safety, doing updates, just translation additional translational clinical which of additional at wait data. but efficacy including we clinical be to as on

should immunogenicity potential data And Sure. is read through efficacy? potential think the there the we a about to from way

of you our if continuously Well, you we follow story, correlates know our have our always efficacy preclinical stated and mechanism that to action. published

is translates and believe And immunogenicity, that escalation so shown improve improved tumor using to multiple data the try would alternating CDAT-cells, set, levels whole our our manner, clearly better we that our times preclinical preclinical else to to that of a vectors dose higher in dose induction based do two in setting. on pre-clinically in because the everything order goal to clearly the the to phase efficacy. to better our trying specific we control I go say And antigen have of

getting can. the data as out We fast we are as

so clinical And AACR. have we little data. we could it wait But the data, is the generate efficacy translational until a that data, bit out efficacy our just clearly for will And we ASCO. timing faster will to clinical think I get the than again,

like sounded multiple regimen. we dose clinical one correct? And may. for that potential the updates alternating it. are just question, I It final if Got having Is

will other make conferences, and AACR, Clearly, some efficacy between we data efficacy. for for No, later XXX, it we come the continue XXX on at AACR the and data data both for will update the months, translational ASCO At we and update several correlations update will XXX, both translational and will mean, next and the in clinical focus data, year two. forth try to will from we to in at from clinical again clearly well, at XXX. XXX, will come clinical on translational ASCO that at ASCO, will the But I no, XXX. the probably will update again, come at we translational

it. Got Thanks.

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Hey, questions. from for Two me. taking my guys, thanks

First on program. the HB-XXX

looking to more data study translational data. to into need into settings, certainly at year. transplant or the expand little you a see I and feel forward guys kidney comfortable bit point But half the are in We what to updates would program of the data this guess like wanted to and what congenital other second the you dig transplant mentioned, or I to the then additional

to of alone as produced combo. percent tumor-specific responses. that recent I guess, how clinical needs surpassed, responses, So, FPR T-cells the there HB-XXX of publications, cancer frame amount be would the I vary achieve from reports, at the T-cells Is this you. your clinical patient-to-patient. looking combo by are anti the T-cell with at HB-XXX/HB-XXX Thank or certain really looking a guess CR. slightly you you or Does differently, or anticipated - education to XX% either that generated

XXX. So let answer me quickly on

earlier confirmation CMV think fewer antivirals control, you that the patients. proof-of-concept. disease. These end patients, was have would the few on relatively of points and and we into We the we extent, are to ability to the is a three the XXX are getting when actually we hypothesis, have we are that we doses which we shown use if viremia is the of a data are CMV want our to publicly, we our significant responses have percent antibody to controlling, that this want you controlling of trial hundred T-cell and administer basis and of are driving a of full things patients, key that, shown proof-of-concept But

many I time, get solid and at, potentially trial organ taking confirming are we think a have that announced transplant? in a way to get which be prevent time, looking proof-of-concept in and confirming Going seen our data get strong to a the be forward, transplant as Could moving or congenital forward. for for have to also if this will solid that of we earlier possible technology. in STEM find program we patients relativity trying in a which as even transplant, to we fast take we are point and it, point in setting. chosen it hematopoietic and cells, congenital would we At it are disease patient are way forward forward very the we signal are trying we we At organ this low CMV it to

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saying, maybe we are that confirming I'm As to would trial. we data we Igor, you second comfortable question. progress the if feel take the seen have before the

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that, in more think specifically, at if the in antigen-specific I TCR I would can comparably T-cells the into patients, say the general, of you ''The response''. get to work space, correlation of blood better most others look the we the

there of line I identified be number, say, just it but magical are many activated guarantees quantity, that of A CDX kind that would non-exhausted. response percentage them a do no are T-cells. quality could How the either. to has been, not a no the of has However, the hard with lot of

like an will straightforward demonstrated demonstrate be you a response chance efficacy. active therapy there, high will remarkable would would if could together, if this, it it to say So realize gives say, T-cell that and would either single-digit past, the not and I would there I a improve in everything say is sponsors would that I very ours, generate know correlate you direct a lead to the like that, has percent from if been look that CDX and at you number. be putting we something we very, that could good probably via a

that percentages. kind of what to would So, of directly measured would number minimum of from say able this any before single-digit in excited, very, no been space demonstrate very we number be blood say I high I would as kind the one artificial has a without patient's kind expansion, a of

again. Great. Thanks

go ahead, Another your question line Gafanhão Ingrid open. from the comes is Kempen. line form Please

you afternoon we I’m is just also glad good morning, and see wondering, there in question. the years? significant good any these Hello the milestones partnership Gilead progress could front. that some thank Was expect to the taking for for in

clinical Yes. Gilead manufacturing should is to HIV what milestone the for where the are Request There moment they development program Tox called to to the they And you for also to in committed and linked request studies clinics. in commit bringing development where to a trial, milestone program. expect for bio-distribution language. a that is is forward

or year standard moved This talk specifically, would are that, we at HPV we would to the year. early year milestones is to the unable We for of it have in as HIV, this HOOKIPA timelines, the late expecting from to and come are to expect Apart passed sometime program looking HPV. next we in and the middle in timelines expect or be industry, clinic. be that about

Thank very much. great. you is That

open. the ahead, Another comes from line question your please from Roy Sir, is Security. line Buchanan JMP go

thanks appreciate Great, questions. CMV the taking program. on the for the clarity I

and you So, for follow-up endpoints to what the any for the are antiviral efficacy. of the the you HB-XXX, COVID in report transplant know half how for you points the going post this on trial going but viremia especially to durations the or for do considering that follow-up. the efficacy a have I have I earlier data and XX-months, has are you and endpoints been II primary mentioned report information any second are Phase update

do Igor take want you that. to

the question. for Thanks

of used, But of So, follow-up the use I course, viremia, et following et will events would a for in they be Well for Were cetera again. concomitant etcetera. XX-months to the points they not of viremic XX-months terms the period. how of duration as all say only insensitive antivirals the I that used, of be and subcategories given cetera, viremia were us transplant. a the of right, also long designed the viremia, course in of number in think you are is overall percentage efficacy program

be at of time will the XX-month that will endpoint be the of all point and information reported all that followed. So,

to going when half are of year how any be We sooner. in been, and, not previously updating perform many trials efforts most so the procedures, on I And in is elective are while a the that being elective terms donor this COVID, but I elective. and the indicated even program, the them procedures, second been more elective they words, simply other still serious I some kidney not think probably we able that stopping to say on, issues. procedure, an is require impact would Many earlier to as our with of that the as it because related say, as stated it the are of on are, would stopping clinical follow-up have has procedures In sites has transplant, due majority Joern live are that of but focus of COVID-related administrative I had of hospitals accrual. course,

our affected routinely follow-up. this follow-up. does followed standard trial for a not not really new say any for I has accruals, care, are and affected, additional, and patients would hardships in order well The continual Now, it as accrual clinical of has have

been these for not follow-up patients So, has affected.

existing the for them? to from particularly And Okay. hard Gilead like haven't technology that agreement, require seen question. new guess, Thanks. good data. disease, and was viruses infectious if vector tolerability thought any replicating That request for and would arenavirus you thought development that should safety about a possible B a the this with under using of and idea, more hepatitis issues make Thanks. for Have you treat kind guys I general be would sense. then,

to The answer those both yes. is, questions

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Okay. Thank you.

Truist comes your Asthika open. from line Goonewardene go the from ahead, question Securities. is Please line of Next

how - you, do of to a morning that you ask on to analyses, you bras translational can little maybe of on percentage kind speak data what and And I Igor T-cell nice to like data patients to afternoon, to many you would total pull color I compartment? about entrance tell good on Hi, of AACR that. to more and CDX good guys. will some that give you to have. please. where what the got off us to specifically, see And then focus have

Sure.

XXX but coming readout. I patients will from present, It most XXX, patients a with be, I our would direct more had a will first So, single-digit combination number on based as [indiscernible] as say, data XXX XXX, a as because analyzed say analysis. would well patients of AACR data we in and mainly them The more focused batch. and be first will using have of

at analysis I it would not closer of ASCO. it [indiscernible] So The say that - reported we is and analysis releasing data, could staining to of first, we probably probably it, much AACR, but reported into percentages back is percentage probably that is analysis. on will have analysis called readout a be based be [indiscernible] translates not as course, and direct as not out performed a that of it the as will percentage, because calculate is releasing we different direct intracellular will be the coming as a percentage data primarily not as a

AACR. then And hampers or wondering know data Great. just I to and happen I'm collections. COVID sample fitness T-cell data would any maybe have new also biopsy on real But you

fitness? say the Is to that question? T-cell

Yes.

are that will will not earlier, be the basically, data T-cell collecting, our at AACR, will be month AACR as looking the at we month So, will is of ASCO. after actually as well, the cytokine Sims and showing, be course data at of available, at we a data, before a that that tumor lymphocytes, biopsy part looking data signature Conference. and Sims any is we will as interferon about at - the be R&D CDX And gamma Joern exhaustion and said data Conference those we T-cells infiltrating fitness the likely showing most the state

Great. for questions you guys. much so Excellent. my taking Thank

another from go [Operator open. H.C. [indiscernible] the line Wainwright. Please your comes line of instructions] is question ahead, And

regarding One HB-XXX. two. for I Thanks have taking the my question.

I So, the also in at second data for Could expect of safety with - any your year? half could this we feedback this year. know some from the FDA we data expect and the interaction

Igor

program. Right. XXX the For

the say way say I looking and second this - the an basically general me could get currently, of of think If would when year. the early I might time, reasonable package, analysis figure doing half together or want be I expected, within the be we for at that FDA So, ballpark FDA. to answer we a response But putting yes. are FDA will is either year from if that you year that a could the package it next a would ballpark, give this for if summer late the a a program amount over be feedback is you

great. we the And just program? you regarding also us more color the this give Could My expect question is I'm general is XXX like XXX, also more alternating be on strategy XXX. Thanks. curious. would clinical for the that Okay, strategy could program. for is like development, that some dosing

Sure.

are primary program in I alternating the to approach. approach is a currently think go about basically with what we directly this thinking as

about to similar we setting approach what to care. advanced with who I are on are the progressed setting into advanced monotherapy use program the in going a we patients we of think, kind XXX this PSA [indiscernible] antigen So going or probably we to spoke alternating to go standard that to directly And two and monotherapy patients, and in in call to PSMA. are into going of the go

both have so will I that. [ITIV] the and the -. with Also, testing you also be follow-up maybe as a IV as well (Ph) in So,

And bone sure into little cancer the for bone, the is injection better because propensity you know bit No, lesions. of fill it I’m different metastatic that bone of prostate No. a for tumor cancer is is lot not a as prostate strategy.

prostate just the present to for the of so pattern And probably which patients to due cancer of metasticies, approach. pursue intravenous the those program majority only will going

you I Thank for update. see. you. Thank

at this are more moment. There continue. no Please questions

that, you done in in the we programs, both I concert us, discussed today, very Well, are in for first like and we I interesting have very just that half. participated very different I'm we in this in say keep that out would half for rich, think, of as data multitude about that where excited front to with XXX case are coming second to And have all of very, we call. just readouts pleased

rich Thanks Thanks let So overall, seeing there are any are new participating data and are directly it and point if questions at we further well. time, curious presenting we as in to us for you. to know folks, bye. call please sync and this from this a we it, Bye, lot. in really that in for

for conference for the concludes Thank That today. you participating.

You all now disconnect. may