HOOK - Earnings call transcript Q4 2019

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Operator

Good morning, and thank you for joining the HOOKIPA Pharma Fourth Quarter and Full Year 2019 Earnings and 2020 Outlook Conference Call. At this time, all participants in listen-only mode. [Operator Instructions].

I’ll now pass the call over to Matthew Beck, Executive Director for Investor Relations. Please go ahead.

Matthew Beck

you. Thank

and our Chief Joern of Medical and Igor today Officer, Chief Global Executive Roman Development, Kandera; Officer, Reinhard Officer Matushansky Chief me Aldag; Officer, Financial Research Necina. Joining Technology Chief and Head

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

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

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

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

For our opening and will the programs. for will remarks. a today's our offer clinical on level Q&A. high comments Reinhard then the progress we'll Joern call, financials, will detail provide open of call Igor

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

Joern Aldag

have And our X. to Matt. safe harbor in happy April our participating everyone, to and year. then see call in since we're on for switch Slide us today. Thank Please very first IPO X, you, to of Thanks, today's with statement. earnings keep Slide call, And you last this

and in the of great in and made the the building infectious areas. clinical and front. We've our had strong year now progress, both a in oncology disease both clinic We're terms on team have

we On U.S. Alliance, Officer side, on managing our Christine hiring see office. is Baker, the slide, who headquarter our Gilead and Chief the our Business you team expanded executive also by here corporate our

process Officer Technology future rounded responsible our Necina keep hires manufacturing. also manufacturing -- as who global We in These and Chief us corporate strategic for and is have November. Roman growth in-house added development. analytical key Roman for including needs out operations,

next stimulate technology system patients. infection the X in transplant immune please. its program against non-replicating to or designed to slide trial based HB-XXX, in VaxWave the reactivation our cytomegalovirus on Switch is a Phase kidney

Before going durable trial showing our T volunteer X and immunogenicity. we public, antibody had completed strong healthy and cell Phase

continue detail Igor to the total and We of shortly. patients from more the immunogenicity in enroll roughly will safety patients provide report XXXX. of half plan one-third and to data first

Flip over once.

immune-oncology our also first positive in We in patient December our dosed cancers trial late in HPVXX XXXX.

can accrual HPVXX. a cohorts about Phase dose excited of begun from first a completing we has It's the in the accrued replication our competent intravenously EX/EX trial were expressing intratumoraly That program fusion is treated patients This protein dose accruing how intravenous this. TheraT-based treated we of for patients HB-XXX imagine technology cohorts. as trial X/X vectors second patients. and speak You the

carrying is for this stronger submit of responses. vector product it's immune Igor on again different the HB-XXX. based HB-XXX IND be a first program to the XXXX. same will in the We more half expect in This detail a for used antigens on provide combination to But backbone progress.

were our with keep HIV proud and therapeutic both development to X, will expand programs. rapidly accelerate the agreed January Hepatitis seeking is Slide with B, XXXX, collaboration of chronic for Gilead of cures Gilead and in We progressing.

partner. they a on be will Gilead us solely a working programs, milestone result, themselves. program, with full triggering of be towards progressing the As a that now couldn't adding development the approved -- payment. Gilead request in The staff focused pleased clinic. cost development We is Gilead HBV the for by a keep which is more call the significant Gilead we what program as borne internally

is of clinical summary Slide a milestones. our X

CMV at data earlier, efficacy deliver for pre-emptive preliminary patients As the will end we communicated for of XXXX.

or Importantly, our safety HB-XXX program early HB-XXX as combination XXXX XXXX our in important efficacy will highest data middle and to of Cell of guided the immune-oncology will data before, and late and show T drive initial the provide XXXX. responses

point our is collaboration and timelines. preparations development. decision Gilead following we programs, provide is difficult communicated In the commit controlling for towards to Gilead earlier, HIV milestone as achieved as at It vectors to advance timelines to HBV Gilead’s one this the these to

affecting pandemic I before virus X, overview, on how my it's HOOKIPA. end like and I'd the Corona Slide to comment

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

working We for sustain policy have is company. to and the U.S. future, the offices instituted to a with foreseeable ongoing are our zero. and the technicians home Travel in both experiments work lab reduced Vienna for from

new Our employees to can. trying best to are from colleagues continue as have non-lab quickly based and as they adapted the circumstances the home business

trial partners. development with research clinical our sites, We organizations are with in the close contact and

is whether to it with time, there any this delays. at will disruptions certainty difficult trial clinical any be However, say or

transplant For voluntary unlikely it centers believe that solid immune-suppression transplants, outbreak. during risk organ the will is we Corona virus

advanced Our and and post the are line second patients metastatic HPVXX first setting treatments. positive in

is the risk willingness So trial to to sites and ability for treatments. get their continued

though our we recruitment milestone disclosed impacted, today, that on-track assume will to the of remain have of as trials with dates. We be

and once milestones more We on of there duration clarity our the effects to slowdown. will updates this communicate is

to -- a XXXX, and to critically time, a at runway. is we While reach activities the with this prioritization extend are cash in are currently of all it the at end important well current looking of the we this with point goal funded our

Our HB-XXX we're else cancer priority. second and Gilead. that CMV is and programs, running our top And studies the HB-XXX, adjuvant everything program, new priorities are

of this the on and effort, internal both our We discussions. have we developments the of communicate results clarity, outcome the will more moment outside the

to I’ll now a HPVXX Igor Igor. over into dive CMV and programs. pass positive deeper for all the call cancer

Igor Matushansky

Research Head Thank and you, Development Global of Matushansky, Joern. Hello, Chief of and this HOOKIPA. Medical is Igor Officer

both a or oncology the at XXXX As disease of readouts efficacy progressing as Joern through mentioned, we're XXXX. proof-of-concept important trials, early end and infectious

Please see Slide X.

Prophylaxis patients. of patients Phase the To donors. randomized, accrue to in and patient clinical of HB-XXX cohorts efficacy on and in the bivalent the design, early continues awaiting kidney transplantation trial and tolerability X to in positive the population positive first dose trial a HB-XXX cytomegalovirus. target helps CMV to CMV for Our cytomegalovirus In program Phase profile kidney CMV XXXX. prophylactic a also living patient Phase placebo-controlled recipients negative is transplantation addition positive positive of review, We will patients believe the trial a evaluate X December from that program XXXX expedite will recently X awaiting insights Based trial vaccine safety of donors gain inform to new to we added CMV either from HB-XXX negative or CMV recruitment. further the

total first XX the XXXX, one-third in the and patients of enrolled. of first first as on of of to period we safety transplantation. patients enrolled. approximately monitoring half expect to XXXX, Joern XX be of of the The that to total Also the the half XX on the the that dose between In mentioned, include patients safety period is is of the be expect we to immunogenicity approximately to XXX date report will report one-quarter the

CDX CMV Cell specific CMV responses. antibody T specific and We both expect

that placebo-controlled who those received is placebo between inter-patient part we patients the expect versus For those the to trial, of that received vaccine. demonstrate effect an

measure administration, leave] effect antibody we baseline an is those receive recipients [will are and vaccine. For will the group, intra-patient Cell X. the in an positive if T that or higher X. patients in our with repeat values demonstrate those Phase to] Cell over neutralizing that increase previously We positively B than Phase line Also, vector also reported in no demonstrated we as have significant we antibody detection in [spoke

the HB-XXX late CMV would XXXX. preliminary The post-transplant focus and be of complete antiviral therapy sets in the plan evidence present. data treated we the viremia efficacy of tested administered are patients to Additionally, data on only important most on of second the antivirals patients in patients when data these number Since, available. quantity, from often and we release based quality half ARM. The pre-emptive

information more later data this the year. about readout We provide in will substantially

Slide XX. see Please

Moving on replication arenavirus is a expressed vector patient HPVXX. competent based non-oncogenic, were of family highly and XXXX. December our a have programs, IND in in excited our July the we in to therapy antigenic protein EX/EX platform to but HB-XXX HB-XXX our from from oncology dosed submitted first fusion

safety, is X/X open and/or tolerability with metastatic designed evaluate dose efficacy Phase is dose and in monotherapy XXX with an inhibitor. to combination trial It and trial an locally the label in with preliminary of as monotherapy and The progressive cancers standard-of-care. expansion HPVXX checkpoint immune escalation advanced patients HB-XXX positive

Phase each. population two into dose groups patient escalation, divided For the is of patients XX X

on and of three will standard-of-care, monotherapy. and/or metastatic intravenous group first cell locally The receive advanced carcinoma as progressing HPVXX neck HB-XXX head squamous is patients then administration positive weeks every enrolling who

site escalation second will with origin advanced tumor a administration a as is log is HPVXX monotherapy. and/or in design, doses three-plus-three of an by locally into or any every metastatic followed It study intravenous receive accessible of group administration tumor who one The enrolling HB-XXX HB-XXX of scales. three will go weeks cancers positive of and standard dose up

to intravenous develop compare options not present. rather as patients administrations, depending to on trying how are but both we Importantly, approaches intra-tumoral to therapeutic

well HB-XXX systemic may into central disease this Other large tumor numerous case, while Some investigators a as body treat patients we patients which directly that across and response [indiscernible] around additional mass approach. them an providing the inject one tiny with with disease. systemic present latter provide for the the tumor still In as body central like with cancer with no tumor, the with to option effect. tumors accelerate metastatic a the with suggested site present

the schedules. already now level to level of between year. Phase earlier, We at study three primary be and safety and intra-tumoral determine in in begin is of the Phase anticipate in completing two dose dosing the that of dose for We accruing backfill level. the and will cohorts X trial intravenous levels will test The level dose patients has [asmispeak]. Joern to plan endpoint the late the first to accrual ARM, this different evaluate already tolerability dose dose half the currently first this second accrual accrue portion mentioned dose completed and of portion. to The X the the ARM second patients recommended trial is three accruing the

by and RECIST as evaluate will X.X activity defined immunogenicity. endpoints Secondary anti-tumor

We in data to be available late XXXX early or expect preliminary XXXX.

Slide please XX. see Now,

half IND expect submission same standalone will follow vector trial and at monotherapy the is benefit get HB-XXX/XXX amend be patience IND year. to are dose a later amendment submit of vectors and alternating currently an be we monotherapy very time arena-viral in The the in We also submission. IND, similar The not HB-XXX current Virus will XXXX. approach protocols going an part will our the to our be It that, the HB-XXX design substantially to the derived different this of first will of able HB-XXX to The trial. Pichinde excited we ongoing using two this and trial LCMV. from HB-XXX as therapy as that

over comments With that, about financials. Reinhard it I'll Reinhard. turn for to

Reinhard Kandera

Good ladies you, morning, and Thank Igor. Thank gentlemen. you.

year you the focus from year-on-year delivering significant developments listed give results on me Slide much we which on of in with financial results, Since Let has in this overview in a company. Gilead, morning line on HOOKIPA full These released with XX that reflects we previous transformation summarized quarter the and on XXXX, the will advancing very pipeline, that a clinical and your publicly fourth and private the a presentation. in progress our short to made the are quarters, are the in our results. I results, corporation

Gilead increased million in included Let milestone $X.X and Gilead corporation from me revenue exclusively which compared the our start resulted recognition payments XXXX. by received to that of million towards payments, upfront reimbursement the $X.X early million triggered development of million and $X.X $X decision million in with and from with move In revenues, we we XXXX of another milestone expenses. $X.X clinic the by entry. B Gilead’s Hepatitis received research from XXXX, program to partial

of of HB general production program, in million of clinical connection XXXX trial in stage program, R&D and to the drivers -XXX of main earlier capacity expansion were trial the cost by trials the programs costs with X HB-XXX R&D HB-XXX our for securing capacities material clinical Phase preparation expenses costs $XX.X and the and clinical and manufacturing the for increase for related increased personnel. cost

in other the It personnel costs by company. of of it a $X.X substantial was costs. organization the was reflects by G&A in of and overall million, and/or increase our and operate increase insurance and driven expenses the $X.X fees as consulting related growth stock-compensation The an to professional and expenses million such including an our cost by increase public as

of and Austrian Our partially balances from million income income the mainly by offset our government other expenses. income cash interest interest in operating grant $X.X includes

cash combined February million million. provided and balance of Our U.S.$XXX D from IPO cash in which investments, burn referred year-end XXXX XXXX. a and roughly was U.S.$XX.X million, activities sometimes net financing Series proceeds that as approximately raised operating April of to with outflow our strong us closed the cash between We U.S.$XXX

Spending increase only any moderately spending our XXXX to to Corona virus related XXXX. expect impacts, compared we

cash reserves our operations end at our expect least XXXX We fund most key importantly through of to and our the clinical beyond milestones.

like I'd with to pass Now Joern. to back that,

Joern Aldag

our products. we compelling very And unfold I'm corporate to develop. us continue closing, proof-of-concept early pleased with in to trials keep execution with see proprietary and keep I'm both focused to and data our In to progress based XXXX arena-viral produce XXXX who clinical excited vector and remained on

close and our we'll We and communicating pandemic will of the plans stay as keep unfolds you any are in impacted. contact -- if with

his like you London working what I'd period. the studies during tree unusual of become of ask early of today's his student breakthroughs an In at plague closed distancing. and the University sent that thought. we home window. He period of final hit during practice his greatest continue outside to famed leave bedrock would this Cambridge We students one gravity. to must indeed individuals was that with some XXXX, and apple had social their of virus gain bedroom can and pandemic One his from company about without ourselves, calculus observations contributors produced professors. version home made Corona papers great and There of as

You him. may name have His heard Isaac of was Newton.

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

Operator

[Operator first SVB the question from Instructions]. Leerink. from you. go Thank ahead. Please the Andrew is coming Berens of And line

Andrew Berens

hear me? Can you. you Thank

Joern Aldag

Yes.

Andrew Berens

despite the on. the Well, call, I want all and thank for that's everything hosting color you to going for

delays -- -- are Just introduce to wanted to happening, intervention transplant number transplant doing the hard hard is a decreasing color are more you a potentially program, get little that this it think the novel into the the on they're transplants if centers sequence? hypothetical of that still it's adjuvant or but

Joern Aldag

would Igor, respond? you

Igor Matushansky

for Andrew thanks the course, Of question.

Certainly, interventions, I redirected however, think requiring current clinical is it in too unique tell. of I surgery is delayed. it may be will to not early resources requiring in immunosuppression pandemic midst what staff stretched to are expected this the that possible similar to be trials related whose is be environment hospital resources keep the in all take hospital be the facing in-patient pandemic, will challenges. Hospital

think but -- the So, we'll to what a a know of the perhaps milestones But, on-track be previously are deliver accrue. stated is difficult to donor kidney transplant as as risk on believe I know, not today, deliver believe patient we to we many question in high you stated. live patients if it's the we the patients, milestones at able we

Joern Aldag

significantly the crisis took the down kidney are heard transplants context in we there. that place China in Andrew, And that of

So that does impact clearly things.

Andrew Berens

Okay.

can us just your and in right? remind -- not China trials just you are though And Okay.

Joern Aldag

No.

Igor Matushansky

in China. not We're

Andrew Berens

And any Okay. to the impacts any impact potentially you on seeing supply manufacturing agents, then, due of the pandemic? are the

Joern Aldag

and this time, running. have are bit At Roman little with want manufacturing working CROs, keep like would -- give their this trying point here? Roman who I sites color to up on We're question. but answered you also very a no. in to hard maybe have impacts, to our more obviously

Roman Necina

Necina Roman everyone. Hello, speaking.

sure in on very to close they relevant sufficient have similar like CMOs also to [indiscernible] well they the tasks. our to external people labs, our GMP challenges execute they are have to to We as make that because [indiscernible] face we as

a solid the of course, have business of the we if lots updating we constantly situation of to they And But line evolves plans. continuity on need updated, so basis. each communication, and be far, have actual regular other

Andrew Berens

Okay.

Joern Aldag

things list. impacting there that material at know not be and anything impacts, CROs trials. time, GMP this but their and our trial high the seeing our clinical material de-prioritized point prioritizing in Whereas to are priority also We for other actually we're in on seems very maybe are

Andrew Berens

and what don't just what it guys there's the remind Okay. Can I if remember just announced could chain, is? anything, you the have publicly you you but supply us about show remind

Joern Aldag

we're CROs who within mean, working You area? the

Andrew Berens

Right?

Joern Aldag

Roman, that of Yes, clinical CROs you quickly several using transferred to trials. processes have in and just we're

people. like which Sweden. in We we're have relationships would very good with brief. to a suppliers, relationship brief side, with I just have of Roman, sort the manufacturing on And our these Roman give own also with these running summary and

Roman Necina

CMOs have in and We U.S. Europe in

For our manufacturing. BiTEs drug substance

And, labs activities. the ramping drug We have up have in capacity in at BiTEs we process are Vienna. our relevant Europe. CMOs substance release doing for And of external we drug and testing eight of product

have of on recently Phase and year, X quarter they GMP material plan a implemented they ramp most up virus to in Corona depending we for of will GMP the second dedicated Here have situation. process our manufacturing this clinical everything course GMP and manufacturing the of

Andrew Berens

Okay. or impact regulatory seeing progress FDA? on with or interactions either BMA are any And then, you

Joern Aldag

Igor, please comment.

Igor Matushansky

not we be not that No, concerned a are in and of I have delays indicates course coming there this being we situation, any realizing or any have diverted the delays and seen any but with have of the kind say as very internal of forthcoming. health any you are and had delays are we conservative course yet. authorities to of guidance delays would that be will there or received not resources indications the of know, any might as kind deal currently that that COVID-XX communications We

Andrew Berens

non-financial infectious Gilead disease forward commitment hogging they bandwidth. Was In go with to payment made you that I'll decided regards the milestone that when maybe program? the they've and there made other obviously Okay, and just one with they question last the collaboration highlighted. any stop

Joern Aldag

the possible a trial. they manufacturing clinical Phase doing Phase commitment, have asked unlocks X the unlocks the program which accelerate, XX commitment they clinical positive capacity we then when people on of term that FTEs, is stage actually It's go we now now reserve us at sites to manufacturing XX It's tells us and for to X. with all towards sign positive something fact the CROs. interpret had the money the have And clinical normal into a RFT Phase in the trial. development trial sign, is a very go And actually programs into longer the made take to a formal X they means the program's that working to trials we for There expect at a this. to be gate, to very the that will into that They studies within Yes. through biological -- into IND and process commitment. that would which get request trial. costs they and go expand is collaboration then these a the clinical you clinical everything move bio-distribution manufactured decide tox for they're sort commitments The timeframe

Andrew Berens

Thanks guys. a for lot good Okay. luck all for And questions, the everything.

Joern Aldag

you too. Thank

Operator

coming Bank from from of Stranahan America. line go the Next of Alec Please question ahead. is

Alec Stranahan

guys. Hey,

Joern Aldag

Hey.

Igor Matushansky

Hey.

Alec Stranahan

for are guys you staying going that's safe on. hope everything given taking questions Thanks and our

then still rationale So change of are X us a is factors just about it up? the that from a couple volunteers? into HB-XXX, Phase I've to if the a safety in may study safety follow from for bit any or the versus in for And we there remind stimulation me, could level And and accelerating first X profile what positive recipients, enrollment? just saw you the the immune could got maybe more primarily on you then as healthy expanding Phase talk

Joern Aldag

Igor.

Igor Matushansky

Thanks, sure. Yes.

the erythema. did local importantly, intramuscular saw what most terms Phase effects reactions of in you administration. intramuscular We X, the of administration Phase I mainly safety as no reminding see the such So, think in to systemic certainly from was X we

they However, observed interestingly was placebo. to were very the what enough, [indiscernible] similar

X it’s kind So a interesting Phase overall, I very from the healthy data -- an say volunteer safe of and our was profile. would --

kind are the we board. do believe under X, being treated being X, as we of we will the treated similar patients immunogenicity before any Phase immunogenicity see in of are terms immunosuppressants transplantation pre are that the on we saw In the on whether and will, Phase are

do a seen And anyway that will the to be immune will our differ seen so, study. what there from volunteer we we in biologically not believe in have that that vaccine the fundamentally be difference healthy response will

And investigators part in was did basically positive our experience observed the with of keen But and this more on viremia. response still, over why or vaccine add third interested and of and signals XX%. post the the It to CMV was, for one who having the noting risk your course question their we a of many safety is to on recipients having year our had ARM. have of risk concerning positive lower transplant more much any order of expanding not

that the suggest applicable, the was, our much us be should demonstrated broadly our more along program. that as more that vaccinate FDA all not us they will This strategy argument. a And very clearly But, were at plan very risk would more to be to safe provide course, a to of well. our support of us as and part -- to therefore, population -- keen additional risk it interest expand which having I this lower course all to for accrual think commerce, a to a profile high data vaccination data serves population. allows importantly, a of helps patient to It

Alec Stranahan

And updates that in right is the the of Corona to people's planned a particularly plan event dissemination to obviously at of B yes, conferences due be lot to safety your minds What the postponed Great, immunogenicity makes ‘XX, and for for for now. HB-XXX? data then virus the top One most continue Okay. that sense. be half virus, will

Joern Aldag

will definitely….. We

Igor Matushansky

All we….. right, as

Joern Aldag

you to something? do the Detailed and data. press want say releases the described on the results Igor that results

Igor Matushansky

I with with I release. mean, And a we'll start press you. agree No,

come most the three at to of also think big submission. conferences at release after, in now the advance point, have will interesting that four be months the more I come the XXXX. shortly you and efficacy know, think the And conference of end to course, press with and that will as follow I data a will

the being So and submitted press presentation by I later, end four months will be of to I in data to of behind present that realistic track. three that any data say, at be release be all am this would point which will will conference ready we able for us, on maybe XXXX by

Alec Stranahan

Okay.

me, lines. Okay, of along sort same those for and last one

developing much of guys but your during pipeline the to yourself know given But, your -- if into perhaps of this vaccine focused core strengths platforms, flexibility [indiscernible], on alluded a you're prepared remarks. sort virus hypothetical You built and later versus I Corona such have given the vaccine your antivirus thought programs, Thanks. you that could your on etc? of platform you through others just talk vaccine a as such you

Joern Aldag

Igor.

Igor Matushansky

you. Thank

in Certainly have in very core timing corona we future, the I is strains. for core we programs. it's a well like to programs. related something do and developing our of decision have focused our prioritize. are currently, So, at virus prioritizing moment our the we you of simply only where And and think the suited as The already think to technology we're and just this vaccine decided, for simply matter laser on is be the this. a suited question for long-term Currently, stated to prioritization

Alec Stranahan

Okay. Thanks questions. the for taking

Operator

of RBC question go next Please coming likes Capital Abrahams is Brian the The ahead. from Markets. from

Brian Abrahams

--. my much very Thanks taking for guys. Hi,

Joern Aldag

Hi.

Brian Abrahams

hear you okay? Can me

Joern Aldag

sure. Yes,

Brian Abrahams

could based potential on you about the with of was if Great. efficacy going you dose sort I I going there guess my the curious on and initial congrats And the all safety wondering, question or all color you types cohorts, Well, much is backfill is on first then what COVID-XX talk XXX, my might a taking mentioned be test sort cohorts appreciate the whether for are things impact. dosing questions those, progress the how of those any -- thanks and far? schedules, little you're more bit the from cohorts. testing on findings and of so so

Joern Aldag

mean you XXX the assuming XXX. program. I'm Brian. Not Thanks the

Brian Abrahams

Yes.

-- to say Sorry. I I yes. XXX, meant sorry.

Joern Aldag

perfect. Nope, no,

nothing we seeing from our two. one, have So the concerns escalated and first safety we dose what to question, very seen level from dose are smoothly level

still package So in our dose that was well, clinical dose Therefore, that remains level as safety kind level concerns see and any on-track with you, any no we know was the two. classes the of GLP very to it surprise remind limiting we smoothly will in safe, not trials. pre-clinical we toxicology, went had completely from dose or we I did toxicity not DLTs that pre-clinical of do studies anticipate therefore, one human completely no no

remember, we logs. escalating by And are going –

So I progress. quite think making rapid we're

monkey that weeks In we our expect We every to and as what somewhat the terms pre-clinical based three schedule of dosing the backfill in a of extrapolation what an number with from you enter cohorts? we do seen trial, know, study weeks, on mouse three was work. of have arbitrary in

such as two every I is to dose However, we frequently, to mean man every responses. like improve more would what by or in to immunogenicity or quickly on weeks explore much to actually aggressive in more our order one quickly schedules and try -- week, by that more there

our internally faster. if you responses that some says you seen give data have the up T can get actually products We recent more indeed cell frequently, CD do

actually the will in schedules more we the backfill cohorts. there. plan So aggressive That is trying be

Brian Abrahams

shifting be back Got it. a to might of outbreak. some facilitate over hop there. you I'll might lot sites virus, Corona the the they this be about That's adequate talked about contingency queue. any or whether plans, really impact the any disruptions XXX, you Thanks. the course then protocol And different helpful. that in of on but I guess Can there And talk potential assuming might backup that to or enrollment there amendments

Joern Aldag

Yes. question. are for Thanks, the you [indiscernible]

of comment kind -- affect to of how we our chronic first milestones. does all, on, think I need this

that the of one-third the XXXX we be will the collected. contribute report of that from at study to already at based for majority current year, most efficacy our and samples our of majority approved of on know, the the of on half will both you current the of the ability the As end data situation been even those patients. the the the XXXX affect The and first have will analysis relevant endpoint on and to first Therefore feel samples do the has reporting those milestones. that of the data been not already patients to other

beyond happens what current that? we think, need Now, how I situation to evolves. see the

know, you current situation equally the is As world. the evolving

protocols from caveats at to CMV have need patients allow center. who get blood their come a sites not sites that local our actually into we trial course to of So on main do in

if delays, are are unexpected time in sure drug life sufficient sufficient given situation. extension also in the We shelf have current we putting to and make products there the order continue trial place that to

Brian Abrahams

Thanks helpful. again. really That's

Operator

next question go the line Wainwright. ahead. The coming is from Chattopadhyay Debjit of from Please

Joern Aldag

Hi, Debjit.

Unidentified Analyst

hi, Good Aaron this is Debjit. Oh, afternoon Good for afternoon. on guys.

So, protocol to those SARS-CoV-X amendments patient expect as made during an for activity to wondering in be patients excluded I'm of prior with or a in with screen if And in might therapy treatment change guys have therapy? active might analysis? from you you to any patient infection

Joern Aldag

Igor.

Igor Matushansky

not Yes, any amendments great specifically have question. or made We provisions.

as for guidance. has signs anybody imagine, However, instituted know hospital for part and of our and at the could which screening, participating COVID-XX as presenting I you suspicious specific who single specific program in guidelines will institutional all are course you symptoms undergoing is that COVID-XX COVID-XX testing spoken say this every are that investigators point I've oncology with that means of to

institutional own sites. complicate of top more in start COVID-XX were sufficient patients. they on processing COVID-screening require are than what a [PI] In institutional and as no to Everyone the screening will own additional but own putting we everybody that of administrative a was measures amendments institutional staff, call their than investigators, guidelines be and therefore already at recent quite speaking comfortable with are at sufficient their their screening guidelines their to only overburdened measure that more feels required are guidelines

we actively say, provisions. that how the make that in to different who from question, to protocols as from patients a of pneumonia And your medical cover going decision a second And or perhaps somewhat do specific situation. part Now, made therefore on the more flu oncology or and on affects a other no of than we that COVID-XX being sufficient the comfortable prevents infection cover treated investigators medical advanced or guidelines trial are and have “have whether investigators recent sort in treated.” I the advanced of to kinds program? either being an all patients to Standard have for is regard. than are would as COVID-XX conditions not that feel them to are of oncology are a built current a the the concomitant are again, standard conversation issues protocol these ability with go in [therapy] So patients

Unidentified Analyst

Okay, interesting. thank you. That's

ratio any CDX to of So you CD are internally T proliferation any you're that threshold T of levels haven't CDX for? or targeting goals that Cell Cells there

Igor Matushansky

showing CDX manner. like that I terms T X% of this Cells adaptive number actually to in efficacy. get studies and impact as And a general other between CDX is data a see somewhere XX% a T Cell therapies, think with on There indeed would pattern from looked that single-digit, could at antigen mainly the is in you we from T comes to specific of CDX can control somewhere correlation the does response demonstrate cancer. actually peripheral cells extrapolated of the

about the VaxWave see in we'd even is our what program monotherapy from We as to like program. ideally somewhere X% to XX% that rate. potent than more single-digit our therapy data is response a know tenfold So pre-clinical

in CDX on therapy will should that increase that that three antibodies administrations to volunteers two of three know a that our to administration. T We administrations. immunogenicity we Therefore healthy after X.X%. two neutralizing to Cell Cell were that we response levels as demonstrated, with And specific the And or was VaxWave get therefore, feel not administrations. program and X% study about than CDX products order more T the of two that we our each for do demonstrate we back should know be three course, since we for at that giving least see

Therefore, we should significant high able we heterologous single-digit with a get we alone, that. that, be course, even the increase believe to XXX of be are upon -- into the and should

Unidentified Analyst

Right.

site? between correlation expansion CDX any to if Cell peripheral tumor blood know you tumor T the in partitioning Do the and question. or last localizing to so, And

Igor Matushansky

great question. a That's

will infiltrating point. periphery this we to that, in But, standard give at have can data infiltrating the we the a All than more studies adaptive is majority T tumor. best of correlation don't between they've actually and comes peripheral more been correlation. think, looked there's have tumor those you I a the correlates could like of anybody think lymphocytes. the there or again, say more say in certainly approaches the for enough will clearly not is now that And [indiscernible] Cell the and between at I you the the say the where ratio kind right from is can more, therapies more with but

Unidentified Analyst

Okay, great. Thank Igor. you,

Operator

van Next question Kempen. from of from coming go ahead. line is Please Suzanne Voorthuizen the

Suzanne van Voorthuizen

impact. on Thanks this Yes, is program. Hi. afternoon one helpful. color good the the virus question or Good morning. that's potential Corona for I've CMC on lot very That's the Suzanne. just a

you would see, So of see to that third risk I'm wondering specifically? patients was in you wish since back lower for that some set ARM what the have have this benchmarks of if other ARMs, your added, you you goals to to what circling communicated ARM like

Joern Aldag

Thanks question. for the

in as of above we -- I’ve specific ARM to Otherwise, I looking is [indiscernible] increases and and think the we're of XX-K, I that our mentioned think those that commented as what additional cell go like variation. T patient our earlier, and -- specific the kind patients. intra the see antibody positive in for kind baseline CDX vaccine CMV the responses CMV the of of -- we'd

the we good be is believe is of the would that improvement fold baseline for to, those correlate to two what three a on to level patients to over right As barometer success. an

Suzanne van Voorthuizen

Okay. That’s a very Thanks lot. clear.

Operator

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

Joern Aldag

questions. No more

Operator

questions. more no sir, No

Joern Aldag

call. HOOKIPA very Then, I to very everyone can it made this its for like I in in that we financial position past call. in clear the a think is thank the close of because strategy we would hope participating financial I strong overcome of to and order middle oncology efficacy in immune the problematic our year particular period. to of whatever in trials. data And can first from from we CMV deliver current this year this in this end the our and doing we're

Stay So Bye-bye. crisis Stay any care. touch there and tuned our we'll everyone. if any thank are continues that you programs. as are And take be in healthy with very impacting this much. news

Operator

conclude for today. our participating. for you Thank does conference That

You may now disconnect.

HOOKIPA Pharma (HOOK) 19 Mar 202019 Q4 Earnings call transcript