HARP - Earnings call transcript Q4 2019 | Harpoon Therapeutics Inc

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Operator

Good day ladies and gentlemen, and welcome to Fourth Quarter and Full Year 2019 Financial Results Webcast and Conference Call. At this time all participants are in listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. Please note that this call is being recorded.

I would now like to turn the call over to Mr. Westwicke. from Uhl Robert begin. may you Sir,

Robert Uhl

Thank you, joining thank for afternoon and good us. everyone, you operator,

call Therapeutics Chief On President from today the Harpoon Executive and and are Officer; Georgia Officer. Erbez, Financial Chief McMahon, Jerry

remarks prepared conducting session. will Following management's we a be Q&A

the I Georgia Erbez, over CFO will call to Harpoon of now Therapeutics. turn

Georgia Erbez

year afternoon. corporate to discussion fourth company's of Therapeutics Robert XXXX, results and a webcast full and financial you, Thank Welcome conference and update. the quarter good Harpoon call a and for

programs, over call remind of the from statements. of implied Harpoon's Before Dr. these call McMahon, and statements include this forward-looking that to risks turn I assumptions These those the by Each on like would to performance the are involves you will forward-looking as I of to expectations differ and results expressed based future or clinical today's or significantly could call. that date forward-looking development uncertainties cause forward-looking Harpoon's statements. statements

with are implied SEC, concerning its the was could on XX, Please actual forward-looking that refer year call. today for the differ Harpoon's December website on those to for including from Harpoon's on discussed results available to cause which Annual and Form XXXX, or filed ended this which factors the XX-K also filings expressed information Harpoon's statements Report in

available. call becomes Except this information any reflect to expectations, as required statements by as law, in new Harpoon assumes change no forward-looking discussed obligation to on even update the any

and I of will now turn to McMahon, call the CEO Jerry over Harpoon Therapeutics. Dr. President

Gerald McMahon

clinical, with thank year. during afternoon. call the and milestones of for the significant the this and operational you, us am you joining all, scientific past Georgia, pleased on achievement I Thank

to to we promise engager platform, committed T-cell refer proprietary of are our TriTAC. the which realizing as We

index to liquid seen construct platform therapeutic solid other tumors, tumors or to T-cell tumors. T-cells goal is the tissues. kill is and successes engagers, in This bring own to optimize our T-cell Try designed the near of and a disease connect patient's convert to activating to

are they treatment for products driving limited the the and benefit provide currently could patients, multiple with potential We options. forward to of cancers treatment

key escalation included of Some clinical in accomplishments a dose candidate our currently the portion the cancer. of patients Harpoon continued with in X HPNXXX, of the which lead in trial Phase prostate advancement for is product XXXX,

also at an initiate an clinic second We three pipeline in are candidate We the of advanced of and last submitted trial and mesothelin cell expect the TriTAC cancer of the for year, other HPNXXX, product XXXX. of initial for including our third first-half ovarian multiple for we in on potential XXXX, IND XXXX. Submission entered focus which an for HPNXXX cancer. is our tumors, tumors, programs, second-half an candidate, other treatment with and the end April for expressing planned for Phase a our of HPNXXX, product of X lung trial of Phase myeloma targeting DLLX initiation X/X IND small clinical the

Harpoon in $XX.X XXXX, of net successful that its February, position also significantly, our financial raised approximately with offering cash. initial strengthened million in public

points strategy, partnering evaluate enhance value our inflection shareholders. bring opportunities of our can As we highest to assets to part and that our the

to our Harpoon with partner HPNXXX expand HPNXXX November to existing discovery As pleased an we our and for of Harpoon six and major of to XXXX, in additional announced exclusive opportunity year, expansion strategy, targeting an an worldwide transaction AbbVie last asset multiple myeloma. AbbVie, have and addition, this and to option were example transactions development further and in for collaboration were accomplishment in align a targets. relationship the with up for in BCMA, These our a

clinical after the fee In in Harpoon license HPNXXX, worldwide global December, trial. Phase a may to exclusive which represents rights as be on This patient option AbbVie development of exercised X/X agreement HPNXXX upon option up dosing potential million granted the and commercial million which of $XXX transaction expect a $XX Under value, to to up royalties receive the we payments, of option agreement, the upfront terms and $XX we milestone milestone an the a a accomplish we upfront received payment, to first million sales. in first-half expect clinical XXXX. in payment, to trial, to and completion

$XX to discovery programs, expanded this multiple deal. payment under of the to development billion, creating work clinical deal to we resources up addition, leading support received put In are a in these from $X.XX our value financial milestones for value research expansion and shareholders. to represents our The a transaction million December, and transactions being collaboration upfront potential

and surface physically patient's Now, in are engineered markers. proteins This aspects that other technology cell after clinical power I of T-cell their platform programs. connect results specific that, is kill key or novel and let approach T-cells. some T-cells unleashing that T-cells of the releasing target to and Harpoon's the a our target describe its own me to factors. proprietary activation engagers TriTAC TriTAC by will proteins a technology natural cytokines express engage to our development review are potent cells,

inhibitor TriTACs Our pipeline of the can the in tumor rely as on PD-X kill interaction. or of immuno such products existence MHC tumor MHC TriTACs approaches, T-cell of other reprogram provide T-cell absence to applications current of antibodies. T-cells, oncology candidate any of to technology. like through alternative product an our oncology recognition drugs the checkpoint recognition do on focuses cell Unlike a specific checkpoint and not

XXXX treatment engager, was first The in Lymphocytic as a known engager, T-cell Leukemia. bispecific also the of Acute or BiTE for T-cell approved

be technology through generation and administered a intravenous short-half infusion. must by life, limited is continuous first this However,

such activity to levels limitations of as we life. on are the appealing strengths which improving size potent set their expression BiTE’s, antigen, application TriTAC of our incorporate solid tumor With of short-half ideal tumors, low platform, in the killing for small and while the at administration

human components binding. address tumor extension, half-life perform primary of a design, our utilized more binds Our single molecules we possible makes derived binding three albumin transiently target larger to three and different binding, domain half-life flexible domain and utilized binding, consisting be which T-cell that We TriTACs To albumin. are than cell that functions, antibodies with modular extension, would smaller by antibody fragments. and serum serum for human

contributing ideal platform expected very domains Furthermore, has target a that inherently these in therapeutic therefore applications to very have potentially stable, and is to a are tumors. little solid window off that activity, for

by can two in proteins Our TriTAC one be delivery weeks. solution, to intravenous that an products administered hour, about patients infusion or or every in formulated globular

of to diffuse into size size one The compared tumor TriTAC proteins to more allows the are of antibodies. typical believe and antibody. TriTACs third tissue, them freely shape XX or about We kilodaltons, a the approximately smaller

that between Our identical is different to each candidates. TriTACs other. the clinical varies are about Since domain only XX% component the target tumor

our therapies or of conventional, CAR-T. TriTAC such standard as manufacturing cell addition, and use antibody techniques, of based personalized the based In which methods avoids complexity cost

we where with review pipeline development me programs. let Now are four our

prostate prostate the Our prostate cancer approximately research new leading targets prostate cancer and with are the the PSMA lead cancer year. the XX,XXX prostate for castration deaths, in cancer. States. is in treatment each United to or metastatic us TriTAC XX% XX% present candidate product HPNXXX third is States metastatic advanced Market resistant XXX,XXX in United There cause death antigen cases of shows patients that of cancer. specific membrane PSMA, of

metastatic an was in resistant castration HPNXXX a patients a enrolling Phase with by designed The dose followed phase. escalation trial, clinical is with cancer. dose prostate trial initial expansion X phase,

second-half in dose We of the enroll an entering the of the the trial phase continue trial, to with in the patients of expansion escalation phase of goal XXXX.

with Preliminary weekly in exposure results year, that intravenous last activate data dose. administration. support continued target first manner enroll provided TriTAC trial, These clinical sufficient serum announced has We've consistent evidence platform to could HPNXXX in early also tumor the increase a continue suggested and that to the have to the patients the engagement. T-cells

to intent an annual upcoming have June. abstract at May in trial update the We meeting ASCO submitted early provide a with or late the

pharmacokinetics, the phase the presentation can the dose the escalation You include clinical in of of activity. safety, phase expect measurement interim trial. the look explored and This of features of of escalation engagement the at the an may preliminary and to evidence cohorts, of doses data the target time the at dose include pharmacodynamics number number data ongoing patients, drug evidence for enrolled and early

provided in the phase that will beyond presentation expect escalation dose expansion entering of continue data the at in XXXX. ASCO, the We second-half dose and a anticipate

others. added second breast on malignant targets of mesothelioma, platinum cell our XXXX. cancer Our initially we've HPNXXX of metastatic first mesothelin lung cancer, Mesothelin ovarian this in and cells product TriTAC candidate and carcinoma, the cancer trial. April non-small pancreatic carcinoma, pancreatic studied cancer to enter expressed patients It recently among refractory and ovarian being clinic in is

T-cell targeted some has mesothelin efforts, of been While clinical the mesothelin to development. CAR-T is focus HPNXXX first enter the engager

with XXXX. cancer has is Patients interim line in HPNXXX experience portion beneficial trial, prostate expectations. of our and second-half we trial, The gained provide data expect receive have proceeding the the weekly dose we of and in the of infusions from from conduct to escalation trial HPNXXX in ongoing the our XXX in been the of

TriTAC are treatment Phase of maturation antigen, initiate myeloma. HPNXXX, IND Our BCMA. candidate the multiple planning or relapsed for product third targets to first-half XXXX, We B-cell XXXX, X/X late the trial a in and clinical in refractory HPNXXX of submitted an in

completion option to Phase of AbbVie, have program before, agreement trial. an mentioned the this under with As they clinical will upon license the X/X exclusively

AACR it and product delta least submit other pharmacokinetic ligand clinical protein the and data data Phase supportive DLLX, cancer October highly a targets data, IND cell primates. a and killing presented We begin of supporting HPNXXX, tumors for X TriTAC a in the potent nonhuman once lung preclinical NCI-EORTC, cell and majority fourth like our to plan at is tumors. We XXXX, small expressed of in HPNXXX demonstrating trial or in second-half weekly at tumor X dosing an XXXX. in safety meeting neuroendocrine

a of This past strong been has pipeline year advancement. period

all goal over data track end are the next our the clinical to the meet on providing having to previously in of couple programs four stated We product additional of programs of candidate by forward look from XXXX. clinic years. We

a off for treat We that have a cells wide a platform engagers reprogram of malignancies. the immune unique variety own to shelf patient's human T-cell

Our value. positioned generate data to shareholder exciting pipeline well is and drive

With that, discussion results, call the for our Erbez financial year and Georgia I'll full a to quarter the of turn XXXX. for fourth over

Georgia Erbez

on performed million, year quarter upfront here our fourth a for related to ended $X.X during more received results payment was the review provide XXXX. December $X.X discussion. from fourth the consisted ended XXXX a services XX, $X.X Thank Revenue our you, filed $X.X for call million, of million quarter I the those AbbVie, year. XXXX Jerry. of overview today Revenue to for XX-K you million brief of detailed agreements December compared prior compared our invite and for XX, financial the December will the research to period. Revenue ended the the portion XX, was and the to development with for

due for manufacturing HPNXXX and The expenses an in million, year. of $XX.X studies, and stages million Research clinical development four in year $XX.X $XX.X candidates million conducting including the increase of our development. quarter to fourth for XX, expenses, million, preclinical XXXX. XXXX quarter and the the HPNXXX, XXXX development expense primarily the R&D of and increase for $X.X is XX, for trials for compared compared to ended the prior related expense activities continuation December fourth for TriTAC to product various was December personnel ended was clinical

for to services headcount XXXX. consulting the XXXX were of increase fees, in million and expenses public legal XX, for and accounting due million were year. and an operations the $X.X ended December services, and company. $XX.X increase General prior professional ended $X.X as quarter The December year to was administrative fourth quarter to compared primarily XX, $X.X the support for ongoing our XXXX compared General million, administrative for in million other expenses increase an a the to

for XX, million, December December the $XX.X $XX.X was fourth compared to for XX, prior quarter million quarter the year. ended ended the was for ended XX, fourth $XX.X $X.X XXXX. XXXX Net XXXX million, loss Net for compared year the December million loss

cash ended proceeds, in cash February primarily initial net by provided activities operations cash $XX.X and XX, of the offering December was public XXXX. year ended in Net XXXX equivalents, December Net million used compared $XX.X for XXXX from cash to December XX, in was million. $XX.X million, XX, We the year cash comprised million XXXX $XXX.X with million our of $XX.X in XXXX. received as ended for financing

$XX we expenses capital XXXX, For to and approximately are cash operating million $XX of estimating million. expenditures

expansion and The to cash We the terms to be option associated AbbVie recognized the which agreement dose statement HPNXXX, the $XX the balance collaboration. of development million income upon of agreement, payment our existing includes payment, payment the HPNXXX. at the the next upfront $XX and for end the in received XXXX we in first will the another million over Under with quarters. up patient with be the triggered December, expect of discovery quarterly receive to will XX XX anticipate from

a actual payments expenses quarterly As period does cash not cash the from the reminder, a not we AbbVie in incurred while The and required offset will by revenue, recognize as is quarterly in cash revenue GAAP. received period. as

With that, the will now call I Jerry. to over turn back

Gerald McMahon

our are the Thank tech you, XXXX, HPNXXX trials expected has pleased made which of clinic, in the past with candidates the TriTAC year. this the Georgia. proprietary our and and clinical begin we more in very HPNXXX Harpoon potential and entered platform. into candidates product year, of HPNXXX with to I two and the progress am are during the have all Two momentum product tremendous HPNXXX for exciting

we to in position is the financial Our strong, our advance have pipeline. and resources place

Before let Q&A, jump our we me near-term into milestones. anticipated review quickly

For abstract, second the with quarter HPNXXX trial data intent dose of interim to of is clinical at the X during portion our submitted XXXX. ASCO ongoing we escalation the and an present Phase

enroll For this escalation end intend patients the Phase trial to preliminary from HPNXXX, of trial XXXX. the of to X/X data by the the We continuing is trial. in present portion dose

$XX in we first the HPNXXX, trigger first-half AbbVie. expect Phase the dose million of For year, payment in trial which X will from to a this patient the

submission of Phase initiation a we followed in of the are an by for second-half X trial IND HPNXXX, planning XXXX. For

now ready So questions. with are operator, for we that

Operator

[Operator instructions] comes of line Jonathan Your Mr. the first question Leerink. from SVB from Chang

Your sir. line is open

David Ruch

our for congratulations progress. this on Hi, and guys, Thanks taking Jonathan. the on is David Ruch for question

prostate First free the regard progression you about benchmarks are and question from for late us this is of to in line response with cancer? rate thinking HPNXXX, survival how setting

Gerald McMahon

you Jerry questions. the for is Thank This McMahon.

stage we a traditional that and of course, make towards assess course, have So, prostate that, look cancer features that in in of various previous late patients, to difficult activity realized treatments it these way. clinical

assessment is we is patient reflects evaluation PSA of is cancer which do for a this on what in the disease. clinical progression, However, patients, feel study follow measurable late in of And disease course, of RECIST levels what another we traditional disease feel relevant time we been These patients. stage in have marker we very and subset population. hallmarks feel the of of activity

David Ruch

Got it. Thank you.

additional have on different that XXX seen of clarity this registrational the for from any enrollment terms from study in the have Second us, you trends strategy of subpopulations the ovarian to-date helped And with cancer. strategy? any

Gerald McMahon

to a that the a pancreatic product clinic. is would be clinical impact little various have this the cancer. particular Clearly, for we regulatory can that and proven path really dose be be breast our observed initially disease. that cancer, benefit ovarian We to clinical translate believe in mesothelioma, goal cell hope And where focus lung cancer to into non-small but also our in strategize diseases for could early is It's where used. this establish dose, a an

And after strategy in we we having to gives registration. with diseases of can't this But to regulatory a trials the until our strategize clinical of go phases different we're course, dose. of product this potential many paths trying our us early multiple time. at really establish there, get still proof concept And towards

David Ruch

question. logistical of kind more one just then And Great.

Or prepared primarily on do For types? call will you enroll XXX, with the lung small you tumor remarks. neuroendocrine this to mentioned I patients earlier the other cell in study be expect in know cancer? potentially

Gerald McMahon

other active types, a but cancer cell entertaining that will for sure, for discussion. evolution focus oriented we that protocol is might lung target. intention in to believe our that is we are tumor cell the mean, lung forward treat is flexibility in where expressed. going to some but is still be and with trial move I DLLX small into small have The But express Yes, cancer trial, also this patients other

David Ruch

the for there. clarity so you much Thank Awesome.

Gerald McMahon

Thank you.

Operator

from from comes question of Baird. Your Mike next the Ulz line

open Your line is sir.

Michael Ulz

taking give as year sense I a through just well. can the just initial the at congrats and Hey think are questions question, And last I for a fourth HPNXXX had you us cohort. were you the dose on on and update, where all currently. you escalation a of the guys. progress in maybe if Thanks few I remember,

overlay you if I currently? follow-up. where can the And have with what curious that that just this So are at you and that point? then you how you And then think far a range is, into therapeutic are

Gerald McMahon

Yes.

where some we we when seventh first the And time product. mild specifically use we symptoms mitigate treating August, to at patients disclosed given this to-date that August, spent were our in being of we year, What did haven't evaluating CRS is last steroid mention spent are. time So cohort. were dexamethasone last we

presentation So what the continue today, that up effect that moving the I job course, middle of and done good that mitigating potential to move can medical this we really this dose one T-cell exceeded is a of into a say very have year, in dose with first And sees we've cohort. engagers.

that's nice this conference our give to going can at but data describing set have point. when say that's at in I say So point. this presentation, all we're all Obviously, hopefully I those patient medical cohorts, a we who's can

Michael Ulz

maybe dose mentioned the that starting expansion, ASCO. this continuing maybe escalate terms And past of also in you mentioned year, later it. to Got but then dose you

picture So that you're you for maybe if selecting can how Thanks. talk just thinking about dose expansion? about big the

Gerald McMahon

general. describing be might concept It in worth the Yes. just trial

any the and that's goal by toxicities. maximum dictated usually study the of dose, in dose tolerated limiting the dose escalation determine So, is to

was one a would driven were to one of observe safe to increasing off the a be dose achieve obviously proceed. by if enough that maximum cohort was expansion tolerated to dose, dose, if So, the efficacy

MTD so then anticipate will and to know not ASCO this tolerated way we we is would to continue which in warrant we that get an we to whether At therefore, a do achieve maximum achievement Again, past efficacy dose maximum to regimen, escalation a to seeing expectation, trial cohort get the by dose, if not we no point, sufficient have we our explore to would the dose. a our and is point of by a dose tolerated we're expectation a this being expansion dictated may an and that is ASCO. particular

that cohort was continue scenario, a that escalate above triggered there clinical point. that because was that dose, But dose and not there would that were to particular yes, evidence expansion to In believe a testing would at and enough reason to we warrant dose activity limited then be at of patient population, regimen. we

So, what's and cohorts our nice bit that lots be have about a guide to quite protocol this used escalations into flexibility expansion regulatory of to future to we do data of studies. generate, is could decision

really particular trial going that's this Is point. in helpful? on this So, at what's that

Michael Ulz

that's Yes, you. helpful. Thank

Gerald McMahon

Yes. Okay.

Operator

Your line Yigal next the question Nochomovitz from comes Citigroup. from of

open. is line Your

Yigal Nochomovitz

you benchmarks the thank of the much one taking more for just ones to on If the Gerald, I back specifically. for question, very but and Hi, questions. XXX, maybe ask earlier go could the

taking In how subsequent would speak about dose you PSA how to terms development see you studies? you. a in asset, like forward into there responses terms responses, into bit feel proceeding this good about and for thinking What RECIST could on the you decision? to then of and expansions, Thank with about a ideally, asset of see go-no-go you're of the success bar

Gerald McMahon

Yes.

us the particular history others, cancer, likely of registrational this stage late very in that to disease clear is look prostate and support you I became in progression strategy the think to most disease. to at a endpoint development if it

to a a for until informative, that a basis is how any would patient a I as regulatory So, been weekly trial study. the would disease endpoint think therapy, to will long therapy because receive path. align most potential weekly patient progression, on continue on this Remember, be

supportive by free. any study patient either being particular support ancillary said, data direct be That on or who PSA RECIST progression to declines by anti-tumor is both, that effect would or of

measure. PSA be to think lead are data ultimately have keeping about from would will to related Remember, if not patient RECIST declines the patients and to you could XX% having ability assess but the only ancillary of focus have will in some this that. an progression to RECIST then a primary so I disease disease, lethality, evaluable, every supportive So, which patient

of also being But to said, that which a to not, being support or those course, of suite activities support, other measured mechanism all changes, say, be action. activation, of mechanism would I in to have parameters measure patients assess other that clinical action, T-cell to we these cytokine activities mention, of will and a including this are a clinical should of in parameters with is potential trial translational associated benefit. let's used that addition that, whether

our patients Since are is here. combination these the drug drug, there's being only no given

of activities these attribute our directly the any So, we of we patients, action. observe in can mechanism to

long but a it's it's disease. a So, answer, complicated

Yigal Nochomovitz

right, But to kind of you in bit what specifics forth rate so threshold level you're of guess response evolve? early it's and how might Would I terms All prefer put things that. data just of a to saying understood. numbers, a for the like as, see specific just be you far as

Gerald McMahon

it, with physicians that But put patient is with most clinical that but than some stays data And study would support months not who associated patient notion an PSA in that would the study, advancement this on a this Is months shrinkage efficacy helpful? we're who good of hard typically, an support disease. is further greater of study. than A either patient deriving is given that a oriented to that that to percentage escalation this patient of the is on greater that good. declines It type to looking is and stays product. also benefit. that is It's generate if tumors, or very study measurable six on three argue

Yigal Nochomovitz

Thank a had I very technology Again, Yes, question. you. helpful.

the weeks. that's is to does development? is that the another doing the level Do potentially of the I that across you're the What you ability every dosing or two have extend say, once rather allow? programs. technology potential with now as to weekly So, it platform, technology understand once What for

Gerald McMahon

Yes.

feasible see think weeks. think, data we we these every it's or possibly both on measuring to weekly or HPNXXX exposure either we're based XXX, emerging measuring would from very that course, because the used derive still either and to the dosed programs, platform the hate But being that not of clinical now, So could be but way. hard trial. know to optimal, much it's as as efficacy, to either allow from product possible in of patient benefit the this is conceptually, two which the We the first

would that the what But based seeing still to every the later, moving call once be two frequency if two not be. the we unreasonable felt the or to regimen, particular could surety weeks. with we a it's early say every platform could either that once once on week benefit But on by a maintained time. what it's support this But ultimate it. we're of week at too platform But with every make can't being

Yigal Nochomovitz

All right, very helpful. very understood. Thanks much,

Operator

question Asthika next comes Your from the Goonewardene line SunTrust. of from

Your line open. is

Asthika Goonewardene

updates here. you the progress guys. all I questions taking Hi, and for appreciate my Thank

the window expectations to So, XXX the back for maybe really XXX therapeutic appreciate discussing broad. that what at going here for Totally ASCO. is

relevant but as sort to kind dose you be at be could give something is now? feel of it's the real you the ASCO how be answers for are of answer maybe to put you you that's will that, right So, maybe in range, cohorts therapy and to that will hard which presenting some -- to many of hard the Jerry, clarity

Gerald McMahon

therapeutic we very large or approaching that August, a were potential we wide of I think said benefit. Well, range last

this know potential this. not to have attempt benefit predict here, of like preclinical the other therapeutic able we hard to products from products very is precise assessment do be enough the benchmarking to because it's to don't and because difficult it's So, to

that be in per to the per tried range estimate could per of we've believe being this we that But microgram said, kilogram therapeutic and hundreds week. week per to nanogram the the kilogram

particular So range this can say all we is that point. broad at

best So, that's can do in terms precision. that of the we

exist PSMA work to We infusion. by a PSMA MTD some that any mean for dose. we also again, an there's MTD not precedent IV know an That targeting doesn't was early T-cell with doesn't engager. continuous based have BiTE, limitation there that no on yet achieved the But

limitation, push trial. that efficacious feel to So at moving warrant a to has the point dose into clinical precision, with and an not efficacy knowing we knowing this up empirically we get until the the sufficient not evaluate oriented product continue dose the and activity we to dose,

So that's this at our thinking point.

Okay?

Asthika Goonewardene

it. Got

criteria patients metastatic a for this. cancer through you resistant the couple have the patients But given in here. prostate a Obviously, metastatic lot castration just Well, hormone of Okay. thinking the do who of about that setting. novel entry cycle might therapies

like metastatic might that think some could you us prior the what the is if pre-chemo I'm chemo And pool this? asset also color patients post-chemo. and wondering a expected how You give the a get patient are? up engaging some on you of in would maybe your setting mix a impact do efficacy the T-cell

Gerald McMahon

little give Yes. a here. bit I can

coming very have study. mentioned, who they to or So, disease, on late these to radiographic as cancer have are with PSA, rising I or come either on progression patients progressive study stage all they both, before are they

those are study you they the if patients So chemo. our treating. onto chemotherapy, to patients that is therapies that About the you is approximately obviously, nature the received. median of the And expect after study failed coming we of might worse have patients come earlier and they're received previously give fare seen our can half population that number have of the were six. before, I hormone patients about therapies therapies And these onto some of that they our

with the is this study we're this product. population first this in treating So

the think obviously, previously phase escalation slide to population nonetheless, trial. patients received disease who of faster, have We But may chemo. dose patient downhill is that have expect might useful chemo because advanced that for they what required we with this intervention

going elaborate expansion have I think when assess of patient the the to to best the we the population to get efficacy. we're phase trial, to

and clinical wide with portion PSMA. make to to pharmacology this which of expressing this are XX% treated a thirdly, activity, for disease trial, secondarily primarily But patients, the we that we wanted XX% patients really sure safety, of the of is variety since

a this target a So still is point from view, very population. patient of relevant

helpful? that is So,

Asthika Goonewardene

that. to appreciate same might investment obviously little terms really community. Last either But one, bit due right ASCO coronavirus I to -- out. see now. consider a How on as we expect follows canceled here. be we just more I press going more path AACR, how if to a It's ASCO can you, for one play Thank to can, releasing the data? that helpful. hard very might data the Yes, you worse in adapt released postpone or if Would any to you of be even have shows, to instance they things going the and of if the to change

Gerald McMahon

Yes. No, don't plan some Obviously, very specific that this nice abstract we a have obviously out presentation. something scenarios. think point. playing it's we're at is any We've submitted for we

our think trial intention I but appropriate goal. the timeframe, provide we update think haven't our the some in we same But, decided to if do this or some is able forum, to our is the Clinical would at but forum when of about update were the not provide Oncology I an specifically is specifically that, trial in to that how have data we in and we present the on meeting. intention course

ASCO not to or provide or have Our an trial, the not. ability we update present whether on intention to at is the

Okay?

Asthika Goonewardene

you get to make clarity, too. guys. hope presentation, guys the the Okay. Well, ASCO hope that for there for I to be you Thanks I all

Gerald McMahon

Okay.

Georgia Erbez

Thank you.

Operator

[Operator Zegbeh from Jallah Capital instructions] Partners. from question Your ROTH comes next

line Your is open.

Zegbeh Jallah

or just quick and may potential a we you XX:XX] positive Jerry, evolves, efficacy. had want that, improved positioning, that have reach for kind not soon? nice it's know for sense ASCO, data program was a either competitive general may as well as Zegbeh. XXX all should the it just some to landscape to hear is be a XX:XX] their This by [indiscernible It question. to from MTD could you. [XXX's like or I'm going the get But competitive about of Thank

Gerald McMahon

you course there. as is potential very programs the in is Yes, prostate their data of don't point, year. engager to program for that for this engagers. Amgen any Amgen, have and targeted some clinic. presented related was PSMA know At for are late believe you ourselves competition Both programs stage the had targeting there out, and early other T-cell gave That encouraging pointed of limited I PSMA last us. some cancer, pretty BiTE to PSMA proof as that concept

have we're we albumin. We which forth is you as human as in our they binding probably trial moving forward know them. FC believe, with BiTE They to fusion a half-life, But before initiated so what to contrast, within are serum trial well. doing brought serum increase their with

in So, to dose don't I some presenting early other I are. as any Amgen other guidance be know Harpoon they're we But, escalation an have would that year expect the do data both around if than that this fact there's so. early that opportunity might I and

Zegbeh Jallah

following a initiation doing you. comment then follow-up 'XX? XQ recognized AbbVie XXX confirmation. a just And the how be the can quick Georgia, or payment the from of Thank here on of much million study $XX you just will

Georgia Erbez

recognize to the straight is program recognize we is expect our that quarters. estimate budget, the a that way based the amount right it And best The entire over to on basis. that best is XX to be now next it which line -- we XX on is

Zegbeh Jallah

you so Perfect. Thank much.

Operator

question the of from comes line next Wainwright. Your Debjit from H.C. Chattopadhyay

Your line open. is

Unidentified Analyst

Thanks taking guys. for question. Debjit. Arun Hi, on the for is This

wanted piggyback just that on I Zegbeh's So, to question.

is So, ASCO the see balance at what longer-half-life could as or expect XX-hours efficacy, conviction CRS to shorter-half half-life optimal to of that data might solidify opposed to life? and presentation, the kind a that the we

Gerald McMahon

Yes.

in We exposure. continuous dexamethasone goes and with initial we patients clinical like systemic to have And not to as to product allow a is mitigate can the on the effect observed. symptoms away. the look way relates those then it this steroids issues initial increases I at to is where symptoms exposure see of the safety to of levels CRS triggered it when CRS. our to cytokines use patients can point think be the treatment

much have do doesn't really half-life. It to with serum the

many fact, folks In lymphoma. is of driven people leukemia CRS least the a phenomenon believe Cmax at in off

allowing in drug exposure the want into every drug bed. the is for mechanism. T-cells in friendly and the circulation the probably week then of the drug patients to to that we of an can with in and any have come that So, so Fine exposure to have engage But, doesn't about tumor IV we the the maintenance issues. CRS upon safety patient a tumor into an we keep cells, total diffuse to more is much hospital continuous case only effect and a the don't want the replacing allow patient hour as a of the

don't with has Is per bed. about se. helpful? more to into to drugs maximize It's index able being do the that anything I But therapeutic think of it CRS the convenience and the tumor penetration the

Unidentified Analyst

that Yes, you. is. Thank

initiate guys second-half in talked expansion the you're expected to in So, cohort about 'XX. the PR that you the

CRS mean expected that handle dose, a recommended X that Phase have you on a dose and safety of management issue? does or the So,

Gerald McMahon

there. questions two Well,

one, So, issues treat using then initially can lower of absence increase what's what CRS think then called step a well, managed the and at in at steroids where using call dose we we or dose. by a to-date by least patients dosing, we taper, the and dexamethasone, doing we've

at the we of done that. a good managing managing do we've continued viewpoint complications, that from very So, job and to good a CRS job

than by may take mechanism potential tissue aspect a the expansion I And a we've as may that it issues. particular has benefit. limited regimen into more believe not a not very expansion we or relates clinical and be way dose Phase are the study always to issues, here, dose That the we seen in study, which cohort which think other criteria. dose based specific we the amplify would because different more CRS, be is safety safety X may to and

the per instance, tissue the can of for that if started imagine, we increase would because is particular to kilogram per to a yet and up instance, dose given managed the outside range. related room nanogram So, see want lot in week the for we that problem have don't you of well, move to there's a a we the dose, as continue tumor, to CRS we

That said, and to more that our be expectation, of being homogeneous to if a study expansion hope is we'd want population we have activity, evidence which in study. able an clinical and

point, So, more by that a necessarily be dose, the this wouldn't expansion limited we're study study but regimen. population X and for a Phase to dictate want would we at it efficacy thinking a homogeneous dose particular that's is at about way the an MTD, would which

Unidentified Analyst

last there you at you to any of guys question. Or can any one a higher the the from XXX? started XXX with accelerate chance Is learnings quick have do Okay. dose that perhaps dose And use escalation?

Gerald McMahon

good That’s a very question.

think I dictated FDA the starting by extent is dose to guidelines some in States. the United

we that where could is So area an advances. any not believe probably we make

to much translated learned XXX allows potentially what a doing protocols, to learning. than XXX we those been XXX, the we're year we faster since lot However, last has move had have now that XXX our from already trial a that and doing of to trials with spend initial lot

right. So you're

lot translated of forward. learnings have a those We

started learnings when those have that first with improvements of FDA negotiations some in protocol for have clinical we XXX. with trial the And we design didn't resulted the

So, yes. is answer the

making in into design of the first and We have other flexibility of because product. being translated the learnings programs. been terms that's And the of quite all bit protocol, a all improvements of from three

So, think the potentially faster first to than much I expect we programs go can those one.

Unidentified Analyst

Thank you. very That's helpful.

Operator

Jerry call session. I turn McMahon, Mr. remarks. the for Q&A the now over will to closing includes That

Gerald McMahon

all once again, for Okay. call Well, thank today. joining our you

everyone. good any have contact evening, a feel free to If additional us. please you questions, Have

Operator

This concludes you Thank joining. for everyone conference call. today's

great a Have disconnect. now day. may You

Harpoon Therapeutics (HARP) 12 Mar 202019 Q4 Earnings call transcript