CUE - Earnings call transcript Q2 2020

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Operator

Thank you for standing by. This is the conference operator. Welcome to the Cue Biopharma Second Quarter 2020 Earnings Call. [Operator Instructions] I would now like to turn the conference over to George Zavoico, Vice President, Investor Relations & Corporate Development. Please go ahead.

George Zavoico

afternoon good and you, everyone. Thank us Thank update investor analyst today’s for joining call. and on

on are Scientific Joining Biopharma's call Officer. Officer; the me today Chief Millar, Anish Pienta, Chief Financial President and Ken Kerri-Ann CEO; Dan Suri, and Dr. Chief Officer; Acting Medical Dr. Cue Passeri,

expectations, including Before the prospects, makes statements Act the making that XXXX. materially forward-looking Various and forward-looking result Private Securities Report today's well Risk we on the Company the as Actual remarks various like Company's during filed Form Company's filed which accessed those of with the Form XX, differ database the of the call, Quarterly that you of made Report plans SEC I on to remind the with would Company this the statements. about the discussed and section at can on call the from in Company purposes future Annual XXXX, to Factors by begin, time, a by constitute for be EDGAR on may SEC time statements XX-K filings XX-Q indicated the other SEC XX, Litigation of to during from as important www.sec.gov. on forward-looking August will March Reform as factors, those the be results

the only subsequent relied of as any represents views today, and Company's as statement representing as upon be forward-looking the should XX, any not addition, Company's In date. of August views

be if slides XX These to for subsequent will are that Please representing relied should of obligation we on and point, date as to presenting The webcast. the be to today's our the call forward-looking days. even any future at our disclaims the these statements advised upon Company's and call today next is any available recording update website Company While may so change. not the views forward-looking views being recorded Company's elect the Company statements a of be some do as specifically today.

via unaddressed I email call on to available will CEO, questions turn the provided the website call. be Cue’s to for our We Dan. over also would now the like during

Dan Passeri

Yes. afternoon, on slides financial thanks your proceed a for in to computer. which August our more are Also ongoing may for second of review the us on Good and as joining today Thanks, be progress we XX. everyone, with results from Form filed our call, the call, detail and SEC the George. directly quarter the remind everyone available XX-Q through advanced in

collaboration events. selectively for to dose and slide provide in only body. Then expanding cells breakthrough activate So further breakthrough directly elicit observations Dr. clinically three, meaningful dose HPV Immuno-oncology a just validation. provide in we to platforms. time in To the or activate program this working selectively throughout who [Indiscernible] to most on-going commitment execution which to point, Suri on in cancer receptor is the difficult we’ve with on of on-going synopsis shows unwavering advancing our TCR for these together and specifically slide our a Neo-STAT call. and differentiated made conditions. importance our towards military targeted the challenges of COVID-XX the is Pienta under highlight CUE-XXX is and our off-target of overview into our selective pandemic CUE-XXX positive the we progress patients. platform emphasize including program Anish we've response directly to made for on disease capable a CUE-XXX and the expansion patients Anish presenting Ken from relevant progress limiting associated are datas that representative our The T cusp demonstrates programs, CUE-XXX the additional dedicated the I'd our will progress [ph] in pipeline agenda neck lead Immuno-STAT T our cell head T continuing adverse stressful employees our approach IL-X, like from of I’ll believe our emphasizing and and X will with continued additional our and directly with Merck. tumor-associated particularly take representative of escalation by describe to case will the today’s or emerging be their the focus next trial this safely intervention on-going cytokine with Phase series with monotherapy without followed antigen I’ll I of thank modulation of disease our relevant X and also cells our Dr. diligently patient’s details a pipeline focused demonstrating in of of because trial CUE-XXX that and brief recent CUE-XXX Phase

review concluding Following provide then a Anish’s financial promoted Financial followed our update, will Kerri-Ann Cue I'll Millar, recently who remarks Chief status? Biopharma Officer has to question-and-answer by session. current as been and

quarter. the Okay, of progress next overview an the in and on core second objectives strategic slide our

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active framework presented In Phase is to cancer the targeted. our regard, so the The peptide earnings series. being and call, CUE-XXX pharmacokinetics primary Moreover, continue since far through of difference largely series, we're predictive and relevant we've tumor proportional X in or those Xmg/kg. believe following clinical Safety which authorization be week, appears likely the by on-going as a is as molecule, the epitope, enrolling we is encouraging indication associated underlying last four with or in agent. observe CUE-XXX data and evidence generated to drug signals early this the or PK, our first determines of is addition, from CUE-XXX clinically trial, that pharmacodynamics all activity and PD molecular be single to the cohorts our cohort the through we biologics at preserved X, the entire X now X, In Review advanced this Committee, last which cohorts,

further cancer Neo-STAT into incorporating third, XXX preclinical by October, cancers, to address X this next further year our as Tumor WT-X biologics Moreover, and to platform, year, our neoadjuvant additional our both Wilms as engineering known protein early expanding trial acceleration patient end enhancement into the other PD-X through studies. diseases. anti coverage. combination antibody Secondly, KEYTRUDA, towards expressing well also demonstrated as a specifically infectious therapeutics the the or or which already setting. in And has [Indiscernible] of We're broaden applications our or for development pipeline developing it's and in autoimmune well in initiating CUE-XXX of we’re and as our broaden frontline as in with and significant platform productivity Pembro expanding trial of promise

the development to will immunity drug now also and SARS-CoV-X. novel particularly we're will where cell immunotherapy, Ken? elaborate on those infectious assessing this T Anish as further upon SARS-CoV-X the in against clinical such of provide to pathogens, the our diseases, cancer infected the progress to responses immediate Ken, to his I'm update series. over clinical going Neo-STAT. addition with which representing CUE-XXX, potential turn protective In applications Neo-STAT CUE-XXX details candidate provide is who regarding call of for first could

Ken Pienta

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Anish Suri

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in Immuno-STAT Neo-STAT protein to promising offer one of maintain our suffering selectivity rational underscored safety to financial toxicities? approach highly immune a and desirable I review breaching We of to which we've results. prior patients the and and upon does by turn diseases the pathogenic engineering, With which Kerri extension, autoimmune challenge, address a patient data Kerri? sets our from threats creating the now solution from is response supporting is fundamental infections. call bolstered by without presentations, specificity a now will platform immunological how As built the believe over that, cancer,

Kerri-Ann Millar

Thank Anish. you,

working to approximately quarter Turning in with million We of our capital update second the now June XX. XXXX. ending approximately to slide finished million. provide for financial and results $XX.X cash a equivalents the $XX.X quarter, XX, cash and brief I'd on like

revenue million our financial as but in in of to ATM CUE-XXX and Stifel of -- part and recorded were expenses second These from the travel XXXX, in laboratory $X.X combination during us million offerings, compensation with the our XXXX. to pipeline that drug We in put throughout general June million General equity hampered in expenses. legal million for and which This Chem increases travel the the expenses, XX based expenses and primarily fees million our offering $X.X with with the offerings ended During Merck from position same compared the Nicolaus second Immuno-STAT and support aftermarket the into agents. of cash is which Development and period $XX.X due clinical development Stifel period recorded XXXX. to same consistent $X.X including XXXX. of quarter the Company, Cash quarter our the of from a $X.X solid sales increase the for of as in to compared of with position manufacturing increase COVID-XX strengthening equity with the $X.X million we costs, Research in expenses for financial decrease due XXXX, we & say were second were primarily quarter. collaboration and through of R&D collaboration a accounting second XXXX. XXXX, pandemic an of was who development LG extended ended pandemic, to runway in platform, increase disciplined presented XXXX. been as June clinical development This quarter stock-based for quarter in received pleased acted our in we've the a to the aftermarket in increase incurred and was momentum offset the the due spending. same the equity million despite I'm in COVID-XX by while expenses an stock XXXX, so maintain compensation the to expenses quarter able $X.X to period administrative challenges and XX administrative

the execute Dan turn call to We well closing back be XXXX positioned for now Dan? our over continue to I'll to objectives. remarks. against

Dan Passeri

and our make showing COVID-XX the Since on-going these call, we're and that as significant associated in progress update due platform to our challenges, despite all to I'm last continued Kerri. confronting here pandemic, across programs Thanks, we've slide XX.

activity. X tolerability or QX October, from platform. our Our key favorable the combination pipeline demonstration allowing Cue monotherapy dose which previously milligrams disruptive leader XXXX, and trial, been cohort trial and safety and patients X, further foundational X and validate the cohort a has in transformative through cancer. enrollment on-going with we as on principles per closer build to which line KEYTRUDA exposure, proportional forward a include significantly preclinical milligrams of diagnosed patients of the continue cohorts, signs as also in CUE-XXX of to monotherapy at evidence our activity differentiated which emerging per immunotherapy head X we're determining accomplishments assess neoadjuvant for recommended enrolled and in on-going to initiate treated this clinical brought based kilogram, of and a biomarkers X CUE-XXX scans having data to establish and into neck CUE-XXX newly through -- to us and These space a to We're now Biopharma and is approach, X trial, in Having and year past untreated beginning at well end as activity. of a quarter, PK as clinical lead and then therapeutic timely with would kilogram de and and with early Phase our a trial cohort the breakthrough X including upon potentially our program, our same X and additional body X projections, our and raised meaningful to risk activity, tolerability, safety, capital and is and patients a dose monotherapy well of and PD data of very both positioned building Phase PD advancing into XXX,

preclinical IND I'd science us for cells T thank clinical Biopharma’s to towards of shareholders during the our in these also our reporting Phase responses PK/PD from like work half the hard support, reporting Phase challenging in I'd Our X, X, by are XXX is advancing initiating largely like with The and results trial call second the end end. that, to XX. guidance year XXXX slide unchanged from employees for to times. platforms enabling perhaps criteria CUE-XXX we're open also And continued to vision potential our line X, and by in they advance year feasibility are our against obviously CUE-XXX that, from resist potential shown a pursue the and X enabling once for and clinical our growth clinical last clinic With cohort with milestones to cohorts X via initiate who pipeline, for Phase platform enhancing extend disease. trial. And of commitment to by KEYTRUDA validation to on positive CUE-XXX board directors providing Most and cancer Neo-STAT Cue and we demonstrate to patients expansion enabling in our our for activities our select And And autoimmune grateful closer combination and further thank our us of assets moving candidates their again neck head validation initial updates need. while for and have identify We for our COVID-XX. our frontline IND to trial finally, finally to CUE-XXX target forward of in all CUE-XXX serve and And October. year-end and like for HPV studies. questions, Neo-STAT look forward importantly, including, perform to manufacturability the the to I'd further noble assessments also efficiencies, activating Operator? expect enabled

Operator

from from Stifel. The Instructions] Please question ahead. [Operator first comes go Willey Absolutely. Stephen

Stephen Willey

cycle therapy, six intensity patients Yes, say, able many three? those kind Of that how seen? have be you cycle just cycles Are you color they I helpful? would on good afternoon. they guess congratulations two? three that beyond with on guess Are average respect to front I in to of any treatment think the are on questions for cycle four, I cycle patients progress. the three and Thanks on taking about remaining five, talked the

Dan Passeri

patients the there. are so early still relatively and Yes,

is cycles the four cycle two, beyond beyond cycle You -- know, at of past this in folks two point. five cohort one beyond cohort are just our the patients and of cycle

patients. for the So in it's for process still relatively these early guys, these

Stephen Willey

is in with seeing. tumor sounds or it and know that And expansion you're it. dose? with is in is the that a respect dose surrogates like But metric I if guess XX it's it's I day latter, engagement And then a that trying any little to of the refined expansion T periphery post just of Got Is effort not to coming cells being peripheral there microenvironment itself data is, it. shown? T to perhaps in pre a like? level? expansion is doses to an Or maybe do the you the peripheral the real on Got impact have bit understand the the best that persistency might look better the or, about suggest respect that maybe within just may to draws with that out respect happening TILs. is some direct of more cell of blood interest between what

Dan Passeri

Yes, great. that's, that's

Anish Suri

in was gonna I'm just jump here. just I gonna, No,

Dan Passeri

Anish. ahead Go

Anish Suri

Sorry.

apart. this analysis. rightfully, days points I to getting sample think what of as that is are one the those well Just that was Ken and the to is was clarify And these XX time Steve, here challenge just post all because

extravasation lesion happens what what if measurable becomes what's exactly to So you here? interim to to, tumor not the and drug mechanistically. very in Ken that study to the is is the time give tissues important after study there the And peripheral alluded neoadjuvant

able course, tumor So tissue that. one be quantitate that to limited is limitations the of here availability of of to

piece neoadjuvant locally. navigate matters happens we'd a cancer important missing that we're is let help mechanism, is Ken in to on the there. which current what times puzzle, immunotherapy clinical I our in surrogate frequency think presented in publication, peripheral is impressive. for you to and I research alluded paper good to ultimately final which that's ultimately I’d and that. here very the comment what is think the that us sampling a that but from I'm will point, again, Steve, The as what the making gets this us we the the

Ken Pienta

more Yes, know, PD add you be Right expanding I about, we now, to learn about just to quite thought more sampling, quite that, going honest. limited any we we to, will, the monitoring the COVID and was that in coming sites patients don't have more and draws. by potentially how even want for hospitals extra we're But constantly data. and in of the blood get we're most as

as using and For thinking to Especially data phlebotomy hard example, try we're know points. that October, future we're trial some we to exploring mobile fill and in about that in if the of those start combo which in you to collecting that we nimble as going need is still likely problem, a be samples. really be it be feel we that, going to is COVID able is to as possible have be

oncologist in the we'd draws a that to in crisis. through CUE-XXX decrease of It so all accrue what a we're, it's I'm the considered medical on of and I these get COVID this into think get open that that, trial options to again, those exploring you our done my to accruing. the COVID. to data oncology important though, managed other that to help them have see, fact by blood keep to all points we is like exposure by ability fill patients And colleagues to we risk why our be once that's administer those patients extra to they've time challenge, the as to is have amazed us to And that continued patients future. I've medical to have humbled noticed

I a answer, was that winded a but that helped. hope bit long of So

Stephen Willey

you very guess dose of combo CUE-XXX start about to lastly will able just say at being you. And me, what commentary. and study. the you I Thank that that target was higher now helpful Yes, KEYTRUDA starting dose talked Are to able for be? a

Dan Passeri

-- we'd on it's is, we're initially. where and say can I analyze what actually to Well, like to start on-going

minus starting we'd on what X.XX is at start to X thinking safe mg/kg. were planning we're we a example, cohort a dose one. really, But doing For at have

at go we mg/kg. depending not may So with start where you are cohort may currently, we we'll that or at on a that And are X accrual know, to mg/kg in time. X

a So we're right mg/kg. at now

Stephen Willey

Right. taking questions. Thanks the for

Dan Passeri

Steve. Thanks,

Operator

Madhu comes question next from go Baird. Kumar Please My Thanks. from ahead.

Madhu Kumar

first so on… questions Hey,

Dan Passeri

a Yeah, then Operator not difficult put to sequence may another be maybe we're getting take in. Madhu, bit question worse. up you’re can breaking catch understand. Madhu we back to you. Operator, and in able

Operator

from Our ahead. next question comes Please from Shrader BTIG. Tom go

Thomas Shrader

surprisingly, same longest afternoon. But are couple I cohort seen? Steve. think Can far? I are you've questions longest the Good the Not from these what I so your know stable X. let you as have diseases us almost guess

Dan Passeri

Ken, you that? take to want

Ken Pienta

Yes.

a XX of a the been have couple weeks. weeks, that therapy was and in longest break had had BP one patient XX we our and that with about total So

Thomas Shrader

And are they both still on therapy?

Ken Pienta

No.

Thomas Shrader

out XX? to T of and of you pretty day a This response. data kind from that's response a time I Or any is data course? this? with you, then quantitative what something good Is a day And Anish. Okay. there like for can between this XX somebody XX, Can patient cells? happens of that kind out naive response the consistent between a building assume memory Is dig that you question dig

Anish Suri

Yes, I think metrics. Tom look, firstly, these are early

need we the So bit this a to promising, looks data out more. build

look see chronic, as staining be memory if to really pre If robust population. a would determinants or dose, not to compare repertoire you fact And don't the This of of you an against with, viral EBV. that. like as this is, a were established at CMV sort much you the even

to rare sort present there treatment being manifest it Hence, couple maybe therapy from frequency you say took that naive and could baseline of it's itself, something was for cycles you or for on time primed to and the So present repertoire. really the is need of at a but there it a itself. it likelihood additional of

out. little see in then blood, that mean, I presented that's of we with example baseline the for at this if a at, fact rare as there of In -- that contrast, you we data population a control you example, you either it see baseline, a the that being don't pre non-prime population bit from I Tom, dose, view. that as how which look simply a present because think that's CUE-XXX interpret if you or could further expanded in pre

cell the escalation are we exposure that's and usually these that. the patients and that and rare start easily in the to So we building detectable out this not is, metrics. frequencies, promising dose and we They is are solidify the to further up know see and encouraging these exactly T very see can if on fact them and going what's

Thomas Shrader

And the see need change a comment weeks that like just to way think then about going really could you if eight this, you maybe on, trial to Ken if a does are response?

Ken Pienta

Yes.

lines So, of we're sick, therapy. had I we I patients to think rapidly treatments. And these progressive all recognize earlier they've will ideally, are that disease; we move got they've right? mean, multiple

what the the combo be see certainly, important. first so patients, makes It as more they gives, those the me pre-treated heavily think also the time have to we about in other think responses. see future whether, about diseases, better. again, Because me will that study, better think responses patients those we'll line patients I optimistic therapy makes even makes and have that's and that less

and optimistic the about first I continue optimistic And am neoadjuvant. be therapy to really patients and as even so the as line well

clinically So, these first safety, is know, first see as and in win. and a well huge a is can huge studies, Phase safety, studies, human X it's you safety, we anything foremost, in

Thomas Shrader

the you Thank details. for Got it.

Dan Passeri

the not add back in I been one point Steve Hey, eight it Tom, the to we just response of for fact the tumor again. clarify, just has to look was discussed an that quantitative. the lesion weeks at things something on is coming with that takes wouldn't because that it

extravasated, may peripheral but coming that to getting central want be which is the presence study important. put to come there, nicely which I articulated there's tumor, just close a really delve it's into are if by to and you've very low deep is the why a caveat, these get Then very analysis. I very being paper is back to why got that neoadjuvant while out, So fully signals, to Ken response is of appreciated is that mechanistically. this always the importance blood not well effect the the that drug important what

Thomas Shrader

Thank it. got you. Yes,

Operator

from next Reni from Security. comes Please Benjamin go Our JMP ahead. question

Reni Benjamin

the for for Hopefully some, Thanks guys. of and afternoon, And of the curious, CDX be we T all measuring? that you metrics off of or guess on ratios. Anish. here? able progress. T be to out. cells questions I selective picture you T at CDA to cell a What start congrats gathering of on cytokine are should taking the other okay. I'm the population can with selective or, me cells For what example, be kind outside focusing levels, keep of happening -- what's good the maybe question help kind and maybe complete looking just you we Selective, are hear expanding Hey, all might

Anish Suri

Yes, intentions are, know, look like you you for Ren subsets, in other at to. Immunophenotyping the pointed parallel to

One from of is are models activation something our that possible attenuated sensitive even molecular of cell the consistent movement be versions. We've up really regulation favorable, and the by not could IL-X Tregs, that's subsets line. T on design. highly data cell of types the consistent with and to encase, in happen should Other any global be they effects could seen preclinical sort on not which

the But in think, to these from at data that consistent. other something that seems and I overall continue we IL-X least continue and to understanding at, be and will periphery, early is, will to strengthened. sets, So, think is and data I that Immunophenotyping, be look

and We on time points. at to we've, as that cytokines, -- course, back we'll accumulate samples, haven't of enough come decide we sampling sort of looked

than tumor important and a just other of metrics back to from very Again, of really The being becomes effector I the what tissue immune composite earlier. recognition mechanism. coming a referred

but that repertoire, can that some to think one not study describe be that immune on the optional effects localized, in that we diversity, where can that the action. which the will the of further monotherapy, have through specific, standard add been of the telling very be I on subsets, So the to garner going and also limited, if biopsies is gold metrics mechanism modality, could and and neoadjuvant in antigen again, would including focus only other and

Reni Benjamin

be going And effect, Got starting we're of effect so X enroll, patient's the about, to kind lines is effect weakened effect a therapy. of profile, like? amounts and a think to of drug are right. there's it. this maybe kind reflection of profile masking Ken looking true good we And side to impact the to then the or, we patient's cell true dose significant immune mentioned this reconcile, can profile continued relative when to are enroll started Does cohort that the have help four potentially is I'm or really what had effect a, actually status, side profile, to the given dose, that system And trying of a think of the profile. side status or he's that is immune the the you prior side course status? in have I the And side effect immune me and Proleukin of

Dan Passeri

Yeah. Ken want one? you to take that

Ken Pienta

Yes, thanks.

question. interesting So that's a really

patients. best through in at data groups think about the think is way that to I similarly, you ill Proleukin that, of and answering the thinking if look [ph] it data the IL-X of

of the pre-treated mean, with. sick I evident. of very we're of attenuation of toxicity the Proleukin. toxicities side heavily Proleukin of see IL-X profile an You like, was saw, The dealing in profile effect all at you didn't even patients

that the three I of and grade lot core. personally So we're, believe why grade not four The seeing, reason don't a that's toxicities.

I because do on think it's we really target. have selective

target a have on We treatment. selective

patients And Proleukin a of did so I would have, the have, really again Pro, lot effects. side

in the patients, saw when advanced them they tremendous that saw the checkpoint in early they, the you inhibitors, in toxicities. when trials, have again, -- also You very

holds I that, that idea think So don't up.

Reni Benjamin

able a me. being see one that is scientific form? when might or think Got I be guess accumulated All this publication in to from know, this final it. we do you you one that And data

Dan Passeri

the Ken, if the Go to in clinical… go the want have ahead, presentations later ahead; data we clinical when comment year. So on you

Ken Pienta

a we not certainly Yes, well, total I through PK/PD this until would where manuscript got the on, typically on went data and RPXD. the all the that forward had we establishing XA data, clinical think publish to patients Phase we XB,

and the between. ASCO, but do we'll and the I will think Citi. wait trials Citi presenting have example, it at And things, But abstracts for and next – we'll complete. that, we till some totality start the but out an year, be data in abstract of putting at

Reni Benjamin

the Great. for taking Thanks guys questions.

Dan Passeri

Thanks, Ren.

Ken Pienta

Thank you Ren.

Operator

Our Breidenbach Oppenheimer. Mark next ahead. from go from question Please comes

Mark Breidenbach

escalation based quick days have all for of revisiting also one what on data the expected clinical T and Anish progress some with in XX. And models seems the looking preclinical the expansion bit and just promotion. to good would on Tom, questions Hey, congrats from Two patient afternoon the Maybe, Obviously, way of the longer the a the the probably I saw of cells or you at we thinking maybe you're this that T I right looking than Kerrie kinetics of kinetics and the Is is congrats in that ones tumor on absolutely preclinical to were me. cell in Ken, seeing in attributing on between models only. maybe and biopsies. fact that want clear, if preclinical discrepancy we're at it? about you're be peripheral two

Anish Suri

a Yes, of status. of the you're In things. performance immune the preclinical compromised there's not a facing headwinds Mark, I models, think couple

as are So these sick patients, you realize. extremely

that multiple a is and you can you of baseline whether to been know, have that's starting obviously your here, patients decipher. so repertoire, the hard tap lines, have spectrum diverse whereas healthy, to And into

preclinical back did boost think the know, you're that where after the patient to have that you I like more bit needs it's in really cases fraction this, to And comes happening reason we're of we're what to a And seeing pre with comes that And reading as very is animals cancer just a knowing indicative. that the Or and the work that, a one without variable you coming the enriched importance what's of out in mass things the that's again model I able put in for in had presence because they always in the not was looked study much centrally. that where relationship a I enough you that lesions, and question neoadjuvant presence -- you once the it are you again back cases been where a and it of you're seen the that in have have using we've like through there in able we really our models, the when didn't that it scenario, out T blood. data establish all. and again, in this the and is in peripheral where the lesional to again immunotherapy then peripheral to be well, here, that's to a back a percent And That fractions what a the if to first of own same that the you and there quantify? at got have showed you we've instances, prime tumor to the blind look in obviously quantify variable, response. site post a enormously. cell cycle. you percent at pinpoint repertoire that's of had hear to that we when, something That's is relative blood hard preclinical

Mark Breidenbach

when question Okay, fair guess enough. to stop second know escalation. my is in And I -- you'll how relation to

So recommended [Indiscernible]? consider it -- per still declare You know dose? and not How it going makes seeing not you are makes when through what, why X, Phase X to a really you do you go cohort decide the higher than DLTs?

Dan Passeri

Ken, to you take one? that want

Ken Pienta

thanks. Yes,

a So could that choose we what we dose, don't we define all BDD by well so the three whole expand trial, biologically the that going we But we will approach that built of forward. And so potentially design, cohorts, are that tolerated approach into as effective us reason by we patients may that on as Bayesian to explore nine to I patients to the to can't clinical dose PD. again, a we see define nine response could specifically we we doses. There's, going think dose this MTD. give and cohorts as put an consider relying effective a higher at go are up why not that dose no to we level, doses. just top over the higher move per biologically if see don't really Because actually and hit again, when confidence have up to on can we three that and three there's if maximally

to really, we the just MTD. can’t we may we this answer shorter just gives so higher us design, answer. thrilled it so safe doses. with to that -- as this opportunity go because decide just anticipated that see effective what longer we I'm be dose, find to But we'll is, So The that's find may We happens. we an that

Mark Breidenbach

And for it. questions. Okay, again. Thanks congrats for taking Thanks got clarifying.

Ken Pienta

Thanks, Mark.

Operator

Kumar Please ahead. Our Madhu Baird. go from from question comes next

Madhu Kumar

better Yes, to hear is able me. hopefully this terms in of being

Dan Passeri

Yes.

Madhu Kumar

Very good.

Okay, great.

up during I'm So been that coming a kind coming this questions call. really of have lot of back to

put so together, what far of nature that's monotherapy. so one-on-one responses dose and drug believe the all of about To refractory with think intervention the population kind of you rank kind due the it do all haven't would reasons the blockade, patient to If absence of How RECIST absence in unlikely far? of or kind of of any or PD you to extent responses seen research and three. three you terms those why you PD-X -- of PDL-X the of mixture

Dan Passeri

Yes.

So answer overview this it over to of the is to qualified and broad Dan, current that I’m turn and give Anish. then going it question. to sort Ken probably a least I'll

great question, Immune condition compromised been by This it's Madhu, poor above good in of So heterogeneous patient in all circumvented population. various aspects. health ways. a is Very question. various the system. And probably a system the tumor has basically immune

with So probably all of play in degrees at patient above I population. think the is this various

with monotherapy is obviously drug the PD is and tolerated effect. the drug the be like dose questions benefit. at on primarily its tying conversation this We that objective as is with safe, on the to the metrics the of appear seeing tumor PK, all that clinical the into show focusing is well properties So proportional And to to what's in showing series level. pertaining going exposure obviously of

the And RECIST encouraging if historic based So out the remind this patient’s criteria, to patient everyone subset average, activity. with point just a on on XX, patient in just dose a of monotherapy, we with we really one to patient this performance where see extremely it's clinical population. escalating that's response, population, see partial of in

seen. we've bodes So, the that move with even data monotherapy, into well metrics the I to Pembro, going this based But we've emerge seen the be clearly with following today. optimism think for we the forward continue with into data already going to line upstream front we're very just of compilation on

than to I'll it lot this want who obviously the oncologist you I do turn a So with over Ken, that, elaborate? to clinician about more do. knows

Ken Pienta

of that. a did job great you Well, answering

seen I turn of amount activity would think, I the go. it amazed we've seen. we've already around I'm and

into those In to activity as active have fact, to already amount seen. things more, that, of do we've of we call. think really seen data got to on we've we've the to more. we neoadjuvant and have as be just study, it's -- by data. I get as even more just early It's confident the we've so me combo, think us mean I'm we into much said as And already. we're to encouraged the the move And I to amazing are that the the -- We've confident is unless as highly already combo mentioned, we that expect drug. enough we because on the forward I trigger seen well an too I pull

seen discouraged as or at not we we've I'm we seen more. all much surprised as So have. surprised that somehow haven't I'm actually

Madhu Kumar

HPVXX, line better really have more XXX and with PD-X combine they revisit you you positive could if second not efficacy for possibly or lateline of of are of Like frontline, that kind line cancer, rather of neck from patients following experimental late kind than so of early head line PD-X PD-X third kind issue you after address therapy being you Okay, super line and revisit patients? see these PD-X of when therapy of agent. be monotherapy immunologically XXX would than second would proximal kind -- and to new you kind of post sort this a really up right a

Ken Pienta

trial seeing lines previous the on see were that four we that's have Platinum -- we'll of of an therapy what neoadjuvant agent, all patients chemo. the point we'll these constrained And we would, FDA out I as of the by be that the average there had I also effects why, the in patients. I absolutely. yes, albeit have in single monotherapy to think based study. see -- we So would had be also a in

again, hints to So, short absolutely answer, started more yes. But about move I that we'll get we as absolutely, forward. get think

Madhu Kumar

Thanks great. for Hey taking questions. our

Ken Pienta

you. Thank

Operator

next Our Please and from Company. ahead. [Indiscernible] Geo question Needham go from comes

Unidentified Analyst

Congratulations progress. the everyone Hello at and squeezing in thanks the there all for me end. on

of couple a just So questions.

just by to Is just First pembro there can itself something, immunosuppressive by combo CUE-XXXthe study, combination due just than a on rate the response that you number with of maybe pembro itself. higher go had maybe is clarify reason this think chemo or to a effects chemo? the a

Dan Passeri

take that? you Ken, to want

Ken Pienta

is there great thought and chemo to so better we're best. that data works as We again, plus it in trying is Yes, pembro. some to wanted – we understand move there some data the cleaner drug with activity. and be how forward would We to expecting our

would would and the thought combo, chemo. cleaner. Merck, did agent and as we made just with dual the with together be sense the do it mix us And it cleaner think most So that in to be

Unidentified Analyst

on a series. question Alright. maybe the And of CUE-XXX a bit That different makes sense. next

with Is required these structures are the the types any tumor necrosis of factor, that's these challenges So and trimerization signals? there the some, agonist. associated from

Dan Passeri

etcetera we sort we optimize systematic these we try do it’s lengths, then and so or molecule, receptors spacial all And where to contraction how of sort of various on of the tethered a the are the systematic relationship cell. the we the sort of of fallacies derivatization of Yes, do T extension, where link look a at together.

the not just each -- collection we of we're putting based on steric It's property. together optimize what intellectual combination relationship sort that trying engage and all sort systematic valence valences, our signals very the molecules with of happens. sort hindrance, that are spacial of in and So of the into these to study with and how other the so that terms resonance this plays optimal factors. receptors of have these, combination of they of sort so able of align seeing don't of a to And we obviously that of have

Unidentified Analyst

using Alright, you the I antibody. sense, on more again definitely by than have each that of makes mean, one potential

might some credibility So be there. that

Dan Passeri

Yes.

Unidentified Analyst

for the else on. got Everyone all juicier it me. questions All right. That's early

Dan Passeri

Alright, well appreciate thanks. really We it.

Operator

session. I to to remark. the like This concludes would the Dan closing back for over turn any conference Passeri question-and-answer

Dan Passeri

very everyone again in. forward We're everyone a listening going stay for company updates. period on-going I entering to you, We thank for forward. your continual very look want you obviously to Thank safe, exciting thank Okay, the providing interest well. stay And and operator. much.

Operator

This conference today's call. concludes

pleasant may Thank day. a your You disconnect and you lines. have for participating

Cue Biopharma (CUE) 1 Sep 202020 Q2 Earnings call transcript