CUE - Earnings call transcript Q2 2022

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Operator

Greetings and welcome to the Cue Biopharma Update Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn this conference over to Mr. Chief Biopharma's Cue Passeri, Executive Officer. Dan you. Thank you begin. Sir, may

Dan Passeri

everyone. you, and afternoon good Thank

advance We as Just in of we're as which can convey to our on well slides we you through our remind CUE-XXX, you, update proceed call the ongoing and your appreciate time presentation regarding we'll and as the interest directly. trials slide CUE-XXX.

candidates series. Our CUE-XXX IL-X-based initial of representative the drug

next Acting Dr. Development; Chief President days. Suri, on Officer; our Dr. President being Ken will available today's Pienta, XX Financial Scientific Chief of Millar, recorded me Matteo our Joining Dr. be is Chief Anish on Officer; Medical Vice and This the Levisetti, and call and Senior website conference our Officer. and our is our Kerri Clinical for

on statements, forward-looking and overview two shown reminder, this of as An any forward-looking As a Difficulty]. may and some [Technical slide number contain made here statements presentation.

on call agenda shown for today's the Our next slide. is

progress well CUE-XXX synopsis introduction Matteo X and positioning turning an As to strategic with data the of the ongoing and call observations describing Ken our prior and our each each Phase a as trial. competitive initiated as to as over provide a well as our and of to will date, update associated of from CUE-XXX, recently provide who status will the trials summary

the a Q&A to up will provide I'll corporate then additional pipeline I'll and call a With and then strategy expansions the which for update and Ken over pass our financials, closing CUE-XXX an I'll remarks for Anish. Matteo, series. the of Following a now that, return of open after Kerri call overview provide within session. our brief

Anish Suri

folks genesis to quest presentation by our of accomplish. we mission Dan. I'd company's start seek today's to Thanks, the like and the of reminding

as anti-tumor We slide fundamental [Technical which objective, very [Technical a accomplish Difficulty] is the address and shown activate our specifically receptor in which four. or we for to immunotherapy, consequential and while is mission avoiding tumor-specific T-cell T-cells, is, can question selectively Our the Difficulty] TCR.

This termed platform figure that FC signals engages the biologic which tumor-specific to activation, off-target molecules desirable to be deliver We Difficulty]structure to to have T-cells. the selectively basis impediment minimizing for a The targeted T-cells, antibody improved left that along immune anti-tumor containing with in TCR essentially many a signals stabilized for consumed framework the depicts selective systemic is Immuno-STAT, an to molecular Immuno-STAT, generates an on T-cells. those of which are biologics based key continues tumor approaches. peptide due an engineered it activating by slide specificity four provides activation, activation other [Technical innovative target immune T-cell tumor-specific broadly way, by for HLA while toxicities immunotherapeutic

low which deliver the hence generating therapeutic series, frequency. On superior the the of which as right this in side is been T-cells a especially tumor a can a figure IL-X slide see a has T-cells potential fullest specific you a tumor-specific a are index IL-X designed very over IL-X, of CUE-XXX to We this for approach is to selectively harnessing depicting of believe since challenge. the relevant T-cell, present for yet

The Our and the share framework takeaways from clinical slide derived summarizes and and the that key current namely next series impactful depicted core CUE-XXX highlight and candidates, clinical CUE-XXX as progress CUE-XXX IL-X five here. platform novel data are the provide slide, that the have and targeting insights detailed patient validation summarize, here. noted clinical selective activation. and a the support for biologics into approach. of [indiscernible] engineered To Matteo will our Immuno-STAT T-cell Ken we benefit conclusions the

a a activation from well-characterized IL-X has therapeutic significant liabilities of to deploy as is IL-X drug signal. index. targeted an suffered due construct safety target, lack initial to As validated we and chose the but therapeutic

mgs IL-X for per evidenced index have generated as and kg kg We X clinical X per to the the due have between effects. per have Most therapeutic fact IL-X by per to kilogram unwanted low-microgram MTD. and clinic mg observed no with adverse mgs dosed up X we that have range are other been kg in those in variants the activity side successfully a that

Our IL-X candidate head attack targets cancers, neck CUE-XXX cancer. HPV and such T-cells specific to first driven clinical HPV to as

for highlights several experience clinical Our technology platform. with CUE-XXX our important findings

The toxicities, exhibit Our as molecules no with or cytokine cost IL-X are of and syndrome including goods. PD support of manufacturability systemic PK, antibody monoclonal leak on signals favorable such desirable target drug-like well evidence tolerated properties like to vascular storms.

monotherapy as neoadjuvant prior clinical that emerging trial failed will mechanistic supported patients T-cell cancer. head our an efficacy in including describe benefit detail, in clinical in Matteo which and neck have catalyzed cancer The checkpoint survival. We signals inhibitors. have is in by benefit ongoing Ken late numerous observed overall stage infiltration, demonstrating signals demonstrated including therapies, and these

in therapy evidence activity which in checkpoint first benefit. expansion data inhibitor these for a extended discussion. will metrics greater All early previously the evolution kinetics immunotherapy for have detail potential others. the patient our experience long combo benefit anti-tumor underscores of described be in also clinical clinical with ensuing significant periods, lastly, supports the beneficial from response, in on And as for We prolonged the patients remaining of noted and by

targeting believe The has to and and validation has for has mg accomplished underscores platform the strategic generate IL-X the clinical positions is WTX operational CUE-XXX trial clinical the repository CUE-XXX authorized the highlight molecules for core that is platform the or efficiencies in CUE-XXX by by To requirement the a targeting CUE-XXX. resource, series, IND X many CUE-XXX the our CUE-XXX a conserved to The believe dose cancers. acceptance higher by Tumor us derisking advantages dose CUE-XXX us our with derisking gained X activity metrics talks than with by rich dose trial no of clinical accepted derisking candidate FDA time kilogram platform we significantly initiate CUE-XXX. derisked IND starting of Wilms’ end, the next recent at therapeutic preclinical our we essentially and clinical for per of obtained These entire per demonstrated Importantly, since the framework modularity the milligram starting X.XX across the coupled kg the platform.

one the As has update. we the our address believe potential our immunotherapy, of for will cancer towards per growth of the evaluate end today's to strategy Ken? of targeting specific that tumor platform IL-X presentation. context cytokine now backdrop, the code clinical cracked repertoire. Ken for call corporate I'll the the Dan With to selective this pass the in of T-cell

Ken Pienta

We're from as the ongoing all presenting Phase our and patients. data data afternoon good a in And this head excited X emerging Denise. the updated be Thanks, monotherapy to listening to as first-line as encouraging from and agent both cancer, combination well pembrolizumab CUE-XXX early third-line trial the study beyond neck and call. to with single

a importantly, date. we is specific we Clinical observed action the confidence data stimulation incurable stimulating rate previously are an and enabling provides still observations overall consistently response to our bolster anti-tumor with the patients of throughout survival. we As these while by Recurrent CUE-XXX. beyond to T-cells. of T-cells enhanced anti-tumor this tolerated and data continue trend confidence observe neck evidenced encouraged the believe enhances monotherapy QX dose data mechanism and stated, cancer ongoing of levels cancer to-date evolving generated maturing, in CUE-XXX in specific resulting The observations our we CUE-XXX continue is of trial have disease. and And subset is a that tough selective effect. head tumor by to overall in median Furthermore more is the effective survival and effect a

For observations slide in the patient pattern period used for example, appear tumor several patients made XX% demonstrate kg measurements a response consistent T-cell time. X tumor we that observed at of tumor by growth by six activity kinetics experiencing observed [resistance] the see on on reduction imaging. resist initially even This This by manifest months no can based seen to other objective demonstrates first with of anti-tumor threshold a that can drug where after per prolonged over criteria. have plotted CUE-XXX mg we beyond periods receiving longer where observation the out be (ph) the was

after the treatment protocol However, clinical continued this. was we the -- to status, allow based on on the patient changed we overall

CR. began approximately the kg demonstrates may and disease HPV-DNA, is experts used seven free a close slide biomarker these is after patients. at remains a after reflect cancers. to months may six suggestive treated HPV-positive from in and starting XX mg XX the represent therapy to test that fact, with pattern shrink ongoing presented treatment RPXD this a And on on patients with by patient of per So months in The of pathologic being This data stable increasingly tumor in that lasting with patient activity a sustained to months CUE-XXX. treatment a guide cell reductions with disease X

our CUE-XXX additional turn well our over patients an have therapeutic upcoming I'll the We meeting. potential Matteo? and as present data. monotherapy confidence plan as other this about talk the to a to path failed registration in data Taken at study therapy. for potential chemo together, in checkpoint Matteo these prior inhibitor data as now that medical to more this of and build therapy, forward in

Matteo Levisetti

we The to prove in Thanks, could and second goal first was for study our in biologic, man Ken. activity. that CUE-XXX prove safety this monotherapy first to demonstrate

a pre-treated approximately XX treated patient clinical overall patients by The described the patients CUE-XXX. the at Ken, an XX%. our with durable of This recommended dose Phase they're patient we has disease and for to metrics. stable XX have in slide observed benefit with pharmacodynamic rate slide, supporting addition the PR In next trial, our completed just monotherapy heavily in eight cycles data of and shows seven one X PR

panel demonstrate population, that general might including specific effects, adverse the cause did CDX Tregs also for patient We T-cells, positive assist tumor cells, immune cells related in increase similar patient pharmacodynamic many demonstrated The an in which two but events. cancer anti-tumor an a Patient a killing. T-cell see upper return can in You demonstrated increase side not unwanted demonstrated day patients. a increase NK NK right attribute in nine-fold response the modest in positive across increase transient XX. sustained observed effects as baseline to that a and by may in the the

conveys DNA a next possible kilogram. activity X dosed cell-free nine by the with same continue recommended imaging. of observed X rapid cell-free patients who the a graph in showing [swimmer] portion other HPV slide, in slide have The the right tumor several patients the predictive a (ph) Phase and per monitor biomarker. lower made antitumor milligrams is the slide as demonstrated with observation decrease We XX to our On for ongoing the DNA, had with burden survival HPV corresponding decrease dose of plot circulating

median the overall liberty We observed the have line in at overall of taken trials and the in to a both months, survival XXX median CheckMate of pembrolizumab patients. survival is which and draw line eight KEYNOTE-XX nivolumab second reflective

as expected experienced any understands third-line less, further treatment become survival oncologist and the to is the more unstable. developed has disease As with be

aligned with Our continues The head position with trial. registrational monotherapy in provides survival that a and our that cancer. support evolving path us investigators bolsters data potentially premise are promising setting pembrolizumab. this effects principal with third-line that with see complementary activity encouraged is treatment with a clearly patients demonstration CUE-XXX we our mechanistic has and should to of belief in to our combination forward the data to increased for neck This trending the they

likely spider antigen killing. supports greater specific As of mechanism the pathway, reminder, the to plot. monotherapy immune-mediated of with these in T-cells. cells treated T-cells used that clearly increases to will patients the have kill freedom by from XX inhibition PD-X cancer Slide that the prevent major a a number is demonstrates data It CUE-XXX

this are one June With PR an CUE-XXX Early As X the cohorts with ASCO of in experiencing and patient pembrolizumab dose patients two disease. study. combination data past patients and of shown the in cohorts activity each in stable at ongoing additional and signs X escalation durable treated confirmed first-line of a of encouraging. experiencing

nodes, XX Slide from X four at look dose patient Phase liver their decrease at all forward the upcoming cohort target to data expand enrollment and presenting to continuing recommended two in the the combination lymph shows are any an I lesions. response. visceral HPV DNA, patient and has shrinkage is shrinkage disease. demonstrated this a additional X lesions, demonstrating including of patient meeting. We tumor emphasize To to This that of a is of clearing cell-free a meaningful significant also in want this ongoing. circulating which not just oncologist is but

continues As before to surrogate mentioned DNA by tumor investigators as response. circulating our be and developed a a principal used for potential

target cohort clearing X circulating in with all of HPV response from in lesions, lesions As shown a and four also XX, slide including two confirmed demonstrated the DNA. lung cell-free their reductions partial patient [indiscernible]

monotherapy in that data this preliminary meetings. adjuvant at excited from data by maturing look report X study, our pancreatic is with targets studies I'm patients presenting along forward with enrolling upcoming positive new the are and and we first additional in advanced a our to CUE-XXX, happy ongoing combination to cancers. We tumors patient which with ovarian data treated also Wilms’ and have gastric, colorectal, that trial Tumor

slide with dose at at As were FDA CUE-XXX. milligram studies enabled Phase XX% shared toxicology and as which shown increase are also able to to kilogram, observed signs for CUE-XXX escalation the time X This us we clear by study the activity amino cost required enabling not CUE-XXX of sequence IND dose and we XX, to initiate biologic X per repeat CUE-XXX and CUE-XXX development on significantly of acid the we identity.

slide the ovarian dose escalation call to colorectal, all actively around the the trial. being gastric all mentioned Dan Matteo. ability ago, in and phase the as just This shows offers are will trial Yeah. is expansion I will patients. us This CUE-XXX at Thanks, indications to monotherapy As the and sites pipeline. of pancreatic the any of talk a our or in be moment accruing XX studies study about performing US. dose -- Dan? opened now in do designed evaluated we to XX and escalation more the turn cancer over

significant the stimulating and CUE-XXX establishment CUE-XXX for system in that Matteo, series As a made progress entire described of implication, against the as by stimulating just system remind immune immune Anish, therapy And patients’ by you the cancer. and breakthrough patient’s towards Ken body. we've directly the

the progress our CUE-XXXand we rapidly XX. to the our in and forward on slide lead continue schematic as expand as conveyed productivities pipeline shown programs, with have potential we CUE-XXX As also to

foster is capital strategic constrained resource fostering development, and clinical measures where development under taken of prioritization activities and conditions However the a we've partnership. and current associated prudent is pipeline our to strategic footprint market streamlined prioritization paramount, operational those and focused with

and leverage core Our ongoing clinical derisk CUE-XXX the creation validate IL-X metrics and retained our and approach XXX shareholders. emerging value the trials is position now XXX from series for based data ourselves associated greater to for and our through with

catalyzed this our a HLA-AXX of target for have We by a cancers preserved trial, coverage preclinical strategic potential in an covering our possible from registration program, extremely and our from have important KRAS broad expanded trial program to data promising with important which allele is emerging our set be into HLA-AXX clinically XXX partnering data XXX. XXX and as as well submission and

rather and protein. for in chemically than Furthermore, selection savings, chemically personalized a single This whereby the made allow to epitope also be for the epitopes CUE-XXX binding tumor instability stabilized derivative, provide for enhanced pocket, the an productivity immunotherapy particular identified attached framework, to as covalent realize empty us greater we efficiencies that's to et enabling as cost production epitope entailing binding for the a chemical cetera, of efficiencies Neo-STAT. one attach and development with attachment with cancer envisage will heterogeneity. with with allele been combination, epitope. each fusion cancer where manufacturing in of innovation and molecule example, HLA AXX, This the AXX, may identify Neo-STAT the AXX, subsequently Neo-STAT of HLA- a MHC with and an tumor the have may be will that flexibility ourselves epitope series as positioned such and for pocket case in, could referred those of sequence the fits We an as potential stabilized

to internal the internal cancer, candidates of efforts on develop currently So aim CUE-XXX treating CUE-XXX These use drug optimal autoimmune our treating of also including CUE discussions our further development for oncology, while of closing programs, turn augmenting our remarks to third-party series are will to focus. return to prioritizing who provide with develop while further Kerri, overview summary then prior in the I'll relationships strategically strategic for to promising we're ensuring engaged parties I'm and provide activities advanced on beyond briefly actively outside with focusing call up call our opening to we disease. enhancing now of at third series resources programs over current a most capacities financials our to questions. and the our some the assets going and brief core

Kerri Millar

Thanks, Dan.

million CUE-XXX to in of with dose second clinical fees the Phase $XX.X and was collaboration development Turning respectively. XX, XX, June laboratory months $X.X of and capital June June the initiated ended $X.X ended for XXXX. respectively. XXXX I'd a the approximately XXXX. the The ended and in our to as slide and increase $XX.X related same to XXXX, the three the for now We the were reported the three was for The financial professional of June substance $X.X drug compared to primarily administrative due and quarter approximately and $XX,XXX as for and to expenses Research General in The escalation Company brief working results expenses compensation ended XXXX $X.X and that to expenses months XXXX was during cash in like provide update approximately decrease clinical during an of a was stock-based XXXX, million period months cash as and on and primarily months second revenue and XXXX, trial quarter manufacturing million XX, well million consulting XX, decrease and respectively. costs, three our increase $X.X million million quarter and XX, three due million. XXXX. ended incurred XXXX equivalents X

will to and restructure cost as proactive cash our functions, the and that quarter and we XXXX specific us took the development savings XXXX. for platform, the through us allocated believe third footprint Immuno-STAT the remarks. now will the equivalents CUE-XXX including allow turn through clinical which call clinical to afford programs. of June of cash company's over significant and steps can Dan XX, the of We our Dan? to be closing support back of Importantly, our to office CUE-XXX development lab decrease I'll

Dan Passeri

Kerri. Yeah. Thanks,

advancing path to As you've the clinical and towards clearly progress not this ability make representative the through anti-tumor target we've safety. while call, a execute significant defined and XXX we towards candidate And to T-cells, lead potential patient of further compromising registration. and continue heard development selectively for CUE-XXX on demonstrated our activate

slide As validation to successfully reduction have and providing continue its executed defined seen we and XX, series on the strategies on and derivatives. execute risk CUE-XXX of

the killer per As you, dose. then And which per per per remind cancer. of the of recommended system, and X we anti-tumor is from mgs with immune such, do the to agent activity, some activity compartment. which dose Phase has kg the want X prolonged CUE-XXX, having mgs HLA-AXX targeting all evidence up to system the see cells, mgs immune stimulating our kg, tolerability in effect obviously, showing kg with we've seen tolerated T-cells targeted as clear of clearly being range X single X well mg per the allele gone dynamically demonstrated immune Clinical to interfacing these no from data kg with X We've effect kinetics of with through of a maximum And tumor of X.XX activity. properties demonstrated cells, on emerging kg. dose that to the pharmacodynamic that the clear natural evidence immune is mgs way specific as

X evidence of obviously in a seven overall survival be to at manifested later that year. CUE-XXX, to upcoming this and anti-tumor further we XXX will determined pembrolizumab of it reviewed. is is is, registration. the that this quality Also it clear responder we a activity and at starting median be potential activity, positive consider medical an providing we meetings we risk basically one XXX path with appear data, reduction be Ken but combination that benefit, longstanding disease PR, kg mg with of this we complete clearly kind validation from emerging showing pathologic stable dose supportive look needs as provide which survival a So the the the was the trending also achieved the major to with encouraging early signs direction, with IND details confirmed a in potential for but achievement, and us accepted per forward to believe forward of underscoring durable underscoring the believe trial. data as what to a we've presenting

will very and you, -- tumors trial expressed remind validation catalyst representing Wilms’ of be range any evidence that creation emerges Tumor And the significant in and a of multiple XXX in regarding should is evidence, have further activity market potential just We modularity. X the and I nature say, analog to types. platforms of tumor value significant a clinical a for

be decreased that again, should remind provide importantly, may our for and And of one add generation then our So with address into we programs peptide a to we and just in XXX as that able the construct derivative tumor but and covalent it a shareholders, a cost goods Neo-STAT also believe those the flexibility, two is attachment. of us series providing validation you significant attachment coupled pocket, the even representing to medicine. value scale next as that's the to HLA substantially heterogeneity, personalized of with and go us flexibility allows

progress. premise have updates preclinical that supporting concept look as We we continue data you proof with attractive to and to of providing forward

and and resources out determine we our call the that strategically the the most any the potential operator to year. over as on their the clinical for as promising will patients survival of for clinical assess trial has next in forward our median medical is is major our to of on And from candidates. XXX, progressing quarter with We'd significant market to the continue helping our trials willingness of We XXX later are a to like date reading drug dose preliminary thank the support of goal us activity need. immuno potential us who further developing and like half of positioned therapies who second allowing data conveyed back pembrolizumab ‘XX year, questions. the and data overall look and represent be we our clinical of employees We just to important this part which CUE-XXX so expansion. second escalation mission ’XX. to and datasets remind coverage continue thank essential business participating you for our much response a recently will important monotherapy upcoming to of CUE-XXX development plus XXX thank importantly will in promising clinical opportunity, These like we've principal We providing milestones slide, initiated, registration us evidence Also in of monotherapy details professionalism coming and of want our rate corporate this a for the Board to work, for by thank and attention this shareholders the and through Clarifying, for trial to patients. like families pipeline milestones are patients and these the end very combination, registrational overall with year, I'd we'd allows clinical I'd turn the therapeutic importantly, potential for an study, reading their their Directors data, the out the start of a guidance. year. thank a several at And conference and throughout resources value to investigators a significant to the in monotherapy. you mid-XX. very anticipate CUE-XXX of the our and we be include believe whose and opportunity benefit next including dedication provide to the well to further commitment to significant development interest. development their efforts catalyze increment. focus that opportunities want perspective And path now your

Operator

time, from a Instructions] At with the question-and-answer [Operator of session. question Our conducting line this be Stifel. comes we'll Stephen Wiley first

proceed with your may question. You

Stephen Wiley

correct? With looks the Yeah. the think if CUE-XXX data about duration to point? the to updated median of and you I here. at you're broadly have following not update be patients may it, for terms wanted I seeing then just And that Good months can of of you that on follow-up off then thanks afternoon. extended just have be taking treatment? these I know discontinuation do to question also, eyeballing speak treatment therapy just to a OS but is your receiving And two in confidence that for respect or that's a guess post-study may just impacting post-study it quick this not CUE-XXXand tie CUE-XXX. Thanks therapy

Dan Passeri

Thanks want to those questions. Okay. you Ken, Steve. take

Ken Pienta

Steve. Hi, Yeah.

So the half line came cycles I cycles, meaning patients same the as point basically two therapy what is second-line, that median is. that's checkpoint and two got the off. just would out see inhibitors we second

comes doesn't what really know. down So it just do survival progression-free correlate as those you overall did to patients as far as survival, because the

don't are some we and all that quite As We still far are up that that really report they patients therapies, haven't therapies. know have doing data yet. to collecting follow do well off as --

data don't yet. just that know we So

yes/no there a is some that's, to order positivity. type on of requiring like kind dose is Is Sorry. CUE-XXX. of kind expansion this escalation Q - that binary I IHC Stephen based Wiley Okay. And assay of antigen just just eligible? or to WTX guessing, a -- graded portion is I'm this and just have clinic expression be presumably needs know then in that

Ken Pienta

IHC Yeah. cells grated It X% of our of requirement WTX. minimal but sort the tumor are based expressing is and is is that it

Stephen Wiley

in of hop you. Thank the queue. back Okay. I'll

Operator

line with comes Benjamin question of Securities. Our JMP Reni the from next

your with proceed may You question.

Reni Benjamin

good you sure out see that talk generated. a bit for Hey, CR. questions data guys. being and just is and better, taking I understand Thanks circulating off, think -- pathological I as a little much. going the more afternoon congrats that's occurring not can I'm -- about if considerably the then HPV-DNA on the And I we too tumor the well sorry, but may called the you not down starting progress. Maybe have clearly how but shrinkage biomarker the correlated.

that use little forward to Would And other for going so planning studies, and you what for a us XXX activities talk XXX. these sorts can biomarker bit both of you you about that? are and

Dan Passeri

to Okay. take Matteo want Ken, you half. cover of the then second that part and the first have

Ken Pienta

Yeah.

what stable it what essentially tumor DNA, with be is we're we that by disease. patient their following, going do IO an therapies that and I at you can early tumor, therapy XX often patients they TIs from be get exist you it active remained really disease inflammatory never of DNA virtually then -- we're or insight has immunotherapy we've that be in the somebody the be could didn't started try that of what had the which change see that, some type XX the as stable And that inflammatory that any cell-free several been when that's And is now for disease X types when tissue suggesting sort getting especially to we going that’s the seeing or several to cell-free could ended the more it on resist, and scar, into left. these resist, had seeing a the don't have cell-free stabilization ongoing trial we their or with and is DNA mg could patients when know be their started up down, our if and -- have with an we more should was disease, up of assays seeing that patient fibrotic therapies stable if room off So increase patients inflammatory going of know, tissue, the follow we with these who we all months. has might of disease operating we months have kg had to and per data durable

stable one talked And tumor so, sitting the with scar data either there disease is this tumor very who about has not DNA the patient just or a sitting we zeroed there and is just we is out. is like cell-free there and what think viable

by are whole and patients pathologic based neck to So we other that that learning is that figure It's out. and -- because how we're the and the the -- if by us all in cell-free that a biomarker this in back don't to learn means. and investigators cancer this But we the do of And why suggests not are that DNA to batches. cell-free the an that's CR data head have use trying any on is out took area FDA and especially accepted we evolving, our this be we yet really DNA. response may

So our of potential. all going we're as to our use and to follow and that that a we're a as it by continue very encouraged biomarker as docs,

DNA We we're about patients. are an stop responses and investigators of about our doing I'll talk in on study fact adjuvant with based about Matteo there, one in what let cell-free talking with doing WTX.

Matteo Levisetti

to I assay. one Thanks, Ken. WTX addressed that the regarding believe comment point. the the have well been want at did add question I the questions previous on

potential with correlate results inside do eligibility, that a the attention for add we expression we data of nuclear paying plasmic so by would this binary use are I Although grade outcomes. just that close very of and patient both can we WTX tracking

Reni Benjamin

you they the seeing this well the And sorry, do patients those are study. accrue pick all kind off thing low are for a as with DNA you sticking HPV of second, in just or kind – progressing patients the through? or of way Are consistently cell-free HPV DNA stay that once in converse up seeing

Ken Pienta

don't will study. for on, question. there DNA do whatever we good come following What We So, patients have cell-free cetera. go truly DNA they are learning does But up over it progress just tumor their a them still who don't cell-free correlates about progressing people are they see also. the see we -- it but with roughly as dynamic, off so survival go why we're what et -- is patients up. can biomarker, but actually we DNA been on that's burden therapies and it's cell-free have in It's after we

Dan Passeri

it I’d a months. yet. it's XX design, as in an this FDA is in use secondary adaptive endpoint gaining over possible Ken, the last it it XX the but there traction Yeah. assessment as not is to that that to with add Whereas, and well, trial really biomarker decisions and use be inform the endpoint may actually future to

So perhaps in that to next biomarker sort in the accelerate introduce trial. that would an enhanced or of opportunity future the decision-making to

Reni Benjamin

Got it.

about FD, obviously the that might And you durable could FD right, I'm thinking able some progressed. these that curves a occurring? been responses. don't marker are of that, I is, durability [indiscernible] about mechanisms have the sort -- guess have, question XXX’s durable question So think be are guys are maximize mean there I their tumors going what assuming at overall look with combination investigate I patients you of but are are clearly growing. you when sorts And And they forward? surviving, that as clearly what have those you survival there that is, therapies of with I have to those there partial second resistance then that have

Dan Passeri

don't of even the certainly question. myriad on come early mechanisms, ones our off $X at durable docs that are overall patients question, know think great by play. and the which are billion that’s surprise these of What caught honestly surprise a us, these have I resistance caught of We Well, it's early on therapy are all in is, fairly is soon. survival

with that which further that to spread consider T-cells to seen cytotoxic I the increasing T-cells therapies and going of periphery when itself, Certainly, to therapies types some the is indications in checkpoint suggest we're be would we've are then that antigen early better. of we're think work something tumor neo-antigens combinations potential future. number for the the specific certainly cancer allowing increase seen we'll in by obviously of

may far with yet, As data, be mechanisms Anish we HLA there's don't clearly down-regulation, have like ones we this, think as checkpoints to know with obvious The as just be but wants we comment cetera, synergies. chemo. going as to that don't et on well other

Anish Suri

will types, of dictate antigen really changing it's intrinsically its whether important because at it We need cell analysis. of loss to just have profile, of Yeah, been loss (ph) is resistance HLA immunogenicity the of a way of the the thing has operational question, from to [TME] Ren, There only look better we've all we add, the these I'd pathways sort to part because of we components further ongoing -- other processing. to enough sort of even on or grasp of already CUE-XXX this than with possible need certainly that even we bring what a see. sort combinations extract in of along sort of sight, as then of to to what gather and that started just the and can more to get data line a in a the benefit analysis tumor

Reni Benjamin

most And study in primarily we that and for an talking study. for time and quite the about samples remarks. before have it. excited a about update final to gotten happening Got was me. biopsy remember, wanted what to just one ability one me kind after. I I get probably I prepared the neo-adjuvant of some as to were what missed was with just this

Anish Suri

a So I'll and comments it Daniel it open I'll give then make to turn turn to on. I'll -- few probably add

a quite feel of to Matteo, got actually So we've going in that locally to study biopsies place batch at is that's free composite cancer, advanced got in we've place, couple neck more are when lens. recruit, well patients please first to analysis as [indiscernible] plans it already recruited a going your few patients, in add and from soon as we more head our the get

Matteo Levisetti

accurate. few, to more when it look quite treated future a becomes sharing we available. really data That's a Anish. than and bit We've the the forward in Thanks,

Reni Benjamin

All right. Thanks guys.

Dan Passeri

you. Thank Okay.

Ken Pienta

Thanks, Ren.

Operator

comes [Operator Mark question of line Instructions] from with Our the Oppenheimer. Breidenbach next

proceed with may your question. You

Mark Breidenbach

good and guys, thanks Hey afternoon for taking questions.

from couple Just a me.

one potential of to so is the Phase interactions from biopsy included of been your study? MLS to why of Does availability meeting to the conjunction And to trial. more then data something registrational that's the just to the looks this changes and the hear And kind start the in the and I'm one So of kind the in I CUE-XXX when now patients. is I that wasn't from X for with the FDA, plan me. have head trial? First, X translational guess regulatory respect be just there wondering I'm a know neck we between any gap path perspective on a collections? question protocol introduced their wondering include data can other forward? Phase CUE-XXX expect with MLS the And also data just end with that paired with of if have upcoming have respect availability right was study. we of the

Dan Passeri

Okay.

So that? to Ken, you want take

Ken Pienta

can Yeah. start regulatory the question regarding the Sure, interaction with with agency. the I

we plan to the preparations we've median a anticipate data year the XX just in X beginning a a patients by designed dose FDA anticipate which begin at recommended X as and sometime open could that be overall trial survival having an for we trial. the present risk the covered global So would Phase in a and have mature end subsequent we here, Phase dose the that trial trial context multi-regional And do again, to to of such trial, we later next registrational we're that year. at of

Mark Breidenbach

well in as biopsies WTX [indiscernible] the trial.

Ken Pienta

Yes.

absolutely we correct. -- So have you're

back forth made we keenly So and the lot that We've of had arranging conversations recruited we in have some protocol with of productive optional. capable investigators interested those. are biopsies and and paired a

by indications indications will, in if question, biopsy. get But to to perhaps it atomic new opportunity [indiscernible] tumor curative to of that that interventional at trial these we're hope standard setting paired procedure resection in the we as in cancer in an an trial the biopsies you locations and to examine adjuvant this post-dose that optional enrolling undergoing biopsies point, patients opportunity and may component more have is with So in of pre a of the care the be, have the will advanced whereas XXX locally that's in we design intent. the your amenable

Mark Breidenbach

might going head what registrational hear is a XXXX that just like look to wouldn’t to just in And I cancer, regulatory until correct? want we be a question. and the regulatory neck Okay. with clear, trial feedback absolutely back to respect

Dan Passeri

setting I interactions requesting by collaborative. we the granted Type would FDA timelines the say agree that upon I confident and in request, think development this would But really we're will where some given that's are depend but the meeting be And early XXXX, correct. of in course, a of that FDA. B

and beyond So it's this the to need unmet development drive cancer. third-line of not in in head drug for with potential medical patients the neck this and

Mark Breidenbach

much. Okay. Thank you so

Ken Pienta

our is conservative of we ’XX is think end I certainly And the estimate. Ken, -- this

be We able to point. that be sooner we and data ready this we -- we what get soon are the be to trial, hopefully trial know -- to want as that we will at as go launch

Mark Breidenbach

Got it.

Operator

of closing end have Ladies question-and-answer to I Passeri Mr. reached remarks. back session. turn like today's to for Daniel and would gentlemen, we this call the over

Dan Passeri

to and very you Thank and questions, for and patients. thank support of helpful thank very and therapies instructive. want ongoing just the want listening much. in Okay. analysts these interest very everyone to our for promising activities research your bringing to I I

much. the very year. throughout you Take thank care. So forward to look updates Take care. And we providing

Operator

This conference. concludes today's

your You for day. this your the Enjoy Thank disconnect you of may rest your participation. lines time. at

Cue Biopharma (CUE) 24 Aug 222022 Q2 Earnings call transcript