Gritstone bio (GRTSQ) 9 May 242024 Q1 Earnings call transcript

Greetings. My name is Latanya, and welcome to Gritstone bio's First Quarter 2024 Conference Call. Please note this event is being recorded. At this time, I'd like to introduce George MacDougall, Head of Investor Relations and Corporate Communications at Gritstone. Please go ahead, sir.

XXXX. thank our for business financial the quarter and call Gritstone's updates Latonya, first discuss to results, of you, you, joining everyone, conference for Thank clinical and

from President With portion Karin Gritstone and me will and Executive Officer. be Chief Economides, and Jooss, R&D. President Celia call for And on today joining CEO; are Allen, us Head Co-Founder, the of Andrew President and Financial Vice Vice Executive are the Q&A

press the release quarter corporate XXXX. available market financial closed, for after The is a results issued Today, and providing we release website. updates the of on first our press

be remind to after our After remarks, on like webcast Investor its live we today's via prepared up the will you I'd also call Q&A. Gritstone's is a being call available again that where for Relations completion. link a website, open and will replay

to current risks may based website. the is forward-looking statements this materially available described. Securities that you During of differ course subject risk the and are number review the we will statements actual expectations. results These most We uncertainties, Commission XX-Q in forward-looking and are a make our of Exchange on call, and from to are factors and recent our U.S. encourage on Form those significant that with also

useful. such basis, to call find update on an ad this to on as except us, hope required Gritstone and available even based today any host we you'll by views currently obligation change. statements All we calls information call are of if made hoc today's on these law, disclaim our as statements

Andrew. that, let to Andrew? me With it turn over

to with other a XXXX This everybody, share and afternoon, joining as Celia a you review for you, call I'll most for recent back our as program, is I'll the will closing present financials, our first time and corporate conference provide data personalized quarter from Thank exciting Then vaccine and today's And Gritstone. come clinical thank well of cancer begin GRANITE George, and our call. remarks. very good updates.

Okay, let's going. get

from study suggest Phase early immune vaccine colorectal II we shared patients our highly GRANITE therapeutically they included is set. and personalized cancer XX data frontline data preliminary So inducing microsatellite recently neoantigen responses in in our stable encouraging patients. that These data metastatic randomized our are of in the preliminary beneficial

Let's we review showed. what

approximately we're patients colorectal in the KRAS cancer them study of mutations. have them treating typical XX% Firstly, and patients. are half this have liver Approximately of metastases,

with the trend indication progression-free of patient PFS terms cut for last randomized X observed the in benefit overall that of efficacy, August this ratio approximately hazard early survival The PFS of we In March X.XX. these population PFS median in months. approximately was meaning data or XX in only in a a in Median patient is towards XXXX this progression-free short or and study on entered study were XX obviously months, of last XXXX, survival months.

event over of that promising immature. That But of patients an death, over a yet not censoring, is though data have data XX% XX% signal. progression with rather are preliminary, renders these meaning achieved these or this even

may the the know, the ratio, you stronger housing the a effect, As lower the than X the of i.e., treatment benefit ratio greater implies and a treatment hazard less benefit.

subset be we patients, would to metastases. all the at therapy what and Now as baseline of matures, overall that a patients likely prior data faster to had these the progress overall a to we see identified as of high refer risk to get them understanding of population. better liver set may than outcomes Nearly we

of versus population. GRANITE benefit than We high-risk GRANITE censoring. is And to in the ratio more was in death were striking progression this risk X.XX, relative of the apparent data population expected, with or associated reduction with PFS the hazard stronger mature a and control. As which in therapy overall XX% PFS group much reported this XX% equates a with

we future. in meaning potential standard We're final clinical to on patients discuss we data FDA. our XXXX. these excited the a become early data of of quarter as faster benefits who patients high-risk The PFS all to mature And progression, the more And more versus patients give experience give disease in with share care the us endpoints mature, III expect Phase into pronounced. the stage window information of the third the to then GRANITE plan us

data been disease point for this overall The at by important. proxy approval has historically a authorities this the early basis time encouraging regulatory of PFS for therefore used and been in novel survival are PFS as has therapies.

point cautious progressive Previously, lead to is the given end immunotherapy. disease. of to having lesions potential labeled as the actually Pseudoprogression prior at PFS the can been with shrinking pseudoprogression about risk phenomenon beginning efficacy incorrectly a grow an patients which treatments being as where of for we've attendant

our approval. FDA have in we II topic II Phase meeting. of will the III use end date, a at this PFS as Phase our perhaps discussed And supports basis psuedoprogression evidence of the which be no for seen endpoint, of To Phase as study, efficacy with

signals advanced Phase I/II was but off-the-shelf also data non-small extension I/II molecular that vaccine cancer XXXX. GRANITE, of It's third-line patients of saw so with published cancer. nonresponding same that I/II and XX% responses with apparently molecular study treated patients. Phase technologies saw of also biochemical wherein with compared responses our extended apparent we in to worth tumor with markers, OS, meaning of patients PFS the platform Phase the microsatellite-stable in extension in study or extended and biochemical noting, uses Medicine and from this linked a cell the seen GRANITE GRANITE, colorectal in reductions OS before, patients and were Nature to interim And in colorectal again, SLATE, we've observed our PFS OS as in The GRANITE, similar we in recall and we this PFS of cancer

concordant are gives signals fact types settings benefit. and could The we studies, be different clinical disease different meaningful further different these across driving us GRANITE that confidence that seeing

method secondary we our the pseudoprogression, ctDNA. Phase a molecular end I'll the PFS course, based as efficacy no response, were Now potential specific And this primary and first for DNA, measuring which seen tumor set the there of change abbreviate set as of point in trial what II was was point to study. Phase impact that end of And in we've on circulating in I/II. controls limit

point to make is unexpectedly assumption actually what prolonged we which So the of what response, ctDNA how chemotherapy has ctDNA would that going time unreflective therefore, a rendering clinical used, benefit. And about had chemo we observed effect, is study. into affect an of we definition single

patients ctDNA are signal. importantly, across in study Now experiencing when see that the period, those entire consistent we trends versus look with ctDNA in evidence reductions is control PFS greater broad indeed the group. the finding at we This GRANITE

Phase quarter could So trial few in patients GRANITE the of PFS randomized II our we the again, a deliver I/II result upon in from mature expect and of observed suggest And in build neoantigen-directed emerging this what that we year. data months' a third in those data metastatic Phase cancer the strong time. immunotherapy GRANITE trial the colorectal

cancer addition be now cause cause and data in females significant mortality being the why and of cancer worldwide. deaths second-leading U.S. would respectively, to of positive leading for the under males Because cancer second-leading But in colorectal patients? is XX,

and A largest cancer desperately metastatic no the XX% Microsatellite-stable immunotherapies highly tumors tumor. would for resistant are few comprise all solid about of options offer colorectal of communities and trial hope randomized diagnosis, one for needed approved result with this treatment cold positive underserved tumor most therefore worldwide.

inhibitor alone for benefit significant believed the cancer. this generally would checkpoint in not to delivered so-called data such cold field? since Why setting. microsatellite-stable GRANITE colorectal tumors Because ineffective be has in be positive immunotherapies as And therapy

of of To personalized have all date, vaccine and/or studied and current to cold with focus efficacy adjuvant Hence, no platforms. their cancer reported our tumors to their competitors our on signal hot tumors. knowledge, indications have little metastatic neoantigen-directed

Success metastatic of in opportunity. patients the of for settings, cold majority immunotherapy solid the overall adjuvant a door for potentially open GRANITE in the to tumor effective expansion tumor dramatic could and metastatic both a

why of may objective colorectal cancer PFS set of unlocking immunologically of broad in within our be of for And suggests because, a reach. potential data for meaningful would be positive us course, it tumors cold and that the big metastatic ahead immediately finally, mature to Gritstone opportunity

PFS, effort. a a the it's Expanding been pursue. us Having gives before and It's cancer a of faster potentially decades therapy grail despite good of holy reason. done of reliable patients our not we to and early is the path cancer of effectiveness of of immuno-oncology regulatory colorectal other immunotherapy wide spectrum indications challenging, in measure the for any scope

in publication a we're our spectrum solid for across and with GRANITE, Nature and recognition promise we which and is the support. advancing programs highlights for tumors, technologies, along ready recent promising off-the-shelf our we The applications slate tumors. plug-and-play Now other attracting great believe Medicine platform solid of of continue platform

This is evaluate by autologous an underscored the KRAS Stephen directed TCR-T Institute with mutant the ongoing cell therapy. Dr. to Rosenberg combination our with collaboration Cancer candidate of vaccine mutant National in promise KRAS directed

within of improvements of neoantigen-directed incurred to state-of-the-art our our targets offers The believe further latest platform be Class in models, prediction field leadership in with positive of recent underscores to of we the we the the field. performance cancer public technology well a predicts GRANITE XX% now intelligence beyond epitopes position neoantigen the HLA presentation value, EDGE, identify predictive EDGE that than to greater I it leading that artificial presentation leverages and vaccines. what

vaccination, model T-cell a II strengthen includes of active in for to predicting HLA which the to our now by presentation state-of-the-art could serve novel context also vaccines. Class further comprehensive responses EDGE peptide

potential continue in further to the among strategic to key in and invest a EDGE this were fashion, be We advantage. believe we we'll AI what to leverage first players technology to

continue Beyond oncology, external leveraging in infectious disease, we largely pushing dollars. forward

utility self-amplifying vaccine presentation findings previous recent conference Phase our at the reinforced I potential COVID-XX. broad and of against Our durability the and highlighted mRNA

dialogue IIb in a very remain XX,XXX The in subject study head-to-head about with we COVID-XX important running and excited this BARDA Phase study. continue, regarding efforts

efforts, vaccine applicability others platform for excited leading infectious of about Along including Gilead remain in we've mRNA players, our self-amplifying engaged capabilities and for And therapeutic HIV. Sciences, from broad prophylaxis BARDA and with we support other potential garnered the in a disease.

position. Celia mature mission most and financial potent And durable our across the to speak portfolio,, of turn to over our we on to vaccines. delivering I'll now As our execute data our to continue

with you, ended quarter million. afternoon, Andrew. the marketable of cash Good and everyone. securities cash equivalents, restricted Thank $XX.X cash, We

Gritstone April we in underwritten an million. marketable you to securities completed restricted to cash, bringing gross proceeds resulting equivalents, and public our cash are As offering in aware, cash XXXX, of forma $XX.X million, of approximately $XX.X pro

by rate burn quarter and estimated cash In these extended February, have actions XXXX. reduce quarterly runway of difficult to our the XX%. approximately Combined, workforce our made fourth decision the our we into reduced

forward program our GRANITE you the OpEx reflects and this. As priority our know, is driving

disease infectious serve additional the have capital. capital date, On we could to the bring programs company. long-standing of funded with disease collaborations our outside continue infectious non-dilutive Several primarily potentially side, to our and to

the about think exploring next approaches to we strategic business. and steps IG for infectious As are business, our disease programs funding support our growing we

collaborations, and as in partnerships In both of current sources addition new to oncology capital. could additional disease serve our infectious

our to same of now the for is of $X.X XXXX million, increase million primarily development million. year. $X.X in $XX.X to our net in an expenses expenses QX in of million million increase Turning collaboration loss We compared decrease research of results. net reported and The $X.X the an period revenue in attributable and increase G&A loss a last operating our with $XX

to part of for license $X.X totaled continue capabilities, collaborations the our establishment our for we platforms and and March XXXX. and in the XX, collaboration unique business XXXX, revenue a our core $X.X first grant This ending The million. quarter leverage is strategy partnerships to compared million of period same is as

X supplies, in decreases March increase and by XXXX. costs due million were development personnel-related in outside Our research was lab R&D and onetime in the compared for $XX partially months with for impairment and same million primarily the costs charge expenses facility-related offset XXXX, to XX, a period in were $XX.X increases ended services. and severance which The costs,

period a expenses $X.X period from and million G&A charge. to for the in last expenses the personnel-related facilities-related $X.X expenses, was primarily increase attributable the same services March period for for XX were up year. severance onetime G&A ending costs, The million, outside

XX.X at a outstanding, approximately As at XX, X.X purchase Gritstone million XXXX, price exercise outstanding of stock of shares nominal common per share. million to stock share warrants shares common approximately of of exercise common approximately March had of $X.XX of nominal million prefunded a shares per $X.XX price and XX.X stock

inflection objectives our In point. growth summary, on in our to toward we are ability execute our confident strategic and

some for closing over turn call now to remarks. I'll back the Andrew

Celia. neoantigen-based Thanks, we focus started supporting very and progress unwavering and in emerging solid goal to on that for with potential pleased We the vaccines. with all Gritstone are cancer to benefits of critical our immunotherapy the made tumors, expand the we've patients

emerging tumors, very started with we've pleased and benefits to unwavering critical made goal, our We in we patients solid Gritstone the to vaccines. expand immunotherapy with that neoantigen-based supporting are the potential progress for focus the of all cancer on

very sharing is following patients We advanced with preliminary we survival a accompanied Importantly, from data at well all these of from newly therapeutic a trends has time in I/II in analysis benefit immunotherapy you, third demonstrate data anticipate diagnosed of in just in of disease. that from overall Phase to a data metastatic colorectal we're PFS favor GRANITE II population The ctDNA patients X PFS years. getting and of ctDNA the much And early additional by on closer randomized diagnosis believe needed stuck quarter over of ever supportive data year. data supportive need advance in time median desperate highly of the are recently around this as remind remained Phase since encouraging. data shared to large metastatic with mature cancer patients. This single-arm group demonstrating as will very key microsatellite-stable are trial the we consistent

prospect determinative We're patients importantly, to a Gritstone population of truly on has unresponsive and their from large and the considered novel the most cusp This for been platform traditionally is families. field in a for that exciting immunotherapy. patient data this for

turn questions. I'd for operator I'll thank call for joining over the like to you all today, and us the to

[Operator Cowen. Instructions] Frahm Our with Marc first question comes from TD

how in the rates QX? have the evolved can kind Maybe, trial that Andrew, isn't mature of are the will February is really they update. event data in how kind still there given of kind you uncertainty speak available just now, where to of And PFS CRT much or since be

have a give Yes, maturity this same we III data because data. little obviously that a we don't with sites early Phase that to it's reason no been do find cuts a the run trials for very because point exhaustive data population lot to of time highly definitive in doubt consistent have but answer at regularly tiresome, this

the around with So months. expect I that arms behave many have before will arm, median PFS as of control strongly other XX control

this demographic of patients to a XX% that the of with aware liver is particularly good data there's very no baseline you're As from so population bad disease having typical believe and recently, metastases, we shared population patients. is reason that or this

is we more vaccine degree is, There on good course, you that working going that less volume GRANITE data and get censoring that informative progress that because patients group we population, the of have progress be in extensive lower arm who high-risk with we the that means to that with disease. you people in gave the way people have will most we to reason And more the And meaning QX. some the that probably data. slowly. bit And believe those data obviously, immunotherapy against a less but on fastest, course, is further be for data, in patients optimistic of of collect in effective us reason average mature data Those faster. data more showed progress in

guys to how doing -- to us related the side? is the actually least risk Okay. any that flu? going remind is that with the on here flu. now does maybe that just COVID? you that Avian it the to be some BARDA That's spent can at of And there helpful. maybe been front, then moved on allocated? on that, are veterinary And And it required may has flu work money on Or side, because over Yes, some avian you for get on, it

Yes.

in contracts the So COVID was back NextGen, the of specific that XXXX was awarded on which we project vaccines. part fall of focused were next-generation

while work were that we period that end and of raw of March, in expired are a As contract, the periods launching study. you for GMP several at that IIb out the there Phase extension may we materials base contract period, on now we the were for of time the no-cost recall, and which

particular COVID. particular So that those contract in dollars specific to was

recall may a funding vehicle called BARDA different or that funds actually not shifted into you may has Now those RPV.

to to are as have that back. waiting So we applied now vehicle hear and well

proteins, then always ongoing is And of particularly often and that environment reacting to hemaglutinin your you. apply -- in question flu, the regards on neuraminidase same is the to which to means, mutation to your applied immune that the surface that within you're concern Marc, flu principles around as the and obviously, those what evasion, can course, [indiscernible], the is is lead there to

underpins are the same basic lesions can have we principles here, not conserved and apply conserved i.e., regions the that cells, mutating, we the SARS-CoV-X other you surface particularly in protein of doing deployed durable against that function would so-called want course, change. flu, nonstructural and in that virus against of because include they're their is you surface because that vaccine, are same T SARS-CoV-X you where logic of other preclinical the even mutating influenza, CDX are both so to that we constrained, The ideally highly immunity proteins science T-cell the for spike to epitopes, the that if can't SARS-CoV-X, i.e., work of include our want as proteins virus nonstructural of that are they critical imagine. case antibodies relevant we and Chimeric proteins That's many

from Evercore. with Miller Next John question comes

your is feel with low Do benefit from is readout moving need forward? for ctDNA bar guess second baseline at PFS Shanshan see to confident the from in for what the year, first of to one John. is you the patients the This half I success?

XX Yes. PFS median is The months.

we're meaningful to means track for ratio better data probably bar. that looking a the so X.XX. we're And we than obviously, exceed on think, that, improvement suggests a I generated certainly, which far hazard on

lower question group a than have group about the generally would ctDNA, have really begins if low we've progression with ctDNA has that the ctDNA have you risk group indeed be low and low low cTDNA. that that because and you study of Your is there at ago lower we high know baseline, if that X the called few are weeks that study rate populations shown the ctDNA, we

lower-risk population, to So a are that is they population although progress. expected all

So of kill effective they some ctDNA of disease immunotherapy in progress. will is disease all that do not between kind benign in level And will more bit be that and patients have but There it's short a sadly, a these disease, perhaps they progress they generally population. vaccine-based slower. And will burden. that nearly order, relatively link

it idea disease have are BioNTech and burden, is low focus reasonable more the therefore population which assert to the immunotherapy. behind is vaccine-based So to Moderna ctDNA pursuing. lower that adjuvant indications on is perhaps obviously the This amenable that

So is it an important population.

group second by then chemo. ctDNA and complete a low induction chemotherapy induction who that negative ctDNA, patients there's are of their which the Then is rendered

able they've good although disease a in means negative the whereby arm, those analysis well vaccines you It and group. them on than patients. numbers and patients weeks in what control quite the Now in group for were for patients the than small, presented done that is progressive that's will in most the difference more is recur, we the obviously that's control radiologic obviously stay the are receiving recall And there X that chemo. a ago. is an vaccine-treated there show longer Sadly, few we may to of however, arms,

and are well. be So as population obviously, those up we'll certainly encouraging, that following data in

principle, on where of So data. them different do group of both answer them important. than the currently ways are question, even in could have better your we mature vaccine high-risk to most And both the two PFS but

on you to want of more therapy? arm any to the be decrease the have thoughts continue chemo predictive on Just sort up ctDNA. might guess what I follow survival? end for point ctDNA after And did why ctDNA induction do in

did. have wouldn't don't that, the -- No one the obviously. We not we did end anticipate set So point know. way we we

had we lost that failure on think the people. end point in study. the of distinction clearly, So of an important a has been I a That's lot

or have can product an or both. a fail end fail You point

induction the dropping weeks for case, point completion end chemo. control we this In just saw the X in the because first group after ctDNA to X failed the of

or that's delayed that And us some effect chemotherapy. the presumably of so is there induction telling persistent

had to We no data we study. the designed did guide we -- before us

that So at highly tripped obviously, relevant and PFS new clear the signals observation But this here some us a is endpoint, because not what is we level, is is a delivering longer, other better and from the certainly And you long-term control and disease as matters, is therapy it's one expect up. regulatory a, signal, PFS important that in active more obviously, discussed this this that vaccine secondly, in consistent with ctDNA patients an setting. call. the would do on in is analysis what for words, ctDNA

or in been disease disease, potentially because be III, forward, II of something will setting. moving be PFS this traditional as now know, in end And has discussing for not you Phase at OS. about approval Now be that's agency PFS endpoints, with meeting. we'll we'll the the we're ctDNA this entering obviously, used And first-line and worried using we Phase

be we'll in cancer. colorectal metastatic what doing that's So

goes ctDNA you if ctDNA endpoints are all trials, way especially a PFS program very developing efficacy and big settings. for we'll useful renders outcomes as understand studies. And OS. interrogate other get be a in clinical the to such of before randomized we that in to important earlier-stage it obviously, is However, particularly potentially how metric we, an it early important well, in single-arm, that therefore, surrogate And as

can data, trials OS long-term the we're single-arm a be of and use the benefit smaller indications. can't the PFS to captures resource in to adeptly enable generating data other I to Today, way that course, out invaluable an us don't in will you we figure because ctDNA mature have be but clinical and give then answer deployed

B. from Riley question Mamtani Next with Securities. comes Mayank

Mayank. Madison here on for

with KRAS, anticipate you guys liver points do just those discuss seen to FDA also III? get GRANITE of XX% the curious if Phase look in that's we've whenever what how patients the to met, wondering it be need touch to And of you kind representative relative could the population? what will So XX%

lastly, then in that something that in do we is pseudoprogression, a or the pseudoprogression? III, would attempt you design you'll see any And address in the the hold to that event fact expect Phase didn't is there

Yes. Thanks, Madison. Good question.

So the which exclusion different straightforward patient much you design, course, the because standard. study order very was of a there's a very it very not asked slightly questions. in a in variety for of centers United with frontline States this By across opportunity good, and that's criteria straightforward And means selection. inclusion

just taking trials aren't that door. You're patients the that there frontline cancer. through the many in colorectal come And

clinical were swiftly, who people site trial is was operating which half where and particularly in the of eligible our most offered at first it why study, would our been have very a enrolled So trial XXXX.

representative anticipate need for unmet recruits don't Why changing III. special patients want Phase that population. selection. any there's without straightforward would We there. and you? very a So The is trial You

news. good that's So

And II. because, That obviously, the KRAS your your from is that be will the is Phase in Phase III III anticipate Phase a mutations we would that new. in dream basically unchanged reduces liver metastases something chance of run course, constant that to the degree of

happening the You've or made something some outcome. altering new is that's else assumption

easy sleep so-called You want III. that Phase

to QX. an towards taking study, is have of year, as end Phase II our is So and this we'd we'll traditional possible. hand as anticipate forum which end them the meeting, the And of FDA go obviously, of to in in to will course, which, incentive little data this from the the change

endpoint, choice PFS then be among And is Phase that primary likely OS. the discussing a and be things, we'll other between and efficacy to III

to on with go. align FDA these complex because in We obviously products. of the manufacturing lockstep the been course, from We've get very are FDA need also, with the

layout before we clinic FDA literally the were first to about in spoke manufacturing the of our fact, we we were when biomanufacturing facility. the designing In

with right were the in So solicit There's terms that input part move we held that a you the meeting just also the end these of way aligned products. sure in in the on then make to end point we're alongside to commercial, That's we sure make a the track II and to we clinical meeting obviously of back discussions. FDA's need Phase we make C as III quality agency. step-up Phase to Type regulatory the of

Polman The with next Kaveri question comes BTIG. from

This is in positive CORAL I first you candidates. South is would update presented I saw patients? program. the an like X data on today. on And there study the question African on Kaveri guys data in recently positive vaccine Christian for the that the My was CORAL

is guys to So candidate which to -- there? any planning Are you guys forward? development there you planning are move

strain -- The we'll course, obviously, the is moving update with required if successful our to the that because, of season forward candidate be an another of there be BARDA for study, expecting we're fall of XXXX.

have the JNX use issued variant. As WHO guidance EU the and you're to aware,

year, it XBBX.X variant. was last If remember, obviously, the you

strain the against protective conserved as chimeric vaccine, responses we'll That's our to nature of that of T-cell antibodies but be that as will vaccine So intended component there We've include well part T-cell a disclosed the the change. exact be will not those design protective antigens. induce included. in

primary the we the of And going that's right now. focus the forward. so program expectation -- that's So CORAL

we study, BARDA be of is I soon just in noticed as will the it's company should -- the that that regarding still in we Or reevaluated? -- can. that as And as XXXX? that initiating they press Okay. expect can being Are release the -- fall

raw around Yes. a on meet the It to GMP ability criteria FDA's our little materials. depends

interactions we about which agency, on at with a why that's obviously, is specific contingent further little are cautious guidance this the So point.

The next question comes from Catherine Jones Novack Trading. with

prevalence due a patients you or to do consider mainly ask to I low of I benefit Just that versus this And high-risk the about guess, fact more had a mature enrichment couple, PFS curves? the disease risk? factor wanted predictive saw

Catherine. Thanks, Yes.

calculated arm. on DNA -- this subject every the down applied the group, way have We information and lower it And we to the just that So cutoff same we arm. population. to slightly median bifurcated that we where circulating then test tumor that we right And vaccine the we vaccine for the control middle. at the the analysis look did the baseline then was than the split was took it we and actually on

control slightly good conservative obviously, vaccine of which the ctDNA data point the patients view. than the higher which, vaccine So from arm, equal, things baseline actually had arm, being a analysis works all against is

how set we that's So it.

was control slightly arm, XX-XX vaccine it the more the in So a in arm.

that mature look what included, set the did everybody was data ourselves because, try reason data. will the like is data The we to of and a when these asking more generate simply course, have mature we question,

trying way we to ctDNA the is patients curves what population the And of events patients that who and so identifying at baseline do fair a faster Kaplan-Meier have we that's who from efficient showed. remarkably clear was a very for faster. have And selecting were find of events,

So we it. did that's why

could disease a that mentioned worst does as high-risk population you on the argue in obviously response belief to And high-risk vaccine better of there immunotherapy. that on setting, adjuvant but signal disease adjuvant on not the do perhaps melanoma. see Moderna seen and we've course, metastatic have particular seen did signal in general I that's population my going and is to by the where, reasonably advanced The now lowest particularly volume lower is the is in on vaccine another question, who volume disease because immunotherapy data that's based success in

have with So they them more minor but within some patients some colorectal more extensive obviously you high-risk splits patients very extensive disease and faster metastatic that data or and gives are population, mild a with it with all disease. in cancer. metastatic very ctDNA disease, group there colorectal

see mature, particular this signal So we we once stronger. be signal then point, may everybody think not we the therefore, that we're works as a data what our a the least want At saw course, treating QX. fact in hopefully anticipate, in everybody is reassuring be out be including group anticipate everybody as the about in of which we is high-risk and everybody, product then there And in at selecting low-risk stratification don't intention to strong such strong a and label you we'll against seeking patients. principle, will to the is because if past

JMP. Roy Buchanan from comes Citizens question next The with

which is question, ctDNA. GRANITE stratifying my answered by just you've think I

Phase sounds So you're not it that like into to III. going forward going the do

Well, clear, let's be Roy.

data the low-risk yet haven't got the in We group.

is today high-risk very data in which group, have saying is What we we're everything got So looks speculation. good. the

data in low-risk Now group. for we wait the

group. no want have that I this. to not be in So about the It's we super low-risk signal clear

We March the them have in of progression a group of event. death because no low-risk early as few very data achieved had or

absence So will based But group as forward. as evidence And any literature the expect the low-risk it's seen and It's effect we of would least evidence And indeed effect. no on that in at of that's going to therefore, of would good group, what others, selection perhaps reason patient in what you wait. be vaccine not what from then that anything. is of worry better. about high-risk just if we've you absence the be the there about see,

Okay. Got it.

Okay.

Just I few a on guess CORAL.

that on this decision vehicle a you're hear holding to versus on from people the waiting going first that when hear they like or it guess new the this might whether sense that? to is So program back I technology that. that And RPV or are or you back decide of and program set any on whatever GRANITE? is,

apparent there is relationships exact the obviously, entity, very is like us. different outsiders It not a those of but relatedness. is nature to But

but distinct. related So

BARDA's a direction. that's It's consortium under

you? And going get do any have when of time you they're to lines back to

any guidance on We provided not that. have

partnering then that program. the mentioned potentially fund potentially to And you Will ID Okay. COVID-XX? include also

Yes, potentially.

comes The from He question Wainwright. with next Arthur H.C.

GRANITE. team, on had please the just for a I regarding Sean. and Andrew ask one quick

opposed the correlation reduction I'm is the reduction -- the of with when you character you for there tumor? the baseline did ctDNA Just to any just curious, the curious see see for the in use is go biomarker way background to as further to future? ctDNA noisy these minimize -- a you you you there to for evaluation if to any guys the chemo, in

pancreatic We cancer. is it to in I wouldn't the tumor But haven't analyses have bevacizumab. Obviously, FOLFOX And it, or this chemotherapy, that used in regimen performed FOLFOXIRI relates great of it's setting. cancer outside guess, colorectal those a response colorectal to derivatives plus specifically used utility phenomenon to of yet. that only cancer

on not program particularly going well chemotherapy who determining critical our so is And to forward. does obviously development

study expect pivotal All ctDNA for other set the PFS we right. PFS, the information further what the could give data more the readout more data, can update Besides third And and quarter. design? in regarding us mature my second question

Yes.

in be overall So X the overall will years survival point, that around survival is data still disease. very median this at immature

shy, to the PFS X following give year again, mature year it basically So just another if to logic, is OS a very same need around you get to data.

Now the we Head R&D of are is phone doing some here. additional our analysis, on Karin,

the as QX you to have might to additional perhaps we Karin, little what So a update. for flavor correlates want give

Yes.

of in perform looking are population. a patient performed analysis. [indiscernible]. ELISpot the We We We subset

translational we Medicine So Nature our actually which data published data, in at we do significant paper. have look

to some So and anticipate data Elspot but work, be our anticipate the manuscript. don't that can But you we teachers different go-forward seek any that. to of do we

an also or ICS upsell have looking polyfunctionality perform potentially for We even if killing. are we

So patients functionality blood intercept depending a looking as we cells TCRs of trials, T-cell we of response, on the we toolbox great will from T for and well number these of as the only these have have cells.

from The Sachs. Johnson Goldman with next question comes Corrine

of Corrine. This strengthen the hazard analysis? is couple matures? I the prespecified questions. What a will you as is confidence for the have data on model a gives Omarion piece-wise PFS Cox-BH that And ratio on

confidence from X and directly the sources comes source. indirect So primary X

of Phase OS. we PFS same cancer and First reductions apparently randomized in this not [indiscernible] the biomarkers, study extension study, the has patients, saw PFS I/II who all, including ctDNA those extended colorectal phenomenon of burn their but third-line had in a in

that repeating observation we're study. So this in

not into group, the reasonable would it's analysis. the I group would obviously easy. asking high-risk risk But obviously, if the be I Secondly, the what you then the peering behave could, perfect way if quite of similar obviously is a No low-risk analysis mature, the the analysis to they a in risk future? one way expect future see question looks future. can would it high gives a And And of encouraging. to very the it's foretell high and

of the bit evidence QX to second optimism the data. that's for mature encourage So direct

you study, data we patients if immunotherapy. the that believe notion best comes suggests in data the are disease lower-risk stronger, Moderna, applies not least we're that population that to this signals for rounds from the at do from see the data those support on that vaccine-based waiting should indirect players, The set low-volume in Therefore, strong, as if ones as and most out the matures. the are notably and other patients that, low-risk

Your question Was second question was about the catch GPW using in statistical in the that test, we quite summer the and I QX? it. couldn't

study. pieces PH with for the The a preadanalysis Cox mode

Yes. Yes.

the it FDA way the treatments statistically in So induction because is with lengthy been not arms for a progression-free of clear patients around identical are use of And the will first, their across analyze the X therefore, to actually that the then and the to we the we've months, study at X dialogue randomized you're the diverge. chemotherapy. study average, of beginning standard is And if the that Kaplan-Meier assumption. log-rank hazards proportional the are test. treatments survival And going plots the a meet requirement on

these the knew rank analyze the was we statistical and appropriate the study was So that the way log to test curves. not way designed appropriate

do was wanted you a time-weighted system. to what fact, In

event months with for piecewise And we've study. discussion them Any that of way weighting is given this model with these and and X prespecified, event is the X. was we've generalized X a analysis. the given simple to X. analyzed the months global And data, entered on we this the a yes. after progression any That's weighting we of So very progression prior done agency, settled GPW,

no for in Allen I'd Thank further back At comments. to you. like the time, this queue. closing call Andrew questions to turn there are

end Thank you call. represents our the of That much. very

So to for move data really waiting some nothing you to to the I able in optimism. patients very reasons QX, to much. for time we your And we thank and who've and time we're been to for long you very that, see these for with excited just further attention. forward Obviously, add. these have like a thank be hope ball

does you. Thank today's This conclude teleconference.

may participation, you this great and have your You time. a disconnect at day. Thank lines for your