- Earnings call transcript Q3 2022

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Operator

Greetings, and welcome to the Cue Biopharma Update Call. 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 the conference over to Dan Passeri, Cue Biopharma's Chief Executive Officer. Thank you, sir. begin. Please

Dan Passeri

good and everyone. afternoon, you, Thank

we I'd Before you need remind what and that to the I to we slides on. manually, you begin, have that in everyone you you like front are notify will operate slide of

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

made As only on November may during Slide represents a the and as here XX, statements, overview XXXX. shown contain presentation and reminder, number some of X, statements and today, this company's as call views this forward-looking forward-looking any

further our momentarily. want and pertaining from the data the Mateo date. this in to -- first, shown from call combination at of an next and But for as data upon SITC and is a Slide agenda underlying CUE-XXX just review competitive trial. and to data of trial this the provide will importance of can I providing of our on -- Our by KEYTRUDA data I'll reported context overview as recently implications CUE-XXX X. both monotherapy the well our provide based begin positioning today's to slide, detail sets strategic observed

engager cells positioned now first-in-class T immunotherapy, will our derived selective become representative activation IL-X-based data of immune trial PD-LX shown therapeutic enhance from the cancer. for and combination amplification monotherapy to mechanistically kill our The combination are our data data T IL-X best-in-class potential you a our as of recognize As of benefit such X. the on CUE-XXX, patient's compilation here and our I'll to and series, of both provide both T-cell and supporting believe as believe engager, the immune to and has bolsters push ultimate the turn neck I'm our synopsis central to can cancer review aware, resulting extent the own in our system from turn overview and eradicate systemic will KEYTRUDA our of complement enhance the QXXX demonstrated cancer-specific is immune head then generated through SITC update cancer We selective cell to patients. antitumor T intrinsic is supports in promise from fullest frontline to belief of from Ken avoiding the and series current action squamous a immunotherapy well enable trial our activation patients -- presentation pertaining inhibition, call trials emerged and of data the CUE-XXX will selective provide well where The of at the thesis of recent combination HPV who be call the activation to the inhibitor and CUE-XXX to systems monotherapy efficacy and cancer-specific number efficacy desired that KEYTRUDA. while potentially that to cells We and checkpoint Slide the mechanism cell IL-X-based monotherapy over recent a carcinoma cancer. Matteo Anish? forward harnessed with presented efficacy. the us in mechanistic key brief data from features transform to and an positions of therapy from the now over and of going to positive data SITC Anish trials

Anish Suri

Dan, this Thanks, welcome to and to update. all listening

cells activation is tumor-specific cancer successful appreciate fact T the the of selective noted immunotherapy. next outcomes in all As to slide, central we that for

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Ken Pienta

Thanks, Anish.

and As slide, combination on shown to derisking and and clinical next trials with as be or We're proof-of-concept have the the clinical ongoing pembrolizumab in with POC data pleased the provided platform. Immuno-STAT presenting of monotherapy CUE-XXX from ongoing monotherapy trial, as beyond our data updated as both encouraging Phase third first-line the the as single-agent data with line a the in emerging and from pembrolizumab from combination I CUE-XXX study patients. well patients

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parameters immunogenicity. in dose see of interpatient of and lack multiple PK clinically may attribute low of attenuation without lower tumor XX, any the increase recommended CUE-XXX Phase And with treatment Slide is with mgs the a relevant modest transient response per pharmakinetics on the throughout of demonstrates left Exposure X of in positive increase as well-behaved with shown can a NK cells maintained you Tregs. variability As CUE-XXX II consistent results at treatment cycles an NK in panel in sustained cells, as in only antitumor killing. the assist kg.

have In in expansion tumor-specific increase in the paired panel, shown cells we the after tumor-infiltrating biopsies as observed and as peripheral patients reactive T the middle administration blood robust T As EX cells X necrosis. demonstrate of and of panel, right post-treatment CUE-XXX. of an in early tumor week

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

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

to increases T pass Matteo CUE-XXX As pathway, freedom in emerging with a the overview by prevent T is efficacy data greater the data in exciting to an major PD-X monotherapy used the of and call clinical mechanism will number cells mediated now that I killing. these the from pembro. with cells Matteo? treated It that clearly combination cancer CUE-XXX supports to a the of likely of reminder, to antigen-specific provide cells. immune inhibition of concurrent is kill have will

Matteo Levisetti

Thanks, Ken.

partial therapy a disease on Phase stable continues we and dose shown we kg, kilogram, our with today. a even stable have Slide durable starting disease. per As patient durable mg patient DLTs. patient who the a response presumed we observed X any with XX, of on at a not not At recommended deep X per only dose, observed with combination milligrams At II observed

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of decrease me patient of responses. on seen show to in including X just their liver. examples XX shows of these metastatic shrinkage the in is partial emphasize X nodes, X, you that the X in Cohort from Let not the lesions Slide a visceral left. liver X demonstrating target lesions, but want scans lymph disease I this the on as shrinkage all tumor

of upper the the of absolute the this any side, This DNA, the meaningful is with oncologist, also ongoing. cell-free measurements response. the target the circulating demonstrated is graph and a On overall of XX%. X a HBV right clearing significant patient lesions approximately which To has best response depicts

as HPV mentioned be surrogate As by DNA continues potential investigators developed circulating and response. a used cell-free to before, principal for our

cell-free circulating Cohort a X X of also lesions in of including Slide as lung in confirmed from clearing well one with demonstrated XX, reductions as HPV. all their the prince lesions, patients As target shown partial X response

decreased patient than absolute on by X have the lesions completely metastatic X, Slide are patients the median in treated you in was the cleared lung, time passed at slide, already the greater right size substantial concurrent And and target we with panel. response. XX%. which of the alive, The in disease are in measurements last patient, in both their all lesions the in very see survival XX.X a X the XX, parental lesions As whom this trial we KEYNOTE-XX tumor DNA overall the observed scans trial, target the from have seen In the still of X can of left, the the months. upper depicted next as RECIST the on see blood combination are that observed

survival mg per an data We pembrolizumab plus as X kg in matures. from anticipate also increase the the progression-free cohort

XX. Taken to overall compared PFS rate, in together, the and along monotherapy, patients therapeutic observed recurrent support may the with neck the of of XX% doubling for setting. observed with response A perspective KEYNOTE-XX reach expand with squamous will historical both the first approval XX% with and in designs in metastatic is on pembrolizumab an high-level attractive increase provide carcinoma Slide in of study an pembrolizumab presented to patient cell line option head median monotherapy combination

happy enrolling in CUE-XXX, We targets trial The with are approval in first we of the is cancers. excited positive the in our colorectal, patients by have patient that get and to ovarian which Fast with registrational realizing and Wilms tumor successful also regulatory lines and confidence that X report interactions. pancreatic combination advanced to our both therapy. gastric, of I'm treated tumors plan for the recent preliminary on Track clarity granting path ongoing further to the monotherapy trial underscores data designation

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

design United in Slide escalation an the States. at and now of escalation Anish? indications upcoming expansion turn trial. more over ability As will phase the present medical any be trial meeting. shows, sites dose study we of all pipeline. to are This CUE-XXX Anish monotherapy colon, to additional actively talk will the pancreatic We XX studies is or dose plan in around in performing gastric, data ovarian do call to I the at the the us about The cancers. the being to XX evaluated and accruing our offers open

Anish Suri

Thanks, next Matteo. the on to And slide. moving

as platform. you by has on derisking shown As the clinical clinical our this believe heard the we entire slide, essentially from update, derisked CUE-XXX and

Matteo, noted platform, derisking As of positions by CUE-XXX, the with Western underscores the molecules time accomplished modularity the highlights cancers. targeting believe targeting us platform recent many the and coupled validation which repository CUE-XXX, by a strategic of resource operational the clinical therapeutic for we acceptance Furthermore, of efficiencies. also our IND rich generate to advantages

or are tumor of mutated examples antigens of an targeted conjugate to we T which even pram tumor to NeoStat HLA application given effectively here. personalized epitopes platform the we have epitope. extend multiple the neoantigens Furthermore, framework can additional be or as molecule our Some with that to chemically incorporate empty can cell shown such KRAS MAGE-AX any or created

the valency tumor again, and many cancers. significant IL-X Neosat realizes efficiencies having target to the cost Here platform by -- an is variant selectively multiple approach off-the-shelf core conserved. across antigens time and expansion

for T Kerri Kerri? this call important has I'll code to believe update. selective the tumor-specific platform of As brief turn targeting financial give to one to of we the now cracked cell for evaluates cytokine a potential With over immunotherapy, that, the cancer IL-X our the repertoire.

Kerri Millar

Anish. Thanks,

quarter drubsextons $XX.X the Turning of ended for XX, months and $X.X XXXX September believe ended We ended as I'd collaboration was cash $XX.X million the and company financing in million marketing a XX, manufacturing our development investment decrease X during securities with to we on XXXX with the incurred $X.X same fees equivalents like equivalents our private rent. the million due XXXX rent consulting X in due for Slide General for into of had now XXXX, approximately compensation The XX, primarily revenue for results ended cash and approximately administrative capital $XX and investors of expenses a September in equity to on remarks. to or securities were for that cases pipe the working update the over expenses Earlier months public call purchase were in and X to our third XXXX. stock-based approximately as Immuno-STAT today, ended X XX, decrease XXXX, The million. CUE-XXX was with XXXX costs, into licensing and I'll we This $X.X million period million marketable and Research XX, the XXXX. of and laboratory a XXXX. $XX.X financial a decrease receive announced provide cash turn the quarter and certain back will respectively. and primarily $XX brief support professional Dan? compared fees CUE-XXX development September XXXX, agreement the respectively. cash, in development Dan securities compensation, the will of to including along platform, employee and and pipe XX, that September months million closing accredited million and months to the us for reported XXXX, and $XX,XXX to respectively. entered million and September financing. clinical and green We $X.X we the from of allow and

Dan Passeri

Yes. Thanks, Kerri.

level SITC HPV to enhance disease-relevant reported a clinical leading breakthrough further company believe to cell as transformative supportive closing, our our very directly our recently well further primarily strategic and of shareholder of well-tolerated now core competitive following T upon and therapy. provider and initiatives as we're of on the core focus With nature positioning and beyond the shown expansion these our The strategic our enhance we're next In catalysts the on shareholder will a with and financing, recent corporate platform approach combination year potential take monotherapy we're by at of initiatives of the preliminary in to positive and data term, the reporting now to T the neck to focused registration cancer With -- year. cancer to competitive overall line head next cohort, milestones enhances positioned quarter cells response refractory development data positioning being promising body. our trial, potential mature and cohort the ongoing on to selectively several have overall initiatives, near second in third extending from clinical we the transforming value. With pembrolizumab emerge mid-next with combined with rate potential year. able survival enhance core end We confidence CUE-XXX of the the defined and median the among modulate patients in slide. the data expansion optimize and metastatic CUE-XXX next runway this trial effective on the patient's anticipate value, plus to engages

year. On the defined XX potential full the of a patients with registration being trial in half the second

their we from with therapeutic reach significant and series value representative XX Data cancer catalyst and indications. by months remind hematologic the believe of reported of CUE-XXX of evidenced want look a Directors of look should gratitude believe this to development the cohort. kg and WTX-positive cancer, our as and will per premise most forward by for patients CUE-XXX for the extend market to our QXXX shareholders ongoing us their the thank in The IL-X-based Again, the demonstrates families The the date want pipeline the of highly treatment reported that reporting patients opportunities potential want and XX participating potential supports and of much patient mg benefit of call Thank forward the the data We on data encouraged data to opportunities support potential CUE-XXX validation X are now platform. providing series of activity inhibition, and shared turn expanding to as questions. to trials. further corporate with your differentiated to Operator? in XXX for you, and the cancers. reported for dose interest, in solid the checkpoint all attention placing vision and platform very is monotherapy for on and the evidence be corporate the for escalation potential cancers. therapeutic the to operator position Immuno-STAT dose the you mid-XXXX, to thank first business We escalation coming Tumor at to updates to Biopharma our a and catalyze sets addressing ongoing SITC we the We partnering. the targeting Board of our our Cue to full back transform clinical X of and further development expansion strategic I'd importantly, should significant trial Wilms like we for our and enhancement expressing and be by current employees,

Operator

you, [Operator Reni Securities. from The JMP is question Instructions] we Thank sir. Benjamin have first from

Reni Benjamin

Maybe post kind talk a of response progression? Congratulations didn't combination are And especially any patients XX the study, sort on the patients are subsequent you start that treatments data who of just can inhibitors in recycling seeing off, in little getting a checkpoint the and first update potentially these what typical that before. maybe have in of bit, seeing at you're SITC. to we

Ken Pienta

for Ren, this Thanks question. is So the Ken.

they regimen you to. don't the reality getting but data we're there's afterwards. collecting, can't It's going multiple on folks and What's -- really might give So what we specific This know. with going on these across update is other an therapies no it's those sites, we are be that folks.

Reni Benjamin

have number, Got Do for ask anyway. it. saw combination the median or two? response this I don't think I a just either those monotherapy for I'll And study. of you duration then but of it the either

Ken Pienta

to get and calculated won't that we the calculate don't the that it's in We monotherapy, because in final No. -- combo. we survival too do we until early that just the data haven't

Reni Benjamin

a switching samples. you Got successful about many you of have to patients the quick And -- the it. is been gears in provide bit obtaining enrolled? or to any that Can any there might study. have little maybe been talk how initial takeaways? color initial then able sort neoadjuvant be from And real just And biopsy you

Matteo Levisetti

Yes.

really tissue CUE-XXX examine the is us study itself, neoadjuvant the a opportunity the to spectacular So of therapy. in really effects for

pre the of in these patients we've data So XX to demonstrates pre- observed biopsies post date. that in NK and in biopsies. we have We've have in findings preliminary patients close increases we're cells, setting obtaining some treated paired we to the and i.e., treatment. post-treatment observed that The neoadjuvant

observed also lymphocytes in consistent we've that in trial. the or TIL, tumor obtained We biopsies the the with patients CUE-XXX paired in increase observed findings the infiltrating in

Reni Benjamin

the I’ll queue. jump back in

Operator

session. ahead, now the closing question-and-answer like would over Please conference our turn Dan back Passeri concludes remarks. go for to This to I sir.

Dan Passeri

Okay. Again, take everyone forward we with for the time again, look Thank updates you, coming and providing our you progress, thank in to we in and want and care, your ongoing interest months. everyone. to

Operator

then and sir. you you, that us. concludes Thank conference. gentlemen, Thank joining for Ladies today's

lines. your disconnect now may You

Cue Biopharma (CUE) 15 Nov 222022 Q3 Earnings call transcript