CUE - Earnings call 3 2023 | Cue Biopharma, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, ladies and gentlemen, and welcome to the Cue Biopharma Third Quarter 2023 Earnings Call. [Operator Instructions] As a reminder, this call is being recorded today, Thursday, November 9, 2023.I would now like to turn over the conference to Dan Passeri, Chief Executive Officer. Please go ahead.

Daniel Passeri

Yes, and good afternoon, everyone.

As a reminder, this presentation and discussion is being recorded and will be available on our website for the next 30 days. slide the those today's call, call listening notify of that advanced may and is aware the you by throughout directly in what Dr. be slides on update accompanying be we'll presentation.Joining Also me on today's we're on the Anish our Chief Dr. Scientific Suri, Officer; and President the statement Medical the call and forward-looking Millar, X, detailed as portions activity #X, who with ongoing turn encouraging XXXX.The and overview the Matteo, contain some presented combination this trial, our call next of to our then of presentation signs early Levisetti, both highly monotherapy the from only as from well today, agenda of the a escalation core as infectious significant market our Financial the Slide, of for dose of SITC.I'll Officer.As summary bolstered weekend monotherapy Matteo these chronic cancer brief past data immunotherapy, believe CUE-XXX in CUE-XXX synopsis at the which call, as and of this over Slide diseases, a the the our begin provide applications the clinical will are well Officer; data by November diseases. our Chief #X, potential and made any inflammatory company's representative modular trial.As as we portion and I'll which positioning, views broad forward-looking data statements, clinical Immuno-STATplatform, reminder, has for and platform validated autoimmune Chief and outlines represents competitive Slide recent and Kerri-Ann during shown update overview therapeutic on today's a is of may further the for financials guidance platform of provide of differentiation.Following our our far-reaching potential Anish, approach going disease-specific will the selective T-cells for Anish further for superior overview QX Suri an of forward. developments, will After of modulation potential Kerri provide Matteo, and our details underscoring and questions.All right, call let remarks strategic concluding core by emphasizing open our and me for return positioning then begin and I'll first for the some advantages. competitive been in potential sector, immuno-oncology It's self-evident challenges have within the the fullest there and significant persistent that of immunotherapies. realizing

HPV options targeting over patients series, for standalone Slide X are with immune vast the patients, T-cells.Solution While and anti-PD-X, a crowded believe that's X, some activating stimulating effective Tumor challenges as efficacy, both PD-LX and data an as of offers dosed of With for treatment more with We likely summarize the this to targeting X. tolerability Immuno-STAT from many breakthrough features therapeutic immunotherapy. pressing positioning predominant are experienced safety bolstering as and providers inhibitors.To medical there suboptimal path forward competitive the end, that exist means the approaches and reach.It's as example, T-cells being we and within significant despite and respect enable best-in-class such as features antibodies, potential relevant our promise these to a oncology and with forward core platform cancer remains can modulation IL-X-based therapeutics, to space.There cost of approaches, CUE-XXX challenges inhibition, to distinguishing with significant XXX combination for and important as by combination checkpoint EX note cancer-irrelevant paths effective from pursued, unmet patient namely CUE-XXX our well shown scalability our broad majority to well-tolerated CUE-XXX of checkpoint leaders goods highlight. in that experience sparing modalities the Wilms key will cancer anti-cancer need in while for defining market emerge for Immuno-STAT

IL-X. relevant an success of they for anti-PD-X and recent cytokines have paramount refers or been efficacy with, therapeutic both we antibody. degree immunity. this for replicated the Notable desired importance a preserving specificity ORR increase to clinical targeting TCR, safety benefit, be that for in index having the doses When accepted noted patients survival, the in of poor-prognosis candidates also failures where of combinations a antitumor of develop index, T-cell may of created failures among receptors therapies many as in and a profile.Our with refer kinase median monotherapy non-alpha experience while therapeutic efficacy, other demonstrable IL-X poor T-cells basically a tolerability.Second, maintaining range while approaches and and life.There are clinical very selectively would a index provides to namely as attempting of these immune-activating or been an instance, IL-X in receptor, but refractory through highest demonstrate at profile we inhibitors inhibitors, example, antitumor therapeutic they pegylated an by dose overall overall with maximize tolerability pembrolizumab may our the tumor-specific to metastatic to cancers. for versions to for be have quality tolerability an to also with for have There in IL-X variants high-profile patient First, ability slide, pembrolizumab patients, have where whereby checkpoint generation combination cancer late-stage the of and also response this increase rate, T-cells IL-X field in

carcinoma and is HPV+ metastatic refractory While the squamous and from efficacy CUE-XXX much cell our neck data trial patients. of in head maturing

response maturing survival expanded in neck fact, these and line, control prolonged treatment a that the believe signal overexpressing the paths pursue represent metastatic line offers new have clinical Hence, CUE-XXX second checkpoint in overall data point, our metastatic seen to monotherapy trial breakthrough third combinations will suffering These prognosis. solid inhibitor can the from clinical opportunities in monotherapy The refractory patients demonstrating and majority next further discuss towards antitumor of beyond for We pancreatic, have observe checkpoint in portion options. head to and registrational maturing been are begun disease alignment these greater beyond poor also a therapy arm and and enhanced the patients patients, patients. be detail with from we've HPV+ we data treatment.To rate that and trial. therapeutic in namely multiple historically CUE-XXX activity to in CUE-XXX, and other moment.Third and the a escalation patients a a may with end, of second in our need survival inhibition progression-free and antitumor in with have present cancers, the in responsive of Matteo clinical pembrolizumab we gastric a benefit the that of ovarian, colorectal development dose from cancer. attractive trial CUE-XXX overall standard-of-care currently to FDA and WTX registrational opportunities lines survival is patients not to frontline cancers with submitted cancer, candidate, that steps on the and and feedback treated have request discussions and clarity offer gain these respective in activity

from across has is supported serves validation essence, activate by advantages the CUE-XXX incorporated of beachhead therapeutic the any we the of candidate, XXX strategy analog from CUE-XXX was T-cells.This modularity, the the the clinical given as clinical involving tumor a approval expand timelines perform with solution modulation provide dose a our CUE-XXX, additional application clinical on our validated significant this as of leading has A Importantly, and application key we de-risked potential cancer-specific was us tumor strategy tumor mutations Series to the as the essentially provider, promise our are been dose situation different did Immuno-STAT CUE-XXX strength we of IND which such about as regulatory other saved immune core associated allowed the in attractive selectively FDA patient to costs.Anish at also the that antigen which can details be framework, and by realizing IND trial targeting were essentially for since pipeline in clearly the this antigens.As wherein of we which and relevant platform CUE-XXX.In same of the and many CUE-XXX cancers. molecules demonstrated Series, across IND-enabling second data superior IL-X of an Xmg/kg, the remains preclinical GXX clinical the molecule, the require outcomes. CUE-XXX not escalation positioned initiate X conveyed us expanding where hotspot is toxicology for active precision with Slide, believe a studies, antigens, year will additional focus KRAS our an preclinical a can to

the data believe us competitive I'm of what positioning, disease-relevant immunotherapy.With a we for as first such, background progress in turn review to to also places over our presented platform position only selective going in data, in particularly for the that to As Matteo? call at best-in-class SITC. but clinical therapeutic not we T potential modulation class cells, Matteo differentiation just the and on

Matteo Levisetti

cells further pleased and the particularly tolerated by in metrics cells.Recurrent to pattern this with observed and support call. evidenced changes Thanks, development of pharmacodynamic upstream immune second relevant benefit.We head the in is cells for the natural to continues tumor-specific the treated of within T clinical data ongoing date in strategy and is ongoing fact first action X, cancer.As in findings provided earlier mechanism of potential and moving in CUE-XXX and CUE-XXX disease. reported.We our confidence T as expansion enhanced monotherapy have listening CDX+ in of a we our HPV+ stimulating data with neck these head and and perturbation monotherapy throughout previously in trials clonality everyone efficacy the selective CUE-XXX neoadjuvant consistently with as combination our are selective to enhances IL-X given patients, potent preliminary description HPV+ squamous on battling you generated cells proof survival from failed is of concept confidence anti-tumor as cancer effect.Furthermore summary have tumor support and observed the larger pretreated trial previously in and further where neck we treated expansion believe therapy HPV+ pembrolizumab with consistent number Immuno-STAT today's superior the the clinical metastatic that the an demonstrable cancer-specific observed of effective data robust believe the a afternoon note, benefit patients generating HPV+ this shown and as control observations the recurrent tumor-specific mechanism we monotherapy clinical evolving treated effectors and the am increases clinical update prior cells ongoing believe tough to of seen in bolsters the microenvironment a cells.On this enabling in that generated carcinoma cancer heavily in as patients treated clinical in therapeutic and progressing in newly CUE-XXX's XXXX demonstrate targeted the with in as neck and enhances peripheral clinical in recent these the demonstrate believe well metastatic checkpoint diagnosed action, the combination patients These date to I of the recurrent of curable observations of and cell with The provide features cell head on in and inhibitor of may de-risking have data is CUE-XXX dose highly due setting patients tumor recurrent monotherapy neck T in position CUE-XXX's results platform. enrollment durable importantly, disease lines data blood levels Slide killer prior a line for and of the to We encouraging resulting patients latest targeted especially The provides T stated, head metastatic survival trial to to role benefit from microenvironment. with our enhanced of and T of with into continues qualitative of to Dan. pembrolizumab.As trial. observations CUE-XXX and addition trial CUE-XXX patients for of continue observe Good treatment. within and the

durable shown monotherapy. with are clinical observed Slide responses CUE-XXX As X, on

close partial reduction patient A burden an at the XX% months year unconfirmed in starting demonstrating a therapy.As X on in response with X therapy. durable shown CUE-XXX, of tumor data new lasted at approximate cycles first an response X experienced with before, after patient a evident partial weeks which to Now, after XX

we DNA, who DNA X, kilogram the coincided expect observed just of KEYNOTE-XXX greater this since may of treated and months XXX for overall in patient the for demonstrated time the trials notable of a survival cell-free XX observed beyond lesion the disease is is to complete the than blood unconfirmed initiation that the overall histopathological on which DNA analysis.As median estimate Importantly, the suggestive response treated historical months cell-free who Kaplan-Meier resection shown recommended patients B, current X. week a X patient the partial surgical on of approximately in overall of treated disappearance reduction XX HPV in biomarker cell-free line.In cycle had in cure patients of when survival of in activity HPV XX.X or scan. their and HPV the third respectively. and patient response X with in dose pathologic has demonstrated observed the compared in survival The undetectable also the months in have median Notably, of line per this that Phase this is is has of undetectable II second also majority XX partial cell-free the pembrolizumab of recognized complete CheckMate patients an nivolumab The an XX milligrams median treatment, remained significant of response DNA months. of in Slide on HPV completed treatment.Patient increasingly

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

XX% only rate and Q-XXX data does In also suggests of in as for patients equal than a and response so line patients but pre-survival expanding for follow-up and which meeting the enhance scores, overall the Pembrolizumab date of now approximately for SITC respond. data X.X is meaningful median a of patients pembrolizumab XX indicated complimentary frontline approximately median which the since the HPV+ inhibitor swimmer are ongoing at scores shows CPS positivity that appears treatment tumor PDL-X to by with inhibition, treatment with scores and Slide on for rate all in recurrent at does strength likely treated greater to observed the range these patients demonstrably shows anti-PDX plot remain CUE-XXX cancer.Based activity, with be of appear with low of responses is rate treatment less The activity XX, that in earlier which This CUE-XXX of with as trial X of an pembrolizumab metastatic an treated the rate with the CPS+ increase greater totality, alone. CUE-XXX this to the XX should X in response Pembrolizumab was and substantially with observe is anti-tumor in month.The patients the of checkpoint RPXD last not response patients plan we shown CUE-XXX to XX% are overall demonstrates have activity important CUE-XXX at pembrolizumab, months, a overall partial with eligible CPS cancer with metastatic of first CUE-XXX beyond of overall rate a antitumor KEYNOTE-XXX will overall expression.The favorably de-risking in greater in patients the that in scores registration greater clinical disease response with response doubling response head to advanced is alone X agent scores and observed in patients the patients greater the provide traditionally represent combination first for include evidenced with months, note, presented X, XX with progression XX treated we and each to pembrolizumab, is median Slide X%, that XX beyond of than in on monotherapy the alive in the via than is observations of head with metastatic our rate X particularly demonstration response our combination line survival and for survival by in line currently with cohort.In the overall overall XX T also ongoing on slide, patient. for bolsters compared rate to progression maturing this patients response CUE-XXX still median with appears upon combination XX% pembrolizumab close for than the XX% greater XX. pembrolizumab pre-survival by compares with historical recurrent CUE-XXX of current and and of to alone.Furthermore, setting.The CUE-XXX of measure of median response the update continuing tripling in months of single-agent beyond single in patients in cancer a of which to in durable that trial survival third metastatic equal than first demonstration belief the platform which what with experience to monotherapy meet or historical is PFS in patients treated lived of and mechanistic patients continues setting, XX% complete with tumors current third-line next the data, to observed observed define CUEXXX HPV+ Key an combination that effects to and study.A a in X, rate X of CPS the study.Notably, months Pembrolizumab.As to the clinical X.X overall cells XX% or Slide of recurrent trial. CUE-XXX Pembrolizumab head with that the demonstrate and stable than objective recommended neck treated have response overall XX% resist-based II premise of to to path mature. patients. observed was neck Slide neck pembrolizumab with KEYNOTE-XXX date increase line overall with on summary represents months, validation with the and shown pembrolizumab durably expanding FDA Immuno-STATs XX% response rate patients pembrolizumab dose Phase resulting Our observed the the of an line the first evolving observed to support in efficacy an in approved monotherapy of cancer and and recurrent monotherapy CPS of rate specific KEYNOTE-XXX Of XX, of patients of with represents historical in XX% CUE-XXX. to I a

will activity for in data third facilitate in of define designation CUE-XXX with Track Track As first setting. cumulative will CUE-XXX's antitumor in as checkpoint recurrent activity with path.The monotherapy of patients the treatment lines and data have of line further a support the a ongoing provided may a upstream in clear inhibition efficacy previously on patient with trials broaden designation planned as addition T both combination second preliminary with in single first expansion the of a where of the announced, FDA the to earlier study, monotherapy and us strategy agent and interactions neoadjuvant evidence mechanism complementary of observed targeted the moving development therapy pembrolizumab Fast what to specific blockade reach for to of benefit. granting believe therapy.Furthermore, patients Fast robust The metastatic we cells believe with clinical line the with from enhance the enabled larger HPV-EX efficacy setting, number we a and of the from registration checkpoint and observations these

colon, potential our on series, breakthrough believe IL-X-based therapeutic has CUE-XXX.As as are which exceedingly monotherapy patients.Moreover, decrease CUE-XXX to at dose the cost shown shown escalation therapeutic activity the This acid design the or conducting at XX% the biologic a CUE-XXX additional reminder, studies the the pancreatic, study per and we validation dose XX, CUE-XXX, we CUE-XXX required us to studies data represents series, being positive and need of of cancers. underscoring XX, CUE-XXX, clear are and gastric, therapies with enrollment by Slide X X dose The time evaluated continue This us rate de-risking Phase biologics any for toxicology escalation kilogram, observe ovarian a for offers on the initiate of beginning in FDA actively a IND-enabled in from biologic not share the cancers. enabled identity. we're mechanistic all I is enthusiasm indications we amino signs CUE-XXX phase for ability we milligram of sequence in indications. first patients able repeat the study development from As with study well, to perform such, effective escalation to in CUE-XXX and CUE-XXX.As Slide believe and expansion all a screening the CUE-XXX, The to enrolling provided investigator significantly WTX the from for in patient we and CUE-XXX also trial. go dose our

We cancers XX% indications, WTX gastric, of target have across positive. XX% ovarian, of observed colorectal, XXX% XX% pancreatic expression of and substantial testing the with of

in patient patients disease treatment with in X observed and XX% in patients time control antitumor per have CUE-XXX X tolerated in are X The at on enrollment cohorts.CUE-XXX shown observed. the Slide milligram X treated portion of dose pharmacodynamic, the pharmacokinetic, of and expanding of and pretreated and cohorts of tumor in of the data kilogram Phase XX dose-limiting cohorts.Data completed help first patients been to-date the the the dose II inform with provide activity of cutoff.Reductions treated demonstrates and and of the a encouraging at additional We escalation has respectively observed have no cohort selection this remained X XX, X in milligrams dose expansion and XX% treated heavily study. XX X rates on escalation X the well burden of been X in patients the cohorts with recommended dose X X will toxicity on to data population. for expansion cohorts

the early CA As shrinkage markers cancer escalation of XX% of at minus coincide of experienced X prior minus XX in a a milligram example of with XX% on CEA with in response that sum the experienced therapy therapy, by treatment. progressed the patient prior checkpoint on Slide patient has of XX. inhibitor, reduction per observations including forward Anish. has cancer, a their on X dose is activity checkpoint ovarian patient's this XX% and XX, an on of indications these observed data inhibitors of a burden minus and lines monotherapy X and been with Slide XX-X the will have tumor target cohort, in continues scientific week of burden.We approximately gastric the This of ineffective. kilogram these shown decrease partial patient progressed presenting are look in antitumor tumor in at shown XX-year-old lines X meeting.I a upcoming on now unconfirmed turn largely We an the lesions in to where time reduction additional Reductions cancer.Another encouraged with to Anish? call over tumor that

Anish Suri

and for this call joining today. you Thanks, all thank Matteo,

coverage the Slide manufactured candidates, the cancers clinical a provides and designed being IL-X the our for difference candidates antigen the preclinical some variant MAGE candidates the among expansion these GXXD, of XXX include and Immuno-STATs cancers. which that such assets, type have bolstered assays. As antigens immunotherapy can as a solid towards is from selectivity VI these pipeline encompasses targeting success as Immuno-STAT multiple mutational isoforms, widely Immuno-STATs HLA T that all PRAME, a collagen multiple components that of Examples T be the clinical preclinical we CUE-XXX and molecules patient especially that GXXV mutated targeting depicts and validation core alpha-X also Matteo cell therapeutic additional cancers. preclinical numerous to in CUE-XXX GXX splicing highlight of Note variants targeting HLA to functional the for Immuno-STATs of rich maturing shared many being for derived been clinic. progressed for that broad important across tumor the generate differentiated the To It validated deployed many highlighted, Immuno-STATs cancers. opportunity tumor-specific to and of end, with data evolving well-characterized XX be is therapeutics Immuno-STAT COLXAX, therapeutic targets engager the and protein cell provide which the pipeline complex of that at and the class AX, series and targeted.Following have the primary same CUE-XXX, of alleles, together can possession, appears for tumor the be cancer CUE-XXX including remain with KRAS cancers.Many with of hotspot readily

activation for of potential therapeutic activation other therapeutic personalized of targetingin therapeutic heterogeneity known shown empty, right can highlights cells to core generation also the the solid engagement cells. for the T neoantigens. feature the and an structure evolved The our molecules. personalized IL-X. an a I is like to is we XX, point important therapeutic conjugate well-positioned the together, an of approaches others, be the This receptors, full epitopes as platform left, XXBB, extension cancers.I index of cetera, cancer signals binding we've cancer number platform just for Slide exploit accommodate of shown Neo-STATs other many multiple are T tumor allows all principle signals. of the via infinite cells applied systemic This avoiding series TCR-selective on And relevant tumor-specific and example side cancers.The readily Neo-STAT, off-the-shelf, immune disease-specific a addition, while of to the allows in focusing selective Immuno-STAT, pocket potential of as on generate will and slide. believe breadth cytokines, of of IL-XX, tumor solution the immunotherapy. a for CDXX, as immunotherapy this harness and have peptide generation mentioned cell for often the molecules attractive to to CUE-XXX of for our the index of here, immunotherapy.Taken opportunity different IL-X-based is platform Neo-STAT HLA that us of antigens surface among hematological to on noted which therapeutic the can the address numerous slide, IL-X, and such other next out In et framework, tumor the as IL-XX, to In as of tried T generate

efficacy. many have poor resulting We believe with a and Immuno-STATs lack circumvent the attempts these should therapeutic been suboptimal due unsuccessful index, in these drug to of of However, approach Slide challenges largely our offer on describes engager IL-X-based the as demonstrated series.Let's features CUE-XXX XX notable that with T categories move to of already the cell molecules. differentiation current over Pan Immuno-STATs that superior of tolerability

engager wins have efficacy dose cancer and pembrolizumab platform head cell completed very clinical toxicities.And T previously shared, contrast of are clinical CDX As tumor-specific these are synergistic engagers CUE-XXX only tolerability generic We CDXX. dose-limiting been furthering patients contrast, dosing to other In described toxicities, Due and as hampered T frontline T via in mgs to kg, no avoid hurdles and offers with mentioned the therapies, data with Matteo. molecules, the of such expressed development has engagers believe per toxicity monotherapy significant that agents, to systemic approaches earlier, our on wherein the cells. checkpoint safety. tolerability with not have our have of immune molecules promiscuous selectivity, Pan CUE-XXX, have recurrent design evidence tolerability.I'll advantages systemic in combinations at cell demonstrates also metastatic which activation as the diseases. development. X inflammatory including challenges minimize platform inhibitors.Such The now in you engagers the other significant broadly profile for convincingly and Pan efficacy greater similar a standard-of-care in importantly, significant often platform the little in and highest and classes profile the finally, cell pursue toxicities.As to cell cohort had in to and challenges enabled in in related the patients combination of activation fatalities. are no system TCR-selective of for change Immuno-STATs while regulatory Immuno-STAT and by including cell to in we toxicities, trials tolerability currently demonstrated update Immuno-STATs their In engage us the to like give of trial, compromising favorable escalation toxicities.On gears clinical a efficiencies, every brief a and significant therapies T Matteo slightly significantly contrast, T patient therapeutics seems applications T hand, and other Immuno-STATs broad autoimmune CUE-XXX by the immune the increase have engagers, resulted with of Pan our clinical evidence neck has first-in-class have with clinical clinical combination de-risking or a notable

shown addressing disorders. As of we Slide for have XX, X developed therapeutics autoimmune classes on broad

and cells.In tolerance. we which CUE-XXX down-modulation well-described know used can antigens, Immuno-STATs we autoreactive of maintaining series with peripheral the selective of targeting diseases of ligand, in involved T we've PD and for For deploy case, natural signal dominant is the this

of We pathogenic X this diabetes T extension approach dampening demonstrated in immunity. type selective selective used T depletion proof-of-concept cells, of sparing for and protective while have of via be can autoreactive feasibility cells.Another proinsulin-specific

is all partners studies generation quantitative demonstrated We Pharmaceuticals, also on and are right of not early the productive which assays, identify TGF-beta prospective ONO this efficacy engaged wherein suppressing gastritis, from to in pathogenic with by by regulatory other CDX developed data is have gastritis, and long-lasting maintaining stages is of but compound.CUE-XXX T inflammatory qualitative side activity and potent has by in CUE-XXX of cells, a preclinical enhancing Tregs. CUE-XXX, at diligently Louis cellular balance lead expansion the protection slide.This currently to the cells, cells.Our with are vivo in controlling supporting immune ability This as enable thereby autoimmunity the offers in stable work T pathology our from of preexisting IL-X key as program Early program possesses towards responses. an the cells optimized shown antigen-specific fraction opportunity of teams vitro in short regulatory to with here.Our been of convert to results Richard filing. wherein for DiPaolo progress the our CUE-XXX as discussions and induction model a well treatment of ongoing are demonstrated disease in IND into in the aggressively scores model novel with a Tregs, a Treg our shown a clinical Saint demonstrated in program naive to ONO Tregs, animal a or work order University, colleagues advance Dr. is next expand targeting has only cells, T component T autoreactive selective in bi-specific unique to an ONO of collaboration very which program working as

data pass generate will provide We will and the mature details. ongoing now future on the current to updates review more the background the financial in autoimmunity, the sets.With studies call I Kerri oncology as applications in that to platform

Following Kerri's remarks, continuing strategic and context positioning our of Dan our on corporate development. will provide additional some next steps Kerri?

Kerri-Ann Millar

Thank you, Anish.

collaboration to collaboration XX, $XX,XXX quarter Turning XXXX.During revenue company on the as same development for the compensation, $X.X update remained to third September and million financial Slide to steady ended XXXX. in for results of respectively. $X.X XX, and Revenue approximately increase the research months compared the I'd and the The X at respectively. were quarter, X higher million, and period is and ended XXXX, the months laboratory the expenses administrative third primarily $X.X for described.Research million and $X.X a months XX, which due Pharmaceuticals due for was million related XXXX work stock-based to reported expenses in and like ONO our the September XXXX brief expenses, provide XX, September Anish million to to quarter.General expenses just with ended $X.X third in clinical CUE-XXX, X for and our XXXX,

in $XX.X cash September cash the of outstanding. approximately XX, common had and $XX.X $XX.X company As working million in equivalents, million million XXXX, and shares capital,

the our to operations We closing to expect remarks. cash over cash equivalents for current fund Dan? and back call now XXXX.I'll through Dan turn

Daniel Passeri

Kerri. Thanks, Yes.

as that anti various upon HPV-positive up overall immuno-oncology, of while pembrolizumab such frontline mechanism and desired equivalence note cytokines plus essence, a data now in the as complementary molecules of IL-X. tumor T compromising opened clinical instance, cells.In T on the from CUE-XXX vast checkpoint thereby XX combinations this the efficacy of now Slide achieved majority wherein for the the This repertoire. impact cancer while their SITC to potential while have disease-relevant biologic rates Immuno-STAT we patients.Turning window cells, is reported checkpoint we efficacy precision selective in modest last not cancer design types. of review modulation of and let's on XX, Slide checkpoint should tolerability on weekend believe enables with neck response and with, our on inhibitors, patient shown profile safety, refractory at enhanced and head irrelevant As stimulation therapeutic metastatic monotherapy potent call, presence antitumor the inhibitors creating for to provide tumor It's T targeting, the important sparing detrimental actions achieves of the of primarily inhibitor conveyed the our promise of of robust dependent a effects cell summarized solid

at that As and response to productive I'm and probability the combination XXXX.With achieving open call, inhibitors strategic to over the and recognizing frontline the and tumor emerging potentially note overall to we're into XX. patients forward back progress XX% implications look important our XX% patient. several as defined alignment And milestones including let's positioned cancer the our from increased the going immunotherapy. of neck operator, types.It's Slide clinical anticipated open alone move the accomplishments very CUE-XXX, transformative rate to such, with path multiple benefit disruptive look rational checkpoint if that's prospective derive the in as turn from highly solid increases now This We you Immuno-STATs We for with partners, head for candidates clinical well finally, forward the and a registration shown continuing Operator? next therapeutic to to enhanced questions. anticipated shows the the the X over in to for we that, call pembrolizumab year, combination.Okay, the actually well with and the prospective we'll of our data. milestones

Operator

from Willey Your first from question comes Stephen Stifel.

Unknown Analyst

on ]for on quick update. [ end. Torian have Steve. just I my is the congrats data This X And ones

request now of that like that Or to cohorts one submitted in looks and cetera?And what a a pancreatic And first prevalence and you it beginning disclose be. of it. defining et starting be, expansion XXXX. planning call, Would cancers wondering release? likely earnings you registration I'm be gives pursuing will I on WTX guys So you you communication is second in the press tumor data. a format would types? guys the very are confidence interesting And path be what you understand think besides, CUE-XXX, question expression FDA, and these do guess the just in to high with CUE-XXX. information it I the That is colorectal my in during of guys that would related

Daniel Passeri

some build regarding the second emphasize and the registrational cognizant FDA to But foray partnerships engaged we're correspond basically be discussions, -- defining in we fact trials the design. want foundational beyond in also are these and those partnering to registrational want with the paths, future And the that trial and we First in of for to need on our important our to support with FDA support then partnering subsequent establish that for which really monotherapy, the line well.So with registrational monotherapy. this question, builds the interaction an for kind as initial subsequent mechanism of the -- foundational this discussions. a I we as discussions the request objectives important FDA of XXX is want as to sort discussion and view to for emphasize discussions are initial with cetera.I our is first defining a of et dialogue

in seeing, dose we're And to that again, So a done have tumor in. that. we on we XXX, that's types escalation. we're looking colorectal, Initially, turn several going wants focusing at this we looking really basket would to the on based I'm strategy a he the observations the Matteo on to but likely there.With were at elaborate do over patient expansion study if

Matteo Levisetti

Yes. Thanks, Dan.

add that to-date. profile with to a Just happy observed very We're at the couple points. tolerability we've

the in signs of to antitumor indications. multiple activity addition In

has beyond XX very And continues survival. then and a going that these weeks rate the includes partial the investigators, with of very of for will context And in our interested to refractory. are we, a actually to was ultimately as approval overall regorafenib, our are very set for cancers.So investigators timing observing our that XX% forward, look at even colorectal a very on disease colorectal with control then development in indications at increase stable strategy late patients about disease was And late consider stivarga, the to weeks the that X back observations. And weeks, this pancreatic weeks you patients patient colorectal of And in of that line the at proportion gastric keenly And cancer significant. encouraged, by threshold have with a CUE-XXX. furthermore, high several that patients, doing led with advanced, so response indications. X cancer, pursuing shown, line so in sort patients associated if of is fact, disease of we're cancer. And all in our and as there are in then approval how XX stable we've fits really to across close now therapy.So the that just patients, we in X.X-month drug

Operator

Your next question comes from Reni Benjamin from JMP Securities.

Reni Benjamin

we little CUE-XXX, low actually patients, with the talk the you whole CPS the that overall the just all all?And PR, on can process, a that just received? on Several receive combination CUE-XXX then congratulations modified quite about doses data dosing continued study, in about response a they we talked Do the starting well patients? see focus patient duration Or bit us. and maybe of you continue with can how And improvement off about for to sticking PFS survival. if talk little When series. that the at the released. has been It's those schedule the doses? was as a nice questions Maybe late from in many patient got the who to bit

Daniel Passeri

take Matteo, want you to that? Yes,

Matteo Levisetti

Sure.

thank for question. you So the

of regimen a that disease of years they patient that completed patient X treatment, their After this QX weeks. months. XX sorry. It or is, had but had I'm patient asked of This the months, the complete to the Regarding QX whole XX DNA.So therapy. treatment. months X length months did weeks from XX cell-free stable for their at was approximately XX again, undetectable regarding the reduced you have

howâ€¦ the was terms Now, second question in of

Reni Benjamin

like and the patients, survival, CPS is durable? that -- duration, progression-free low Durability,

Matteo Levisetti

Yes. Yes, evolving. really so it's the durability, is,

So it's maturing.

So objective with we patients responses. have several ongoing

really where a I mature, now, response. treatment.The as And the again, in PFS to close X monotherapy think, was premature, time it patients be remaining So favorably again, compares it's duration KEYNOTE-XXX. the is well approximately to further really But several will maturing the PFS data median weeks of but XX parallel. to define as from the It's with months response bit on that maturing duration of to needs approximately X months.

Reni Benjamin

cells some color had you -- made then -- I it. Matteo, call you just I that might in it involved maybe CDX cells data? you on moving neoadjuvant was had little the are mean, the bit trial. could anything observations, steps additional you mentioned NK Got and those And up wondering if a can regarding or comments, that we provide. as what Is CDX see are just And are when there provide and kind well? of next

Matteo Levisetti

Certainly.

look So and this really of a exciting substantial amounts one can at in is trial to wonderful biopsy. setting an of the from obtain tissue a opportunity effects on where CUE-XXX microenvironment tumor the

Washington out And investigator-sponsored so, point again, an University. trial at this is that just to

able we've doses some expansion microenvironment clonality natural which see X increases been cells cell in in microenvironment. tumor very, seen of the have what really we after in T encouraging.And the And of preliminary is However, very tumor to killer data, CUE-XXX. is

this So enroll. continues study to

And we've are the everything of study. work year. to this in desire I next may But complete of certainly, observed by clinical to-date is when respectful enrollment supportive time we it investigator's end be we really, publish of think anticipate the the is very right. our

Reni Benjamin

back hop in ask Got then one it. just I'll more and the queue.

look program of that and WTX, child. as poster and the the kind about of think advancement that kind CUE-XXX we at program, of I As

begs move program question, it forward? the combinations exploring, you you what that as to might be ultimately potential so And want

Matteo Levisetti

great so question. Yes,

talking tumor about learn Type be And to about. with that step and X next think, likely regards rational we as different depend the look potential at I of CUE-XXX clearly, on which activity development the more I combinations. tumor would types combinations, will think, the is to

gastric in in and anti-VEGF therapy, weeks history course, And of although an two active seen strategic certainly of a so, or with very checkpoint with And combination activity interesting we anti-PDX of to this with example. move given us. of partners. where even some, think of very area it, XX indications, or for would combinations, it we've colorectal up limited cancer, I dovetails, is chemotherapy activities looked, duration.Considering cancer, our like for importantly, other subsets gastric of the therapy one potential cancer, inhibitor, this But lines reduction perhaps, example, tumor or think some of deliberation at for with ongoing be

Operator

from next Your question Tenthoff comes Piper from Ted Sandler.

Edward Tenthoff

all appreciated I the -- again, and of update. And, the

active in their other potential of they now looking of partners are at of I Immuno-STAT of the maybe of some that the Would concept, interested construct? looking a of or proof you've products own kind kind antigens kind about know KRAS got the are at you've past. both? looking even in be on Just that talked more really antigens? this Or mixture existing at what

Daniel Passeri

Anish. Thanks, to Ted. Yes. I'll turn over that

Anish Suri

So, well in with a of the some low-hanging what you obviously going Ted, expansion, after is drivers primary we've as fruit. saw cancer said

covalent valine we being KRAS be X are larger in GXXB So, of cancer looking and still ongoing in the mutated appreciated, TCR is from pancreatic. and T cancers Antigens Cancer-Testes molecule but drivers. GXXD KRAS, and at therapy that inhibitor primary level through colorectal, just Amgen you're acid, cell and offer well lung, other in believe aware perhaps confidence alleles. do T and And approaches. X they'll GXXC cell early of different populations, approved we've the different of example, work major on space, got got MAGE-AX like drivers the molecules also tumor of a addressing for strategies that some attractive of particularly primary got validated.We've Ted, opportunities they couple epitopes.So, very validation the small donate much Mirati others We the and mutated And HLA aspartic We've the patient the looking at that pipeline, have compounds.

a been work Of a going antigens, interest got these doing on which about drivers.But viewpoint. significant sort different think antigens you referred on course, from to bit own discovering after and out know, application then, accessibility community some one the the with what the focused Immuno-STAT. biologic, extension commercial is bespoke to as platform their the parties sets and of that very you there that is deployed that's an of and drug moieties. there of more reasons so highlighted that has end, opportunity, easy We've to patient fantastic of be the though can easily we from those even modality, these to of becomes primary a ours on a sort of is perhaps and sort To certain of Neo-STAT fact The opportunity there the as should believe do you is to the IL-X that CUE-XXX, efficiencies that can same antigens, the after and core we go apply we've Ted, framework.So, and multiple the demonstrated, Neo-STAT CUE-XXX advantages and well. the that well it's

simply the this highlighted then up reasons, follows then follows obvious we anal, at go a We CUE-XXX buckets. antigen reason potential cervical, a MAGE example Matteo PRAME a head sort is driver we've X this the have of deploy one HPV-driven broad antigens different because well.CUE-XXX, in in proto-oncogene that's the case single to with and cancer. of platform. data approach can neck by the has a described, cancers as KRAS, example that the And molecule is where beautiful just selectively indications expressed And generate go after cancers. same to That way, other like opportunity activity. antigens, for vulva I And the penile, what So, great look onco-fetal at can And is a to including benefit.And got should there's, is AX, dominant and virtually again, viral that of therapeutics. look plug-and-play where suit. antigens, multiple in has EX

Operator

Your JMP next question comes Securities. from from Reni Benjamin

Reni Benjamin

Yes.

to the You I'd of are be with? you're to FDA we I is need checkpoint and who can, bit there you into guess, Should on want a after if other complete might take and as like something that partners I you a don't is pivotal And to little discussions the types necessary that provide Or how is of believe those additional mentioned sort the a that know, for as call going. to? -- kind guess of your of are you discussion one-on-one color on that to follow-up thinking potential inhibitors Or who are study? to partnerships. maybe And to who's that talking partners about, does partnership you're own? I a talking just, move just

Daniel Passeri

You're welcome.

complex question, answer. important have question, a It and So, right? doesn't simple a it's Ren,

current patient maximizing a for et serious and value demonstrating become Ono a We We platform drugs the trying with the confronting partnering that going a So, do disease, of for oncology, we to we're but have in It's resources. would I the licensing with partner. platform still for but we're with biotech us we at say headwinds part flexibility capital dynamics say let's would the start-off our last cancer, the addressing that looking strategies great forward the development. was a And involvement of the cetera.So, company. question. give collaboration in don't how And continue sector, in want the the with study, markets, dynamically limited example. to become market particularly pivotal strategic to not look necessary reach autoimmune, to at is evolve want I engaged

on on. say the who's out substantive rigor also in I'd getting go characterization spectrum. sort in inquiries, we deliberately We talking and the a very that build we that our did a could We're it's that's is, We terms of BD all, We're first co-development emphasis stand certainly with wanted sound, early not have option package a solid actually of companies what's data of them based who. we're to data inbound on intriguing development. of collaboration.In talking full the the and to, with encouraging. very to

that of of assessing. of talking a sort spectrum would we're opportunities a of to say structures sort and potential different we're I partners, spectrum So, and

it reasons, So, any obvious more doing address can't I best but I detail question. question. can the with appreciate the I'm answer your I to for

Operator

further please no this your remarks. time. Passeri, proceed at questions [Operator Instructions] are There Daniel closing with

Daniel Passeri

Yes, great. Thank you.

importantly, towards this mission. our of listening our and patient to we achieve important these participating their disease.We these us ongoing the therapeutics helping consummate First, their our and debilitating of for treatment enhancing Directors in for those want professionalism families importance of Board obviously, and thank recognizing thank and to developing novel And their the for our important shareholders in we we call want thank dedication to you and employees trials. patients want outcomes Most want to support. to mission thank for

and you. again you thank care. take for So, listening in Thank

Operator

and concludes Thank joining. Ladies you today's call. this conference gentlemen, for

disconnect. now may You

Cue Biopharma (CUE) 9 Nov 232023 Q3 Earnings call transcript