Earnings call transcript Q2 2023

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Operator

Greetings, and welcome to the Cue Biopharma Investor Update Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to Dan Passeri, Cue Biopharma’s Chief Executive Officer. you. Thank

begin. may You

Dan Passeri

very good you everyone. much, Thank afternoon, and Hi.

Also being presentation will through for As directly that by days. the maybe this proceed in and today’s discussions slide the be recorded accompanying the XX those website a reminder, we advance our we'll and notifying and the update as aware presentation. on be next on listening please call, available you

Matteo Chief Levisetti, call today's Dr. Suri, Scientific is and Officer; and Millar, Officer. Dr. Chief Joining Chief me on Kerri our our Anish Officer; Medical Financial President our

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

associated outlines Immuno-STAT with the today's and regarding provide On some a the brief background next in brief clinical slide, ongoing a result context you which of developments is advantages Anish. and trials. pertaining agenda our with platform from just with I'll approach call, the our Anish begin slide followed competitive pertaining it the summary to by number will synopsis observations for to X,

having ongoing Following development an update our provided then regarding will provide corporate the observations for from mechanistic by background on our implications Anish, Matteo corporate insights, ongoing positioning. development clinical strategic

we'll is to immunotherapy to premise, data and of and and steady progress realization that context discussed treatment foundational of the presented but provide previously providing cancer. serves consistent Both enable helping calls. in the forward, and the also precision during updates repeat slides continuity the our vision to to transform presentation, of Anish foundational demonstrating reinforce our been having data be on the Matteo, with and some of meant The prior

for brief Matteo, by financials be Following and overview will and they who then return pipeline going will developments of guidance. Kerri, will followed our a QX an forward overview of provide preclinical with our Anish

now I'm for the over open and going to the call call return Anish. questions. then we'll for concluding remarks, Anish? to I'll up turn

Anish Suri

Dan. Thanks,

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and goods using manufacturability Immuno-STATs perspective, and and of a antibodies monoclonal from Lastly, fusion protocols are conventional cost CMC proteins. for Fc manufactured established

liter antibodies similar been are yields GMP stability in to grams has per impressive. and Our monoclonal

to north monoclonal CUE-XXX example, shelf-life or goes antibodies. For which most a than better is that of years, comparable three has

With pass I to call recent to for clinical the update the synopsis, that Matteo CUE-XXX most Matteo? QXX. will now provide and

Matteo Levisetti

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relevant evidence of clinically immunogenicity.

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patients indicated with an ongoing As cancer. is provide approved recurrent now update on neck patients XX, on Slide with Pembrolizumab CUE-XXX for I in trial will of first-line pembrolizumab head in combination the metastatic the equal treatment PD-LX with to measure neck with a that of scores greater than of is expression first-line metastatic tumor. the have and in recurrent head tumors X%, or cancer CPS CPS

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response overall to-date in equal compares pembrolizumab in rate or in The to patients CUE-XXX historical rate with to than confirmed of pembrolizumab with response the of observed CPS with monotherapy greater KEYNOTE-XXX XX% observed study. one treated with favorably XX%, combination the

patients scores XX% of than of combination with responses four CPS with or pembrolizumab out eight of experienced PD-LX XX% to one is, Notably, the greater objective which the approximately low of expression, XX rate i.e., alone. expected

PD-LX enhance response that patients patients significantly rate the to approximately for of with inhibition, expression, half anti-PD-X the in represents inhibitor which appears a CUE-XXX treatment eligible of such, As the particularly in have low checkpoint setting. frontline

of XX, combination according slide subgroups overall observed treated the slide, KEYNOTE-XXX alone, overall next observed shows values The response the with rates and compared therapy. rates to CPS response pembrolizumab in the CUE-XXX pembrolizumab trial, to with patients in

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increase pembro CPS rate also Furthermore, scores XX% with in response greater pembrolizumab a rate appears of XX% with of overall and CUE-XXX and CUE-XXX alone. rate to XX the response than for for an patients response

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progression-free SITC. at to strengthen meeting data also an Society the combination survival November as on of patients data well The dose The for an the additional swimmer and forward Cancer, emerging in Immunotherapy CUE-XXX at patients the with trend to new Phase extension update treated emerging as plot on first of follow-up cumulative known also pembrolizumab. shows in patients therapy of of the these of recommended continues data at on we II providing XX treated look

and beyond of in demonstration overall the as and XX, recommended based in and median by third CUE-XXX include detailed in patients partial Phase cohort. monotherapy evidence on in follow-up dose survival II line a resist single-agent stable treated third with patients neck observations cancer Slide antitumor survival durable metastatic the response head disease and benefit recurrent efficacy from beyond line Key and

a patients robust The announced, FDA treatment the designation previously Fast on monotherapy define for facilitate the enable will in first with registration the line data and with Track path. activity third both As pembrolizumab, settings. monotherapy granting of Track of the designation CUE-XXX's Fast the combination and in interactions to planned in

these from HPV-EX targeted checkpoint clear with as of and blockade complementary T activity data agent with we cumulative inhibition expansion evidence enhance of and The a efficacy a specific cells with antitumor ongoing for us have believe CUE-XXX provided of checkpoint trials mechanism as patient what will therapy. reach broaden with single

As series for potential has believe we patients. from CUE-XXX IL-X-based from a the breakthrough biologics a CUE-XXX from believe first biologic CUE-XXX. our such, CUE-XXX validation beginning provided the CUE-XXX, and with our data additional therapeutic derisking we therapeutic represents series Furthermore, for mechanistic

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enrolling or gastric, the to ability the cancers. for and continues indications all monotherapy go observed Slide studies screening study CUE-XXX all design well, pancreatic enrollment being XX. date investigator of in on therapies escalation WTX in effective in of in The rate underscoring us escalation conducting study dose patient in offers This four the in expressing are summarized The evaluated colon, trial. the are is indications. cancers. phase perform We Findings enthusiasm ovarian need to the dose exceedingly actively patients any the expansion to

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the that XX% X XX continues seen cancer sum X observed progressed the experienced gastric on activity at lesions with scans prior scans lines of as therapy, with a approximately are per clinical kilogram a minus the kilogram at X of including X patients decrease signs three on weeks particularly of treatment. kilogram inhibitor, patient and pending. on currently and milligram were and X, the dosed dose and has per of a milligrams in These example, are currently patient XX early the and three For per milligram at in encouraging levels they checkpoint target milligrams

where We November. largely to the indications are these have antitumor look forward been of activity SITC inhibitors additional these meeting encouraged by data We checkpoint early monotherapy observations ineffective. in in presenting at

turn now will call I over to the Anish? Anish.

Anish Suri

Matteo. Thanks,

by with platform discussed data exploit cancers. many Matteo, us provides the confidence XXX the As cover to to our enormous validation and breadth CUE-XXX clinical of

to As each shown these each is The of Immuno-STATs specificity. essentially that between for on Slide analogs difference In XX, other. distinct the core cell primary constant. each IL-X unique remains words, are different targeting which cancer moiety, state T other molecule immuno the framework is

class that end, unique platform, significant platform can for technology provides first through we experience entire validation this believe clinical be To developed has candidate, of that derisking.We clinical which with advantage. believe platform therapeutic a CUE-XXX, read competitive provides the a molecules our the and using positioning our that

advantage core enhance modularity exemplified this around on The slide. platform is precision also immunotherapy to

that Wilms tumor different cell cancers. shown, validation targets many X preclinical serves CUE-XXX mutated provides multiple CUE-XXX As cancers a antigens that cetera. This as by we as for immuno et not modules for is a proof cancers, to stats developing cover for also indications tumor-specific of highlighted by such provides path MAGE, additional targets Tumor and important of additional shared antigens, but targeting can tumor that T immuno-STAT tumor KRAS, registrational concept for only and/or swap neoantigens. extensibility personalized beachhead by HPV-driven different incorporate targeting easily

AXX to patient multiple allows versatility modularity patient AXX, this HLA generating other We've of as The and already alleles coverage. HLA-AXX, with expand global platform examples. immunostatus us to AOX, by aspect demonstrated -- incorporate

of pipeline in strongly and to clinical patient XX positions next us remain of expand pipeline The snapshot benefit which generate the data CUE-XXX current assets, is additional We activity. demonstrating oncology and slide, focused validation and clinical that indications, evidence stage into continue believe XXX durable on Slide a mentioned. our We as gives our this to autoimmunity.

To can that end, we different clinical assets. stats into have immuno that several preclinically be progressed validated stage

currently We forward discussions strategic pipeline are engaged the oncology in for assets. our map path to

me on Let our comment autoimmune briefly pipeline.

Earlier this year, we disorders. announced a collaboration with therapeutic Ono Pharmaceuticals many for to develop CUE-XXXas autoimmune a

CUE-XXXis an a the being to novel CUE-XXX of enhancing cells bispecific Tregs. expansion and a mutein of T composed IL-X for in natural regulatory these molecule subset is for and variant. TGF-beta induction or Many of developed are IL-X muteins, Tregs variant small contrast

Both promise mutein also to holds populations Tregs IL-X known Tregs. action cytokines Hence, from other new differentiates well Tregs, together we of as balance. of the expand induce have the generate CUE-XXX and these pre-existing there's been natural reset to as all dual as demonstrated mode immune believe

with very sets make good and are us an forward that moving this to IND. asset continue We towards data progress support generating actively

to discussions additional autoimmune to develop continue within further We in pipeline. engaged also our be assets

With to Kerri? review the our will on to Kerri I that financial data. call pass synopsis,

Kerri Millar

XXXX. for like June to brief provide I'd six our XX, three results update the Anish. ended Thanks, and financial on months a

a level consistent when second the to XXXX. during overall of slide spend efficient its of same in while As maintaining period shown in company and on XX, XXXX, resources a the continued use the manner to compared disciplined quarter

XXXX, $X.X million the ended $XX,XXX revenue as three for approximately collaboration reported XXXX. three for of we June compared the June Importantly, months ended to months XX,

collaboration Anish with mentioned. that of quarter due Pharmaceuticals second work agreement was option XXXX the related in the Revenue just and to Ono recent to

approximately June and June as equivalents XX, had marketable $XX.X million of the cash, As securities XXXX, XXXX. compared $XX.X in of cash with million company XX,

from July current shares XXXX position common of cash agreement our of in the under Our sale ATM stock with October the includes proceeds Jefferies.

position, current the marketable cash our equivalents operations quarter expect and of securities XXXX. cash third through fund to We

closing to the for now call I'll Dan? over back Dan the remarks. turn

Dan Passeri

Kerri. Thanks, Yeah.

we therapies, system transformational view updated ongoing to destroy be we CUE-XXX in of summary, checkpoint significantly So developments may Immuno-STAT standard data cancer. own and reach enabling precision cancer from immunotherapy. by with breakthrough care These for consider be immune CUE-XXX our be patient efficacy. the foundational, Furthermore, of in as expand such trials the and patient's existing activation clinical to with what potential future the representing inhibitors, of could combination to and

to especially CUE-XXX for in these our therapeutic already trial to metrics need for significant we demand the inhibitor of to addressing been unmet medical Furthermore, patients anti-tumor many the access activity trial, several very and escalation underscores checkpoint largely we're And platform's observe our pleased dose unresponsive patient increased of cancers potential in since believe, the portion. an patients, these have therapy.

broad modularity global Our expansion opportunities and to also platform coverage versatility into indications and market additional HLA offers treat patient populations.

market treatment autoimmune upon. Anish myriad believe CUE-XXX diseases. We also as possible a for just of autoimmune the More blockbuster as application specifically, of potential in disease, holds our platform touched a

with forward program to details impressive later continue partner, in on forward progress and make we Pharmaceutical, this to providing look our further year. We Ono the

our thank for ongoing important shareholders everyone therapeutics appreciate progress promising patients developing for and listening to I particularly want their interest the need. support and for in in, our

I well of, as as forward. for in families to their the I thank therapeutic and dedicated promising our want for our constant commitment participating trials Speaking also bringing their for candidates patients employees thank want these support. professionalism to

I'll operator that, over for now any open and up turn call the With questions. Operator? to the

Operator

Piper Please question go and ahead. first Ted now comes Your Thank from we Sandler. will the Tenthoff Instructions] from [Operator begin session. you. Ladies question-and-answer gentlemen,

Ted Tenthoff

you congrats very for you And Great. the Thank and on much. update to date. thank the data strong

where more later path really generate now of into we're at KEYTRUDA that well of stage sort year looking of in Thank forward. going data, as win-win a all with how activity kind you're sort forward in data, presented goes even enhanced financial, whether strategic frontline our be top seeing come patients, scenario is of are what SITC. together and they process the guys to throughout that process. to What you to XXX And You the rest into the here an on chart as go of does factors, other that as with the you. or beyond what monotherapy

Dan Passeri

Yes. dilemma cancer data both because Yes. have I a question. and Thanks, not resources. platform have limited Ted. on appreciate This is head we positive fronts, company It we Dan. company, is more the importantly, a we're neck and a but

with we're initiatives, developing various strategic initiatives, So meeting this And strategy the define combination. best do registration has plan obviously I our do for as be with both would a on partnering also asset thinking a path. that level. to will have to in for months, development an think We FDA particular possible discussions the well. monotherapy This corporate and and scenarios, what's asset that the very strategic coming partnering

from tumors cold that's we're that by also into the responsive inhibition. not reach, and put have in been application an enviable to enabling available. have us previously we a and of going position that can been we emerging patient CUE-XXX in expanding monotherapy have hot to and And checkpoints terms But checkpoint in if tumors not turning large, that this of demonstrate data cancers as cancers these

is in all ongoing various process. this looking we're scenarios, decision at this, a in we're part strategic of Board, dialogue looking obviously, and with our at which we're ultimately So manner, pragmatic of strategic

and and on So question. address partnering. and access strategic based us have. It's to an a of for manner to timely a to have capital capital important based define I on them have are tree And in are on and all to we're good And -- various decision I essence, problems cons, think requirements, continue to our We just cost pros one appreciate the going these alternatives on forward. they in of refine. head going

Ted Tenthoff

the in you. back I'll Thank hop queue. Great.

Dan Passeri

Thank you.

Operator

you. Thank

Ren Benjamin from ahead. from Please go comes JMP question next Your Securities.

Ren Benjamin

the thanks of couple a with guys, taking congratulations all what I on about maybe I if meeting? a the for and starting And book the had couple study, have overall you the with regulatory so have really will Hey trial talk be little a off on study agreement progress. would from can of body, discussion? you've then questions, bit that additional you win, monotherapy appointment a questions, the needed the that to you follow-ups. -- Can is information what just and once survival. of the design consider you terms in And your update have

Dan Passeri

handle Sure. to going to ask Matteo I'm question. that

Matteo Levisetti

Certainly.

for question. thanks the So

of data which this strengthened really with patients an X at kg, favorably even median mgs OS really in setting of at in second-line the months. XX approximate months, has XX very cohort eight matured now the compares to treated observed that, which it's As per was

the of of most a monotherapy it's FDA synopsis registrational trial, trial. interaction a put that chemotherapeutic a potential component for investigator's of randomized and for design proposal planned We've developed X:X three CUE-XXX basically randomization forth a to choice is to likely, trial regimens. and So

the of statistical all and details have we So parameters defined.

late-line if in an will, And so in approval support win, interaction with “for our endorsements -- to a with to regards having, it's anticipate you patients. registrational we really FDA single trial”

Ren Benjamin

you prepared that talk move switching importance data? Got gears, remarks, but forward? it. study. about And where are, then just neoadjuvant might can little to might missed the study, when program the it past how we've talked And might the because neoadjuvant know expect we a the about we see of ultimately in any in I bit the have I

Dan Passeri

Yeah. Matteoo, think I also that's you.

Matteo Levisetti

Yes, certainly.

the So trial currently And patients the Washington treatment very, doses with well, in two enrolling are is curative which surgery schedule, CUE-XXX chemo-RT. is either patients going trial or is of okay? intent, getting at neoadjuvant University before the second very

so as is IND for there group to presenting collaboration this this So investigator-sponsored trial an a and the the hold IST. note the that data will sharing with of important the timing occur that and

some seen data early have We encouraging. looks very that

CUE-XXX's really post-treatment the is pre our be characterization our the of of this T even in really tumor in cell is tissue-based that analysis to effect And understanding further going receptor blood-based presented presence data and really and since TME microenvironment, so when immune exciting to the and collaborators. with markers tumor it at we feel look will set an

Ren Benjamin

clinical as then tumors an think, activity those you it. in after can the sorry, maybe call, seen you've And some -- think CUE-XXX about the saw Can responses we just you you -- on color mentioned I guess, you additional where -- that Got provide CUE-XXX, going on I impact? finally, CUE-XXX.

And and you to with forward, the checkpoints? maybe thinking be that potential subsequent sequence think program combinations the about we how related ideal should moving about to that, as

Dan Passeri

Certainly.

question. the for thanks So

escalation dose, So the to next okay? the really Phase to the recommended dose are primary that begin, So the component. X determine steps is of objective

okay, over And cancer seen that now been sustained activity to patient we've reduction we a here. four have regards we're that's for cancer. stated, observing, in with as With the types we've metastatic a XX weeks gastric advanced

stable several indications. confirmed to up now We patients have different have so XX disease that across weeks,

seen formal look on to to of the forward effects at regards with CT the we've analysis presenting tumors meeting. what So we

going, And really of will where indications importantly, to data these forward. I be combinations monotherapy establish think okay, biologies understanding combine consider we to would once based to activity QX types, that tumor different where it XX. rational we'll sense the on direct taking the regards various assess think make certainly may unique I that okay, With really

resistance So inhibitors think, just that we born pretty believe -- of an environment. accepted immunosuppressive as it's of to in colorectal look dominant in they're out checkpoint that much is to seeing I forward the example, a cancer, part immunotherapy

type, make to could tumor something TKI, that it that with it with be in combining that so it And interferes agent. be that would sense a another pathway, immunosuppressive could consider

think what that it checkpoint combine gastric we'll I inhibitors. targeting an agent for anti-PD-X think And So in with there's other subset heading. There's example, that's be HERX considering. an HERX-positive plus that's a in with indication activity be cancer I cancer, for been the checkpoint and some approval inhibitor, where may of sense be cancer make pembro to gastric where would or we'll

Ren Benjamin

Thanks very taking Perfect. luck. for the Good much questions.

Dan Passeri

Thanks, Ren.

Operator

Thank you.

Stifel. question go next Please comes Stephen ahead. from with Your Willey

Unidentified Analyst

hear okay? is Steve. [ph] Toni you for Can guys This on me Hi, guys.

Dan Passeri

We you can fine. hear you. just Thank

Unidentified Analyst

you you. Thank Great. my Okay. taking questions. Thank for

the my CUE-XXX about on population Starting you questions target end. pursue two have cohort, guys with mentioned I specific you lot have combination a Like plus the So think you will do pembrolizumab, moving because forward? improves would be example, be specific think potential population. targeting guys score you how that better you let's even any say, low-figure do to, indication population combination for there signal will high, low this compared CPS

So that's related to CUE-XXX.

you And week? So additional end. dynamics so possibly at color maybe you on on regarding more been disclosure please And data like how comment color like and that's Thank little on provide enrolled pieces can six all possible, very if maybe far? update CUE-XXX, on many much. have enrollment my a data additional

Dan Passeri

score. first had question with do CPS with the I to stratifying think

Matteo Levisetti

-- I happy it. can Yes. take I'm to

Dan Passeri

Yes, go ahead.

Matteo Levisetti

super Thank you the great questions. for

high with where times have so increase right, regards And we're data observing, we a response in to meaningful Also, CUE-XXX really in CPS and have the low about we of the population. X.X tripling pembrolizumab the rate population. CPS and that

I such way in pembrolizumab. as thinking actually about the that is the this, patients checkpoint for think are setting win-win So this we're really a treated any first-line being with a inhibitor

a at benefit if the in have you one population, low the actually look less on that five So it's or than patients data response.

we And even high fantastic so the clear XX% that's the the in we have improving benefit population, And there. to up CPS can push for that a if then patients. activity of

or all that Pembrolizumab to any I where more X%. stand combination. line equal would approved of first specific since to be or stratification than not the So think really needed CPS patients is from clear are patients appear things And greater benefit in the now. for treating that it's these really targeting

And to of enthusiasm advanced enrollment the underscores out escalation these the four -- remarkable in experience, large really the unmet a fastest CUE-XXX been of close disease also as is mentioned in of to it this patients the And borne for I is study. X advanced think dose investigators. need indications. my cancer with the Phase regards With before, I

initial think is Regarding the CUE-XXX SITC XX the more observations on presenting safety initial we tolerability on in November. and And that the at approximately I we'll the numbers patients patients, data be anticipate or the presenting at time monotherapy. that data of of

from characterized course that out sets share any and escalation also and observed the available dose correlative clinical We more data some fill time. have the been we patients will we that's have already data that at preliminary pharmacokinetic

that As to that some share I'm to know and vendors different do well, of at us working hope you sure to help very we several analysis, actively well. we're with as the going SITC are have data correlative

Unidentified Analyst

very you much. Thank

Operator

next go you. comes Instructions] Your [ph] Thank from Please ahead. Peter [Operator Oppenheimer. with Lard question

Unidentified Analyst

Excited Trevor. the It's Thanks for guys. taking to question. SITC Hey the updates. see

additional the some might you we So, throughout discuss guys looking can ahead of that year XXXX, data the to see there?

Dan Passeri

resolution what our also on from partnering discussions, XXXX, what what decision FDA On strategic front indication, by on line, on obviously, -- strategy is and the and structure? in have third Yes. both XXX whether of the decision line, line, whom, our XXXX, also we we'll XXX clarity have with we're what should

articulated, enviable a Matteo as just have XXX, we very position.

early cancers. and We have dose escalation. activity seeing We're multiple

mg to level. and during reiterate conveyed we've seen dose the at call, X mg Just Matteo activity the X what

X So, we SITC. and X at also scans for the be providing will have

So, to we pretty this of from Obviously, prioritizing. going we're year a in climate, resource be into just have XXXX, it's to requirements going current exciting standpoint to address. a have going financial that

So likely most strategic. through

us. important emerging, We year of also have for going consider data We a is from have XXX by that year that really end clarity to transitional be we'll into XXXX.

year as it's to clearly So, well I a of year milestones end the of will that going by the be multiple as think defining be expansion decisions.

Unidentified Analyst

Thank you.

Dan Passeri

appreciate Yes, Okay. it.

Operator

further Thank your no you. with Please closing there remarks. questions. time, proceed are this At

Dan Passeri

time further updates and SITC progress. everyone to we forward, to the making move you good We're clearly steady interest providing of we're with progress for looking for the very and and want I year. in continued your developing forward continue thank we Yes. remainder our as as

week. I again, wish your everyone you take and interest And thank a pleasant care. for the remainder of

Operator

This concludes for your conference today. call

disconnect You your may Thank now you. lines.

Cue Biopharma (CUE) 9 Aug 232023 Q2 Earnings call transcript