CUE - Earnings call transcript Q2 2024

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

Operator

Good day, and welcome to the Cue Biopharma Second Quarter 2024 Earnings Call. [Operator Instructions]

Please note this event is being recorded.

I would now like to turn the conference over to our Chief Executive Officer, Mr. Passeri. Dan sir. ahead, go Please

Daniel Passeri

Thank you, afternoon, and good everyone. Okay.

aware and being our we're presentation. update recorded a please for reminder, in. will may slide is we presentation this be Also, by days. on As be and advanced accompanying those what discussion be the will next notify XX on the on directly throughout that slides the listening today's website And available you

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

on overview as call only here any with represents forward-looking upon shown to forward-looking Slide recent corporate contain XXXX. I and I'd views company's developments like near-term restructuring. of As to X. begin programs context you today, This and statements, announcement, this the our some may and focused the August presentation statements XX, during made our providing with autoimmune call associated pertaining some by

to savings for advantages probability competitive the data should survival particularly of our the market bolster veracity to balanced as mature achieving patient's care measures brief The capital series and implemented objectives potential further our focusing upon optimizing we recently of new model, cancer registration. also a more probabilities relating partnerships. Furthermore, strategic enhance cost mechanistic path additional our within capital-intensive begin taken trial launch evaluated enabling for strategic the our success business options current patients. of requirements anticipated synopsis positioning, assessed towards I'll challenges of through establishing and capital delaying various the near-term a a of data, be provides of and of to while enhanced aim resources what conditions. through positioning carefully for higher a productivity reduce consider measures. standard we've mature basically capital of accessing to a underlying And of to we This a the the with and measures underscore, for just clinical constraints data these success to

#X, breakthrough restoring As treating patient's standard a developed balance Slide and diseases immune by of to therapeutic shown to in a system. we the approach we've new care autoimmune for immune both establish believe cancer proprietary

our with Matteo elaborate trial. saw be trial substantial similar ongoing plus from second the will appears setting and combination As patients of upon treated clearly shortly, Phase in line KEYTRUDA, monotherapy data also with data monotherapy a survival evidence Ib CUE-XXX CUE-XXX emerging in prolongation trial frontline with of demonstrates pembrolizumab the following from we what as to that the in it's the pattern

We to believe be underscoring data competitive positioning remarkable our believe be we to what of approach. true quite the this

our and address support it's antitumor can activity data our aberrant we the platform such, in to to intention disease. can that believe autoimmune rebalance taken enable foundational with mature further or to be clinical immune the As develop effective to measures responses induce of and long-lasting harnessed

the year. candidate, progress the address unmet being program, multibillion-dollar with multiple lupus in first selection large, to graft-versus-host Through ONO significant partnership, rheumatoid coming arthritis, with representing others, disease, autoimmune collaboration addressing made We've we we've and which partner, significant our to medical anticipate lead made inflammatory lead a sclerosis, progress multiple need. potential of of this as amongst our CUE-XXX, Pharmaceuticals, bowel market disease also such psoriasis, quarter towards and impressive diseases autoimmune inflammatory moving date developed in disease,

disease expand several to or supportive a been productive highly control CUE-XXX has date. Tregs tested cells regulatory to disease growing and in promising Our of body and collaboration fostering ONO resulting the demonstrating of and data, with in ability generate models T

codevelopment U.S. retained Cue Biopharma CUE-XXX. reminder, an co-marketing option to XX% a a right has As to

with cell-mediated of program forward diseases progress medical multiple market and biologic. B eliminating a advance addressing the representing selective B-cells gravis, has to with autoreactive This potential. amongst myositis, others, disease multibillion-dollar of with continues program unmet the needs autoimmune significant highly well-tolerated large promise This as potential such XXX. to and and Sjogren's myasthenia Turning lupus,

of they we to ablation development in B-cell furthering program mechanism We're and same presently to would as updates assessing the action strategic alternatives such forward partnering malignancies the Furthermore, seeing may disease look promising this that of become be autoimmune available. be lymphoma. providing for as deployed for B-cell address B-cell

ourselves growing market medical and significant both portfolio a unmet oncology opportunities candidates needs. positioned in of major with highly promising addressing of disease, have represent We autoimmune which drug all

near-term sets derisked pertaining with established data to enabling rebalance therapeutics and We CUE-XXX our on to partnering and CUE-XXX believe potential validated from platform model, emphasis validating We've programs, business a our restore with reduction patient's programs foundational immune structures. autoimmune implemented health. to preclinical data an we've our have the with capital a system existing requirements the cash-efficient and of

Anish additional both turn to will attributes our disease. underlying to treating and autoimmune over oncology approach on of well as and context developments who core provide now going as the platform call some I'm disease advantages the for our describe autoimmune for

brief maturing a provide Matteo attention to metrics before the trials data survival will that I'll sets then and niche, clinical further to after call emerging. and highlight a importance updates for opening CUE-XXX the questions. And summary of the up with return the on XXX are the particular Anish?

Anish Suri

afternoon start and restoring good immune summarizing all autoimmune the in I'll of today's and for approach for by balance our to our treating and call. Dan, Thanks, platform briefly listening potential cancers significant diseases. on

while immune of This maximize efficacy the us allows to disease-relevant enables of approach platform system. safety. while As preserving patient avoiding previously, described Immuno-STAT immune cells modulation the perturbations broad selective

have series cells. to cytokine while sparing safely the irrelevant tumor-specific clinically indicated as TCR on X, activating IL-X Immuno-STATs the now potent summarized with and activate previously and signal Dan Slide we other along As selectively CUE-XXX T delivers the preferentially validated via all that T cells

cancer remarkable therapeutic XXX over we for demonstrate CUE-XXX patients patients a tolerability. impressive to index Matteo to will others of data with generation and IL-X, therapies. treated for which the CUE-XXX. develop In that many with alluded dosed, a increase in for allows efficacy continue on have further details benefit stimulation selective the has clinical favorable This provide latest demonstrated IL-X-based trying being

On T control the we lymphocytes. approaches possess distinct and reset highly cell health. immune generation are to X a to on and the are important an immune Hence, focused balance. promising autoimmune front, type or that dampen and regulatory is cells to homeostasis the stimulates bispecific T expansion and novel autoreactive of Tregs, cells. ability Regulatory CUE-XXX maintain

partnered ONO collaboration been this has forward continues and with Pharmaceuticals, CUE-XXX strongly. to move

we've in developing series CUE-XXX to of depletion to which cell T progress from approaches. CAR CUE-XXX, CUE-XXX, to patient addition while B significant cells. has made biologic the preserving T approach enable In a differentiation efficacy competing safety, potential offers also significant from like deliver the mediated other This

autoimmune CUE-XXX designed with across patient large inflammatory numerous and series are multibillion-dollar Both address a market potential. populations to and CUE-XXX diseases

expand unique on will of We expansion next few induction attributes CUE-XXX both The Slide programs and exemplifies next the the slides. of in slide, X, in Trex.

to with of as cells known new prospects Tregs. the IL-X natural of to convert approaches This CUE-XXX T preexisting is composed superiority cytokines, a CDX over are deploying induce peripheral natural X on focus and to pre-existing significant Tregs ability Tregs. other CUE-XXX Tregs as only the expand well TGF-beta that populations of IL-X provides bispecific variants into the key

As of and regulatory of Trex targeting IL-X on is is to receptor shown of quantitatively Slide expressed affinity subunit to the the on action CDXX, cells. mechanism T superior believe CUE-XXX mutants we which enhance X, IL-X high qualitatively the

generation. superiority show that in sets data an mutein of highlights X IL-X currently analog Slide for CUE-XXX development Treg over clinical

alone the IL-X side this unable In bottom an for The contrast, of in is and on for CUE-XXX assay, of that slide, an to which shown effects. Treg differentiation disease, signals and induces needed Treg-directed in vitro model confirms Tregs. generation is vitro human is left MLR a mutant the unable TGF-beta As expansion in achieve to panel are left effect. both these IL-X achieve either graft-versus-host

in as with and notable in ONO extended from in the administration cytokines. several with gastritis. we results disease where a in short-term further significant long-term CUE-XXX Pharmaceuticals, increase other autoimmune efficacy have In CUE-XXX decrease case, shown our we have previously of Tregs pro-inflammatory noted As a by side, vivo the on in models and accompanied collaboration ongoing protection discussed, autoimmunity, this right

now an cells systemic update to provide design and behind goal T T primary and the on The X activation the of immune all depletion. cell effects B-cell Slide B cell of T overview adverse Let's the to CUE-XXX to broad depletion for achieve the move while avoiding of cells. was CUE-XXX of engagement series engagers mediated

potential enables like the achieve safety cell engagers. to the of T Our avoiding pitfalls efficacy while CAR-T pan approach

CMV. as memory effectively and to the cells shown By epitope of frequency the of reactivity killing due human systemic would trained targets. in the cell present And design, B virus-specific cells cells, recognized antiviral cells CDXX killer such with Engaging the viral self in rapid the against the several as T be then or population. cells killed antigens, B series engagers. immune on and activation offers tissue CUE-XXX readily with These They bind avoid T tissue perform Immuno-STATs are potential slide. the cells disease as VSTs across advantages. are VSTs virus and T the or paint are localized B These T in to risk high pan specificity the by of

mediate the in on specific degree case, this case, memory shown anti-CDXX since cells CUE-XXX killing same an cells Noting cells pan of VSTs Importantly, HIV absent the achieve of in an as engagers, CMV individuals. molecule. and that most T to as largely T CMV-specific Slide bispecific cells the B specific can unable expressing anti-CDX molecule X, this in cell T killing killing is engagement B-cell of T since HIV are is epitope to

Slide and interferon not X cell cytokines, does engager release, inflammatory and pan drug high a which high in ultimately molecule, between T due to production molecule difference TNF, all the copious shown CUE-XXX Due its significantly In and production in cytokine safety further compromises here. selective gamma of in results such the as contrast, cells to of the and binding engagers. result pan patient engagement, anti-CDX exemplifies to CUE-XXX cell levels T T as tolerability. cytokine safety

some selectively it's slide, systemic can memory kill and B killing in reduction of molecules. The preserving Slide X Note but all should activation engage of a efficacy. pan only approaches approaches T selective patient T involve B-cells. engagement and highlights and in release cell engager series that CUE-XXX and significant following while which cells, to cytokine cell-mediated CAR-T results notable points between safety The redirect while target T toxicities, killer them of trained the related differentiation the cells X that favor CUE-XXX avoiding

across patients as series positioned summary, address autoimmune could T-cell We biologics X very many likely takeaway for there In the engagers messages. of are indications. segment believe key the are large and depletion best-in-class B-cell CUE-XXX a of

due clinically the including core immunogenicity to and of clinical of series structural the the via lack Immuno-STAT CUE-XXX autoimmunity. in application supports First, depletion shared relevant validation bolsters for of clinical and CUE-XXX, and framework, oncology B-cell CUE-XXX and derisking

safety avoiding high therapeutic levels autoimmune achieve safety, relevance to the while Second, to cell systemic not memory considering is cell selective B clinical harnessing applications series with pro-inflammatory when of desirable risk antiviral while And T CUE-XXX as which circumvent demonstrating associated cytokine kill noted compromising killing patient pan-T the with of the highest production efficacy, comparable in engagers. third, diseases. cells, cells activation data T positions

Matteo? from Matteo the With data background maturing over call ongoing the to the turn and I'll to that clinical trials. update, oncology describe

Matteo Levisetti

Anish. Thanks, clinical to clinical CUE-XXX demonstrate afternoon today's with trial to HPV monotherapy. pembrolizumab robust encouraging recurrent highly and heavily data in continues for positive with positive and and maturing metastatic in call. everyone pretreated the cancer of Good HPV and from benefit patients diagnosed ongoing head listening combination neck treated cancer with head on metrics neck recurrent newly for patients The metastatic treated

prior observations, as patients confidence The to new further improve battling CUE-XXX in therapeutic HPV potential care outcomes bolster our head and latest neck standard data cancer. enhancing continues a for to of positive

head dosing overall than tolerated of care an stated, of is is expression. with cancer on a action, to approval score The of XX.X equal measure consistently data tumors median we and cells. months objective approved the setting by observed PDL survival selective a greater Pembrolizumab and neck with in this was score pembrolizumab KEYNOTE-XXX response or combined believe the of X%, standard positive mechanism evidenced date the the unique enables to effective previously generated of of which and study. that of have as of T with patients based a and as XX% CPS treatment first-line metastatic expansion current rate tumor-specific targeted in or and CUE-XXX's as recurrent As of

objective as X, of As greater combination response shown presented and ORR Slide rate with observed to greater XX%, with XX, the than compared CUE-XXX the doubling patients at pembrolizumab on represents historical with CPS June, in of or a to treatment XX% monotherapy. following observed ASCO equal in than

evaluable As across reductions confirmed shown of out in on confirmed partial patients, patients, of patient. response including and many the one we in these a have XX significant waterfall tumor plot, patients observed XX responses complete

XX% with or on than with disease that which one was patients in CUE-XXX X observed with lesions a stable XX Importantly, X historical of of remain alone. the treatment, in of for including tripling of to ORR scores low minus target a ORR approximately with reduction Notably, pembrolizumab their observed CPS scores, XX%. exhibits greater and patients represents XX% of pembrolizumab,

approximately not response enhancing that particularly appear inhibition, positive so the also by low observed responses The XX-month scores that patients PD-X and been shown in patients in for important responses represent only OS have CUE-XXX these XX. of since XX% all slide, frontline likely but durable, with next is data to CPS less respond. reflected are pembrolizumab suggests OS, the enhance totality, of and as in In rate treatment demonstrably does with are traditionally is median substantially setting. the This to the does our in on CPS eligible which that patients Slide patients

that favorably was X.X For the the of CUE-XXX treatment, pembrolizumab KEYNOTE-XXX PFS as months the first-line trial. in months with in patients X.X treated compares of median observed the PFS median pebrolizumab arm of to

and and monotherapy, are treatment substantially respectively. high observed in PD-LX evident than continue OS combination historical pembrolizumab the greater These the OS than looking XX-month which XX% with OS expression, patients when data to were as equal is where to better OS particularly XX.X the median on and of shown both survival metrics, XX.X treated XX. in followed, Importantly, patients of months with CPS and with months, the at or with notable median XX-month XX% Slide enhanced be low X

Consistent and these patients patients with CUE-XXX survival. low and In PD-LX with with metrics patients are in demonstrating expression of the enhanced observed pembrolizumab, low favorable with CPS treated ORR treated in OS KEYNOTE-XXX XX-month months the notable XX% median of is importantly values the in XX.X the observed pembrolizumab, study. given XX% for months and OS historical XX.X pembrolizumab of of the CUE-XXX

with XXX% pembrolizumab that greater to has high XX-month of months, OS XX% and XX, been treated CPS XX.X yet a patients to to of benefit The in and median CUE-XXX is also with reached not noteworthy the historical OS patients respectively. compared values equal CPS than with and or

these CUE-XXX slide, following the from As demonstrated second-line in we in prolongation following appear data to the as survival shown significant be the where a monotherapy combination observed maturing reminder, of Slide what XX. plus setting, trial

the a X median remarkable those CUE-XXX The is to OS survival at inhibitors, these respectively. when of tumor-specific by observed with of for where OS in nivolumab mediated the to We targeted of survival and checkpoint this X.X and line expansion enhancement dose monotherapy As months observed treated with months at observed shown CUE-XXX was mg/kg. OS left, in median months on compared the for and patients were be median XX.X X.X believe XX.X second the and the in CUE-XXX. treated with by mg/kg cells T pembrolizumab, patients durable X selective of observed

number inhibition our of to and patients In CUE-XXX substantially improved benefiting survival suggests totality, these have increases appears data patients. checkpoint that in the from

in treatment look update an November. We SITC and as carefully at to the forward monitor and follow-up remaining in as continue follow on to survival patients well providing

to and CUE-XXX to to a date, we what and observations to of over competitive enhancement to position and substantial favorable continues believe appears care. the place the a implication of become mature time, The will survival pertaining by be CUE-XXX standard new and particularly data a potentially series

CUE-XXX tolerated on DLTs to ovarian and being well pancreatic, in is program, the been including to been date no expressing gastric CUE-XXX have WTX which colon, tumors, cancers, Moving observed. and with explored patients has

have dose-dependent on active and X WTX T expansion treated emerging Patients and X and remain treatment mg/kg specific and shows expansion at all indications increases in Preliminary data activation been or cells. an dose in exposure of of the follow-up.

observed cancer. As several and well we and pancreatic types, previously disease antitumor durable in gastric look continue control ovarian in tumor mature, SITC presenting we've patients activity These reported, to forward to as at including as data data in November. updated

With that, I will back call now turn over Dan. Dan? to the

Daniel Passeri

Yes. Thanks, Matteo.

we disease. autoimmune selectively T treatment. and what a be approach Slide to update progress make this both autoimmune call slide, superior cells conveyed significant to believe therapeutic XX, the in we and disease and oncology the to next across both programs targeted ability We've As platform throughout on our modulate with demonstrated continue providing in shown oncology

these CUE-XXX We continue to approach believe potential what from We a resulting our anticancer particularly premise tumor-specific strengthen lead is meaningful of to X the data supported providing effect expanding data cells, CUE-XXX observations new support survival. to standard generate and will T a our and ongoing bolster highly survival be to generation our and oncology programs, believe activating remarkable data pertaining by durable the continue and care the as in and position appears that enhancement. enhanced selectively

battle of as of believe standard care the well establishing a we the have in against autoimmune We new potential cancer disease. as

clinic selection to our mature, capital to CUE-XXX our CUE-XXX, recently and towards in we measures milestones and enhance programs, as capacity. enhance and continue resource ONO our well partnering deployment prioritize to extend development near-term our for in to runway for as advancement with further positioning the partnership strategic data lead focus our oncology as Importantly, have autoimmune taken upon near-term including

year. proactive right has with our we've runway our potential cash to cash milestone market As from sponsored the with autoimmune a multibillion-dollar further as various equivalent supports. $XX per reduce extended CUE-XXX, our to operational million upfront importantly, reduced burn application full-time partnering year approximately million position taken, our multiple $XX we going forward mid-XXXX, approximately and diseases payments which retained potential. co-development as to have will Through And per burn reminder, enhance through requirements cash measures a co-marketing to additional well XX%

means we we'll and partnerships operational measures, continuity these through increasingly of support. be other capable Through believe sustaining of

risk-reducing towards maturing we of the of a combined believe programs, and milestones with ongoing result positioned we approach our value-driving across continue with to well restore cancer of immune we're new our a progress realize as these of As both with balance. the autoimmune upcoming measures, data very by disease our and to for standard treating a care goal establishing health restoring series

With that, to up questions. to the I'd now Operator? like open call

Operator

will Instructions] from [Operator first with come Stephen Stifel. And question Willey the

Stephen Willey

Anish this also you the I positivity you know what's capacity point at speak of of and the what just just correlated age. was population? Dan, to or could wondering traffic know And if it's maybe CUE-XXX. CMV your to then X estimate general in about

think versus base what context lower be in I to you just and whether on males this estimate positivity females. would wondering screen the in it your need of would be dose CMV for a trial. tends But of general to kind of escalation

Anish Suri

Yes.

other So CUE-XXX But with we well. both and SARS-CoV-X an Steve, to EPB CMV and viral have very [ molecules made presented. make we the questions, just good is Steve. epitopes as ] example point,

of for our presented case this particular point obvious been anywhere donors mankind, XXX% the experience, screened SARS have So positive we've to CMV history time In around with in SARS-CoV-X XX%. at the In case virtually XX% in of CMV. we reasons. for a when seropositivity

to are a and well where Ploegh Immuno-PET in recognize tissue as used are series, with that T methods can Steve, in point back, and hold to to bound had the an directly by for able in engage have we the Hidde we we these Immuno-STATs true the paper years penetrate the nature cells, published believe tumor infectious be make with engagement molecules. imaging extravasation Immuno-STATs relevant should we solid could studies, general, local as pieces trafficking, several doing model the the that same antigen-specific vivo XXX but you From and now essentially where

Stephen Willey

just then And helpful. question. Okay. That's CUE-XXX a maybe

kind allowing of data in of the neck understand mature. I survival pausing of But I that frontline that now be XX and increasing for monotherapy, are what right capable So things of you the primarily, obviously as the context head pembro the guys to and guess and to LEAP now data. think subject debate function a I appears of I some is guess,

you survival strategic if more attract curious could mature just a statistics interest. So help think

far And terms conversations parties just capable anything historically curious if that of? interested is you monotherapy about what share of in terms of can with they're thus the thinking potentially had you've how pembro in

Daniel Passeri

Dan. Thanks, Sure. This is Steve.

looks know we've Phase how important We've we healthy had So we've the question. at dialogue I partners sets that potential the randomized emphasize it's that's of comment look of reasons When that with patients. the an data, we the mean for monotherapy we historically. so on one by biased multiple II. had data haven't had they data the selecting the the promising strategy And that do actually

cetera, important different response. data what's in of landscape at of inhibitors, here survival competing an we position this triggering kinase with in advantage in you advantage think I really CUE terms and of a differentiate a et the durability is the really competitive truly and when think immune look the space, molecules,

as it to survival mature. that continues So data

monotherapy in what think impressive. very is we've seen I

the to we're appears be that's think combination positive following emerge the long in going run. with be What to just And seeing suit. I

important I agent. ultimately, and basically And an XXX. study dialogue you're directly a do ongoing on it a watched. going it pembro companies is think against topic, But randomized convincing is far because more being single have with is we as

Operator

question Reni with Citizens next JMP. will The from come Benjamin

Reni Benjamin

question mentioned sort first the be I kind landscape study? developing on provide update of results that KEYTRUDA about combination XXX follow-up kind from data the in the these ASCO provocative well, of don't at others landscape. current to comments, And in in an the KEYTRUDA update was would you and saw some for to and -- the given combination think I in guess as the neoadjuvant a in a thanks on it with as that, given we monotherapy. the also space. And any in of how curious, So my just can of earlier Merck think are I'm the particular,

Daniel Passeri

why don't Matteo, take Sure. that question? you

Matteo Levisetti

Yes. the survival And XX-month, -- prior this like early underscores LEAP-XXX looking at specifically really think okay, a data median survival just follow trial No, Again, metrics, on I and question. it the OS the of to matures. up will. again, the I from also as importance

so at patients look And look the okay? at mono LEAP-XXX, survival is set is high, at the Okay. you CPS look the XXX% combination data, If And XX actually pembro of data CUE-XXX we if XX% you at XX%, from XX-month it's our are current XX-month survival alive months. if

to so to that with guess, at data and shared look the the to And ]. to the regards really Again, with, landscape particular, compound they now regards have of it's pertuzumab I in with Merck's important [ question evolving months put mg their we're almost in -- second-line XX.X With and even okay? beyond, cohort. And survival and CUE-XXX setting survival, okay? at X X so currently XX the the mono, per months a XX.X they months, kg reported in to of

immunotherapy. survival this clinical defined monotherapy, is in okay, of the have benefit about as now with response So they we And Their fully line in although a patterns is again, XX%. reported half X%. plus, rate well consistent of rate response of long, a observed where as second been that CUE

approval. look uveal we KIMMTRAK, survival but response approved for recently melanoma, really benefit rate, to if modest its a So at led clear

reported now patients very only frontline they on data. minimal treated with -- actually at data very ] follow-up. pertuzumab were that about in preliminary some half [ reported to They setting, back of ASCO the the so And --

follow-up, if at So with swimmer looked X you a the months. plot follow-up, median the about

And at XX-month would have are both use I before, here and OS we OS as I again, and clearly mature. to that needs data caution just established. metrics, the So maturing mentioned median

immune for data, it to up expansion pathways, real what to that's of one forward So tumor the pathways, inducing with inhibitors and a see T pertuzumab]. And be will hypothesize and which durable they're engaging of we'll perhaps different the bypass could population. pop of hence, advantages similar going inevitably and [ have anti system cell happens these

Reni Benjamin

Got it. And just...

Matteo Levisetti

about was one the am I And Ren, recall. sorry, if adjuvant, I question there other new

is enrollment of tissue investigators and and this have that have we're intent are seen high-level publication Again, two treatment. submitting getting are in completing looks Schedule this at very study pre- so University preliminary And journal. Washington XXX, doses B, close well. The that to is -- progressing getting post- know where very of very really, in encouraging. The think, investigators the a -- data I for we've I the patients

this proceed. And public choose depends become shared to they so really and when will on how

Reni Benjamin

of the How you Got final of question and position see Can that kind us from milestone of on cash your unfolding? payments gap it. like. maybe the between bridging just And current selection do maybe how now then lead and like. on you funding a the plan kind help kind expected opt-in the understand ONO you versus initial and of candidates and

Daniel Passeri

go have Ren. important looking one I want emphasize, dynamic were One Yes. very The an we question. prudent and deliberate way. that very has financing. in terms cost to we chosen chosen It's of at been a capital -- compressed to question not historically biotech and in basically dilutive do Dan. This a is small-cap to massively not the we valuations. as have out Thanks, sector thing of basically with and the do thing

taken design. with -- a high-quality business a development, data supporting closely we'll have getting we a they're actually kind They're then us. we working resulted with subsidizing our with time, nice milestones. there. Even we very helping into one of They're lead candidate model going that opt-in that body really look partnered forward clinic, a moving with back ONO. XXX it scientists. basically if now, have all objective in at was XX% the preclinical over of XX% opt-in, to good right a we've that, of a And has looks And really have where that the at are programs So our the program receive select the

So They the milestones that development triggered. get program. if subsidize of help those

upfront. an to objective have companies, several discussions with transaction We a late-stage there in the have is we consummate XXX where

support with milestones of have be rate program. with selection, going additional filing. really the continuity. that our milestones committed of IND are give important We a to That overlapped beginning then burn obviously, ONO are reduces milestones to that Those and candidate our series scientists us to basically lead

on data So burn mature enabling II going reducing XXX to prudent a basically we're what term, for Phase in very the about supplement. the partnering and being taken into costly we've without measures focusing just on near focusing XXX to our

of runway milestones help these manner. sort tiered extend So the a in

going to, any key. And need raise So capital keep if cost to modest trying of to it's we're minimum ultimately, further going robustness do a to stock cost milestones, we but some And where positioning. clinical, ultimately, down need further do to we as what demonstrate not onerous. if now be want develop of is point capital of we the to is because in and really capital our at to we're a do, dilution isn't when sure competitive future amount, hit the valuation right pipeline, the these a is healthier

it's have a a analysis. And answer, hope that's met up, lot building very we at but capital. balanced that's basically I of coming moving a I options manner parts prudent model, of and a basically a but dynamic triggered by So cost it's clear business here, of based raising these pragmatic with a sort in capital looking of milestones stream being on in having capital why

Operator

will Maury with from come question Jefferies. Raycroft Next

Maurice Raycroft

I on will ask series. Congrats on one the CUE-XXX the update, data

could key next for enhance potential about this the can help to buy-in or for you feedback options got development investigator it steps CUE-XXX, you if partnering. clinical BD for to more even look or regulator position define program like? Would what For path plans talk

Daniel Passeri

question. important Very Yes.

the obviously, think partnership on autoimmune ONO of space. sort enhanced the our insight I has

preclinical to of a very pharma differentiated the stages -- a being attractive on with was been CDX, now. XXX, favorably CDXX highly that is basically various have compares It's able what based of data the very bispecifics, on is, intent progression. diligence We in on with just discussions set biologic a molecules. We've sort several attractive partners asset. we right do potential based confident have the and that's what lupus, with CAR-T mirrors that feedback We're

off a partner partnered a for obviously engage series to dialogue retain We'd or look of as cells, that preserve with us an molecule, focus sort of means sort mass upside those presents a of data of where strategic going think for on in development. until we a we're in we're important in number dialogue program, for I that types. set term. indications the indications. But the partnering we -- hold with of to eosinophils subsidizing control that, from what like near to to And terms and a So on partner the able and of in instance, at cell opportunity assets we to think aim cell type, of something a also indications

I So question, hope answers Maury. that your

Maurice Raycroft

this at to financial as really negotiate Yes, follow-up and I any the well. milestones that you've Or for ONO helpful. guess that a far? Yes. is try there generated on do opt-in on just potentially room based make accelerate would to side sense maybe so potential it to point? opt-in, the the And or not data

Daniel Passeri

right They've outstandingly to next We've Yes. make are. The on it really making -- has productive. sense partnership I think the try of an don't supportive actually to really it steps modify And been what extremely would been we're kind partner. good progress. aligned been we're now.

much things very we're think I So from perspective. similar a seeing

Operator

with will come Oppenheimer. from question Leland Next Gershell

Leland Gershell

in us present have to indications that prioritize respect assets? are be you to to those studies your there good Maybe preclinical XXX, process looking the with the looks -- you data just thought XXX of for data guide to for few might doing Anish. what set for of or both I and that you're for here we that you, particular base you know nonclinical next a that might that be wanted may It like any Dan have might a and

Anish Suri

Yes. is this Anish. Thanks, Leland,

data is seizing So which due the reversing to collaboratively or in inflammatory XXX generates and to along does efficacy with mentioned, that exciting in in for amounts what and of programs cells generate signatures several domain. molecule we collectively and autoimmune I've halting for and both of pathologies. with a T continue copious seen related sort processes, models. pretty regulatory activity And In data total, cytokine collaboration seem minimizing production time, in autoimmunity release with ONO, disease we have where will public that the in obviously, reflect

of in of the and start sort dosing, of we have process some again, we release that For -- to XXX, we're hope we B-cell relationship the experiments. in depletion models between characterizing vivo understanding as are that And now. further

in the both to year this go through emerge. they about continue to able this are programs, intentions talk we as sets So -- to be these data as

Operator

come Our Piper with Ted Tenthoff [Operator will Sandler. Instructions] next from question

Edward Tenthoff

is investors targeting potential disease. the cell autoimmune on something is from CDXX XXX, To the How that to blade from therapies safety sort Immuno-STAT profile of differentiating on. and that much safety, generated platform you've for focused to evolving the the B-cells that -- the XXX are of world

Anish Suri

Ted, tried but Simply, of you And look immuno-STAT we We've in or XXX and series think of XXX with to derisking trials up positive XXX, of again, years. tolerability vulnerability man, an the relevant and drug implication very immunogenicity, we enormous I know, general, even to you believe, with XXX in XXX. shown metrics well Yes, the at that, have depletion. we've as B-cell the I X receiving of what stress series clinical any good from has had if clinically immunogenicity, seen patients not question. XXX

framework. speaks So engagement via the TCR that of to nature selective again, this

also -- we of the based which your is a repertoire fact virtue approaches, old pan small bombing you're T second peripheral engages, T anti-CDX with believe in cell should superior co-opting to cells not The very and offer fact we the of the carpet that that as cell only and individual percentage by tolerability refer safety metrics. T an

as cytokine molecules was this we pan release opposed you in that shows And very some this to production but reduced CUE-XXX it killing of of of evident profound T did despite cytokines B-cells. of the vitro that is where fact CUE-XXX, saw efficacy cell that by of significantly assessment metrics engager from comparable

also cells that us we're time think have through sort I through reemphasize of should the born of antiviral important. And the us harbored memory we fact from protective nature, thirdly, is immunity. provide something So all that T quite your that's our life to

that compared what So cells no T offer. killer population as better cell one other T to there's long-lasting harvest

kill So we them cells. able think to being targets as redirect do B such to

very for potential really has exciting of nature a already the individual. harnessing avenue given provides it the So what

Edward Tenthoff

obviously, the with we're And very manufacturing different seeing great. approach a what T-cell.. Very autologous than CAR

Anish Suri

That's right. exactly right. That's exactly

product. So is shelf with which biologics. stability seen at what similar point. for important we've a manufacturability XXX, add liter in The what grams clinically yielded per antibody-based XXX, just of yields exactly products Immuno-STAT, the are to very are to very great have that, good seen the with in with That's GMP we've stages line

Operator

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

Daniel Passeri

the you listening want look We to for continued everyone keeping forward and you. just interest in with in, we forward. make going we thank Thank progress, our updated your to progress

take So much very you thank and care.

Operator

you The for presentation. conference today's has now concluded. attending Thank

disconnect. You now may

Cue Biopharma (CUE) 19 Aug 242024 Q2 Earnings call transcript