CUE - Earnings call transcript Q4 2023

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Operator

Greetings and welcome to the Cue Biopharma Investor Update Call. [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 may begin now.

Daniel Passeri

right. All good and everyone. afternoon, you, Thank

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

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

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

Okay.

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Anish Suri

Good platform and afternoon brief autoimmune our treating listening our of on call. of today's cancers Dan. to a the in and summary diseases. all for provide Thanks, potential therapeutics significant I'll

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Matteo Levisetti

a continues multiple not treated in newly clinical only Anish. outcomes Thanks, and CUE-XXX and guidance for diagnosed a for highly with today's series you the everyone listening of demonstrated cancer the robust also to we FDA, with HPV+ aligned end and ongoing data in forward a of benefit patient trial metastatic defined for cancer metrics but CUE-XXX or forward, metastatic the cancers. The breakthrough opportunity on the had demonstrate meeting with clinical recurrent with data summary the recurrent treated from pembrolizumab improving as received trial patients heavily have recent of call. I an to achieved the on monotherapy. combination of Phase head across Good neck potential head path CUE-XXX. we to pleased pretreated milestones registration afternoon believe and have Type encouraging and we I the am recently for registration where We with and provide B as path with to clinical important patients developmental neck update particularly

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inhibition, expand and this expanding therapeutic As complements and We mechanism just T platform patient benefit reach that demonstrated represents short, thus the a benefit our immunotherapy. in by chart. as conveyed, of towards number we to the has the believe cells of enhancing enhancing expand platform therapeutic selectively of patients ability tumor-specific benefit. In significantly of potential the the to our the targeted checkpoint believe CUE-XXX major and full realizing patient magnitude of activate reach increasing potential that breakthrough

early across will further Anish. are both forward observations in ASCO have programs monotherapy, CUE-XXX additional checkpoint call now of over largely activity multiple look by at We indications encouraged inhibitors I presenting June. to on antitumor to ineffective. turn data the been the where We Anish?

Anish Suri

Thanks, Matteo.

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depletion. that modalities, In of or very cells to disease. In the a contrast cells propagating memory potential B-cell long-lasting drive This to threat With achieve exploiting offers avoiding the real and CUE-XXX modalities. turn with call CAR-T-like and antiviral both the addition, selectively applications I'll on off-the-shelf potential efficacy, to these the activating while elegant overview T CUE-XXX may details. financial an they T series offers autoimmune their post CUE-XXX the reactive in Kerri? therefore, exacerbate and for therapy associated that disorders, further approach, to pitfalls underlying immune cell review solution the to the Kerri

Kerri-Ann Millar

Thanks, Anish.

to X XXXX. full results for brief on Slide Turning months XX, the financial like year XX. our ended to provide a and I'd update December

Revenue to The was and quarter CUE-XXX, reported of development due $XXX,XXX and which for approximately primarily For in related expenses option $XX.X the XX, million $XX.X in Pharmaceuticals administrative XXXX, ONO collaboration Research projects that to of months million million was due an XX, the with to for executed quarter were in XXXX, for The first was consulting due compared were for and time. to December $X.X work expenses XXXX, agreement manufacturing professional CUE-XXX substance period CUE-XXX the and was drug respectively. for million XX, and during fourth primarily collaboration the increase XXXX. General and revenue primarily December December respectively. and completed as same in decrease $X.X were to X months the ended in million fees the XXXX. ended and X and X the ended XXXX, this company the $X.X XXXX. XXXX, increase months

XXXX, General ended billion The ended approximately respectively. was the decreases and $XX.X million and expenses, by respectively. agreement for laboratory in ended XX.X And our approximately collaboration due revenue clinical of at were million the as administrative research the XX, offset increase XXXX, XXXX, ONO working development $XX.X collaboration and strategic December million shares December expense. increase million and and XX, in December of relatively million with Pharmaceutical. Research cash and and in from For $X.X XX, primarily costs and capital which was had December XXXX, earned XX, and the the the company company XXXX, to cash equivalents, development for expenses $X.X costs rent $XX.X expenses years $XX.X the and million partially remained revenue and years flat $XX.X outstanding. reported $XX.X million XXXX, XXXX, million and employee years common effectively, were due and

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

Daniel Passeri

Kerri. Thanks, Yes.

for date a disease potential oncology generated activation just tolerated reinforce cancer-relevant and manner. We platform of qualitatively antitumor data in and have have our autoimmune with data CUE-XXX by oncology body T believe distinctive manner. in signs to you premise in and and CUE-XXX support central both and system patient's checkpoint belief tremendous and activity clear autoimmune we've cells data immunotherapy heard, As clearly of preclinical growing demonstrated to transform holds both immune with selective inhibitors. CDX-positive targeted modulating mechanistic Cue's with our targeted expansion selectively Furthermore, in disease cancer and these demonstrate a that to the complementarity highly the and clinical and durable the firm continues

that are we're the treating to their has after Let to locations also me prior metastatic. not patients recurred but resistant spread only remind has That is primary treatment. multiple everyone and listening in is cancer therapy that refractory

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randomized patients, underscore potential application XX of far-reaching interim establish XX tumors care checkpoint has of to inhibitor plus response choice expect CUE-XXX and checkpoint frontline of both our analysis the enhancing and have and carcinoma large combinations range implications checkpoint historically in strength and to new in median analysis broad where in Immuno-STAT standard enhancing survival segments to of rate place checkpoint We partner Cue as CUE-XXX between XX for but also and reach months, readout per a a of positions which clinical of patient neck platform inhibitors in expanding and metastatic progression-free a breakthrough approval. Phase solid expansion indication leverage checkpoint by cancers. overall a benefits, achieve these patient benefits inhibitor the with with and months, clinical Successful se, inhibitors position inhibitors for squamous cell failed II would head franchises. Furthermore, for refractory at

autoimmune Treg advantages of we data and the potential being B-cell-driven potential with with B-cell disease mechanistic of for Ono generated also disruptive induction near-term retained XX% have partnered with X our interest We such body the lupus. for namely which programs, ablation for the currently supportive a option And potentially to with CUE-XXX realized. of milestones in CUE-XXX autoimmune of highly as market biologic have displace an a a CAR-T for U.S.

and As our have to conveyed the the and the we've rate, strategic in date, Cue programs, median proof-of-concept establishment potential oncology demonstrated with and the with ongoing we development and these in Resulting and the generated revitalize that to indications. checkpoint U.S. Through meaningful business survival novel have data, response promise clinical progression-free the #XX, X quarter and significant lead overall pharmaceutical have global we and well significant and and modularity application platform demonstrated also scalability. Through made address paradigm our that treatment and the competitive for we corporate we've to platform, some shift having potential our increase have positioning and to initiatives. our developments, over autoimmune the in potential enhance clinical of reach have development this progress survival. solid scalability, largest market whereby the in with the next of sector modularity past markets multiple tumors, overall positioned the slide, of inhibitor for applications disease

I'd respect our trials, and we continued participated most continued and for in Directors, ongoing prospective clinical are for questions. in open enhancing of clinical and committed engaging and discourse who we're highly the transactions us of passionate requisite capital their like diseases. extend our in towards on our I'd these And cancer to to call With Board, to other over strategic a enabling development that, or partners. extend profound the consummating strategic to be up and presently these the to corporate -- like like guidance operator debilitating patients our employees, enabling would Scientific for against in and investigators successful essential we'll their confident have gain enabling trust. thanks shareholders, Operator? We fight the realization our families strategic mission. On to multiple and with the support, partners capacity Board collaboration ongoing Based of knowledge more insights timely discussions, our for our alignment, or sincere manner, access to now importantly, appreciation to back Advisory that, to turn continued and progress appreciation one we

Operator

Instructions]. [Operator

comes from from first Maury Jefferies. question Your Raycroft

Maurice Raycroft

the progress. was you overall about a rate, combo if ask first that talk about the I And III? to randomized registrational would anticipate successful on you into in many to how you're Phase interim you'll study. that you advance II Congrats need Phase patients going Can arm? on response allow each on

Daniel Passeri

Matteo, you to want Maury. question? Sure. take that Thanks, do

Matteo Levisetti

Yes, certainly.

the regarding be arm. And patients per trial, serve sample proceed XXX safety the bit fair although interim then provide patient entire have a XX final done analysis, results recommendation is substrate continue the analysis, trial to we'll to a one for at trial the size recommendation protocol XX for the the less if as first So provides a interim really trial patients, to and it's XX the data to analysis registrational trial, first at everything this that could the will so looks at XX given would interim startup months, good, that positive randomized forward. first the approximately that board into a a to and is once of be look planned a months monitoring that than move

Maurice Raycroft

and Can That's it it. helpful. Phase a could to the Phase partnering. Dan, the economic then would Would And III? Got running look be II clarify you And potential look from as like talked development you you're stage before or partnership about what potential what standpoint? partner? you potentially

Daniel Passeri

that Sure. consider. we at number Very looking one important of to question. really that. no factors And will a and there's Maury, a as question you know, that answer dynamic It's it's

across let's So asset to parties enhance the just the pertaining requisite we're promise be have classes own discussions, key -- think is with insight the want appropriate an that I we and support. We CUE-XXX, sort say, to on identifying various presently requisite our economics so much capacity disease party in the there with on CUE-XXX, of those certainly indication assets. provide up of of the can giving the sort don't of multiple too

economics be would in in Phase sort downstream. the really we based our So particularly the randomized continued have to going II, on of the of type involvement, it's support

parties, in we're decision. structures to we'll And and ultimately, at make with different economic that Board various So be it's discussions looking decision. a

an and structure use basis They've on ultimately, the we in would make of autoimmune, ongoing of just They're partnership with analysis. So outstanding the scenarios same the actually regarding favorable. basically subsidizing as very an dynamic accordingly. And I The example. and we've development. an decision dialogue with of ONO was partner Board sort been asset. an early present that various will been type

stages upside option upon particularly the we upside a subsidized. sort XX% of early is And of well, partnership, the as risk IND-enabling clinical selection the us in candidate we've studies. to begin very shareholders retained interactive being preserve our allows sort capital, for a optimal have that We when of but

answers options the question, based manner front on looking in a various us. have So I at in hope your that of we we'll but dynamic be it

Maurice Raycroft

the the it -- you be That's be one And Series program. about XXX partnering series, it. at this too. talked with a program, can How helpful. think you're Would potentially asset? for this little one, that? you part where bit XXX you of about that would And from would talk XXX about be this for platform? Got development Or would wondering more preclinical just if it

Anish Suri

Anish this niche. What we scaffold tested evidence have Yes, that is see. across clear active, different to T you is and Maury, this memory biologically make been of number is specificity. we've so can as We've this far a able cell

the very at SARS-CoVX or from present that protein point So conserved cells, there's specific it's of a in highly T whether in the by vaccination is natural CMV but us, being should this infection. in today of also a virtually which have one majority world us spike epitope time, all

into strongly about tumors of mean, think TropX, and very tumor you that can I the cetera. a you substrate use can setting, to is a redirect types. I about beyond swap provides extend destroying et where good, think cell we nicely B cells think cells pathogenic think but concept pathogenic to which extending to actually down that just about Maury, B think to oncology cells solid essentially antigen. it these this the to also and road. with very just the great the PSMA, think about cell We also initially [indiscernible] into something other B So pandemic out started HERX, the CDXX, surface particularly

think I vast for there's So this. potential a

been parties in the was really interest and like demonstrated studies started efficacy of has been have small [ extraordinary getting talking, As interested in what companies an recently additional amount these ] from in inbound autoimmunity. that we CAR-T in interest actually

has stressed -- actually The the is scaffold the of same. no sort I a good the of So made and by anchoring remains XXX core obviously much IL-X. position, we've [indiscernible] is very and It's starting peptide as the the SCF. Instead that's that, that. [indiscernible] progress. mods derisked that and why HLA component

a again, the the series, learnings XXX good that lot there's series. of XXX XXX, of beneficially XXX impact sort from So

Operator

question Willey comes Stephen from Stifel. from next Your

Stephen Willey

for the Can into And I you having contemplating, that Phase background Phase the CUE-XXX maybe II noise. apologize just you're a maybe more speak to randomized just including But questions. second dose of couple the then II? can interim of And have analysis? I then a specific some of the triggers to what of you as Is also follow-up? given just that just speak another question. kind beyond patients number duration out

Daniel Passeri

Matteo? Okay.

Matteo Levisetti

-- So questions. very I good can

examining that And we doses in XX kilogram we've X-milligram close the are anticipate that so the dose certainly really now patients per response XX%. studied to of with objective rate

the other the haven't We of dose. selection finalized

as experience that observed in escalation response. mg actually X a kilogram quite of with very X at patients of a then survival. extended set We patients. see of have we per in pembrolizumab, the profound, However, per And durable dose we kg with also X objective milligrams very a bit monotherapy. We're pronounced

a cycle design can final very will likely determined rate. That which, monotherapy primary we've really trial to data doses. really have overall again, X rate X a the very that follow-up regards then have we per analysis start cycle forward and for the to for XX% to X would okay? response scan, this to will for anticipate III. be X we've for be get answer trial. XXX of And analysis, X their having we then that a the cycle date is SMB analysis the And up of to it dose, very when of we'd to once, wait PFS hold first the So what to to observe be the analysis to sure it's what activity through approximately supplemental I observe follow-up way valuable Phase interim historical of based final per really to because that on now be point, kg look to then think yields data as the gotten that OS patients through complete Phase X XX% observed would at your the to in there that brought also have patients don't of mg and anticipate scan. make III XX% patients your with the but the the seen then be assessment to the strong the that analysis mgs ultimately progress gotten well. With of So can all set that believe or initiation triggering that, allows kg we I and Certainly, that as where will XX% mentioned, it's

Stephen Willey

to talk seamless? II about do were in of bit what trying Okay. Can as you adaptive you out you guess, about consideration versus informed strategic carving extent, I to And kind of that's a Phase more forward that answering that, II/III helpful. and kind maybe an speak I little can just if path thought something the these this Phase by guess any, to, was ongoing maybe under discussions? of pushes independent of randomized some pulls kind

Matteo Levisetti

is So to question. good the certainly, And design. of with II/III go seamless further an a Phase combination a develop sort very option to

Phase of as become, the effect dose the to has a mandate randomized have then think, lead Optimus select and sort III go I in component The to to with a X of into common your first gone or directive quite since that, into portion. is this doses and has a Project

no multiple considerations. Phase dose the Phase And opportunity design, I a that will, of Phase also data initiation think, The trial. gives have, the confirmatory Phase there's being endeavor of would increase bit III, is at to then lead confidence analysis a and investment, components opportunity So to -- there's therefore, ultimately offers where simpler and confirms actually a in in time, is And the you III quite in I the II think generate go that year really to Phase larger the if a clearly. successful is that the into II/III to in takes least to do. which one's III in,

Stephen Willey

from away years of couple around the do a was as the you a that And pembro but II, that expectation had your presented I if maybe even in survival influences think then like? what number the to just quick was And context from know just number look recently just of Phase still you study, that we're I registrational thoughts wondering [indiscernible] a Matteo, might survival trial. any how Okay. follow-up. one

Matteo Levisetti

Yes.

think, a rate me. objective explanation. it's a of So I a the well, I'm response was that or that know that a to bit aware surprise heard I've mystery clear don't of a I opposed as historical XX%. Also of XX% rate to

anticipated. than the So do did -- trial that so to arm appear in better

combination again, I monotherapy Phase doing gain to value effect. is trial with XXx Phase the we track with regards the just investment the it then really effect believe what think, engaging II registrational into to III that X supports current treatment we're a a before almost confidence the to on of to

on array your checkpoint But I I Conference Neck in was of don't really explanation. or Arizona, my to the and the have the conceptions one when broad there's this part. But a conjecture some ideas the whole I on was effects with again, So hope to head and neck in hope with question. regards again, negative immunotherapy sort there kinase question. that bit coverage think think may -- and to of an the quite at seems lenvatinib no But that I of inhibitor. experts response I addresses Head that addresses again, The that's -- presented discussion have and

Operator

comes Reni from JMP. question Your from next Benjamin

Reni Benjamin

progress. data to give Can think mentioned just the ASCO XXX. of some I us that coming on and I Congrats you Matteo, out as XXX I sense there largely what you we was -- mean I'm just a for there. data XXX, about for of Correct many if follow-up the then kind think studies, and patients how XXX worth longer-term expecting? of should be follow-up. And me it's wrong both

Matteo Levisetti

certainly. Yes,

selected follow-up. an can to, to XX share analysis will June. you for with So set ASCO of the CUE-XXX alluded It on longer at here oral actually I comprehensive as our all that data been delighted a data in we're presentation have be,

at With out X selected or as was some now to which follow-up on data to patients a approximately also for months. XX poster having we the ASCO, long CUE-XXX, with more anticipate as as presentation regards

Reni Benjamin

as back Terrific. And you're that the and going then partnerships to of -- evaluating. strategic things just sort

of paying that a XXX I in let's about just you investors that how you move the potentially the ] you which to acquisition to. are a more allows think to that provides [ fund, wrapping potential nice guess, attention autoimmune As type thinking are kind as a up way upfront and presenting and forward, about a programs, XXX lot say, significant

to be seeing strategic by XXX data. very with clearly forward? cell the that well. You're therapy trying How making moving while seem do kind a enamored autoimmune the both to XXX as of money you can in find that space take They move and spending own that that your versus you decision

Daniel Passeri

in particularly, think, Yes, and markets capital in a question really the in I Probing Reni, oncology. current Dan. important headwinds this is one, the

in the I insight strategic think into oncology prudent a I it's with, the question think, clearly challenges sector.

more thinking capital requirement capital more would and So current be looking data. in the that but we mature value have increasing favor our autoimmune dynamic. It in for frame for markets, the that hasn't shareholders we much evaded probably are deeper at time of the

registrational the for would upside be our able to shareholders. a retain has to competencies think align with for that a the for key oncology to and company be is through much path get to and capacity I us So as objective the

upon alignment a substantial the discrete by we've with capital if confidence parties. repeats companies structure a was very with seen to that's very Phase finding we can Matteo a decision defined A part going the pharma And address oncology do ultimately of decide we're And are Phase our of how value. way, having that to to the amount the attractive, rationale which that a that path. of and as B. -- with confidence articulated the where data calculus we as number randomized randomized of for and deep be degree add of do the also registration the part that requirements, So pretty is up patients, our II think goes in I what strategic dramatically to And analysis, I are in

and question, we and important of part very determines analysis path a what overall calculus is it's chose. ultimately it our that the So

Reni Benjamin

I it. autoimmune side. for on guess me one Got final the question

confused bit targeting to upcoming completely preclinical see at this cells but all conferences any are that imagine there. might some are cells data can And bit proportion, as a of B deplete On T all better? a the the I one CMV hand, of we may help Anish kind it, understand can I'm little how this little be some can year? when me that

Anish Suri

Ren. Yes,

T the out B-cell anchoring CDXX circulation. deflation mediated at So in the is of cell an on essentially every that's simply depletion B-cell because least

the T infected virally presenting into when CMV the cell the peptide So displaying effective stat the for binds mechanism. HLA, immuno it simply and cell cell, the that's for surrogate B-cell as CMV goes to a the a

the effective dependent on on not virus specific this for Ren, ability One of the application, reasons much to is respond co-stimulation. is we their that because focus of rapidly and the memory compartment one

importantly, in We in body these in the memory the know decades they're of exhausted. from a frequencies you large had population. that can majority longer-lasting not of they're rapidly for high repertoire. present recall now a actually terms And So literature of we've that

those -- make together as that for gave strong population. for the of long-lasting what harnessing really case a sort nature things you So nature of killer selective

from could to you a chooses achieve You one mean and if a B-cell it B-cell CDXX swap to the to something else. targeting specific market that would make and discrete just that would selective subset depletion,

remains enough, early robust the at is us. so data metrics CDXX least we've looks I with and a with was attractive And central seen. since But as proof-of-concept the that that particularly pretty with CAR-T think mechanistic optionality targeting early CDXX also

amount this to body a aim of of a at intensity likely for generating significant be midst sort the There's out are an these actually concepts is looking we organization thinking So more. either able bring meeting the autoimmune to translational in large autoimmune with to bit of part of a a meeting or data. some of

to this. year year the So in half either the be hopefully, able more next early talk maybe to of to second find about or something try

Daniel Passeri

This is Dan.

operator. have the think I Yes. lost we

Kerri-Ann Millar

a that waiting person the question we'll we're There's one Difficulty] difficulty. queue think get in try technical having I to more off. [Technical

Daniel Passeri

seem be to issue We resolve with not Okay. to technical the able the operator.

call. everyone want of to updates I -- think the And to much. I'll have X that, listening Dan, look that Matteo thank end for to everyone pleasant will available conferences presentations we and coming they appropriate [indiscernible] quarter. become want everyone over forward with I evening. data and have your care. for the coming autoimmune we attention the providing at to a afternoon coming the as and up ASCO, stated, thank presenting year. Thank I -- So data in, looking forward with you very Take over at and as we

Cue Biopharma (CUE) 8 Apr 242023 Q4 Earnings call transcript