Earnings call transcript Q4 2022

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Operator

Greetings, and welcome to the Cue Biopharma Fourth Quarter and Full Year 2022 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded.

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

Dan Passeri

Yes. afternoon, good and you, everyone. Thank

in, this As and a to available as advance be of we'll listening and the at slides are you will our a a webcast, website listening, need those Also notify reminder, on on days. for recorded XX which given aware we're you conference time. the you be just as reminder, the next slide

now today's call Suri, Officer; is Dr. the our Clinical Levisetti, a Medical Pienta, Chief our Scientific Anish on Matteo Dr. Officer; Millar, Chief Advisory Ken and me Officer. in and Dr. as role Kerri Joining Cue; Financial Chief President

at briefly investigator provide Surgical today's of observations a and trial Director our the Also is Dr. clinical to Hospital. date. Research ongoing We'll Head on She is Mass Oncologist joining in with General an and brief Sara Pai, CUE-XXX. Translational of us Cancer perspective call Neck

Pienta, adviser recently Dr. going also forward. Dr. has Biopharma to our strategies define Cue addition to to In clinical Pai clinical a become helping

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

next slide, the please. On

call. today's You'll agenda see our for

that Just noticed results, before want under that. the third not note read this fourth XXXX, just the on call. that's slide to please that financial quarter to for meant quarter. We Apologies

corporate our has various capital into our markets. We're strategic we 'XX. generated I'll and capital overview numerous development, believe well begin the of differentiated And multiple and in status stages describe current of opportunities. us a strength position opportunity positioning, Okay. representing our by of an with advantage, of places at challenges providing we'll partnering positioned update present of the competitive the despite programs which second half and platform importantly, also

in activator regulatory with strategic inducer autoimmune for for of CUE-XXX, of a broad we our As is bispecific a a into addressing entered T Ono spectrum which reminder, partnership Pharmaceuticals diseases. recently cell development the potentially

requisite transaction capital development this Importantly, XX% with subsidizing thereby funding, costs us ongoing market. co-development and retaining option U.S. program the through CUE a with provide was structured for the to research

So this was company. for transaction very the a obviously balanced

clinical reduction for data IL-X-based appears corresponding continues to the of series support us options registration the risk and clinical CUE-XXX the for to paths. validation and provide entire with defined potential CUE-XXX's importantly,

data the CUE-XXX and unmet in CUE-XXX now promising we believe medical indications. development breakthrough cancer capital transactions we're we to partnerships building date, of upside our Ono currently significant to portfolio ensure for out positioned structured multiple well potential in partnership Both pipeline retain upside seek clinical to and need therapeutics. oncology potentially address generated clinical Based addressing on across to the similarly involvement optimal our with -- access while

corporate activity in slide, demonstrated, cancer single-agent Slide it's on important therapeutic here and and as various patients CUE-XXX is are slide, this next that chemotherapies of the are competitive believe potential We late-stage in a an seen but foundational our To-date, is basically data established firmly monotherapy advantage As the inhibitors. positioning CUE-XXX X. What's to patients. series number also this represents CUE-XXX activity you refractory on breakthrough. has exemplary as checkpoint solid see a in

inhibitors. at than patients is with compared significant response date To-date, greater monotherapy dosed release XX tolerability. syndrome. inhibition least of historic we're of observing leak evidence increase, syndrome combination Favorable overall or checkpoint with that to no checkpoint with doubling the cytokine We've vascular a with

advantages. XX months, manufacturability, significant the for greater and goods of cost actually, stable to gone to-date out demonstrated favorable us has drug whereas stability gives astonishingly regulatory characteristics design Antibody-based has than

with cost. basically combination. a time saving will mono no viewing as requirement data and IND CUE-XXX based an IND-enabling authorized safety dose, Track and And We designation importantly, CUE-XXX, on and at analog significant trial approval the FDA to the Matteo both start momentarily. have for upon well from elaborate observations higher Fast as CUE-XXX toxicology the as these

of delivery cytokines believe We therapeutic activity, namely a and the series more nature's IL-X-based by nonselective and represents platform data T to enables by targeting premise, seen with our disease-relevant therapeutic the other enabling receptor harnessing a or often that the side cytokines supportive of modalities. cell We IL-X That's avoiding the targeted achievement approach such the cells. as specifically, other central for of T IL-X of Immuno-STAT cumulative index view this breakthrough the deleterious CUE-XXX as the effects through TCR specificity. indiscriminate

allows As CUE-XXX to Sara brief and our our developments, describe for generally the based over clinical Matteo observations will turn on I'm be trials, he'll provide CUE-XXX other IL-X now a by summary to ongoing same partnership then principle. the Matteo? to autoimmune us modulatory Ono. to deploy also CUE-XXX with call the and the modularity then followed emerging platform from Anish programs, a and Ken reminder, co-stimulators emphasizing beyond recent and including the our going

Matteo Levisetti

Thanks, Dan.

pembrolizumab. continues HPV neck neck clinical robust treated HPV from head in for clinical recurrent with positive cell carcinoma monotherapy squamous heavily patients and cancer positive benefit the ongoing metrics CUE-XXX and head pretreated of combination demonstrate The for patients metastatic to data diagnosed treated with trial newly and with recurrent metastatic

with derisking pembrolizumab CUE-XXX Slide with clinical combination trials the and Immuno-STAT carcinoma. in date continues observations clinical provided potential our as for latest a and to squamous head As of our The shown have generated platform. in further proof-of-concept and support monotherapy X, confidence therapeutic prior on patients in battling HPV-positive ongoing enhances data data from XXXX CUE-XXX as cell to neck in

generated targeted within the that action, subset patient's our of is disease. consistently enhances levels, HPV believe and and in demonstrable dose is cancer of these date, provides monotherapy body. and resulting evidenced effective of the incurable we positive directly metastatic tolerated T by our have data antitumor as effect. The to CUE-XXX's head selective patients, fact data cells throughout Recurrent stated, confidence neck CUE-XXX mechanism the stimulating enabling expansion the tough a previously position we T cancer-specific cells bolsters ongoing in trial As tumor-specific a in and observed targeted

Furthermore, survival believe observe survival cells expansion to enhanced We due T CUE-XXX's this the of an the action. of evolving of and is tumor-specific importantly, mechanism enhanced in given persistent pattern continue to monotherapy we trial.

treatment evidence clinically As consistent premise shown of on is Slide relevant with the pharmacokinetics any low CUE-XXX PK multiple X, of Phase at demonstrates exposure parameters, cycles immunogenicity. kilogram. dose variability supporting The milligrams inter-patient of that is no attenuation X well-behaved per pattern recommended there of the without throughout X

tumor observed results cells or cells killer with pharmacodynamic cells in consistently response in PD to natural assist NK as its a or sustained Regarding increase treatment profile, known CUE-XXX attribute NK associated positive also antitumor killing. in are a an

observed we and T a transient Importantly, in increase only regulatory cells. modest

Regarding shown observed, tumor in PD i.e., increase T in as associated and infiltrating tumor-specific of of tumor-specific patients of the and intended their middle after blood T cells cells effect, administration early as post-treatment panel, necrosis. expansion robust EX CUE-XXX, cells, paired we tumor peripheral in activation one targeted week the have T reactive an biopsies as of demonstrate

intriguing favorable HPV-positive head patterns just the to advanced described neck experiencing patients with addition are and of cancer PD PK clinical benefit. in and In

HPV six a partial response DNA reduction on demonstrated evident coincided Patient lasted the that CUE-XXX. year. and of A, cell-free of the on a weeks one the significant with partial time patient DNA undetectable for two X. initiation This to XX% experienced in tumor This approximate in of an examples response after reduction close treatment. Three most cell-free are response durable with at HPV Slide cycles shown was burden the

present to for at with the Patient treatment than approximately tumor reduction greater present time time XX% stable B, at who maintained and XX has observed on XX had weeks. X.X week the of years at remains approximately burden disease

analysis. also the which we blood expect have Notably, week has had of disappearance a this in of patient DNA an HPV pathologic of who potential may biomarker response, DNA, the recognized in for patient disease undetectable a histopathological cell-free activity increasingly this And lesion surgical suggestive HPV since cure i.e., six. of is is complete complete resection the cell-free

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recommended trend Phase mgs kilogram. plot dose of the demonstrates the compared XX at a KEYNOTE-XXX per conveys of of plot treated survival milligrams X, The patients for XX survival line eight swimmer months median X the in in to in RPXD patients the the historic ongoing our The next survival dosed X trial of second months Slide approximately survival reported the per kg of swimmer for observed of dosed slide, the pembrolizumab. overall approximately increased patients XX II

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

HPV for be positive the Our in CUE-XXX registrational and evolving a a to patients system treatment our monotherapy path immune offers to results potential premise a data support in appears data head and advanced patient's increase neck to recurrent This has and the with investigators stimulates principal that survival metastatic trial. encouraged with continues what forward cancer. meaningful

checkpoint XX% inhibition the that combination. XX% right demonstrated tumor The response enhanced for of studies demonstrated compared respectively. monotherapy for monotherapy, when aggressive As anti-PD-X X, mirroring our observed have end-of-study should preclinical the shown given in survival complementary mice complementary pembrolizumab. have and panel, HPV-positive action with survival effects and are in patients CUE-XXX bolsters this combination of Slide the we mechanisms to anti-PD-X X% and in In activity and CUE-XXX curves and of of shown mechanistic survival on model demonstration combination beliefs in and CUE-XXX survival have in treated with both

CUE-XXX by the the treated supports cells the study in kill reminder, coupled in the tumor-specific cells a cells to major XXXX body. this In immune-mediated mechanism that cells As capacity a with patients killing. T the greater Clearly, appears used increases pembrolizumab, these the data activated T with approach trial. have cancer of monotherapy the prevent number of from pathway, cancer it the combination to patient's inhibition PD-X when

on reported XX. As and last November the year SITC shown on Slide of plot waterfall in as at

of Four a of plus reduction greater. two X combination treated of II the dose the cumulative first or consecutive XX at at CUE-XXX tumor i.e., milligrams have at burden evaluable recommended experienced XX% per of demonstrating least responses, partial pembrolizumab patients kilogram Phase scans minus

low PD-X with -- tumors Notably, expression by XX. been more of in XX studies, PD-LX three than four been partial indicated or responses have rates have of as scores blockade compared less. been greater had responsive scores with as to tumors less the that exhibit has scores XX objective and higher response tumors CPS other evidenced observed CPS than CPS to by

of response the of observed rate with in pembrolizumab compares The response XX% the objective greater XX% monotherapy favorably in and date to observed overall rate than CUE-XXX KEYNOTE-XXX to study. historical with combination pembrolizumab with

look data update The data additional and providing upcoming to as first an an at as on we new cumulative patients the on on meeting. with emerging forward combination follow-up treated therapy patients these well continues oncology data XX strengthen, to

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

and both with in the we patient of line As provided Fast Track with CUE-XXX robust the single and cumulative treatment previously designation therapy. complementary cells in as reach the monotherapy believe checkpoint CUE-XXX's announced, of for expansion these trials in what will granting third agent first activity ongoing pembrolizumab of enabled setting. data The the on of efficacy inhibition with combination with enhance from a antitumor a blockade have us clear checkpoint data patients with and activity T broaden as targeted mechanism evidence HPV EX-specific of and for

and we derisking additional As updated forward an additional patients, breakthrough our believe Furthermore, data Slide biologic as with conference. from you therapeutic and oncology we mechanistic a our providing such, beginning series represents at CUE-XXX CUE-XXX the the potential believe with first as from upcoming CUE-XXX series provided shown biologics therapeutic CUE-XXX for validation a for data on has we look from to XX. CUE-XXX

targets of which pancreatic is colorectal, CUE-XXX, We update gastric, with and Tumor escalation portion a pertaining progress patients cancers. the ovarian our Regarding that dose in Wilms trial the from X, no to We anticipate of treatment with escalation completing the trial present positive date. advanced tumors trial to well the observed tolerated by has plan oncology portion dose upcoming at to an midyear -- DLTs been this conference. preliminary data enrolling

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

offers of in will oncology pancreatic expansion corresponding sites data. phase actively ability design plan States. us dose is accruing in and open colon, look As presenting any escalation studies to Slide conference shows, all ovarian to being monotherapy of perform at we at trial. This be evaluated the We the forward the data or indications the XX throughout This trial the study United conducting dose the to an escalation present upcoming the and cancers. additional and gastric, are CUE-XXX XX

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

Ken Pienta

Matteo. Thanks,

evolving data Cue, on see as to the could and promise engineering is these so target for biologics me extremely from to platform that gratifying The adviser early I an potential programs the cancer-specific recommend of meaningful for with levels that the patients with such cytokine IL-X Aldesleukin. and we as are vascular could potentially IL-X to without associated all T cells release toxicities of, and well-known leak syndrome aware syndrome clinically deliver maturing observed of

clinical to and you, trials as XXX affect the that XXX and subsequently programs clinical role handed initial taken and to I acting you've Shepherd CMO trials took Matteo, of the proud the bring maturing have to role promising so initial the the on behavior would activity. to And CMO, therapeutic role establish forward. and those to pleased on to have very over these I'm

the forward the the Now develop patients. company, of I to in again, XXX once role assets future CUE-XXX, and advisers the for help benefits clinical of continuing of to look

this Dr. world's foremost Sara and head of lab the cancer adviser only this opportunity introduce of as a investigator is testing of agents Pai, neck trials has one take I'd lead to to a the running cancer, as program and and taking time, served expertise this well care neck disease PhD all now as head for CUE-XXX clinical the HPV-driven a studying like our to At scientist, for and has cancer. joined deep but in MD as as surgeon, disease of has the in treatment clinical patients this who as not company. Pai well me as with the development experts

Sara, welcome.

Sara Pai

Thank you, Ken.

metastatic for also that life exciting recurrent cancer cancer therapies activity an patients and/or of head and have original HPV-associated good part and quality need it's help that is to important the as treatment. neck Well, the new to antitumor me take to promising designed investigator while side maintaining personally the a effects CUE-XXX without of It debilitating trials. on emphasize studies and

most we difficult a biomarker certainly addressing hitting consistently with these with what patients to CUE-XXX And often as CUE-XXX those activity PD-LX What in appears by KEYTRUDA low monotherapy. immunotherapy. mark be this a unmet have are even with synergistic score patients Therefore, clinical is activity the observed with in is to need. and combination treat the furthermore,

key the which creates with without limited historically This index of has important that assessment systemically. many side since challenge CUE-XXX cytokine have and attribute effective is for a when is IL-X of significant effects a for therapeutic of we it well immunotherapy. the doses has clinically full Importantly, IL-X, CUE-XXX been at the active associated tolerated observed of given potential this cancer

in seeing is continued on median patient patients a results over underscores potential cancer This of readily some forward an side Immuno-STATs. CUE-XXX agent highly have looking immunotherapy manageable XX. cancer now the observation effects I'm population year is which or relevant to for of of age increasingly really To in the trials. aging an setting importance the the the with

I Ken. will call to back the now hand

Ken Pienta

Thanks, Sara.

for thank And throughout and and thoughtful your to today march of and soon. I'll forward of to to Anish some to over advice CUE your appreciate want collaboration turn brief be help this with we from these discuss I We participation to for that as in the patients platform CUE-XXX. with the a again this autoimmune to will process. giving really who applications you off guidance do along Pharmaceuticals Ono recent your call disease. comment We'll offer of us your the again, for the device benefit with thoughts And developments continue we talk the available afflicted want development now

Anish?

Anish Suri

Thanks, call. to all Ken, welcome this joining and

significant by of perspective broad tolerance with providing immune functional begin platform for balance me spectrum on Let resetting opportunities a the our autoimmune or assets. within diseases the

As here strategy focusing Slide disorders by and for three addressing on inflammatory developed key overarching XX, on an autoimmune have we shown approaches.

termed T as CUE-XXX into of the expand and induction the Ono cells that an controlling approach natural collaboration biologic regulatory T cells Pharmaceuticals cells. pathogenic announced convert has first our guardians immune pathogenic inflammatory The recurring T unique well selective the development of defined is composed cells, to bispecific supports the expansion developed end, have a T TGF-beta are variant regulatory we CUE-XXX We the through variant as which of a that with responses. potential of IL-X recently for To and regulatory that milestones. natural

and association known of is T and via This strong diseases Immuno-STAT to applies platform. dampening control autoantigens. dominant selective a approach second cells HLA The our approach with autoreactive those driver

the have selective of inhibition approach type X reactive we shared in data have this for T insulin cells. diabetes, We previously proof-of-concept

molecule, cells incorporate HLA-G for to is has nonclassical expansion T escape bispecific checkpoint immune as molecules is also the regulatory recognized been of implicated tumors cancer T suppression that approach Incidentally, tolerogenic HLA-G cells. HLA-G of the and up-regulated And of in detection. dendritic cells autoreactive the in activation immunotherapy, which generation where of important an third

potential this will a the focus of differentiation the cells, of remainder section, I of in regulatory For driver. induction CUE-XXX and highlight significant position T representing the significant competitive and value

a gained from within in the two cells. a cells T being peripheral mutein that wealth differentiated slide, teams regulatory of Tregs approach describing of known shown TGF-beta regulatory expansion builds knowledge pursued IL-X the other highly T is IL-X the As next convert upon CUE-XXX all for immunology signals CDX-positive and community into fact over can the iTregs. past cells induced decades, as also T CUE-XXX or

to induced And contrast the mutein all expand Tregs of other on focus natural Tregs, preexisting simply IL-X new generates natural of or also can small populations fraction the pre-existing Tregs Tregs. approaches that and CUE-XXX in

very shown the we of tolerance. to highlighted table attractive as and approach. CUE-XXX's other can XX. example of An providing slide hence the T activity convert on to T into significant demonstrated, Importantly, reset opportunity is autoreactive regulatory differentiation on a have CUE-XXX in cells the pathogenic cells, Slide immune is CUE-XXX CDXX slide, next the mutein biased bottom shown IL-X comparing This

vitro were shown with of the the from or as followed this induction disease on of inflammatory rheumatoid assays, patients treated arthritis In and CUE-XXX from in suffering FOXPX then cells T graph. y-axis positive the CDX bowel for

cells cells. T FOXPX the for regulatory master T cells T transcription and obligatory of into is expressed differentiation the lineage is regulatory factor by

of XX% T T the As Treg of up base X% phenotype. of The regulatory positive noted X% upon CDX T CUE-XXX significant to into and cells. differentiated of treatment with or the treatment natural CDX-positive cells here, level is greater induction around expansion cells Tregs CUE-XXX to with in the resulted

the expanded robust genotype DiPaolo's Richard also are extensively by suppression a Tregs these autoimmunity. The vivo in at In models St. cells with we've cell-based have they CUE-XXX. T the in characterized of and of and and functionality assays. in phenotype functional stable and of murine conversion demonstrate the collaboration We induced Tregs laboratory Louis and University, demonstrated Dr.

and CUE-XXX In example two An model were post with XX this and performed the Slide doses X at of day XX, day XX. mice gastritis on disease next assessments of only cell-mediated autoimmune days. is the slide, were shown treated T

analysis various controlled protection In to reduction QXXX-treated pathology is compared controlled panel. measures As and the graph with to stomach similar shown right In of the histological PBS, treated PBS-treated and this score. histology to demonstrated mice the scores in more in mice. a showed generate the disease histology gastritis here, treated their The a autoimmune from extensive composite mice. sections, middle The. the on with the significant CUE-XXX which healthy look mice stomach of tissues metrics destruction contrast, the the the blinded tissue gastritis assessment exhibited destruction mice

from in such highlights lupus, diabetes, CUE-XXX. opportunities slide with and the and These indications therapeutic next type inflammatory autoimmune open NGVHD. pulmonary and diseases to sclerosis, such transplantation span well-known as as metabolic rheumatoid, opportunities to Alzheimer's, X neuro the arthritis, multiple ALS, diseases et vast IBD, cetera. disorders sod

We are the of most excited about developing indications CUE-XXX to address here. noted many

Ono the provides The filing us recently towards CUE-XXX support support of to with and series payments defined resource milestone with clinical of IND development. as as development announced Pharmaceuticals further partnership a well

retained XX% in Importantly, the the is market, successfully commercial have and drug interest if for providing CUE potential developed we approved. to U.S. option an significant

call a With give that, now Kerri? turn to brief financial Kerri update. to the us I'll over

Kerri Millar

Anish. Thanks,

completion three research financial the company was on collaboration ended the to XXXX December million of like year and I'd of $X.X the XX. due of Slide reported $X.XX XXXX. XX, The to of for for primarily now XX, LGC months quarter the collaboration approximately decrease our to provide first ended XXXX. December update revenue the phase in respectively. XXXX, a million results and brief Turning the The

the respectively. decrease to squamous due and for the primarily XXXX, or clinical compensation of enrollment recorded million stock-based in first beginning the decrease recurrent December XXXX, carcinoma as quarter monotherapy ended Research CUE-XXX neck and XX, the of and during compared and of XXXX due XXXX. in million $X.X The We was head to respectively. months was lower and General expenses Phase administrative of the the I completion months development and period to expense in $XX.X were ended million $X.X metastatic $XX.X December XXXX XXXX. cell for three XXXX trial The three in the XX, expenses same million were and

company year XXXX, was collaboration phase December the costs trial to the and years were decrease $XX.X and respectively. first ended for XXXX, million due the trials XXXX million XXXX XXXX. quarter decrease CUE-XXX and The $XX.X in of and million monotherapy of for lower $XX.X XX, the completion the approximately development December the manufacturing revenue was research a XX, LGC combination of and for decrease collaboration to million and the due respectively, reported Research clinical in CUE-XXX The clinical the expenses costs and $X.X for related and related primarily the activity clinical to to CUE-XXX material. and of

and million $XX.X for XXXX, the professional compensation rent general fees, to XXXX and and ended respectively. General administrative million $XX.X expenses decrease December lower stock-based in and The consulting XXXX. were was and administrative in and due years XX, expenses primarily

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

of Our fund second into securities current equivalents will the and cash operations half marketable XXXX.

call remarks. now Dan? to for will his back I'll Dan, turn the closing over -- who

Dan Passeri

Kerri. Thanks, Yes.

IL-X-based to next exemplary With And our clear look, positioned we I to to what breakthrough. CUE-XXX in evidence combination series, slide. stated in what therapeutic the of prove patients. KEYTRUDA can single-agent frontline are clinical we're go summary, overall with to demonstrating and objectives. of believe well the to be a beginning believe we CUE-XXX may of achieve We least activity a and appears observe at response be doubling

with competitive outcome. believe expanding well-tolerated inactive following CUE-XXX therapeutic our the a activating thought in checkpoint cancer-specific whose Importantly, active, our tumors a initiatives activity inhibitor T reach mechanistically is provide be to demonstrated in to and that thereby manner, a cells We're has in We focused strengthen be where is benefit. further drug patients patient KEYTRUDA or targeted appear patients in checkpoint intended low core the to combination clinical complementing CPS likely and to milestones broadening on immunologically having score, less and is by positioning. inhibition enhancing less

in data cohort compared refractory The median the represents the substantial head and is beyond, positive benefit observed in emerging survival neck median checkpoint and survival approaching historical expansion with HPV the months overall second a months line inhibitors. when survival metastatic patients. in XX third which of of eight monotherapy cancer line to CUE-XXX

with in complete and the opportunity trial or full patients on potential of defined a combination chemotherapy the therapy. that have year. expected with patients of Registrational XX KEYTRUDA the trial of potential conducting checkpoint a The strength cohort in us provides midyear to prior CUE-XXX inhibitor the this progressed the enrollment expansion data pembrolizumab end by plus being is registrational of

As a to date, the by highly XX based to data to on be first to encouraged inhibition on the of SITC or what to be reported, compared we the continue the enrolled these follow-up additional doubling patients alone of analysis data reported. at as enhance patients presented hold initial date historical ORR appears evaluated XX continue as dosed and to patients as checkpoint well

appears observations believe inhibition. checkpoint therapeutic the mechanistically growing to Our support as benefit from our checkpoints. pipeline, reach by implication, expands And and CUE-XXX complements the we such, that trials CUE-XXX of and clinical the patient entire platform and series ongoing premise

Turning escalation X. to tumor CUE-XXX, trial dose CUE-XXX the going monotherapy target is well. quite Wilms

potential clinical Just very broad WTX with that to opportunities, evidence of for would We significant as half activity validation opportunity. I and a believe cancers be value further positive the our expressing of the represents that remind catalyst data platform. you trial year cancer enhancement to stated, we dose-escalation second indications. the significant in report from And WTX of a market in expect

and those in the for we'd for the look months, operator in back turn you we and that, forward Operator? I'd to attention coming call listening ongoing your the With to much Biopharma, Cue to in to and providing updates very with like thank like questions. interest

Operator

comes Sandler. first Our [Operator of with Please Piper line from question Tenthoff Ted the Instructions] proceed.

Ted Tenthoff

very you Thank Great. much.

data? Looking or from be wanted like terms to sorry, we really helping exciting trial? And for what guys get you it's picking up the of what to year sense of guys. do define to expect be XXX terms in expecting else a design, should learn you else you. for registrational a I in Thank

Dan Passeri

Sure.

you. and over Matteo then Ted. take from and turn thanks, to to Good So that I'll that hear I'll generically, Ken.

So the of right patient now, we're the combination. still dose phase the in expansion --

out, we've to be -- continues We stated, that looks and as data be and are followed say, promising. going to let's by midyear that filling

rate, PK/PD of DNA HPV response as We're very metrics these proxy self-circulating We're also clearly of as the response. looking at at overall biomarker we're what we're Anish's a patients. such encouraged by seeing. looking evaluates and group the

So those we're progression-free metrics monitored well obviously, is as following being survival survival. accordingly. And overall as

these looking of supportive and promising. currently are metrics very All

we intend into corresponding year, strategy. that the of all to half of and gathering the registration So what our reporting, -- and go be say, that's second will

strategy forward, monotherapy, the have of And path supporting have registration the on overall a but into registration metrics we going median based trial for principally we potential survival, Regarding the with potential lot combination. going that.

just What we looking fortunate we're -- feel have is we doing that options there.

which on actual and trial the discussions participating potential and working based current we discussion approach our determining on limited capital et the FDA in and focus have we're prioritize be obviously, we to to discussions we're take what the with Just with with going design the resources, of prudent very upon, investigators, need we're going partners out markets to to cetera. and

something there, to going Ken and stop I'm over more if further they want to in Matteo to turn detail. add it

Matteo Levisetti

just represents area have it think monotherapy strength inhibitor and options quite patients, that's registrational of no really really a an progressed evolving really on in reemphasize it's from that data provides is need unmet that No, for development, I regulatory that really well. as so really point care. an view, of it's there's and would Dan. Thanks, of where laddered that maturing line as both I a you've the the late lines chemo prior patients standard checkpoint covered

have And could end patients of sets looking so data think, the to about data enrolled that of earlier investigator's trial rate observing combination, the that enable efficacy potentially the the approval. at if the we're have envision Part of really support to D. or a should efficient on very enrolled a one an a considering that's an to in the date, randomized proximal mature I and context really, to regimens. response a confirmatory that rather we could the ask that the regards really, maintained you'd rates trial XX be patient objective of PFS really monotherapy With for the strengthened versus in And response endpoint choice could year, trial, by positions

just the many I the both of consider. to us strength couple gives thoughts. really options of lines So think, as evolves, a in It's it that additional data

Ted Tenthoff

That's very Excellent. helpful.

[indiscernible]. Looking forward

Matteo Levisetti

Okay. Thanks Ted.

Operator

line JMP Please question Our comes of from Benjamin next the with Ren proceed. Securities.

Reni Benjamin

Thanks guys. on And of off, for guess kind I'd like questions. afternoon, I the Hi, to progress. start congratulations off. taking the good just start

that? potential anything of is that thoughts there You that one from any work or studies give some any or biomarker clues interacting able to from you patient be to mentioned patient for reasons with to the I'd patient A, or gather as patient might Ken the you might kind as Sara love to C your B get maybe relapse, she's of just and if on

more are other think you you And did PRs, the the kinds response to becoming these where of follow-up. of is combo like have driving the the PRs those SDs responses? but have observed, it, the responses deepening have portion monotherapy is what I in then side then you And kind of of objective a a I and related study, on

Ken Pienta

an nests therapy go see. Ken. behind. left ago just minutes system wipe off is activated few out basically, is a patient. microscopic don't -- a to are So drop currently, remaining Sara that tumor to see not of a to because had But we patients cells fail place cells immune And this any in primary

So immune don't up. them have own and a systems our with we left clean just or behind radiation cell surgery,

that of very we what over -- on over get figure to by neoadjuvant in cancer going system. cells we're out that the cancer, so and see immune head up few have up. And the cleaned neck in have mean and try cleaned we seeing how that get can to we left last study behind cancer, T example, for these and we're to unseeable cells cells interested, to all including are those activating by it's using CUE-XXX I if activate that's

you further see if I'll -- or need there question that your and So stop more. need answered if

Reni Benjamin

Yes.

this you that's see I study. regarding I kind Can the and year, when missed mentioned how the might from that to neoadjuvant neoadjuvant and for study you when might an was quickly milestones stepping just as of out give see update So we the might something us results have as initial we progressing some study?

Ken Pienta

I'll give that one to Matteo since.

Matteo Levisetti

trial well. neoadjuvant is going The

looks expansion schema NK cells VX seen whereby very of intriguing, enrolled. evidence T fully reactive have preliminary very, of been and we've cells. cohort first And of increases in The in X data patients the

year. enrollment doses the by is definitive currently of anticipate B, -- So the two is to Schedule end recruiting now treatment. that the completing enrolling prior we'd And and study surgery or which into cohort

Reni Benjamin

Got it.

studies, registrational as if Okay. a for then I just think out potential take then, you. we guess registrational Thank the we about potential the partner. And

long. But trial the would a thinking the you are way that you refractory to that that just Let's taking as too I ahead maybe the decide the be commit guess, don't might to take know and like think is go steps you go. I other one factors that's other? say study or Can I help about that to to you the monotherapy through what discussion up like winds which us would, just start decide

Dan Passeri

Yes.

are Ren. And at really and we consider. so that question, looking obviously it's to dynamically a And various very it's the important seriously in factors one we have

overall forward. primary since just you basically direct it path maybe is is survival. the mentioned more instance, It's monotherapy for ones is So median monotherapy, -- the readout attractive

it's market. in We follow smaller a mind, patients. have to Also bear

so broader these we're market countering seeing line, And upstream is part promising that very patients, of of results. the which in is front further

further. of even potentially of would the downstream essence promise that by results, those So shrinking market be we

but instance. there would moving and more the also even -- following rate, at we'd is survival, market. median with overall be overall what there it's you we're adjuvant we'd neoadjuvant be upstream So probably be measuring setting, clearly, And response a for broader looking

the we we capital that ourselves, the these it the about to access has So study. do factors the to of with we're And have partnership, various that through have a consider. of also we size it to duration kind if study the are of have, think and whether doing is it

considered. So variables those being are all of

this path I time more important to think is now the choose us of from. than point in prospect right we one have for registration at home the potential take

Reni Benjamin

taking very questions. Fair much for the Thanks enough.

Dan Passeri

Okay. Thank you, Ren.

Operator

line Our call of comes the next Breidenbach with question Mark from Oppenheimer. Please proceed.

Mark Breidenbach

Hi, good afternoon. for taking questions. Thanks our

correctly. to second the questions study heard both guys half timing from make in as sure expecting from year data well me the as of some the the CUE-XXX. this combination I for next data be initial We should CUE-XXX Just you

kind cohorts And So second, data? first initially? in the that? expect of Is be just more And should we follow-up. a it should dose Or all, is we have expect a of escalation that analysis complete correct? of from CUE-XXX PK what the data and I safety

Dan Passeri

Thanks, right. All Appreciate Mark. Sure. it.

we first XX half So sort or is of oncology the question, next year, an that's the analysis completed the of the we'll to of be analysis The just conference. upcoming expansion. patient the second said the clarify, when completed at providing update

an the until could be that release year So of midyear. wait half update. to going to second not We're

cetera, that's So deeper XX surveyed, what we're all analysis. completed half referring more to et a second is the patients

PK/PD, update the couched way, is that's been probably possibility, as then at that's metrics doing I the half at corresponding going well. an question has you the we'll by XXX, of the that's metrics obviously, the think the So be cancer And and midyear, we'll We're be measuring along a fact, which, to midyear, completing midyear escalation, I be dose year. the way clinical that to regarding answer second on hope we've And that providing some conference. of in a helpful. actually do the activity looking with

fine. add I that's that? know you if Matteo, If don't not, want to to anything

Matteo Levisetti

No, fine. that's Nothing to add.

Mark Breidenbach

for you plans And maybe comparisons CUE-XXX. Thanks muteins for IL-X some on for something to just have then out clarification. that's preclinical I'm the Anish Okay. there? one that if XXXX? of other that the any head-to-head That's just wondering present agenda are that super on helpful. versus Is

Anish Suri

convert. where in It And May, build where as meeting did mutein last where show Mark, we're Treg there's well, as year, and we this the talking. we But not is on IL-X and in the that's induction vivo the clear surprising. we and future. actually, We're in compare not Yes, in upcoming Paris previous that that expected, a continuing to this presented be an we'll where CDXX-biL-X-mutein we've models to meetings, by in on discussing in immunological anticipated meeting CUE-XXX outcome. data

populations of cannot. can induction IL XXX mutein so far, biased CDXX But which supports but strongly obviously Tregs biology the of do the new and generation a

Mark Breidenbach

taking for the Thanks Okay. question.

Anish Suri

Thanks Mark.

Operator

Willey proceed. Instructions] [Operator the you. Stifel. question comes our Stephen Thank line And Please of from next with

Stephen Willey

questions. Yes, good Congrats on afternoon. taking the for progress. Thanks

So with you're monotherapy with to are that monotherapy. something dose to I expect initiate talking But about with I escalation checkpoint combination is guess, there on initiating the start that dose know in CUE-XXX, inhibitor? CUE-XXX dose escalation plans monotherapy And parallel you expansion escalation? in would dose

Dan Passeri

And XXX. similar good answer mean, very the yes. question. Very to it's obviously, is I

pattern. We same expect general

with remind pembrolizumab, will any -- we but is trial first work to our just are in platform drugs our that expect We with everyone, checkpoint.

our in with the we're expect also to combination alternatives natural tolerability mirror that will But profile, what monotherapy be in data the to which So it's then as having to, looking that's XXX. show is that intent first stated, essence, obviously, And but have next at various step. important. seen we options survey and presently, you we've

Stephen Willey

as types with inform expansion Okay. And combination would maybe tumors expansion And you combo? the then select be guess, to does well? tumor prespecifying dose positive I monotherapy be with WTX the for then

Dan Passeri

thinking will answer guide both terms XXX of the of are be And cancers. I'm type WTX based of sorry, our more certainly tumors of the Yes, the on we XXX stratifying in is then expression those So that -- yes and to responsive. the will patients monotherapy questions. also

absolutely both So on spot questions. that's

Stephen Willey

maybe to here you we Or opportunity of the that that some kind CUE-XXX know programs about do bid? CUE-XXX more philosophically, an the to just guess, for I I And series? bit the maybe discussion there's with more autoimmune are that be Okay. with you of around curious two a opportunities guess partnering more think opportunities. proximal pursuit And could know about, that appears we be you focus, think don't put either there just the if also out

Dan Passeri

Yes.

different because on question are we complicated question, variables a and important consider. there lot really that a to it's Steve, So have perspectives of

They're just with it's a -- collaborator. I of emphasize some is preclinical license we we're supporting sort work. Ono. involved. They're announced money. It's this a not trying what the actively think to for classic We're partnership development

have codevelop. an We option to

assets a Those along state basically we're preclinical want portion to with doing to the upside. sets to where leverage data work XXX following And and We key that that They the and then payments no XXX co-develop significant partnering we're subsidizing think we're of here is we hopefully what to through if just go assets. way. we licensing way milestone power the retain upside long we're the generating. that we trying of basically a And have to pay milestones decide developing. us but intention to be the involved, our and have the that is so monetizing allows data we're behind

of some partnerships basically capitalization position Series. allow the XXX of This like be i.e., in whole structuring significant a risk but that And in costs, validates retain us what we'd terms of upside. to to leverage subsidize the

of in We also the would checkpoint various benefit space. from clinical development depth partners capabilities from the

we're certainly preclinical the upside going not hand to somebody and work. do adverse partnering over and of XXX not So just to we're to asset the but XXX,

intend we be So involved. to

XXX series have But the point is stated, So partnering interest as well. we also for and and involvement hopefully natural commercialization also retained you rates in a co-development. what

very data set a We attractive have there.

Stephen Willey

very All Thanks questions. the for taking helpful. right. It's

Dan Passeri

thank you. Yes,

Operator

to There closing questions to the at like are remarks. time. no further this Dan for I'd back you. Thank turn call Passeri

Dan Passeri

you. for right. to providing you Thank much. I appreciate everyone just market these time, Bye-bye. forward want during particularly and Thank in really times we very Yes. the updates and look trying thank time to with ongoing midyear, your you attention and Again, your

Operator

This concludes conference. today's

and lines participation, have time. your a your day. at for you this disconnect may great You Thank

Cue Biopharma (CUE) 21 Mar 232022 Q4 Earnings call transcript