Kyverna Therapeutics (KYTX) 7 Aug 242024 Q2 Earnings call transcript

Good day and welcome to the Chimera Therapeutics Second Quarter 2024 Results Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. please then questions, your withdraw press two. star To being note, this is event Please recorded. like conference turn Koenigsberg, would to I now the Investor Head Relations. over of Justine to Please ahead. go

Chimera's Good welcome quarterly update morning to call. and

are Joining Medical Chief Bruce Nello me and this Manalfi, and Golub, Officer, Financial CEO, Chief our President Jacobs, our Jared Officer. morning

a have your remarks, address everyone's to we prepared call questions our time one open the to please enough limit relevant questions. Following will In to and order follow-up. to questions,

our would I forward-looking XX-Q SEC. will recent today's about be future made These begin, risks these Before and filed cause only of remind in discussion any materially can to forward-looking call. expectations, risks Any that, to call prospects. assume now today's actual found update statements Nello. we that today's the to differ we of may from like to as include turn you to and uncertainties subject date, speak forward-looking our the that statements those statements I'll results description and projected. over statements on With obligation are with plans, no most A

address a maximize to our our Justine, underserved strategies, company, patients' fidelity approach development deliver to our highlights progress commitment clinic, day of steps Every Thank settings quarter of goal preclinical science that lives. drug that the large we've from The good target global the emphasizes and impact improve programs made demonstrating first-and-best-in-class the the over molecular to translation integrated we important novel to development of to disease with innovative design, past the data-driven take and you, our potential morning. ability consistently building fully biotechnology towards to pathways validated areas.

evident publications peer-reviewed degrader Our with as the potential unique journals congresses for and past and few major the change medicines exciting a the of in months. multiple has treatment diseases, our presentations of at in recent medical paradigms approach to development pipeline updates to led over

at Our STATX at AACR for EHA. featured and MDMX and ASCO, example, DDW, and STATX at program, was both APS

In evaluating highlight the Terminology. our Journal non-interventional trial differentiated addition, shared these programs. forums expression profiles with we Investigative published data The of in from findings HS across patients the our we've in of IRECX

call Before our a to in highlight I the over start to handing detailed IRECX will our overview, program. with for important more pipeline. Jared two I wanted immunology updates

reminder, and then dosed a IRECX been and our partnered the hetero-bifunctional volunteers in KCXXX, Sanofis, first AP As HS degrader molecule to healthy patients. with have

have inflammation, the skin, of We on studies patients. resulting and and and biomarkers AD robust Phase skin measured in has and profile clinical AD I of studied impact a shown IRECX been degradation in and HS. our HS easy in deep Phase This in score KTXXX blood of I PD most in has in resulted likely pain provided both in systemically high the degrader setting. and by in benefits scores

studies we to that review ongoing an of allows III II and impact expansions Phase transition these for of us of AP. AP these to a with expand month registration to effectively Phase the safety of studies. both trials trials, more path both into efficacy and One the accelerate range-finding dose II Phase seamlessly after HS expansive and of to Sanofi announced goal HS The intends interim

Phase anticipated. than will and transition Phase the into extended, III a larger quickly more enable As trials be direct the is result, modified a while will this expectation II that

in for Chimera's concept with unique platform value talking Staying this the activity, immunology, degraders area. about been oral biologics-like therapeutic attractive proposition with we've a of

Our best STATX concept. exemplifies program this

STATX, with with THX blockbuster a doing $XX diseases one are developed factor is a and the we've billion, so Chimera is way. a lives At industry. Dupilumab of mega superior IL-XXX this able or to by the in drug almost in the targeting drugs the selective similar become, in has block reach projected oral transcription pathway the that, largest that of has that of the an pathway, patients sales transformed to degrader and million

that is blocking in THX picomolar In superior more disease orally STATX preclinical Dupilumab fact, cell equal degrader, at at KTXXX, THX than an inflammation studies potent signaling and active systems blocking models. in we've preclinical shown or in

drug Overall, pill. the potential, profile Dupilumab-like an with with for date how the We potential to has generated paradigm-shifting preclinical asthma, in change to believe and of treated. be THX opportunity and diseases others can data demonstrates that pathway convenience COPD, as oral best activity its KTXXX the a the given oral such AD, this

mission target trial XXX than so that soon. are on biologics, doing biologics to Phase not by we and millions have the not but our Our to KTXXX patients potential around only globe. on million patients that more currently change X the lives are the of excited start We're is to the currently

most comment findings we usually for the is in brief the kind. We one any for current enabling future. the all patients the program, events kind. we any the status to millions all completed not wanted provide toxicology is the of to have IND of and important at on don't did IND the enabling of frequently since questions of a for asked I'm happy tested that doses results I studies our say an status adverse GLP studies, hopefully see of of program, This Chimera, ongoing studies, with receive any In but we update. no safety of or milestone

be us, update subject. With next the when those dose activities will you we first our expect should behind

more answer questions. let XXXX. we I'll Importantly, forward half results the be Jared Jared? happy in I to Phase and X will our to look then sharing of programs share on details first the

with Nello. Thanks, Starting KTXXX.

X interim Sanofi's safety Chimera and studies we program. great independent to expand the an a and following announced in KTXXX Phase by committee. As ongoing last decision exciting efficacy mentioned, and IRECX data development of month This outcome an monitoring HS AD is our analysis for

program, way should in overall accelerate also the commitment Sanofi's Importantly, timelines. provides to the future trials inform strong to but it that not a potential only registrational reinforces

will structure the with expansion a for transition effectively necessary X goal X. to dose regulatory expansive seamless perspective range selection studies into Phase more finding the Phase allow is enable dose studies. The The to

While Phase X. X longer the moving be should it shorter. in and take Phase X trials will to expanded directly HS to to complete two timelines support to Phase registration X, overall AD Therefore, ultimately will these and Phase meaningfully

details timing to Sanofi is trial clinicaltrials.gov. posted the last is work will activities protocols Once be completion the the on updated to and that data and will this be happens, month, Since related we update to update undertaking complete, new discuss expect we once able releases.

their which be will shared guidance of the this in first expect our expansion, a half results, XXXX. entirety As following will result, be we X beyond prior the Phase of

in be of of model, reduced lungs the As the KTXXX infiltrates presented at IL-X-alpha degrader, all dupilumab-like severity and ATS dupilumab. comparable an a daily Nello conference dupilumab of capable oral We robust additional mentioned, the after of of dose the delivering doses tested to that the potential in low a demonstrated prevalent once KTXXX has STATX and inflammation KTXXX, to The oral cell medicine demonstrated comparable disease chemokines, asthma inhibition data efficacy diseases. daily data involved safety cytokines, including and THX activity also antibody recently to in activity our first-in-class allergic highly saturating asthma. in

in with program XXXX. ascending now meeting mentioned, clinical GLP for the plan at single also around share well on adverse studies track KTXXX in tolerated updates to presenting more both the at of was largest study additional session with development testing, that coming our data later this I preclinical non-GLP dose EADV, in and month look year. should preclinical on I international subjects commence We tox Nello first doses. events multiple to remain in no details in in the Europe our Phase a healthy a data forward dermatology. half KTXXX additional as provide of We when note, poster and to and we I expected KTXXX any beyond plans Phase for months, We in the next

at we day. first-in-class TICX out our pipeline, KTXXX, Rounding immunology degrader, R&D our unveiled our oral

profile. inhibitors molecule the therefore not block do TICX functions of not loss-of-function We all to that able have TICX scaffolding shown are the replicate small and

fully inhibitors In catalytic addition, function state. small steady molecule cannot at the block

with inhibitors, arthritis, and thereby blocker not a than incrementally just The better small best-in-class to drug is psoriasis, biologic-like have program, among a and but depletion is to psoriatic molecule others. bring conditions opportunity for pathway of oral IBD, TICX, this deliver to TICX that for agent an patients like lupus,

expect testing For XXXX. complete Phase this in program, initiate we to and I

data position to busy a XXXX, a up in Phase programs, I and Chimera. our immunology us share TICX, in put STATX two timelines very for to be and shaping which new for is year these exciting summary, In

MDMX targeting major updates in and disease-modifying our a ASCO these been to recently Moving degraders clinical for and We've also EHA, has of responses STATX, oncology, programs, demonstrating tumors. two MDMXXX KTXXX, by busy solid highlighted this and shared respectively. the impact at liquid stretch and

to has has addition our in than activity particularly to the in to tolerability, we our In have higher dose clinical which been has exceeded resulted demonstrated, by cases. been levels both ability encouraged That that expectations escalate expected.

MDMX common oncogenic is reminder, that an a PXX. most suppressor, As tumor protein the modulates

PXX expression, this clinical increases benefits overcome to been with inability have acceptable that feedback to PXX is developed is upregulate and of margins. due loop We stabilize While show molecule protein likely they upregulated. been small when levels believe unable PXX to safety inhibitors meaningful to MDMX stabilization their have a

to rapidly data differentiated in emerging apoptosis encouraged has by opportunity the an feedback its ability exposures escalation induce provides X This safety from KTXXX Due and efficacy Phase with the and an mechanism, trial. shown to MDMX overcome studies. improved KTXXX dose the profile. brief loop the We're preclinical for

responses of signs at cell and seen post-myeloproliferative of to models, two anti-tumor small poster XX B of a demonstrated patients in high-grade solid myeloid dose traditional with to dose We April valuable X and two be as inhibitors. tumors without neoplasm biomarkers upregulation PXX provided lymphomas level one Merkel up types X. hematological in preclinical That molecule in shown to with tolerated update multiple with clinical myeloid in that the leukemia X. patients two malignancies of eight with patients and update arm arm were potent patients in doses in and acute from up ASCO including toxicity our included In pathway we activity sensitive level well with carcinoma XX of patients A June, tumor

we the the the development the this medical guidance in Phase and trial later strategy meeting present steps. Phase clinical next a XXXX biomarker-based and in complete Separately, subsequently is of KTXXX to XA XA second to phase half for and ongoing, of patient to selection on escalation next expect expect at year. Dose enrollment we dataset our share

transcription degrader European against provided degrader the program is Association we a highly a doses. to annual undruggable potent, of The enrolled at clinical Hematology heterobifunctional selective clinical June X meeting. dose as the with June, levels update STATX provided and In the clinic. our KTXXX XX historically update STATX first on a a of of seven factor from a enter patients poster X.X through mean

are of tumor, and doses. the in knockdown of We generated encouraged date, blood interferon by tolerated in gamma and in clinical to showing and response lymphomas induction tumor, strong at data target blood signs efficacy preliminary

seen three why had responses rationale for the as We we've we heavily should clinic inhibitor CTCL, who Preclinically, with Hodgkin's in in stem robust and data patients lymphoma, seen in anti-tumor and a ADC, cell potentially active intriguing and is cell the complete of particularly well lymphoma. T lymphomas, curative transplants. prior of in subsequent NK the Hodgkin's genetic terms translated lymphoma. emerging well be activity checkpoint therapy STATX anti-CDXX lymphoma enabling after in responses This cell as pretreated progressed patients in has targeting believe two Hodgkin's NK have single-agent in strong

of patients not see stable been a tumors, in a did strong enrolled the handful single not in surprising preclinical that have tumor as we disease observed trial. into Because activity it's agent we of signals solid only solid

have in with provides likely in combination and mouse solid anti-PDX Hodgkin's This seen in drugs. which we believe for patients. tumor with However, an tumor driven mechanism, solid lymphoma both combination activity opportunity is we syngeneic by anti-PDX models immunomodulatory STATX's

believe two combination on additional lymphoma in also lymphoma, solid observed enrollment anti-PDX there tumors and which the we've opportunity encouraging is focused therapies. activity expansion other targeted are the seen we've of aforementioned includes activity very complete an Given to further responses, the with We we Hodgkin's for into there. explore in patients future Hodgkin's

to and enrollment of preclinical data in on half share to study complete clinical keeping XXXX. expect and second all look We programs. forward the of updated this you We our

we to Before questions, hand to take quarter I'll financial second review discussion Bruce the results. our

Jared. you, Thank

With second found quarter tables our Of expenses, all collaboration. R&D XXXX represented million our attributable reference to In the As of to I million. quarter press operating for financial the compensation. review non-cash release. which million, our highlights, $X.X second that, Sanofi was $XX.X in XXXX, please today's respect was $XX.X total quarter was approximately of the the stock-based

adjusted quarter of $XX.X that excludes comp, The of spend first XX% in cash which increase stock-based the million, comparable the from reflects XXXX. R&D a amount

On spend was increase which the excluding comp, quarter reflects of the $XX.X comparable G&A again G&A side, million, the from our comp. stock-based was a spending non-cash $X.X in prior the for million cash The quarter. million, XX% adjusted stock-based $XX.X amount sequential of

was at Finishing with $XXX balance the quarter up million. our of cash end the

several and inflection Our STATX programs to concept runway enable execute readouts, proof clinical in multiple half KTXXX on of TICX provide for and into XXXX. XXXX of in results is to will X us cash expected expected our oncology first points balance XXXX, the data, data Phase including and

This questions may have. we to concludes and would remarks, address you prepared be happy our any now

We press one question, and keypad. your answer will telephone a you then session. ask star question begin To the now on may

would using At this to If any please star handset question and been time are we speakerphone, will your If two. you assemble withdraw to addressed like has roster. please pause you question, time, keys. pick our your pressing a then at the press momentarily up before your

was within. Oh, and of wondering just type little be And an thereof. elaborate bit could able after on might their I'm efficacy X Sanofi work based Phase as it for morning. wondering know whether decision whether there could be, to that review the sense I part was there you trial when the I hi. the moving the to parts here, but we or some I'm program. of safety there Thanks just there's you if guess on expanded surrogate component a of a further interim expand and Phase question. see or you Thanks. X to data some when were data through Good it's have readouts might from whether taking loose

Yes. Thanks for the question, Eric.

data. we was So both we to both access as said. speak both And an that of to data. the analysis access and there interim blinded an was efficacy, to, had and and can't IDMC Chimera, as the companies, had safety again, Sanofi blinded unblinded I said, There provided from data we're obviously is of the was further content should that but weeks update review that review a and were the few the the the or we this questions supportive ago again conclude that asked, obviously the investment of now program. we what of highlighting into

Sanofi is Don't where control concept the the a run a few of proof one forget that of in Phase this programs in X running manner. multiple parallel previously study is in placebo studies having pipeline without

have to both speaks again, it of that think, for level I program. this we the So enthusiasm

on completion And clinicaltrials.gov timelines. With the see regards expected And dates. in to comment we hopefully timelines, will also to that be we to be on next, able update upcoming at an in the months. will able will the time, include that

going As to, at was provide the guidance. not beyond half but to we first that said, point accurate initially be Jared guided able to we're said of XXXX this earlier, more it's

in Thanks. Okay, and the great. taking Thanks I'll for back question queue. hop

from Our go next question Jeff Jones Oppenheimer. ahead. with comes Please

guys, Good for taking thanks question. morning, the and

going Just one work significantly have quarter trends. R&D the a extensive with you prior and quick the on up Obviously G&A on. picked from the

well as in think on the you. we Thank revenues Just moving follow Sanofi? trends that collaboration How from should then the about And how up think should forward? there? we jump about

Jeff, Yeah, This sure. for the Bruce. is thanks call.

over the we of what terms terms expected. there's had of unusual nothing versus trends, the there growth quarter in quarter So in

studies line. of is through G&A see in for we through get As growth just to that you'll the organization. STATX, R&D the the obviously year the start modest the come closer progresses, as

the don't, of right little see what loaded haven't annual years the We how a that's but definitely typically ballpark. last And generally I for you'll But looked towards guided burn, year. at representative and they're more gone year, front-end loaded. our than this street, in typically have back-end this

revenue, the there revenue revenue a to in Sanofi the related alliance. result of the a just of terms catch-up In All that. was is

think be So some a might deferred how based the vis-à-vis can year coming little balances look quarter, will this the the so. the for you higher unusually resulted year. calculations a do I revenue in of rest but on balance you our And it level or that sheet high over on

helps Happy a well hopefully bit. little that So offline take to as more you'd like. if

I'll Appreciate that, queue. jump Bruce. back in

Our next Please comes Jefferies. ahead. from question Kelly Shee with go

indications based more been single specific the taking on plans on program, from multiple progress you or thank a for on has the Congrats the my on for indication multiple comment which Phase studies Thank like the preclinical one discoveries it the preclinical Would prioritize? or studies, STATX to with, presented you be the and you Maybe on you. X? findings have made could questions. decision

comment plans. Yeah, on Maybe I'll thanks. the let X Phase Jared

We haven't before described the the plans details of our healthy volunteers.

on the able able just remind, to maybe our our we're that path studies. think fact were Phase to actually we accelerate to giving I X we're the complete to is really the update that on and program today IND-enabling conclude and

our not are Maybe we said compared high-level what the so study. healthy on start And of Jared, can earlier, Phase if some description to we X volunteers provide track, you studies. to had

the pharmacodynamic a example, be for to will expect a that Phase portion daily it dose we did number several at being multiple the measures opportunity to study. in able able look different to Phase volunteers. THX traditional And an the will the TARC, study, The have X, particular to of those healthy and doses. also healthy IgE circulation, include IL-X-IL-XX dose an of opportunity volunteers MAD so we'll biomarkers and that we'll Within will will measures, to an volunteers, look of blood looking study move at different in be critical Phase IREC-X X addition STATX, have XX And be the Yeah, be study, looking impact single consist quickly. on for as we skin. which even importantly, through to show X ascending healthy pathway, to ascending It giving to in and safety. in us at biology in at

Thank you.

with question ahead. Stanley. Please Vikram go next Paroth from comes Our Morgan

taking morning. Thank had We you for good I&I on two pipeline. Hi, questions. the our

HS wanted to learn expansion program, thinking data and on XXX, those when TICX to the selection, do for might the those how on what make we just help you're Sanofi and program decisions? be will And what to get beyond indication wanted your could you Thanks. decisions. initial just X on yourself see latest Phase AD How about secondly, First could then expansion broad indication flowing more be development be from into indication for or thoughts think in rather. looking and the you and

Yeah, thanks Vikram.

XXX, in in we as this has on a the past, diseases. broad variety So said believe we of relevance pathway

in expect to inflammation, is and well foray skin initial on in AD. so of GI as traditional, IBD, derms, concept, RA agents both existing with as COPD, pathway and respiratory, asthma this be Our in relevant and HS lupus. Again, pathway and this in target proof both say, with rheumatology, based we and let's

the vast. are So opportunities

the that hopefully around that potential will and it we're program decision-making I enthusiasm to the prioritize And in Sanofi all of that process past, again, speak closer can say the cannot what seen communicated say to of indications be but the that decision. to Sanofi that, and the at ongoing getting update for eventual done. the is collaboration to on to has timing recent the I'll the been least a a continues leave we've As support within that expansion. has will I to final this, who team the but I is series there have speak we

really said and profile, again, unique With an as this for molecule is biologic-like us with oral earlier, an regard profile. to provide TICX, program opportunity to Jared biologic-like actually

three IL-XX, single differentiated fully small If being IL-XX, to you interferon, with a provide pathways molecule highly profile. should think about and oral in block this X pathway involved able type those is and

are arthritis, of lots the after, gone interesting. there's ones obviously go others that that have after, So diseases psoriasis, be are potentially could psoriasis, up IBD, could one others there. lupus, There potential that

our pathways, And be actually of any of demonstrate think I study a with other these then be concept plan of our to our we're been far. action Phase details X would goal closer to we'll differentiated mechanism X proof show full unlike in our a in tested so about speak that profile. blockade has to demonstrate is will Phase agents study. that that that do indication to an But more will once able that

Understood. the for context. Thanks

question Stifel. ahead. next Canino comes go Our Please from with Brad

a you I talked about would some you. of how And back then IBD? the highlighted but as but also you the that how can this are naturally What question, and at TICX the individually named of clinical me. lot tractable while ask, Thank pipeline areas today? collectively given a you lot strategy the second, evolved I really a Chimera. for the to of asking and pull is you. to before discovery maintain questions do external know focus this and for of a of the a mean, now? discovery shape Two news, efforts little want of across target degree of Thank you just efforts bit, characterize a confidence discuss the just I years it maybe ago you pipeline recent bit today, And

Sure.

to to TICX and in In show expectations our our for IBD, your with targeting approach some terms there I activity small been around have molecule in mean, IBD. of inhibitors TICX the activity question challenges

You if IBD the sort part in with interfere that. problem you TICX, might know, selective mucosal IL-XX, be because you're just it's hitting it's say, for also be IL-XX, going to IL-XX, you IL-XX, be hitting, of going for don't because with therapeutic component interfere of of JAK, to while is also with where can which also example, it's probably which due healing, any important not to affecting that block real Ducre, it's a that fact an

that's same degrader is that block And IL-XX, that maximally our be completely IL-XX, of TICX interferon, key sparing one time signaling. the our So and for Nello think that inflammatory while room disease approach at discussing we derm the indications in anticipate lupus. including was indications will in we IBD as in we advantages the well advantage activity indications IL-XX we TICX distinct to why the earlier, real able the like being that psoriasis as and can pathways, and of other show think like a this

maybe of I just small look on it's add and the important relevant profile data, tested at and Yeah, to a the molecules pathways. the statement recent to the think their activity of blocking

difficult, And a value to the particular or the in so context it's that other as profile. the taking well, you of you as, without you to into know, use compare molecule actual the to Brad, know trials testament that disease, know, of biology

regards you if after, drugged I the as type really at with main drugged that the TICX. you to transcription the efforts, scaffolding been degree that going discovery been that STATX classes, of not I and are IRECX, the after on well. gone we've has two validation. and pathways, have, think we pathways rises at that targets been With have And Chimera one or targets think what example, we've STATX mean, look a consistent protein, high have an within to know, focus thing those of I or factors, top

be philosophy the continue believe that will to the general And same. I

years amazing great for an talked IRECX year, We've far. We've we earlier As talked about TICX effort STATX increased have with with about profile now. potential. talked substantially we've in our so in immunology. mentioned we about Again, the

year, You'll immunology new context to hear know, the targets know, same again, hopefully as drug other to within, difficult about of, programs, early you in drug you impossible next landscape. with or the as modalities

I the will we pipeline, have that. don't should our immunology us goal you confidence, oral few is where think if industry what, best that months And the today, the I degree vision from already that's next think and expect the in and in and world know, I years. highest our of sit have we

question comes from Cowen. next Please go TD with Mark ahead. Our Brown

I&I the but just very maybe one just quick approach, is lot of the update. my oncology, clinical for A the broader should question to be view to the you maybe know, that or is one And portfolio just approach. acceptable kind so guys of as, oral event? year this develop molecules your you having that end answers, Chimera's that and or presentation it's clinical molecules going of update XXX expect on of the convenience on biomarker important profiles also Do up leading questions. clarify, as Thanks of year injectables? we this a much Or as as good then Can to this really every of you not that than that's there? not full more year, taking idea kind year if show kind a the happen efficacy, or here maybe you anything quite to the out have data bit good next kind the is

about forward-looking biomarker-based recruitment our is, you you talking been while a share sensitive strategy commitment know, for for XXX and So on MDMX we've strategy to know, your first on biomarker. a said we've what question, based for,

a year And to that share at so hopefully we will medical this able be meeting.

to clinical should complete our our that dose year. plan, this able What we you about data said our be we expectations escalations are know, is,

know, be drug depend our it and us, safety many doesn't MTD. you how but on depends only required that As profile on also of to doses the would reach

As we our we profile than than probably safety you've ended based anticipated was up because better seen had anticipated had more escalating actually data. for pre-clinical STATX, the we on

the after for we why complete MDMX, all the escalation share data, we'll reason the share when depends of the data so so desire on totality saying the again, is and we're it And the escalation. escalation, to our we complete

the critical The a profile safety fast, again, of timing patients trial definitely the depend, on to do to should but end be MTD. we extremely year, drug. the It's will path. of is that the that really recruiting so and expect that on and We recruitment of by the it the able not profile is reach

pathways for it With activity the the superior be family blockers. said for that mean, of so show able way. for blocking TICX to should the to—or individual that and can upstream be we pipeline, is should shown immunology actually, hopefully Dupilumab. combined the year, in We'll be the superior cytokine targets which be should I able actually biologics. also upstream pathway able that to we the IL-X regards It those equal, we've biologics, the pathway That selected given I IL-X IRECX, than have true are to same block We've have say—or a I true to fully for clinic that clinical superior to STATX block program. in the and is TICX, think it early at

what which So are does not have drug an to is the to is of to compared That on-pathway efficacy. that unprecedented trying goal, our immunology oral compromise biologics. again, on we in I is think do, development, history

I the again, as so we example well as blocker. believe, We experimented that just so have shown alpha which is to block we based the is and biology have Dupilumab, IL-X outline. the the easiest And far, on receptor that can STATX pathway think

so expect the in terms to of we Dupilumab. be results least clinical good And as as clinical in activity, at blockade profile, pathway that

historically think efficacy had on compromise oral to with an I we've So drug.

how about programs can that that from think just patients paradigm case say anymore. that concept is programs, diseases. is ability the as our has about is these ambition with not a to embraced community And for few change should past the been shift, will that actually are the—when And what suffers We the change be that's take the a really by our that we paradigm. here also say trying It's drug that think our months broader I that. which that to we

next Patel ahead. from comes Please Riley. B. Our question go with CalPIT

Yeah. morning. Hey. taking Thanks questions. Good the for

includes help you follow-up, why of can decision-making XX understand a be specifically share, dose and testing more additional as to expansion us now. the the Maybe that the if the tested mentioned additional any new You if of doses. daily to for doses you of range? color are need also doses And trials us you. Thank IRECX give XXX-milligram can outside the

CalPIT. question, Great

sponsor it a efficacy know, the Phase ranging safety. study, between relationship have expected initiate you establish order and a Phase to X—a as in registration of is to dose X a So to degree from

if now still Phase go study without a we—that you actually would dose if existing—let's that X of study impossible, doses. clinicaltrials.gov extremely placebo. at X registration the have had on It that study multiple Phase been exploring difficult, HS from type one so And actually that and not looked to into one is use

of sooner doses, actually So that's acceleration would into—after point X this at With other also are a to study. I that study addition to much into is what's regard revealed the type the not of the doses in U.S. actually Europe, doses comment. to actually the than of Phase the in liberty driving we're getting again,

figure to I'll work, if you the here. know, out existing will you that hard but dose some the So, maybe doses be, not what do versus stop investigative new it's

on What the I they can't that more I Unfortunately, will say said. will comment range you is will where doses the within that be be.

Okay, you. great. Thank

Our next go with Please Schmidt ahead. question Guggenheim. comes from Michael

our This taking Hi, for thanks on for is question. Paul Michael.

certain is follow-up, your reduction you. program? then PD threshold instance, any give directional Just is there confidence following TARC should actually you up on or prior indication that biomarker on just guide STATX, see, volunteers prioritization? target serum or that data can to the next you're the about Thank interpret coming And data or a out could just concept, a is proof a in of reduction the question to to as For hoping talk we sufficient dose-dependent thinking goal year? healthy IgE that on you establish early and here of how of

Paul. no, Yeah, question, great

picomolar cell GI. So these robust in let relevant, derm, to with all I with… relevant built cell first a we human all When fully me really concentrations shown this are say whether degrade it's Obviously, types respiratory, diseases, start preclinical package. step, relevant mean that THX we vitro, in We've target I types.

downstream as at receptor—we're atopic the model, if than asthma we well plethora biology potently the that block derm an equally THX degradation that IL-XXX more better inhibition—so in biomarker endpoints, to translationally pathway disease model, actually Dupilumab. Dupilumab. look you vivo, a that's with that of to shown a go either more able we've pathway or in block either shown an we of model HDM We've If shown in or XX% as we've than of have the STATX, XX-day ability

adverse adverse even compelling. in so earlier So very tox. Today, January, tox, best-in-class any the profile terms GLP shown be behaves quite saying inhibitor. we've we've the in very, to our about absolutely safety which that as pathway like that We've this in we far update we've we pharmacology any robust, the hadn't we're non-GLP of shown any events drug the that also talked pristine, events preclinically Also, a probably year, an going in about profile in fact seen tested. seen through haven't doses is that safety

we've in study preclinical everything far humans. the done we've in of demonstrate that of goal at that species—replicated so the Phase The is to that done least most preclinical things species—or X

Dupixent totally biomarker degradation in PK that to preclinical in the STATX a be to Then shown sorts and expected—but using that honest, dose-dependent again Importantly, all robust extensively it's humans we've lead will the changes, biomarker and just confirming blocking of downstream we're blood that models. modulated has skin. leads confirm—to to which in

kind encourage expectations, you look IgE study Dupixent that TARC of everybody has data at you seen reduce they're Dupixent, If aligned shown, with the also and days. XX that I to so on you've in can and that

don't at look between ongoing that healthy on It's the data, you again volunteers it pathway XX%, that even XX% and target is that inhibition in there inflammation. confirmation shows have If somewhere depending you a use, that engagement. of a biomarker

that are don't healthy believe regards I a biomarker volunteer for qualitative data indications, again those to will population. any decision-making use with given that we in

patients mechanism establish both go soon of to proof robust of will to goal be in and a concept. Our more proof thereafter

comes from Merle UBS. Ellie with question go ahead. next Our Please

question. Hi, this taking is Jasmine so Ellie. for for much our Thanks

two on have oncology. We

your specifically your on you color opportunity Hodgkin's a on most your when action, of set you. can of on update on see what say you Thank this biomarker And give mechanism you tumors? secondly, give tumors, talk you could more going what about strategy, then based and hear are lymphoma? just MDMX to about the applicable an this in little solid patient for as in we view So selection And STATX, potential update the solid the year?

question Yeah, seen hopefully in reported in STATX on on and transplant. lymphoma who maybe patients complete have starting to that then Hodgkin's, we curative responses with gone we've your Hodgkin's

those consistent targeting. amplification of PDLX of about where STATX Hodgkin's is amplification, tumors known So disease, well there's which would that Hodgkin's encouraging as to the what potentially genetics both responsive render is with data as very in of JAK

we've see drug. enrolling we've as dose the Phase We previously, continue study, those see is escalation sort opportunities So being guided now focused different on as completed for a to there that Hodgkin's the opportunities activity additional development several seen with X date, of now for and really enrollment monotherapy line include to If drug third we we've in beyond. the the and patients.

a with anti-CDXX or So anti-PDX for and patients anti-PDX. in upline ADCs, who have also in potential combination second line prior had opportunity prior drugs

we data interesting once in this So the Hodgkin's those of I year the safety see later and the what can completed think remainder year. at study both it'll that that enrollment very on We additional we've terms of this be provide efficacy of for plan patients time. reporting update

regard to this to selection, think referred Nello With and I patient MDMX earlier.

so for sensitivity the to sensitive see pre-clinical of are plan to people how of types certain program. action. solid data to enrich And tumor signature We medical different the present various that potentially at this solid a developing specifically we And that guiding solid showing using those for tumor later have extensive of identify how biomarker those had meeting pre-clinically to degrader further a are can been update tumor types mechanism models. an and what is degrader year MDMX in process sort are plan of our effort an ongoing we've the

stay like. for can presentation later strategy going provide more tuned on details biomarker where to is this that what that hopefully look So year we

you. thank Great,

Please Our next with Andy from comes Chen question Wolf ahead. Research. go

mind, you you the if you hurdles stage degrader? puts difficult be? What how Congrats the STATX it, the their were company creating please to progress were how discovery from they another of Brandon this the Andy. discuss quickly on And go and for developing process in could IND mind Hey, is first thus challenges some it? can when far. degrader would to that Would

Great question.

STATX made the STATX of XX depth to biopharma would years our early since I this of companies and inflammation. all of have in to talk target a first, going can And at with has that At And other companies as clinical to ambition is I priority industry stage, We've But going is have. years other been far. points haven't so don't some the is point I THX no and not is what's blockade STATX, that all I target say believe relevance data timing on think compete spent stage that the others. to the view past had company will that and that So details. of effort we've what We're are. clinical to so remember pharma capabilities of been effort speak any working And company. given shown the had has concept at from almost eight work past both breadth about one that it Chimera we've of of be own any And on pathway's in Chimera list we molecules there that I the nobody, this take that least of the space. quality Dupilumab proof program. pharmacological we've to this most driving everything completely and the that for know an it's far. years. the there I This will. I fundamentally think seen on best I I can't we've difficult know we this done is that from

So competition. comment the me it's for hard on to

Our Please ahead. next with Truist. go question comes Devrakonda from Kripa

question. thank my you much taking guys, for so Hey

your Sanofi. like developing, peers close the it's the following not but question they're collaboration not STATX up developing it's STATX previous Nello, anywhere in degrader, is clinic, on regarding with in the of you to Just degrader said the one a

But they're not perspective, you understand us you obviously big talked know, you expanding degrader seems X about STATX IRACX a picture already? just degrader? develop, more a discussed an potentially wide So clarification on you this Phase adding with collaboration dose you you know, the acceleration been can net. you've Thank there study. then doses. And Sanofi's a a develop your like, clarify FDA there It from being the to cast any impact help overlap? KTXXX Do might or announced, you. collaboration whether think trying could be how might for a to the that Can towards just patients, you're has expansion

Yeah, so thanks for the question.

different know, and first accomplish different companies we together know, the in STATX. around have is, else of come that obviously We there's you as strategies goals. aware obviously, is independent know, interested their obviously and other. Sanofi one, Sanofi everything goals highly you each Chimera And you we're But know, we, do So independent to we that IRACX.

world. even all they In have—they've in our are that ours there, out in know, available STATX STATX you if And, the competitor licensed agents fact, only isn't. Sanofi's the STATX,

small for think, this we the view, know, I two valuable so And think do, validate inhibitor and target from important company, personally, given degrader. target you but that if had and again, how same it, we collaborations any for one two Sanofi target, of point a is, this right, how has modalities I a need is don't with that molecule

But a we are—we have relationship. very strong

competition have will don't XXX. impact on We our have believe, works don't on And know, you on expect that, XXX team any an ends. we both amazing that STATX

know the With with as so the—I doses goal we've the don't is expansion, specific accelerate the the you've order just asked said, regards entry into a discuss if to there I'll And for think study. a about, question. in to was that registrational FDA. I

yeah. Ah,

path. Obviously, process. Jared. regards sponsor, the they're in is that protocol amendment, official is there to—yeah, FDA, given a comment that. can't whenever on Sanofi thank With I regards a with But of to particular that the charge So you, is there

next Sachs. ahead. Shibutani Goldman go Our Chris from question Please comes with

indications how how selection to therapies, expand better there that rheumatoid to is and traditional patient being bigger any there? the lot year industry selection my better Many terms slide And your side. might a very Sanofi additional much. from about One, very started small what thinking but MS in into also immunology two, success? are indications, know, patient looking clinical tend perhaps strategies of are how And the indications patients, vast know questions that in you starting the larger? molecules you feeling way like study market seem to of figure I Thank your you advanced been of a picture biomarker that a of strategies. about to on existing ago, that Thanks. the And asked, twofold. is noting opportunities arthritis. identify the chisel in R&D is is number think you thinking One, in have control sort two data enhance you development, to success a It that but work, patient can CNS-type that be some the thread degraders scientific are how probabilities a potential about the playbook. out of combinations had day there's to Great. inform are be helping would out population you enhance questions of to end you included, to

Yeah, no, thanks, Chris.

So, Chimera. I we this do and center what at is here of mean, front

the one work I think that way, therapy ability it's STATX THX of the inflammation, and targeted a examples it's to comes although obviously in immunology. something patients few mechanism, with with with select in of the that our

in Dupixent terms in then one example on selection. example and patients the Jared how eosinophilic asthma do of and now I'll let also you patient know, just populations. actually are with select COPD more As what you an these address I'll can for prospectively comment we of

I brain, can extensively degraders But on the have compartment. and demonstrated that on think access CNS we the angle, say, CNS would others, I the

We we've shown examples, that pre-clinically. several examples have internal internal that

CNS by of mechanism, ability unmet the the will need, indications So, of less the and by the going opportunity, the—or of capability technology. choice the driven be into I don't—the the

want to Jared, generally, to comment how on bit a on, select? do you

in as Maybe TICX patient think selection, and terms to IRACX this to and STATX applies of I to well.

STATX as these of very and we the we these If important upfront have patients these upfront as activity very important is large that population used TICX. upstream that a approved patient think be I IRACX competitive. across and broad should to our the for think to question, be indications and oral it's regarding drugs degraders not in that believe could we also narrow it's order active but of biologics, populations I to are for emphasize expectations very

therapeutics. our X being whether proteomics said, on on TICX—extensive diseases pharmacodynamic our X are in we STATX studies—we help that are benefiting various retrospectively greater allow whether this to STATX be might and that differentiate population come potentially and AD when and doing transcriptomics lesions that and for it Phase Phase important that might on us and broader a other transcriptomic these did from proteomic be study, the at and to to building will also, in psoriasis in us include with patient they patients for to understand then With extent IRACX blood this TICX. skin subsets with for be and example, even assays us profiles than skin certainly or we're with helping That for look to there

any answer I to question Manalfi like This over session. concludes turn and our closing would the Nello conference remarks. back to for

Thank you.

So I Actually, we thank almost made to everybody. want just to it X:XX.

our with the news their KTXXX with highlight And the So completed Phase today, showing we Phase excited of expansion program. to both studies ago and increased maybe and IND-enabling then close the for and X a more in that very Sanofi great of weeks shared HS in really, confidence a especially today recently, profile. We're we've key safety news and one which initiating X the the investment we're programs had all on that was just thankful of really to XXX study AD. the to few

And so progress first all happen that dose time updating should soon. our on our about we're towards excited in-human you next really

with So any thanks today. again. We're follow-ups available

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

disconnect. may You now