KYTX - Earnings call transcript Q3 2024 | Kyverna Therapeutics, Inc.

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Operator

Good day and welcome to the Chimera Therapeutics Third Quarter 2024 Results Conference Call.

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like conference turn Komigsberg, would to I now the Investor Head Relations. over of Justine to

Please ahead. go

Justine Komigsberg

Thank you.

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

Gullop, Officer. morning are Bruce Founder, CEO, Officer, Joining me our Chief Nellie Medical Financial this Chief our President, Monofi, and Jared Jacobs, and

the slides corporate presentation, which Please note we remarks, at our Jared's of intend to website available in within IR that during reference section our data from is chimera.tx.com.

will we remarks, prepared the call our Following questions. open to

We you and limit enough questions a questions. your relevant address have to ask we please that to follow-up one to time everyone's ensure

we Before about would statements our you remind future expectations, that prospects. to today's begin, plans, will forward-looking I discussion include and like

that materially to actual These statements may are cause from projected. subject differ uncertainties results to those and risks

A can these filed the found SEC. most our risks with in recent XXQ description of be

call. update obligation speak statements made Any assume we forward-looking of today's no and statements today's any forward-looking date, only to as on

turn to With will call Nellie. that, now I the over

Nellie Monofi

Thank you, and everybody. good Justine, morning,

a have in. today, so important lot updates right let's jump of We

to we enter First study and started extremely medicine we're first excited have and degrader, KTXX, that STATX STATX a the of phase development. first-in-class foremost, clinical oral the one ever

were we and to increased focus that our pipeline. immunology capital towards highlight growing to given of that to a important accelerate the path resources able clinic, It's the recent we're directing

an also moment the for is this important believe I whole industry.

STATX can cellular degrader shown both biologic importantly, KTXX vivo Dupilumab, IL-X upstream a have IL-XX species in even like like that and similarly, more an We models. than in preclinical and block or in

preclinical that wide we well-tolerated was KTXX a all species. have of in run that studies safety variety shown also We've in

a potential in investigational has the Dupilumab-like daily pill. we drug oral have to an In profile summary, a that have

the Many of inflammation. more suffer associated from just are diseases there XXX Europe, with in than THX you Japan patients and US, who million know

than less of data, those a receive Dupilumab. market million to According patients

on currently is effective pill. expanding of tens oral million for Dupilumab, millions focus access While waiting on of and roughly focused the one on safe, the patients Chimera patients could across convenient, a

require doctor's that syringes, refrigeration, frequent and to the One doesn't needles, trips office.

believe as EOE, to transform We such asthma, diseases the is treatment COPD, atopic patients, that has paradigms to many millions dermatitis, that affect name of a and medicine KTXX in just few. potential a

given addition, diseases in life that children, will change believe a the prevalent that potential THX has we to In the for highly are in many drug of future. quality families this be

to the point in half be Our Volunteer expected full of share Study first upon the next we the will results. STATX which at XXXX, update Healthy is completion of

completion our move Following phase the study, the of one plan patients. to quickly is into

plans next those stage provide and have clinical development to year. the we on We guidance next expect X-X of established, well

around more the Jared details call. study in ongoing later the phase will share one

KTXXX, update another IRAKX I on our degrader. briefly important also to highlight want first-in-class

Chimera program the with another to with first companies following and several that was other is has industry, lead assets. This clinic success IRAKX-directed where has influenced our

We Sanofi. being are on two our more the partner are phase share studies that information able run expanded finally to by

transitioning from of is phase of As to phase studies, fully studies phase B program path our powered proof-of-concept-like at accelerating three a today, of as the right two have ongoing registration you dose-ranging in studies release read earlier two means press may studies. conclusion our the to with the

select subsequent the so added of we to to one the the for dose registration dose studies. basically have study trial information we have changes, phase three of enough terms In group specific each

program. to to this confidence in are our important and partner commitment the We for Sanofi increased thankful

Turning exciting to as progress report to TICX, have well. we

lead At an in of molecule TICX R&D program KTXXX. we our day year, our January introduced this and

advanced we other promising on our KTXXX compounds. was programs, had through parallel as being of ongoing preclinical Similar work development, to all

in vivo a compelling more compounds profile. demonstrated by similar greater and evaluating were selectivity profile KTXXX, One activity we even with an of highlighted the safety than

a as KTXXX our we've clinical lead new candidate. decided compound the As result, advance to

our development without we of Finally, in that stated XXXX. previously believe start TICX do first timelines, which phase can the we half impacting one assume trial the

Finally, a programs. and update with broader wanted strategic to our it as pertains to provide just I everyone oncology specifically

As recall, increased it this focus year time many of immunology. in you shared that first we was we last had around our

rationale in we that injectable impactful in profoundly terms was safety. oral The believe of with generate with degraders driven efficacy we biologics compete by profiles the could could and immunology

TICX with and potential of clinic opportunities and the preclinically, millions to As shown oral patients. we're immunology our portfolio impact with with to assets think we efforts KTXXX in develop the STATX best-in-industry positioned of

KTXXX We clinic, today and the B KTXXX clinic. to close the phase trials, two multiple in with more have KTXXX in

Other exciting starting next unveiled immunology programs year. will be

focus time to this can We resources the we we where value. is believe space outsized more into create even of our now believe

enrollment, promising one will we we that result, As we've made KTXXX, have phase our our decision with progress our a demonstrating the activity beyond STATX clinical KTXXX, tumor a one a phase partner. types made only oncology completed degrader, while degrader, some with in encouraging as clinical we have of and advance pipeline, MDMX variety

that share to do it this so. expect on we'll sense can more makes You when if and

focused are contributed considerations pipeline. resources, on that our believe many internal to there both capital people, this we and While are expanding ultimately decision, our best immunology

patients. not without impact on we this thinking be decision did take or noted about should the It potential lightly that

who grateful their the Chimera families, and support investigators, to team We're and these patients, studies programs.

as trajectory XXXX, year-end, has see especially we the immunology it quite that pipeline. to had In is exciting in Chimera approach our within conclusion,

advanced what one become our We've in in biggest the could with clinic programs KTXX of the industry.

studies. into KTXXX Sanofi We expanded have two supported to phase advance

with a We've developed clinic. degrader the compelling closer to a are profile and TICX

in raised And our mid-XXXX into across have of through inflection XXXX, several million points a enabling cash and just approximately $XXX us pipeline. total we've to

programs, through Bruce the I'll details pause more third-quarter here you share let and Jared on our financial walk will results. and

to prepared remarks. end our forward session looking at I'm Q&A the the of

Jared Gullop

Nella. Thanks,

the in this phase the to volunteer IND-enabling one program As progression culminating it relates this first for immunology, initiation month. recognize and through study to of advance to first-in-class healthy I'd studies, team the adherence IND earlier like KTXX rapid our the

we provide of details a to I the design, As overview opportunity the on many design. now shared not phase the one quick wanted have take trial to

healthy volunteer and placebo. evaluating SAD-MAD trial to ascending The single multiple KTXX dose compared as cohorts includes

component, placebo. receives a dose the In or each SAD KTXX either subject single of

receives dose component, In subject KTXX of each a or either XX the daily MAD placebo over days.

safe to skin In that and main objective degrade terms we STATX doses to of tolerated. and can data in that of share, well demonstrate plan robustly trial the the blood is at are we

preclinical Based we our in strong degradation are of STATX which at biologics-like we models. or which activity more, targeting saw on XX% level is the our work, preclinical

of measured the are data translatable be shown have case STATX by levels pathway In to this patient in levels, that fact, blockade, to efficacy.

said, As we degradation safety tolerability from STATX have readouts and key and this the study. are

plan measure certain and in we specifically know, the you of many TARC, THX healthy volunteers on as IgE to biomarkers, our Additionally, study.

We impact fully an biomarkers. to these on expect KTXX have

robust is believe likely also much more and Dupilumab. be for true to relevant we as the patients, However, impact is in

phase for first With of enrollment in underway, we half XXXX. continue the full to one expect the results to KTXX SAD-MAD report

At KTXX's that time, we will share development. before stage the or also of for our plans next

program. I'll now our turn to TICX

stated believe phase the into new decision to do we the impacting timelines first study. Nello the for our can over which start XXXX development KTXXX, candidate, a of we the the half made of mentioned, one clinic, without we advance As

some around our influenced thought to comparison details KTXXX, KTXXX decision. particularly I that a would I to minutes take share a few

presentation, our slides website. the You can available on also program reference is in TICX corporate our which

TICX interferon On X corporate of can testing, pathways, IL-XX, that preclinical type demonstrated you the IL-XX, loss-of-function and showing potency slides and see of inhibition and potential XX picomolar recapitulate XX our mutations. the in its to human deck, of degradation KTXXX biology potent

Like inflammatory of spared signaling, bowel JAK the disease. KTXXX on the XX, a slide of not impact important IL-XX did feature KTXXX, treatment in any proteins other and

had compared slide vivo shown back to in KTXXX greater activity Importantly, as XX. KTXXX on

doses achieve With this TICX at has KTXXX predicted than loss-of-function activity KTXXX. and for profile replicate to what the was the biologics-like profile, lower potential

out franchise, our will I cover I&I IRAKX. round To

We are to development Sanofi steps has pleased that KTXXX the program. accelerate overall taken

the atopic regulatory dose X meaningfully the to reminder, the enable Phase perspective to Phase and program decision timeline. trials suppurativa X the with necessary with previously expand goal to of a pivotal selection ultimately directly a As to dermatitis and studies, was announced advancement structure shorter hidradenitis the

with the both trials. the increased strategy, being this doses evaluated size of in support studies has To additional

changes There study no are to endpoints.

HS just one to been and expanded patients has evaluate XXX XX placebo trial dose versus X will the to previously. compared from KTXXX active Phase two Specifically, doses of

AD increased versus three The to has evaluate from active and X Phase trial XXX XXX will compared to doses previously. just doses two KTXXX patients placebo of

completion to XXXX primary of for first HS dates the drive changes respectively. AD, half the and and These mid-XXXX

reduce a KTXXX to before the will X While time program path complete development it expect the that allowing we overall data that pivotal studies. readout, obviously faster meaningfully for the timelines Phase by extends

of impact programs, potential pipeline-in-a-product by We're representing progress and energized the immunology each our opportunities.

efficacy need indications. to multiple our uniquely high-unmet the oral are degraders development with believe and biologics safety positioned We both large opportunities of and have

Finishing up much on not earlier. will add more to what oncology, Nella I too said

I the But everyone STATX for KTXXX, degrader, at that Phase we of will to in sharing want ASH our totality be remind did X data the December.

focused included our patients population, lymphoma we promising Hodgkin's poster will a in results and reminder, presentation. As was the latest on responses the observed be enrollment that given those in

here and review ask results. stop financial quarter I'll to Bruce third the

Bruce Jacobs

Jared. Thanks,

statements then normal in and questions, financials all have cover overview to refer provide call, this XXQ, I'm a many to which you lot going we the press sure to our than release the our have we quicker you this morning. As and filed financial on I'm a and of

we In of $X.X recognized revenue. million the quarter,

and all the was collaboration. attributable to That Sanofi

the SG&A, the that's Combined non-cash was spending from $XX million of sequentially and quarter, quarter. R&D and stock-based June compensation, in down X% about excluding

quarter mid-XXXX. a cash the of ended to cash $XXX our we sheet, Finally, runway balance with million providing on

I'll to now Nella. turn back call the

Nellie Monofi

Bruce and Jared. Thanks,

enthusiastic open questions, reiterate front we're of ever we just want the that more the us. in to I opportunities call about Before for than

a drug Advancing based preclinical and our clinic milestone is for exciting the significant on and KTXX Chimera so with findings. the very we're a in doing industry, profile

which updates immunology rest We're TICX on on forward other we disclose, yet to sharing providing of likely executing have next the year. visibility programs, pipeline, look more and to pipeline and our we on

you forward our best-in-industry with to advance well-resourced and to degrader therapeutics, updated We're progress. our pipeline of look keeping

The provide multiple these twelve to to and sharing forward six you. value-creating we with will catalysts, months next look

I on and first-in-industry Finally, the endeavors. goals team deliver very continuing want collaborators Chimera and ambitious to to for our thank

I'll pause open here the call the ask to and to questions. operator

Operator

you. Thank

begin the and session. We will now answer question

then star your question, X a press ask may touchtone you phone. on To

please If you're up the handset keys. before your pick speakerphone, a pressing using

like time please press any addressed and it, question at your withdraw X. then been you has If would star to

question that ask one to one limit you follow-up. We yourself and

momentarily At we pause roster. this will our time, to assemble

Mark Fram (TD Cohen)

for taking my Thanks questions.

data, where Maybe Healthy the for thanks target about clarity KTXX is. Volunteer profile the and the on thinking exactly

seem THX But really to Dupilumab, was seen what to to this as be thinking compare to. the maybe biomarkers, to through with alluded investors trying you

Volunteer study really Healthy think a How the you these decade reliable TARC do ago almost in IgE changes and percentage from are?

comparable to? range How how you a you tight to do think of need and get

Nellie Monofi

Maybe I'll start. Jared, please jump in.

to first but is, for main Jared study program, safety phase seen us, the first profile we that the from of as especially well-tolerated the preclinically. have we've for PKs explained, goal predictable translating amazingly is is The demonstrate and thing the that one any

we've a direct access we done have With unique degrader, as multiple biomarker. to this a opportunity times,

don't proximal use a have So because downstream and forget to biomarkers companies modalities they're lots of that biomarker. other not able

We biomarker, have is which most protein STATX proximal levels. the

IL-XX can protein that and IL-X in to show and we're fully. skin at look pathway block We blood STATX to levels the able

the has to That That's study. correlated disease only of the is been goal biomarker that impact. the

impact. has to correlated disease pathway the been Blocking

variants protective loss-of-function In where partial were THX was that found STATX recent fact, there of a against paper asthma. they

that So now, first protection the levels correlates THX. to in protein and time, function for actually

Regeneron their back downstream with others can't and long-acting direct biomarkers. at look they including measure day, companies, in levels because the Many biologics,

is companies. detected People have looked IgE and from I publications other IgE data, think Dupilumab TARC. mostly by recent at and

TARC and key phosphorylated STATX companies. for other levels are

of important modestly degree these healthy predict it to in variability, It's with to elevated intersubject reduction. difficult making that understand are volunteers, the

variability. you look IgE Dupilumab percent, sub-Q to paper in XX published the dose, XX healthy XX of impact at percent volunteers, with up between and the is If for

XX data from and phase XX biologics TARC percent, with IL-XX in line is one. long-acting in between

can data noisy. from I the since be people would exposure-to-biomarker discourage overanalyzing relationship

PK, STATX which and The are critical degradation goals efficacy. correlate with safety, levels,

within change other range known to biomarkers a in expect agents. We clinical seen

Sorry for the long answer.

Mark Fram

helpful. very but Long,

continued Then prioritization just the on immunology with model, the with more the Bruce: side? you maybe could of talk through

or Are savings from there immunology? be all any into redeployed oncology, resources will

Bruce Jacobs

a It's question. Mark. thanks, Yeah, good

some internally. clinical be pursued in savings of development we aggregate because contemplated plans the are won’t There

However, most be immunology of not all, will reinvested pipeline. our in if that,

know you haven’t about both includes of programs That clinical we development disclosed those and yet.

modest be guidance, change While there runway, savings might in be not change reinvested. our enough expect cash a our most to to

Operator

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

CalPIT Patel

taking Yeah, thanks morning, hey, the good for and question.

preclinically, Dupilumab to model, comparisons the made you the atopic regarding have especially program, ear STATX the On in dermatitis MCXXX? thickness

the IgE. reduction dose human in Also, kilogram does most per in doses? translate showed I to What that the think XX milligrams

Nellie Monofi

question. Great

We mice mg/kg, but in in use a monkeys, doses, degradation, lower XX% in single-digit XX-XX dogs to mg/kg dose reach effective. and are

higher monkeys, protein or a to compared humans. larger have Mice dose requiring binding, dogs,

accurate Projections are using or mice. monkey dog data more rather than

of exploration that dose will mirror our IRAKX likely Our programs.

Regarding and models lung models, biomarkers outcomes, for we THX and infiltrate using on focus asthma biomarkers.

a composite non-THX. Ear and monitored because thickness it’s isn’t more outcome

CalPIT Patel

it. got questions. taking Okay, Thanks for the

Operator

comes Tuist Please next Veraconda Crepa ahead. from from de question Our Securities. go

Alex Sanagathon (for Crepa de Veraconda)

Alex Sanagathon is this Hi, Crepa. for

On the TICX could do degrader conditions in like challenges you a efficacy asset: address IBD? think seen

trials? enrolling TICX consider you future Would patients inhibitor-experienced in

Nellie Monofi

question. Great

validated, driven molecules TICX function. multiple they forward, TICX inhibitors only have genetically address is and but partial

protein blocks entirely, transformative. removing TICX, fully we degrader the Our be which will believe

inhibitor, would looks like the degrader we have failed. If our

even an aim molecule for drug that more in active We a KTXXX. with biologics, with competes

the add recruitment do question? want Jared, on to you

Jared Gullop

initially on TICX wouldn’t enroll progressed prior who inhibitors. we Yes, patients

include tolerability who those to stopped might We due issues.

understanding efficacy the have on in but drug’s not progressed who study. be patients first prior Later, in we’d inhibitors, interested our in

Operator

comes question ahead. go of next Canino Stiefel. Brad Our from Please

Brad Canino

Hi, good morning.

the that will steps stated after SAD-MAD the patients question. You Dupilumab next replication THX major results, in for the be is but shared STATX

THX type to that’s of test Is best disease there this? a

be, would will or clinical required, and long endpoints need suffice? biomarkers testing How to are

Nellie Monofi

Great question.

The safely. have in phase biomarker STATX is AD to Dupilumab’s degradation goal one and well show therapeutic signature Regeneron patients. defined Sanofi

in validate in biomarker a degradation's could impact We patients. STATX quickly study

into This moving could studies key accelerate large indications. in

patient We’ll share studies plans for soon.

Operator

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

Gospel (for Vikram Paroheed)

morning. good Hi,

look and an On KTXXX like? what ideal KTXXX, would partnership

should we Are discussions a and soon? partnership underway, expect

Nellie Monofi

pipeline into clinic, well the has on comment activity. early discussions, translated oncology ongoing with exciting but our can’t We

for data and commercial Given we the partner with area. a franchises in promising look hematologic strong would cancers, clinical that in

while serve goal is on The internal immunology. to best patients focusing our resources

Operator

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

Kelly Shee

the progress, on Congratulations taking you thank questions. and for my

differentiators a or the STATX OXXX of are to from targeting compared perspective? IL-X, What major biological IL-XX,

could immunity STATX in as indications STATX pursue? is well, involved program innate the what so

Nellie Monofi

Great question.

blocking cells reduced phosphorylated by immune in STATX by those and IL-X activity STATX’s driven when is shown signaling, IL-XX pathways.

to STATX THX degradation expect We effectively. biology address

Gain-of-function are allergic variants partial variants severe cause STATX diseases, THX loss-of-function while protective.

IL-XX with diseases blockade, STATX potential like targeting and COPD, full dermatitis, IL-X more. atopic in mimics and asthma,

Jared Gullop

with degradation compared could STATX blockade sustained upstream pathway benefiting antibodies, THX to complex components. more achieve diseases

neurons key STATX degradation We’ve transcripts, human itch in models that and AD. shown in sensory reduces symptoms and pain

We believe provides STATX and targeting comprehensive approach. unique a

Operator

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

Jeff Jones

question. thanks Good for morning, my and taking

others your partner is Sanofi targeting IRAKX with KTXXX, STATX. On collaborating

a degrader and does your from compare, differentiation Nurex? How approach there is competitors like

Nellie Monofi

drugs, data company only showing STATX activity the extensive We’re comparing to better. Dupilumab-like approved with or preclinical degradation

blockade. Our that unlike degrader blocks STATX fully and pathway signaling, inhibitors may not achieve full

believe on highly that rely have potent, a We degrader we correlation. doesn’t PK/PD catalytic

since It’s on hard shown haven’t candidates. data comment development to competitors they or nominated

in in this space. remain leadership We confident our

Operator

question JP from Eric next ahead. Our Please of Morgan. comes Joseph go

Eric Joseph

in the numbers morning. Could good components? dose and discuss the of you and SAD patient number Hi, cohorts MAD

partial? components, Will the or be first-half both will include it readout

is Also, prior the a one IRAKX roadmap for phase good expectations?

Jared Gullop

is full phase provide details, one can't reasonable. IRAKX to We but the it comparing

and of be days SAD MAD Both XX components MAD involving placebo-controlled, will dosing. with

set data next year. the complete report first the to SAD-MAD expect in of We half

Nellie Monofi

participants will SAD entry showing MAD. clinicaltrials.gov soon, XXX and trial be around for on The

Eric Joseph

That you. things. thank clarifies Great,

Operator

from ahead. of Our Ellie go Murrell comes next Please UBS. question

Sam (for Ellie Murrell)

it's Hey, for Ellie. Sam on

discuss efficacy IRAKX's you HS versus confidence Could your in in AD?

you after move soon do into studies, an KTXXX how timeline to patient filing? Also, and any for SAD-MAD IND expect

Nellie Monofi

plan to not soon patients into yet. but phase We details move after we're one, sharing

will strategy when more. competitive Our disclose dictate we

thoughts on your Jared, IRAKX?

Jared Gullop

mechanistic in HS high confidence have AD on data. and based We

HS we both AD trials. robust and biomarker in expect phase efficacy two in Phase showed symptom and one modulation patients, so

Operator

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

Michael Schmidt

Hey, you on-target On expect off-target high might KTXXX, what good morning. potential or in are doses? AEs

models? from have do you learnings STATX What knockout

Nellie Monofi

dose events degradation XX-fold adverse STATX in even studies. question. has effective preclinical shown at Great no the

testing. off-target no highly is compound extensive activity selective, Our in with

protective in humans are fertile, STATX and knockout and are THX diseases. partial loss-of-function mice against variants normal

is safety and clinic. believe our target perfect the to hope a We STATX translates preclinical

Michael Schmidt

for will How subsequent you Thanks. prioritize indications studies?

approach? Are top and the do broader AD of asthma you or at list, the have a

Nellie Monofi

consider We limited to AD or drug, THX KTXXX a asthma. not

relevant aiming indications diseases. COPD impact, AD, addressing but all committed large asthma, broad We’re prioritizing for like to and are

Operator

Faisal from Partners. next go Khashid Our Please comes from question Leary ahead.

Faisal Khashid

taking about you potential for it’s realize early, for I KTXXX? but question. thanks how Hey, are thinking the partnerships

Nellie Monofi

to We through we’re two KTXXX for it now. aren’t right B. positioned thinking phase about best develop believe We partnerships

When we focus advancing phase get options, consider closer ourselves. our we’ll but our is the program three, to current

Operator

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

Chuka (for Andy Chen)

clarifying changes. for IRAKX thanks the Hey, trial

Sanofi safe were previous enough? that because an is not is doses too adding effective dose; extra or

Nellie Monofi

Great but about The or question. concerns efficacy fulfilling isn’t safety additional dose requirements for dose-ranging. regulatory

Early showed so data enough for meeting this phase regulatory promise accelerate study, the three. is to about expectations

Chuka

you. sense. Makes Thank

Nellie Monofi

Thanks, joining. everyone, for

hard Thanks for follow-up questions. We’re collaborators always their team and for available our work. to

updating exciting Looking on to forward you year our ahead.

Operator

This concludes presentation. today’s

You may now disconnect.

Kyverna Therapeutics (KYTX) 31 Oct 242024 Q3 Earnings call transcript