ACRS - Earnings call transcript Q1 2024 | Aclaris Therapeutics, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the Aclaris Therapeutics First Quarter 2024 Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Kevin Balthaser. Please go ahead.

Kevin Balthaser

Thank you. Chief for Balthaser, Kevin am Financial Aclaris. Officer I we press financial release note and that our a today, earlier XXXX Please highlighting issued first business matters. other results quarter

you under the Releases it, of For our yet section the Press have website the posted find at page seen www.aclaristx.com. those release you who Investors will of of not

the our on slide portfolio, which ITK and addition, will the Presentations an our In Investor entitled exhibit we of the be we Form deck referring earlier Investors page as furnished X-K of be today. website filed to found section SEC a to can with that

Joining Joe and Consultant will me our and Monahan, Walker, our the Neal also be Chief Business Development available Wally the portion today Scientific call. call for of Scientific the are our Officer; Interim Chief Q&A Executive Officer. for Smith,

would operations prepared various results about forward-looking begin of our are statements Before objectives securities plans considered position, meaning the laws. for Aclaris' make statements and federal remarks, the during we that future of we to call operations and strategy business this I the remind and within you future financial company's like

filings on Aclaris available the website filings XX-K Aclaris' Factors to provided and no involve Our this differ the we reflected uncertainties events upon All www.aclaristx.com. call based statements expectations statements make Investors section Events changes and statements. being These are the Form Investors over of account of is SEC section with link for the Neal. provide and year obligation call makes can webcast results of page of now other on XX, from forward-looking turn section of time. These the December time of ended advised SEC current under under new such today, or and future accessed in documents call in the forward-looking any is otherwise. Please call circumstances, may information, to Risk this our the information XXXX, in we as website. I'll materially described today's page on assumptions webcast. that that the the actual are cause undertake be be those could recorded at risks, conference update to from are A risks to that of we the to our

Neal Walker

that to IL-X Thank for forward we Kevin. to overall study ITK small in dermatitis. Atopic that an review quarter, in T everyone. Good addition molecule disease, various ATI-XXXX an and reevaluating and activation afternoon, strategy, block a dermatitis IL-XX. production also ATI-XXXX, you, inhibitor. cost-cutting business proof-of-concept our is we Last our of TX in which oral and Today, indication I'm decided ITK we selection have to are cell-driven move of inhibition the to announce measures differentiation, a moderate announced JAKX pleased severe cell atopic is

data and In various fact, overview regulating there that ThX ITK far. have will both literature Joe? ATI-XXXX pathways cells is by of role production cytokines the we extensive generated are in plays of the we to an the on central mass an that and provide the cells. Today, signaling thus

Joseph Monahan

ITK site using for function drug focusing that containing a the cytokine-associated is kinase a ATP and receptor and drug and common generated X the utilize covalent the downstream files pathways through cell ITK that regulation treat cytokines Neal. cell effective IL-XX. ATI-XXXX from receptor, of structure-based the JAKX. broad T inhibitor you, of targeting of cell JAKX critical is high IL-X, positioned molecules targets as Connect while ITK for discovery is well Thank electro target gamma affinity signaling cell our reversible ATI-XXXX in and T similarly provides set as to as a with is was design, T T these of autoimmune diseases. the the such JAKX. potential the on of platform kinase ATI-XXXX IL-X proprietary that cysteine important required

the ATP also and in differentiates approved As binds proprietary demonstrating JAK drug, and JAKX, reversible shown complex. unique areata. on of the has Slide thereby is inhibitors, for with JAKX JAK ATI-XXXX alopecia ITK X, ritlecitinib, the therapy isoform both covalency and Pfizer's and ATI-XXXX pharmacology to by residue engagement demonstrated engages best-in-class was CYS-XXX targeted been and site. This ritlecitinib of which cystine also the in structure crystal CYST-XXX only this potential. effectively ATI-XXXX the recently from from

cells, exposures and stimulated an blood gamma translated alopecia potencies panel the shown MAD expected is readouts is studies lack in may whole less crossover XX.X JAKX-dependent production demonstrated ITK spectrum As to and on to to in dose the ITK ITK blocking JAKX X. The shown to human potent ITK hematopoietic relative the more is ritlecitinib human both panel on potent impact have on production, restricted ATI-XXXX Slide at pharmacology. growth on of profile with other in is ritlecitinib JAKX covalent JAKX of bias ritlecitinib, pathways coupled would on JAKs compares other inhibitors. X.X recommended to than the to impact improved blood but potency little signaling dependent comparable with anti-CDX JAKX right-hand on while in contrast differentiation JAKX-dependent inhibiting in on Clear JAKX stimulated fold in the respective meaningful gamma an SAD compares release. for the similar demonstrates isoforms. The pathway. ATI-XXXX ritlecitinib, both to the to be compounds interferon QD JAK the from left IL-X In selected crossover times JAKX X and PD potent interferon contrast, more expression ATI-XXXX ATI-XXXX for cytokine X, inhibitor of FDA XXXX readout. The no which in dependent high the XX-milligram for result inhibit safety Slide studies. has similar JAK and and ritlecitinib ATI-XXXX reversible for and areata, whole ITK of

pharmacodynamic analysis Exposures across and between Linear mRNA dose and inject in dosing was metal demonstrated per MAD important tech MAD on is simulation T XX. demonstrated X pharmacodynamic following is clinical shown and of X evaluating alone with the interferon activity greater of kilogram of swelling ITK cells Slide on by phenotypes right. current JAKX readouts in inhibition XX ThXX final and Phase the right the Slide ITK IL-X ITK activation. of XX% studies shows in required time-dependent and/or demonstrates key ITK activity inflammation as from colitis modulation is shows PD results target? from anti-IL-XXPXX THX are and with with vivo production analysis. characteristics the as ankle in left the the clinical response is exposure as study. a the for PK dependent blood dose both whole X, ilium model XX% X from observed MAD dermatitis. ATI-XXXX blood XX and X MAD the as The than gamma extent to and antibody. Preclinical readouts. Slide on of to XX dose kilogram SAD conditions. protected inhibitors mouse the is held-for-sale XX the the of well vitro all summarized studies formulated XX. MAD Slide transfer to have dual concentration under characteristics from Chao adoptive doses QD. Activity stimuli. of production distal THX understanding inhibition doses driven Treg disease study. histology ex PK Oral the the ITK on data gamma compares left the BID and and in number the PK dependent following the the models. proportionality in shown per studies with is observed the inhibition well translation on cell steady-state Slide XX milligrams such Of observed panel and the to and from X effective various atopic following shown of cells of and THX, the into tolerated, the phenotypes. activity right. generally pathways. ATI-XXXX on PD preclinical in and THXX readout as in following ATI-XXXX of for the X-week on demonstrate a in and dose-dependent ATI-XXXX These I ATI-XXXX as of ATI-XXXX BID. Slide oxime skewing AUC. Slide kinases, supported activation and drug XX was ECXXs period ATI-XXXX differentiation from observed advancement panel doses the differentiation interferon to adjuvant-induced in or role immune both The studies measuring dose potential the stimulation SAD shown of XX dosing TCR across the a as diseases the arthritis, ThX left of and human similar colon whole T-helper and knockdown an panel as ThXX the inflammatory ITK the the milligrams inhibition well was is why has proportionality ITK had at demonstrated oral results Cmax weeks drugs day shows human strong Now blood, also the strong stimulation the treat favorable study preclinical correspondent JAKX-dependent milligrams on from cells observed of and the of X

similar As is expected, observed stimulation and potency inhibition. dual pathway, the ITK JAKX for

Successful to effectively from Phase provide studies the both pathways. meaningful XX Phase milligrams sufficient completion blockade ATI-XXXX to Finally, were dosing, milligrams of the advance of exposures into to I X II. positioned generated BID

rationale first JAC positions be the T indication TCR evaluated atopic of dermatitis. shown for will XX. The of treatment which effectively specificity is in ATI-XXXX dermatitis, on which dual The it Slide atopic ATI-XXXX for

of the THX oral IL-X with for the and activation targeting potential role cell ATI-XXXX an ThX supports as cytokines, coupled to and these important The the biologics. with differentiation efficacy the alternative and biologics IL-XX ITK observed

add study is summarized on study dermatitis. a early the in should will efficacy IL-X ATI-XXXX complementary Additionally, as XX-week moderate open-label to dermatitis. The of and signaling examine number an of XX-patient of blockade efficacy of of inhibitors atopic be study the patients in efficacy atopic Slide safety, by inhibiting JAK XX. dermatitis PK signs JAKX severe of to IL-X evidenced the design through and This atopic with

dermatitis. of ITK on markers activity, emphasis PD there will study. of ATI-XXXX inhibitor atopic The demonstrate support clinical II next-generation a to as pathways feature I shown and provide is ADME In the our best-in-class advance moving addition Moreover, and molecule. In the SAD in pathway plan on into studies this to ITK moderate into ATI-XXXX and to study and potency, compound Nonclinical clinical severe Phase in is differentiating ITK JAKX. ITK with proof-of-concept potential data positive summary, beyond of from development. the ATI-XXXX we inhibition focused supported heavy of discovery Aclaris XX, dual the disease Phase importance the a safety clinical studies a our expanding Slide be as on in to reference MAD efforts readouts, a inhibitors.

proven interest in has poor for described clinical as on Corvus development. More difficult-to-drug properties, While in ITK efficiency focused biochemical on ITK over XX development. efforts pharmaceutical been to of in with slide XX. ATP-competitive of have clinical by advanced it have covalent has early to described be they years, the this recently, not inhibitors outlined and inhibitors a due the CPI-XXX been on Slide The companies of research have evidenced kinase pharmaceutical

inhibition Slide of diseases, JAK supports on inflammatory and a range on and diseases, are kinase T functions as potential of ITK data that a inhibition and Our pharmacological provide a inhibitors on validate THXX This, targeting genetic broad Slide crossover number the indications. the are in of and cell Human mouse of coupled XX. Selective efforts and summarized and biology ITK both regulated strongly modulation this ThXX-driven as focusing next-generation involved on for THX of selective as should of T with approach selective XX. as cell atopic with shown of ITK effective as treating an well ITK pathophysiology. treat fact role eliminating to cells immune

Neal Walker

it turn our now to Thank financial highlights to for discuss you, I'll the quarter. Kevin over Joe.

Kevin Balthaser

Thank you, Neal.

marketable balance year-end. a a $XXX balance and maintain compared $XXX quarter We with strong of million outstanding X was with securities first sheet cash to to equivalents at which and cash, debt. ended million, continue the We robust cash

and in and associated quarter, force Of with by the including million of to be force announced and are development in first the the Our are nonrecurring cost to our research cash XXXX. agreement. Activities substantially owed progressing third by amount related discontinued for second reduction December the initiatives and track impacted payments expected parties reduction completed expenditures was total severance nicely. licensing programs received to Sun upfront the benefits the in approximately individuals related quarter payments, $XX under on in to programs, discontinued containment

result, we the business when year development remainder significantly quarterly with quarter any potential for be our cash giving effect a a As basis reduced expenditures the transactions. the on without expect to compared first of to

opportunities that, the over We capital continue turn closing our I development source of term. With across of to be evaluate could for back assets business nondilutive near remarks. call to in the now a Neal will portfolio

Neal Walker

Thank you, Kevin.

are pleased We atopic portfolio indication the provide for proof-of-concept you dermatitis update to first ATI-XXXX. decision to our as with to the on shift

questions. forward near we reminder, of process a term. Kyle, and are still options updates would like forward the providing in reviewing we now As strategic for moving to the look in various poll to additional

Operator

Song of first Jefferies. question, comes for from line Roger the And from Instructions] [Operator it your

Jiale Song

starting Maybe the Great. question. biology with

and pan-JAK of the a IT understanding JAKX for the to has you lot So the compared seen advantages. the inhibitor

how about additive see curious JAKX JAKX of inhibit preclinical for in think ITK And you -- of then just I have have do those any compared curious the synergistic for IT or and both question. when a you Just model? effect kind having alone clinical the those in they're you Just if you follow-up the preclinical terms models? or

Neal Walker

Yes. ITK Wally. and attractive of things one hypotheses could and/or our that indication the with and effect. really start Roger. But there. THX it if that's atopic effect the see a Thank the to molecule boost about we ought an We layer in inhibit to I'll yes, the the targets it maybe about of particularly Joe one was where JAKX more robust original you, like then on hyper then ITK,

at preclinical out didn't I know ITK so effect actually, anything tease markers you in there? this, proof-of-concept maybe, we study, differential that if initial definitively through And going to molecule. to that but we contribution in you want out pharmacodynamic endeavor that add Joe, prove from hypothesis various will looking tested this certainly to models. And the And just forward, out ask

Joseph Monahan

add in that model T profiled is doses and Yes. XXXX we JAKX that in activity The to would ritlecitinib thing ritlecitinib. cell we with and inhibitor, adoptive did I ATI-XXXX transfer selective have compared exposures, of equivalent see only boost anti-inflammatory versus colitis the more a

Jiale Song

the curious that's be Phase in Got to efficient it. ITK to And market dose. I Yes. selective the understand Phase II, and to you're compound. Phase test sense sure. compared component. XX then the the makes the terms selecting IIas, want That see Maybe more JAKX, PD more But to in mg of capital the II for the BID at you windows.

efficacy efficacy to also testing IIa, trial? And then kind will any ultimate do the the you signal, future the some tell you that the you forward? what of And potentially in can dose for clinical also potential but for if that curious, dose those powering Phase order goal move IIa dose is the other other what the preclinical? think dose best is what's see Just Phase dose the from for

Neal Walker

Yes.

label. So it open is

that show in-market objective effect. of the So in something the think this fair to JAK mean absolute I of to want from see north treatment is And to we some inhibitors. be our indication, my main I standard AD one? to set the of historically, second from perspective. efficacy the perspective, first they've want in the do rate. And for tackle we Joe, bar you then question, -- placebo kind an the And understand

Joseph Monahan

Yes.

do to our higher the clinical ritlecitinib -- they have study with milligrams this the in looked on than with coupled the of preclinical exposure XX BID with we if that ability we that various based choose models the had. So data the in identified dosing, dose disease in milligrams in We BID, all, at, exposures XX go regard first to. we to as

is against more It think both I Cmax. BID C level and And of ITK doesn't be inhibition we have ITK equivalent at exposure higher driven driven potency JAKX, BID, significantly against C C likely ritlecitinib have at XX-milligram trough. seem driven It Cmax potency this doesn't we with by described. XX JAKX by at And and by as to does average. to dose. be the average, this as we a mechanism. of at It milligrams seem more

preclinical So on dose. to chose ritlecitinib, based the and we models based the comparison on how that's

Operator

for it from Thomas Leerink Partners. Smith And next from Instructions] the [Operator of line comes the question,

Thomas Smith

is on up all curious I just comparing Just I'm atopic and indication models in like rutlicitinib. the to selected how if comparisons appreciate generated an any data. likely stack the preclinical JAKX any preclinically? on data versus dermatitis inhibition upadacitinib in versus upadacitinib? XXXX you've thoughts And to XXXX

Neal Walker

Thanks Yes. for question. that

the really ITK inhibition the X at -- the ITK it cytokine. think is on the here when it's to ThX I think in look literature And I inhibiting inhibition. you factor skews general,

et So IL-X, it IL-X, directly cetera. acts on

that give so direct not covalent a JAKX, in we And is AD. versus I'm the going JAKX comparisons really JAKX think of Wally, that, boost. Joe, aware the between pure to side specifically,

I that think mechanism we've a dual ought have an we our synergy, hypothesis when you effect. -- have and additive to demonstrated

to So be the goal that outperform upside. is would

Thomas Smith

clinical a But IIa definitively And the specifically, you're have -- curious that an the look little I'm some of in talk terms trial of versus in maybe a choice Understood. just design? That's It rationale Phase can a to terms you design, of signal the biomarkers, finding. just larger design trial helpful. identify maybe at here slightly signal like open-label on like interest I the you you'd open-label choice placebo-controlled of here, teasing guess, sounds design. bit? about take in out the the more

Neal Walker

-- and what for was our a And categories, molecules a be looking different things. speed. think to is when like if studies days this other in across just One good these we lot And enroll do, think competitive if signal get drug think study these needs finding, have think of just an relatively very responder at lot a these I active look Well, a these the we is kind understanding I can absolute of environment couple the way what -- answers. And measures. goal pecitinib easier what and we we of surrogates cost-efficient rate that all to of it's arm. know we're to relative I I a it's a have that compare

And out be so we quickly works little would it and balance here, we the in to I data certainly think a has indications as some blaze at ritlecitinib get areata. started ground bit Vitalia, study. as in that that can. of expect, looking if progressing looking alopecia already And to way at trying interested the larger the we looking hope was also But importantly, the AD on, at

I for of different we We us premise study. enhance given which AD So we're we is original initial question, think this having couple of and lose post to But think a don't just data placebo a too group. the back to cadence that I think much where think your at go ways the there's moment. go the to important at, enrollment not quicker, when get I I

Thomas Smith

data makes with operational the the able early sense. putting some to I early Neal, along protocol lines, to we just IIa? are and line start? And together Got preparations Phase when respect sense those have guess, -- an study be might it. I Like we're the understand expect Do of That from top you underway.

Neal Walker

a call, get be in. think don't it's Tom, -- that give first be this back-end but giving of patient more we'll within going color year definitely give as I just -- you going right? So we that but to marker, it's guidance I'll it's the we're once on yet, a to

Operator

Jenkins Goldman line question, from from it And your the next Sachs. of Corinne comes

Unknown Analyst

This Corinne. on Omar for is

questions. the are a strategy, couple dermatitis? complete atopic you then to in And see One funded need on proof-of-concept I study? unmet where do had is, So of two, you

Neal Walker

cost-efficient study. to We're design. This is study, which exceedingly complete was certainly by funded an kind of the

the in so lot a is more a last And more of UC, trying This in to time. was generate at quickly. was to year, lot we we're study which a to contrast data what originally which very end proposed take expensive going had tail

balance through So sheet to And the we as to end Kevin a of his change balance year. is robust not comments too going the appreciably that have in sheet. alluded

we burn amount first was a continue -- options. And to the sorry, -- what very second so the feel question? we And small very comfortable. various what It's of while review strategic

Unknown Analyst

see or Yes. the Where a do dermatitis strategy? need in atopic unmet you

Neal Walker

aren't Yes. could the certainly ago. market. We psoriasis this efficacy that Week even Obviously, a We're XX% suboptimal get by wildly in near response. think dupilumab a -- atopic space. of is at we've XX% patients of getting anybody we successful but years clear I or the and maxed end drug of This front don't in is claim where out was then XX the clear those patients,

that's and -- So side. on biologics the

better we here inhibitor as we're think by lot JAK to where are see out any efficacy effect. is headroom landscape with is to It's approach the a its look because really lot that a in is A still queue? of -- where we're mechanistic tease And have continuing the this there XXXs. Kyle, aren't clinicaltrials.gov competitive side, you still what space. much at PASI space talking other this On to psoriasis let's to about evolve. but We can we in of there's we're strong questions starting is at infancy. people the in this the ITK do And category. trying AD in

Operator

Harrison question or Julian of the BTIG. next from line comment Our from comes

Julian Harrison

for I this And use if your I'm thinking portfolio you how can scope going covered. alopecia? that apologies already IP remind be if the got has we of on of late, a so JAK of But been opportunity to inhibitors few should wondering us the minutes about related forward?

Neal Walker

Julian. Thanks, Sure.

executed a year. for is that the Pharma, and have is the Sun far with treatment deals. One we date, of use we for And with alopecia. last various of which to had other ruxolitinib, types executed JAK with And baricitinib thus alopecia in had of time utilizing long ago duterated Concert, back also rights had transaction the or announced royalty the alopecia a securing other Columbia use was inhibitors who late areata actually to X method and areata. various Lilly XXXX, IP So for XXXX around yes, acquired so

molecules that have are current so those the IP. And access to utilizing our we granted X

a we X think looking we've at to Clearly, that it's the of estate. ways constantly value enhance done So be portfolio. valuable very deals. We'll

Operator

Our next from Alex or comment the of Thompson from comes question line Stifel.

Alexander Thompson

just then any you little guess And about for I Pfizer on there compound. expect if Alex. black guys the more is a box It's the talk warning? you case this differs could how differentiation box drug the bit black warning? from Do

Neal Walker

a Thanks, and have black different about have a of warning, they're all Sure. Alex. black thinking through do process all box. you until whenever In have different NDA dialogues at out get tofacitinib, in think you actual slightly lot those an tickling if that Think JAC is But we're approval there, inhibitors you cetera. and different. you'll think the always this at box stage et to JAK you than go the boats look

drug will data and you some between question -- Joe, rutlicitinib. our differentiating that. key the features are about And drive of different the So if maybe can the what handle

Joseph Monahan

both that that exposures on colo depending they -- on ATI-XXXX us potent than what used. is we on the and you plan including are clinical to a doses they're have differentiation and use in of I use potency The very and when is similar ITK. inhibitors And cysteine The see readout to tactics. And with of any that and cases contrast, it's JAKX what type target is key potent It's lot it more significantly mean, similar dose ricitinib inhibitors has kinases. both residue Yes. a you XX. ritlecitinib

block and clear I a clinical JAKX significantly little have exposures whereas more exposure. that ITK, of and similarly ritlecitinib bias ITK that pretty we'll dose JAKX think the drug with on is impact it's

Operator

for the And Gavin from your ISI. from line Clark-Gartner question, Evercore next it of comes

Gavin Clark-Gartner

believe things, view of profile that black just JAKX. box the from other to the safety how will relative the Apart you I'm providers side wondering

are rheumatoid wondering some that space hints I'm there into alopecia arthritis or the if may may Specifically, any how this. from give learnings view they early even

Neal Walker

tell think having I because a the list mean, Gavin. chore a face, Thanks, you things a say, I well, then And to and the It's it practice for Yes. happen. good black laundry of oftentimes, on I that it's explain at could you look physician the could box. of question more it's

colleagues years, that think, it's that really a of However, And that know really disease at been I end their their there talking I don't in really last patients I off of to big I once it's all. reflected think would think couple sales. various you say to the don't in better. of over the been day, hindrance much at issues. explain tail the the be hasn't And want we and

have In in growing areata. fact, alopecia baricitinib been

a You've with growth nice of seen provides it for dermatitis. atopic RINVOQ over biologics, magnitude And sure. in there's order benefit reason

patients get of the a that's think waiting to end perhaps at and to take, the than they're quickly relief I know So when kind very XX for of day, want rather to it max they biologic going get weeks effect, important.

Operator

closing to remarks. give I'm questions showing to back no Walker for like the conference now Neal further at this would time. I

Neal Walker

thanks excited appreciate updates in provide coming and call today. months We're time. your Thank the to joining our everybody for Well, additional you.

Operator

This call. disconnect. participating, you Thank concludes conference and for now you today's may

Aclaris Therapeutics (ACRS) 7 May 242024 Q1 Earnings call transcript