Earnings call transcript Q4 2022

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Operator

Good morning, and welcome to the Selecta Bio Fourth Quarter 2022 Earnings Release Conference Call. [Operator Instructions] Please note this event is being recorded.

I would now like to turn the conference over to Blaine Davis, Chief Financial Officer. Please go ahead.

Blaine Davis

Thank you, and good morning, everyone. quarter Conference year Call. fourth and Financial our Update Business to and XXXX full Results Welcome Selecta's in The and the is XX-K which Investors SEC. of was available the release for Exchange in at press reporting December this the Commission and our the year filed Media or XX, on earlier Annual Securities Report our financial ended results website Form www.selectabio.com XXXX, section with morning

Kei Kishimoto, me and Officer; Joining today's Chief Traber, Peter Carsten call Officer. Scientific President Brunn, Chief our on are Medical and Officer; Executive Chief

are we statements, our clinical candidates, call, potential progress statements today's described safety, subject that will on quarterly without the the statements risks plans, Form Report recent product with our financial During made subsequent These in filings be including Form projections making forward-looking about various are and of our SEC, including, and certain efficacy our most reports XX-Q. regulatory on Annual to prospects. and and and expectations, limitation, the future XX-K partnerships

cautioned required management's to to today, statements, of reliance speak undue and which even not law, except place on as forward-looking X, statements, as disclaims such these any only update XXXX, Selecta views obligation change. by if March are You

like that, call With now to over I'd the turn to Carsten.

Carsten Brunn

In clinical its to on differentiated once-monthly I Good priorities SEL-XXX from partner, steady III of results confident year. throughout DISSOLVE make we SEL-XXX’s in on our trials XXXX chronic in we to based from this execute the and our multi taking dosing [ph] trials Blaine. improve data and We suffering to collaboration the of In profile expect of Sobi, potential quarter with we line the quarter. we we’re the reach milestones lives we time across morning. and top which observed continue regimen, patients believe and everyone you, I gout. from appreciate to pipeline, data announce today. remain blinded first remain of Thank fourth previous to key our join in this to well-positioned the later the us Phase progress XXXX, the and II convenient months refractory

safety to plan development combination IgA our we clinical next-generation to trial and our continue our the programs forward. recently of ReiMMAgine our Notably, or SEL-XXX growing treatment clinical an MMA, leverage autoimmune with in Phase propel to ongoing treatment programs to ImmTOR for advance Interleukin-X we database broad of of methylmalonic for indications a for the protease acidemia, Further, IgA IL-X in candidate be of Nephropathy. an or as well identified candidate potential set started ImmTOR as I/II

with accelerate following in to Astellas IgG AAV-based an combination virus a study early Protease or we of signed ATXXX the Xork continue our also in January, Pompe adeno-associated deal investigational with for treatment called Late-Onset involves which We Xork Disease.

As value we we advance and additional our pipeline collaborations our intend maximize of continue pipeline. explore to ImmTOR platform disease autoimmune the to look and to ahead, in

our treatments of activities standards versus T-cells to adequately current recent like in often unwanted the for the fail On these the Unfortunately, associated care provide challenges utilize share imbalance programs the and this or regulatory autoimmune of growth and effective update to with malignancies align company’s cause T-cells. an treatment. drugs serious is disease disease, trajectory, of symptom-masking immunogenicity. on patients which immunosuppressive these infections, leave on solve address of an mission vulnerable underlying the we’d cusp moment The details pivotal to to toughest with how

of immune by has and the restoring T-cells the potential Selecta’s in and of immunotherapy. tolerance autoimmune autoimmune landscape duration expansion induction Selecta, in are believe we’re At still evolution IL-X, balance reimagining regulatory transform and ImmTOR treated treatment potential platform further through over XX vivo. the diseases. system has diseases. of the We that The natural tolerance million combination precision patients represents immune to magnitude we immune from There of an which for Americans ImmTOR-IL enhance suffering to ImmTOR call

differentiated that and IL-X believe ImmTOR-IL an suffering in autoimmune for for those be that liver. to the to has ImmTOR with candidate on be this initiate be plan combination have multiple We pipeline indications We started study XXXX exciting a this focus preclinical with potential initiate studies plan potentially to autoimmune ImmTOR-IL We our in diseases further from year expand of combination. will I also We diseases. enabling truly with with while chosen first-in-class to autoimmune the multiple development studies initial may disease. in exploring suitable advance treatment

thereby has Moving therapy patients to of receive the believe and such is up of ImmTOR treatment mitigate to and to doses, the therapy, vertical, potential and broaden AAV gene safety ImmTOR patient gene population enable our initiated dosing from MMA. I/II efficacy designed for low-and-slow. we the on an trial effects lower with SEL-XXX, gene for combined a we gene ‘XX, associated benefit AAV [indiscernible] which transforming December of higher of therapeutic to therapy. therapy AAV the titrate Phase therapy In clinical a to side doses one-and-done vector the enhance ReiMMAgine, paradigm to multiple with

and X.X to a human where titers at efficacy we We at the XX potential indicate volunteers, on study and subjects is utilizing the primates provide to two now and of subjects the ImmTOR that additional aims antibodies dose of SEL-XXX. monthly proof-of-concept safety, Day nonhuman mice preclinical Nabs. mg/kg, below our Nab ImmTOR anti-AAV our single have enrolling of inhibition XX. all healthy in ReiMMAgine two-thirds of below durable in at data maintained of builds and trial that ReiMMAgine dose or maintained doses tolerability observed ImmTOR this at believe The evaluate patients of X:X titers X:XX Nab Day with

be in current licensing dosing and programs therapy into a therapy XXXX, by to developed and from use an in their the human protease. of our prevalence derived IgG antibodies these ImmTOR Late-Onset the believe with follow. in regulatory next-generation help exclusive investigational Pompe result AAV-based We’ve their ATXXX, blueprint can against to partners we Xork Most a regimen that gene in treatment clinical development this Astellas a IgG gene adults. other future advancing can for providing and agreement development restrict as trial. January In SEL-XXX accelerate we for ReiMMAgine high utility. are clinic, Xork incorporated and pathogens Disease common By is use the of protease for there a announced the we pre-existing proteases

therapies trials potential it reactivity debilitating broader has expand we human treatments in investigational ineligible by anti-AAV life-changing with therapies the of naturally capsids. deliver differentiated to believe the due patients cross occurring pre-existing serum, gene selective has against antibodies gene gene therapy presence addressing a potential AAV to Nabs, of antibodies transformative patients Due Many Xork diseases. to its the to living to AAV for access to is low activity range against protease by to Xork currently its to we AAV. immunity and believe preexisting are clinical with

objective the to enable commercial help candidates development. not other plan make for value therapy our and commercial development to business viable gene who vertical uneconomic of The the otherwise may to and to of is bring options, targets pursue continue to We therapy companies gene out-licensing platform. candidates maximize patients hope to opportunities to their potential gene maximize treatment have many therapy of our

treatment to an our discontinue highly clinical many unwanted We be proof-of-concept in the served may to a of due XXX approach outcomes. over turning treatment. program, who dosed reactions or with for as resulting continuous response antidrug therapies. immune and ImmTOR reduce to the SEL-XXX, immunogenic, use biologics suboptimal believe believe promising immune Now biologics pipeline; to our to improved forced after ImmTOR as of to-date. patients adverse to biologics adjunct can advanced offers most an responses Patients patient has development our We responses platform antibodies be develop the experience

reminder, SEL-XXX Sobi and for was chronic to comprised a ImmTOR a treatment of refractory the uricase, licensed XXXX. As of in gout proprietary pegadricase co-administered with is

two of X.XX clinical SEL-XXX. with single placebo-controlled X.X and Phase program being pegadricase X.X Our In evaluated double-blind, and off quarter levels dose ImmTOR, at is trials, of of at mg/kg XXXX trials both of dose a mg/kg. III third DISSOLVE consists SEL-XXX level the in mg/kg two of kicked

to III this program, Phase partner, regulatory Sobi, and our to for providers clinical of to with on II we completion I later closely authorities continue trial are the our successful and track DISSOLVE work advance quarter. line We and towards data top the announce

SEL-XXX’s crystal in segment. Based standard is results differentiated profile dosing previous believe from In and on once-monthly treatment the acid as the observed this X class Phase X. statistically current or convenient and that clinically in tissue regimen, observed visible SEL-XXX in responders other relevant drugs we in target against and of trial, of both we’ve and well-positioned a periods without which care II well with we uric patients patient uric percentage our the trials serum tophi high as levels in significant reductions and tophi deposits,

immune These responses dosing favorable tolerability of achieved suppression. were profile, avoidance with and simplified a

or that to-date IgAN believe learnings or we’re IgAN, protease studies complexes a XXXX. the XXXX, and Biosciences biologics I-enabling disease for antibody leverage from promising December accumulates nephropathy IgA kidney in occurs AX, in we generated these indication initiate the of well-positioned data to IgAX, a IGAN IgA called In in With III, of clinical currently next-generation immune SEL-XXX and to when treatment in into selected Phase we an second immunoglobulin kidneys. plan our the

the IgA novel renal By believe our dysfunction. IgA of protease, the pathophysiology kidneys markers has with address injurious improve by potential of removing combining and approach underlying the ImmTOR we the from an disease to

to We We’re our of in of coming our extremely across year. our showcasing clinical of ImmTOR excited forward continuing applications. and momentum the about growing number data look a the platform the the advancements body in pipeline promise

Affairs financial more the I’ll for to quarter year. Financial Marketing full an on that, point, newly a turn call of years XX have for and Corporate Relations, life appointed experience and the Development, Davis, inflection record Sales focus Investor and him diseases. on our board. Selecta this Chief to our fit at than him impressive with truly track makes Blaine companies through brings Officer, science results critical to Blaine’s in at Business over With rare delighted run we’re Blaine particular fourth and ideal

Blaine?

Blaine Davis

to improve to I'm everyone thrilled team the deliver forward the and our lives our patients. we Carsten. join mission Selecta closely to working of with look as you, Thank

Now periods in for the incurred XXXX. the Phase supply from resulting license primarily $XX.X and program. I Sobi, of full XX.X the was for fourth to and XXXX. quarter our million, year $XXX.X XX.X would for financial respectively, briefly compared the and run by to full shipment DISSOLVE of Revenue was fourth and III the for Revenue costs with year clinical and million the agreement reimbursement quarter like same results XXXX through driven as the clinical

development stock The decrease and expenses for $XX.X was and million, the increase and expenses primarily and XX.X Research and annual $XX.X full million primarily increased programs, quarter decrease was compensation by driven respectively, for the a were XXXX clinical XXXX. preclinical XX periods the year The quarterly in compared expense by program. quarter and respectively, expense. fourth and incurred fourth million, and XXXX General driven in $XX.X expenses $XX.X compared the X.X same same year as were to in million the personnel for for full X.X for as for to administrative SEL-XXX and incurred expenses XXXX. periods

primarily quarterly stock in personnel-related The increases and expenses. by were compensation increases and driven annual

per million net full or share respectively. XXXX, net For income $X.X income of of $X.XX, quarter $X.XX per million share fourth and or $XX.X and the income basic Selecta year basic net of net reported of income

December as cash be to believe cash, mid-XXXX. fourth our $X.XX as Selecta cash of marketable compared We equivalents, cash net $X.XX in sufficient quarter of $XXX.X or restricted $XX.X restricted loss million to $XX.X had December million and share the of cash, reported income equivalents, or cash marketable $XXX.X XXXX, our securities operating and per year available meet For XXXX per and and share, XXXX. Selecta as full respectively. a million net will XX, of securities million into XX, requirements

back call to I'd that, for closing now remarks. like Carsten to the With turn

Carsten Brunn

In Blaine. believe milestones breadth we we you, further the innovative our validated on platform. and Thank of that ImmTOR XXXX, delivered key value

the refractory we identification Astellas gout believe with trials, We to that top II of and MMA, clinical I Pompe advance our to building candidate, the collaborations of chronic remain propel deal on our the announced in trial clinical Phase selection IgA in momentum of and III I/II our track IL-X continue we pipeline, later multiple on SEL-XXX investigating of next-generation Protease line from candidate and and programs look the Xork we to forward an recently toward this diversified and filings. data Phase an DISSOLVE initiation report for quarter. disease, can We IND established strategic

as refractory blind on We confident are updates the data, competitive forward to results weeks. but further and remain in We profile gout previous chronic to trials. stated, based to positive providing previously from treat coming in look potential SEL-XXX's the the

deeply we helping remain in challenges autoimmune Looking committed to the ahead, immunogenicity. solving autoimmunity and patients disease hardest overcome unwanted and

In to platform. the to gene maximize strategically seek parallel, opportunities of we therapy to to in vertical our intend continue our value partner

conclude we been once Before to the entire supportive patients way, call, including Selecta have the today's our investors the families. many again thank along and I team, would our like their people and who

happy take to With we're questions. that,

Operator

question first from our And Instructions] [Operator come SVB of Schwartz Securities. will Joseph

Joseph Schwartz

data data dosed expect I think, But we you all, to to wondering since from basis. if I know that if first as see I dosed could data patient of to you until this present first with set? SEL-XXX, study you’ve is ImmTOR. commencing? the the the wait first expect have patient, well previously without the ImmTOR you a expect initial you’re patient-by-patient that first might release wondering, what on more us was being provide readout you from was any on clarity to said I

Carsten Brunn

we've that's And is the in obviously, study, Yes, Yes, also Nab previously months three we are we specifically, this and a primarily of disease. but safety so as biomarker response. interested question. it's ImmTOR a report looking data, will interim -- the then data, great guided,

rightly you first only the patient of to the expect gene ImmTOR. we second receive this as will data the year, then receives patient the said, So therapy, end towards release

So release the end the we'll of towards likely data year.

Joseph Schwartz

Okay. PBC plan success? recent you perhaps could preclinical for new And suited any data [ph]? ImmTOR-IL, the early-stage I to we pipeline do then is your IL-X failure if in your was program why think on on wondering year? your SLE get do trial And across thoughts And better report you this

Carsten Brunn

we in ImmTOR of think with of Obviously, question. inducing by we great actually haven’t engineered looked obviously, data sales. expanding detail. another at is differentiated the really first-in-class where highly combination are that’s Yes, But and a an are lot we Treg-selective We IL-X. a the

approach a end specific is underlying I have -- think approach that addressing unique the chance better So the disease. -- really much and of you

low-hanging accumulates already fruit of of shown is the liver. in it’s We also ImmTOR going liver. diseases autoimmune And are into that because the of ImmTOR hepatoprotective. And we’ve couple models think we actually in really actually, alone a

DISSOLVE So release the eyes in which models we been that on, his encouraging. animal from we’re provide approach. pretty Kei the liver data this various confident also yes, DISSOLVE year, but And working on will the throughout we’ll team after after and very have everybody we’ll quarter are readout, more has

Operator

The question comes Kluska next Cantor Kristen of from Fitzgerald.

Kristen Kluska

quarter on first The to two gene one therapy.

some and the current but believe before your reading open regulatory for of partners how were it with could partners, with potentially to the data even in deals agencies that with to of out ahead of also your empty interested? given that door conversations MMA know data, the some are you that cases, wanted I So with willing could respective sign how MMA course, you capsid further help then others discussions the and your

Carsten Brunn

Yes, a question. great Kristen, that's

tremendous And a path. believe data give we have the most have I ahead think shows that chance a in important data this dose. of I capsid unmet and that clear signed the patients We prevent is and the regulatory mean unmet the there's an second NAbs just empty definitely to the available Sarepta, capsid field. deals empty of importantly, we fact a with two formation need just medical fact that to we Takeda receive need point.

helpful doses the way and in MMA be reason important. That's obviously, develop how program, case, along And MMA from the really we our partners will the guidance give study data that's actually and can well. running we're that monthly also clear think believe the ImmTOR. with on this to as I to ImmTOR of we the three

Kristen Kluska

have part of given data general say you’ve potential and second course, more safety durability the you here been others deals of been as, on you’re that you’ve the increased would seeing time, well. as is, to awareness of platform in there space hiccups the therapy as had able well execute this number over how Then has from gene

Carsten Brunn

you repeat up just the on you here my question, Can breaking sorry. were end,

Kristen Kluska

Yes.

just understanding that. about on The platform the question was potential. Sorry of awareness the

you’ve Given deals striking you’ve had had safety some as in have just the seeing others. well with this more been durability data, as execution there and hiccups through space

Carsten Brunn

sorry been I of field associated Yes, the setbacks with Yes, therapy years in with that. -- is have the increased there it. mean obviously, number gene AAV. and Got last awareness there's a about toxicities two there

I increase And is the with also, gene pursue gene solution redose a ourselves the but as is of ImmTOR of And IgG to in and a therapy, the we've we we around awareness Astellas in that. perspective. challenges testament pretty number our key the This patients interest which, I lot want in deal addressing is vertical a from really also think provider, a ability to to really as some but therapy. and think Xork acute ImmTOR, genotherapy been well. the number there's potential eligible potentially ImmTOR So with one, There's secondly, Protease of of position to partnering platform outspoken. awareness our to with

Kristen Kluska

what with? believe on essentially roughly be then I the could for your are in? of last list criteria wish some And Great. which evaluated ImmTOR-IL liver might start you is then diseases just question have you indication do the choosing you how more many And when

Carsten Brunn

in but also Yes, talk I'll our to interested Peter? other in great and throw question indications maybe that's why we're PBC, actually hepatologist, resident question. interested we're this and that. And about a Peter,

Peter Traber

for Carsten. Kristen. thanks And question, Thanks, the Yes.

autoimmune there and one, the such a and going ImmTOR-IL. giving data are There a we’re specific once is information and forth, are think more how of mediated be underlying we’re be with is choose quintessential associated to how affect your will DISSOLVE and primary clearly needs, liver that number on types mediology. an there out are important but the I diseases are biliary to more which autoimmune T-cell of more hepatitis. as comes medical disorder, liver question chosen, have diseases which about a giving are liver. autoimmune for so we a lot PBC unmet bowel to that of going But cholangitis, clearly even diseases has couple really we’ve that others inflammatory clinically diseases,

And are hepatitis then liver autoimmune parts forth. number need. But syndromes significant with of overlap each medical PBC and with -- there diseases significant represent so of collectively, those and -- affected individuals those a unmet autoimmune

While there’s primary therapies to there’s sclerosing hepatitis successful a available, autoimmune PSC. and no you know, cholangitis, only therapy as AI PBC in in single approach

our So we impact, we’ll which only area think Not make focuses. one. that there’s to an will the autoimmune be of disease, but a an one focus have in key there

Operator

The Canaccord next question comes from John Genuity. Newman of

John Newman

flares the as know I to how to specifically Regarding incidence addition improve data efficacy, the to good bit. safety, curious actually line be a some gout flares. you information just able that the may much to that lower for gout regarding the in able share be suggested you early developments I’m the might top that maybe of SEL-XXX, of

curious on line talk you’ll the able Just all, about be if readout? at top excuse that to me,

Carsten Brunn

let data, we've but I'll what note showing obviously, And the haven't the been perspective. we address expect to seen important so data, Peter terms the line John. that to blinded question, great a that's Yes, in completely what's top of we

Peter Traber

bit data clarify expect, tell I'll what program. Yes, of historical of our you little the we John, just kind from I'll a some but

established done. gout trials So pegloticase therapy. increase uricase all that -- of first That's that flares established been of in been by with have all, the it's well

receiving did you the trial, as a flares. start patients large get SEL-XXX was gout was body. In reduction there So reduce an to the early SEL-XXX. didn’t flares know, you reduction we which as gout COMPARE increase appear in II, a comparison do with some incidents flares in gout deposits it in real see I dissolve and and that urate you Phase trial with the XX in in Phase But

we’ll be periods comparison number at flares because we’ll DISSOLVE, comparing be the of versus best the therapy flares in gout the Now we’ll in able be gout of to different comparing -- look versus time we’ll placebo. doing of placebo. be And

data, that. So those we we’ll to have on will and able be report

Operator

question of from Yun next comes Zhong BTIG. The

Yun Zhong

to of that do So on choose I confirm preclinical question ImmTOR-IL-X. will the kind sorry, a is PBC you selection I I to the likely first indication or XXXX specifically multiple studies one I believe that the is PBC. follow-up press enabling -- XXXX. be don’t mentioned wanted in release indication for initiated see first still the mentioned that just

studies So are different for I indications. those assume

Carsten Brunn

and It's great very -- observant question. a Yes. a great

of As indications look We as are Peter to autoimmune also of that want I disease, we said, indications the where impacting like at of mentioned, there the interest little the but funnel well still is like open autoantigen mix. indications high the definitely and autoimmune PBC-X, are bit PBC, a high mean, united, broader Peter know PBC part as there's multiple liver with the hepatitis. suited for ImmTOR-IL other

still readout. definitely, and the PBC funnel the we want after we'll So to part detailed up mix, the guidance more open DISSOLVE but give of is

Yun Zhong

in very one. empty therapy the gene be exciting on happens the with capsid used I It’s which a Okay. to the Astellas. program believe second capsid But collaboration Then study. question AAVX the uses

of just are ImmTOR So both the agnostic wanted interest did in also also ImmTOR? study. just And any them used and Astellas curious, capsid to Xork I show that to the confirm in

not to effect is that choose. capsid the Is So affected which correct? by

Carsten Brunn

far prevents as Yes, the you're that's licensees Astellas both Xork We've approaches agnostic. know, of question. good exclusive use we are yes, right program. so for Pompe a in their that also as And And to that's for patients a Xork AAV same pretreatment, that exposure actually losing assume agnostic formation antibodies. ImmTOR of shown that AAV different we same the subtypes as And had. the the with the

Operator

of Blum Needham & The from next comes Gil Company. question

Gil Blum

simple a Maybe here. question

much to for the liver, pretty of going finding how So autoimmunity, a is be in even the this number indications partner? given large of

Carsten Brunn

a we've landed question large we that's and kind It a good significant a an as and prioritizing area. well. liver -- is Gil, of spent the as area, amount of on interesting indeed time indications Yes, kind of

As on I -- attractive, that accumulation are are actually. company as through commercial these indications there but all can orphan-type still think execute low-hanging a same Peter the mean then because mentioned, We the kind larger in we all indications initial which we potentially specific way there its At you can fruit it's do for disease but we interest. into liver, look execute of proof-of-concept expertise, that for on. time, are the that through the would sure, study, indications, this of given an are might the programs. partnerships but complexity to cost also see this of the

Gil Blum

organize us from things Excellent. to for of are milestones studies And a maybe the you readout here? pivotal Sobi positive just sort expecting here. on What for

Carsten Brunn

Yes. Good well. question as

I we've think in So the -- guided and past.

to of just the you terms. So remind overall deal

So Sobi $XXX XXXX, we upfront. licensed the received million in asset to

the million, $XX and regulatory development in million That's so have million milestones. $XXX and $XX in million received down broken Out also far. million $XXX we of in commercial. We $XX received

So still receive eligible we were $XX million. to

event are as eligible to. also, in We well. the receive then haven't And to which tied out double digits broken we to royalties are these

Operator

Marchell question comes Blair. William next of Tiffany The from

Tiffany Marchell

This is Tiffany Raj. for on

antibodies for just preexisting it here? that still effective use you much plan maybe you imagine For do certain could expand or prophylactically of a Protease a preexisting really discuss Xork And there’s Astellas how Xork you the might you can cutoff IgG imagine for do in the be to how the population treatable Xork, antibodies? level bit and

Carsten Brunn

this, kind Yes, how comment can great the that's but And comment I develop approach. question. of a view obviously, I to how Astellas just we plans can't on

which that specifically, data here prevent infection. basically IgG AAV there's cleave they natural had we're so looking from And patients a And preexisting Protease dosing. antibodies, interesting

receive between patients high more all inflicts necessarily looking natural that hear to AAV to had not infections. in the an We're So get titers therapy. XX% not eligible to thousands. were AAV AAV patients of gene And natural infection, at very a XX% to gene exposed therapy that

that very both perspective potentially that's a we why think So from Xork. commercial eligible part a patients also number definitely a perspective, patient attractive, double but license of played and of Astellas the you

Tiffany Marchell

to And Great, I any Xork, makes that? plan this year on additional sense. also that you share guess preclinical do data for

Carsten Brunn

So to we that. haven’t guided

at have think we additional data. I initial to I data. guided not shared specifically the we point, mean, have this don’t of But some -- we share

Operator

The Wainwright. next comes of from Pachaiyappan question Boobalan H.C.

Boobalan Pachaiyappan

Can hear me Boobalan. you okay? This is

Carsten Brunn

Yes. Boobalan, Thank you. hear can you. we

Boobalan Pachaiyappan

few A questions Great. end. from our right. All

firstly, to might have Filspari, of So of are you respect Nephropathy, obviously, you with IgA -- approval sparsentan. aware FDA

risk curious I’m alter liver the may fact approval defects. dynamics the how light increase was this that that in especially agent IgAN and approved FDA your program, So the of might of of injury the birth

Carsten Brunn

Yes.

see So maybe of truly it's a complementary really approach I'll approach our Peter? novel talk this products think why let little and to bit and Peter here about just we other a some development, the in

Peter Traber

that question. answer Yes, happy to

warnings latest to course, of but adults. on we age you're on starting don't issues, approval age think referring group be is that some group. I in based were program our the there that development anticipate will We what

-- approach, or IgA only approach, those type the see that the complexes in clear of improve kidney. effects of downstream approved at the all IgA to which Now upstream to We're targeting which the with the are specific looking regard is to deposits a immune development affects the production the of or disease. whether try in in will the kidney are have to that the either either been are steroid, approaches

development of So recently all the those our as been approach as drugs two in pipeline. have complementary approved well the is that to

But have approach ours from certainly recent the that drugs to exclusions no But by and the affect one approvals. additional standpoint is program forth. novel of so a with wait see and to development is inclusions this at how standard of approval Now that utilizing. will the and we’ll else point of and evolves large, care

Boobalan Pachaiyappan

attention there gain biomarkers thinking deeply addition close paying IgAN you’ll to quarters to specific you’re maybe your in the that the [indiscernible]? just next few As in about curious, are say program, in be confidence program

Peter Traber

Yes.

about So biomarkers, Yes. of effect in you're IgAN. talking

Yes. Okay.

variety number important That's would two we understood properly. are we're been important to Number But of markers on kind that of But of So utilize. most course, a one. is most eGFR, the other exploring that have important I eGFR. also function, effect your the if at, the and and are biomarkers the is excretion. might markers be be protein for kidney most and which one protein looked question excretion two albumin able urinary is urinary urinary

Boobalan Pachaiyappan

maybe then a question it. Got And opportunity in IgAN. market

So to patients. roughly XX,XXX XX,XXX

patients? So general for or that with it target or population is agent your planning IgAN a specific you’re to all there is

Peter Traber

Well, I are think that we that looking carefully. at

progressive rapidly that they that program will be made really how patient they decided patients we progressive function evidence to an disease those have We'll what all segmentation that in into take segment program. slowly the on. program. part focus haven't -- failed patient ways therapies, of whether there at were decisions disease. looking diagnosed, baseline progressive think focus of yet, are to have population haven't terms whether of Obviously, their we the be of but exactly or which account renal do different our they And segment important will our other is, when or we We to development

Boobalan Pachaiyappan

skeletal therapy the more a respect gene Great. should agent is And Astellas maybe cardiac plus it therapy your or a collaboration. gene clarification. to agent one your Is muscles. there to the Xork with get requirement that final This question and

Carsten Brunn

this If is I around Xork. or understand the correctly, question ImmTOR

address systemically do have why there's believe Sarepta neuromuscular But the migrate, liver-directed through also we data have a but where disease, liver, have partnership as [indiscernible] we ImmTOR the we partnerships that obviously, in obviously, we we a is at ImmTOR that and and works use could generated the hopefully Just looking rationale vectors. well question? all good with

Boobalan Pachaiyappan

the yes, was but thanks for not it there. was the color Xork So about ImmTOR, question about

Peter Traber

comment can Xork. the I on

works of neutralizing systemic of the included. the antibodies variance So IgG Xork through so

target as So delivered, be it's is, capsid the to regardless it's it's by of antibodies. where systemically neutralizing -- going going long the intercepted

the So should situation. in Xork be enzyme that active

Operator

question Uy from of comes Mizuho. Next Ear

Uy Ear

the you on MMA guess I So ongoing. is guys first are study that the question

see question X you of R&D projecting sense XXXX. a and what yes, therapy? if patients’ us seeing XXXX. of to it. is to given I can curious curious the my you’re It R&D sort of kind interest that’s in X DISSOLVE second of understand And flat for Just get essentially terms looks the studies, of to help And DISSOLVE better guess like just curious to how gene versus consensus think -- is completion the about the in

Carsten Brunn

to I'll running Great. involved is in ReMagine center single trial, we're the NIH, the Peter, question give the intimately which Peter? Yes. first obviously who a at at

Peter Traber

happy to that. Yes, answer

interest, the both forth. the a a the we the through terms website of Society, In have of this subjects deal Acidemia of course, gotten and done interest sequentially so promotion we of for the trial in And trial trial a enrolling time. patient lot internationally. is U.S. the Organic and over we of But are have good where

is like at on interested very we’re because group be course going enroll trial over dependent success beginning to the right it’s So going years. to a not the sequentially the patients of large of them two

the We been you trial end last has year. since is know, active. It have, as the of

extensive have the through treatment. date subject. that, that is and don’t the yet subject program to a is first specific going enrolled and along subject -- it's with have moving -- the evaluating but or screening leading for first screening timing up process a we And We subject,

Carsten Brunn

Great. And Blaine, handle the second R&D expenses. around if you

Blaine Davis

Yes. Sure.

kind we to expenses R&D the to of relative how organization well, specifically overall. think don't to expenses, future about for guide So

little context. Let me give a of bit

we a be pipeline the with have SEL-XXX other expenses. decent associated we'll program the clinical amount as of to around trial in with activity continuing will continue expenses So have kind sort well you that start activities as also number a associated earlier of then stage R&D-related of of And could to obviously XXXX. preclinical expect, as ramp-up

context expenses overall. some a activities basis. to do we at So I this to bit go-forward of start particular of of don’t the R&D kind on moving provide think of start guidance those We where shift XXXX. overall of the have there gives to study juncture think a of associated to about a are in ongoing number a kind that But But in hopefully, shift a and will MMA early-stage well have on want specific about be that as how will little kind programs as parts expenses. as

Operator

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

Carsten Brunn

concludes everyone call. thank us who today's joined and operator, This you Thank Thanks. you, morning. healthy. Stay and this safe to

Cartesian Therapeutics (RNAC) 2 Mar 232022 Q4 Earnings call transcript