SELB - Earnings call transcript Q3 2018 | Cartesian Therapeutics, Inc.

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Operator

Welcome to the Selecta Biosciences Third Quarter 2018 Conference Call. At this time, all participants are in a listen-only mode. This call is being webcast live on the Investors and Media section of Selecta's website at www.selectabio.com, and it is being recorded.

For opening remarks, I would now like to turn the call over to John Leaman, Selecta's Chief Financial Officer and Head of Corporate Strategy. Please go ahead.

John Leaman

morning good and you everyone. Thank issued Earlier third we release our press XXXX today, filed financial XX-Q. and we quarter updates, results containing corporate a and our other our XX-Q accessed and can release www.selectabio.com. the by This visiting website at be our of joined Stephen Commercial the the will call. Smolinski; I'm for us of Officer be members Chief joining Werner other the by CEO management today Cautreels; and Q&A portion

future indicated remarks expectations, get Harbor Before Securities Selecta's and filed with of may about report like that in certain are XXXX. those be of we'd statements that these call purposes XX-Q made discussed forward-looking Reform result most started, on Litigation selectabio.com. Risk forward-looking Form which factors, we SEC, the provisions constitute results accessed those as section advise Factors recent company's plans prospects the at including Private statements materially the this during to Act Actual differ quarterly of under by also can of from the for the Safe a the various important

of of subsequent forward-looking representing In as views the only upon and November views be X, the XXXX, company's as company's any statements should as represent date. not addition, today, relied any

update to While Selecta at any in some point future, forward-looking may elect it to so, these change. even views statements do the obligation disclaims specifically if management's

things kick Now, will introduce off. let who Werner, me

Werner Cautreels

shows real flares us clinical well gout it robust change the our gout fulfill lead patients gout approved, achieve on severe John morning our package convenient treatment generated with this to severe Thank needs could the who if SEL-XXX chronic accomplishments everyone. options. in study positioned and has chronic reduced X good once-monthly has clinical of the a chronic serum and sustained make several important new collected for believe patients of you, for that need treatment therapeutic Phase severe unmet In uric We dosing. in upcoming based We that several SEL-XXX data are program particular clinical to reduction, date, milestones. believe to patients, including in potential paradigm year's

the the Let us uricase superiority KRYSTEXXA, FDA-approved year. into data the therapy that me next head-to-head the you quarter trial in take of start going current against a of now confidence through gives first

SEL-XXX gout on Just receiving reminder, pegylated SEL-XXX as proprietary uricase. is of SEL-XXX immune technology, collected ongoing new been crystals period study inflammasome combination treatment five are we inflammation known data from ACR indicated at our five production. that not acid based on data repeated to to continued our rapamycin interleukin-X generally The at pending in in and mouse XXXX, of the an trending received doses have in in the of by combination rate suggest serum a inflammasome show milligram beta are by the of trial monosodium ACR urate impact correlates presented Projections model. mild pathway, the SEL-XXX, event, a in for that SVP-Rapamycin which in mitigation related the with study in X uric October production induced been also novel to monthly of will no data of addressed drug. patients five our of adverse a the patients a presented flares moderate maintain the had date data as SVP-Rapamycin, flares nor Phase the to or of related control against severity, of at data patients following monthly been month reported The patient active doses trial. XX% patients Chicago. the of In the deciliter still cohort during Overall to five X enzyme. therapy. resulting five cause ongoing in presented flares Preclinical SEL-XXX preclinical Approximately of believe continued with crystals approximately month interim and is Final activating doses has we the five potential of months inhibited may flares. the but after receiving per has X Indeed, experienced may monthly with out the beta in XX% Phase population conference. control and free data the interleukin-X shown then monosodium treated the pegadricase pathway of well-tolerated resulted first XX% the Phase discontinuation in flares administrations serious antibodies evaluable six below new reduction trial treatment up gout the of data to clinical had throughout be upcoming tolerance uric pegadricase, at SVP-Rapamycin, ACR and who that five. acid And of at to for serum clinically urate that cohort antidrug

over call our Officer, Commercial Stephen commercialization discuss our Smolinski, development and to will who Let plans strategy. clinical me pass Chief the now

Stephen Smolinski

Thank you, Werner.

are in initiate we start next to KRYSTEXXA, in year. actively the preparations We for plan the trial first head-to-head the six-month now versus which superiority engaged of of quarter

SEL-XXX interim and We first quarter six-month which and XXXX. KRYSTEXXA interim report three-month set, data data during will include data expect full head-to-head the for of in data XXXX to and both the

program. scheduled X an clinical discuss have meeting with our X FDA the to planned end-of-Phase Phase We

gout prioritize strategy head-to-head are are start currently gout and have unmet to decided needs same, X XXXX, we believe States head-to-head also a study, has severe of potential with patients. chronic year. start rheumatologists. later first the but the expect remains quarter to confirm small percentage to the and being the Phase We Our treated we the address plan SEL-XXX's patients which to only severe United that by ability to There in roughly XXX,XXX the the next several in for superiority we

patient billion call I back needs and to now aiming develop we SUA dosing, opportunity. identified updates. for population discuss this turn potential are other over currently flare low Werner and the in monthly the $X over As which control, consistent will address rates we to SEL-XXX, represents corporate has to unmet market

Werner Cautreels

Thank you, Stephen.

goal the it may immunosuppression. has the to has our technology technology, believe a For SEL-XXX believe use for In our of a be biologics, generated to including of clinical many the re-dosing we tolerance benefit we programs. We possible beyond with therapy. projects based in cure our other European systemic collaboration the it our we antigen-specific therapy promising program and CureCN, consortium a potentially potential SVP-Rapamycin allow new gene SVP-Rapamycin gene platform, from re-dosing technology pipeline that differentiated gene our working potential for Using of trials. rare third areas the Crigler-Najjar our full diseases of that in technology announced syndrome, the induce SEL-XXX quarter, to and the disease, ultra-rare of core on have AAV with therapy

John phone starting would I In of in Therefore to That was to who as the strategy for Xst. we toxicology appointment Selecta. have is Ph. that of the then the express upon to This Carsten a in candidate on It would in benefits that make like the really animal technology studies, in your confident quarterly will December. have and the features the is models. a preclinical combination therapeutic the potential years work update I D. on full has to transition financial work provide joins colleagues believe results. to company's unlock will over therapy. technology to for after over shown XXXX. discuss Brunn, quarterly means opportunity that preclinical second to closing, company call the of the Nature together With was opportunity the Officer webcast. Chief in the let this of be we December announced September, remain of has is with an the President he and with Executive enter of projected This in me interest Carsten gene SVP-Rapamycin the gratitude unique re-dose XXXX. in potential in with all the and work Selecta Genethon to ability the difference builds privilege Following patients. last Communications only unique in my my the technology product clinic turn that, to all to half published I the also to my AAV you SVP-Rapamycin to October therapies

John Leaman

Werner. Thank you,

incremental and third SEL-XXX compares for in revenue, quarter increase the Research compares which is of to the for result collaborations. which than the headcount-related revenue for to primarily development program administrative and of reduced third The result of $XX.X of the $X.X and quarter the XXXX from XXXX, for and the $X.X to patent-related company's preparation XXXX employee million, grants of were third no quarter General and Phase related reduction quarter primarily clinical salaries $XXX,XXX result of trial the quarter expenses quarter third cost of compares company with XXXX. the recognized is reduced the head-to-read costs. the for of trial, is costs million company's million, the of of XXXX. of the the the and and X Phase X recognized clinical were less expenses. higher third benefits for expenses XXXX. third the million SEL-XXX, For decline start The $X.X The which

for net loss For per $X.XX Selecta the million or quarter of $XX compared net the third period XXXX. loss to $XX.X reported of share a a per of XXXX, or share million same in $X.XX

cash XXth, short-term equivalents, September XXth, and compares had $XX.X of Selecta of and which to XXXX. million cash, million equivalents investments in cash $XX.X As at June cash XXXX,

additional sufficient of our head-to-head XXXX. sources that require KRYSTEXXA. an The to other fund against the equity company to conduct balance in operations is offering or the will expect planned QX external We trial capital cash our

Healthcare That will formal York upcoming XXth. our see Stifel We of New November be many at you to presenting hope we there. in the Finally, remarks. on concludes Conference

questions. the Now, open Operator? line for we'll

Operator

Thank you.

with proceed We your question the Instructions] question-and-answer The Please begin [Operator question. the will first Carter Gould comes UBS. line session. now of from with

Unidentified Analyst

for this in for Andrew is my guys, Carter. question. Thanks taking Hi

the months, mentioned pivotal see would had want So, generally the how readouts? first what coming the and XXX? six FDA And competitor rheumatologists ACR that three comfort conducting what the X. the you with with initiating Phase to get couple. Have to a conversations I comfortable on the with moving study had kind patients Just with gating year; following those or you in you Phase and for a initiating to thinking are And get that of factors head-to-head a of a market secondly, are with conversations sense X in is your about you. for since or forward you opportunity data prior have the month's quarter? those the plan had data to what wanted with immunomodulator a you next Thank

Werner Cautreels

to you and afterwards, the like address Carter John, would first right? then [ph]. Thanks Stephen,

John Leaman

have we've guided we an that's meeting, as happening quarter. previously, X So, end-of-Phase this

we what Phase of do understanding good a have for program. will we our will conversation, that in think I X

we've reprioritize And our of X we looking sort at of part were stated, always as commercialization the As development as that the described, program plan. we head-to-head Phase we of of part forward. moving sort and

So, we look like, the first the will good what quarter put I question, in discussions into of we're in FDA, the think with in plan head-to-head answering the sense trial we'll of year. doing the a X have Phase that your and will to that next

your data thinking that think the how going with reaction first question. address forward. to going we're ACR sort Officer, to Commercial answers swing Chief to it the Smolinski, I and of Stephen So, over the marketplace the rheumatologists our about I'm to

Stephen Smolinski

conversations I on had rheumatologists the think is and Sure. challenging and with some go rheumatologists it the I Thanks several patient have identifying that MIRROR conversations to John. seen several with of and combination the analysts, plus a right methotrexate about finding actually or combination study there've KRYSTEXXA. been Having that

that. ahead challenges So, there's I on think

they're market we to what taking out is again, I leaders think our where that do the hear dosing, complexity the control the system. of our But our think flare trying low kind around opinion rates to from we're I SUA of is important pleased KRYSTEXXA. once-monthly on and something them really and

is terms our what I showed profile So, our of pretty forward ACR to see I said favorable doing think they as what with leads results head-to-head with product we they're think trying moving that But, again, product. around in we're to really and well their our head-to-head. as do at something the rheumatologists

John Leaman

we is the of the piece, additional there as out we've we've And with think chatted or which in an uric in that, this strategies one for in strategy, I And immune with about and for fact our there's marketplace tolerance, platform. is the obviously, right? on serum additional talk I going months two immunosuppression is our tried about being to lot, trials that acid [Indiscernible] talks a needs it Andrew, I think immune highlight is I One which tolerance is an just patients what six competitors to marketplace unmet think there want by immunosuppressive described to are control. which do different basically strategy,

look trial, be ourselves And forward played do that so helping I that apples-to-apples to think the data. patients forward And think looking allow we and head-to-head versus we out. to KRYSTEXXA to will

Unidentified Analyst

Thanks. Thanks. whole might a of but as too a are -- happened part that the follow-up hasn't doing do for And these your you or or -- early meeting X studies I of envision this and X just program? separate in study comparator yet, on clinical little be head-to-head Phase as needing two a know active kind your extending Phase the your

John Leaman

think studies. two I And that separate we've way. felt always They're

is and think we with the approval that I we a understanding. have we good pretty think what to a and have pivotals, know pathway I

this are questions to allow think an what just we answer to allow is it in the head-to-head patients therapy it, one an I there can the marketplace. and think I best here apples-to-apples important know that with do because will comparison is

Unidentified Analyst

Thanks guys. Great.

Operator

question Please Co. & proceed. line comes Blum from next of The of Needham Gil the

Gil Blum

This is Chad. everyone. Hi, for Gil

of have I So, couple questions. a

dosing gene First repeat dosing on correct Do you've therapy in been the of newly believe out SEL-XXX that of far you what trial. so learned announced rapamycin worked all, gout? from has the

Werner Cautreels

in of Yes, Hey our data have the Xb therapy, our data trial we And package that the don't, the that good we that first extrapolate why Werner. from very indeed X in can clearly the to that. have this Phase to populations. Phase to also that which we but believe wanted dose the SEL-XXX, then kind patient patients in to so population we morning. from is we from therefore, which trial be impossible that ranging, This do patient guidance and was gives from generated need field preclinical in from previous the study would data extensive of rationale other place, be gene this we also

Gil Blum

with And Thank KRYSTEXXA. head-to-head you. right. All another the about question

you this? we with thinking how blinded you KRYSTEXXA steroids differences are all What do given premedication, of has -- using? this can And as the are So, going that you be pretty know pretreatment in guys kind trial? to how at extensive And of steroids. designed a a look

John Leaman

can the certainly comfortable patients in the very that head-to-head, feel We we keep blinded.

feel that. we think I about So, very good

on utilized you in when think, I Secondarily, preparations regimens. think pretreatment I colchicine look are and at steroids both the it,

our I what protocol. know those, So, there difference will huge is don't be between KRYSTEXXA label the a at sort of least, versus upon for SEL-XXX based

Gil Blum

Thank All right. and the all very you much best.

John Leaman

Thanks. it. We appreciate

Operator

comes of the with Newman John next The question Please Canaccord. line from proceed.

John Newman

give head-to-head. taking ask with how study in they you your Good you the Phase thinking put study? about are rules rules morning. reason of to stopping that about to stringent I question. guys. agency pretty The head-to-head were But REMS. can know Thanks stopping that stopping the curious meet the any Thanks. terms obviously correctly, X. is I just to Hi for as had going of Phase part the But X actually to some head-to-head afterwards study. discuss I sense in rules. The have of sort my as as you're If obviously how remember thinking you didn't in because in KRYSTEXXA pivotal you're

John Leaman

John. Thanks

X; we in uricase. I were to our about. wanted ranging of think which feel very one our think I safety, dose rapamycin both and from very, ensure thoughts: Phase at a couple patient we is the we perspective, our looking good And

obviously, rule Phase head will also head-to-head data, very the at we when that to to into looking you expanded we the the be we a study X. able in stopping good guide think and feel new I

with feel the think and I data pretty is that, there. we comfortable

will first when we'll I basically So, enhanced have thing on rule. also Maybe us our X certainly, draws, to a do it trial. as the allow well that's the comes think an other less us setting Phase X compliance to I think, stopping Phase that, will allow with to and in patient the that head-to-head blood show it our head-to-head is

want in And patient benchmark interim rules in head-to-head, and assumptions want also data beyond do sort to think at stopping our three that we the we six think compliance we on the so will that months. superiority show that able to this be that to of I show set also expanded and

John Newman

you. Thank great. Okay,

Operator

comes the The Stifel. next Derek question from line Archila of with Please proceed.

Derek Archila

Hi, for good taking morning and thanks my guys questions.

kind the to perhaps whether So, apples-to-apples maybe of the this rightly I think guess, we or will again versus argue head-to-head that as KRYSTEXXA, KRYSTEXXA, an that is head-to-head about thinking this Obviously, real PhaseX? study. be I of other KRYSTEXXA, people about this the perception in fit you the you I rate are And from the of this might that internally some be trying methotrexate to from in confident really caveats that what a comparing move guess, be kind or maybe see -- into we study, investor immunosuppressant some perspective this then, guys to better Thanks. seeing KRYSTEXXA response versus apples-to-apples. other it showing some guess, But head-to-head really need into from wrongly versus can the so helpful. and like of methotrexate to forward you be alone things would should versus standpoint, other comparing -- the

John Leaman

lot. Thanks Derek. Sure a

we've think would that trial. confident KRYSTEXXA, right? think is for but the label, feel we the at and six comparison us, looks ultimately, statistical the I months, that looking we head-to-head primarily will KRYSTEXXA head-to-head, and described, in have that six trial the interim three superiority So be superiority result So, ultimately this we're for with as at apples-to-apples is I very the versus versus statistical the

to have the will we right to on think I described, you to as leave you is combination. secondarily, what think debate I it

confident out, strongly but that I but we've feel proper our both efficacy patient it X, we group, feel we feel sort well. compliance the said, side head-to-head suppression this that And efficacy of way. that look be combination very, tolerance a we on product then as Phase a product, of rate the like is at We're immune side in not and both good with and very we will the think effect immune a are as very satisfied think And the that marketplace laid remain side profile. and we competitive the very and obviously I the we'll the of about very we in well. from dosing, treated flare have very monthly

Derek Archila

question. And that's then last just Great, helpful.

guys the you. to cost of about this you're thoughts would modeling helpful from you head-to-head the as be again need Phase perspective? So, trial talk on overall in is the did of Thank size you the with or something sort this FDA of that any And the a discuss X? also

John Leaman

Derek. Thanks

I think we to from patient first the perspective the will when guide of we put that in. size,

think have we're FDA going and that actively lot I million for don't think working has to power the to is we're cost, X that it's do $XX million between I much give of would be to prepare the and head-to-head, looking a taking allow around Phase And with for. would discussion $XX we on rate us I a but how I perspective going guided do statistical us the that about. on I run and at look think not that, think us will that what that. think It's to it. get

Derek Archila

guys. Great. Thanks

Operator

Mizuho. Yang from comes Please question Difei next line of with The the proceed.

Difei Yang

for and questions. morning my good thanks Hi, taking

X that end-of-Phase the what's the are part just additional or So, you that you for data wait data. patients meeting X and meeting? in are present well as having is to five of I end-of-Phase before waiting the for as there? or do to who that FDA a way do there there delay is need -- in -- a think small need Is couple. Or

John Leaman

in we any had haven't end-of-Phase we the X and patients. need the don't Difei, meeting, delay five

weeks like end-of-Phase feel the several very we the that meeting. feel to we ago. have complete X had and think obviously, I package that send We to it's in

the there. go guided, have we from X and will quarter end-of-Phase So, meeting as we've this we'll

Difei Yang

there level regards any months with -- their whether control may expectation is some about over controlled then scientific reason And to patients, Okay. over there debates for uric that at there? any are acid monthly lost reason, was think to be five point. whatever the well Is there two next these and

John Leaman

look we I data we trial a presented take take data through at the think that generally in XX them Difei, we both our first XX what when five control ACR control made reason And that that months. UR look out this is the when when it the in XX months. the that and ACR, about and we've the data at of we weeks seen to patients through we we a projection they that Chicago, out three we presented was was in good made patients month, felt

that's think projections. So, that's we and trend feel a this pretty we impressive good why very about

Difei Yang

to those able or to any situations me, And surprise recall related to you. few losing Thank find my acid surprise? patients Okay. of month you at is month data? -- there there that one data because weeks or data or couple patients, slightly level, final a a it question, there back one. And where was -- a few a presented the control at was think then uric you are specific the it if I least Were the quite of after situation is a any the or specific patients or is

John Leaman

I think, Difei, the data is the data.

is numbers. We on the side This that middle. of forward. when five we both head-to-head in somewhere wall the on high you in X go as conversion. a And of in the of was the probably think side to patient they're and probably the Phase as think that show take we it's population the at look low believe I described, UR small when months looked you I population, data; And probably the this at the conversion. we the look

Difei Yang

Okay. John. Thank you,

Operator

Janney. of with question from comes the Please next line The Yun Zhong proceed.

Yun Zhong

And questions. head-to-head guess about I a the taking for study. question Thanks Hi.

data months' time seen haven't any We point. at six

seen would study. to KRYSTEXXA versus at from definition responder potentially what don't six your be know projection I little of believe I seems different that can months? study also, So, your be a be internal what And on

head-to-head wonder I your you go would study. in definition like by which to So,

John Leaman

question. the for Thanks

I asking think earlier. one, on think, the Difei to, what it goes was first back I

XX you I a we weeks, what at control generally them at we control think see patient five is months. if that

think is any to be going that at six reason to no different. months, there I believe it's

think we're at that control And then itself. confident month I patients at we out. we if So, and data of controlling one, typically very control our sort we them by five-month feel month hangs then will three them

So, about. that's that I are at least I think the think, projection, we internally thinking

I basically exactly think the study, head-to-head as what it to to stated we when comes earlier, rules I to guide think use. we'll going we're

when we right study a controlled sure was actually that we absolutely label the You're was guide And by than different put definition that we that forward. were head-to-head going study when KRYSTEXXA's we'll in typically make up it approved what using.

Yun Zhong

And on last head-to-head to about design potentially think there information. And now to changes you XXXX, conference any I the would your going -- XXXX X based FDA? study disclosed on the initiate discussion can that the sorry based Okay. the from your design, Phase or you what the call, with you're in some study see -- on

John Leaman

think the I answer yes. is absolutely,

of to me Obviously, things as here, if of the feedback the what's is head-to-head of get we'll months Phase the X, it's think X and ultimately because a time and the forward. the let to that's big of and one the in point, that plan so at helpful meeting, with development the the use marketing prioritizing is make clear and some the and six do end-of-Phase materials. reasons I done I is sort do point be And to three just this want in is will Phase that. data things can study think, think we same -- that having one our X way about the great I always commercialization This been the part part to us study. going that head-to-head strategy, this we'll great we learn, continue has FDA's in

Yun Zhong

you. Thank Okay.

Operator

follow-up We from line Difei Mizuho. have of with a Please Yang proceed. question the

Difei Yang

thanks my taking Hi, for follow-up.

have finish head-to-head have from the perspective, you enough you to study? do do funding financial -- So,

John Leaman

I think form to find guided, head-to-head need capital or that we study. equity Difei, to in as funding, we've will other whether some raise of finish

Difei Yang

the Okay, independent of so X. that's Phase

so funding So, head-to-head, I'm just finish to not enough clear?

John Leaman

Correct.

Difei Yang

Okay. Thank you.

Operator

concludes to would the like conference to turn session. question-and-answer I This remarks. you. for any management our Thank closing back

Werner Cautreels

in time. this close and everybody, again, your call. Thanks operator And I point the time, we thanks for at can think

Operator

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

You may disconnect. now

Cartesian Therapeutics (RNAC) 10 Nov 182018 Q3 Earnings call transcript