SELB - Earnings call transcript Q4 2018 | Cartesian Therapeutics, Inc.

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Operator

Welcome to the Selecta Biosciences Fourth Quarter and Full-Year 2018 Financial Results 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, sir.

John Leaman

Keith. you, Thank everyone. morning, And good Earlier today, quarter corporate containing fourth press issued full-year XXXX a and other release financial our we results updates. and this expect XX-K we file afternoon. market And to post our at filed This and accessed our the when www.selectabio.com. release can XX-K by be visiting website I'm of our and the our Carsten call. Stephen us for Brunn, be who will joining by the joined Smolinski, today CEO; CCO, Q&A portion

by statements related remarks XX-K cash ability results a including XXXX. the forward-looking about materially from meaning Act get future sufficiency readout trials, statements Before rate company's timing under those burn and equivalents results including, CureCN, like the trials, that discussed indicated company's of certain forward-looking its section at the to most are on report selectabio.com, the Private quarterly we'd be that investments Reform call anticipated important made cash, cash may constitute started, plans with data we inform without expectations, and advise of limitations, the the of our and which XX-Q future factors, the Factors differ of and with Litigation our our various filed and Form these in recent Securities Form the accessed statements Actual Selecta's surrounding filed. this collaboration SEC, short-term of of during projections those result to as prospects, the Risk planned can when of

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

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

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

Carsten Brunn

approximately lot preparing Thank year of off candidate $XX a We're treatment SEL-XXX proceeds against million for equity gout And our COMPARE with Selecta in execution stages we're for a successfully we gross start of January six-month morning, to start, that year laid in you, kicking head-to-head later and a month. this a solid final XXXX XXXX. this program off strong of trial accomplished fundraise a to foundation good I lead in the and of in the believe Krystexxa everyone. John. in an clinical

Although on mission But on potential pipeline past at differentiated potential, candidates in to gene our lead is of we technology, antibody that which there's to future and intent mitigate biologic neutralizes focused vast maximize tolerance efforts our for technology, therapeutic our its have based immunogenicity a and centered here unwanted remain therapy. program our formation. advance We immune ImmTOR, full on believe gout. with Selecta starting

our let clinical development strong reduction, lead organization We in going by programs, reduced continue refractory budgeted me our us package, pipeline, by in more believe flares, and workforce we of unmet pipeline on leaving Before in needs our including is SEL-XXX Starting to to monthly based our a reduction streamlined advance robust painful detail once reduce reviewing our dosing. restructuring we potential to January. with yearly burn start announced acid program, to serum several that, our a cash patients, position XX%, which in corporate sustained XX%, address the coupled projected has to programs. the gout with on chronic reprioritization by and the

not clinical Krystexxa of this COMPARE in this our quarter an design six-month in against head-to-head fourth the of The ability to chronic address cohorts showed anticipate analysis with including a patients. this five five reached from controlled, COMPARE Furthermore, to several we patients can XX% are fourth doses to year trial SEL-XXX, combination treatments and a planned treatment data total technology, combination the announcing the but monthly uricase. reminder, plan well or the pegadricase. uricase approved forward of evaluable We being novel our of continued mgs first is trial, SEL-XXX to by Phase ACR with months of head-to-head FDA our are this results gout to reported for were in a only current burden in that had SEL-XXX's initiate initiation III XXX,XXX severe we statistical currently at in quarter all XXXX. this data presented are immune five superiority clinical showing X.X of tolerated. of which In from the year. at up expected and X.XX the with percentage the Chicago. refractory mgs five current trial the We interim once-monthly urate of subsequently who patients, a plan data SEL-XXX data kg below X, the be month. develop pegylated ImmTOR, FDA the patients and new of uricase. SEL-XXX believe of readout receiving ImmTOR kg at reduction patients of of We quarter program full October the XXXX, to acid per approved There combination pegadricase, per ACR, maintained potentially Just proprietary as of small in United of treated continuing serum rates and gout X.X doses that announce We States needs in look therapy, inform to to generally roughly data confirm unmet and lowered severity. flare tolerance levels

which patient population and low SEL-XXX, unmet consistent for monthly flare we billion opportunity. market below needs six and represents in dosing, As we're develop currently control defined SUA to SUA this identified as $X aiming over address X has potential rates for months,

maximizing potential for our ImmTOR. turning our proprietary Now, other the to platform, priorities technology of

Crigler-Najjar in Syndrome, an builds clear published in collaboration this by in suggesting regimens well-controlled second induce this by the convert We encouraged bilirubin approved announced therapy consortium, a use Genethon the that tolerance differentiation of for ImmTOR for communications We’re immunosuppressive yet the our to potentially therapy gene in of the are trial. AAV October and AAV technology. This dosing that its not of re-dosing we including our the inability rare biologics, together We potential product from XXXX, therapy a can re-dosing genetic with XXXX, September with gene our combination and first the preclinical to programs. for complete properly with technology allow CureCN gene from with the forward was European full and In of major collaboration disorder upon in the work technology candidate characterized ability half look year. systemic body. a products patient with clinical the to believe combination to benefit

biologics immunogenicity fourth continue to exploring year XXXX of from to issues. significant believe utilize in superiority XXXX. data we the active trial conclusion, of the be initial we results ImmTOR in interim therapy collaborations COMPARE clinical In for with ImmTOR Finally, platform, of year, additional platform, head-to-head be potential a in in statistical with gene our will and other which with expected our full this quarter with QX expected data both

to for gene to the our XXXX Secondly, potentially We through financial fourth ImmTOR of clinic. me potentially be CureCN, in re-dosing first you quarter discuss second to will with XXXX the call preclinical updates to translate half opportunity the full-year therapy plan we data coming XXXX collaboration the results. the that, with in With our the which published AAV to Nature to in providing over year. and with forward look October turn John in let dose

John Leaman

Carsten. you, Thank

for reducing down product decrease The fourth consulting was with expenditures $X.X in grant XXXX. with which was of quarter trial to XXXX. of XXXX. our our for compares of fourth fourth Research SEL-XXX preclinical than the for expenses fourth XXXX with $X.X $XXX,XXX $XX.X driven the company combined fourth fees. of the our $XXX,XXX in the the cost for primarily NIDA. quarter For second II of of $XX.X in reduced expenses million, the the the development million, compares quarter The to The of candidates of clinical compares General quarter conclusion fourth grant and the XXXX, winding the was in and less Phase by for for were of recognized administrative XXXX half of the of which revenue revenue result quarter million result were which of million quarter sole increase reduction XXXX. the

For company's Selecta the cash net of loss to net a period million quarter December underwriting $XX.X remarks. $XX.X cash in $XX.X XXXX. runway to compared into company of discounts and as which commissions includes cash share expected That compares proceeds reported short-term million at and per XXXX, from a $XX.X recent has our restricted the $X.XX of equivalents net loss $X.XX fourth per follow-on XXXX, XXXX. has XX, of million which formal or QX XX, million in the equivalents of investments of concludes million cash cash, $XX.X same an The offering or cash, in XXXX, of Selecta currently and January for XXXX. share September

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

Operator

thank Instructions]. And Messer Yes, Company. question from comes Needham first morning's this with [Operator Chad and you.

Chad Messer

certain for SEL-XXX interim? it thank patients? of much Can with taking the Maybe questions. is of with you our just a data Great. readout. that my you Is And triggers number expectations, How readout? Good set the morning. interim kind start what coming

Carsten Brunn

Chad. great a It's Thanks, question.

recruitment basically. who because plan So, six of in active have of head-to-head we'll And, look as two first, one half the the to comparison. we QX, and guided, we're is it the the patients a to assuming with latter it's the obviously, understanding, do months my rapid arms. readout we at And actually trial completed

interest the who readout. and drives expect from so we interim in both patients from investigators this, So, that the participate

Chad Messer

over a And can look would And Thanks. least sort is share not, if great. what beat it view powered what Okay, at to guys discuss meaningful you it's you’d to possible like? for? you Krystexxa of

Carsten Brunn

Yeah.

and we the Krystexxa, ACR the we kind can data detail. data we and don't anticipate of XX% label not XXs, in on look expect at think middle look so you in this the at we're trial. efficacy So, have and that at had in plan of the guided if the where for the I somewhere published EULAR for and we presented But this, to expect guide and data spread to the you then we where

Chad Messer

Great, thank right. All you.

Carsten Brunn

Thanks, Chad.

Operator

next Thank Stifel. with you. And Derek the comes from Archila question

Unidentified Analyst

opt still Thanks. you in – they in recent of, I guess, Derek. of I Ben year? end Spark to think, on This it. hear the for actually I line Thanks. the this we said, light -- is think deal, , by That's if can expect the

Carsten Brunn

Thank for that. you Derek. Yeah,

this after So, plan would we connect chance why to the but this, had a We obviously no reason Spark change. guidance Roche acquisition. there's not do with have to

opt So, Spark/Roche has in the of opportunity end until this the to year.

this to remains our that point. unchanged knowledge at So,

Unidentified Analyst

Great, thanks.

Carsten Brunn

Thanks, Derek.

Operator

Canaccord. from with And you. John Thank the question Newman next comes

John Newman

for morning. my question. Thanks Guys, good taking

I of the had First study. question the was design clinical regarding just head-to-head

about bit those sites we'll number a Just us and if the of States? of all sites enrolling the the geography that United could in wondering be of if you talk to be Thanks. those will

Carsten Brunn

John. question, Good

we So, per States Phase looking to as to throughout we're to XX for we also the sites trial. this patients our And we and use XX III this, earlier, XX then, are guided United sites at planning guided XX for arm.

answer to XX XX So, to your question. sites

John Newman

about in Great, this can you thanks. how head-to-head the for talk study? you what is will statistical results of And you the So, able these length patients long follow-up early to after follow in XXXX, be the overall study? report

Carsten Brunn

we right are speak. John, actually we determining as now, this

John Newman

Okay, great. Excellent. guys. Thanks,

Operator

from question Difei Mizuho. you. next with the And comes Thank Yang

Unidentified Analyst

therapy patients provide how are around liver on helpful? good selecting around design color insights for taking questions. function, looking Any example? you going on would few to at you Thank the the in what Alex This be be is guys. look additional gene and can color Any Thank for you. additional first Hey, the Crigler-Najjar any you're for the would like, Difei. you trial morning,

John Leaman

think, iron. from the think agreement is on post their John. that use know, is platform agencies of therapy the I the basically would basically we're Alex at our Crigler-Najjar. as looking with – regulatory And Broadly, it's works way AAV we gene it metabolism ImmTOR I you this for vector enzyme getting an

to actually didn't immediately have is, you'd know we the to patient – whether produce vector. antibody AAV allow think antibodies ImmTOR have against the I you'd data what

ability that, you the re-dose what the I depending have knew then potentially that their to think therapy, patient after levels patient. they once enzymatic were on that received in gene you'd

have producing mentioned, be would at produce against that gene we'd a enzymatic that the actually not see so, looking at secondarily, transplant. would did them levels at allow And basically, AAV think re-dosing. you've liver to which metabolite looking allow that data whether for minimum, the in patient's give And was enough the I potential be the we'll liver they the to of to antibodies vector, then, as them a the them that therapy is

Unidentified Analyst

you very Thank much. great. Okay,

Operator

Yun Zhong And you. the from comes with Janney. question Thank

Yun Zhong

the morning. question. for Good Thanks taking

patient any a terms given enrollment So, ongoing on the I there the pace patient head-to-head studies to follow-up study. question wanted expectation population? patient have if enrollment, first, in are the other in of you similar for that ask And the of

Carsten Brunn

Yes.

we because this that arms. mentioned, that rapidly active And to believe I you we sites, patients there's As fast do interest the active arms in study. feedback from the recruit two also drug received that's of have will on get an anticipate recruitment here because this both we

Yun Zhong

therapy Okay. on will And – on have study, be then, guided available? gene provided when on initial the CureCN you study, guidance data

Carsten Brunn

We not. have

year half trials. that the guided this We the have initiate the second this in clinical extra half the first year studies of of conducting and only we are preclinical

get will We we have on when results. not guided

Yun Zhong

the start the you or the FDA do for to with III Okay. meet last you Phase you plan or no? before requirement – study, then, And question, is

John Leaman

on just the time, this programs we interaction we'll At Yeah. move forward. confirm probably design those to another Phase as the of plan that with FDA III

Yun Zhong

be That from data the study? after the interim head-to-head will

John Leaman

determine different points of submit time lot We'll and seeking bit. their down different to There's them guidance. can points a we data a in that when

that, as forward again, we'll next the sure So, as on we to keep steps. we people informed move make

Yun Zhong

Okay, thank you.

Operator

more as for present at questions are you. no closing to would floor Thank turn to time, there comments. the I And like any management the

Carsten Brunn

Thank very attention. much your you Thank for you.

Operator

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

You disconnect lines. now your may

Cartesian Therapeutics (RNAC) 15 Mar 192018 Q4 Earnings call transcript