SELB - Earnings call transcript Q1 2018 | Cartesian Therapeutics, Inc.

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Operator

Welcome to the Selecta Biosciences First Quarter 2018 Conference Call. [Operator Instructions] 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

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

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

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

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

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

Werner Cautreels

SEL-XXX Phase recently the Associations more over and X-month lead serum may FDA-approved to XXXX data of gout uric therapy. dosing severe candidate for and time, provide convenient with is reported that or presented uric PANLAR indicates acid I'm acid data off Pan-American say John, strong the better that for our gout. control you, for XXXX chronic data proud product morning, recent a Those start. treatment compared monthly current good our flares fewer level profile sustained and Rheumatology of Thank We everyone. and at product for to Congress League II the

medical on begin at quarter. data Cancer III additional receiving on our the trial: with XX, third Phase of plans the data a SEL-XXX Congress doses for expected track be in PANLAR at trial the We next SEL-XXX, expansion these outlined conference actively readouts European patients X from XXXX; to data XXXX. the First, remain presented trial treatment National ongoing our clinical patients we for Meanwhile, EULAR from also reported at enrolling to from I X of Phase our the be Rheumatology of our this mesothelioma is then, will and are candidate, in June cohorts Institute. In

the While this from note also will technology a data to our patients demonstrate to from this do trial treatment, focus setting. is clinical on our with a that second benefit in opportunity us that translation of present want SVP-Rapamycin could I

SEL-XXX. with Now starting

many As comprehensive, program designed was and of severe which we of trial is SVP-Rapamycin, mitigation first a positions Phase II with of III immune clinical allow proprietary antibodies later SEL-XXX know, uricase, Phase would we for be doses dose-ranging to a pegylated non-immunogenic are the antidrug of and administration which our enzyme. against effective for SEL-XXX combination lead us novel chronic concurrent the gout, conducting for you year. our well uricase. intolerance technology, of our And version safe this our multiple beginning believe pegsiticase, the for candidate

dosed mg two in evaluable Furthermore, kilogram initial SEL-XXX serum uric per mg initial needs in the XX% X.X acid data the last immune the mitigation pegsiticase That Aires. at ability by of of SEL-XXX XX% then alone antidrug alone. therapy the of Approximately of moment up chronic evidence kilogram following: months we data maintained in our pegsiticase of in patients let potential to patients after show with data SVP-Rapamycin PANLAR received deciliter showed with serum the SVP-Rapamycin three to was This month per meet believe providing was We monthly patients unmet platform control, tolerance presented take patients with pegsiticase. of me pegsiticase during severe to or three the against followed to doses summary, highlight acid of of The of from setting. that clinical X four a SEL-XXX monthly enzyme. So month with antibodies the three level obtained combination of maintained X.XX induce doses gout. in a monthly the concurrent of X.X Buenos uric doses data, of of milligrams these control per PANLAR below

new the data SVP-Rapamycin the on at was Importantly, present of patient will In an host are expanded June Eastern then, has receiving of June we additional per to cohorts five monthly combination receiving which dataset medical rapidly mgs the will after monthly and it monthly trial anticipate clinical of about easy which strongly mg flares than of plan III be a with by XX%, The in it antibody with treatment-related the flares six- with uricase. preparing our the define I patients milligrams II of entire dosing, plan clinical strong Phase We to the deciliter, three we the to X These combination SEL-XXX to level And FDA, combination the day, incidence meeting low the are patients the treatment-related be we doses period. overall X.X X.X significantly are acid present mentioned measure kilogram And mid-February, EULAR correlated control below provided negative Patients these or III meeting these Phase we as trial activity seen of to serum third remains XXXX. X.XX from primary to to of SEL-XXX with discuss design X.XX kilogram an per regimens for with doses initiate the an end-of-phase quarter conference for that doses enrolling actively lower with incidence us of from cohorts endpoint be product. cohorts on data is FDA-approved We XX began therapy expected conference program. pegsiticase. Meanwhile, in XX. month II titers. dosed that ranging can time. in the patients. per the these will earlier, basis uric the at Phase at call PANLAR upon reported upcoming of of

have the Beyond III patients the study who a are have two in pivotal activity of SEL-XXX discussed KRYSTEXXA versus above, trials SEL-XXX. head- now immune study test these KRYSTEXXA considering Phase potentially patients as oncology With no in-licensed failed our to-head indeed additional SVP-Rapamycin. to agent our product LMB-XXX options. it candidate, trials that, endpoint with other called a asset with let also from over such and as clinical-stage combined National we proprietary therapy the placebo-controlled clinical next We the Cancer tolerance to approved and me treatment Institute turn

NCI trials absence causing all promise recombinant solid including of While trial with patients, mesothelioma, at open-label research of who patients the a I under tolerability highly turn to dosed the or historically the as an least patient and data breast negated regimen to our This this uniformly in great at Leaman objective results. of Phase mesothelioma, the has I undergone and first agreement significant call the peritoneal malignant corporative Phase immunosuppressive antidrug in was that, March over on various evaluate for SEL-XXX one mesothelin I in chemotherapy. will with is pleural pancreatic targeting tumors, this agent John activity XXXX, safety to as clinical as response levels proven development discuss have antibodies clinical The be treatment me of Phase treatment enroll least immunotoxin on holds expected and assessments. in and patients. quarter immunogenic, trial escalation trial which ADA rate the and let to With dose being cancer, XX cancer it of conducted first the provide is the financial therapy. In pharmacokinetics, clinical well drug’s for

John Leaman

XXXX. million last the quarter the XXXX quarter The the down revenue salaries approximately development and were of and first the expenses quarter from primarily for grants for Research General public result Selecta the of headcount of for expenses last for compares same a first clinical-stage no which maturing which reported of related from $XX the million relatively administrative needed the quarter Werner. of XXXX, unchanged in company’s and revenue first The is is the of quarter Thank greater $XXX,XXX for increase year. with which $X.X company. and $X.X support to is of the quarter collaborations. million, year. result million, reduced you, from the recognized comparable XXXX first $XX.X is decline were

common the million For of share. we per or the attributable recorded $X.XX same or $XX.X quarter share loss stockholders $X.XX net $XX.X net of XXXX. first loss compares for of This a per in million XXXX, period to a to

of XXXX, XX, we December equivalents, As and million XXXX. million cash, in $XX deposits, cash. This $XX.X from is approximately down had restricted short-term XX, cash investments at March approximately

We sufficient or we additional from the payments guideline any fund might remarks. is expect into that receive our excludes formal that to other our concludes collaborations. Spark cash That potential balance operations Note, midXXXX.

we for Operator? Now will the line up open questions.

Operator

first Gould Please go ahead. Instructions] of Carter UBS. question [Operator comes from Our

Jeff Hung

for what in point This II end-of-phase the for view, meeting? key for your discussion Jeff Thanks taking are my is question. of the Carter. points From of

Werner Cautreels

Good then, not then but of design clear, trials. are. will for what and power the And controls of have the It’s be for terms morning. of This terms the the placebo of the the Werner. the of exposure in just trials, to trial, course, conventional and questions efficacy I safety of believe, about pivotal design we the is that. only think all It for course, about of in endpoints also pretty

an items be you critical meeting. end-of-phase the that ones address II in So will normally the

Jeff Hung

when then, will meeting And be takeaways Great. from how communicated? that and will

Werner Cautreels

that. we when guidance provided haven’t do We

then As of back the come soon street. we the that have information, to course, guidance with will we as

Jeff Hung

roughly to Great. opportunity is the I $XXX size And gout? just a product now. of curious thoughts looking guess, commercial million on on latest the right then, KRYSTEXXA of be your

Werner Cautreels

feel – again, the very with help to you small severe think know, amount a chronic their penetrated as of we Well, to support we look KRYSTEXXA they’ve like gout. may patients fully we marketplace. efforts and continue And

and treatment potential can So a given this we is efficacious be to for more that longer a a period greatly is marketplace. great think expand there therapy for

sales As And something the not at peak believe that we million. least greater. aware, expanded like also market market research our upon guidance if you’re they based their much of probably to that, $XXX have year is

Jeff Hung

Great you. thank

Operator

question Mizuho Securities. is from next The Yang Difei of

Difei Yang

So just couple. a

talk kilo and per dose, mg a the For – to X–dose X.X us why for X those combo the combo could the you not picked you X.X.

Werner Cautreels

on decision like that ongoing data to And the from be Difei, we it XX–day would had Phase to looks dose. a a sufficient – cover window. the data, from II make X.X

And therefore so we went cohorts. with dose these in that

Difei Yang

for on maybe then be What very competitor. the is SEL–XXX – KRYSTEXXA in – question in would immunosuppressant let’s And differentiated to their case? a say, dosing – that be would generic Okay. regimen, how if KRYSTEXXA that add that

Werner Cautreels

that to take want you question? John,

John Leaman

Sure.

we’ve get immunosuppressive? are So Difei, and I are think we we argue, not. spoken it the And question, often we would about we

immunotolerant. cells, And the regulatory T our believe drugs. are we We that SVP–Rapamycin highly for which produces basically tolerance immunogenic for allows platform

So think, immune differentiate we’re would tolerant, not way ourselves immunosuppressive. – that that I I

– that at goes data talking the and pretty obviously, the about the come we’ll are some – without think I not up look themselves are that forward, significant is to immunosuppressants they other have question effects. the it side as drugs will

we I be months idea lengthen efficacy profile two be look correlation giving of able will And going with to therapy, we the it at it KRYSTEXXA an effect so side take three you an and immunosuppressive then think to the in of forward. that interesting as period, proposition might weeks with treatment think, be a

Difei Yang

for you explanation. Thank the

Operator

of is ahead. Stifel. next Schwartz The question Alex from go Please

Alex Schwartz

now X–month full then how question, visibility good months release, of many data? early? combo SVP–Rapamycin the at are can when a data of completed that the five you you is right time trial will released your too it or pegsiticase many Do slightly patients full you patients that into in a And have you testing? plus have off, us different regimen sense the First how give

Werner Cautreels

you will take John, that?

John Leaman

Sure.

bring that for obviously think because we’ll meaty we’ll the open- in So have medical appropriate Alex, so I that difficult it’s all but that to we patients enough displaying think look certainly QX, sort I is take a how guiding meeting to many meeting, at. be label an and I data, think, to you trial, find of, want on it’s

So that’s number I think one.

we’re think have between I X.X various I of patients X.XX to enroll per SVP-Rapamycin. the ability is about when to looking number multiple those guided think Within cohorts that talking to cohorts, we’re at cohorts, patients. cohorts of we up what potentially kilogram within milligrams and the XX we’ve the –

there as give And around seeing of may be cohorts to dosed you so evaluate. think the in better But specifically, potentially will larger been least about just of statistically to are the chance you’ve as I think might that at Phase have that we a patients for be it, several as cohorts, think we previously II. numbers cohorts large

So we’ve actually what give present I closer as when we’re going that’s and think we more guided we’ll get the to guidance data. to

Alex Schwartz

thank taking that’s for Thanks on great, for question. Okay, my you that’s progress.

Operator

ahead. question Please next Canaccord. from is John go The Newman of

John Newman

and and Hi, morning continue guys, congrats good my taking for question. progress, thanks

cohorts. presenting you’ll in just press a little data what expansion that terms this – look referred the to you release talk your if bit like, talk the wondering you more that might can you be curious, that some you morning, EULAR? I’m of I’m about at Thanks. data additional in about So

Werner Cautreels

Okay, X cohorts. so in number only those the X, had reached of good PANLAR morning. patients conference X, webcasted, month not few think which John. also weeks a a I at we Sure, ago,

picture so data those that so present complete will conference, And at EULAR of we you a much will in the that patients we have cohorts. these those different expect more

John Newman

comments, additional head-to-head still then your study you that I if curious, In prepared study this one conceptually, just study? small something like KRYSTEXXA. that what I’m And you are question, you Great. look that’s considering, that it with need with after study, until in may. might you would your if if at point, if a program, a large Thanks. be III could Phase run would If it completed? conjunction wait could be to that mentioned

Werner Cautreels

we study because be be that and to head-to-head in to will that need that likely and will the parallel Then large absolutely, that. be of III most the No, those plan trials Sure. clinical significance the with will do Phase placebo-controlled, important. measured of not endpoints pivotal

smaller And so a be that study. will

We that. haven’t bit the faster the parallel a But conducted and clearly, design in completed even of program. will that maybe than be pivotal

John Newman

Okay, you. great thank

Operator

are concludes over There conference turn This to Cautreels would at questions other our closing Werner session. Instructions] [Operator I the time. to like no back question-and-answer for this remarks.

Werner Cautreels

that conference again, thanks Selecta, your be will and And the upcoming the for interest Jefferies – Kate. morning. Thanks, everybody presenting attending will this UBS we be We at and two conferences we the again, listen New SEL-XXX, the in both conference, in then, an the opportunity give York. update And have you about at as in next will EULAR month, will to again.

conferences and you. again, these each one in see we Thank So thanks maybe other at York. of New soon

Operator

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

now may disconnect. You

Cartesian Therapeutics (RNAC) 9 May 182018 Q1 Earnings call transcript