SELB - Earnings call transcript Q2 2020 | Cartesian Therapeutics, Inc.

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Operator

Good morning, and welcome to the Selecta Biosciences Second Quarter 2020 Financial Results and Corporate Update Conference Call. [Operator Instructions] This call is being webcast live on the Investors & Media section of Selecta's website at www.selectabio.com and it is being recorded.

For opening remarks, I would like to introduce you to Brad Dahms, Chief Financial Officer of Selecta. Please go ahead.

Brad Dahms

Thank you, operator, and good morning. quarter results second conference corporate our call. to XXXX and financial update Welcome reporting is financial Investors press our The release results section our and of available website www.selectabio.com. Media the on the report Form will quarterly filed with today SEC. later June our And be XX-Q for XXth, quarter on XXXX the ended

the Joining be our our portion Chief Chief newly Q&A Officer me Medical Brunn, available Chief Dr. and Officer. and is President Carsten Kishimoto, Scientific appointed will Officer Peter for today Takashi call. the our Executive G. of Traber,

today's to we'll subject without expectations, future clinical financial potential and During call, forward-looking candidates, be statements are our and limitation, safety, plans, Commission, SEC. making with including including, XX-Q, partnerships most regulatory progress on certain product and risks, outbreak the of filings and which our statements filed prospects. those COVID-XX about will our projections in statements report today efficacy various that our These Exchange with the described including the and be Form made related the recent quarterly Securities are to later

views such now statements, Carsten even not call Brunn, disclaims cautioned forward-looking CEO. on any these and and of speak to to Xth, only undue like as obligation to update reliance turn are to today, management Selecta would place if August You change. over which I XXXX statements the our President

Carsten Brunn

you today. us I joining you, Brad. Good appreciate morning. Thank

We've our immune that for of us as have of immune quarter a that entered the Selecta. allows time Sobi second tolerance XXXX the full of The ImmTOR position made potential in in transformational financial important licensing described platform. efforts strategic can we unlock leader agreement best position business a number puts The be with our to reinforced tolerance. us to decisions strategic as maximize the a into

and believe that the Sobi's provides given resources. also commercial SEL-XXX, value it most for presence We

of The licensing biologics, the III and on immunotherapies to to gene lifesaving the enable same, Sobi responsibility agreement, for development, Chronic safety therapies, researching the on all autoimmune with Sobi. use all of which of redosing ImmTOR SEL-XXX, commercial create regulatory Under potential optimize strategic in assumes in diseases. efficacy agreement Phase the objectives Sobi is while terms the and and technology product closed the XXXX and of the Our applications study except our treatment of novel for III of remain Refractory markets will expenses XXth, Selecta the candidate for Phase July for China, behalf run Gout. activities

year. program We're effective share. program, milestone of the of also per the paid expenses have and tiered has stock eligible the kilogram will one months private consist XX on as X.X to and As Phase and We expected enroll of initiation per Sobi SEL-XXX. patients a XX patients is six patients Sobi the program to are SEL-XXX third kilogram of milligrams of milligrams and regulatory expected this COMPARE anticipate ImmTOR and Sobi fee receive license in and a of trial II III milligrams trials Each days the placement $X.XX have investment commercial development of an committed net kilogram of Each XX common placebo. million million per with $XX patients ImmTOR Phase to pegadricase; of per an from clinical third pay up This the potential addition six data reminder, Top at of royalties double-digit in $XX of they trial $XXX double covering endpoint the and Phase We with receiving of Selecta payments look million from milligrams per in receiving the X.X and development, to have quarter as the receiving for trials line date year. primary the months working of double-blinded this X.X trial quarter a will SEL-XXX. upfront the X.XX will extension. two -- kilogram and III forward of XXX to remain pegadricase; XX have sales. placebo-controlled and tiered in to

is with and study doses into of ImmTOR Sarepta milligrams this the terms We're per in has of combination know, research June. in of rights option neuromuscular serum pegadricase ImmTOR patients. to you muscular months. for particular and limb-girdle evaluate primary ImmTOR and in levels Under with endpoint enrolled antibodies. As select less to Sarepta with Duchenne of of use of commercialize ImmTOR a the to is trial dystrophy the agreement to certain Sarepta have very neutralizing and its option to uric acid entered dose agreement, formation license platform of minimize neuromuscular the of of a therapies diseases license prevent once-monthly in diseases, three COMPARE in which the pegloticase The biweekly develop six combination deciliter and this the for X muscular XXX of the a head-to-head use investigational than gene SEL-XXX at maintenance also dystrophies. the of compared has will pleased

timing priority the gene to initiatives. development pleased programs we these us Our confirm and autoimmune and for and a therapy for disease research remain are

MMA, in clinic methylmalonic Our of is lead data XXXX. AskBio, expected the in which program half first acidemia, with preliminary or the with XXXX, gene in of conducted being half collaboration enter is in second to expected therapy the

on later also advance We our year. an the program transcarbamylase, program in to or and deficiency proprietary intend in OTC update provide ornithine we'll that

addition, one in Drug programs for of an XXXX. In Application New disease submit autoimmune Investigational intend our we to

kidney to immunoglobulin de-risk trials. learnings safely indication antibody occurs through advancing of accumulates nephropathy, program when first in intend kidneys. our be SEL-XXX immunogenic disease ImmTOR will The the this the within We effectively program from an combining upon called enzyme that and to a IgA and clinical and build

Affairs Dr. need, suited Medical to primary Both the Officer. G. recently in an of our target as Peter Peter of significant Peter since application he Galectin has CEO Officer of pleased strengthened Pennsylvania be welcoming or was He CEO University Senior Health includes; experience platform. to scientific and President, Phase March ImmTOR GSK; will have of aspects large Medicine to in and wealth management Clinical biliary & development X, of cholangitis, at Chief capacity prior XXXX Baylor position III unmet well well-defined have will Medical indication of business been diseases Development second College Peter the We're also academia. a of our Medical of are serving His brings The the of clinical PBC. System. Chairman oversee for and Medicine; medical and team CEO potential Chief company as biotech and and medical time of a full affairs, that interim guided development NASH. August well most in experience Traber, a initiatives. program us guidance pharma, provide in XXXX. recently and Vice clinical to now strategy joined as Therapeutics, and had and of antigens, biotech all

call a Peter? will Before over say our Peter Financial Chief Officer, to few words. I turn the

Dr. Peter G. Traber

first both kick there MMA team from and in clinical and number and scientific challenging OTC patients and products efforts to pivotal acumen value translate specific I'm in first this help our its our I of of undisputed safely, III autoimmune immediate year ultimately off in substantial enrollment advancing partnerships an that I'm am Sobi. to that and in as Thank kick help and primary part the the in therapy help advance are a is we Selecta and I'll positioned the believe into very to goal benefit quickly and Selecta proprietary commence with Selecta the role to driving of platform with have the unmet ensure that is to term, program program Furthermore, of innovations helping a half next patients. is and become ImmTOR disease look our my has IgA cholangitis. helping In immune excited program off applicability Phase leader ImmTOR I to diseases medical efforts, treatment be successful the biliary Overall, our to to deficiency. my and development achieve I of gene forward near help our excited nephropathy team you need unmet strategic to goal. generate perspective. evaluating we patients. be pioneering science well targeted is explore right may here tolerance, the organization deep studies to we much, a innovation In capabilities the proud conduct and and needs. the goal will on at term, advance that opportunities very also Carsten. the believe business clinical in the team

Chief our to over call Dahms. the Officer, turn Brad? I'll Now Financial Brad

Brad Dahms

you, Thank Peter.

we Our filed press laid in be outlined our out our earnings which this will morning, detailed XX-Q. further are financials release, in

few here. which to December items million a We XX, highlight in $XX.X XXXX. as as just cash, key XXXX, I'll had restricted cash equivalents of and $XX.X of June cash cash, restricted equivalents compares of cash cash and XX, So million

$XX.X and effective the increases to which of of travel equivalents contractually does expenditures expenses June XX, our and the quarter Sobi offset date the XX, compared was of for in with legal administrative our The result We from in which $XX cash, Our fees, license payment us XX, under XXXX the for believe therapy million from enable quarter under first XXXX. for in agreement of million, incurred and Sobi. decreased expenses a our XXXX, million compares million initial development XXXX were same Net in with cash million trial Sobi for million of $XX.X the cost with were for collaboration and XXXX, partially days salaries, months placement of $XX.X not expense into in after in that with Sobi July expenses quarter AskBio include XX XXXX cash activities period for the balance million, for same cash and for the which Sobi the payment program the The used cash million decrease General period and compares primarily fund million operating by XXXX, ended salaries for is at our XXXX. $X.X $XXX benefits. SEL-XXX, result in professional in for payments to and available $XX expense. private received Phase as second offset the June was $X.X second X the was of the operating gene the restricted together in July Research COMPARE the will expenses under and the capital license, obligated increase due XXXX. XXXX. less by cost with same II $XX.X period

net a loss Selecta the million $X.XX $XX.X Carsten? $XX.X call will of reported period quarter or XXXX. same million back of over For $X.XX or of the second to for to loss in the net share a share Carsten, hand XXXX, a a I now compared

Carsten Brunn

Thank you, Brad.

second research to As in grow to quarter for fuel the was and been the a able mentioned transformational opportunities to have business ImmTOR. efforts, I'm and development pleased capitalize applications Selecta will that on way development earlier, our of

therapy in that our diseases questions. Our happy we're host diseases very is unwavering commitment efficacy details safety biologics, on gene to Day sometime provide and to that, optimize programs possibilities gene lifesaving of immunotherapies the of therapies, provides. and and the we to and take R&D plan we're technology With at ImmTOR about an specific or use autoimmune platform to create redosing excited novel autoimmune We'll the October. enable for our

Operator

Thank you.

will Eliana now Merle come [Operator question with go question-and-answer And will We Instructions] ahead. Fitzgerald. first from Please Cantor the our begin session.

Eliana Merle

for much so taking Thanks on and progress. the congrats all my question

entering curious kind before clinic. Just terms front, of on steps in of the like the therapy gene just

I but the then sort you of patients? of to that collaboration like curious with you also guess guess dose both I from you And I FDA. of We've Sarepta curious is are first I need pre-clinical just ImmTOR seen of, this you guess can kind to if neuromuscular, have the clinic of kind to perspective, exactly can well gating do ImmTOR in into and sort steps sort with before guess internally first humans, MMA, Just patients I Gout. with safe mean patient? all Thanks. the of guess of you patients? more do therapies. already, as there dose take as guess, just what kind can what I from FDA on how I in a can you've in Sarepta's you perspective in number so curious both guess of first gene AskBio quickly color move the I the those enter across with platform before needed, on support maybe safety factors what the kind work and before seen just

Carsten Brunn

thanks on on M&A IND finalizing conducting a with for working front, pre-IND had and compiling the filing. our studies, the we FDA Yes, currently meeting question, as we're currently always. and already preparing Yes, working or -- for tox the the

first we to So on in trial the next the Sarepta half are collaborations. regards track of the year. to In start

remind just is So to a this agreement. you, research

trying really neuromuscular generated liver-based so in and we have replicate preclinical disorders. learnings data apply they're basically that in So diseases to the those far

So that's really they do focus so. to and XX months have the

So first it's really step replicate in -- models. those the to is animal results

Operator

question next Canaccord. with ahead. Please Newman come John our will from And go

John Newman

Hi, my taking good morning. guys, questions. Thank you for

more be to haven't other how I'm you dosing deficiency. could looking of go ability redose. when -- wondered the to Really also talk define you'll to given if seen just kind advance curious as you'll proprietary any do have as able ImmTOR once. should in that just And to your how OTC to with I little success schedule be Carsten. curious determining you you So, what demonstrate to the a we about than just about been you And bit able program definitively programs here. dose really

wonder, first? part will the program OTC maybe that on of if So focus Thanks.

Carsten Brunn

Yeah, John, question. thanks the for

is, define we'll So we'll in you know success but do terms October, the which first I were in know MMA into neutralizing timing details at in rodents -- And go we half the the primates. formation in And in neutralizing our really, more to preclinical have terms finding And will clinics R&D you dose you obviously step of we that's have first of those how we then second really that's of we're for year. we a demonstrated -- both we think the we we what able And to risk. formation of obviously, kind but demonstrated an able question, to the on are the from mitigate animal in concept, and data initial is, are the in learnings of program the that have able clearly that I think to good next Day prevent provide really antibodies. models, looking we and and prevent raise also proof-of-concept non-human proof able ultimately antibodies? first are retreat are of as

John Newman

Great.

follow-up Just one if may. question quick I

indications and about mentioned talked You you program kidney your the indication autoimmune IgA the one nephropathy. of being

what It's have you Just specific mind might curious of go in I'm you're interesting with approach just looking take. platform. to you. that there. antigens if indication, after kind type an your especially of you wondering Thank

Carsten Brunn

Yeah, great John. that's question, a

to similar. patients really combine an the of The makes So has we're we the a immunogenic approach We really will deposits debulking clear which where defined it on very indication here ImmTOR nephropathy plan we're be an building would IgA to we program Uricase immune be complex protease trying what what enzyme, and our a specifically us and that antigen -- in do uric IgA IgA ImmTOR attractive learnings combine Gout with kidney. addresses -- from and the approach deposits. the with acid with clear

similar very ImmTOR. plan approach a the patients immune in it's where the basically we kidney IgA to here So debulk with complex and of redosing enable would

need, nephropathy. IgA there a transfer from that is therapies we on a moment. that there unmet market obviously, learnings the we'd So significant have, approved And the to indication Gout plan is there is the to of at lot no obviously medical

John Newman

Great. Thank you.

Operator

ahead. will Please question Raju go with Prasad from come William next Our Blair.

Raju Prasad

But of next-gen I've in done Kind X, coming, know all platform are Thanks ImmTOR I data some serotype. relates then your gene on of AAVX it. of thoughts what ImmTOR translatability you've to in mean, and with follow-up for taking it kind the capsids I kind question. I serotypes? on a wondering got as believe. the the across therapy of on And

Carsten Brunn

great Thanks, That's a Yes. Raj. question.

ImmTOR. combine So antigen any technology is as can basically pretty ImmTOR know, you as you with much -- a

basically which well you demonstrated antibodies, believe it's with specifically preexisting are agnostic serotypes. able to evade and but AAVX we as basically capsids, the AAVX as designed As are there believe quite for capsids to we immunogenic we we're an definitely next-generation rightly to those said, that themselves. ImmTOR regards re-treat in that to application novel is the an actually of have And

that definitely we're gene well. address we challenges AAV-mediated but addressing So to think those potentially also as capsids replaces well prepared therapy, next-generation

Raj Prasad

Great.

between autoimmune On the that's we nephropathy? derisking maybe Is data COMPARE similarities the in there trial, disease think with any how should versus pegadricase to about regards developed the immunogenicity program? IgA

Carsten Brunn

Yes.

now the definitely the III, study. -- the -- I think, is we going derisks to definitely have that we data also we believe with Phase placebo-controlled approach I mean,

feel able an IgA is with fairly immunogenic where and derisk, really we've to an So nephropathy enzyme one-to-one we a protease, to immunogenic IgA indication And combine ImmTOR. ImmTOR. really, plan we'll we're definitely that the that basically we translation, demonstrated combine especially enzyme, with a

have So in gout learnings have transfer we and ADAs, Phase of in addressing terms demonstrated here we already we I definitely which trial the in can II.

Operator

Derek come question next Our from will with Stifel. Archila

Ben Porter

This Most asked. been is Derek. Ben of for have mine on

Brad. and guess just then OpEx about the studies guess, Sobi this year should the for starting I also I next So as ramp how we just deal one well? think considering year the and

Brad Dahms

Yes.

and So for thanks good it's a it. question,

expenses is so be Phase Sobi Selecta down that reimbursing significantly. the for to going take obviously, So III, our should

Sobi SEL-XXX lower our programs, of expect that operating the think expect were XXXX, go up. going line years they gene kind given you versus expenses autoimmune diseases But where ramp if can particularly program starting So going our to and the forma we the that of cash coming forward. you June the up, to in R&D therapy for of in XX get to not pro kind we balance as significantly the we're you'd be flavor we for Obviously, with deal, where XXXX. see late as a funding it's in advance

Operator

next Please with question from The ahead. go Yang will Difei come Mizuho.

Dan Clark

is for final Clark recent changes Difei. in of for on the process hiring role? the the the hiring This you. Dan Did decision the Thank or deal change Sobi CMO

Carsten Brunn

next and have III Peter. and So, He is in both impressive But in ideally critical. a obvious with as also suited clinic know and talked the specialist, therapy an about we oversee science skillset, big as oversee the obviously worked unique accumulates has pursuing into Phase gene Peter MMA step an in academia of a which biliary quite indication. pharma, biotech you having program, the is also, program. and background as our actually and liver cholangitis the in to translation as actually the ImmTOR we're -- But but liver also the he's primary

a just have table wealth think, forward actually a funding as And to addition Peter obviously move experience. definitely well the of process the part Peter's decision-making lot I there's in So that Selecta. disease of in we knowledge key to to now our to join brings do platform actually was, which his

Dan Clark

a Thank you. And then just, follow-up. as

For sort that expect for licensing future Uricase? of XSBio we product structure a see Should to to opportunities have with you Selecta. similar and for

Carsten Brunn

on immunogenic can license can other So, be an opportunities activities. But where looking that definitely retreated as want model be replicated be licensing model indications definitely think a well. at think think are we to bidding for definitely and we to can the and we this I XSBio don't is I and which without ImmTOR enzyme replicated and do comment fund I say have suffice to now, in is

Operator

from Pachaiyappan question with Please Wainwright. Boobalan will Our go ahead. come H.C. next

Boobalan Pachaiyappan

All right, great.

have to regarding previously, Sobi? start to to asked hear responsibilities Can just off, your So, calls. you the SEL-XXX like the would Phase partnership I I of was trial. respect Sobi with the jumping thoughts clarify been this III but might

Carsten Brunn

Yes.

behalf and part. the will on reimbursed and So execute fully the seat III collaboratively. Sobi get final But are we that actually the and going have the it's in execute will for will Sobi Obviously But of behalf Sobi reimburse they Sobi. by say this we be driver's on program. study to run on us of Phase

Boobalan Pachaiyappan

helpful. that's Okay, actually very

Is the MIRROR like the I lines, is future Pharma to for some to would trial the MIRROR expectations? Horizon So trial results what discuss scenarios exceed currently MIRROR if make along a positive positive a regardless be trial of it as SEL-XXX and happens data running. for of is are that likely SEL-XXX the difference the possible reckoned are the going to long with Or to to study? COMPARE the force as be and

Carsten Brunn

Yeah.

tell last looked So the Methotrexate. you results extensively we with of is don't There of obviously limitations the that use potential have months, feel this will the commercial the SEL-XXX of over at and I'll impact really why. couple and

first The eligibility, patient right. one is

from that to that have is of every with population disease KRYSTEXXA have We gout patients general about chronic III at believe be XX% disease. the Phase actually studies know chronic the looking about in and kidney exclude patients had we XX% patients You to kidney excluded. actually data

to than have more exclude per beverages alcoholic patients We week. consume drinks, three that

alcohol. you in that that's to have studies then know two don't So patient don't that actually And weeks. we population obviously first tolerate an from the abuses other about issue, this XX% oftentimes tolerate patient And Methotrexate. of patients that exclude

So patient -- to a in quite leading know, Obviously question just, think errors. look population Methotrexate, patients. medication has black error you actually it's And around toxicities, there this of to transaminases. critical Methotrexate comes at you I death when a of cause which a it exclude, is warning elevated organ to the especially medication box of you end is when safety. number also, due have

the And you think most retreat with a, convenience lack the another practical the you So Methotrexate you in or as that's actually therapy. have concern is non-compliant for third weeks maybe initiate I convenience quite the one, population. six really before know, of to

You have daily a intervention.

every weeks, disease you and know where weeks, a and on around You use. therapy therapy versus once after weekly two alcohol you have kidney monthly have don't folic layer daily to restriction take acid, Methotrexate, the then six chronic

have know, we product we differentiated SEL-XXX. with that you a So, feel

Boobalan Pachaiyappan

III that. both, this SEL-XXX SEL-XXX Is be be and big That's much on end why? initiate or it phase by year, And going your the focus? Thanks to would will you helpful. or very, so then, next very assuming what of Sobi and

Carsten Brunn

start And the we will guided quarter. III actually today, as this Phase Yeah. we

milestone really, So data into in first the our I least next year. the of preliminary you we of we That's late the us. think half we'll plan plan half second and our in enter know, really are that's a know, and plan on our and as next, next an gene at focus also autoimmune important year clinic to clinics, one in to cholangitis nephropathy And specifically next as is the October But for biliary focus. the of going which you therapy, have MMA more diseases IND guide and program for well. indications OTC in IgA year primary and forward we moving to file an the asset

Boobalan Pachaiyappan

then, And me. just helpful. from couple that's a Okay, more

collaboration your a to respect and would no determine whether or collaboration? efficacy what timeline associated with Sarepta, a with be specific this And go? go this signals would program there safety is So, with

Carsten Brunn

point. capsid AAV a have do months animal ImmTOR run experiments opportunity response immune it therapy. at plan the the agreement. to of And conducting. demonstrate been so that's have Yeah, will It's be details of in prompt that generated obviously, a exact so. which number know, by can generated of But to to prevention that demonstrate we the antibodies when XX and have great experiments you Sarepta have obviously, gene data they they the any neutralizing XX-month And to diseases, research disclosed able we're combine impressed far, you to the opt with question. liver-based where in we to been a Obviously, haven't the have they

Boobalan Pachaiyappan

R&D very year? cost the remainder we about Okay. the helpful. And That's how should think modeling of for

Carsten Brunn

Brad let that. I'll Yes. answer

Brad Dahms

Yes.

III So Sobi. on obviously, behalf of running so the we're Phase

So reduction obviously will the expect booked quarter-over-quarter. see we're we're winding burn to can that the given running III cash It's with as significantly accountants whether we're Phase -- closed And revenue QX, Phase were that working the or costs. as for a would would or down, net from the you same But -- III. our our still as R&D down be not that transaction study determine we're effect. in as in our down paying the well, COMPARE expenses not go you overall

continue. think how further guys guide I the of for on you Sobi. reimbursement expense trend should we'll So that then account And we'll sort from to

Operator

John come Newman question next Canaccord. will from with Our

John Newman

Carsten, have the I over you terms just wonder of AskBio terms partnership. go if in the you that briefly economic could

programs there be that You've got several you'll on working together.

that Just the curious term, successful. look would be should long over programs how those

Carsten Brunn

Yes, that's great question, a John.

One ImmTOR -- They is a license with there be in where X associated and $X disease. upfront. in their lead will development for we they will a that. plus classical commercial licensing licensed deal We have then million AskBio. with regulatory be Pompe December ImmTOR disclosed, partnerships asset as And actually year with last royalties there milestones

The second strategic of have profits. also where collaboration we is the the part is program collaboration, MMA and the share costs a true we where

where indications And partnership. to XX-XX have to together. commercialize a it's up we So XX that plan we and develop together

Operator

back Mr. Brunn, Brunn? call. like closing Selecta's to now the Carsten for over turn remarks. to of portion conference CEO, I the question-and-answer the concludes would This any

Carsten Brunn

and excited We growth and the who platform half the forward Thank information sharing the you of continued Thank everyone growth XXXX more to you, joined This morning. throughout platform. today's company about to We're look ImmTOR thank and about the extremely concludes operator, the second our year. you. this us of call. our

Operator

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

You may now disconnect.

Cartesian Therapeutics (RNAC) 9 Aug 202020 Q2 Earnings call transcript