SELB - Earnings call transcript Q1 2020 | Cartesian Therapeutics, Inc.

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Operator

Good morning, and welcome to the Selecta Biosciences First Quarter 2020 Financial Results Conference Call. [Operator Instructions]. This call is being live on the -- 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'd like to introduce Elona Kogan, General Counsel of Selecta. Please go ahead.

Elona Kogan

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

our today Chief Financial Brunn, Chief Officer; President me Joining Carsten and Executive Officer. and is Brad our Dahms,

available Kishimoto, call. for Chief will the portion Kei Scientific our addition, be In the Q&A of Officer,

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

if not as to only these views statements, update on forward-looking place intention And statements reliance disclaims undue speak to such even cautioned X, change. any today, which Selecta May of are XXXX. management's You

Brunn, to call turn would I like now and over our to CEO. the Carsten President Carsten?

Carsten Brunn

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

of properly been ability. of safety first from COVID-XX the and risk navigate to able the these to mitigated has patients the quarter the ensure to best obstacles care Selecta health providers While of continually any pandemic, XXXX to presented and due is our COVID-XX that while prioritizing health challenges our

material and data plan is on SEL-XXX To this third of of in to we this seen still trial study. announce clinical on chronic in compare a line not head-to-head refractory have ongoing date, quarter impact year. the top gout we schedule, The

continue with ongoing we there associated is unpredictability this recognize inherent to that However, situation.

patients in CRO, ensure this to continue sites in a and clinical the that work are trial measured We investigators treated safe with to real-time and manner. with our

SEL-XXX, a study As comparison SEL-XXX once-monthly a a COMPARE doses study, reminder, biweekly pegloticase. of combination the to to candidate and in the is Selecta's ImmTOR compared pegloticase. COMPARE of In dose of lead which being is is product evaluating pegadricase

endpoint X maintenance of and and XXXX, as per X levels and deciliter primary uric XXXX months. April had the patients reached completed December the of X serum of study, of less With enrollment months the half patients had completed of milligrams acid X the The trial than in of all at treatment.

schedule, Phase preparations barring also XXXX, program impact for We're of III our second the the SEL-XXX to due initiate unforeseen any of the study remain plan to announce to of pleased commencement half that this on and in COVID-XX. we

several SEL-XXX the taken have Phase from clinical complete measures program. ensure also III have supply to a perspective We to we of enough manufacturing planned

their and therapy enter priority the partnership potential redosing both gene this technology jointly a portfolio AskBio, In key broad with clinic in could therapy the a This leverage and partner advancement proof-of-concept represent proprietary for program therapies. Our by human of companies we are for significant platforms developing Selecta a this AAV remains of products gene to Selecta. gene intends validate next-generation unique with patients our to of field. of end AskBio collaboration the program in XXXX. trial portfolio which the with will a

the of the study Additionally, initial half the further in second year. proof-of-concept details provide we plan to of

continues to in Finally, transcarbamylase ornithine program Selecta proprietary its advance deficiency.

him to record development executive and further support with Goran advancement both a our journey. for Dr. proven announce the the will appointment part His execution, to to and brings a ImmTOR, and of in is Dr. be excited Ando Directors. of of of Board wealth product of also Ando enable track a of We're we're experience the commercialization. excited pharmaceutical

I'd from today. for replacing we we with beginning, his like support. long-term thank Amir and Nashat, He Selecta to was where is put also the are Selecta Ando Dr. him who thank for helping

turn Brad call Financial Dahms. over now Chief to Officer, I our Brad? the will

Bradford Dahms

Thank Carsten. you,

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

same restricted XXXX. few I'll as in equivalents million cash here. So $XX.X million cash, activities for just quarter a in highlight used compared We $XX.X key ended million cash operating the items with was $XX.X period Net the in and to cash.

XXXX in Disease signed $X used January. December $X receivable remainder million cash the for million received related the received activities XXXX, license was their them operating from in million with we $X in quarter Pompe was program. a Net includes the agreement the for in AskBio to and of

the a clinical program provide us runway Phase reminder, into net our receive royalties We in of commencement commercial to to development plus million XXXX, of guidance is will III current up this $XXX milestones, sales. of our As eligible and Selecta first SEL-XXX. cash includes believe on position and quarter the

increase COMPARE R&D quarter expenses were SEL-XXX for our and in XXXX. million costs which of period collaboration clinical with for million, trial The for compares additional in AskBio. incurred $X.X reflects program quarterly same to specific $XX.X the first the gene with our therapy head-to-head

XXXX. which consulting in expenses reduced same the was the were million reduction with partially G&A period increased salaries, comp offset costs first $X.X fees, compares the million, professional for The expense. quarter by of in stock and result $X.X for

quarter, or with $X.XX share, per For a $XX.X million the the of net same $X.XX for or million $XX.X share in of which we first loss compares period a per loss net reported XXXX.

closing over back hand to now for I'll the Carsten? Carsten remarks. call

Carsten Brunn

Brad. you, Thank

the the top I'm earlier, companies. trials of unwavering SEL-XXX I'm and line flexibility, and as as data the our from the a Phase I'm pleased of our of of gene mentioned our for schedule that grateful of their clinic announcement are ensure us, milestones most their by to QX. second for continue dedication on and proud result further efforts, half to for QX, of in did study that into we team the trial first programs and year as The unprecedented challenges a this and the it III commitment development progress. key As therapy unexpected posed clinical today, of of in program the COMPARE the initiation entry for year. quarter

Our commitment redosing that can gene benefit therapy value breakthroughs diseases we treating from new in remains from pursuing to to platform. and of additional generating forward our look ImmTOR strong,

and by along helping our conclude to supportive gratitude our people like us families, our many at investigators, with their who great been COMPARE I'd reiterating way, to the our the patients Selecta. including and have team

to take that, happy With questions. we're

Operator

Instructions]. [Operator

line Merle question a first Ellie the of We have from Cantor from Fitzgerald.

Ellie Merle

us COMPARE color more you of any been impact little give any, COVID what bit study, have can missed just the a the of terms COVID-related in Just on proportion to if on due disruptions. doses,

us therapy of sort doses. question treat sort front. little to of guess, from potential more color you in were then there a be contingency of remind you us and terms give I could then you the to saw perspective, in final just of missed is gene of my planning, just disruption, missed terms data doses were And if how in SARS a if on And anything all? bit terms if at terms collection be far, contingencies Just a this if of you in and/or would the there can disruption

us moving antibody proof-of-concept demonstrating in would you looking from do of constitute little terms a As what you and and of for about you'd and be potentially the terms titers? sort a are guys to bit guess, I clinic dosing perspective your the immunogenicity towards what patients. redosing tell in ability Can of, any

Carsten Brunn

Great. Ellie. Great you. Thank question,

that think also it's I that important, in impact, COVID what's administered drugs. we part dedicated of terms drugs infusion to in They important centers as So life-saving note this mentioned I we think practices. administer discussion the rheumatology had are and of in previous

either health actually care and a this provider centers from to open sites with a Patients basically trial not got -- COVID. running. a or X sites sites doesn't a redirected crisis. impact We time throughout the the alternative at So went will due But all offline the remain we patient, not an necessarily all COVID weeks number our of and have up for the study. are on had to have diagnosed

So how It PIs extremely both I think is. to Overall, important are the infusions. shows disease patients motivated. in that's the terms the of severe obviously note and

patient, of date, actually. obviously, the to and the And there working reduce safety seen sites. are the with to lot next done consultations not infusion disinfected. that the centers. the impact, we the measures by infusion come taken They all a telemedicine. sites, patients A via sterilized number the have before actually are infusion, closely are material are suites So are we After and of

So we impact. did I those perspective. far, are operational But think not have material a from changed all so

of so the patients pre-COVID. obviously months, completed the -- would a for the is account contingency get to and out patient terms do in make approaches and patients plan and changes that plan a So And study, completed you you project to SAP of that data we So to potential dataset what missing half your could we're X those even on completed question, pleased of that mean the between call months potential do working dropouts, for study. worst-case in a various have the to kind all second potentially right? X I We're contingency patients I X we and to take. analysis not could there's scenario, have could and

you that, around updated through keep So we're working this. and we'll

great after a proof-of-concept, of retreat a to as we're measure terms prevent together able antibodies. for for frame, of of and well. therapy antibodies, a terms question is a In we prevention second that and that's antibodies the to to dose. fairly And formation check of that give XX presence time would certain good is would would we're And simple within indicator administer formation really we think gene ImmTOR, I to here that of trying and with neutralizing it's what gene therapy, a gene do a of therapy at look which with days neutralizing ImmTOR believe XX think the and in we I the obviously administration

Operator

of Blair. question have Prasad Raju the from from William We next line

Raju Prasad

potential And curious kind do pivotal a Krystexxa gout patients? of follow-ups. kidney you I you experienced transplant then I would just patients? likely could enroll couple have on trial was well intend to in as the -- patients trial, know, of or be as pivotal naive-uncontrolled Or

Carsten Brunn

questions. Raj, good

exclude prior. patients we also with been a So yes, patients have treated transplant. mean Krystexxa I would And we with exclude would kidney

So we're naive the to pivotal looking patients recruit study. to

Raju Prasad

angle. with then rheumatologists obviously, dosing. or hearing? situation have of, that And increased anecdotal there from spoken about thinking increased the benefits regarding anything any you of -- the said would Is a COVID-XX Great. frequency different that Have information you're durability

Carsten Brunn

In regards or...? SEL-XXX specifically to

Raju Prasad

Yes.

Carsten Brunn

Yes.

visit potentially is a basically which per in I month, factor, once one light advantages of obviously, also COVID I a the is think, big of mean, that especially month. SEL-XXX one it's only convenience dosed of we're only but

seen So month. has as in even also for I definitely it's patient come infusion one as fewer per obviously, is mean, with a the positive, but sites, interactions seen now, pre-COVID only a positive. there's the to

I patients other piece the are that think with very important treat dedicated gout. chronic refractory to is still rheumatologists

be is of to to taken consideration suppressants, as risk rheumatologists moment the also have best with are COVID-XX. the room, if try other would emergency which which them they gout treated the off is -- there gout to given moment doses place flares of And high at that oftentimes well. they steroids, lead go very decompensation, As a is which therapy, which are oftentimes at something avoid the immune the not means which is would be flares, could to severe probably

Raju Prasad

And Great. on the platform. gene then therapy

saw abstract So there's of from looked And as color poster been neutralizing the the Or then presentations kind of it treating the MMA that increased like that be you as antibodies ASGCT. on can learning you're with significant further far there -- in of Anything mice. can maternal in you Is will datasets paradigm didn't anything provide that? presentation ImmTOR at juvenile any that the matter AAV. treatment you there color from were couple there? a in

Carsten Brunn

We'll bit point. Yes. questions at more poster, the a Kei this provide additional to to color those give but I'll hand color with

Kei Kishimoto

Yes.

So observation. it interesting very a was actually

eventually, in to mice all for were of that mice. when was to born had vector, transgene. So we of had observed maternally the looking And with together the preexisting those antibodies at AAV gave even what And And ImmTOR redosing. those we rescue allows this presence we the transferred that were survival able to pups we the antibodies. we much MUT better

that. into a encourage it's interesting So to tune study and you very of kind

Operator

have of Zhong We the Yun next question line Janney. from from

Yun Zhong

terms much question wonder on the have if, of how line the no a So timing to flexibility say, data It's know I But impact. COVID-XX follow-up still is material of impact. alternative on you top good is in not do goes day. track, that flexibility? do Is how to -- there infusion on it if a the you patient specific terms And available a in that is an in have to the acceptable go of room he center much dosing, day?

Carsten Brunn

do Yes, dosing, Yes, question. great days. around X the have that's a indeed flexibilities plus/minus you it's of some kind

case to able the you to an had mentioned. go do in be miss obviously to opportunity So dose, rescheduled. to site this previously, I was there is to we a down, If are Or get the infusion. a you alternative side which shut

yes, the So there dosing. flexibility is around

visits to We've their I think or blood back I important sites think patients go also the for labs alternative potential for are alternative home their explored protocol don't to nursing home. to other is site, to And go The allows closer piece also draws. the the that have can flexibility. draws. blood they initial

terms So draw flexibility we're in the as providing well. blood of also

Yun Zhong

then to first And main confirm be or to to clinic will Okay. program I that -- the clinic? the looking program, to both? that And proof-of-concept initial for be enter therapy is data for wanted the patients from the start the OTC the or gene to at the on OTC redosing are dosing going you have objective program going MMA the move antibodies OTC to program wait the And program, the into MMA. preexisting

Carsten Brunn

Yes.

have we I a past. the So think in discussion

our with we AskBio. into So program was MMA the that partnership put

which We clinic. go the program into haven't be guided the to first will

collaboration indication with which mentioned MMA will as we'll AskBio. part the the guide is So of earlier, first but year, be, throughout the

efforts but go of we we're mean OTC, of that which through plan quite initial to are will still Obviously, ultimately, OTC. with dose, terms just the in demonstrate? early but kind basically. would we can question, show able read, to we what the our that enable we prevent trying after second to I the the be first plans, the redose if we we working around want to of to we continue can And In back demonstrate initial successfully MMA neutralizing the impactful, dose, formation believe, are antibodies.

Operator

[Operator Instructions].

have We Canaccord. next John of the from line from question the Newman

John Newman

on the progress congrats COVID. all -- process given And

is, XXXX, for period the regarding different number dropout So control rate data of was interesting initial you some gave my group the at in two that a end the higher. groups us the active study question in dropout the

the because potentially the arm might week. your out to control is be crisis, a missing what your it is COVID on dosed have often the monthly. wondering what center is Just opinion twice drug, feasible Is which than we dropping there expect expect during that go to infusions given given active into they would more that more patients or

Carsten Brunn

good on a to I And John. want that's speculate Yes, data. don't question, the

key month. a once as dosing in benefit feel a the in to regimen. I is of in say to think definitely PIs that differentiator come actual the COVID we and study to But arms. strongly both have the I fair patients but motivated very definitely are I there's But is a think the or data, monthly it expect without don't only with any SEL-XXX

John Newman

may gout question. gout In Okay. for XXX, if presented I curious the to flares study. I'm the low. And flares COMPARE you more been Great. data the to quite ask earlier that have And just have one as been how plan in analyze the

the to general, X to as in curious of arms? what between you'll analyses, look that do Just types

Carsten Brunn

is as Yes. the secondary question. And John, in study. gout And that's a a you flares great know, endpoint

gout will number at be the we So looking of flares.

do analysis into we as built But well. think also other -- there's that's analysis. I there's So the can

reduce the terms concomitant the look of example, For of as where there's steroids, of of the gout patients a experience refractory trend physicians throughout good clear use obviously, of the at is flares. And in use indicator study, to which gout, in steroids. can for well who a use the example, we -- chronic treatment the try

are of I even quite with immune think steroids, high COVID acute around the where are more doses that's crisis, now administering suppressive. rheumatologists which nervous

Operator

the Securities. Mizuho Difei We question have from line next from Yang of

Difei Yang

initiation couple. just permanent a Would pivotal we on for to be trials a XXX? So of board CMO expect the before

Carsten Brunn

pleased We and the and lot preparation academic but for And search, have for Peter's we and Peter both Difei. also very CMO. a biotech. brings might potentially start the experience, that's as Traber our medicine to from good acting pharma overseeing a COMPARE Yes, now, question, of Peter were Phase III. a big trial

on So -- project important have what's SEL-XXX beginning. below well, strong and to a we manager has note the as been team the very program -- Peter, since

team below well. a we very experienced as have him So

Difei Yang

us Then the turning acid X And a program. what's from down of of is us uric would the the the little the you analysis if going change? remind X. for help level to just so that lately implication you be inclusion out COMPARE, criteria just that we -- broadened. amendment It for to then data protocol to plan your can could readout. understand been statistical And on seems SEL-XXX has ready A there of QX like

Carsten Brunn

Yes.

help pretty actually on Obviously, and They previously chronic definition, above changed at considered have like levels X are with present. speed uric compounds the X.X tophi the for allopurinol, sUA of had by we inclusion criteria lowering with to on refractory. failed So early example, recruitment. least serum patients

So severe still very population. it patient is a

there's The here. of speed key here key don't difference a driver was recruitment. we So think

this terms of statistical discussed previously. In plan, have think I we

powered note superiority We not statistical have detail. in in But show that control. to the terms that guided important is sUA study to to of

Operator

Instructions]. [Operator

from the Ram next Selvaraju from have Ram Salad question H.C. We Wainwright. line from of

Boobalan P.

dialing Boobalan in is This for Selvaraju. Ram

to what XXX? to items trial run are trial long what run analysis Then, an XXXX, you point? Is any will Phase in X get expect time planning III approval for how there at run? FDA only to be trial planned? investigated so, assuming that the So sometime about would the you SEL-XXX, interim If you'll

Carsten Brunn

meet to question Nice for the And you. III. Phase Yes. your around thanks

run months X So studies are having we have months X extension. -- with Phase as studies. we previously, guided placebo-controlled safety do to study X plan They X to two III a

So the we're We second the half in that timing. X study, start of that. year, driver plan key will on to for and terms of in obviously, the still track Phase III feel this be we

recruitment, guided the we'll another recruitment. readout XX and speed have study, of X-month we'll have then not it's complete after readout once months. But have of a we We to basically,

Boobalan P.

discovery additional space is next direct Gulf we in your maintain competitor, question, And that its see the pursuing Horizon, leadership. programs to

you franchise? your plans have similar gout do to any strengthen So

Carsten Brunn

mean, SEL-XXX question. III a it at strongly Yes, of bring we're in at this that's the think moment. I this great point, into I year. half focused key Phase And focus that's our on the and second

Boobalan P.

be final And would question. my Okay. this

So the XXX, can has are facilitate to slated especially the collaboration. talk entry? end? what remaining maybe the your I XXX are which about you if year, understand What be items order the And enter are that in the items this AskBio from gating into the and to clinic about, to do completed to AskBio

Carsten Brunn

Yes, that's a good question.

of first ImmTOR. program we and the that indication, think, we it's important collaboration, specific into obviously, MMA have the I bring all, but not to So guided both

manufacturing ImmTOR those currently forward We on and capsid. for is are jointly AAV of things, AskBio responsible we we're of on the that focused move the we're going with. the responsible to indications and the And decide for manufacturing

Operator

question-and-answer Brunn Carsten? This for Thank Carsten over I CEO, portion of call. the Selecta's will now closing like remarks, concludes to to the turn Instructions]. [Operator back you.

Carsten Brunn

the in XXXX throughout today's who call. operator, company everyone you, upcoming you. Thank potential of and our continued sharing forward to extremely ImmTOR growth excited the concludes milestones platform. That further the broad thank Yes. the and look about platform to Thank of We're this our the year. us about joined and updates We you morning.

Operator

Thank gentlemen, now with Thank you that us, joining very your may you and and Ladies this call. for disconnect conference concludes lines. you much.

Cartesian Therapeutics (RNAC) 9 May 202020 Q1 Earnings call transcript