SELB - Earnings call transcript Q3 2019 | Cartesian Therapeutics, Inc.

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Operator

Good morning and welcome to the Selecta Biosciences' third quarter 2019 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 like to introduce Elona Kogan, General Counsel of Selecta. Please go ahead.

Elona Kogan

morning good and you everyone. Thank third Welcome corporate financial and XXXX conference to call. our update results quarter The reporting press we filed, our press XX-Q, www.selectabio.com. is the release website, available our financial in the release of and section results which

Brunn, Officer. Joining Chief President our Medical Executive is Dahms, Brad Schecter, and Officer Alison our and me Dr. our call for Chief today's Carsten Officer, Chief Financial

company's results made limitations, like anticipated reminder, advise related constitute Harbor that provisions and ImmTOR cash, the purposes are we the statements of that Reform to ability without AskBio, including, Safe would our company's to with for readouts forward-looking of expectations, XXXX. data trials, equivalents prospects, the Private the during sufficiency a timing and the Act collaboration and short-term call, of of As remarks this of statements market trials, plans cash inform the future about certain and for investments development of our Litigation Securities future our under potential planned the potential platform, product, the

on Selecta's with statements www.selectabio.com. recent differ be the may forward-looking by Risk these discussed various a section at including result those the of Factors SEC, of indicated which results materially important Report in filed from Quarterly factors, Actual Form accessed as XX-Q those most can

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

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

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

Carsten Brunn

ImmTOR both re-dose important new possible recent to the neutralizing announced you I ability address Congress, the treatments good Annual and re-dosing. the refractory not presented was to gene therapy today. therapy, everyone. European advancements antibodies our achievements demonstrated gene demonstrating as specifically for several key Cell data we gene Thank and therapy potential of at the to chronic Gene Selecta We Society gout in It AAV for and which you of appreciate against is programs. of AAV joining quarter capsid. us challenges key of development the due Elona Therapy it morning an Currently, the

Officer, data Our Chief Medical details Schecter provide Dr. minutes. will Alison this a more on few in compelling

a strategic August, clinic in alliance proven with therapies. AAV a jointly in to we of gene life-changing anticipate and Selecta key to leader effort are for is therapies partner a This and commercialize thrilled announced this with to next-generation entering milestone broad AskBio, In develop, we manufacture we them the gene portfolio and a forward XXXX. move

soon. further We will indications and details around initial provide timing

program of superiority head-to-head in announcing during interim We of and candidate XXXX lead refractory the quarter statistical chronic expected by product SEL-XXX data of to significant our Our COMPARE, mid-XXXX. completing data make the progress. announcing gout development enrollment by end anticipate continues topline the trial of XXXX first

Phase the be pleased regarding also the clinical meeting X January with We we are a plan in that FDA confirmed to held SEL-XXX. development for have XXXX

SEL-XXX gout with about Based of subpopulation in the impacting affected approximately because chronic patients represents the U.S. to represents needs market most for opportunity. on condition potential severely gout We are to excited refractory our data research potential people many and help has XXX,XXX the believe address and debilitating rheumatologists, over the in quantitative this billion SEL-XXX $X with unmet XXX market we significant patients

of that quarter market financing consisted closed team a price. Board Directors, We third in the primarily of management and at million which was the $X.X done

of in the broad financing applicability the demonstrates confidence the this to In addition extending platform. our ImmTOR runway, continued

Brad Alison Schecter Dahms also company's as management addition Officer and executive made the team Financial of Chief advancement with strengthening the Chief business, have important our Officer. Dr. We Medical a as as

Alison several from stage led strategic and late sciences through and development is and an for as has DMA translation FDA scientist experience his physician experience banker medicine and and with deep unique financial expertise assets life investment early both approval. companies. in a Brad brings

now I call to the some color gout provide refractory and gene to more therapies our turn programs. will over Allison Allison? chronic on

Alison Schecter

Carsten. you Thank

alone. immune the the As to that Carsten ImmTOR therapy, which capsid. studies previously re-dosing enables the These which key the the presented address from data further repeat dosing responses update therapy vector gene gene limitation and and up development we at mentioned, move therapy in new we as data to We programs first our ESGCT from enhances dose AAV with forward specifically in in and provide to gene October programs four stem MMA of these preclinical OTC transgene demonstrated clinical ImmTOR challenges forward. adaptive to demonstrate AAV will compared look against deficiency fourfold ability expression lead

ability platform partnership human antibodies the proof to the by our the with is both portfolio capsid. therapy technology validate this trial of has this patients. the with is against Currently, and AAV potential AskBio, companies a gene their terms potential We the proportion maintain of concept increase to of for In benefit. leverage achieve AAV in platforms of products unique alliance re-dosing patients limited believe neutralizing who to will therapeutic of proprietary systemic re-dose and that our

scaled of potentially gene development of the library capsid therapy, therapies. will gene extensive and these capabilities accelerate curative pipeline manufacturing robust their AskBio's

As anticipate Carsten the in mentioned, entering AskBio we and XXXX. clinic

presentation these studies Annual three press the our gout our forward lift. embargo results release to of of American We detailing on SEL-XXX X Moving from data at College following on encouraging the Phase dose meeting's refractory be issued Rheumatology's A of chronic ranging Meeting XX. study will of of look program. November additional abstracts the to the

trial. clinical COMPARE head-to-head the to Turning

pegloticase. five SUA these levels of dose-ranging study of below first SUA The which acid to of patients than plan that advance less only in XX% will We XXXX. and XXXX the statistical cohorts of XX% in of and in the trial to treatment. enroll COMPARE The of mid-XXXX. evaluable at safety pegloticase mg/dL interim the which This report patients of built upon in that topline the X experienced compares compared against SEL-XXX, plus a combination is end approximately quarter flares trial is data to primary of SEL-XXX superiority Xmg/dL six continue in the XXX we enrollment X is evaluating of once-monthly cohorts, current to month study uric monthly dose trial that month of the six uricase. expect pegloticase, which maintenance proprietary The SEL-XXX showed and of patients completed data FDA is approved be the of maintained pegylated in and endpoint ImmTOR We a the efficacy by levels first our report or months. dosing Phase COMPARE uricase serum plus

we clinical in guidance look to with development forward on our the meeting Phase X Finally, January plan. FDA receiving in our XXXX

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

Brad Dahms

everyone. release Thank are and be and good laid will financials Allison our you The filed our XX-Q. earnings morning detailed press in out in

sufficient cash will to just short-term our with We operating as equivalents meet $XX.X compares XX, the here. be XXXX. our We cash cash, highlight I and first equivalents, items believe which cash, of investments few key a XXXX. million the $XX to and restricted requirements cash million will So cash of ended June in through restricted third quarter quarter

transaction. resulted Board the at transaction close management and private million net primarily from $X.X the completed team time we of price price which proceeds noted, the with million. at approximately $X.XX, of of shares Carsten participation financing in the quarter X.X a issued consists this As of The a market

the R&D period the in reduced our head-to-head million and same decrease benefits programs. which expenses from for quarter headcount reflects of million, XXXX $XX.X September The addition XXXX. salaries resulting XXXX XX, COMPARE the in of the recognized timing for work prior were ended completion $X.X and study of expense the reduction early compares with to for

September ended expenses professional of and $X.X compares and XXXX. for million, third The result for cost were the in $X.X which General legal was million with administrative primarily fees. of reduced XX, XXXX fees the quarter the reduction quarter

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

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

Carsten Brunn

you Brad. Thank

an earlier, reiterate third exciting head-to-head focused like our study in COMPARE priorities As refractory two that advancing in gene on we important and to our the quarter. chronic on and our I would gout teams had mentioned executing pipeline. therapy near-term,

that to have in are we by year announce January to from We COMPARE to clinical Phase pleased on the the plan XXXX. expect X the and in the of FDA enrollment end study development guidance expect this complete

data We statistical in by XXXX will QX interim provide mid-XXXX. topline and superiority data

vectors AAV show With of potentially which preclinical regards feasible. data the not enables repeat is that presented to ESGCT our technology dosing therapeutic therapy gene at currently our program,

XXXX effort forward. into Our in allow not this we and us could better partnership a the to with have will drive AskBio partner move to clinic

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

questions. are With that, we take happy to

Operator

our comes of Messer [Operator question & Needham Instructions]. first ahead. And Chad Company. from go Please

Chad Messer

morning Good questions. my Thanks. and for Great. taking thanks

regarding example, in can just had? follow-up discuss data we update might you that have much of how College days, how in more something there? a at is off us? much Rheumatology of this For to Just it be to possible start tell more time few Is

Carsten Brunn

Thanks for question the Chad.

will we there have data and more than shown. it mentioned, three detailed as posters So we we is have

flares initial where is month of I the gout after analysis new on a flares in flare and is that month we specifically think, gout what were two. there no had specific one XX% patients new see

Chad Messer

Okay. All right.

All more are new these So right. deeper analysis.

Carsten Brunn

as analysis. Yes, on It's antibodies. analysis between correlation deeper a SUA is using deep control well exactly. and There a the

information here. the So we that's show

information detailed have on So presented it's we the more past. data in

Chad Messer

any is that. Okay. your any And CureCN? released wondering Thanks therapy for been have They they while there's dosing about if a their And agent gene collaboration data proceeding? right. have single on update for just now. study then with All how

Carsten Brunn

To disclosed. not Yes. they my understanding, have

remains guidance to from that authorities. And will in unchanged, get so guidance the German our you waiting Q see our

we on excited and are call. was it as partnership shifting track As this towards guided obviously are kind there with no AskBio of earnings Obviously, took we update, very still the we But last that. real so of quarter. out about

Chad Messer

the eagerly congrats understood are you we all what progress. more Thanks awaiting say that. about to and on be No, move able and Yes. could

Carsten Brunn

Chad. Thank you

Operator

Stifel. Our of next Derek Archila question from Please go ahead. comes

Bill Grau

for Hi. our Bill, on Derek. question. Thanks taking for

a into what Just the might kind And length might study the of for proof then X Phase of Ask? you and phasing of expense of Thanks. of what with and timing enrollment obviously look about think then R&D like complete study the think on as you COMPARE your can insight you size AskBio more thinking are study of human concept? Sort give be? partnership, the that us you little and the and the

Carsten Brunn

Yes.

excellent details So thanks and in will future. definitely the for the guide question more And question. we

as think XXXX. I plan AskBio for we be clinic now, we to in in guided with the today,

that that Because and of have of you neutralizing think is, We a will XX one of XX ImmTOR. programs formation what programs. antibodies? can own past can at I of we our It MMA. the prevent the dose be something looking the we think after And one will of guided giving are measure be the fast primarily with we AAV to endpoint days that's together capsid in

that's going the of guidance. at. detailed we one call, that But in mentioned more So going be look we give the to to definitely will endpoints as are

plan. now and We right with high-speed are ahead the and steam indications both to obviously AskBio full at development finalize clinical working

stay So tuned.

Bill Grau

So can just if I --

Carsten Brunn

-- It's ahead. to the Go around going be yes.

Bill Grau

may a of couple need re-doses to in that you not study. So do actually

think should NAB be just the showing You enough?

Carsten Brunn

the transgene, done so we course. far, obviously express and the is will studies ultimate we actually to be ability or formation neutralizing from So But think antibodies. can a the prevent have marker of good of re-dose proof the developing

re-treatment So is will have the fact to longer. we readout the think because that's take

Bill Grau

Thanks. sense. That makes

Carsten Brunn

Just R&D the once as follow-up, we expense well complete to down expense significantly. obviously on will go COMPARE, the

around Phase expenses X guided We have yet and gene in have not expenses therapy. also on the guided the not obviously we

is, these note much smaller trials. important one the think are I

Bill Grau

that makes No, Thank Yes. you. sense.

Carsten Brunn

you. Thank

Operator

go Please question Our John Newman from Canaccord. next ahead. of comes

Chris French

pre-existing This ImmTOR something is and level Newman. antibodies, Chris, was if if one that antibodies. you that poster still a this wondering Hi. that use that had you say, I taking also that was circumvent low overcome meant could my Thanks for AAV can had, was else? let's just for last thing dosed kind mentioned of Per the someone of that? meant levels question. to John an product with low was of you Or it if guys they

Carsten Brunn

So thanks Chris. for the question,

overcome in I think say, I actually shown point, I lower that we this can have you this that levels of would animal antibodies. at speculation experiments think mutant

will think as translates I can have this far say to now. how we that's studies as We right human Yes, see into obviously.

Chris French

therapy a to row. just the I programs gene wanted And get it. Got in

programs? kind be are from and So the you to of so timing And the going can the when they about of timing clinic to straight last, therapy yes? the talk I gene could first just to going get

Carsten Brunn

Yes.

So part we in to in do AskBio. have, OTC, we of we have phase as with you be call, the pre-clinical X heard Around guided OTC. are MMA We are the guided have not on will and that we collaboration still MMA previously the going and clinic. when the programs

on that. what disclosed indication at said, we as to clinic. have we collaboration which mentioned the other once to But time, clarity guided move I which plan And I guide and indications MMA have to. So in will forward take we as to not earlier, there's more the we yet haven't

Chris French

just question Got it. the SEL-XXX. for on And last

For anything could for gout more Will us see? data example is tell quarter you SUA other the specific interim and about readout we there it XXXX, things? what in will flares first be

Carsten Brunn

Yes. question. That's a good

We question comes of have guided the and not course. up, detail in

numerical and month going think that to SEL-XXX look at at I three we can I and difference six. say pegloticase what month between is are

so think readout. closer for enrollment year. are we we as to of that's as the and plan to we we we the to I happy far announce able data update an this provide complete of by And guided that more have once are we end that are will now,

Chris French

Got you. it. Thank

Carsten Brunn

you Thank Chris.

Operator

go from of Difei ahead. Mizuho. question Please Yang comes next Our

Alex Lim

could COMPARE morning is This Hi. the was for Alex, a if on bit guess on the Difei. there? shift the terms you I timeline just I wondering in comment guys. little Good trial of in

Carsten Brunn

the question Thanks Yes. for Alex.

recall, patients sites. with timelines quarter disease XXX that guided aggressive extremely orphan completely we driven in we recruit new you fact delay, that as by we is So a have the last quarter had to an which

running. So it's just those get longer taking to up sites and

we very now. are the with rates recruitment pleased are We seeing right

are So readout. of to times guiding the we different not

We are interim readout. all investors a and just provide meaningful looking at, to obviously, you of

changed that You we But shifted next of into to QX used of timeline are enrollment otherwise patients not than the by that, this going or a and certain has end that. number why complete year. moved we the guiding That's we this kind of for year. are

Alex Lim

if on the opting gene And front, with therapy was indications? you update Spark? had collaboration additional you. Thank an on I then wondering into Okay. then the And

Carsten Brunn

Yes.

additional recall, So indications And around once the additional will of will guide year licensed from and Spark combination four you to the Spark A. treatment opt And for end collaboration, in ImmTOR we hear them. this the by hemophilia end the as to year. of of right hear we towards have the this we into the we

Alex Lim

Okay. Thank you.

Carsten Brunn

Thanks.

Operator

go Our Zhong comes Please ahead. next question Yun of from Janney.

Yun Zhong

Hi. the question. Thanks for taking

ever information if had And data not you the FDA. with you case, guess, to the with before interim Phase provide to I that meeting in you be likely the the what different if that's the on be the the will correctly when have And the to FDA? another with meet able you So I FDA January, will be most have meeting agency? remember will X meeting able

Carsten Brunn

Yes. Good question.

the had Just COMPARE with But end obviously not from important our X what year remind is Phase you, in I trial to private is of December that disclosing of meeting FDA. independent discussions and X. we an think we is Phase the the last are

very Allison that get the guidance is, plan X. is think I important. Phase what on we to final mentions, as And

Yun Zhong

you. Thank Okay.

Operator

call the for will Brunn, call. remarks. now This CEO, concludes Selecta's back turn question-and-answer portion to closing our over I the of the Carsten

Carsten Brunn

everyone and us thank who morning. joined this you Thank to you operator

in achieved gene gout critical across benchmarks refractory this We have platform and progress quarter the ImmTOR chronic as we significant therapy. have advancing made

extremely the forward potential Thank excited we platform. We broad today's ImmTOR continued concludes developments to company our the are the to continuing call. growth about of and technology you. of the and unlock That

Operator

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

disconnect. You may now

Cartesian Therapeutics (RNAC) 11 Nov 192019 Q3 Earnings call transcript