SELB - Earnings call transcript Q2 2019 | Cartesian Therapeutics, Inc.

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Operator

Good morning. Thank you for holding. Welcome to the Selecta Biosciences’ Second Quarter Financial Results Conference Call. At this time, all participants are in listen-only mode. This call is being webcast live on the Investors and Media section of the Selecta's website at www.selectabio.com, and it is being recorded.

would to I over the remarks, Elona. to opening now turn like call For ahead. go Please

Elona Kogan

other and accessed you, a second results the filed containing issued everyone. release This press our and and and our financial XX-Q. XXXX can Thank quarter morning, release good be Earlier XX-Q updates, for we corporate today, Kishimoto, our Stephen Smolinski, available our by visiting I'm Q&A www.selectabio.com. will and at the Scientific joined today who Dr. the CEO; Kei our of our website by Chief Officer, Carsten call. Brunn, portion COO; be we

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

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

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

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

Brunn, Carsten kick me off will And now things today. introduce who let

Carsten Brunn

Elona, you, everyone. good and morning, Thank

AAV traction we're potential gene particularly therapeutic biologics, for transplant, excited and and quarter, to immune enzymes in This momentum tolerance its about continued gain therapy. we ImmTOR, and

The Many the the development these response. antibodies to trigger in their is current drug therapies neutralizing benefit. therapeutic areas caused administered biologic system limitations will challenge immune develop immune counteract that by own when for body's the

to answer immune challenge achieved. allowing platform, goal therapy, of therapeutic the selective which tolerance be the promotes to this is ImmTOR Our our

our SEL-XXX, the gout, we made of to For progressing chronic our patient treatment six lead to progress compared program, trial evaluate months enrollment COMPARE development for and head-to-head refractory in have good SEL-XXX is gout. detail will Krystexxa moment. the opportunity in us If about refractory more an adult demonstrate patients will program talk with to in in this Stephen trial SEL-XXX. of chronic give a this successful, designed superiority

are extremely AskBio, thrilled commercialize and scaled proven known of a therapies. portfolio Asklepios We as strategic manufacturing also develop, a announced by manufacture recently next-generation gene therapy BioPharmaceutical, in gene broad with jointly AAV leader and development partnership to our

platform AskBio's of and includes and gene library, pipeline process development. captive gene a under robust several a flexible potentially scalable AAV initiatives therapy curative advanced extensive therapies and manufacturing

neutralizing joint our by potential patients. the readminister capsid. gene therapy AAV to of portfolio validate ImmTOR the Zolgensma This also platform will platform trial combine with in was development today, FDA-approved of to development the is Currently, products for AskBio unique ability available redosing the in technology systemic gene of Luxterna. of proof-of-concept two The our and the AAV human partnership against for and AskBio therapies limited the used antibodies

proportion maintain who and our to increase the achieve therapeutic that patients the has of benefit. believe We platform potential

expression. which as wane or expression or transgene lose organ as expression over safely liver ability they patients who such experience For patients redose time. restore in This initially can are grow expression may whom inflammation, in who transgene damage patients example, time over in adversely pediatric is particularly help affect transgene the who will may benefit to important patients underdosed for

rare the we year, body. with a from in use characterized and their clear the Syndrome, last AAV gene properly of in bilirubin a inability convert Consortium, platform therapy disorder with announced Crigler-Najjar combination for [POCM], our European genetic collaboration ImmTOR the by Additionally, to

continuing collaboration in scientific are QCM XXXX. to and expect drug regulatory half the from German second obtain to the advance We this authority of advice

We clinical guidance trial will expect design. inform this the

and disorders metabolic solutions therapeutic differentiated the for vector We We effectively and therapies needed ImmTOR are therapy. likely transform and a platform remain administrations by muscular more believe intravenous as our vision gene portfolio focused us which We believe with on efficacy. gene to targeting to achieve diseases patients partnerships strategic therapy realize to can provide multiple dystrophies, such full families. durable that requiring that our of ImmTOR for administration in gene to partnerships inherited their has systemic potential

Head, it And gout chronic I hand some XXXX, to Medical look Project updates. Diseases Chief programs. I experience at detail to and to as our Stephen to we extensive before In our more continue on program, was go our welcomed recently team over advance forward her to into most Dr. as as Rare grew corporate July, like from the Alison drug development benefiting we Officer. Alison recent would Schecter we refractory Global we in Sanofi, highlight

and Additionally, joined prior CEO of an of Scott Therapeutics strategic Board Myers leader in with Directors. June, Scott experience. our Rainier accomplished is significant

support platform. see, momentum program can building our AAV gene in we and in a advances therapy have to team our of our you developing continued lot built As both ImmTOR

I'll more With to talk hand over about Stephen that, to call SEL-XXX. the

Stephen Smolinski

than patients. patients, represents the debilitating gout and other high from severely Carsten. experience most refractory of Chronic you, Thank disability. gout and affected patients These subpopulation pain who suffer gout morbidity mortality

to As the gout convenient acid flares more patients, Carsten several refractory reduction, reduced painful that dosing. address monthly chronic and in believe including sustained unmet potential to needs we uric serum once SEL-XXX has continue mentioned,

and SEL-XXX ImmTOR, novel pegylated pegadricase, is As a platform, reminder, our a of proprietary our uricase. immune tolerance combination

presented we from of full EULAR, completed our II trial SEL-XXX. at data Phase Recently the

after maintained treatments of serum of uric milligrams We per milligrams pegadricase. five ImmTOR in patients X.XX per what deciliter saw kilogram of acid we dose evaluable showed continue six than X.X to monthly at be less encouraged data X.X that levels or once combination the of of SEL-XXX with by milligrams per of kilogram as XX%

gout Additionally, it doses with were over active flares month treated burden, tissue observed. the tolerated been in first doses treatment two has and patients in continued flare reduction repeated months experienced reduced during Only rates flares the with of trail. in gout gout to rates of administrations urate XX% five SEL-XXX SEL-XXX generally following well severity of five. flare clinically of low

uricase In SEL-XXX adult to COMPARE patients compare with to Clinical in we safety March which Krystexxa, our the of current efficacy of refractory and Krystexxa initiation chronic of designed head-to-head year, against the announced this FDA-approved is therapy, gout. six-month Trial the

serum data Patient acid expect deciliter is has levels per XXX patients. include six six milligrams life, questionnaires to quarter fourth in as providing and We The below ongoing trial in resolution. enrollment superiority the data in the full interim analysis endpoint maintenance months health secondary points assessment of flares, tophi quarter of this XXXX. and of year second analysis anticipate primary been and at we of quality end the uric well enroll as statistical

are of chronic a in small percentage and is roughly there a market the painful currently severe inflammatory can of terms patients resulting erosions being form of XXX,XXX function arthritis with joint these bone U.S. In in the to treated. gout. refractory that lead refractory disability. deformities patients Only loss are Chronic potential, and of and

providers. SUA its for their very we months We for six we and clinical rates. with product patients makes profile are As low looking believe a SEL-XXX, over convenient monthly flare develop consistent compelling dosing control this and along more SEL-XXX

and In bring recently treatment that incidence of positively allow rheumatologists flare them product fact, increase we conducted duration rates, SUA SEL-XXX potentially very market low product control, would to which research, infusion the as dosing, once with monthly received showed third-party patients. the treat reactions along more of and profile was characteristics low

address Based the on believe represents market market this currently unmet opportunity. and has $X in and data needs to patient firmly we population many identified SEL-XXX over billion research, our potential

to With the results. over that, Carsten quarter financial back our XXXX turn second me discuss let to call

Carsten Brunn

agreement than to Spark, for for revenue under quarter quarter XXXX Thank with you, recognized compares less which Stephen. Revenue the was million no XXXX. second our the $X.X of collaboration of second recognized

in of quarter R&D second and costs $XX.X the salaries programs. by and of Phase as as result decrease year-over-year fiscal for completion headcount reduction cost work driven of on was a both result million of were Phase the reductions expenses reduced compares reductions $XX.X benefits quarter our with a The XXXX further timing our second These programs. XXXX. our were offset the were clinical at beginning XXXX. cost which II incurred of for for III million, of the There the discontinued by of

was for compares fees, increased primarily the second of XXXX G&A reduced $X.X quarter of reduction $X.X in result The fees. cost expenses of the offset with quarter XXXX. million second million, for the by professional legal which were

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

be and quarter As believe cash compared of meet of to to and available will XXXX. XXXX. million investments operating into XX, sufficient Selecta our cash March its XX, June short-term of $XX equivalents restricted million XXXX, cash, first in equivalents, as cash had $XX.X cash, restricted the as requirements cash We

to chronic enthusiastic announcing has In asset our feedback summary, about refractory and Based the research particularly from broad fourth truly physicians, are our the interim and market late-stage COMPARE platform look in quarter. data, gout, clinical potential. for forward on unique we data our

particularly Additionally, with with our to progress potential partnerships, therapy value in to and new strategic AskBio. our with the unlock partnership redose we platform to are our further eager gene of the platform AAV

formal our concludes remarks. That

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

Operator

you. Thank

now Messer & comes begin ahead, question Instructions] Chad from And [Operator question-and-answer sir. will go first Company. the Needham We Please the session. from

Chad Messer

morning a be of the your give are portfolio situation, would other bit hoping would Good what partnerships are, assume working It to the strategic like you which in Thanks a the appreciated. that's do But was two them? be reasons. for And you'll is terms one can understand not little much to for that little can a other competitive and my partnership partnership? impact broad You group. a and couple your the on Any a be your be those on taking term. you of would on AskBio. high-quality basically sounds particular, retained better, have in you financial Details what or me I in with Great. with things on I the help congratulations ability talked have near about light help question. partnership on the

Carsten Brunn

Chad, thank you for question. the

partner was Yes, details Their we're so products, So involved in spun excited. very in They companies. to out having the kept gene extremely think a we proven therapy, indeed, excited because choice. of they're FDA technology have approved we're a partner with track both AskBio record light. we

us in for to think at is have partnership. into announced obviously liver and We all get can be clinic I just the into going as possible. to XXXX. go the is the plan quickly clinic point we I to And plan The as a share this

And a more we of would partner which time. disclosed in have we yet, not details but over we'll share indications, number

terms partnership little the little We'll of that will guide rate. next a in impact, think year we financial now, actually what be. XXXX. our cost I believe have But for be In impact will on run financial impact for there the

additional I as we think we look a that at obviously talk about what's partnerships. so platform And this and well important company as

from We this us disclose further lock those, in a of any way. in in up future. but the us So number we'll AskBio with and partnerships this does not does indications not limit partner

Chad Messer

Great. next that quarter. XXX and Thanks again, information. for congrats, to added data the forward looking And

Carsten Brunn

you, Chad. Thank

Operator

comes The ahead. go Please Derek next Stifel. from from Archila question

Benjamin Porter

on thanks Hey, guys. Ben is line. the This actually

that's update Thanks. if And for an Just heard wondering Spark in? have us. from it them guys about you opting

Carsten Brunn

you. Thank

already we are obviously hemophilia indications contact we four Spark. which they we will you news they to opt indication, still the have addition And our in A to once update So with into hear And more in opportunity them. partner additional from the have.

Benjamin Porter

you. Thank Okay.

Carsten Brunn

Thanks.

Operator

Mizuho next comes from Yang Difei The from go Please Securities. question ahead, sir.

Difei Yang

and Hi, good thanks for question. my taking morning,

after you XXX. the is interim Would XXX if Phase readouts? us question tell will readouts the the III/IV or of interim around the ahead start you First,

Carsten Brunn

good the nothing a the that fact this into remember COMPARE what's us do and is And both don't Difei, have reason in point, We was funding basically we initial at going the from to parallel. financial had reasons. at the question. except COMPARE plans this we trial for I III prevents Phase point. III, the Phase that's important But think started to

plans of have additional to III able as still independent kind Phase we somewhat driven So for COMPARE, we start it of it but funds whether the is to see that. we're raise

possible. still the start Phase is that and to QX So III still the in plan is

Difei Yang

for the Thank of Okay. be should of the the readout, to we is patients' data expecting? you how And patients? range regards the clarification. that number interim many then with What

Carsten Brunn

a Difei. well, That's good as question

So we we'll as for and we an guidance think which but of year, good to well. have to interim this towards I expect give this, guided commit not the guide not to this actually what the end to readout final readout on will

Difei Yang

Okay, thank you.

So make up upfront what's to on there but not be Spark that then the comments of financial you to what level specifically on to opt related you And in with the et then general, development, additional would retreatment cetera regard for high in changing on to Spark. programs? to looking following the the typical for? very royalty, arrangement, the subject a piece typical AskBio, with regards is would the Is and deadline

Carsten Brunn

upfronts and Obviously, question, potential good royalties. Another we on comment don't Difei.

can't I answer question. unfortunately, So that

have Spark, of that will exact QX, terms in they we actually disclosed to towards four opt you time, addition the In have end in they outstanding the but indications in hemophilia already. are the expect still not which opted of A, additional to can

Difei Yang

much so question. my taking Thanks Yes. for

Carsten Brunn

Thank you, Difei.

Operator

The ahead. comes go next from Janney. Please Zhong from question Yun

Yun Zhong

format quality on on the Phase for be data? in questions. patients one depending on that possible like in will first quarter. full be Is the fourth data some And follow-up completed you taking readout the Thank interim have it did period? not data, the can analysis the Hi. the of for the there II who And statistical it also, some with projection you is

Carsten Brunn

Yun. question, the Thanks for

we the So, guided, do a as readout. will final have we'll numerical QX, then plan statistical and analysis do readout for to the in we

think a a trial. I what's penalty readout an don't important we take doing open-label as it's

Yun Zhong

develop gout question, the think the internal that understand next programs. therapy still the right the also a the have have then gene program do resources, have. good programs? sufficient is that you way on still now focus you your and It's two advantage of collaborations. I to But you to have therapy And you And – platform if Okay. gene take plan, I internal

Carsten Brunn

Yun, excellent question. two therapy you internal we asked an gene programs. have And indeed,

actually And we of the once to with put into detailed MMA details disease. have the that's plan areas We AskBio have with but developed the a the share partnership liver-directed as OTC. AskBio, and be MMA clinical I partnership we bringing a plan program to ImmTOR. one will that We'll addition we more think into in

Yun Zhong

you. Thank Great. Okay.

Carsten Brunn

Thank you.

Operator

from next Please Canaccord. ahead. comes go question The John Newman from

Justin Zelin

very Hi, I'd on is John good Zelin morning. actually Justin agreement This for partnership AskBio. on the Newman. you It's like to with exciting. congratulate

Now I'm if acidemia partnership to addition methylmalonic follow-up. your contains agreement have And additional a the plans I who have in just program? quick programs curious development

Carsten Brunn

question, please, you the Can Justin. repeat

Justin Zelin

your AskBio have was to partnership question The have to with Yes. additional development plans with agreement if programs the in addition MMA you program?

Carsten Brunn

a is indications with to answer a There's of AskBio. The clear together pursue number yes. we're going

be over time. guide liver-directed we'll will those first absolutely, The additional we'll but indications and a to disease, have

Justin Zelin

the kind profit-cost a depend has program? agreement the be putting of noticed AskBio that share cost percent how I Or provision XX-XX with they're split? the much to And will Great. breakdown Okay. on agreement. Will

Carsten Brunn

Yes. think. I It's exactly what

in excited develop, partner One reasons of And success that record we're said, true products. in partnership. is we partnership profits. but about this the we equal that I costs, think of jointly of AskBio, I that's we're extremely to equals XX-XX it is a And partnership proven actually so also it's manufacture us for a share what's and with commercialize where a where a this excited as track partners

Justin Zelin

questions. and thanks again on taking Congrats deal the for Excellent. the

Carsten Brunn

Thank you.

Operator

Carsten over closing Officer remarks. to Brunn, concludes conference like Chief for Financial session. the turn question-and-answer our This to any I back would

Carsten Brunn

for We just our to your late-stage questions. about quarter. that COMPARE the particularly and data want attention gout. broad all that announcing interim forward has I reiterate the for to asset chronic And for Thanks so platform potential much. fourth and truly Thanks we're look the in excited refractory

attention. potential our strategic your and particularly with gene with to our progress partnership Additionally, Thanks platform partnerships, we value of the to and our are for very the in your AAV AskBio. with redose unlock questions further again eager new therapy

Operator

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

You may and your rest now enjoy of the day. disconnect,

Elona Kogan	General Counsel and Corporate Secretary
Carsten Brunn	President and Chief Executive Officer
Stephen Smolinski	Chief Commercial Officer
Kei Kishimoto	Chief Scientific Officer
Chad Messer	Needham & Company, LLC
Benjamin Porter	Stifel, Nicolaus & Company, Inc.,
Difei Yang	Mizuho Securities USA LLC
Yun Zhong	Janney Montgomery Scott, LLC
Justin Zelin	Canaccord Genuity

Cartesian Therapeutics (RNAC) 8 Aug 192019 Q2 Earnings call transcript