SESN - Earnings call transcript Q1 2019 | Carisma Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen and welcome to the Sesen Bio 1Q 2019 Business Update. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, this conference call may be recorded. I would now like to assist you host for today’s conference Executive Director of Strategic Planning & Investor Relations, Erin Clark.

begin. may You

Erin Clark

good discuss and and to conference today’s milestones. Thank updated morning. preliminary to our data Phase call you Welcome III upcoming clinical

On call refer, will to Planning XX-K to uncertainties. differ and are filings. which Richard other press Fitzgerald, financial and Thomas Sesen Financial XXXX Officer, issued these Actual future update factors, are those The subject date. Form expectations, Dr. me turn over as of release undertakes a to any due These which results. section Chad release as we slides, the Kim, that, materially the Earlier sesenbio.com. will statements Chief the represent on our most turn Myskiw, publicly this Bio to it Bio's Dr. and to website described are on and and upon we relied first Strategic may Dennis Officer, this quarter to President call CMC. CEO, Dr. Bio's Medical Chief and call of with available I'll & outlining and press obligation current - report Investors including include no statements. Sesen the at views Cannell, the plans in various to Sesen SEC of With forward-looking statements the annual be today results related company's not company's Tom. Today's forward-looking discussion recent should morning, risks

Thomas Cannell

cut, March journey with when before the recommending bladder cystectomy. all In true and of experience again that patient commercial endpoints nothing III I get the full joining the the meetings. this as update. radical other a one into Today, to with for U.S. in is start is removal, of radical of seeing than internal to the patient's unfortunately, cancer through bladder in to the patients BCG more X, regulatory share as cancer past, since thanks, along said patient we in bladder company, to of known only the based shortage doctor are expect so X of will slide. quality know has and updated another to always study is BCG for the and BCG slide announced surveys, external data agenda, Phase everyone, data us Based life has prior our with the patient cystectomy. the Erin, worst the north on January, shortage on non-muscle last with damaging we shortages a a we But Thanks, our for please the our and option Slide our The we high-risk, been turn journey and sole invasive morning. cancers, And United it States. least of supplier In BCG compared XXXX. those

market to of and to Vicinium find As many to for of as certainly improve a adds such to save these advocating prominent the FDA the help and sense in quickly urgency AUA BCAN, solutions. patients. lives our result, are groups, This bringing

an turn Sesen please the I Bio's to story agenda Slide key X slide. to parts want Now There are X, really to provide that on our update today.

of the the updated Vicinium. we data demonstrate further our safety compelling clinical First, and efficacy believe III Phase profile

of the finally, and simple success. we the will of probability commercial have we chain and process And and a we minimizes reliable and shortages chance of confident are result goods. believe cost supply strong regulatory Second, product in in that the manufacturing lower

strong quarter runway XX, into and XX-Q sheet Form finished we X. Slide a with XXXX. to on cash Turning our balance May the We and filed Friday,

on next a May the we on with C meeting type the pre-BLA meetings B XX a face-to-face XX addition, have in and FDA two June type In meeting days, X.

have year, we that subset point Please us of pre-BLA to walk X remains fully our and aligned in sixth my data submitted most Phase to based February which issued mind type important guidance cut, allowed Slide In I'd on meetings the updated one the both like the with March last type be turn a FDA and the guidance. meeting FDA slides. X, books development to and structure briefing will of cancer. with high-quality through the out our for end and interactions to our Because accordingly. those of will able on the agency, We series anticipate for FDA clinical partnership were of therapies this June bladder meeting BLA invasive data since program meeting draft the for I our on we that guidance of non-muscle long-term B X of with Vicinium, has today. B the

the the regulatory reason strong a can As on the success. we have with aligned all of we FDA XXXX along you is And set, with believe probability key data see slide, guidance. we're our the compelling clinical alignment, of elements this

for patients. XXXX Slide rate X, data the complete meaningful. are FDA profile based one of are approval. that for as benefit-risk to Three guidance Vicinium, to in takes our Slide the which things X, of response secondary primary here very all now for and cut, we the to Turning you we favorable product endpoints, of situ March the where the review endpoints carcinoma on see present turn X Please able to basis data primary demonstrate

BLA giving rates two Phase and First, us Phase and response between complete the trials II reproducible for well-matched significant submission. III,

per which Second, graph. lower shown on we bound span the by response illustrated guidance, interval the content XX% the believe rules clinically a of the is out rate complete confidence unimportant FDA

or courses, III patients at our receive of receive of entering patients have patient Third, seven installations of Phase Many two BCG in installations average to the received required BCG. least criteria before Phase XX more eligibility trial. the two significantly than III our courses and

given a XX% shortage, to issued the have where as updated which of three response who situ. efficacy Slide of more response primary may guidance. In patients at in in Phase and the see physicians in shows to recommending II from as the trial practice other as partial addition some carcinoma to the situ XX% therapeutic at the years seven were carcinoma partial demonstrates that which investigators to response to of response additional give our and is we complete in patients less complete which BCG a II, months. greater BCG. switched This XX we on the not in in will field in leaders and and quickly went rate XX Please III who be organizations, bladder response learned Phase such is partial that of cases Slide guidelines, level XX in a positive can endpoint very our in other be have treated can X, in had many believe patients done three a and months, in options Phase difficulty was who XX% doses in such you response. turn of practice. treating change an shows data important they complete especially outcome, BCG, months, of light As patients patients we who III slide, A there aggressive received receive have AUA, response BCG journey. key-opinion required their are patients mapping, duration Phase know talking patients that FDA who had a we the a believe the clinical in for options. reduced of clinical We in forward significant in not installations on What roughly utilized was recommending another these disease move

can XX% the of slide, for start response or who of important had the note patient has the at that a duration measurement the the after you response duration based X on achieved see months, confirmed months side of complete patients It of complete point left a As X response the XX-day been with longer. at Kaplan-Meier response. is on to estimate

So see for have XX months, at you response that probability can complete therapy. you at on after a least XX% of graph in maintaining months at other words, the have when if response three complete looking a roughly you started you

or And should be majority rate have complete to you successfully you invasive a very our in X On is carcinoma situ high-risk, if the believe three antitumor demonstrates context complete Phase considered all going has and Cohort evaluate bladder of the this Slide made months. evidence it who a visible data months, months. had at the it because papillary By durable for the X we patients lanes therefore, important disease. is have side are still slide patients of shows says the tumor the nine appropriate in complete show vast from response that XX transparency, day duration no at which is Again, response. at -- the effect non-muscle the of swim definition, resected. Vicinium's responders for of time-to-disease Therefore, The the guidance to patients. endpoint trial look patients in response cancer XX right these trial, for we FDA recurrence very response. at with slide disease of strong been III as

have a XX% disease-free XX see, probability high-risk year papillary of for starting least a months. and As you for Vicinium, XX% chance disease-free after least treatment remaining patients with at can a at remaining

option two who who and present think X courses patients cystectomy. radical XX is for disease-free high-risk with are that for projected average to at these able In or BCG third future, that that XXX disease on explain doctor disease a only receives to papillary of patient days have way over it the their about papillary approximately are Another be is years. may months and with their is another option Vicinium disease-free over to least and be of the patients failed

patient lead messages the is favorable with doctors Vicinium their choose XX time data shows across becomes. and Finally, tolerability the than I patients I profile cystectomy efficacy combination of the that to radical treated and explain many cystectomy. those We in function durability they're our can that Vicinium, will longer you better believe will rather Slide just prognosis the and to efficacy show strong patients doctor data the a the with to reviewed. all disease-free, the

Although will of to months, or for as not XX from most reached X, data and perspective, believe at are physicians, as months the Kaplan-Meier. a it estimated at of updated patient the Since approximately payers. will we trial. meeting our based this March this the days the endpoint our of now patients is majority the the patients for cystectomy-free XXX means a Using of patients average are secondary that regulatory be endpoint cystectomy-free remain the arguably on be most important likely is valuable end

Slide avoid look on cystectomy. these likely of have to years, are BCG-unresponsive are data nonresponder these states will we feel that X At important that patients this of which the data on we of commercial know ratio Therefore, is responders secondary XX, versus for the cystectomy, to cystectomy-free remain non-muscle see goal the see can X.X very to with strong for regulatory with When cohorts. treated endpoint, You additional an On We for progression-free estimate. cancer the invasive versus from you bladder to slide, in the time approximately provides although responders at confounding FDA is nonresponders, remain on a guidance the very to times patients data XX and Vicinium see responder years. over at factors, progression-free nonresponders more than survival therapy Kaplan-Meier we based time XX% Vicinium all patient perspective. compelling cystectomy FDA. can and

were XX, for recurrence, survival. approximately At events two Event-free XX to survival months, endpoints: XX% survival you consist overall data or which event-free event-free. and measures disease Slide secondary progression patients death. of additional of Turning see

estimated of an Looking at the an patients than based X.X have of survival estimate. XX% Kaplan-Meier with overall overall years survival, Vicinium greater on treated

the use of we safety to with where the of so still were population Phase moderate see certainly with durability patient endpoints, have far, mild the support turn III Slide events to which XX, with consistent Vicinium. and Although it the adverse are further catheterization. majority and is survival and were tolerability considered we trial. the Please early The of we treatment pleased for our data frequent data of

helps slide regulatory and Therefore, are covered Overall, of Slide we the and our reviewing sets III VALSTAR and data efficacy perspective. In available tissue findings. summarize for with selectively is alone. that and in are a both having puts pre-BLA BCG, and this, safety key data believe these treatment-related this addition, know we III, see and of turn totality the position XX, in a exciting Vicinium On Phase data June low cancer regulatory trials. that definitions clinical a which to fact relative strong profile cells to favorable of inhibitors. us of the we strong - safety healthy greater We commercial that is We to of of on new data same Slide a and favorable dual Phase forward most favorable probability success. to unlike look for we there X able while and We adverse well-matched believe of was at X. and safety our to meeting tolerability across consistent that demonstrate lot Phase II Vicinium's Phase depth and from BLA to actions, the and events. profile checkpoint other significant a Please believe Phase clinical III XX. the we the II in data We unique FDA Because leaving favorable data, just suggest targets advantage and tolerability therapies believe submission. a rate due mechanism discontinuation safety

I'd discussion of to Now shift Vicinium. to the like opportunity a commercial for

strategy. to continue which payers, on patients, research overall for go-to-market conduct We market the builds physicians and foundation our among

last after BLA we gated be call, submission. commercial on the However, investment said significant will as until any stage

and It please and unique segments: by opportunity a public. which and is X all commercial cycle to where turn driven customer patients families; and situation, virtuous care outlines hypothesis physicians across there's key the and private strategy. caregivers both that health Slide So ancillary XX, commercial our their demand driving is payers, professionals; our

March behavior of segment, advocacy version help and this action key customers products uptake each after unusual these showed It's to growth in with and all support advocacy for rapid see for drivers we updated Slide and we of slide segments, on While approval of we is to of an different for XX are potential launch. a call. think will X Vicinium. from launch the all from customer or of strong dynamic drive and Vicinium oncology

on is important outlined our customer product We to a slide label. really prevalent in opportunity is It's understanding in need the for with that cancer; and two, on-label build to opportunity function X highly continue addressable of Vicinium relative there this potential market a unmet anticipated to value. note the and learned U.S. have of represents meaningful in and use a a only the indication one, is our the things: huge market

sensitivity XX. spill-over As time. is often our the as treat opportunity, is models at case, there may and also which not in Please we be upside an significant this turn to Slide

we We our second XX payer research, over have spoken payers, finished and have and commercial now recently both round of Medicare.

We most Vicinium. reimbursement significant limited to the pricing seem appropriate shows reimbursement the the relates States. the it benchmark of that believe and is use pleasantly United surprised we there by and payers We markets likely. to have the for common been advocacy Slide gained for as the outside XX potential by insights restrictions have

the the U.S. for even we U.S. opportunity larger. While substantial Vicinium represents the is that estimate opportunity, we believe a outside

and as including market regions Japan, sizable can you on such slide, see Asia, Vicinium. Europe opportunities the represent for As

on As to to cover last X our the to strategy OUS process XX know X said, we XX take I That partnerships to sign minimum being XX is it said that the countries. regional partnering XX can a months. of call,

progress the specifics planning we pleased be providing until XXXX. will probably early today. I'm made realistically, with very So commercial our on OUS not partnerships in

submission Please Slide I'm if we and is ability and realize the closer XX. that I'll to get approval, Vicinium more opportunity details. BLA sharing turn As in commercial confident to to But approved. our be opportunity

fusion has is potential microbial the straightforward expression and and chain protein of simple our You a reduce supply to cost supply manufacturing and a and reliable with that example chain. see can system Vicinium of create a the elegant single-step an illustrative goods.

Turning Slide XX. to

We in completed the XX. announced with preliminary the May which on as in the morning, the primary results. of discussion manufacturing we confident recently on GMP partner, this slide. transfer the press And run encouraging this FUJIFILM's ongoing CMC outlined remain our release Facility will meeting process, components at As overall comparability our C we plan, our full-scale type of the part FDA be topic have of are analytical during tech

Slide Finally, to please XX. turn

elements data and As months III a with our work our to analysis very improve lives of non-muscle has are we most XX market our closely invasive forward of summary cancer. encouraged of continuing recent FDA the by bring bladder of and X potential story, save to with patients the expeditiously to key the the Phase product to the look to that

to me open have I your stage. to patients we employees well value thank helped the are their our shareholders. line families to courageous meaningful would this providing as all to we'll about With today as have very Let and conclude mission we advance us the for our excited who Operator? that, Sesen our by fulfill while take opportunities like saying dedicated questions.

Operator

And Newman [Operator Instructions] comes from you. Thank with first Canaccord. our John question

You proceed. may

John Newman

Hi, morning for my update. question. and Thanks good taking for the thanks

also talk have, So that your you to to curious the working And about a little way are still to that illustrations us could bit VALSTAR what understand Tom, proper was in through think the cystectomy. just I be walk is I could data, Just I if time kind efficacy your will of context about And you curious, of overall? that data general, if how just compared to feel that? investors VALSTAR?

Thomas Cannell

John. Thanks, great. Yes,

sounds like two there's it questions. So

of context some data, mentioned, FDA to their says in be XXXX kind needs variability. a it side a VALSTAR. guidance of of time all, about relative cystectomy you data, First, of by patient little physician the to I that as cystectomy the in relevance second and just the the -- to just talk February The to side give taken more the then to and Vicinium of

told decline still know cystectomy doctors we who they surgery. their radical that need example, the are patients XX% For by of

So lot of be late What to obviously, for emphasis invasive reason time working. needs it's build cystectomy. in the a is measured. difference meeting because non-muscle an of for nonresponders responders cystectomy bladder we analysis as the puts terms XXXX responders delighted well and The the on learned 'XXs the for the that for that carefully from is in between ADCOM product to as to avoid FDA you're that the VALSTAR ADCOM cancer

radical may have cystectomy. But them not, For if like other therapies. chance expeditiously nonresponders, to they see try would you to to a move

show important and be data So it's piece is fold especially perspective, payers. additional very information responders will And and and very to that I in that that's approval now probably cystectomy going important physicians, a efficacy differential XX for relevant months between compelling nonresponders. that and of hence a time our delay us to XX average the an of a But for equally from data. the be part of think regulatory give process patients

we're So step next really side that's sure I'm continue a me doing on VALSTAR these be just and we'll forward very round that get and We're it, do And know, this as, data Vicinium. new just the looking about just let versus you -- start research of and their to comparisons. where we make by can to Then back customers cystectomy. market reaction. very let's side difficult excited it's to show the the

did to You've a compare their you're trying current the different aligned -- subject and guidance. got VALSTAR, was from XXXXs product which of it the that's perfectly set to which And rules then was FDA. with completely studies to approved FDA in

probably the that taken because safety decades. to just grain let's of be salt difference spanned I biggest think trial has compare was start with it clinical -- everything to that so just But I the hard with profile. are is the So say

is cells. remember cytotoxic And chemotherapy BCG-unresponsive is is healthy it for a got patients. this agent. equally VALSTAR It -- tumor that attacks you've to So and

pain, data their clinical trials, XX% than installations BCG, is excruciating for so So in is that had then inflammatory also X%. which spasm in use looking product granulomatous the difficult which patients many it's have and bladder bladder We less reaction. the to see trials cause to patients, And inflammatory just a know VALSTAR causes we an a because their at and reaction. over Vicinium of going very it then like

to we products. the the that's have very when safety like So there's probably significant biggest they talk efficacy. between our difference to at really the a carefully. versus Vicinium VALSTAR, Then X feel we in and And this you difference of and turn to again, investigators, look tolerability

XX%. VALSTAR complete interval, VALSTAR complete their reported the We trial in only as their And at exclude response Vicinium response confidence using in And rate you know, Clopper-Pearson we X XX%. at we now II their So label Phase again, that their know -- endpoint months. report that's at XX%. the report is they

duration complete months. we remember FDA have complete look measured X months we is So you difference the But at response, in a rate. when guidance, at statistically think duration of have response response. VALSTAR Then the response significant X after the a current the at says three efficacy month didn't in the

at of patients label looks six duration who their XX.X-month VALSTAR So their have calculate response a months at complete response. to in

we So of is backups, duration do look it's and comparison what at patients we back have if had X see for apples-to-apples have Vicinium that months, response the of for complete XX.X. as the to response or go the an in you'll and one

response, you only only the limited XX.X. XX. They So when compare and XX that takes their to is response, carcinoma for a radical patients. in contraindicated compare what our it's you I have would XX.X to complete Then our cystectomy you label, their label. Duration say to situ of very is

to be in of front positioned a have label, cystectomy. expect radical very to use. to and limited for we off-label are full reimburse of payers expect Because label, reluctant We their

I mentioned, patient radical for added prior when So to require comes contraindicated auths VALSTAR. things like reimbursement is We, minimal to that the proving payers expect have step cystectomy, it medically prescribing big for a [ph]. authorizations and challenges that's a physician as barrier and prior

and that the that that. safety efficacy But in a we Does kind two. make there's to It's label sense, feel of action compare of John? that's like the hard the comes big and So picture. meaningful and difference from again, mechanism in

John Newman

does. Tom. Thank you. it Thanks, Yes,

Thomas Cannell

John. you, Thank

Operator

Yale next our Laidlaw Company. question Jen from comes & with And

You may proceed.

Yale Jen

and on and for taking thanks question the morning data. Good the congrats

the that may Just become maybe slightly trying up before attractive you the that more pricing bit our on side But market. be suggested revealed to you details. the using price may - little have to actually follow than a value pricing have value-based early

of secondly, can to additional any First is you And color that add all, that? still thoughts here? the

Thomas Cannell

Yale. Thanks, great Thanks, that's Yes. a question.

So as show getting price we of XX, on Slide understanding common we're benchmarks. most the a better

As we the we and after until mentioned guide product. approval on as you know, -- before, I won't shortly of pricing

So we'll value-based can it's a reimbursement guide they're interested on in payers. commercial see until while price. price we contracts. CMS But We the about the at this receiving in as provide to as we're that from talking plans, Medicare very point, benchmarks well

We'll work And it it'll if as little words, that doesn't be a our that. other then if works be risk we'll -- the price even bit and from the benchmark, a little well, product benchmarks. around come will better would little the quite product strategy. that. so will above share the And expected, pick down than price a In a

you measurability a is few most executing execute and in-patient we easy know, lot are this are people cancer contracts. As fortunate A them, about track always to in bladder very relatively can case hardest because talk costs part of and value-based them. of But measure. these the

Yale? and price contracts private after and you then to we set expect shortly approval to public with follow-up have So have both value-based -- question, payers. a negotiate the to Did

Yale Jen

do. I Yes,

that there? the get point, options the you the this have that to response, commercially question of appreciate Thanks. treatment follow-up at -- duration here competing my I how colors. do options -- is other all And -- you First, for see

Thomas Cannell

a straightforward a of call, we tell of the through a of the Slide story. Yes. the you. part lot simple, put are the of Thank like as I about looking XX durability an look we the interesting. the backup just only mentioned, I've become slides part reference backup know There's important on down slide, And -- it's XX, slides. to I'll part doing it's slide. a and very important you extra your -- we for just very for just as clear, guidance. strong everyone really And Well, half have everyone's road story. of at our went put FDA Again, has reference. but we for very a very tried side We feel just you're is story, Slide the left-hand at the diligence the

X the X If response having next chance you in the response at complete of months, a months XX% you have at have check-in XX-month at a the complete point.

So you are in odds the of can response. we complete terms go that long, they what have a the having at months, see significantly complete their XX up response of

side way the we months. of are XX cut other additional response on The the data right-hand an was what for a your complete odds having

the efficacy investigators is key-opinion leaders point, of one XX% So XX have is from story again, that you if chance XX-month and to contextual. you a for making make it learned the it another data we months. And thing that

disease, or failed also in you you that'll shrinking, locks have a in completely the future, chance, a response. be chance say, XX% disease-free and field even And carcinoma your you'll means it's options. the situ. whole The hopefully, they'll BCG. a least if have XX% X complete a us or of which only we've Vicinium. change you a give months. tumor means the And progression in partial there's you have XX% response, So talks lot a says, of of That There's stopped chance, and doctor, in option two on And the patient is there's radical the courses cystectomy. try to say, can they a at doctor they'll

now, and maintaining at response Then now again X So those the radical complete patient cystectomy this or I of is odds months, for patients for right the X have patients' that having do confident thinking to have have months. do the product response I their prognosis try check-in, your cystectomy. a more three a months And ability patient in discussion up future, complete gone for their the each their comes doctor they're the about radical that -- every and significantly. time avoid prognosis

a think response important So follow-up? response is arena in you initial actually rate. have more the of the commercial that complete duration than And we

Yale Jen

terms now. That's I appreciate lot. there. the that patient fine in really Thanks I'm very a dynamics very, colors helpful. of

Thomas Cannell

you. Thank Great.

Operator

from next Chris our Jefferies. comes Howerton And with question

You may proceed.

Chris Howerton

Congrats embedded morning. the comprehensive. good Hey, you deck on all Tom. together, the here, very put the it's information. Appreciate And quite update

I think for me, FDA just a related couple questions, upcoming to primarily meetings. the

maybe in So start to is CMC maybe on meeting, FDA? alignment get May. the to I easier think you issues one think the are with hoping hopefully here there? And I the that What accomplish outstanding are you with for hope what which

Thomas Cannell

in They're exciting We're for forward our focus us. meeting Yes. will type meetings both plan. analytical comparability down the Good X The time Spring. FDA to Thanks, a CMC X very C on Silver face-to-face looking in It's morning. Chris. meetings next weeks.

As we've our made tech clinical of and Winnipeg our Fuji. be will mentioned, -- supply transfer for supply manufactured trials did out site, our commercial we in manufacturing we

So tech with plan. process. And going transfer through we're analytical alignment is the asking FDA what for we're the our comparability

briefing be -- primary primary The... So were centered around and the the that's objective the the questions book in comparability. that'll that analytical

Chris Howerton

I I guess, for too, superpose. the similar yes, clinical meaning question

Thomas Cannell

Yes.

the side. meeting. course, that's That'll on of a clinical So focus pre-BLA

that to because separately. luxury CMC totality show the we of want data. course, covered But the of have We of we the

we is compelling. alignment about get priority lot to questions just about regular very a which full there's accelerated safety will that adequacy will at overall as set review not, submitting -- alignment be slide from BLA the or we'll We submission. mentioned forward. show We've -- think, And it shows really those secondary the question with is ask, of the meetings clear that very we a data agency the want I of and know. you the So you're XX-month going the you suffice you you regulatory and put There's that be data for that profile, story the saw our the tried that but rolling approval set summary then after? today. deck, approval to that efficacy set overall, about benefit-risk path the in submission, at to that we about submission, we from transparent, primary As we'll the is data learn that as want get all feedback or very does

we now a we have call today a call in had a So March, we in in had May. January, call

as call from We as release the be confident which be make we actual those a out meetings then usually the know outcome will in all or very of to FDA transparent transparent we feel sure very means the meeting meetings. and soon come we as with minutes agency, we have you as the have will press those response well

Chris Howerton

it. Got

kind Okay. BLA topics aware of that That's right the you they operational you're perfect. And to gating execute FDA, factors activities the obviously, then on? Tom. alignment have just there outside of other of Are submission that discussed, and to now that or that with

Thomas Cannell

Yes.

about. many just last to a agency to I runs. of stability, think Module in talking how looking which is X, the factor has terms Those with issues, much is be the From types PPQ for. do CMC gating data agency we'll how of

we'll then I next to over timing I the call, the specific on couple timing better have a at, issue guided we're getting probably I give looking think meetings last anticipated we but we approval, or submission months - think of guidance, as get mention that's last terms the BLA that haven't of yet of timing once in Chris. really through of but of these opportunity

Chris Howerton

Well, thanks that’s the right. look forward for to questions. taking All and again those meetings perfect. I

Thomas Cannell

Thanks, Great. Chris.

Operator

And next Ramakanth with comes Swayampakula our H.C. Wainwright. from question

You may proceed.

Swayampakula Ramakanth

but quick Tom. question. been my just morning, .Most Good you. questions of have Thank have answered, I one

important on many and process also you have and do the discussed of it which approval So you commercialization? data the the slides, that have for points these you think FDA for of is

Thomas Cannell

Yes.

a -- a That's like go We we RK. risk-benefit. kind you I -- had you, feel we the X. graphically really FDA, few thank if question. really a with Slide the we've - depicted it's all in to try and to interactions the that great feel of So it's

very take they I of and I profile? different they a the So complete and efficacy it And So themselves, ask very empirically, favorable they all FDA that things. risk-benefit of view think think, data Commercially, safety view view all in the is there are context data. they set. the data things, the

have mentioned, I to is according in response cystectomy to is know for I it's we've commercially to trial, rate But will an not we heard. physicians We durability obviously is the mentioned, I As important to physicians most probably as but relevant very endpoint the partial of to very and think time patients. what motivating that endpoint response our payers.

are radical the and for cystectomy know, you into of cost As $XX,XXX hospital costs there readmission X-month is because $XX,XXX. say, many the morbidity estimates rates high cost just of then -- to the the those And that, patients, the those to continue escalate.

not to very the data. hot keep do all many preserving -- that like then, excruciating, say so And and your committed patients cystectomies. in time courses that their So patients they their shows loader bladder bladder suffer compelling it hear having with are course, so to It's -- but products through will patients many the to payers how BCG anything bladder. having in cystectomy interested of radical BCG. taking are We time is patients have to

but So their to for not -- factor be we for think motivating the cystectomy as very often time that well. a and meaningful data only for families will patients for caregivers

Swayampakula Ramakanth

in like question other cystectomy how you Has your having being was, XX% they I the through have to point, do in a -- use know Vicinium, been of your that you cystectomy? that discussion recommended you an patients. with you slides, patients XX% have all looked after will get about And also, many up go come at of think do ADCOM, point to follow-up? of one At an to at, to idea And something had you do the any the radical had FDA? is

Thomas Cannell

Yes. Thank you.

about talk ADCOM. the piece, talk me let and So then need for cystectomy I'll the an about

for is time months. that trial end better, average it obviously, that data we could the the but know approximately we up track our we to are drop quarterly years in the for product months. trial, years XX know the on them you track with they or until at successful Then trial clinical X X patients for data the given -- patients the significantly check-ins. these currently have we up trial still ongoing, another XX that as again, they to out And yes, in of is months So still our cystectomy XX so

continue think, do data as I So together, -- that we we as time to very impressive we tracking. cystectomy will those

So on time tell mid-XXXX. months, cystectomy, story. reason But a study X to important final it'll will clinical until I estimated stronger report an we more the think that's data stronger and come the out and every that to get is

So and just continue -- updates. we that's we'll currently where are to with provide

ADCOM. the Regarding for need an

this think about required. ADCOM extent there there second, a submission are? are Based clinically of FDA a always is aligned whether say to couple that required have extent ADCOMs, there is of gain updated decisions makes more certainly because you we'll and BLA on on data straightforward is keep that is it's feel with is I what the data And first of would meaningful RK? will definitely for we the are, what I but variables follow-up, our everyone to review how much one question unlikely submission, insight between how now of set in BLA FDA. that that. be is another something on understanding Did and on an how terms the we'll

Swayampakula Ramakanth

you That's now, the all you to Thank talk additional very Tom. it for And soon. much for data.

Thomas Cannell

you, RK. Great. Thank

Operator

remarks. Q&A back you Tom concludes now and Ladies like Cannell proceed. may session call. turn call any to Sir, of the I closing for would this gentlemen, our you. Thank now today's to

Thomas Cannell

you, Well, thank operator.

we minutes. a was little expected, the few So we than have a shorter Q&A and

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Operator

you and Ladies the day. and may conclude today's for disconnect. a program, you does conference. gentlemen, thank great This attending all have Everyone,

Carisma Therapeutics (CARM) 13 May 192019 Q1 Earnings call transcript