SESN - Earnings call transcript Q1 2020 | Carisma Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Sesen Bio May 2020 Business Update Conference Call. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Ms. Erin Clark, VP of Corporate Strategy and Investor Relations. Thank you, and please go ahead.

Erin Clark

you. Thank everyone. morning good And hope you challenging safe these families and your circumstances. are despite We call first regulatory On results discuss we today’s our as opportunity Vicinium. update commercial as quarter an on and the progress for well financial XXXX

Dr. Officer. Joining Cannell, Chief Myskiw, Planning, President Chad Forbes, Monica Thomas CMC; me Dr. call and Officer; our and today's Strategic on are Executive Chief Financial

release that call a Investors morning, release website outlining available press highlights we today. the the on issued are press sesenbio.com. the at which will this section to covered Earlier of be refer Company's slides we and The some of will the the on

this to statements that publicly be filings. related may Bio's date. most results and materially I would current forward-looking views and Bio's other uncertainties. any due to of expectations, undertakes Company's differ you recent SEC Sesen of including factors, to Sesen will statements. and subject include these and in on XX-K today's to future remind those Bio annual no risks the represent Forward-Looking described Statements Sesen Form like upon Actual plans to as various call obligation These update are should report discussion which as relied not

pandemic. areas the business Cannell at would through the Sesen like Now, it call agenda, to before critical to as I to I on update to hand Dr. take COVID-XX the the us provide relates an

ensure concern safety remains number we employees wellbeing. a our their health have primary XX and to are our and new and First health All policies ongoing of wellbeing good foremost, the and of in employees. instituted

from businesses that there being critical said, of are to-date. continually see, Turning business we to can That as Slide have COVID-XX are the had areas monitoring. four no we X, disruptions you

third to for and a regulatory, of CMC, The is a I And take review is points each is fourth area. minute will operations. clinical, couple second first is key

data mark month quarter of the last at cut the XX, XXXX. VISTA our the as in did was XXXX trial patients fourth This XX all in went which the clinical, for point cut. the of of basis Regarding our through submission we May BOA data initiation

no patient is for terms such enrollment. there risk of us as practices critical So in

we in remain the second XXXX. plans half at original to regulatory, complete with BLA on-track our the Looking submission of

may you the the expect and meetings As not and we email. in our any do to teleconferences our we and submission had maintain additional be of meetings FDA face-to-face recall, to via four prior with face-to-face expect we needed anticipated to with correspondence FDA completion BLA regular the XXXX

advice and going we through have will EMA written a Additionally, little correspondence via able the do Chad and scientific were been later. the through teleconference outcomes in us process to more details take which we through

our close with CMOs, inputs the Next been in and the distributors as has the as manufacturing team terms in contact well CMC, Fuji and our the into process. distribute Baxter that of consumables

of in Overall, remain they ability terms maintain confident to continuity. remain business fully PPQ in the run operational to and their

U.S. and at levels. flexible instituted are internal Canada all normal the all for in a looking policy Finally employees have and operations we at continuing work-from-home operations,

time this to a disruptions So again, there at of result is our COVID-XX. business as no

employees. committed the the of to to of regarding pandemic monitor continue environment we and health potential and caregivers impacts evolving patients, a We rapidly safety remain and the

Tom. I call With will that, the turn over to

Dr. Thomas Cannell

and four There topics morning families turn our you are to your for today. calling in everyone. are you like would hope safe. so slide. good I and Erin Slide agenda to important all Please healthy and and Thanks about we X, talk Thanks, much to

that available profile. helps and pipeline the differentiated agents of highly versus and mechanism First, safety favorable we believe Vicinium explain has to a action efficacy

market recent strong are in confident commercial research opportunities supported our we by results. the Second,

completed successfully clear the both Third, Fuji in we path finally U.S regulatory the have meaningful the the And for forward manufacturing of pre-PPQ Europe. comparability. we batch demonstrating and a CMC at of first in progress quarter XXXX,

bladder Please to forced so The their turn journey to with travel. cancer pandemic frightening patient average the patient even Slide X, diagnosed in bladder which resulted with of long is arduous shows cancers more in seventies the challenging and has experience. patient

with the patients a the Vicinium and committed ever what as these and know to are ever We to EMA FDA market our and that new remained could help huge lifesaving and make motivated I lives solutions saving for assure in you the than and bring we patients product cancer. of current difference bladder despite challenges, improving to find as can more

Vicinium Slide important a X Please turn which works. very is how to description of

First to selectively of cells. Vicinium healthy while EpCAM, cells Vicinium allows which cells attaches to expressed kill cancer is alone. This leaving bladder all, cancer generally bladder by

cancer able more also T cell peers expressed interesting are the even of tumor alone. fact that immune T Those activate activated while cells cells But also cells, they to thus patient's and to bladder response. leaving the Vicinium mediated healthy are identify the being the by attack neoantigens able

What VALSTAR. is agents and the which such striking chemotherapeutic from differentiates BCG us as is about volt mytomycin, selectivity, other mechanisms gemcitabine, and

agents of and in which cancer a these attack cells, results profile. and safety very healthy All tolerability different indiscriminately

the year are conducted bladder physicians of treatment So with to prescribers X, please first who cancer. the Slide this in-depth quarter in the turn highest for invasive we non-muscle of interviews

invasive no spoke unbiased collect cancer not non-muscle we research market in industry bladder us involved with any been relationship to to physicians and results. The trials, allowing clinical had had

the of the physicians can XXXX. on the Sesen FDA X, these is quarter fourth world prescribed Merck you KEYTRUDA, the in of by Vicinium data Slide show which On currently to clinical based the Bio product and commonly we profiles the most submitted and that see oncology in

demonstrate strong see the Vicinium that response of and response. key which data, duration a can You complete

XC three of data You receive years. an in XX% cystectomy, measured least at can that also see Vicinium important to that who kind the able Vicinium radical of avoid cystectomy advantage for our are a show patients very a has

Vicinium the rate grades Therapy and events, one-third to need roughly adverse related results treatment to between is featured five of But the Vicinium at biggest difference three discontinue and the in therapy. the safety one-third tolerability. with

to given of be needs the that and that believe fact to causes intravenously given may due We believe immune therapy. may KEYTRUDA causes discontinue fact a higher We the safety mediated has rate is KEYTRUDA to this and intravenously high due be this issues.

Slide XX% X a over and physician would product profiles of the use when Physicians agent, that the time. shows KEYTRUDA. reaction prescribing to they the the report Vicinium Vicinium of branded

in the ease physicians right-hand You of can integration. XC of safety the products also while Vicinium advantage on have data, that report that clear two side has terms and a comparable see

offered Vicinium and why they physicians over On KEYTRUDA for Slide explanations. XX, we prefer then asked they

prefer the referring journey oncologist. urologists of medical to ownership rather retain First, than the patient patients to

and patient conducting Given is follow-up part administered the Vicinium which of to urology clinic the diagnostics, is that an they keep treating are important able business intravasically, keep the model.

the clinical of a they identical told Vicinium patient allowing and continuity. for value of treatment they of protocol the KEYTRUDA Physicians us that Vicinium is seamless profile over that fact the preferred to that BCG,

number new Finally, psychological as opposed stay important prefer there a a a medical reasons referred physician or to patients that to in center. with new to hospital of are being the urologist

wide think we variety valuable and is that summarize, a for to important across patients product So a of very indications. KEYTRUDA

significant of approval. Vicinium that cancer, once the the Having commercial regulatory highly compelling, that we appears gain said profile are differentiated, that, Vicinium is for non-muscle in it opportunities the invasive to to able more which and bladder exist the speaks

With Chad? that, it I over turn will to Chad.

Dr. Chad Myskiw

to Tom. Vicinium an on manufacturing analytical contract to related demonstrating manufacturing I on decision outsource manufacturers. to we provide activities Slide background XX Thanks firs On have our to update want comparability. some

global In long-term meeting XXXX, after of demand. conducted related invasive anticipated market determined of cancer, would non-muscle that capable of several be the our not research market the we bladder therapeutic size rounds manufacturing we the facility in to

outsource to the Fuji made to supply Baxter. manufacturing we and commercial Vicinium decision for So of

on experience, We considerable did supply to not anticipated market. us this which in their significant and meet also allow enough regulatory will related leverage to only larger demand produce expertise scale to to the this but manufacturing capitalize their

of manufacturing we today's of recently pre-PPQ completed Fuji. batch and update, release testing the to Returning

criteria. similar all batch quality acceptance to batch scale Importantly, first and met the our Fuji, of GMP commercial pre-PPQ,

This this campaign I, demonstrate a review III Performance Process Qualification, consisted the on Fuji way manufacturing that compatibility our analytical to process ability Baxter. and transfer our from trial the at II Phase provides or PPQ came through to during positive to believe We all the and Vicinium Fuji.

we Turning to Slide confident in the ability why PPQ XX, the are to campaign we our and reasons key have compatibility. captured analytical demonstrate

from drug products. we the three drug requirements on First, consist clear have consecutive and will substance which runs campaign, manufacturing of FDA for the

support of the our of history Second, clinical experience us Company likelihood the we batches. helps and this manufacturing success. a our from And considerable amount within CMOs with process Vicinium have producing increase of to the

each and standards. met of already at batches have at the scale we one manufactured required Third, and Baxter Fuji commercial all to quality those

structure drug biophysical based the have In trial. substance the comparable the clinical GMP Phase primary, for the and believe the to material addition, extensive first we we III similar previously tertiary protein. meaning on by - of manufactured is the that, for material done Sesen highly And of testing secondary

fact, Building manufacturing also to experience And that our place at on disruptions routes CMOs. what Aaron not in consumables have based PPQ with we CMOs required due confident chain and in our our supply we for on said major we COVID-XX. earlier, feel discussions the batches all the already to-date, will

with and pre-BLA product also that are in of us during Turning see substance required manufactured the a discussion to to CMC finalize produce the to X been submission. drug an meeting. pre-PPQ XXXX the which Slide at timeline complete the PPQ at batch first Fuji, BLA that XX, at drug you FDA our was used approach will developed Baxter successfully We the has activities Module for CMC batch

X part in submission then expect first from second and we date, half BLA the XXXX. Working forward of the the half we finalize of anticipate Module complete approval potential PPQ U.S. of XXXX. campaign the middle to and that the the year, in In

specifically scientific the Company's This to use, we of Europe. approach to recently Medicinal Agency. the human XX, slide application European from turning received for regulatory known approval submitting Committee the official the relates Medicines advice the Vicinium a for to for of CHMP advise authorization as Products marketing Finally,

application. provided sufficient meeting the very safety the additional not the the this non-clinical trials response marketing pharmacology that we for clinical from agreed of and authorization was And did were of importantly, purposes of package pleased also They submission. that in submission request our CHMP. in the We data with the they support

to It the cystectomy non-muscle considerable of development cancer, was also that avoid invasive burden patients help would cystectomy that of be patients lives welcomed. due therapies on with radical of the bladder acknowledged the would

analyses lead also guidance Phase should to some included We We the additional perform could marketing submit guidance, be application this potential early on early which on will with CHMP Based authorization expect believe that approval Vicinium authorization in in data. be to our we received III application. able that EMA for we to to data analyses XXXX. the helpful the in XXXX, these marketing

that, turn over I the will With Monica. call Monica, to

Monica Forbes

Thank you, Todd.

build to strategy U.S. our the continue commercial the stated in go-to-market state with standard We foundation for

On will how an of terms the next few financial slides, about inputs thinking walk progress assumptions our update on across in through our we key and in are areas model. them and I you

to invasive of bladder cancer know who XX% are please We in group practices. urologist So or co-located XX% Slide there treat patients, XXXX most roughly are of non-muscle turn about which large XX. urology approximately of

We sales representatives have deploy we roughly launch. which a to shortly via focused before XX sales XX organization believe this to us of and sales a force allow will contract plan very to efficient

while million levels investment basis assumption a and This to $XX successful an on estimated translates to for the launch. frequency annualized an million necessary achieving $XX reach

Slide our of through have the meaningful patient gained a research, understanding we XX, interactions. Turning to doctor

in a have during male on a learnt the patient, seventies treatment average office their regular their usually to or that urologist diagnostics. own their course go of We

at interaction starting the treatment role decisions caregiver family prominent urologist. with However, on will or new times therapy, play drug of the such a member a a as pivotal in

Our spouse, such in of Google, media for a high as medical this that is we granddaughter they engage social Twitter research and digital time daughter more and information. Facebook shows likely and know to a or the percentage caregiver are

of believe we treatment the making in family can Vicinium. we social highly that to reach influential members caregivers on them is and know channels educate are we through digital It reason for value this who the and process decision

traditional an strategy also but channels digital help inform social will and provide usually only commercial versus caregivers, a spend be Since advertising. the scalable is not of the and for fraction important direct-to-consumer tools and to This television will approach. these efficient right like investment

see you seen the On Slide associated rounds XX pricing payer reimbursement we market benchmarks research during and can have research. our of results

authorizations use of think not prior we form in the the expect for the step from suggests payers Vicinium edits. and We are will significant encouraged research the of by of there we advocacy level appropriate or can barriers be our

insights driver full uptake market will learned of a Will thoughtful have launch. safe while that and believe the spending. profitability. is at way to-date We paving to combination the commercial of critical approach this Vicinium our view with opportunity stated be Our help Vicinium realize for for we customer the the rapid us in

Finally, our priorities $XX.X quarter the XX into first We please fund XXXX results. to an with million is turn of we Slide quarter finished overview in equivalents, which cash XXXX. believe strategic our approximately and first to cash of for XXXX financial sufficient

less it our ATM than We last of the to above ATM the with in an which minimizes daily program far. a level while sheet. use are pleased strengthening XX% ATM operated the impact year We quarter balance the at our price. low established very us when down market of we and and run how fourth and take has demand sell allows on average average trading This outweighs we days supply, strategically most thus volume

current the no for on we ended before, XXX strength carries obviously is have even Company which with million shares in debts, and of outstanding the stock fully basis an highlighted XXX a diluted as We greater common year the million environment.

that, back turn the Tom. With to I will Tom. call

Dr. Thomas Cannell

Monica. Thanks

I XX. earlier believe are summarize to Vicinium think I substantial on We So presented market action. clinical Slide shows what research its call. please profile differentiated the of a four believe based highly commercial I takeaways to key want mechanism from the has opportunity. just unique turn this We the

by in the and United very team forward drug between analytical our product, the clinics progress have demonstrating - Europe we comparability States. I'm pleased made a very the believe commercial regulatory has we and path clear

that, the Operator. I With open will line up to questions.

Operator

question Your John comes Instructions] with from Newman Canaccord. [Operator first

John Newman

the just has It like Could manufacturing steps of progress, Hey all is you couple well. Thanks. the EMA. submission. through with run My pre-PPQ few steps. next to just you the regarding the wondering and get the if maybe manufacturing next of BLA just congrats of us sort take I'm the to end on guys walk through gone good could morning, question Tom. you especially us through the the sounds

Dr. Thomas Cannell

make will and will like a and comments in Okay. then Sure. I few to would if see I Chad check add anything.

first run at have as Fuji as PPQ Baxter. run completed we at pre-PPQ, well the So the

this the know campaign, to to is PPQ ready runs that are And at we Fuji. the So go complete product PPQ. summer with we fill three consecutive which finish ship as then happen will steps of and the you drug the will supply Baxter to and

the are We submission build will the which of of will hoping wrap modules that all for our side well, the BLA those that year. we module of end finalize is up three, BLA we CMC a go the completion and assuming

So forward. that is next kind going of process the

Chad, anything that that? add you would to like to

Dr. Chad Myskiw

No Tom.

well. really covered you that think I

Dr. Thomas Cannell

thanks. Great, John.

John Newman

Great. one I regarding If have could Europe. additional said question

of the a if all of able you and run you terms could some the cancer wondering bit non-muscle then Thank about to bladder market. for curious also analyses opportunity invasive you EMA at would like Europe commercial that Just the that talk in in size you. just are talk of if about to the

Dr. Thomas Cannell

Yes.

to FDA. clear bit So February, of guidance the duration high orientation can mean, FDA of primary additional on the The response. the in of different in points that say a EMA and that with they complete end are I cancer guidance, XXXX response terms what bladder very than the, put trials of out is a invasive just I non-muscle at level, is single-arm

to like trials The looking controlled survival is relative they at more care European endpoint. standard of approach looking clinical see - to at

points overall three end event survival survival secondary free progression survival, end have are that you we and As survival. point, know, free do

making are that So is data sure way and fully a it analyzed to aligned all matter place at the see of are that of data. the those you with

market a Regarding is the of interesting analysis opportunity, it Europe. very

Europe, is smoking. bladder the is most World As at Health Organization And data United rate is the you cancer factor the for XX% from about risk smoking cigarette you look in the primary it States, if about recent XX%. of know, in the

you cancer, the smoking larger So the that is the see of that take when add European and you you are bladder risk to two additional opportunity population that there for demographics number you look at patients three the with cancer. at are what full a have bladder times

Again, in bladder the U.S. to it with cancer. times is each year, XX,XXX amount. patients are In diagnosed that Europe, two three

is the incident And so, is that significant. very

we in that inhibitors and cancer, bladder the that look know data see invasive available thing for are The we metastatic like or advanced U.S. benchmarks is both for checkpoint when for [urothelial] at carcinoma Europe. (Ph) muscle other the you

that XX% the XX% to bit price, a which in about other the higher than benchmarks. is Europe see price U.S. quite We of is

currently So it Europe. good price is fair being a reimbursed and that is very in

sales those higher be when things and know, is even market as the but the which has we can larger two estimate opportunity. So you you dynamics put find peak actually United backups. in in together, opportunity, our data will that U.S. all than on the a Europe you substantial The States, the a Europe

we on are have cancer, So, the not of had forward. the opportunity pleased successful pleased with going process, the invasive for previously bladder standards scientific we guided non-muscle to very but and opinion different very EMA because

Did a John? you question, have follow-up

John Newman

Nope. That is all. you Thank Tom.

Dr. Thomas Cannell

John. Yes. Thank you

Operator

from comes Chris Howerton with question next Your Jefferies.

Chris Howerton

maybe Great. perhaps great A question good taking site, is first the Thanks question directed for think, I and Monica. Tom. my morning towards

what in the the bit payers. that the perception in a terms saw interested edits and of prior little you understanding more of the So of some step is maybe in authorizations

of you a think few do then know, it they prior would and questions. to be expecting are exactly follow-up you what at have And, constitution the authorization. what the through You I step

Dr. Thomas Cannell

And of then lot then, a ask have at I it. been parents to I to you will talking Well those will onto that. take because Monica I Great. a crack and add

significant as through So that now escalating costs we knows, Managed see everybody I well Care, restraints mean, is of such a right giving the pharmaceuticals. there cost just

And step and that can should have patient are so in make edits Organizations two been doctors is has everything Care is prior Managed where approaches the document where been of to take sure that therapy. authorizations then common tried tried them previously

in is see we bladder What quite unique. cancer

cancer. the cancer going is will between billion $X expensive maybe with most States. of treatment cancer bladder bladder be It now on the the in cost, So, more United everything

payers. And, and as most of that the commercial well is by as on Medicare taken

find interventions help can cystectomy this that And radical treat very so to help anxious potentially pharmaceutical are overall help and they disease, avoid costs. lower

go and them and a could about actual on outcomes So of talk in price lot benchmarks so of value when backup. we talk to the steps be that to that would arrange about interested edits our off. we them relative from you we and exist there and What are based the minimal contract benchmarks obviously how based see hear is in prior we the that, them that therapy we

definitely question availability So would unresponsiveness like are what invasive it not either and to see BCG is to to also lack answer your high of grade. cancer bladder like looking they is demonstrated would non-muscle BCG or at low they about the they for grade see that

XX% grade. cancer of as to know, is you non-muscle invasive And bladder about XX% high

will on and BCG. edits has failed the is making ops So, are around the high risk disease be that and it patient step sure making prior sure doing

like anything you would that? Let stop. to to Monica, just add me

Monica Forbes

thanks. Tom, No,

I it well. think you covered

Dr. Thomas Cannell

Great, thanks. a have Chris. follow-up? Did you

Chris Howerton

okay. it questions follow-up if a Yes of is couple

that that seen guess, the initial they Because indication? a probably couple of any penetration KEYTRUDA additional So what in do of we or today. access perhaps that and months perhaps in insights suspect in I have market marketing have I had we of from indication terms

far? any penetration so visibility and in access terms with KEYTRUDA So of

Dr. Thomas Cannell

but don't, have have the data, to I obviously physicians. thanks. because we I lag, data any Yes, don't been talking of lots of quantitative

using they IV rooms. the or So - centers hospitals. that, what infusion in is mostly I can tell are They it medical oncologist, it you their obviously the in is are using teaching medical academic

are in really or far They talking pushback terms so is they - a was And step not significant really we not getting from ops I what any with of are what perspective, about. hear consistent prior payers from reimbursement just edits.

it seem reimbursing payers are they same to the So be urothelial way carcinoma. much the that reimbursing advanced

Chris Howerton

Excellent. Okay.

I two is given be Okay. trial, market confirmatory if thinking we were wanted COVID-XX the then, all. with or of And proven I'm the that successful. about that, to there in to terms are what be secondly, the in access, would think about should then to if curious both parts and any views updates respect pandemic EU be if trial curious, and your the guess to how at And U.S., just foremost, to in see and your respect confirmatory timelines I first thinking with

Dr. Thomas Cannell

Yes. Great. you. Thank

would roughly right timing, of we initiating the terms around be of timing XXXX. second quarter in are on so the approval time planning of So the in the U.S. that

European also approval we We accelerated then pathway, a find we well. trial which whether MAA, confirmatory a as out of have as pathway, the submit conditional equivalent require the will is would which

trial, we picture and before, the statistical is Gemcitabine can compare of such to agents the as a superiority. care, chemotherapeutic versus said so show we global confirmatory and we study have design standard that Japan show up a mitomycin As Europe trial, general to and U.S., a set being and

And trial expect the conditional early are pathway approval. of then in path, again still right we of the down European XXXX the Europe. would arm we that So time start in that going still around actually

it be So phased. a will bit little

because yes, data show response maybe (Ph) at patient more less Showing allow then this exposure. access. standard superiority does population superiority, on a improve the really complete versus agents it of statistical global a of XX% three patients to is months. question care because have And [PCG] think we in we have XX% And our us your show chemotherapeutic that trial about reimbursement, will XXX, those XXX

those able would countries quite us you of us in U.S. around be help big the but world other all the data price the in and and it same same help Europe, would it So frankly, show to benchmarks. because those

reimbursement. expands definitely not the could opportunity further only us, strengthen a even market but we think expect but good for I confirmatory positive trial, So reimbursement,

Chris Howerton

Okay. you Thanks. will in I queue. and hop the tom back Thank

Dr. Thomas Cannell

Chris. Thanks Okay.

Operator

Sean is question last Your with H.C. Wainwright. from Lee

Sean Lee

I two quick for Good morning guys. have question. ones. And my thanks taking just

company’s commented you bladder within treated how So FDA two and the regions? reviews how you Europe significant the any are bladder differences commercial start to on timeline on there could the is between the - a for could on comments And that? strategy on and potential comment partnership different - you of secondly, tell you in cancer EMA Thanks. a cancer little whether discussions do bit whether the differences when

Dr. Thomas Cannell

morning. Thanks and Great. Sean good

So in like all, say just between I first differences Europe in are of cancer. whereas treatment are the bladder China in U.S. I parts think and kind quite of talking and about of mean, of Japan world. the there and general, the significant they of difference terms would other I similar,

Europe of the use both both, standard workhorse first-line radical and standard the line U.S. cystectomy of as pretty of of that BCG as They They kind the as care. are of They similar. the agent. second both think But think care.

cystectomy. UK some they especially the and countries might like radical even Germany, Europe, In do more

systems think I approved in little harder health less a little the a not chemotherapy. is probably the even Unlike Europe. uses push Valstar U.S. and Europe

to on tend they little So go lighter chemotherapy. the a

in of terms when leaders general practices. U.S. we Europe, would general, treatment I versus market bigger market of much but appears earlier, in to I the similarity we in the price the say in XX% and the is to the European as and to key benchmark in But then opinion be a see But, a talk obviously mentioned and lot and XX% U.S.

are mean, I partnerships, very for regarding then moving things us. nicely And

European process in success of as Asia terms As of Europe. in our we our opinion have really definitely probability This a discussions said and increase partnership of in will partnership good help scientific Europe. well as before, accelerate the both

these we responsibility XX/XX read being marketing And share would regulatory commercial. partner the they agreements value partnerships as said, the have we for clinical, that and picture holder, authorization take

it means a XX are U.S. outside the minimal the in XX headcount have keep which to outside will terms infrastructure us picturing of and very kind U.S. XX covering efficient So we investment model. six still we to of lets countries, partnerships

So positive the there process. help opinion is no that accelerate European will doubt that

Sean? Did you have a follow-up

Sean Lee

Thank you color for is additional That have. No. on these. all I the

Dr. Thomas Cannell

Okay. you. Thank Great.

Operator

line follow-up Howerton Jefferies. a of from with have You Chris question the

Chris Howerton

Hey of I kind I Whereas to meant of believe ask. saying. commentary, there, hoping perhaps I data within that was terms Chad the interpretation of EU and to in I would thanks ask, else for was mentioned the time forgot the within ask, prominently phone. to somebody cystectomy the or those taking

seems somewhat the that of at soft perception end is a it least point. here So, in U.S. a

So just wanted way? that to a in different see thought - maybe is EU about there

Dr. Thomas Cannell

is help because It in a is really of point FDA say so they is We explicit question. the guidance, avoid pharmaceutical their wondered whole good cystectomy. that the intervention to to radical

years. So the update show value three at has really been crystal data delay that have we the like by least patients cystectomy clear, they of XX%

delay radical Why meaningful were especially that We are in to to unmet need, cystectomy. accelerated assessment. Chad provide significant unmet for and that is is for need, we the defining products think that pleased spoke that it able basis by to could Europe that they agree us there is it a

accelerated Europe you XXX days. there as in know, processes, think XXX I assessment, days regular and assessment, assessment is is which is which two

positive unmet on the that plan is based submit our reaction, with EMA protocol assessment consistent accelerated months And need. to based request MAA, we our before so it on three that

So we of FDA they were as an pleased to the as see considered need unmet much does.

Chris? follow-up you Did

Chris Howerton

No, think don't Tom. so. you I Thank

Dr. Thomas Cannell

you. Thank Great.

Operator

time. at I Dr. Tom CEO. this now conference showing Cannell, like further no to back would questions to the I’m President and turn

Dr. Thomas Cannell

questions you morning. operator. thanks your great for this everyone again and to And engagement active Thank

save Bio we lives their thank to pandemic as patients have at and would the serve. would like help appreciative as more couldn't to go, employees patients I caregivers XX team. the the who the well of been group and of I we working brave family or I Sesen be like proud tirelessly and Before to Sesen our improve despite the thank

today. hope week healthy we and soon. for concludes to all talking forward look that you I operator. and to safe a our all So call you, have you Thank

Operator

this Ladies participating. for call. conference and gentlemen, Thank today's you concludes

now disconnect. may You

Carisma Therapeutics (CARM) 11 May 202020 Q1 Earnings call transcript