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.