cancer. the bringing us. bladder non-muscle and data our progress preliminary from our joining Erin trial. January Thanks, patients updates a Vicinium on thanks happened I we everyone trial to with number Today to announced positive share our called A since Xrd, Vicinium has lot VISTA for toward am invasive last of III where call excited in Phase
today. an slide, to to key story Sesen you that I on turn the agenda provide there really are five to parts If X, Slide Bio wanted update our
seeing First, support new bladder patients for from strong are need of we and is regulators, physicians. unmet payers, cancer treatments significant and area an
Phase FDA with II guidance. III are trials Phase our and Second, clinical highly aligned
upcoming to regulatory FDA. approval discussions probability forward and We we look in of the with are confident the
the preferred combination dual made Vicinium with create action And believe for biologics, their or expression microbial that Drug fusion supply chain. ADCs, the and inhibitors. support choice finally, significant. the commercial from cost and elegant opportunity Vicinium checkpoint of especially and we a believe protein has physicians, patients is for reliable as action, unique see has and we Antibody which many is and a a and in therapy of reduce manufacturing payers potential Third, advocacy and we simple mechanism unlike goods a potential physician Vicinium and straightforward it Conjugates of to with a system caregivers Fourth,
If cancer you X, arduous from for other the believe always that bladder and turn experience. which journey regard. in this is diseases is we to patient humbling most We with start bladder cancer a long different Slide
quality experience that more In to patient the life we compared surveys bladder life known as when these fact, one removal poorest radical shown bladder heard with is in Nothing treating of patient’s other and of than important physicians patients. to that of those cancer from the factor the damaging most is the quality cystectomy. is have of cancers full
slide things. to two of need the a really in function Turning bladder cancer huge is X, unmet
to considered always all higher is cancer. few Each few sometimes used And quality There both non-muscle carcinoma morbidity radical which If the on treat of tremendously most to a to first-line field therapy form which to risk. left of two patient rigorous, those persist, is a second, from gold will in bladder X BCG invasive response in and impact expensive treat. minutes, urine the of with could may entire is non-muscle urothelium. a untreated expressive and time with radical that bladder describe in burden and microscopic independent and is very of high impact second-line changes progress VISTA muscle-invasive treatment cytology States significant courses in of progression. involve patients is tumors. type complete failed the which are in we difficult over XX% high-grade most cancer extremely high are with situ will cancers disease be for of and the To First, to be clean needed for change results show trial fail field standard to the field the a and are and treatment in of cancer clinical the BCG, bladder cancer and This new is of that risk colorectal context the most difficult patients therapy in supportive Radical life. cystectomy situ, mortality, eventually patients. helps United and extremely cancer are such as these cancers the at know a we throughout on and disease provide the bladder is samples BCG local choices limited. carcinoma cancer cystectomy. change is are that will lung And each because of significant from cystectomy bladder change disease invasive of this, lieu stakeholders review met some situ Carcinoma completely any cancer central to bladder confirmed treat. point. Slide the biopsy cancer-free
activity. regulatory the Slide proliferating is and comprised favorable Vicinium cells, to generally discussion synthesis which ties its strand probability the cytotoxic believe kill targets important protein anti-tumor antibody rapidly we for to safety small a to and payload. turn just to a Vicinium approvals to profile. which fragment my reminder of which ties of turn and our cells the X Now and of slides. that Please strong an cells, of confidence while single-protein Please X, one durable both able in mind slow-growing is Vicinium inhibits avoiding most is its Slide to healthy in selectively Vicinium. a tethered turn to cancer let’s
highly the the FDA’s of with on the based step clinical have every feel XXXX we way. our Phase now with clinical this a all alignment, recent to-date trial we We been of key confidence input of the in in aligned a Meeting in we designed with requested In and for us elements along III and the II guidance the FDA come to probability trials the observed have are and that give eight collaborative teleconference FDA, We regulatory results approval. pre-BLA with they Phase mid-XXXX.
Slide look Phase primary We future will of all that agency. III and with discussions the to scheduling meeting on and captures graph secondary The our be endpoints trial. the VISTA XX forward
BCG. to patients studied a our As trial across histology recurrence divided cohorts VISTA after XXX a by three and reminder, time
important previously recurrence which want three is Vicinium. and a of that one durable Vicinium favorable an inhibitors. cystectomy. a is and spectrum cells Intravesical basis the based administration, is strong primary other of really for slide to the complete to II that for generally in to of III recurrence-free confidence and assessment trials for this feel guidance turn endpoints. review Phase a Equally clinical application targets and benefit time on as rate from response, a the Vicinium profile. will duration to is while are meaningful. FDA endpoints. Vicinium and is is Today, I consistent I’ll approvability. We response our data endpoints, BCG, marketing of is is time reported emphasize safety What favorable provide Slide FDA. which you rate, disease What our approval Phase cells that a including our avoiding across risk efficacy Valstar complete important response preference The on BCG we in to of that Please ratio We robust to have update says very of the the is with have and a on Two tolerability data checkpoint see of cancer fact XX for our efficacy profile quick the our relative healthy that things
complete rate significant us the submission. Phase trials two and important between reproducible BLA II III giving First, for response and
Kaplan-Meier on three for estimate of Second, band means clinically chance per a response the you three you are shown if XX response duration based confidence responder response interval of months, is our a months, of have XX% a carcinoma the complete unimportant all complete patients you had VISTA Slide that through a on at XX% which who nine achieved illustrated out a trial, months therapy. longer. guidance, complete three response maintaining bound response in That year a complete graph. first your by at situ of rules XX% had we see, the can patients or that a a confidence roughly the in complete months as believe rate FDA shows lower at
non-muscle cancer these VISTA pleased but preliminary or with to when patients of for will present we We disease evaluate appropriate and These cohort is disease are recurrence dataset patients endpoints trial therefore high-risk, are was reflected Slide that from the at time more rates recurrence in anti-tumor bladder trial thereof invasive the our shows information no we XX durable which activity X the TX. certainly response. Ta data have disease to mid-XXXX, updated of data. have who have and visible progressed to days evidence XX-month
disease in FDA the reminder the that in next these however are whom if the be including patients recurrence. As important risk not they these the patients cystectomy the for patients primary should on is will note overall have recommends endpoint. guidance step benefit these An you high-risk Slide, included radical is analysis,
on population. further activity remain all time of patients. XX% You patients meaningful can Slide demonstration six XX% free high-risk that anti-tumor of papillary On this We slide XX, and believe patients disease-free. supports patient Vicinium’s remain recurrence is see at months, the clinically of at disease a XX-months, for in disease this
median demonstrates Slide XXX recurrence, see, we and data cystectomy on patients. days. endpoint as is we disease have across an all we update on XX, based see Again, estimate time well believe and On in significant mid-XXXX. will the to can you this As to this efficacy Kaplan-Meier Vicinium’s durable time
the is the the to a they can preferences of effectiveness. cystectomy. to submit variations two, these the direct Therefore, this intervals intensive, the data that approach Because interpretation by delay on number current of the BCG are sets cystectomy trends method, using the of this to-date confidence of goal provides FDA unresponsive cystectomy estimated as or is evidence one, significant number is trials to in preliminary time patient is to on in generate FDA median nonparametric in calculated. slide, note we notes cancer bladder estimates of on be healthcare that median says guidance a supportive based was that and data Based or the cystectomy-free and important and while for that cancer invasive with median existing VISTA observed therapy patients in shown days and or months, days confound of radical just an and low, so data. cannot cystectomies clinical the recommends patients the data dates. Nonetheless, patients a that there endpoint. avoid is no benefit non-muscle And for in this collect trials As XXX with that cystectomy, Phase it replacements. bladder II approximately patient trial XX that on are delay sampling commonly incomplete used either through III in estimate clinical Despite provider metastatic develop Phase cut-off therapy all
of appears on very patients. our will safety see targets to we meaningful healthy this cells leaving Phase and physicians felt benefit that continue endpoint demonstrated II data to XX, important updates those clinical consistent tolerability Again, we this tissues Phase be intravesical are selectively and Slide the payers, provide cancer We these by III as trials. the while alone. to an and On importance product
well the ask sometimes have profile Vicinium tolerated BCG, is high-prescribing investigators urologists that had treatment even to favorable their are it view some the is of opinion on relative whether patients safety leaders say checkpoint to that be and Valstar key and so that We seems they inhibitors. and for Vicinium
and given to January Slide and choice unique, we happy that Durvalumab, for have hypothesis therapy Cancer Vicinium a positioned Vicinium think which a we by which like Turning story data but of could Vicinium Institute patient’s system. slide could response Q&A. showed we – In shows have when call, of has be at this through in very and achieve checkpoint not Xrd on of the activate action, scientific assess clinical the combination it our dual effect, presented to checkpoint level, Slide ability shift a are to BCG part that is to preclinical we XX, to National the scientific significant discussion have high of detail are during before leads go with discuss our combination for anti-PD-LX that the important who could so immune hypothesis more us as with be an it checkpoint with this the complete that inhibitors Vicinium. inhibitors. XX demonstrating alternative mechanism it support first combination on combination I’d additive be do of it And Slide will we a and or to opportunity hypothesis future, is the synergistic in Vicinium inhibitor. even either testing shows we XX for the preferred a or valuable commercial the Vicinium. patients to a that exciting on an I
any our for research course, go-to-market the patients, stage-gated BLA slides, will commercial physicians you among This be will and but next see on strategy, until As after sets preliminary begun of significant have submission. foundation market payers. work investment few overall the we
So XX. please turn to Slide
feel cystectomy was relevance ten them response the and currently the But life. lot Slide we opportunity with would on requests that general, results of potential conducted We ten a clinical action due not colleagues. lives benchmarks they their impact is invasive average the the have we questions data very their XX opinion bladder view to Vicinium and we such key efficacy leaders which to of late one sharing time approximately look would with high-prescribing Vicinium any recommend prescribe to general going interviews mid-to additional stated, with have get to which physicians, data of the XX approximately through in-depth as three to XX% were data. as at their patients, These address and recent remarkable endured are further these patients bladder be From leaders potential unresponsive, is journey responds to go decision-making our This and while they for of to and out of in treatment our of on mechanism to of of importance, the it’s results. non-muscle after to forward interviews this, research of most XXs, their our of a pleased prescribing and detail unmet significant grueling talking all we for have glad their self-explanatory price I their data, know of today, rated very duration favorable cancer the diagnosis. forefront am that and and getting market Overall, urologists checkpoint and was Because need significant these is for in think enhanced quality stated in believe tolerability the viewing is BCG key went urologists and high-risk to prescribing physicians clear cancer. they and dual I All promising I’d their it our inhibitors. available and well Valstar collecting of in patient XX% to since patients. data. Vicinium, treatments and by recently Q&A. to on referenced. been safety overall hours opinion resonated In
a market good We forecasts. and research price and that at moving the this the of benchmarks time are understanding exists addressable demand-based U.S., in with forward we and quantitative have
We the have the partners are potential we outside U.S. research and been U.S. to talking from also outside doing market
future. global six in that Latin could opportunities. represents total market U.S. also a that minimum sales partnering of the Vicinium the to of East months. We America, know and can XX the Because believe Middle Asia-Pacific, XX% about for OUS outpace of sales accounts we market U.S. OUS the take While opportunity, of this, process Europe, sizable
be the well. OUS get I’ll U.S., to you the with as more sharing opportunity on we submission BLA in closer as So,
understanding just will that Turning a to catheter including BCG to patients. use test use physicians we lieu cystoscopy. and In lab same still BCG the talk of urinary first-line the radical same Slide we from treatment undergo XX, has hard and urologists patient change and infusion the to in future, when reminder switch into know the the pursuing cytology same our second-line is and they type journey, nurses, utilize indicated the and same for the to patients In the are Vicinium, cystectomy. center, drive of
lead and Therefore, Vicinium patient is to is me to to to will a is for we at their therapy. hospital, new BCG new advantage go therapy, medical oncologist the huge treatment of more a Slide between adoption slide. would prescribed systemic if very have and much of a rapid a center to and or and continuity However, Vicinium launch. infusion that compelling to uptake a intravenous care nurses XX, new to a they talk go and believe new intravenous then center
are our very a or will highly ask that opportunity unique trial the clear demand very three response situation and of customer understanding motivated gaining likely opportunity three and this all we approved their from could each the for drive their Vicinium think data virtuous their groups. recommend for will are be customer a the drivers where have by different We be our will to driving a favorable doctor progression action we be their and We believe families disease patients. segment, to advocacy what We a radical see avoid caregivers while We behavior from of is if from very segments. delay cystectomy think for and to will doctors clinical cycle Vicinium. and motivated patients, and
that delighted introduction of bladder $X could we that billion healthcare reduce spending overall a be the who cancer payers actually cost. therapies over year Finally, currently by for believe are will
are appropriately significant based is they that risk and contracts that the talking there by believe started payers for potential Medicare we in for appropriate reimbursement Vicinium. that payers, on as use advocacy as value. have of to share We a interested commercial know and We well value-based
As key this possible we growth Vicinium, And commercial strong the opportunity. I to begins very unique a could I given the significant we am smooth and dynamic be the an said, it first-line sustained motivated commercial for there opportunity and take to made all customer of today segments market from regulatory outline be the to action. believe second-line pleased gaining believe approval. will our is planning and advocates are that where think transition after progress with in BCG
area. can time, As of lot will interest we this you our On be through this important we XX, further the an this on chain. more are I closer to supply sharing we get a topic illustration Slide In in quickly, launch, discuss on of I’ll it walk have happy Q&A. to details but and more see information
this much top our illustrative ADCs enables us different to and believe most is single-step and simple slide and of of is optimize reliability inelegant the On example biologics process chain. We an supply this than efficiency.
finished to Slide March in $XX equivalents. on XX-K with turning XXXX cash filed Finally, we Xst our roughly we XX, and million cash Friday, and
runs options manage that important commercial capital on work last to we financial and the one. this as noted have company ensure development we to available a we required we XXXX we call, evolution have have our the a advance As runway multiple a into late-stage that to from
now. to of XX, turn the parts our story right five Slide key reminder please So of a as
mission fulfill have shareholders. the We lives the we of ahead are patients, and improve very while excited to value of for us providing save our about opportunities to
the advance worked to to by incredibly who development. of Sesen have Bio today congratulating stage hard team Vicinium conclude me Let entire this
company. and in Vicinium our confidence We have tremendous
open journey. we would like their your line the questions. courage, thank important and to our patients for honor I their the their part of families take will Finally, being for that, to Operator? With of and
