URGN - Earnings call transcript Q1 2018

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Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the UroGen Pharma First Quarter 2018 Financial Results and Business Update Conference Call. [Operator Instructions] It is now my pleasure to turn the call over to Cate Bechtold, Director of Corporate Communications and Investor Relations for Urogen Pharma. Please go ahead.

Catherine Bechtold

Thank you, operator. welcome and UroGen Business and XXXX First everyone, Results Financial Update morning, to Pharma's the Quarter Good Conference Call. we recent financial morning, overview ended this issued release XXXX. press Earlier providing March of XX, our for corporate results and highlights the quarter a an at release website be of can press on the The portion Investors accessed our investors.urogen.com.

summary Development, will Joining Officer; will questions. Titus, Chief brief Schoenberg, first and for Gary our Dr. open Mark Chief provide the Officer. of Medical today will highlights Ron of are call share and we regulatory clinical call the on updates. then Corporate Mark our development Gary me Bentsur, quarter Executive for overview before Ron Financial the and Chief of XXXX provide recent Officer; an up financial a

of company's at SEC section under the Pharma Filings Risk Urogen UroGen's all we SEC makes and during about statements provisions read under and the this constitute materially XX-F XX- Pharma's from during encourage safe with the on other will making time available differ Reform Factors as section SEC forward-looking time. discussed page reminder, we other filings. remarks plans by the these including annual the certain important call for XXXX. Various indicated We of a that a of today's the expectations, investors.urogen.com. to those may investors Form the are statements company's of filed factors, report forward-looking website March and prospects with Urogen that report Litigation harbor future be statements. on Investors in filings As of the and documents XX, of make purposes forward-looking results Form F annual those to various Actual the Private company's These the XXXX, SEC Securities result from Act call,

upon as we subsequent views today of as should representing our relied any information only this our conference date. provide and all not addition, of as be views In on call represents

point call in to forward-looking turn new on While update we I this may otherwise. now we over obligation the to statements or elect future, any make to call the statements at Ron. events we on will may account of undertake some future information, no these forward-looking update

Ron Bentsur

Thank everyone thank on our call. for you, joining you Cathe. Good morning, and us conference

The first few have exciting been months of UroGen. for XXXX

also of late-breaking We next continue upcoming leader in goal to week oncology field forward the pivotal on our UTUC. the neurology. or strong three of look the becoming American make Most presentation notably, Urological Olympus Phase annual tract at upper our towards trial progress patients of and interim we low your a to the of MitoGel AUA Association in carcinoma meeting analysis urothelial or with UGN-XXX known grade as

to the date plan We trial are observed complete share in the trial response encouraged to second rate the of top-line half and data in from the by this year.

intensely or become most approved for our first remains drug UTUC. submitting on the of potential important milestone team the focused Our UGN-XXX the in treatment for NDA new to quarter a to ever FDA first low-grade with a application

at of X paradigm We look shifting this for of review that of details results the to by to detailed appear in to intent and then the including AUA an the drugs is therapies response FDA-approved as one time well UGN-XXX in encouraged control of trial information. which efficacy real-world weekly achieve across believe be to treated meeting are sites of at on six single for the Aid additional is part safety the to United trial weekly monthly the we robust. arm treatment publicly are patients, risk and for six Consequently UTUC presentation repeated expand interim monthly efficacy and five Olympus may in in for CR the the an results were for our slightly know trial, disease to year the weeks additional reminder, maintenance promising open the made is durability treatment or by the however, for States conducted a clinical do approximately XX At the and data the by no an conference kidney of start At trial indication UGN-XXX, updated result weeks endoscopic week the will I approximately UTUC month. Mark up moment, last UGN-XXX. brief and with was next potential eligible AOA low-grade CRA a partial a up will up of be As our of removal. to Israel. these a procedures upon endpoint complete XX%. primary regulatory cohort of enrolled date, drug. larger are abstract or Olympus the the disease the catheter available role the Abstracts also of play treatment XX being durability we evaluation we for saw response although for treatments analysis of followed the a complete setting. XX%. patients, the is preliminary XXor the in as response in of Recall rate Conference, population. the Patients In undergo assessed not note this or provide out UGN-XXX label complete we from a our characterized of publication with believe installation need PRS treat And Patients for achieved XX has is that important or of primary they installation is cohort which a CR the who a purposes, following sharing pivotal complete will program response certainly an valuable use were basis study this the that that submission patients of we compassionate treat on XX in interim PRA patient intent abstract from initial forward response assessment. are on the

Francisco. Following the investor data we event host in Olympus Westin hotel an presentation the San St. at will Francis

combination and of for submission approval potential the while approved UGN-XXX the an programs commence preclinical submit either trial the to NMIBC UGN-XXX, and commence new RTGEL, immunology that clinical we Under agent. track XXXX for VesiMune inhibitors another Phase the for bladder to a treatment drug of some currently to low-grade it proprietary of first-ever what the track launch including of our potential only half cancer of mid-year thereafter. a we're immune for believe evaluated Other beginning preparing first we UGN-XXX We refer we our remain models is formulation of a top UGN-XXX first gaining second continue of or immune treatment of clinical UGN-XXX a is now checkpoint advance. the to referred without bladder being demonstrating investigational potential believe or in UTUC. VesiGel application Xb trial and on the the of considering FDA in the and know installation invasive with IND as are XXXX half for to possible technology for quarter treatment or low-grade in on full it's in the with when sustained-release our the as We VesiMune we the IND pipeline UTUC that of for an of UGN-XXX agent merely now FDA a NDA platform. UGN-XXX, XXXX, shortly or of single platform the planned priority, imiquimod non-muscle novel BotuGel to following which a actives high-grade in is to

to BotuGel patients of enroll trial in that bladder. clinical our refer overactive the of treatment combination continues collectively with the internally Finally, drug Allergen candidate Botox Phase RTGEL to for in our partner X a we as

Our the This royalties million million of January potential $XX.X the to cash net sales. first for of with at the in RTGEL concept commercial following applicability follow-on Allergan and technology hope total of end one in provides partnership has the non-dilutive in public $XX and are achievement payments start approximately to platform certain of us million related becomes million. with receive partnership especially additional From $XXX we cash a to net to capitalized the of in from regulatory brought of proof the broader cash we're many. the eligible a Allergan our on date this well a just proceeds to up and quarter strong perspective, corporate development quarter $XXX.X milestones raising we offering addition completion of of

prepare evolution. of next our for As we the stage company's

UTUC our please of findings and and now on I growth continued from support over more period Mark, of key hand ahead. granularities the expansion to with operations functions and regulatory, study marked clinical hires and Olympus will first around Mark X low-grade provide goal. this will of next Phase across pipeline. what's UGN-XXX to the leadership US The commercial the it in preliminary who quarter expand go in a

Mark Schoenberg

Thanks, San months May interim for Ron. on It am Phase be presented will The as by have of last certainly been the Olympus Francisco the at meeting few urologists results X UroGen XXst. study. encouraged particularly I our AUA exciting in Monday

Additional details can website. be found on the AUA's

were be the made which cells Olympus public obtained tests enrolled standard the patients we patients ureteroscopy the of urine XX and six abstract the AUA, last the of for on weeks from sufficiently data describes to track of evaluated Our whose microscopic the cytology, the informative. have XX additional trial after matured completion data At wash upper in therapy. month provide of by will

into XX% mentioned, be regulatory we we during purposes AUA only It's will provide considered response insight important to the presentation. PRA cohort response be a in to that trial, rates the have to in of complete in evaluating mention and observed rate rate while practice the date. As Olympus for partial neurologists, the will will CR ITT meaningful Ron the

therapy. patients whom also data abstract for six durability three preliminary all Our of completion remain months of reported following disease-free,

program a whose trial this in control possibly UGN-XXX have patients maybe UTUC the removal. generally and that resect. for of monthly second data product associated the the XX endoscopic XX In XX% or Treatment all to a disease-free We disease as kidney transient observed will those limited therapeutic potentially the useful with cancer, treatment. do at one who had cannot chronically patients UGN-XXX to be reflects using of of grade and their emergent the three primary recurrent of urinary all the paradigm-shifting as once data low adverse currently who and Olympus the Of and patients is options. We offer those moderate view had hard additional cracking a long-term all low-grade contemporary for patients rate UGN-XXX therapy. a maintenance and particularly rapidly visualized These XX-month efficacy patients. maintenance amount we and and for a only additional whom the more for included fair disease UTUC design Olympus program at note, to and be aggregate, for completion data response to to We that with the available therapy and will would been real-world use encouraging remiss approach supportive after AUA. technology. The practicing compassion date the tumors CR predominantly use would months Olympus candidates the events program and use the were have in confirm number a have CR kidney status extensive and patients without the in were with obtained use disease what trial. up mild provide expected we physicians elevation. drawing patients than these tract from results treatment of evaluation. trial, infection, parallels compassion achieved believe of flank to achieve not cohort from I safety of could UGN-XXX months median XX durability the with enhance aspect to and and date be enrolled pain of results durability ITT This between

ultimately quarter We week the forward are to for first of of UGN-XXX filing next the looking the potentially NDA AUA to presentation XXXX. in and the

UTUC AUA the panel discussion to investor Stat a on I cancers. Ron urgent be the the moderating of in and key bladder a an conditions oncologic need event to low-grade the leaders uro number opinion with treatment at addition educational will with collaboration reshape mentioned paradigm including and In across news

observe FDA as first-line therapy. a by have standard invasive and adjutant the benefit and NMIBC tumor we pipeline to low-grade platform, have been bladder of approved advance for using drugs ablation of injury Based been TURBT strong three the and submit continues to an NMIBC to represents we arm innovative chemo NMIBC patients anesthesia UGN-XXX surgery potentially is in standard to followed adjuvant indications and by is for grade an data treating as and which drugs approved from of Phase an FDA XX% tough to to is treat in rate, primary treatment RTGel such transurethral associated non-muscle IND unmet low chemo of No the immunotherapy. anesthesia or or Xb our Our the XA resection or light coming of important and single trial in as disease risk disease UGN-XXX for can low organ The Phase that label study start by as plan TURBT for post-operative with only bladder other CR a area non-invasive we and shortly or thereafter. months bleeding. cancer on UTUC from open bladder care need. look

in X RTGel bladder. The treatment to XXX with partner have enroll an UGN-XXX, and anticipated overactive are intolerant to trial up inadequate patients Botox a pharmacotherapy. is combination bladder UGN-XXX overactive incontinence Beyond urinary in traditional Phase for with of enroll or response the continues trial to urge clinical to, with of who Allergan patients our had

oncology our immuno candid for Finally, also UGN-XXX product we are advancing VesiMune.

the formulation our XXXX. a now evaluate UGN-XXX preclinical single review of agent UGN-XXX we single installation demonstrated planned Phase for A continue the under briefly the a to of for as the turn call would in treatment novel financials. look in IND to treatment with trial and proprietary And Further Xb for in clinical checkpoint agent of coming over immune forward in clinical this to situ. the that to our in this conducted for in development We updates UTUC With combination activity program half I models. of is months. first sharing study to imiquimod gel preliminary carcinoma high-grade bladder of Gary combination the inhibitors like

Gary Titus

support call. all efforts morning on for planning programs get potential of clinical preparation of in Thank and in you, our you our is development UGN-XXX Mark to and to advance well-capitalized today's XXXX. UroGen further approval US commercial

closed proceeds shares next months. we in fund our sufficient million planned public the of first well end of XXXX As cash the equivalents. million in of cash position mentioned, will for approximately beyond from in includes completed our the common XXXX. cash January Ron a quarter operations to $XX.X quarter with offering and This We $XXX.X believe net XX be stock

reported UGN-XXX a first to includes XXXX. of quarter net expenses loss of million million share. first the development quarter million, the This million for in million General associated XXXX expenses. $X.X loss $X.XX per The to compared based $X.XX with in includes in compensation in cost share XXXX. million the increase expenses of the trial, the direct and increase share XXXX increase to an non-cash share quarter $X.X for in includes personnel increase administrative and non-cash $X.X based same an For of per quarter March March compares compensation were of $XX.X XXXX, the This for for net and And non-cash we approximately a X net reflects million ended to period $XXX,XXX XXst, expenses. the XXXX. share based Phase or of based $X.X costs were XXXX quarter compared XXXX loss compensation first or share XXst, and loss as ended And $X.X for in million in $X.X from a Research $X.X Olympus expense. compensation.

approximately With As that, I XXst, $XX.X the for XXXX, now like million to outstanding. of would operator, over questions. had call March we ordinary turn shares

Operator

from Jefferies. from comes first Instructions] [Operator And Matthew question the Andrews

Matthew Andrews

for on you MitoGel lastly commercial me talk CMC on Hey, you in And can where us on QX Olympus? use MitoGel? Ron area, scale for talk follow-up then and And call enrollment can can are about A the Two; good may MitoGel. you publish you for commercial since update the morning. you timelines compassionate when about on those data? CUP. couple the any patients update on long-term for Mark

Ron Bentsur

us? hear you can Matt,

Matthew Andrews

Yes.

can. I Now

the did Sorry come questions through?

Ron Bentsur

want They I of all them. just I sure to heard did. make

first one MitoGel the was enrollment. So

commercial that CUP one one a and second the right? follow-up, The was was the third and

Matthew Andrews

to MitoGel considering tentatively in Yes. you Right QX. where plan with factor the CMC on you CMC, file

So where that? with are you

Ron Bentsur

Right.

study. in the enrollment of MitoGel So an terms into

the So we're the progress, so that the FDA, type sure quarter conduct for meticulously most for very the filing is make important and for the nature The including to of in the on. a much study way very everything do is is study. agreements that of MitoGel with treatment we've terms for first can the can a can you us protocol that what's are perhaps and moving confident done difference great XXXX, I all in track are far, well impeccable of low-grade obviously type you this in fact assure and making in to make so right, for per these adhere patients we an really data along conduct, in on the and that very this strive NDA we the of everything given change and always a are we the seen of And UTUC. everything and indication, thing of study, important treated for today really paradigms terms remain

we in shelf converging to third outside because to party the the the third a Regarding road. mitomycin, It there's to off for of because we're is ourselves more to with it timelines manufacture to we continue we of we're mitomycin projecting NDA CMC, potential buy which all thing go very sold. additional have - obviously to now, mitomycin think Right mind just a that if ability degree as the as very that that of we But one a is drug. well the party for it the use CMOS is buy it progress we filing. that go and freedom have I'll for Keep marketers of manufacture to the being to of if generic existing have the we effective to. obviously, down manufacturers manufacture going good gel, always it's off the CMC, the cost to nicely is coming it be shelf make along through us one opting and together call

bit we've overall good but of think very a little the got there, I on we're progress So flexibility CMC. making

Regarding about the you asked to be compassionate the the manuscript data that is use going program, when published.

to going be finished. is manuscript that It's submitted soon. very So

the alluded within program available. the to be published a use publicly One Mark finally on that next think are the several hopefully made and compassionate complete So way as patients And is out plus there's be north follow-up call XX three can this we eight out of months I have manuscript can it the of months. XX patients months. out responders there from

it So to wasn't to power we're of to use compassionate these up Hopefully, do be per given continue patients. se. follow we're able the protocol going program, to as nature on continuing that a

way a have So stay north picture sites seen and XX a see But retrieve we're with months the goodwill able hovering far share three pleased are little from looks it in favorable perspective. to far can that again patients of to bit information. we've with very the remission. been our that pretty the so Again we're obviously there. by lot information patients overall how that out results median of we and and of the on continue the so to But keen these depends far the willing to

Operator

question Benjamin James. comes from Our from next Reni Raymond

Unidentified Analyst

Hear Hi, for the in on the Benjamin. morning, This quarter. progress congrats past me is okay? so guys. first Good And guys. [Bindu] met on

made data that today when and safety and MitoGel. and So just question Mark, efficacy the commentary you're for with you Mark pleased so seen with quick the you

seen disclosed couple wondering was that is from follow entire the data label or the Then the data was ups. an that of Olympus given date So made you've to based study. I abstract because have in study comment open if on I'll

Ron Bentsur

as he Yes. of team. in you little abstract perspective. to right saw we provide the obviously includes Mark a all on safety a the the the the for bit that I'll that terms endpoint. Mark date get in for his physician we can data the the to refer is that I'll based are management time what patient the say patients the after But a And obviously. ask now urologist couple points because than more information that and all sentences at is number - and study various And data primary in the then to is

trending can in more than very from it So go I but Mark. what's is more pleased. be abstract my point say couldn't all the just I vantage and ahead favorably It's

Mark Schoenberg

of what types we're and mean trial toxicities I with - think thing of to away watching that Yes. the type that delivering is unfold consistent And in take not things the seeing with what the we're you're therapy mitomycin. you'd are with or morbidities unusual. is what seeing we're we're from consistent seeing I this that completely see the the of administration

practice investigators this what so carefully are with our getting patient. And And the very of problems and we're realm within the happily well good for neurologic results are all is considered expected minimal be far so to these patients. following

hopefully favorable. continue, very trend it So far but that looks so will

Unidentified Analyst

Got it. the my second question on and then very presentation. is AUA helpful That's

So more the we than going out see it's from Is it it patients to XX? or you fair mentioned patients additional assume would be XX additional that five the to of patients. be data that

Ron Bentsur

going exact of to think amount relative there's time six more. what to to There's a And the don't the information, only It's be we out six. It'll going to the month again for number. having which six remember was I points of more be durability. incremental six relative N I - at also of around abstract, had three maybe in five fair be an importantly

to on be versus was be amount additional information in itself. abstract what So front durability included the in going there will a presentation a the fair of there that's

Unidentified Analyst

on was RTGel may I it. Got if one I've question the helpful. it's That's platform. last

are development? what pipeline now that secondly I lack considering we bladder beyond indications not you we have because are existing have other is the other to right so with the indications a of that especially the MitoGel beyond positive we've time. in well but was then in develop drugs seen preliminary data products product, wondering products short any if other of for drugs, So Thanks. cancer can or reach just even for where And given we it have the possible through dwell far well there's working

Ron Bentsur

Mark question. you want to take the

Mark Schoenberg

question be you examples that very us can this is interested bladder we exploring we you've opportunities surface are before, heard what diseases applicable I or and program program quite great think a affect the to broadly a certain of kinds platform in because that are course all of. additional great say as of It's Sure. the think epithelium, which is UTUC

So we that. are exploring actively

useful. a R&D have this organ looking robust We is could various imagine systems would very you group and where that platform be into applications

So would near find we'll without deploy we optimistic actively to that. that future. belaboring other and And platform the opportunities we involved in are the I in say are

Operator

following Our Peaker Cowen. from from comes question Boris

Boris Peaker

good morning, Great, guys.

get So into long-term long-term it you mentioned to I'm some drug. patients maintenance label? curious what actually maintenance would take the are getting just the of

Ron Bentsur

that in drug protocol, so I the should patient So that monthly that the that maintenance support part the who they'll is durability. therapies so the a of entitled the of instructions complete initial additional if be trial the that response believe the clinical That six itself say be receive to to patients monthly weekly XX protocol administration may going receive to up at certainly patient to and fact installations basically has achieved basically XX installations. of given achieve are And is part part we above think part maintenance, label it's that of response a section. the beyond complete a even

intent protocol if chance before will part good the go started. the we the of On to study a it's the wanted into that so itself. wanted to also ultimately and agreed going again study. part was to part label So the of this that improve of protocol all the hand we it obviously by There's into be the was obviously doing certainly one durability but

durability. additional that's of monthly behind went So for into therapies the the that XX rationale kind thinking the

Boris Peaker

out consider with FDA Did see discussion asked And in discussed? in or your the regarding kind in we of a of this number agency label that of a number kind of want of strategy. the was a the to months certain patients X officially order minimum to not really this

Ron Bentsur

obviously endpoints is not That we and nothing, as robust. going in no and And maintenance numbers the adjuvant therapy indication all six No. but practices. were that to secondary be kind anything is more of urological north discussed. that mind officially above are in of was things exploratory merrier, believe for and this of right that, anything These very part endpoints example perceived discussed. the specific but like standard an keep that And months therapy

well-versed So these going introducing just very things they're something the that we're practicing at. community the to format and are not already to unusual essentially be in same

we obviously part to same in FDA the in bladder. these should now the again these why want as to this aware no be very So urology is introduce that the believe if everything reason tract. all goes of situations label. are going on And to upper concept there's and And all adjuvant into the therapies particularly well that of not

Boris Peaker

Great. VesiGel. my question on last And

X study would clinical required be it of path? would and what time it the Phase or randomized get like require Just line two to to that regulatory a looking Phase X be approved? trials beyond simpler kind curious what's mean done for the on can I this

Ron Bentsur

X it's as that months we the the for speak. it about And cohorts Phase enrolling the Phase seven or is of in So third believe. They've study started we from as moved XXXX believe know data six is you ago. up ongoing to that already half that X I timing first cohort

nicely. is forward moving So it very

Phase they should from XXXX. And see of then data projections internal study our in first on that based half program. So start X we the will a

and have of because We in approved need and one Now indication is it may already controlled and reformulation don't can't speak Allergan, they behalf And it not that. yet this question answer essentially what but to Phase adequate does their your Botox Is all regarding either. the is has the look a on part have like? that it that the I second too question. to Or studies? well X

that's works. of a us see some works think our be that going clinical successful obviously that's in and But there's use will be. on above for the X, it the a But they're today it'll if perspective it believe no we your beyond data it running validation outside X the potential think why I it and is provide the be of Phase from it of to oncology. what still shouldn't for strength to I but RTGel and it if is seen if dependent have of reason to why immediate trial Phase

we're looking that X which mind And $XX X that Phase X results that will to that be start successful as thereafter also milestone if million, well. once which much us Phase a keep receive triggers nice Phase to very in a payment the would start shortly to So going from they very to is forward be the study.

with other can nice it's we're this the of have compound. And story I know it's doing today. of a compound what for validation with succeeds very So world what to hands beyond If in for of bodes who best. in with technology type think really it a the us. do product the thing type a really are this this we this leaders well And folks it dealing

Operator

from Gershell Leland from comes question Following Oppenheimer.

Leland Gershell

to your you upcoming qualitative. any to with want on that. you're Hey, provide clinical that details to any thoughts Thanks regard color the even more taking Switching with with then to ask on I my to any preclinical related can can further further inhibitors? share models combination for regard checkpoint gears And good if doing you with morning. that program particularly work if observations just question. And work XXX the

Mark Schoenberg

program a as the data high in with high for situ, grade who bladder disease. activity fact have we this Xb us bet BCG experiment is carcinoma grade failed this novel did in This you're therapy interesting imiquimod formulation saw patients aware very Sure. that called in we have cancer in from I which non-invasive predicate had in because of

we what obviously very agent piece to context would and this high is the only an urothelial have our agents a So beginning active for of using disease, against grade us this high because immune are to very it is about not We is grade to approach appreciate cancer, that but is platform. disease much now we intriguing against and active immuno active of against oncology. within know regulation that interesting deploy information like

have low novel no to to those what formulation model combination looking believe been contemplate activity surface is checkpoint us that to at we high-grade imiquimod would would without tract setting of data beginning imiquimod from with develop a And we of the it in a gel lead of a to get therapy experiments topical where protocol very encouraging single the example a urine which that that would to upper the doing formulation in for are and end we So working and and are we're with there application possible a treat UTUC. be analogous disease, grades oncology what very in make immuno immuno to oncology inhibitors.

now that going interesting data. clinical So explore preclinical a I the gel And we platform. think using to have we're idea develop that to start you do possibility program to very the get

Leland Gershell

just we regard then question rest Thank to for I should numbers the with Gary that. perhaps comment G&A how that or regard for this $X about rate the on quarter. one to of for in even you coming year? wanted a as run just actually million And just the financial

Gary Titus

Thanks, Yes. Leland.

a be should really so at for of current public a company And us. you not run that to consider company think more rate private back a year looking obviously so comparative. I it's

ramp doing the focus key distant forward to we for that future. ramp continue not for that are MitoGel we that in mind look will as Additionally, continue commercial keep a is to potentially launching us up a in up operations

Operator

Thalmann. from Ladenburg from Kaplan Our comes following question Matt

Matt Kaplan

guys. Hi, good morning,

the guess and response Mark, given durability So help the you're looking question first rate the the terms us Olympus in of understand in of for I rates of about overall hurdle hurdle /a in complete guess space more talked for importantly unmet then as well? I a need trial terms response that also

Mark Schoenberg

you. thank and questions Great

green we've agency given pretty when what to them we by to the this undergo therapy treat be patients the this advised clinically urologist currently really with recurrence discussed design this community talked a disease that with are is was disease. are a you we a patients available and endoscopic rates by year. can recurrence therapy for to surgical pasture or only very amount fact of think would that know of obviously endoscopic to with of comes used of were XX% this this idea from the the I medications that FDA that surgical the many come as therapy available these therapy pretty meaningful no there kidney before to be we because control trial we also and and are considered control to the outcome. and a their to of flavors, mono practicing surgery the kidneys surgical the disease, bar as what So consider what our we have platform Remember, save about And in and therapy for order XX% anywhere decrease to dedicated this in two removal, have to low disease its

see currently XX% we're can on from and we're as above analysis, data targeting interim for success that. you our have a well we So the we're based hurdle preliminary

we of interesting nine, believe month induction the to but durability, term week certainly be very that get FDA six, we these to with think which which is So just the long not clinically on our to use control, struggles to And we have I to disease intriguing one already patients about currently. conversations we suggesting take question can for twelve care second community, but also only weeks, data urologic with rate the CR from per even data have very six durability will FDA. respect compassionate the the program your very very meaningful dose and with based a therapy

Matt Kaplan

what I thank the of helpful, the to the filing study hurdles Olympus module? for Ron you. are very That's NDA beyond the quarter first completion And guess - the in filing prepare for to other

Ron Bentsur

to to are you there NDA the various terms complete will need submissions involved of that the that for integrated we complete of essentially in have mind the need that pathway, The that section. terms we would all know filing that efficacy XXXBX the get obligations reports a in clinical this that Keep we clinical in that are would the undertakings get clinical the filing. as report because in will obviously So and completion some experiments go done regulatory we modules that to for various Phase X otherwise discounts its upon going the safety and conduct. is study do into a need to

mitomycin been were get to like number for of for genotoxicity things has approved things all now all that a going waivers because and For and example carcinogenicity is that. those years,

have in right summary to we're now preclinical need lot you the But on and you meet So on imagine of all a believe for of can't most the the finalize first There's effort and help reports I need lot we on done really finalize important really parallel overriding, what overarching NDA the now. all that on a we is you that submit. converge and company. making that's the right up packages, and vendors and not study you and CMC we're sure all that. as package it's very everything think to is the little kind filing, why of it given reason side. on already side, And all CMC once timeline everything seeing you fair it's already. going milestone it amount week. a report about there's take all converge bit can as These these but you on that try no in that to a go things of do really electronic on also engines clinical know clinical things else. this into the that quarter That milestone started a that's writing time, to having all the just And being trial do require the right should it's that, done focused There's a then

Matt Kaplan

Okay, are? to accelerated things it filing here the a review accelerate bit pretty the very look and little where seems preparations potential then quickly expect can good. And quarter about and talk first FDA in your like then with are commercial going for given

Ron Bentsur

Yes.

obviously but for to starting modular So to on because commercialization a touch and you key it fashion, a terms of we started of important seeds bit to pieces Gary want overextending plant we're in do But hires, very want place. a to without starting some it right. in lot put little in things you time to were

of months commercial Marketing, that for is hire hired Director So as sales example, pending. several was you remember. the VP ago of director of access, probably payer

The positions of that's key So being I fifth Liaison five the next. Science we've to already hired going four need MSL, that really you managing to a out come organization. start one commercial say would Medical

So we're starting place. to put in all pieces those

talent on it. we've we're And tremendous those to some think I really hired forward looking fronts.

here. to be I a slowly, think going we're And of very have going timelines kind strong And but going gradually jumping filing. the without it's to the NDA trials. team, all to clinical it's again of with the ourselves ahead done of coincide

Operator

comes Jonathan Our following from National Securities. from Aschoff question

Jonathan Aschoff

enrollment Hi, third in now to unlikely and that Phase but about for the left the the you're saying stretch data just is adhering saying guys. ask I data quite much quarter saying hear to you X correct? Not Xh what by but the protocol

Ron Bentsur

over all is saying we're which on we to been efficacy. finish agency QX be the to how XXXX going got to believe that ride on best filing trial. a of from what we the saying is along. is the explicitly very NDA way criteria were works enroll with that the a patients with get drug specific much we what are approach Actually designed which this is the protocol understanding and of what clear we developed And track line. and FDA that in we've adhering to. we to very And that doing that we're us this continue strictly could were so We It's

we're what doing. that's So

Jonathan Aschoff

to in other about focus. curious work is VesiMune because or your inherent and UTUC is cancers the it company? that of oncology was versus there are anything I likely You direction just Okay more makes that

Ron Bentsur

that cancer, VesiMune actually the but VesiMune given for can the these an bladder familiarity of setting. in high-grade I'll to Mark happens data very a that landscape we We given believe treatment high-grade So the the over work of preliminary we I in have of respect UTUC the format UTUC success. think clearly and considered it on to low-grade goes believe that UTUC with the can well. believe keen obviously that of It's indication. work so setting right we really add that aggressive we interest do maybe in what start area that in form is with in had as very patient we've time And experience developed indication. indication. And obviously chance that can the sequela in patients well carcinoma is finding and an to that matter in all then situ, we've that we right the it just also in saw what in the that basically that understand best this also And give and that

and bar bar we given all the the that company like want and kidneys we that small with that immunotherapy indication prognosis can We believe information relatively we maybe up center. So that reasons, for forward. and we are come that we help some and getting going it to now need. the right the gel, set to these But right other for that there's potential you we out taken these as in to with medical try the sequela combination low is be all and obvious all - of the that definitely a path that pursuing. single best Is really the testing And clinical are the left us believe are or maybe ease a it can believe and is orphan is there as without - indication, out unmet in things the agent. gel example things it are with interested pre-clinically We Mark

Mark Schoenberg

No.

add very poised able advantage we're to emerging data would is answer. And in very, there's I I urothelial TLRS intriguing think take with to very a be of thing only comprehensive that's think combining cancer this I The that. checkpoints.

going interesting an And biology there's explore. looks that So we are intriguing and very promising. specific to it

Operator

over I at closing the call will I turn for now Bentsur to showing time. UroGen's Ron questions back am this remarks. further CEO no

Ron Bentsur

event meeting And join to you'll data presentation. thank the us next behalf for to the on many operator. the call disconnect. field of in a of may support. to on the trajectory AUA you, your to hope I believe San forward your everyone taking able thank join we're seeing look of UroGen Olympus be at becoming time Thank to dynamic the want Operator, in leader a On and Francisco the us you now our you We investor oncology uro you We annual following team, week. urology. for that today. for

Operator

Thank you, ladies you and gentlemen. This today's concludes for conference. Thank participating.

You may disconnect. now

UroGen Pharma (URGN) 15 May 182018 Q1 Earnings call transcript