Athenex (ATNXQ) 7 Aug 212021 Q2 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Second Quarter 2021 Athenex Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I'd now like to hand the conference over to Tim McCarthy of LifeSci Advisors. Thank you.

You may begin.

you our thank call. and morning, for conference joining Good of Athenex' an well results Today, quarter provide on for business second financial we will of update as review as the XXXX. a results crossed news and available the on detailing The website. the is release company's earlier this wire morning the the A this on also be will of website. replay archived call company's

in review SEC, and the the statements. call, the business forward-looking forward-looking We or events, future regarding those that about conference company financial, or XXXX During including the clinical company's and fiscal with to from past and the results encourage which may you anticipated filings future actual milestones statements events beyond. the materially in will make factors to year differ identify specific statements described cause projections

find by Jeff Officer; section I call Officer; website at Athenex or in for database Chief the You of and now SEC comments. Kwan, Dan after Rudolf Officer; morning, Johnson our joined Executive Operating Dr. filings Lau, Relations EDGAR Mr. we in Investor can Yordon, at our Dr. Chief Sze, answer are Officer; the will Dr. prepared This at Financial www.athenex.com. the Johnson Johnson? available www.sec.gov, Chief President questions the remarks. Randoll management turn to therapy. Lang, be over The cell to Mr. team will introductory Medical Chief

to developments Therapeutics Athenex have cover of Klisyri recent the paclitaxel in in ongoing of well as we as an at important the second build acquisition, encequidar, cell presence I is several the were Kuur the therapy. which oral I morning. this on to a There part want would plus ongoing plan FDA the with commercialization that Tim. like you, to Thank made progress quarter discuss

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the of study and the the present year. such that clinical now a we working FDA conducting option a to plan study are for design later to We evaluating optimal this on new

We creation we we Kwan, the course, can very there are conscious, about our will and is capital more there for Officer, requirements. of provide Dr. that stakeholders. viable, on path our a later. Rudolf will some time Chief details and value that agree be Ultimately, is hope Medical

oral clinical the that very paclitaxel compared that demonstrated has and with offers position chemotherapy in to believe to breast choice paclitaxel. of it cancer. efficacy as strong intend continue metastatic approved, compelling safety it a If We superior IV we profile and and

in main later. breast keratosis Almirall. Klisyri partner, and trial. the to progress the in therapies. and the the payer by additional led on provide their our the other ointment, gaining Almirall microtubule on Their U.S. provided actinic coverage pembrolizumab in update more Again, U.S. treatment is at launch sales strategy with for study, As it inhibitor focus recent that of study combination includes this the February, evaluating our launch will in have other or details programs, most is remember first-in-class metastatic indications or in This Kwan for angiosarcoma in with drive the important face launched our the ,our call. we earnings consider to we of an scar, indication, cancer tirbanibulin Dr. oral I-SPYX volume. the on point paclitaxel combination

existing new ATE gain has market for the associated given been therapies and market. Klisyri with highlighted positive. share in side feedback that that see that to dermatologists effects. from Almirall delighted therapies significant are And to the topical like need We ours continues patients

are of to has Beta the America, Europe. plan over a now an major option this term, near the in in from innovative developed neuroblastoma important North X as Europe, approval additional New Klisyri Australia Medicine. well around licensed Pharma Athenex presence clinical China. College year. preparing XX and for next license more additional is the as that the potential Kuur the expand and melasma announced and pleased for the Klisyri. we part new Europe the a Therapeutics. Commission European the Canada. Japan to has patients. patients strategic commercialize allogeneic NKT disease tirbanibulin hematologic for acquisition AK with milestone second recently partnerships in expected for another launch technology the markets, including to XX In we to platform May, to Australia, Athenex from solid access have in Kuur based more readouts is is market treatment We agreements Klisyri received and attractive signed These market of and global in In first-in-class data in Almirall with the acquired product cell a half Seqirus, assets CSL, to This treatment new therapy Avir world. partner to potential of in on agreements and solid for data provides We a months. place develop subsidiary of our July Almirall also game that that and report will to will bring in Zealand,

promise treatment since update discuss. to with also a the Cell being I medical this to therapy patients, discuss holds of increasingly is the allogeneic cells game in Acquiring recognized on progress cancer. our Dan cell is our for tumors. becoming an a and in there and President a made to move an the made their Dr. Lang, update cell opportunity TCR-T also Kuur innovative Therapy, of changer Importantly, acquisition. therapy provide NKT we Athenex will management our want of There's a mission to and strategically bring treatments important scientific communities, combine with Kuur in cancer solid is Athenex consistent

We variable made return to have that a Chief a with been the of that Athenex. well to $XXX.X Randoll hands. XXXX in sector. the position. take will quarter search Sze, Mr. with second and the the will CFO. our on Officer. financial him is capable in has to Steve decision Athenex has initiating our he Randoll has the Controller, his member leaving want contributions is for of given Corporate meantime, was role wish with Steven a next been million. Mr. formal aspects Financial thank be We'll us of since very business. and financial his team, replacement very Adams, of all Chief end and him for be function The Officer, announced at I Randoll a our notice In Cash has interim Accounting familiar

As to conserve continue and previously, efficiently cash. carefully stated very about assess how we resources our utilize to manage and

to financing Our programs on to in [indiscernible] you we business. growth for potential opportunistically, options prudent will cell current our cash supporting maximize are learn while review management, APS/APD our priorities discussion our and financials. a the more Randoll continue as our therapy Coupled with from

Dr. our will and our turn scenarios maximizing the over Rudolf all to remain Kwan. for value for on evaluate With I shareholders. focused business that, will call We

Thank you, Johnson.

and held FDA to A on the to cancer. meeting The Let well-conducted used oral extensively time Type we paclitaxel. me oral may metastatic in on CRL. encouraged deficiencies They some discuss the in FDA address provide was the supportive reiterate and our continue with develop more trial this prepared paclitaxel ahead us adequately deficiencies. that raised breast a We the detail to meeting of

carefully data thinking want are we about of new overall mentioned, year. Johnson survival this a trial and As the additional collect design to

We around trial the quarter. that the a time. ready that design be We we'll update share our to fourth to plan expect further provide proposed agency with in

indicated, our intend also the a in angiosarcoma oral are registration Jonathan pathway we prioritizing As program FDA. to discuss with paclitaxel and

Phase in II enrollment of have trial. patients We XX completed ongoing our

paclitaxel Orphan data a at that received disease at reminder, reported interim time. oral which response has rate Designation. is XX%, the options Angiosarcoma last and treatment and we year evaluable respectively, As XX the and partial for patients Drug with ASCO of complete in XX% a showed limited previously

provide we an FDA clarity from next have will We the steps. update once on

of results to dose-finding Virtual in Phase ESMO at September. taking will tumors, presented be in solid our the pembrolizumab in Conference study study place study oral I this the paclitaxel with from As combination

Our e-poster been presentation. for accepted abstract has

We lung patients. cancer of are cohort a into currently patients proceeding cancer the for gastric into phase plans of the this study with expand cohort of to expansion second

neoadjuvant Lastly, on is and would in well. the cancer, update on now our oral this breast cell an provide Lang being programs. and Dr. paclitaxel in combination I-SPYX treatment GlaxoSmithKline, progressing trial, studied trial therapy Dan ongoing with for is carboplatin I let in dostarlimab which

Rudolf. you, Thank

therapy. cell a of Athenex major capabilities Therapeutics at Kuur in world-class acquisition of Our to strategic part build initiative was

potential attack cell what are NK potential by TCRs, limited have cells classical is tremendous NKT NKT because improve GvHD outcomes the in possess cryopreserve. GvHD, cause to tumors of properties and cells NKT cells We may expansion and T can prove tissue, can in clinical the has which also well making an expansion excited the NKT have exhibits cells. be achieved technology than believe solid following the technology vivo, and therapy Unlike that platform to cells excellent have to better stability Conversely, could cell We them NK the functionality difficult CAR-T potential, risk that tumors. by typically solid therapy. first-generation T landscape be both vitro and minimal. and cell been render positioned our of NKT ideal in or following attributes to cryopreservation. cells conventional to NKT cells cells hone beyond don't activation and

a bridging and systems. synergies Lastly, role propagating benefited smooth the existing acquisition, been NKT response which image has adaptive in cells immune there amplifying Athenex integration and infrastructure. the cell announcing therapy operations, by has from played of Since immune the with an and team important the the

us the INDs and of actively convert meet been is Kuur working of cell industry to have the requirements current an at sites center complete. construction across IND, which in expand all allow facility to patient accelerate up multiple to Baylor Buffalo single manufacturing study regulatory We and enrollments. our will trial scale academic The

studies. study refractory with running cell in validation begin of to [indiscernible] batches therapy year half product autologous I neuroblastoma, Phase expect with the currently I or the the capability the as aim the relapsed in is trial. KUR-XXX Phase second of the patients in known support a to our We having

cohort and or the patients evaluable and leukemia lymphoma with as pediatric neuroblastoma CDXX a in trial. We refractory known where total this X disclosed we ASGCT, have now up response data out partial stable one response, and complete We patients out recently cohorts. product, with to pretreated our trial relapsed evaluated one of the I of presented Phase patients. a being disease heavily allogeneic XX is of level in at dosed X KUR-XXX, X positive ANCHOR

disclosed we the one response first As Kuur and treated at the one partial we the complete of observed level. at patients in time lowest response the acquisition, X dose

therapy with tumors cells NKT In the XXXX. through providing excited I summary, abstract platforms the TCR-T We in the which an Because NY-ESO NY-ESO-X In future. I tumors. clinical express in merge and can to this community. include of on at plan enrollment look the product, solid over cells kill with study will screening our are trial carcinoma. studies meeting. have cell there on engineered and to antigen, study, platform an NKT IND targeting clinical will testing this turn Athenex, with and be generating cell-therapy NKT TCR Phase data and KUR-XXX, therapy TCRs safety our our the to our to and we the are of clinic are initiated expressed are with the high-affinity therapy GPCX begin will will and is about is more TCR-T. to our in transformative be transgenes, data anticipate and TCR-T program, submit it which now allogeneic and cell new activities news ongoing important efficacy an we variety quarter. opportunity cell The to likely high-affinity on submitting we to candidate Jeff. sharing two autologous The significant patients next expecting ASH this another We annual We one enter forward potential hepatocellular a medical

the you, We second Thank in Dan. product $XX.X XXXX. with quarter QX $XX.X million generated in sales compared million of of

the a we countries X is for to there the sales million was QX between revenues and As in in $XX sold that nonrecurring the out called in XXXX, reason difference other major previously, quarters. results

In there addition, in challenges a half been first of have supply chain the our significant in COVID-related in this China. and, Indian lesser year, to extent,

The of half of These factors currently both APD at new in time. Other to drugs in pandemic these India fulfilling treat started COVID the sales cases introductions, will few high India APD potential will XX with demand were product from revenues the APS, demand improvements had of and Athenex positions our that FDA higher Construction the we amount and Solutions increase a wave certain product of Pharma in in period sales facility XXXX. Division shipping as As COVID the the started. capacity products. inventory last XX shortage with and from that sales products in the and products, new we York products factors inventory for SKUs are is for New patients, increased particularly receive that options year were that there SKUs. COVID essentially XX in QX experienced able with of better include Pharmaceutical issues be anticipate product continued sales include to a for fact shortage sales regions improvement result, markets complete. markets China, products. and just product not hospitalize in given will of used XXXX of for in a Dunkirk, company relevant increase pandemic second APS a improves second China, quarter Athenex We several COVID-related as certain and key X

We built XXXX. manufacturing XXXB bays expanded and have there in dedicated for the plan business commence to X QX

over our to will current I discuss turn utilized, clearance the now fully call at facility substantially our to is the Our increase these Randoll and new will capacity financials. bays capacity.

Thank same year. in you, a the product the updates second sales through quarter. will million financial Revenues period $XX.X for I go key compared with Jeff. were from million few QX last for $XX.X

second COVID-related from half product quarter we our some nonrecurring compared our in this orders COVID were and drugs XXXX, mentioned, affecting of the $XX.X receive experienced to a supply of challenges the XXXX, regions. pandemic Jeff also we Indian started, of quarter year. approximately and As In also last we inventories million. the decrease of chains, In for China affected amount by COVID-XX-related first the significant could partners demand just in sales recorded in these

million second an $XX.X decrease which to approximately product cell of secular million $XXX,XXX XXXB these to a down offset partially from and took clinical oral the of costs. a QX, benefit of quarter oral Almirall totaled upon compensation connection same same the quarter second received launch, second in were paclitaxel U.S. and the a costs XXXX. was R&D-related compared preparation year. revenues, decrease fees occurred $XX.X In in Athenex well $X.XX revenue. $XX.X operations. an recorded with to licensing due ago. of million API These as for decrease quarter XXXX in $XX in and generally increase to sales last $XX Kuur expenses For in The This of the million as million, diluted decrease a together costs paclitaxel loss APD related Net tax for the February expense from compared the in million, year professional in we loss per primarily to second for that $XX.X share, CRL a to slowed Klisyri quarter, the decrease tax or for license costs is acquisition as for period an increases recorded to partially SG&A the the attributable primarily and increases in year and a $XX.X This was and $X.XX ago. million, totaled operating increases to royalties million, sales, activities fees increase in and acquisition year for income in the regulatory operations with product of in expenses in included preparing the of compensation-related tax costs the million we on net with therapy other increases an its Cost second offset from decrease in $XX.X drug line by The related in was R&D other due receipt period and as costs, development. current The $XX.X million primarily income share, due for expenses, diluted ago. in costs, cost in in expenses quarter launched commercialize totaled per was by $X.X preclinical was in items to significantly a XXXX. versus benefit May. place down sales or

In terms In of international result product revenues We limiting customers a nature. Athenex amount the not recorded global a we revenues to pandemic. in existing guidance, do recurring guidance only. of of product we as as significant these as are portfolio the sales XXXX, financial from before, see

we XXXX, excluding While line on at now to in that we guidance provided same affirming be from and sales we to royalties XXXX, XXXX continue product the expect any product portfolio, with the expand our levels. time, X, in Klisyri sales are May currently

XXXX, investments XX, CRL expenses deferring include cash receipt FDA. from As year, slowing cash short-term the have certain $XXX.X in programs equivalents, this of cash, clinical earlier had CAR-T the cash of and we more started after which putting Since Athenex and June we commercialization-related have preservation restricted place, managers down million. of

XXXX. a cash result, we will us our believe the into quarter As get fourth of

with and as corporate Athenex all to as a to to our partners to treatments. see Board my during period been helping the grateful have a mentioned, tenure. investors very cancer my and innovative Johnson milestones. of as advance worked to been have I in as it And major I'm Athenex. of Finally, been and well The the CFO. number played team a bring past and management has has tendered evolve market especially role rewarding have have company achieve resignation tremendously exciting X at opportunity for years great It

XX, on be financials, further For to the Johnson ended now I months with XX-Q refer closing I the details including filed will results to turn for our call to you our Form comments. back for XXXX, the X June will SEC.

Randoll. you, Thank

heard As from team, value. you at create are a have opportunities multiple to there the of and other of members the lot today developments Athenex

We running best our activities. in overall determine careful and resources. all divisions of manage our and to will be This business scenarios strategy about with tandem on across evaluation are are how to carefully thinking scientific our returns of

to has work on deficiencies we continued clinical an the to breast Regarding some oral want in We another multiyear time, be At needs and paclitaxel that continue of in may is believe cancer development. cancer, conducting We the our the and address profile same large significant potentially that we the explore in medical paclitaxel to addresses that designing supportive be metastatic further FDA and that of optimal can certainly are capital. not breast best use updates. CRL oral additional the multiple pleased study look realistic in pathways. trial We'll firmly providing forward indications. compelling recognize

We now for open will the questions. call

Our Robyn of from the first with comes Securities. question Karnauskas line Truist [Operator Instructions]

This lines the as book to sort the time is big the decide any line if FDA terms and the But I additional design trial, And would clarity you forward how of the might the the concerned, XQ you that between trial -- before you as know with? you some a to have need now are Is about will far it. ends you to with the you from in have what you can trial what can that submit are provide additional you help Can you FDA go Robyn. color did settled? a in what it's get communication there FDA? is would a of [Kripa] And think maybe on mentioned on for more you large controlled design?

Rudolf?

is to until Yes. study questions. of discuss the to the Thank we you It FDA. for have -- your chance with the timing the scope premature the of agree

on that the I a say the well-conducted request reiterate the is for of think I safety. proposal what FDA it is. the will that would determine study, focus and basically

input. So before and have we to fourth -- now proposal between intend the quarter, and FDA a the submit

answer have once we your that So Does disclose input, the will that question? we design.

it And question. Yes, then follow-up does. one

patients and at on any how will you on? duration color Can what maybe of expect -- what to sort at So many see we ESMO? would of provide data ESMO what they be

time – course, XX have completed at completed of We patients. enrollment would of ESMO. not the XX And them all of Yes. of study the

will the ESMO represent XX in to quite full a patient XX than expect So but more lot you see subset. patients not

next question Umer the Raffat comes ISI. Our line of from with Evercore

may. I if ones, quick X have I

First, I trial sounds aggressive an to refiling? you like guess, not have a anyway. run do It why

in second you could in well-conducted context various making signal FDA divisions? neutropenia been first I what So for febrile you XX or in have weeks think in Secondly, decisions from the this because the why next do other in of data year? study I the recall. do do you interim not have was that all mind, has X And ask half

that So in finally, sort competitor then then run but I is commercial which very the true just issue, not trial but against of And for you wonder more wouldn't really fast? I midsized have positioning. study, is market, not commercial regulatory reasons, versus could ultimate to capecitabine, regulatory importantly, reason for And a whereby the to too, yourself you feel the solve study, a a which run why capecitabine. the run establish reason to there's there's like a

Rudolf? Thank Umer. you,

can you your repeat question? Umer, first

we a discussion more question of is should NDA first aggressive current refiling with of whether consider FDA. instead the The

is What very certainly, FDA and encouraging the Umer, indication. we supportive U.S. breast reiterate reiterate of study request that the a all in new also for are in options. They the cancer at development the we looking

consult to certainly, acceptable all be to we'll the take consideration. -- will refiling we whether aggressive one And So thing that but to them. those into is as still FDA with consider, it's that have we

I point. time So that's this all I at think can say

in carefully that will like, the study the quarter, we looking the of FDA that's in study, occur and serious we early, the Regarding that the issue neutropenia more febrile that although you're U.S., be at. second please, pivotal the would what correct absolutely and believe we specify timing addressed have

but timing, the in the of certainly the design, depend signal in important ultimate on part it safety that So is occurring early will correct study.

U.S., Regarding study your... having as the FDA would commercialization. in have Does the the a answer certainly the commercial want, they in eventual indicated aspect, that it certainly

you you have would guess second data from have in I mind 'XX? study this in half

too study. define on that and that design, but is the to could the FDA. that design there scope until cannot depending to It early be it's have really I depends the more results, acceptable And we FDA. go the the certainly, into think I interim on an agreement with

a us have regulatory would guess clear instead to towards relevant, March just maybe say it's likely on randomized out trial I having complete a second I'm should quarter response that initiated submission. very in is, very type was all acceptable also asked trying X. randomized wait not. different back for midsized it is to midsized whether what way, it And single of not or have some was not of time, we And was tell And that questions. trial a heading have of for figure to but we that the trial lost arm FDA sort answered And I commercial. because these for

easy I consider alternatives. different think it's to

an question to where go is the agreement with is what FDA the think to required. I

we one study. the refining new explore hand, aggressive a our On more with

want Phase FDA interpret one repeat extreme, On the III other of program. a the could a

think they and it's them. I is we safety, more on, FDA -- are on towards repeating is they focus with to the have the we U.S., So that study that a focused have clarity dialogue that working ongoing we the a which bit a have say in to not what FDA. well-conducted as -- it and what with and is Sufficient

or -- what way help? whether have lost the go speculate time would time gained I So not that we or to Does we retrospectively. whether

some Umer, add let me color here.

adopting. are authorities can Your sort it's of the year are the opinion, Umer. data. them regulatory questions with And we mean, strategy, your and the regard important in are answers the with actually interpretation their to with case good hopefully second we that that that them but very the safety working some there remember differences case respect I and think are most working studies we that are then best-case FDA FDA always range accept important is to with with respect of approach very next we'll closely closely ideal a of very some scenario, And have overall working resolve by We together signal to to for of think I certainly, we design. our I And half that of question, a study provide. is already the certainly, in

very helpful. That's very that's helpful,

yes. Yes,

So second there's for data. half next year a path

now the But a you then path. I key conservative. -- always that is we There right are thing is very we think as know,

to most only any agreement work and helpful that sure safe will important the opinion make data share is be making have we them always of the population for that We the for to premature with component the with comment have us respectful communication. patients. until in drug once FDA is a good to regulatory And the certainly, terms we to and together opinion it's is authorities' and

I be to really respectful. think we need

Makes sense.

the question last by ESMO. to Yes. on that component also want Robyn the about more I is one add,

to study Robyn of extract was that also combination in the with -- ESMO think I be to regard the combination asking in terms presented in study. -- at the

I think -- to was that you mentioned highlight on combination other the asking probably study Robyn want regard that study angiosarcoma. the on about? Rudolf, do with the to that Rudolf study

right. Johnson. All you, Thank

And really about sorry study. other the thinking for

dose the up patients And cohort. altogether. in ESMO study the include is presentation pembro for the that initial all study, will around XX-odd So expansion the

first that as we see So planning to cancer, the the the we currently cohort. you of cohort indicate and from expect cohort expansion initial of second study, all are have safety of that the gastric lung gone cancer. data for and And activity we into indication

be activity -- in will So escalation, cohort data safety and initial all those presented safety on initial ESMO.

as the color. Allow and quick will be one Certainly, anti-PD-X to some to monotherapy. data Thank to Obviously, patients of were with in oral those will any question will Umer be we whether we’re previously regard well the and with more meeting those going efficacy add data respond paclitaxel it whether answered nonresponders. be you. me combination presented previously with have both provide to who in these will anti-PD-X Robyn. ESMO any to to of anti-PD-X questions patients hope the fail analyzed, to whether regard I

question with of Markets. RBC line Kennen next from Our the MacKay comes Capital

Really U.S. trial, U.S. but think entry of the which a trial, of III what neutropenia. or trial simple result sad study Oraxol's managed impression from goal understand can a is. an Phase And population in in sort on severe obviously, surface, second same hear your but with risk -- patient profile I about I'd with better essentially help resignation. understand criteria. whether can run and supportive Phase supportive which sensitivities the sort versus U.S. whether you It FDA's love just very III care, a could neutropenia the whether to was or the sounds U.S. narrowed that, the the achieved Maybe understand profile me of determine additional be Latin of i.e. on with to the to to the risk/reward American of there's patient spectrum goal guidelines is to when request line for is requesting achieved it's care the in

risk of FDA's just age Can sort delineate that So your febrile scenarios it's something recruitment or help it utilizing might X or for of which those or else biomarkers maybe at be if label, patient understanding on severe the lower you a requested some or could medical which be population potentially just ultimately altogether? or neutropenia comorbidities of for history, neutropenia. a

Rudolf?

U.S. from is the data the is that we the Kennen, from meeting, study that have well from the CRL the population is letter in Type of safety best interpretation a focus from and conducted. a FDA A

generally we address I Does a afford think that generally help? optimal are where is that So -- to design that.

Okay.

more maybe sort looks former Sounds standard with asking managed just understanding rigorous the when care. it's and of what of an safety like care the of supportive like they're U.S. for that

are they what study study basically the for. interpretation in that practice, means are in U.S. think to not looking they of would help that because design kind guess the my U.S. using the is data. the -- supportive intent I the the which them we I it And which study. data center a be of of the -- to medical trying did to safety is any include U.S. population,

would a would that of be risk enrollment those stratification enrollment, sort possible could any subgroup anticipated of And patients provide severe enable efficacy I potentially of provide the be pass-to-market be if neutropenia, in patients? in of backup neutropenia? the patients are a to Understood. is again, again, patients of risk/reward either who supportive risk, include there to know ask lower that because that And goal, of or at could upfront only of at a portion biomarkers that. are for high it as is the febrile on lower shot a we could there is still if those potentially who obviously, risk then Or neutropenia advantageous patients.

Rudolf?

of FDA. planning sorry. into put a Oh, the are it's we -- at and the our what all to additional will subgroup be Indeed looking good with -- that's Kennen, that very proposal analysis, analysis, Indeed, question.

certainly, considerations our we additional take in So those analysis. current all

the be Got next about of II trial a what registrational Can it. a you the Obviously, angiosarcoma Phase of FDA program? yet backup forward on maybe in sort angiosarcoma? for in final that I trial? talked potentially just goal, bit expanded had question. a have talked we little that as to mind, sort mentioned. And the shots And one steps about are into With path

a it's Orphan disease from Drug speak, is is treatment disease, it's Bear -- what indication. on exactly that the treatment it common, a therapy. intend a is path in seek as That's a And not aggressive rare no we a to angiosarcoma a input and very approved we forward. FDA has mind,

small is number. a So patients not XX

an to So what will with talk package FDA an approvable for represent intend the indication. we

So we will be them. talking with

Got -- it. And apologies, ahead. go

a I [indiscernible] current in heard have FDA us light address what Rudolf value Kennen, to of the concerns. some everybody fact encouraging with have. to that with develop the want to regard have profile was color we certainly, what to was just here. is But trying FDA to communicate further of Obviously, to we add you the discussion positive.

then concern the design safety safety. is if study is only Now on the focused

situation. FDA the forward will then agreed So good and with therefore, going will to ideal allow a a study big on always a path end hopefully nice have one communication, study that to without be It's together. not accelerate back having an to design, an not actually doing FDA us

regard relation mentioned alternative Now path Rudolf there's in with also to that that, angiosarcoma. an to

are such that position. these So way two concern forward best I a balance FDA's to a at the in how the interesting very think product approval? we can for satisfy in that giving same time, we the half

path we time one We trying to to -- decisions product to the then the to capital be for right and use so multiple and have as opportunities, have efficiently patients. to available than more this make we're and

think I way, in a Kennen? comments. that actually Rudolf's different summarized

follow-up your years what the at on bit could a Absolutely. some about PGP terms And you Day, forward sort had clinic? sort Several next-generation pump within talk on maybe R&D little into Orascovery are of of Totally paclitaxel. where of just improve the development maybe talked seen even oral inhibitors Oraxol ago those the understand. hearing plus you looking sort a platform. again, potentially we've And to of, [indiscernible] about in moving Could more. in next-generation that a

let the Thank address you. Kennen, me question.

with inhibiting intestinal regard as dual inhibitor XXX the is well generation paclitaxel, to P-glycoprotein the So the enzyme. next as oral the both

good. in more tablet substrate, formulation, for regard in paclitaxel sort more now do completed, looks appropriate tablet of docetaxel ongoing. to were study which I second-generation in I question, be mean with Kennen. And XXXX. the will right good of And the oral [indiscernible] we paid it’s of The XXX that a we generation, which extension perfect and therefore, XXXX, be path a our that to line pharmacokinetic pump more doing Where oral ready data, With the we studies profile forward developing and flow is further which can paclitaxel a the first really, in the we your docetaxel for are well. substrate. up paclitaxel, XXX the the believe already oral I shown I So be I terms Where Phase designed already again, when development presented is to inhibitor. is of formulation cell is we one time. the the going will hope very second substrate answered we think docetaxel, the the PGP that load which we very is really oral will have stand formulation. at data cash tablet have and

from of [Operator with next line Instructions] Our comes Kevin the Oppenheimer. DeGeeter question

to just towards as to guess, of KUR-XX clinical from profile into bit contract little to it's Yes, kind Dan, how is [XXXb-Xc] about keep of little Maybe similar, the part your a is for one regard -- this I'll stage the a that thinking bit more product and of X talk moving And acquired -- can try programs, about you're IND I there? if program -- the Dan. you surfaced. acquisition? license structure how or a dissimilar you with profile part standpoint, target

Dan?

the for thanks Kevin, Sure. question.

very So benefit NKT, have these submit to profile risk/reward for in target the is GPCX serve XXXX. the looking we patients we're planning will for an hopefully, And little for for CAR, that sometime drug that IND balanced are treatments. of a options that

liver indication really some very the And know, the is of the a outside large undesirable U.S. you are clinical efficacy second-line and is primarily As suboptimal. really and cancer first-line treatments

is be information the So ongoing, year. about the once still sometime information have on next target this we to of more preclinical product we'll which data, profile provide more able

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our session. I'll concludes Lau floor you. Dr. final for question-and-answer comments. and Thank gentlemen, turn back Ladies any this to the

today. joining through for the working path on continue metastatic everyone time, viable forward paclitaxel Orphan paclitaxel cancer. us same a you We’ll we for are additional an path in an Drug oral for Designation. oral At the Thank FDA to breast with work on

candidate, clinical oral the the of demonstrated study with compelling With pembrolizumab. are profile progress by this we seen by in paclitaxel drug ongoing excited in also the combination

nicely, programs data cell Our advancing more sharing upcoming in to we and are clinical forward therapy scientific look meetings.

Europe. Klisyri On received the has regulatory already commercial and both the front, in U.S. approvals

which bring appreciate the look therapy world, partnerships and more to variable will – future. in key providing around help established updates in geographic you. Thank near all have in to and more We interest attention this forward areas the We your bring need. patients

today's This concludes you. Thank conference.

You this time. lines your for you participation. at may Thank disconnect your