Athenex (ATNXQ) 8 May 212021 Q1 Earnings call transcript

Welcome to the Q1 2021 Athenex, Inc. Earnings Conference Call. My name is Richard, and I’ll be your operator for today’s call. [Operator Instructions]. I am now going to call over Mr. Investor Director, Senior Rubis, Relations. Steven Mr. begin. Rubis, you may

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

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

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

paclitaxel top addressing the the Medical letter an end on February. and for before to address I efforts oral Kwan. Rudolf complete letter priority complete of Thank Klisyri for Kuur the our response response over to turning acquisition updates provide Dr. Officer, will the our paclitaxel regarding received Therapeutics from we Steve. you, performance call at remains and overview FDA oral the the Chief The

and a A within perform expect a In to we understand to well additional agency expressed additional worked assessment weeks, complete the of paclitaxel. type request in response And schedule align our A end Over risk reward pathway hope before diligently oral analysis days. as the letter of type several on to the support meeting organization FDA to to the to concerns data the collect May. past agency’s with plan forward as approval. meeting for meeting, optimal the the to required the better obtain XX We

of chemotherapy our keratosis, safety safety our partner Klisyri profile launched and progressed Almirall. in metastatic that inhibitor of Athenex the treatment Athenex. milestones Almirall microtubule choice both a the actinic If or intend the February, approved, a in then believe paclitaxel. demonstrate of of oral compared with clinical led it for face cancer. strong or AK, position it Klisyri, the in treatment by very to continue efficacy we to scalp, superior We and FDA that IV represent breast U.S. through and Klisyri efficacy The paclitaxel offers as approval. December successfully around discovery represents company’s with in propriety from company attractive for approval and the important first that AK treatment partnership the represents short due subsequent launch Klisyri. its protocol, product of Athenex a profile. forward five-day this Klisyri step to proven retains significant economics first-in-class for

additional and the to receive eligible quarter to received associated milestone Klisyri upfront first the additional to milestone Klisyri payment a XXXX, the and payments and already addition million indications. first in in milestone by to U.S. $XX million into payments expansion Athenex additional quarter $XX up million $XX is an the prior launch aggregate In of checked launch received with of in

X, NY-ESO-X milestone Dr. an we platform was cell program, Kuur Kuur allogeneic of approach an of today. with Kuur is eligible to our XX% in asked the targeting transaction which and in is $XXX therapy to call to million annual President Athenex therapy program Baylor royalty Therapy tumors Kuur is additional acquisition On million payments complements Kuur few the solid Athenex’s eligible existing and payments Dan of totaling Medicine. or in an expressed to Additionally, developed receive details acquisition will announced starting high-affinity $XX licensed associated therapy tiered on May of at opportunity all receive apply the The company minutes. Lang, solid consideration College a milestone to an net Therapeutics innovative has Cell sales additional primary opportunity TCR an evaluating of on T-cell the platform on the a tumors. allogeneic from in T-cell based I receptor up payments. technology stock NKT cell autologous T-cell join The have us to in antigen. Dan our sales. provide

is Our business, to a compelling specialty opportunity now there and perform further. business grow continue pharma We APD this believe well. APS to

cGMP is our Dunkirk, in Our completion. expand online, will becomes facility it York Once nearing this New capacity.

actions the value clarity efficiently with our shareholders. we the response and Given from letter, cash. taking and manage FDA are our for invest resources effectively the efficiently pathway, to regulatory to conserve and be we actions Once to complete will prioritize initial further resources create taken further have

for pragmatic multiple during value this may scenarios shareholder and investors our are to an are we maximize and experienced period. team actively business uncertain appreciate, evaluating As

current while date, our successful paclitaxel and a what Given advance outcome our we to oral our APS/APD programs to priorities therapy regulatory know to business. cell supporting are bring to

balancing Randoll I to over financials. more are seek his the turn prudent in our against We of discussion now the cash runway. Kwan. Rudolf call provide will stewardship, we Dr. and details disparities to extend will cash

diligently forward Despite to disappointment the regarding Johnson. CRL to working paclitaxel. address CRL, Thank are we our you, oral fight the and for

we by CRM. to begin on some me Let to plan respond providing how detail the

several to the develop have FDA. working response past team our the and the For I weeks, been to

and agency’s Our concerns preparation in the the collecting include developing additional questions address additional CRL. data analysis in to

including we and assist to Additionally, several advisors biostatistics our regulatory as preparation, part of have and consultants, us. advisors engaged

finalizing are meeting submission request package. our We

Our A quarter. end type meeting to to meeting May, requests the by the plan second end submit and of type accept by is the a A the expect of

continue to we the on be an concerns in addresses FDA CRL. path agreement We outlined reach that can that forward the hopeful a

We will possible our FDA steps meeting to regarding of when outcome update the the and an provide community next available. investor

GSKs paclitaxel We paclitaxel continue cutaneous combination to and for oral angiosarcoma pembrolizumab with paclitaxel being in programs, combination including treatment program advance and in cancer. studied where is I-SPYX breast with in neoadjuvant the Dostarlimab oral oral

FDA drug regulatory path continues Our we this to with discuss forward. indication program angiosarcoma for plan and a meeting to to the progress in Oral cutaneous orphan received the paclitaxel designation has well. request

in update tumors. finding We with complete. regulatory an portion the when our combination of available. trial on Phase becomes will discussion clinical The clarity varies oral is advanced provide paclitaxel paclitaxel The trial of oral solid plus in pembrolizumab combination dose pembrolizumab I

to later year. data expect those finding this We present

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

terms clinical June. we presenting three at presentations, In trial are abstracts of ASCO in

abstract cancer. first study to of prostate docetaxel in metastatic oral The I pertains phase a

paclitaxel breast is Dan from will over of metastatic Encequidar sub-analysis of molecular the interaction Lang. abstract a abstract the on response subtype of and cancer. oral second tumor turn to by I now in on on dabigatran III the The PK Phase third study call

of therapy. developer allogeneic we you, X, On existing announced Kuur cell acquisition Athenex’s CAR-NKT Rudolf. bolsters of program. acquisition Therapeutics, the leading of cell the Thank The therapy May Kuur

walk could therapy disruptive We technologies that looking time what significant potential almost drew our in technology. innovative we cell technology. several have through year been and a a for to TCR I us with be like this you platform evaluating technology to for spent would have synergistic

versus there including in success believe cell time, the We course a patient and While extended the future require of approach relative to for Kuur’s off approach. be the first-generation an generated have transformative an company for solid developed data We We NKT graft of shelf have that allogeneic compelling remains limitations several cell effects NKT to could could patient key type cells. allogeneic low lead has cell cell effects. current tumor as a because first-generation a variability, they manufacturing the autologous safety toxic mix will NKT is type on and one NK therapy. They have on ideal direct host TCRs. of important classical two CAR-T tumors. have cells clinical cell believe efficacy, like the costs, anti-tumor cells platform believe NKT leading cells technology cell don’t therapies. disease elements an therapy risk be

and dendritic thus immune NKT cells, cascade with recruit through can T-cells NK propagating cells of their cytokines, the cells response. addition, the of release the and activate In further through interactions

This trial. approach. That’s to out have first been is by demonstrate XXXX, complete GDX, utilizing in safe January targeting Side response phase that that is CAR-NKT in expressed In neuroblastoma. NKT response I goal one vitally cells of patients, XX the doing of neuroblastoma GINAKITX is we’re autologous disclosed Our a which are tolerated. partial and evaluable well one Kuur an were effects observed.

at from May XX. of data Gene on Additional American trial presented Therapy GINAKITX the will be Cell I Conference the Society and phase

preclinical, The these healthy is opportunity being to TCRs venture to the from second This in transfuse to clinical in in joint cells future resources I studied unmet is platform, program CAR-NKT exciting study came a adult medical does to targeting clinical Phase the CD-XX solid manufacturing in tumors. evaluate donor. needs allogeneic with The of is ability solid ANCHOR within allows pipeline a observed of that trial this an The and the targeting refractory revolves only tumors. one the cells leverage NKT program evaluable the patients an therapy XLife Athenex been TCRT affinity-enhanced Sciences around and that Not have cell The present ANCHOR Out further a leukemia. meter dose lowest program square. platform lymphoma bolster timesXX^X NYE-SO assets. patients, but advance to years two with Athenex cell cell X it began address ago onto with therapy current level CR per also two Athenex autologous PR relapsed and one the and already at acquisition us trial. of

line, continues unlock to and our over oral our the now While I the work to Kuur to commitment call advancing to finish Athenex Jeff. therapy will our of turn company to the program shareholders. acquisition illustrates on for the cell paclitaxel value

and Piperacillin The product in negative supply was I existing The hospitals Athenex our quarter prepared business. be the in biggest been Dan. the The current an in the and fourth spike million Dexmedetomidine, update XXXX first within had contributors and developments inventory excess spike our XX specialty in partners. have provide business a you, results. quarter. our Tazobactam COVID-XX commercial ordering sales receiving pharmaceutical the Thank impact long better cases on generated causing significant and on in quarter COVID the of first infrastructure chain products will to manifested pandemic for recently sales as from delays Azithromycin, to India such in by Levothyroxine. QX and inventory growth impact

The is to all will operate room-temperature-stable advantages facility ready commence plants products equipment Solution recently markets Cyclophosphamide, quarter. manufacturing portion with will and APS of for now a year, manufacturing currently expansion manufacturing are significant our our complete The the in Athenex equipment. business this complete. we also for in Dunkirk, Athenex team The products. of in that products six pharmaceutical of a the facility and specialty quarter Beginning Division In over fourth of second to is we be Dunkirk already nearly should hire competitive to and Pharmaceutical We XX working validation York in XX has launched New of Pharma SKUs XX Chongqing, which business. SKUs. plan products QX facility. a of commercial our XXXX. commence the Construction in activities needs in facility the markets XXXB serve our to this

hard We look these continue opportunities take to the available to a businesses. grow at

and and these products, the a The to new margins. own allowing substantially we relied develop logical as so of products on Currently, market Specialty products. at us Pharmaceuticals our we products. a analysis of products identified Athenex Our increasing interests step of that own next source launch particular formation on partnerships our acting range ANDAs to are is

will oncolytics, to us advantage products allows in strategy. have We product be oncology cornerstone will the of continue to Athenex’s also we line adding proprietary which the oral to Developing be market. our and existing of take relationships launching

manufacturing our advantage as deep well pharma a Our specialty as scale provide tactical facilities, relationships business. to know-how

will leverage opportunities Randoll. for a in over continue for will stakeholders. competitive look I way unlock to We the that advantages call value to turn these our now to

increase of of go sales. year-over-year I’ll sales million. through to products. of increase Revenue first were increased Jeff. you, sales These updates XX%, by API from key for offset in a $X.X million, by few million increases a Thank sales a product to of decrease $XX.X in product attributable quarter. financial an primarily QX increased $X.X the XXXB APD

paclitaxel ended to and costs. for XXXX was of For cost product the to $X royalty completion offset the or in $XX.X Agreement the upon by ago. recorded upfront or partially in professional to XXXX. of loss million and XXXX partially $XX.X License first to $XX.X study incurred decrease $X.XX a U.S. the of as of III million license License first up increase costs pursuant decrease million March fee net revenue was totaled This primarily activities million down share attributable pursuant preclinical patient of million, clinical administrative on share year decreases to after compared the months million loss cost. $XX.X of commercialize quarter $XX.X and million, $X.X oral diluted XXXX, preparing first XXXX. Increase to on offset quarter, from CRL Xiangxue. was development as the regulatory, in for XX, in R&D primarily the primarily XXXX and pre-launch million costs to operational study in revenues costs diluted $XX.X increase of expenses other Phase the Agreement. due development API pre-launch $XX.X operation decrease for million for per costs. $XX expenses launch Almirall slowed by to million to was to quarter IT and the to was million, we was year related due Klisyri increase Athenex This ago. significant the the oral the receipt SG&A paclitaxel to the in of year development Cost Net first period XXXX in down the per the of an costs $X.XX a three PharmaEssentia ago. payment The Hanmi Second license hiring quarter a an and due the and Amendment from a in for XXXX XXXB totaled same totaled as This from sales $XX.X from occurred upon fees, general as in well related

$XXX.X million As of company March of had cash investments short-term of million, and XXXX, equivalent cash and XX, cash $XX.X $XX of the restricted million.

identified and conserve for have out is operation of launch opportunities opportunity we to to additional non-core C&D cost. CRL, Oncology, cost result savings. taken pushed XXXX. these the have forward. expect steps and the and As second cash well clarity operating we can opportunity exists on our half plan, where Athenex possible and R&D One initial expenses cash our we be capital adjustments An approval greater cash and path several based can various until Considering equivalent we expenditures as now fund the current our reduce current into as certain of on

to only become the limiting customers guidance, any until products product international product, guidance XXXX, amount from available. recorded meaningful pandemic. financial proprietary significant global company terms sales the the a proprietary portfolio, is which excludes revenues a the In as existing Klisyri, of from result data sales company of of In the product

currently guidance However, expects royalties from in as the is product be nature. Johnson. the in portfolio. see continues as sales these with not back XXXX, now XXXX XXXX, affirming its The to call March I the revenues recurring it levels. does to will excluding on company X, turn provided company to line its expand it any the product The in Klisyri, company

open you, the for questions. Thank now call We’ll Randoll.

Raffat ISI. question in [Operator comes from Instructions] Evercore first line from Umer And our

Umer. Rudolf is and Johnson. one for Maybe This

additional from population the analysis? to are that additional sites? what analysis, for include going data pathway? at the regulatory does that paclitaxel have some the that that Phase oral data, U.S. kind the PK For trials on trial and collection you’re or from analysis or the going of sub other And analysis does ASCO mean data cancer additional more III elaborate You present for some breast

you. Thank Rudolf?

you for question. Thank Yes. the

neutropenia-related the primary CRL and improve the collection rate strategies to of and include the the mitigation analysis and conducted by sequelae, objective data-related additional data endpoint to additional toxicity. Our these risk in FDA BICR are address concerns response

in molecular data Regarding to we’ll FDA. study providing ASCO, OXX to not the subtypes and that are the ASCO new to data be the question, regarding

the of So analysis that is not in part submission. the

question next Capital line in from Our Kennen comes RBC from MacKay Markets.

[indiscernible] CRL? clarify Just wondering, FDA have you the some feedback if had paclitaxel, from away FDA or trial exchanges that I for secondary you had oral could additional time question had their to paclitaxel us, know docetaxel after then Odonate any an last CRL, just data walk help the obviously there, seen had to or additional was the conversations certainly a the since And there. that, we the asked from with we of spoke.

that if something trial could table versus and that even in? here that’s situation FDA what you the or wondering be that perhaps see Just on the their do you’re differences the feedback they ran between

you, Rudolf? Thank Kennen.

question. Yes. Kennen, first

the FDA are on We request. talk to based the with the CRL meeting waiting on

no have speak. we as yet So we additional exchange

next the the we meeting, be shall timely at requesting. exchange So be will which

the Regarding we... Odonate,

Rudolf – their everyone comment company Kennen, we interpretation. not it’s and companies' our certainly other have do products, can on own that policy

but have And comments. that Kennen. understand, we’ll hopefully be interpretation, you We company aspects not can have a making certain policy our we

Leerink. online Our next Jonathan from comes question from Chang SVB

scenarios for the any whether guess, up I would the different about to just question, you do you How not First thoughts questions. that previous or the on program? Do out think with follow play development of could and on next steps you Oraxol? have the proceed

our do move FDA’s concern additional try Jonathan. complete from provide to so we will question, we to that FDA. best data can forward. to It have to letter us response essential additional the a for you analysis, for address now Thank be Certainly, provide

before of active well very hopefully hopeful In particular, to that going were end paclitaxel the are cutaneous are in as the other were quarter. also actively angiosarcoma the of indications. paclitaxel that potential happen meantime, we the that as oral combination in have programs the being is now. In second this soon, explore in of pursued right oral immunotherapy. with programs use They We

Dr. as As for cancer. that the have we of forward our information are pushing a as with an can we team FDA’s belief the we and addition that to oral as important can team, is diligently provide myself Kwan, satisfy arsenal And drugs to concerns. and patients paclitaxel we to we firm entire hard as together, ensure

And can rationale your cell existing further discuss question, and how to second efforts? Kuur impacts it. acquisition the Got also the investment you efforts? cell TCR the into curious behind I’m acquisition know therapy therapy Kuur your

transaction. I Dan share questions what our have there turn to let I to to were Certainly, regards with highlight it before the that Lang and think Dr. such to with seen, a timing, lot me also regards philosophy a the doing of we fact

that to me Let trying the therapy Athenex emphasize best patients. is develop for cancer

regard developing will have this question. And creating to then regards regards timing, with refer different to for also to with Lang to strategies actually take We been value opportunity, how the this with and I evaluate, Dr. stakeholders. rationale to we the behind Dan our address to

of helping are very and the critical we but generation TCRT you’re the aware a so manufacturing an evaluating an you, key success have Thank and patient-to-patient is interesting of we their did in approach I’m different having patients, a time, other cell could sure Current Jonathan, for our augment current that what believe technologies also that have costs, on that variability they limitations on we program. safety are allogenic considering of. analysis Johnson. leader that data element. CAR-Ts therapy, future really elements long Sure. limitations embarked the When actually off-the-shelf efficacy

could us a one program. technologies of nine So those we try is been when transformative bolster spending question bring over unmet approach different program. us we’ve really at to allow therapeutics NKT And a platform, past lot TCRT and time believe TCRT our current leapfrog medical to to a companies our an in, that onto technologies which solid to enhance address to ask this T need and could tumors. does current therapies. the looking cell could months, currency TCR help And you put current the first-generation allogeneic of on have CAR off-the-shelf One complement how for the

I So your Jonathan. hope answers that questions,

tumors engineered look if TCRs will that very And case, is case targeting then also at with can NKT Jonathan, this And the this with that current that, appropriate might an and this we the questions, I on be active and is, there antigens. cells, allogeneic we cells the hope obviously other addressed your be express NKT Jonathan. therapies. the product and based T-cell the

question Securities. online Truist from Karnauskas comes next Our from Robyn

question week? stable More the many And to on you think forward? cash. to was for XX manage Can give these new And And updated, the guided the confusing. other previously patients abstracts Like patients follow-up. capital XXXX, you color how get on acquisition could with the some to I actually the us stable of little It know out going when how of this know about it’s how out, but was it’s I patients? I give I are need just you’re a durability? going but cash for cash little I a us it disease, bit. you lot we a are the a get the characterization think just patients second, we have completes, some disease How in are tie then for acquisition, could cash. the then up thinking abstract. going and far on going next Cash from

XX question. to Heczey study, you, neuroblastoma May Robyn, the on conference for additional information. Thank present ASGCT is Relating at Sure. to going Dr. with the GINAKITX the

in the defer Randoll. Johnson The that have conference the I I XX far enrolled ahead or because response study. terms presentation, months. ASGCT question, going of provide additional so the that discuss about cannot the further in to is don’t of on And duration So of patients data cash then really to We in information to the would the his want the have embargo. but we longest it’s of either we to pre-empt study information six

on we fronts to execute projections? cash to comment Randoll, do to current going want you our able position and the confidence on are be based the that Randoll? on all

Yes. question. Sure. for Robyn, Thank you, your

So And how our including thinking have we we therapy ever we been And carefully very cell have programs, Kuur and actually associated cash since cashflow very paclitaxel. for on guidance accounted about path been to expenses with received and the CRL, cautious advancing has latest for our platform. the our forward clarity we’ve efficiently to manage we resources effectively. trying have more until conserve the been oral

So this maximize we’ve for business been actively during scenarios evaluating period. uncertain multiple our to shareholder value

So are our potential therapy to support priorities the And our time, cell at platform APS maximize the for current our and we’re currently to APD continuing business. and growth programs. same

capital priorities these balancing seek extend question our cashflow your we further to that as Hopefully, we’re our on addresses beyond So catalysts. near-term against cashflow. prudent allocation

manufacturing manufacturing CAR-NKT manufacturing, Yes. ability cheaper, these allogeneic of know And obviously for your Do someone and current is you? you these on status new What a then in-house? little I it’s it the therapies. so cells, else for expensive for but even have are is

Thank Robyn. Sure. you,

neuroblastoma for I facility our those in QX which by probably cell in year. of the running a And Phase and program are to facility able in actually own programs, clinical in addition we’re manufacturing refractory Phase building up will our in, and we’re Baylor support headquarter, be Houston. actually studies that, lymphoma, cell program the and Buffalo study the for GINAKITX – this I I positive both to be both of GMP So Phase the the supported CDXX relapsing manufacturing ANCHOR

current in of come online happen. to a GMP the headquarter have will And which a patient that a in additional we a Buffalo months. will Baylor So support few have to then continue backup out we’ll facility enrollment,

online comes question next Oppenheimer. DeGeeter from Our Kevin from

on up follow GDX an program the Really to Kuur as well. transaction. this autologous construct. understand point, I this If want I interesting is at

we Just updated continued or to allogeneic? regards with thoughts any transitioning into provide neuroblastoma some any should of about can timeframe see think an when potentially data that have in from you investment And ANCHOR? we program for in terms you may general autologous

Sure.

and In the years the for the as terms for to and a it’s at was time study, adaptive of the approach type embarked safe GINAKITX this use a cells to of autologous NKT that was cell couple upon ago, show goal transfer. efficacious cell

So disease, very allogeneic we going the that NKT we I host future, future. think that because to positions going allogeneic allogeneic But itself ideal low approach. to suffice program say, the would graft are resources a in additional invest yet. into made cell in an haven’t approach to into as the that whether we’re determination the versus of invest

the few because there Going autologous orphan an GDX okay, drug are is because it’s neuroblastoma, an back to approach disease, patients. very for

there about a think I will only be this disease X,XXX state. patients year in

important terms In CAR-NKT a is plan ANCHOR, out into to study study. our very single that current for accrual the center CDXX of Baylor will multicenter this accrual allogeneic study the of expand help accelerate of in patients

building any as or last about manufacturing, model about, components economics? question meaningful a think royalty out as the think you stack about net evolve And financial Great. other of on then, that and think we building

product that during we the to would owe warranty other process. no royalty is that would pay but the There’s is once to there we have Baylor R&D commercial,

that hitting the on million based clinical As of regulatory there Johnson milestone and $XXX of those those are are part described, really transaction but milestones. success payments, and

So those be are consider not royalties. I what would to

a also transaction. To basically to see in based shareholders College, transaction sort Baylor this have a they do confidence terms us, the stock go of that of the lot transaction, upfront we further payment in are that is were and Kevin all that delighted a

all. delighted our sheet didn’t their So confidence then at impact to therefore we’re it receive balance And working in us.

be is percentage, very, to very a forward, economics remain small such very our owe the small the that we percentage, overall Going data royalty attractive. and

from Messer Our next Chad question from line comes Needham.

correctly, around that one the questions. talked was surprised a there a a Could or of my it data, adjudication concern one of appreciate Oraxol? me, I start bit, if to getting the worried but concerns I bias. know was about Sure remember just with this a that you we’ve you somehow FDA that over what bit about

with this address guys that’s something a other additional you Oraxol program with you just oral to comment as specifically, really extensive you can on. So can if just not clinical have data? follow-up a that, you wondering, on, If chemotherapies. that’s something And going with think

are existing to of you of the the anything the lessons or of or sort there learned any trial to incident of it’s stay of if wondering out Just this collaborator studies the think needs at to division or appears this plan change least FDA sort that network sensitivity about, that from that’s this or FDA, way design future whether have?

you, Thank Rudolf?

PICL FDA problematic Chad, endpoint thank PICL you open the perspective. that label from regarding the standard for scientific industry the the strongly the question the feel the FDA is for analysis, sense study. the the question. is primary In We

we believe of their we to back position the intend strong very have we validation a to position So and FDA. it argument external get and casing

the lot other take a certainly our to for the platform, Oraxol strategic indications oral we discovery metastatic more the breast and forward. experience certainly cancer from Regarding are going we

for [indiscernible] extensively very program, collaboration QuantumLeap, I-SPYX large centers we in and the which angiosarcoma for on with be external example, and a also drug we the will much Glaxo for in on the So clinic. obviously, that input conducting status Mayo we in with U.S. consulting are of the all is companies orphan leverage using program FDA early the

lessons that that we hope we Chad. take those I your into those programs So hope learned will those have question, programs. answers

Chad, here. Johnson

then we government providing it’s them a take very that add should a slight to learn believe is And well. as a firmly feedback, pullback agency. an as they’re them bit and from seriously we when FDA further, organization, good Just

as data a been that are right. think that government as is to have fair we of to I What not we context, very the have questions. saying doing show A do this They they not are convince agency. it source in related agency, possible government to much is we correctly. doing So really that have

Now for always The are with your whether something avoid question, we regard their to to and FDA learning. share to look learned to is concern it this we we to would going us able sensitivities will certain with lead able then on directions. way be FDA guidance from that at that occasion, we’ve be forward. And

programs our our all whatever going the FDA. highest ensure forward, standard seriously data we to of by very them to all as taking provide up is We’re requested for in that planning,

closely So a work we’ll be with all we going as well going to so to the as path either you. more are concerns to FDA and the Thank smooth resolve able forward. in that we very intend differences way, enjoy working forward, FDA with opinions

from next Ladenburg line Thalmann. Our comes question Matt Kaplan from

for to talk more about these from wanted conditioning guess the currently tolerability bit of the your Therapeutics Can I going CAR-NKT forward patients Just platform. of focus I kind on and view acquisition, being point safety what interesting guess, the regimen? and very of a potentially you of transaction. thoughts, the are utilized regimen that’s the little Kuur pre-conditioning and

Thank Dan? you.

Sure. Thank for question. the you, Matt,

for that cyclophosphamide includes the it’s the for regimen, which used cell fludarabine. pre-conditioning and been lymphodepletion has field, standard So therapy current the

of which we’ve terms safety study, we seen tolerability the neuroblastoma patients. of study, GINAKITX a two In that grade and the so saw is CRS one far, in XX out

against higher well very programs, think And a small CAR-T I numbers, So rates. compares about XX%. that but first the generation current CRS have which that’s obviously,

to program, that, graft that’s two any reminding so addition in seen that not or the we patients you allogenic and neurotoxicity. far we an ANCHOR study CRS and any host, currently have enrolled versus In have

pretty the some data. hard to appears too maybe to don’t that an or to we’ll question, be like I good at currently question lymphodepletion. Thank questions but safety point And then with whether and the of we interpret far burden very it think we So a well later I asked many in explore the That’s certainly Phase you additional to make ameliorate tolerated. want can you. time, so reduce confound

Matt. be program, of to eliminate there’s that a Matt. to, the our the reducing we going are the currently excited. add will based data of certain my I planning review of which that able on to was delighted DP the a circumstances, further, in share and With conditioning. just background And I to thinking, share got are fact, immunology. the bit wanted biology the we what of you And of us of explore NKT also DP very possibility with is will one background, to in be attractive option we our to conditioning. majority points To cells, that be

Umer from from Raffat comes ISI. question Evercore final Our

paclitaxel for thoughts allogeneic follow-up running. trials does redosing? want And for clarify lot program durability additional to some collection the is there share for you’re the the a I data not could the the for additional the Thanks that data Kuur other you question. of that the U.S. acquisition, And include maybe program? from technical on COVID-XX barrier any

Thank you.

data in angiosarcoma response? going that For the data addressed, to like Rudolf, you incorporate the the you’re want first our do question, of part additional whether

efficacy from they we current data the with Nevertheless, we obviously other data on the are But the collecting including response complete question. and the if all studies, right focused speak safety angiosarcoma. all the focus on the ask the that letter. with is and respond from studies will data FDA as meeting complete the letter, response in The additional data planning, definitely now we

second and on approach data, your the question to regard allogeneic the With Dan?

Sure.

ANCHOR we have patients two we two enrolled and the study, So for responses. had

his The about far so CR, his repeat three another that patient I with to ANCHOR you And related had Can first patient I please? question the you is months. response PR, it’s was study, the initial with response the months, think second forgot. then about and which a six

for study? allogeneic redosing this for Barrier

approach, redosing CAR-T. Yes. No, the Re-dosing reality, with done great which a becomes more been the Autologous first for the limitation study. GINAKITX question the in because generation has in certainly a that’s past, allogeneic a is of

We data a more dose thing the study, gather to GINAKITX ANCHOR same the of study. were these planning two neuroblastoma hypothesis single the do in to redosing the redose testing or In are want first. received, fact, patients that with I patients we there in ability the and to think redosing

So far, patients. have we won’t two

maybe explore more we trial allow we once data, So and gather so we’ll for potentially dose that the amend can redosing. single

be So plans, stable a disease, make details these able report that into patient a hopefully have we once things So all for idea and PR SD decision. on to a redosing? one turn the are are be a that could more drawing a we’ll with can we that

that is and addressed redosing can we question. further, technicality, within add also what To your both I the from certainly the is is market we a scientific something hope that feasibility well do. the scope that potential, perspective, of and

questions no over call to We to for the turn like Johnson this have at time. I’d closing further comments.

for Thank us joining today. you all

on oral therapy paclitaxel the to work continue and supporting APD, businesses. our program We cell APS clarity toward while the from FDA

to capital shareholders. continue our for to for goal participating to Our forward unlock this Thank updating in efficiently allocate to call. value look We again is everyone while executing you this summer. on opportunities

today’s participating. you Thank ladies concludes you, thank and conference. for gentlemen, And this

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