ZIOP - Earnings call transcript Q1 2019 | Alaunos Therapeutics, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Ziopharm Oncology First Quarter 2019 Results Call. [Operator Instructions]. I would now like to turn the conference over to your host, Mr. Chris Taylor, Vice President, Investor Relations, Corporate Communications. Sir, you may begin.

Christopher Taylor

afternoon. good Bridget, you, Thank Welcome to review and to conference Ziopharm for the Oncology results XXXX. call first webcast the quarter of we our website, and XX-Q both available filed QX ziopharm.com. the afternoon, in of release, are of issued Section Investors news which This our our

statements development trends. course including pipeline, financial and this business regulatory forward-looking of therapeutic potential the the company status, the During make candidates will call, statements, regarding in our information

and today as Forward-looking other statements SEC. numerous call to we Mauney, in President. will Q&A. make filings of within are Laurence our XX-Q may risks and that the Each David for CEO provide described Participating our uncertainties, and on are subject with and Cooper, commentary Dr. open company Ziopharm; the the Dr. call we'll

to to Good Now turn Mauney. over call the Dr. like David. afternoon, I'd

David Mauney

thanks, thank And for call. at and you you, welcome us for today Yes, aboard everyone, here thank the on joining -- Ziopharm. Chris, everyone

of this at an few those see of have results are to welcome we pleased afternoon supportive and the are provide update We with year. programs strong a an on for new months. XXXX, value-creating we this new our this extend the and you expect look to base evidence quarter who for special and a overview Ziopharm We year. We to an milestones taken core increasingly pleased benefit of you support from last over provide now of to shareholders, highlight first to to speak you of

momentum. Ziopharm in XXXX We call, them new this coverage each with of welcome began two also We weeks. of analyst significant corporate on recent initiated

programs, year, and to milestones multiple-critical achieve and IL-XX. we now filler the all namely addition are this a in sheet, TCR-T, CAR-T In Controlled balance being with and our reinforced clinic structure of value-driving to corporate including well-positioned

for attaining we clinical the timelines those on are call to and We track, today, of are all that reaffirmed milestones on pleased important articulated report our year-end our events.

strong essentially the believe With To set with recognized established our table think, most what accomplish milestones balance partnerships the are of us, upon the have is for in field. a year. our strong we we those, we these very be will leaders goals,

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internal some for Now updates.

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the We as market are now going forward ability opportunistic capitalize will very and the company in be confident and creative sufficiently to in updating our efforts, appropriate. these

Before up few I let turn me Laurence, the thoughts. call over final with wrap to a

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Laurence Cooper

thanks David. everyone today. us for And Thank to you, joining

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third with combining this PD-X expect inhibitor later enrollment complete the now, the commenced quarter. quarter IL-XX to have and We

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Operator

Instructions]. [Operator

question line Benjamin comes Raymond with of Our from first James. the Ren

Reni Benjamin

okay? me hear you Can

Laurence Cooper

Yes.

Reni Benjamin

my third you FDA? generate process the consistently above remind the whether are we threshold you've viability Thanks able with for start kind and the the the can product of getting in that's just that. where Maybe just the trial of to progress. to sort us of required CAR-T, questions Laurence, taking on been now by And congratulations about generation Sorry started? off

Laurence Cooper

and really Ren, idea was nonviral really The didn't Yes. and core other good that days with less would. to Sleeping bulk delivered being T or of from produce are to rapidly patient not Thanks, doing the hear in the you. product, if you associated essentially, gene cells out key penetrate went talking in when and the systems, the those from approach. electroporator you concern transfer, a so to X the cells, as from the FDA It coming we're Beauty words, this

June physical viable to guided gone mixture a cells that and of that, last have ratio cells. there's of had favor So viable be that nonviable. us in year through process The that XX% FDA of essentially in

time other achieve process we've to develop in threshold words, achieve X-X, the what since that is that of basically, viability. XX% So done, critical a goal,

behind track So engineers, in process to who of based good And by in progress to reiterating grateful year, and are that trial giving The by been seeing I'm if guidance, in you very the delighted think, second them, would. area. open today that I really Street made we this half to the I'm I've what Houston we're this on this have really scenes significant the are

Reni Benjamin

each have maybe program. just a us, have Can what as be you how you How the that switching be patients And And focused on? ASCO we it. for? in give those follow-up and poster, looking many to to color The should gears Got key endpoints IL-XX should a you any the just, much presentation. follow-up of are as data, presentations? oral an we

Laurence Cooper

you. Thank Sure.

there expansion monotherapy cohort. to presentations, an is start the able addressing oral. focus really poster on is going The and the So and be poster a to two

study rapidly as has very recall, Now that accrued. expansion you'll

fact, In we've the actually completed accrual.

in, data patient historical basically reason they to who locked the And diagnosis survive hold And patients X controls, survive, GBM, quality is do a will highlight of I to that is the and essentially, that ourselves high going. that X stopwatch data but so benchmark. do is, of the that is lethal we the data than a the around recurrent months have longer standard

we patients have this bulk for the of follow year. that, out essentially to So to either for that, -- achieve those

The desert really within the immunologic story use why inhibitors, engage we've T a IL-XX monotherapy. published most presentation for reason is Ziopharm for because opportunity to think, aren't And first had of that unfold disinhibit society, T will this track year. to can as flush just oral will sterile. the company presentation will answer, asset. This essentially is be and has, is such that interest in in it's record guide have the presentation, oral Libtayo, in that important the really of are will is community reason you I address continue the cells investor of a the update. a this think would immunologically the a I from that interim And you problem your lot and T the we've treatment upside a I and and the because an with of GBMs we're time in that way tumor the that one of I type and into long technology. of unfold GBM difficult or abstract they be it's solving there and with PD-X the why for think, PD-X change this cells where the but such has the to time. got obviously, cells Opdivo that those a So lot investors They this it or will the now and of these and data reside lot with showing community, for

with the can first about think, how with outstanding really learn opportunity it's time, in brain for investors for partnered be and really, community scientific patients the the tumor. I again, for to So PD-X IL-XX,

Operator

next from Morgan. comes question our with Eric And Joseph JP

Eric Joseph

trying on based and the start for get the -- question to sort assay the TCR of, given just visibility NCI on the on I walk on -- program being program. IND, hematology Rens' -- you just path the CDXX the just the better wanted regarding I'm Beauty of to clinical maybe Sleeping the follow-up technology, outstanding also to trial, start program. to

-- are or Or -- exempt? sort you they potentially a guess about for of CRADA having do you'd I Sort -- program? of, been thinking is in be place the you IND formal filed

Laurence Cooper

Yes. Sure.

the therapy type the or gene any company. follows So of have first-in-human approval essentially this would academic they any the FDA NCI same In words, other trial. as for procedures through

Eric Joseph

gating the you of I just year, half And on guys wondering, what is in feedback it. -- CAR. program the clinic. means a T-cell, guess, is To the in CAR Got key remaining particularly hurdles the T-cell can to CDXX data what the other modifying extent of overcome? similar it. like know with approach? but through in The the Got providing track of platform that that, potentially your of, competitor what on hematology approaches are. any, you sort [indiscernible] the modifying -- kind using itself Beauty given Okay. the the are offer to clarity terms platform of, Sleeping differentiated just unnecessarily from is but be looks technology can just steps currently I is that the

Laurence Cooper

modify manufacturing or can't but patients. the essentially that to it not also that in and the I rapid CAR-T. you the is. what essentially these less, is comment X invented their of on open days path others But cells and program We to genetically very trial what Yes, T are talking team understand only get accruing what is to

viability are is primary It we question. we the on thrust is really are that. developed solution solution where associated track. the So That to working. That's with the

they're own, and our data developed the elegant, are have I reproducible. seen, they we've that solutions are that from And

chances not about only trial, think clinical we're of So enrolling buoyant our at I this now patients hold and this but year.

Operator

Our from next comes question RK the from H.C. Wainwright. of line

Swayampakula Ramakanth

better study Libtayo combination Regarding before can we Regeneron's protocols from you up do the with combination initial the newer steady come -- mature data the so molecule? looking what And to with also, finalizing to of need wait a drug, with study? that you tumors bit little are sort a study for with Libtayo, the the more at

Laurence Cooper

Sure.

our we've actually the would, II but year here. combination a I if that announced number, a that enrolled study of just Phase And We've PD-X starting package, reason Street, essentially through This was is can may combined cohort off -- it with that now being about to is this able June XXXX. why last The the the to risk gone of terms in have move here, you paying took really apparent is with So, just asset. benefited in Ziopharm been dosing work have is we the Opdivo. not third the forward risk be really a how and into IL-XX from understood

successful enrolling So been clear signal us a also will what has our transmitted data so, that very II can Regeneron that that are the patients that essentially IL-XX to in achieve doing essentially allowed signals to partner we are a gives trial, such to think marrying in a at essentially been we the way, and essentially PD-X the which get correct Phase careful we've doses. you asset be and -- That and this now that quarter.

In tumor, remains patients on terms something everything, patients of those of of will diagnosis recur of XX they they XX, to that's X this currently despite types Most really out die and months with X X like commercially recur, out when it's the focused GBM. a GBM, of recurrent available. X of

interested and our that essentially with have therapies. we that the and So waiting enthusiasm. execute and our want out would we as patients to PD-X patients are those those see to, the to for providers goes heart Patients be I able the add are see combination really trial, that in list are IL-XX on that a are the and just life-changing,

Operator

Jen question I-Eh with comes Company. of next And & from our line Laidlaw the

I-Eh Jen

little bit Probably follow-up a the on IL-X just part well as a more.

about you with why feel of, suggested. The some IL-XX overcome hurdles, been been has as sort could, the GBM is there's of their potentially some and there have paper now in potential PD-X -- you regarding was hypothesis in mentioned the the publications? that published that first studies Do combination failed those one ago a has years X

Laurence Cooper

for story. really Yes. in being Thanks, our I-Eh. also Thanks involved

fact the for GBM, setting, the primarily that in in the isolated. is So especially driven understand the reasons I failure, by as recurrent is PD-X immunologically and that,

cells get in T can't there. You

can cells even PD-X, activate essentially asset So PD-X disinhibiting PD-LX the though the T those access. by

have you T problem. essentially If intratumoral. and not and get don't can't those cells they're you into circulating with tumor the in nested T would, to the then if cells They're

ago, activated essentially data -- a by totally this idea So inhibitor. landscape on monotherapy from that we I tumor, with essentially essentially Medicine clearly tumor probably cells is And buzzwords, I'm In in you positive. takes that T would, the Nature are been an of that being essentially immunological around you years will we The those words, how couple turning paper be going other work think also guide the can buoyant and to getting critical, recently and of there microenvironment, saw around IL-XX in the IL-XX will if a PD-X papers very updated then what about. -- well immune signature said monographs change to signal the talking what the a series using periodical. to the understanding negative a of of from cold and is PD-X, be in PD-X getting hot, administered, signature intratumorally I've a immunological

I-Eh Jen

on up just Maybe That's Great. helpful. bit very little very, a follow Okay. that.

what For the higher going starting dose you dose? you for repeating have, are the X with with study curious, before starting PD-LX, Regeneron's the to collaboration might -- on what you maybe be just the jump X combo will dose be or whether or

Laurence Cooper

question. excellent an That Yes. is

up building we're with Opdivo. here, our So data

study. strategy really to I that dose-finding So a dosing we be it, Phase trial. a II not is for going we mean appropriate doing are have

Libtayo the confident we cemiplimab confident, really what all We done are spot know creep where approval that that are on inflection where we is we up pretty incrementally because dose-finding know for the had know and that the dose that point sweet the to those we to for can we essentially sort We the think of together studies put of the we or is. of we've asset. pretty IL-XX, based

to get pressure -- study, enroll think essentially dosing. as testing should correct II what rapidly a it we it which be we're is the So ready would enroll, because we Phase will

Operator

line capital. Thomas comes Flaten of next with the Street question Lake from Our

Thomas Flaten

Great.

the outstanding? would the about been on heard I question follow-up actually subject is that NCI. IND IND's at Or the the same they to that but you confirmed FDA? be that could submitted a you confirm Just to rules, still

Laurence Cooper

Yes. and involved also for being Thanks, thanks our story. Thomas, in

guidance that open, essentially, our is to mid-XXXX. So here we're be going

us give we regulatory weeks that just and patients giving confidence essentially call should a when are here, the few intent get has not well. rhythm essentially, But our in from As you, are -- that to to they we status on the the we served partnership were the essentially ago, updated Ziopharm past, mentioning sort processes. Street, here really of And day-to-day last nor the give the That, NCI, are about they're away on signal to going of with talking process. them, in you full what's working a to about about mid-XXXX. track enroll when good regulatory confidence the on is

Thomas Flaten

the good be of should forward? quarter R&D then for though of down. last to Is fourth R&D different to And the Or there spend, bit quarter, of quarter for housekeeping year? level number the first three quick we a an even a great. use year, the first spend us from uptick about a follow-up. compared it was That's Yes. thinking spend On just going was last quarters a

Laurence Cooper

Sure. with color need little offline can a you hear all to bit there. some And if we you additional work

is of were separated I we of primary has R&D a from care think part own, our was of the up our the taking That agreement. for Intrexon, really on that about what the way been when we they went to us. think partner lot

As we reflect as R&D independent, has our well as know are to budget we're commercial in shop that essentially R&D that prosecuting assets.

I control investors, our now think is for the fully good think, that of I the that's news are So assets. story, in and we of part the

to we make our now prosecuting for essentially are on are opportunities. on inroads to full cancer opportunity ideas to own, a full Ziopharm my and we're force our on going see ideas the clear I We extent go And because of a team, that can we with together essentially variety and that those. can

essentially is, think the small investors. I yes, be that uptick, sort news welcome but of for So there a a may

Operator

follow-up James. a have Ren with do we from Raymond Benjamin And

Reni Benjamin

Yes.

me you Just -- you okay? are hear Can there?

Laurence Cooper

Ren. Thanks, Yes.

David Mauney

Yes.

Reni Benjamin

Great.

to are can really -- be Eden to But think gets a which able the lot feel, provide talk little why the mentioned might who the you as just When a best some color I know the of. -- where the aware they're nonviral just you you be can joint there Just provide partner you ventures, about it, do you we interest. and as are? we technology get that companies different are? as like they're developing bit then a follow-up it seems nonviral are Can you seems of several several And approach, there there to taking China? guys is maybe Beauty sort are that's had really a of your is Sleeping months. it's option roughly others what or Or into maybe feel first? that, that out of Just You a maybe you race same to just thoughts there? clinic in the now systems and

Laurence Cooper

Sure.

the infrastructure access you after sort regulatory company. this -- would, Eden -- really and asset. got accelerator additional, essentially actually to while manufacturing all essentially people it to And the scoop in being insight I And to rival progress, is X, sort can out our based China. remarkable now, from the if they going rapid you go months. just are back the external BioCell, fantastic. So then have certainly the a it's infrastructure I was to I people, being first be and is if any help an to from really really share from in greater People I China. of here short dramatic built clinicians, of other of, this the GMP Those tell essentially, able proud would can't here that that essentially able and going few married CDXX just would they're now it essentially it be you mean now place, to infrastructure's of money set be hired, XXX. And is operation in looks Boston, that overview of a of

a patients, next So further it's of around in tuned to rocket going be the transfer. stay The nonviral the when terms is much lining the treating up ride. of beautifully, part really say conversation go and gene it's can't people, time right than -- they're all your I right because it's

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Operator

questions. any showing additional not I'm And

Laurence Cooper

Okay.

day. on all phone. you Have thank the And a operator. you, thank So great

Operator

does the Ladies program. and gentlemen, this conclude

disconnect. now may You

Alaunos Therapeutics (TCRT) 8 May 192019 Q1 Earnings call transcript