ZIOP - Earnings call transcript Q1 2020 | Alaunos Therapeutics, Inc.

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Operator

Greetings and welcome to the Ziopharm Oncology First Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Chris Taylor, Investor Relations at Ziopharm. sir. you, Thank

begin. You may

Chris Taylor

we operator. which Oncology Good for to you, section website, news This and first our our and first of quarter available afternoon call and in Ziopharm financial afternoon XXXX. conference XX, results both ended the our webcast XX-Q quarter issued of Thank release, March welcome filed are to the Investors Ziopharm.com. review the

accompany section. of today’s have also included our PowerPoint For also slides set found in to These informational our we purposes, be commentary. webcast in can slides website a on the Investors

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

risks XX-Q in numerous we as Forward-looking time filings SEC that subject and and make other time. statements our with the to may from to described within uncertainties are

and Executive Cooper, Participating Shukla, Chief on Dr. be our Officer; Laurence David will call for Sath Officer; Ziopharm Dr. Mauney, Chief today Financial President.

our from will then return time, for In that management we commentary feel and and queue. follow-up to the Following please call as you of free kindly request a needed, the we one to open Q&A. question interest the ask team,

physically in the bear today. information of mind this Please also disrupts flow you. apologies management distancing, team that in are so the if call advance during Thank our

the to Cooper. Dr. turn over Good call I’ll started, Laurence. get to And afternoon,

Laurence Cooper

you, Thank afternoon, good everyone. Chris, and

we you to weeks and today past quarter. of with businesses, an experienced. people any be COVID-XX have been progress pleased affecting With here unlike have We adversely are this for our globally update the

new having for our the of proud executed and employees adapted environment. I’m working to

are remained business prepared capacity. were remotely for we and and thus already open have at working In full well for working fact,

executing For those working virtually are they home, and from who meetings seamlessly. taking can,

ensure schedules our have who trials and and laboratory modified personnel, to space, our we manufacturing as and a adapted be productivity. partnered safety team, physical in For to staff, such clinical those need clinicians our

revisiting to governments, hospital-based from allow been our policies high pleased commitment of testament our keep a the freedom well on guidance operating at we’ve are as state very federal of our which and a safely to team. is that Based to able I’m as continuously partners, we level, movement.

at partners clinical as Institute non-COVID-XX Cancer not clinical restrictions Center MD our trials. our at employees. just IND the on Externally, NCI a their to industry are the and result, delay And Cancer with implemented executing or patients National temporarily impacts have and us, large, studies This Anderson paused. X protect institutions these under work but

and active are communications adapting the We real with NCI in in MD time. Anderson and

investors enrolling. Of these have will when begin questions can course, studies on and stakeholders

lift, are we is up While timing to of their our though once control. the under back with them, ready start restrictions not this

venture, to Eden China. restrictions and our we’ve of Controlled recurrent patients for other with operates with our that hospitals, work also Greater With to trials. less to Other to countries news has enabled joint us accrue clinical continued with BioCell, IL-XX. good however, are glioblastoma rGBM able to under within regards to This able be which is continue COVID-XX dosing or

we will our uncertainty, created strengthen carefully The as pandemic be weather to accelerate our quarter we capital certain ahead last describe to completed strategically While COVID-XX increased we and has we storm. of teams meaningful internally. expansion this and activities, are also well us We positioned into fund through enables mid-XXXX. us activities milestones to and to financing believe sufficient fortunate the cash have

finishing non-viral in previously for will engineering midst patients of allow mentioned, detailed the they the review programs, Turning which in we of a the study X phase the more Steven of Rosenberg, as to our NCI-sponsored led T-cell Dr. treatment were final to by runs, TCR-T trial. have

restrictions work the current reacted certain at and has activities. to prioritized NCI the internal Ziopharm

Specifically, so then NCI, TCR-T to can are at provide undertaking to the enroll our ready runs company, engineering partners we the within tumors the to trial. they which of patients details these with solid

opening accomplished completed space during we in additional end, of successfully pandemic. Houston, the the laboratory this To

from are several will runs the full We up they resume speed back activities. out get in to quickly, and these Anderson Houston, optimistic open with program TCR-T Building affords the data help more once NCI us MD advantages.

trial with collaborating and deep experience collaborators have with investigators targeting pool as products tumors, we patients to variety multiple large develop help be principal which of is tumor of solid We a clinical neoantigens. drawing helpful in T-cell with a from enrollment. expected which types, will are These

within personalized our solid are In campus, the nested our Anderson we and [ph] [live TCR-T re] tumors. develop MD laboratory targeting continuing to programs

TCRs have sufficient begin Anderson. As hotspots already MD arm TCR-T we a the public to targeting neoantigens in reminder, at

We progress the sections. and CMC clinical undertaking as have with meeting pre-IND non-clinical already which included made a as well FDA, information,

We the status are provide of at quarterly call. timing trial the the evaluating their feedback update expect an on and the and the factoring COVID-XX to in of impact next and

We solid T-cell thought neoantigens with look partners strength. of with them. are program, the And of leaders immuno-oncology, and in receptors. both we work MD the as in forward a to position in tumors Sleeping targeting have aligned move gratified Being NCI and Beauty our forward world’s continuing we ability our to to have Anderson X optionality in with

Moving Controlled to program. IL-XX our

to have our Libtayo. teams we pandemic, enroll to combination actively with the rGBM X our phase been continue Regeneron’s And with able patients trial execute. in During

have minor delays, supply of while have our year, anticipate the had Patients we as adequate previously lifesaving fact, vendors we some motivated enrollment completing receive highly guided. in our physicians remain guided. we’ve this drug And We potentially for studies. and track remain on first-half previously this to current as In treatment. currently

IL-XX study OPDIVO, quarter trial are with throughout data fourth this disclose In from enrollment completed XXXX, X to year. phase combination the track on our in we and of that

from which results XXXX. anticipate completed the through course enrollment the quarter we study first of the monotherapy of Additionally, in our year,

format. looking data are year its teams presenting clinical forward to new this ASCO and at scientific Our clinical virtual with

to products believe MOS We the Overall MOS, by follow Median that or as XX for used based continue Survival, patients matures, on as rGBM. emphasize encouraging. to As endpoint, rGBM published with metric recently data, for this we is approve beyond months is FDA the up oncology

phase Anderson our with CAR-T visit program, or the SIV trial created to for MD with initiation pandemic X CDXX-specific site has delays the the In administer CAR-T.

as As when And take using previously open input wait meeting we, this transfer this to step the is last needed technology as This Manufacturing like Rapid delay policies CAR-T MD the will the infuses after others, place. referred due to Personalized guided, day was regarding soon Anderson’s or the on study RPM. pandemic. gene as their The our to on trial.

including T-cells. Anderson can from occurs, of from viability infuse engineered Once ZIOPHARM MD and all place meet begin patient. approval the is first SIV enroll FDA, the our from the IND that of can and XX% trial, To to side IRB we verification reassure the clearance reiterate, runs in

As a malignancies. have this reminder, allogeneic marrow T-cells that donor-derived with or trial CDXX in infuses expressing patients bone relapsed transplantation after

We this patient-derived are efforts, update we or CDXX-specific RPM. the undertake pursuing partner Greater autologous with BioCell in To and CAR-T you to have China. our Eden work of infusion also aligned on these

manufacturing process RPM MD runs, of of prioritizes This advantage team financials and with change autologous multiple recent our reduces takes with the challenges success their burden Developing our the to activities Anderson. in on also pandemic. with navigate the and Asia their ability Ziopharm’s our

progress asset, trial. in for tremendous China, file year to RPM RPM first This this making with to been has CAR-T on specifically strategic track on is and clinical Greater IND leveraging clinical specific for for implementing CDXX their in Taiwan. is autologous both BioCell continue the this plan a process autologous to Eden supports potential engage allergenic our this partners which data from program, and trial

trust thank It is making this difficult dedication pandemic progress challenging, providers partners, to in the will strong patients employees, want for position but we our time. lifts. their and I emerge and when a during and are

for to like our turn review I of that, With a Sath would call to over financials. the now

Satyavrat Shukla

Thank and good everyone. you, Laurence, afternoon,

with me for the quick our Let results review start quarter. a of financial

development of progress of programs, quarter in our $X.X compared in reflects clinical of of million first costs of $XX.X expansion The for IP TCR the increase the NCI, program. expenses for research our and noted licensing including the with assist As our XXXX. QX from XXXX, were associated to the million unusually,

to manufacturing Libtayo. with MD to cell cost CAR-T Anderson continued reflected expand designed for and of study trial therapy, X our Cancer personnel enrollment and capabilities expenses our allo phase research IL-XX the once Center Manufacturing with combination CDXX increased Controlled therapy further on gene of

XXXX. expenses capabilities G&A of and first to our those expanding the personnel, our and other facilities associated related key business, a extent, expanding the $X of our to this first growth increase portfolio, of XXXX of headcount, patent support quarter majority $X.X were costs The expenses. such as for lesser including with million to compared reflects increased million of our quarter recruitment for the the

$XX.X and XXXX, for basic a the reported $X.XX quarter of or loss or to $XX.X we a share shareholders Comparably recorded of On net basis the of share. million diluted. net Ziopharm $X.XX applicable of and loss million first diluted in the cumulative to applicable XXXX, common per shareholders quarter first common per basic

March was from our financing. marketable and Cash million, recent XX, securities, as XXXX, of $XXX proceeds including

work balance to prepayment company also for by $XX at of MD had Anderson. we million be addition, In conducted approximately a the

to the in for Houston to and is TCR the funding allow cash add And build mid-XXXX. position programs, Our sufficient and in will to hotspots our personalized infrastructure provide enrolling arms. to all us trial

program, to for support recruitment IL-XX support system our new will the program, our of to TCR-T commercial facility proprietary for of which the arm, out Anderson, program. TCR TCR-T library as for clinical our build expansion also TCR-T continued hotspot campus potential and path advanced on foundation serve the personnel with a MD specialist Controlled broadening our the of for the the Proceeds of initiatives continued

studies state As and towards you indications. other progress potentially later

And finally, will and comments. personnel the final With to I turn over both to take David manufacturing TCR-T infrastructure. that, with for control call of

David Mauney

Sath. you, Thank

very be of global capacity Laurence mentioned the from in the proud are earlier, we operating the pandemic. full midst at COVID-XX impact As to

protecting manner plans. of and to as we mindful execute very and well-being the a been our employees. prudent have in And We our strategic will safe continue of operate on we health

of progress the our phase first recently. expansion in a will laboratory have We asset made key our be which strategy the tremendous an Houston, completed to down believe buildout road. commercialization the we in We

when complete support patient to to timeline Ziopharm’s dosing in engineering operational runs facilities, working are NCI, reopen. the We at the they for

FDA pandemic TCR-T our during from received instructive in the also the with have trials to regards Houston. feedback We

awaiting SIV RPM, We are enrollment. at are to all along trial, Anderson and begin CAR, MD our moving for allo set expeditiously, the

is progress complete transfer BioCell tech well. very buildout Eden an IND Our and with our going are

support IL-XX driven our on and our Our in the great by own teams. execution clinicians remains by of tremendous track, patients

milestones this throughout We anticipate our in year. programs continue meaningful to

approaches. platform We have company especially multiple X primarily build to XX tremendous progress solid last worked extremely the a over made strategically hard and tumors targeting months have to with

efforts for to rights enable therapies, foundation building all which effective with the solid generation the have our We during potential tumors. in next experienced We this we space, to by address our pandemic. a to scalable these full immunotherapy with strong potential dollar currently cost Like have multibillion markets. others delays treat a commercial patients have

to strategic and have in continue to appear see data. dialogues position, we our cash engage expanded both And in-licensing these clinical with discussions with we However, who out-licensing our potential. strengthened partners, enthusiastic include to

for BD flexibility assets. Our anticipated advisors term year, our course and new provide already core the over and our value. options outside plans with data shareholder with enhance human process With this expanding and counsel each advise internal ultimately review on to is headcount, and valuation to continue of from supported longer of

Over and are to our and employees year, just our focused in significantly on XX TCR-T over have many XXXX the in today, employees December past XX whom from located carefully Houston of expanded program. team we

XXXX. continue to We growth expect in targeted

core tumor and phase Given that to our programs it’s we important entering also we our solid strengthen capabilities. in senior each X, that of or think continue are team

Medical programs. search Chief drive that end, drug and additional add also our senior we’ll Officer, business in executives can developers, activities have as a who across we To engaged as for our further well development a

important our of and needs as last and evaluating the further bring increase expand business believe will refresh in to to able investor all have our organization. our been addition contributions whom capabilities also our are with better of X shareholders strategy. expanding reflect to the board relations new developing XX order our engagement we months, growing with Also, over know, shareholders and directors, We the of we our

well next suited this enter one so into trusted we As our a we activities. our full us are that board, business anticipate of complement leaders our to move of execution, guiding with phase drug we addition development, phase and development to financing in next

our to thanks sincere our and my board express team, to want our I partners.

times the unprecedented Controlled these achieving CAR-T. including during meaningful teeth forward move for across IL-XX and and still each to with board, able of been have We RPM TCR-T, this programs anticipate milestones our year

presenting the year. participate in upcoming look forward data of events will industry and throughout the also a to ASCO We at conference variety

In with closing, our financial and we the are base. in plan the with on executing a assets, right right strong space

push we the we you path on world thank your continued continue paused appreciate to and While forward company. that the as a ahead. is We to has acknowledge support, exciting moment, move all. continue And we on for for placed as the stress now especially execute progressing and a

And the for now, I any call the open will up operator turn to over questions. it to

Operator

you. Thank

Please We our Our Instructions] question-and-answer with conducting be will question. from Young with first [Operator now Alethia comes Cantor. session. question proceed your

Alethia Young

that of like like and are kind sure queue, for puts MD can which I’m times. my getting or taking kind of and are how running, you want sure questions back they the congrats studies Hey, throughout on on NCI Anderson of curious just get much forgive back and kind about, I’m takes studies up the their I’m this. One, Thanks to? tough and quarter guys. the evaluating offer how progress in the navigating and not what metrics what the for to

And about forward the confidence get IL-XX what just PD-X gave what and of can and with you talk the Thank moving data, kind then, combination you. of you then steps program? you that next Libtayo, about think with kind with you results, once how

Laurence Cooper

in Thanks, welcome Yeah. the And story. Alethia. to also, Ziopharm you

X trials that important and them. would half of us for I of a guidance terms had out maybe Morgan in framing JP think obviously at NCI MD the be it’s back But statement, also we for So hit. major in just put Anderson, and the that XXXX milestones first we

data For IL-XX combination instance, be would on X would we phase we Opdivo, have complete readout readout data. for with With – for our enrollment Libtayo, our data would monotherapy. be

on TCR, we addition, in clinical allo patients Anderson. a placing with Sleeping the patients be trial And to hoped the the enrolling Beauty at at trial on NCI RPM and

X of be So if And major milestones, those those you strong just kind that they at giving guidance we’re will hit. there. of look X we’ve X

and MD that a Anderson, the us, factored thinks pandemic not partnerships United turned and way across so Now, the just about COVID-XX back it is the Ziopharm hospitals spectrum, really off in reacted regarding the light like impacted NCI with the States, but the the in They appropriately forth. when patients they these March, switch. oncology as

sure That NCI the reopening. to and is indeed, beginning loosen. And a now Anderson that’s same Alethia. MD But the towards saying are I’m are gingerly thing. process others heading

what done regularly. frequently to So those has is Ziopharm and with communicate of institutions both

others. they and faster are a than institutions. And also own this instance, NCI priority and forward Steve trials phase to them for that MD For these talked that’s NCI, as at will Anderson, week, the trials important, opening, essentially to to our at that just hear their essentially in Rosenberg I talked I words X MD will because be selecting their the Anderson from leadership go in

believe every part that And first wave. to we that and are reason of exciting we have

addition to they all essentially have worked with they reopen. in to pain have them we minimize So that, the when of

For MD instance, we a have Anderson. JSC with

working We’re as with they problems same senior leadership with said back actively their online team. can come be And the through NCI. the

to. just we’re talking Dr. Steven not It’s Rosenberg,

facility, it’s whether We’re it’s it’s entire team, scientists. talking the whether the leadership from or GMP entire whether to the the representatives, purchasing,

great among us wave the puts of that open the All trial, be to that, first in happens. essentially, shape when to

been is The hard in very laboratory And expand either. that more to has there, team footprints add one still and our haven’t I’ll piece Houston. that just sitting Alethia, we worked

These off some human instance, already because the NCI Sath and David to as recover. for work they efforts capital are burden You we the the additions. about talk taking off, of are paying well heard as as the

engineering launching can we’re we be patients And that essentially so that they call into essentially when that box we open. so what can accrued runs, tick

many, sure one. first to it’s around longwinded But answer be will So your questions a I’m this. many

a comments just I set give fulsome there. to of So wanted

the Libtayo and The the steps. with PD-X second is next study

trial the with is the X tumors. time done phase the first the with phase that really understanding a really X trial brain phase Opdivo. stage be off treatment of the a inhibitor checkpoint builds Regeneron. So this it can for partnered with for And sets X trial IL-XX That

call. And some that We’ve been out the indicated. earnings repeatedly way that patients reporting patients guided, as Sizeable accrual Libtayo to trial. we’ve to for year. forward median finishing shortly, excuse data accrual said be will data are me is these this that we’ve – by will done. we We, on going these has measured first-half really on – ASCO said finished essentially a as data in survival. overall X of for we PD-X then be going phase we with and And will be – of at The We’ve number incubate. And be the the trial. are

And we the therefore need understand median time overall survival. essentially to

Now, that, additional in I the not hope the study, only study, in for which we bubbled data monotherapy demonstrates that IL-XX some – up Opdivo brain having and agent is therapeutic think, really a the Libtayo also there have really said are interesting, tumors. also in that but

biopsy just a important their MRI been diminution out we we’ve lesions. multiple are show patients, based And imaging, the on mechanism are immunohistochemistry. having but action in instance, For where studies not X now of patients to and patient, quite reporting again elegant doing

full enthusiasm, program. to more make for So, Alethia, wanted sure of wanted, GBM are have give the gave we perhaps I the you sense where the you than we you does that but I and

Alethia Young

Yeah. you. very That helpful. Thank was

Laurence Cooper

Sure.

Operator

Thank you.

comes question proceed question. Novak David Please with Raymond from your James. next Our with

David Novak

X timing. today guess ones I Thanks on for for my Good questions. quick afternoon. taking me

were And would some in I to in have prior some CARs. validation was SP allo to some [manufactured rapid with think looking really third-gen The data [ph] been being, around to order forward we in in first CDXX hope garner the which the dose QX, to one that have the trial, we market back there respect would enabled] October, impact. patient first the here COVID-XX

or to hoping here was any? that technical I might able just play otherwise, discuss clarify have COVID-XX So as beyond into might be the that you come challenges, of some or

Laurence Cooper

And you. the I line, David. Sure, keep the I you on heard Thank think well, second question. because let’s

trial enroll So actually Morgan reacting hit, guidance really That the the RPM we would indeed, trial, the J.P. MD to Anderson’s XXXX. out half was we that stood following allo of first put situation. the frankly in still that quite MD terms the of guidance they until Anderson in react patient at in COVID we and at and as really lead pandemic

robust remarks to to the Anderson really really I prepared we everything trial. effort demonstrated highlighted my we IND, to achieve needs today, In to that some that And this went manufacturing have we’ve done is IRB, viability. we it MD repeatedly show like XX% the the have has open

MD So And of COVID as partner soon us, that and be last ticked, in said I think, the we last be kind after responded But down work partners, our site literally Anderson, earnings call, – just to box Anderson. we hit others COVID. not the they are will ticked. of essentially our visit appropriately all And ready. their at initiation with to texted slowed but MD box the is

What you’re is I top me this today hearing of from think loosening. on that,

obviously, certainly get expect going. But fluid we you ready pressing side, an side our MD But situation, this. a so prioritize that really as go. from trial we’re it’s can’t they time. can we’re you I really And to the so on hard And tell Ziopharm from I Anderson to exact give their

David Novak

enrollment estimated just first and more once you give what Laurence. that enrolled example, the trial, you around be interval of could might lifted. and us look bit quickly think for gears, first been secondly, TCR-T dose? restrictions timeline, have actually Thanks, how patient detail a between Great. And like switching that post-easing NCI Could restrictions, and

Laurence Cooper

uncertainties question around Yeah, a really on the thanks, building COVID-XX situation. David. the Again, critical

the sort be we last from as the runs numbers, the robust research were so market, to the and NCI was COVID to going it the auspices environment. guided perspective, bench but our about of be under NCI. a hit box runs checked. and that from was was to that scaled have there these engineering of wasn’t earnings more the achieve transition or to So world a call unanticipated, necessary Those engineering essentially GMP There essentially academia underway, a when

online, offense into So up and around a we engineering put essentially laboratory are place those runs. in Houston entered in assets of MD in our and Those campus. hurry sort additional are Anderson undertaking they and assets

still to that, I’m hearing has sure, So following. open. this he’s to essentially we’re half in to NCI COVID, it be you’re factoring first online. our again, that a move think think, Prior a companies COVID the assure of should the I’m back as communicating to your they as will they some that trial Rosenberg, come of priority. phase when I dosing But Obviously, rest you uncertainty that And help guidance when for patient I was first Steve in. XXXX. going big this fast you’re X that for as David, and around possible talking many put this we’re

David Novak

I’ll Well, you looking very to and back that Excellent. data and forward hop at the thank in queue. ASCO, much

Laurence Cooper

you, David. Thank

Operator

you. Thank

H.C. question. line with question RK Please the of your Our next comes Wainwright. with proceed from

Ramakanth Swayampakula

you Can Laurence? you. okay, hear Thank me,

Laurence Cooper

you, RK. Yes. Thank

Ramakanth Swayampakula

the questions of been some have So answered.

would and another So for question Libtayo to next Sath. what from be the just trying the trial, steps also understand,

Just to saying others. expenses through with

of are terms they So and expenses. in numbers R&D your – operational other

Laurence Cooper

will repeat question for your just because I purposes. Got is faint. the transcription it. line RK,

the expenses is So me to to Sath second and around is operation. first the and

in the question of year. on that the – what really enrollment Libtayo builds off step? where next saying, trial first is the what going phase this So we’re half to Alethia to So X was complete your and

really at be this survival. top-line data asset. to median for then the Obviously, out the providers reported I enthusiasm It overall think track so. meetings. on and essentially is the will do That patients data demonstrates upcoming We’re around have

reporting their patients as essentially So these be we survival, will out. through that mature

shown the like as investors, observations working we are will shrunk for tumor that past is have potential action. our actually we MRI IL-XX data for we the in show a datasets of biopsy to other And again In the on mechanism therapy. the of result where have also, interesting addition, hard

that you cold would, IL-XX So turning, hot. tumors if to

therefore out some inhibitors PD-X with put encouraging arm earlier, program in think we in compared past, steroids. monotherapy robust monotherapy I who to the The low be this survival quite can have very we And itself. data of obviously, the the subgroup patients, dose started looks

data the would at And trial I from so forward designs. I we’ll going them the data to to if And help be combination how update could, will package compares the advanced looking with monotherapy and package part. that financial more because, an obviously, steps RK, Sath then next for transition

Ramakanth Swayampakula

Thank Thank Laurence. you. you,

Satyavrat Shukla

Yeah, sure.

are How Laurence. thanks, So you, RK?

Ramakanth Swayampakula

Surviving. good. Doing

Satyavrat Shukla

All Great. right.

So to just this R&D, as the about quarter answer by last our spend your for up saw for quarter. question, R&D I went you it, our is that compared $X-million-and-change understood to priority.

we year. we after have So ramp the compared trial And some the take down, that, then will middle by a place more expect costs people of COVID we last notwithstanding, will to but had to year. would similar sort of wind than

bump, flattish the year, year, the of – up ramping and of year So after for I up middle be the can probably to to of sum next for I some R&D this that year. near-term rest then starting flattish, R&D of a the before in the and rest so for expect you outs ins a

four partly actually change that seeing in by say, end XX% you end on saw G&A. the we dependent we’ll some want as to ramp. be But probably G&A bringing a so bring and up comes will On on senior somewhere by a be did the in increase of G&A, disclose of on the more the quarter year, It’s that’ll side the some personnel, we let’s – we I when in. expertise

precedence, ramp know want a take as we the So the really will Did the R&D ramp, that you go to than because frankly, route is company, your site. be with spend answer question? for R&D that’s that the slower which always

Ramakanth Swayampakula

of you much. you Perfect. guys. both Thank Thank very you,

Laurence Cooper

RK. you, Thank

Satyavrat Shukla

RK. Thanks,

Operator

you. Thank

from with the with question Capital comes Flaten Thomas line Markets. next Street Please Our of your Lake question. proceed

Thomas Flaten

the around Thank was trouble TCR call some received means. description FDA feedback study. the And guys instructive I if wondering from me with I you earlier. help you Anderson the respect could MD understand more to given had for taking was had you. And thanks I that if questions. if curious And some the what you the didn’t, you with that

Laurence Cooper

instructive. Thomas, actually, you the word actually, caught with Yeah, it,

So we very FDA was a fulsome. data. It was this despite the that’s touched with because Ziopharm’s from process. on really through pre-IND they stress the to very, they’re manufacturing. going guidance provided with you to we’re data, was responsive preclinical us That tracking be And COVID, forward, move It dialogue IND. and were CMC under helpful, as know, sponsored

that is others personalized not the are covers receptor antigens patient. for targeting therapy, the to that therapy unique neoantigens, therapy receptor And perhaps just to individual call, T-cell and only the on that’s I’ll amplify that say T-cell personalized

And will real very so that Steve T-cell we looks a the whereby have the IND at neoantigens the be FDA those similar talking with in X Rosenberg, we’re about to that we branch phase process time. generating against receptors with the

of dialogue. FDA part one that’s the So

I was around hotspots. kind in Those words the shared that or a are are T dialogue FDA of science are but in shared receptors. the that of part receptors T-cell cell use, library means really second allogeneic The that against neoantigens are what antigens

going Nothing that in from surprising the feedback expectations – plot are indicated those on factor team It really, FDA. a these should and that, forward. company essentially from too gave was the So comments, the what earnings have has we That’s They been we’ve forward. really next our – as the know feedback we of path the the were IND? both you as sponsored more that sent investors, We FDA the for think, for feedback. for helpful and on FDA have helpful. how I into received reassuring on that would and really we we investors me, call the prepared COVID-XX a in remarks the was

Thomas Flaten

then… And Great.

Laurence Cooper

Company. please. Yeah,

Thomas Flaten

could a you IND Eden with down no, what of we how And that you. should helpful. submission narrow Thank I IND first No, one, beyond very then to respect That’s timing then bit and if submission, to wondering – enrollment? about little the patient BioCell, timing no. the think was

Laurence Cooper

you. thank Yeah,

BioCell, And work headquartered China. Eden the so Greater they in with are they have for Shanghai, reached but across

presence. major of in there. with at this will not be Taiwan strong a first Taiwan significant, work have the does The will because their And part moment party a hospital be

Eden So this among first in the CDXX BioCell be space. could

the rapid IND be you frankly, a detail general infrastructure very, do able reminder, to patient Thomas, – owned will of as think Eden have and Mainland they this a the the group the that China that well. that, is a in in BioCell like for manufacturing I’d appealing group Eden as more submit side, that the to from provide and to And investor BioCell to we Eden be the and population us sort hopefully informs clarity. year. quite system, tech-transferred very There I as sit XX-XX ready with BioCell. we statement, with Taiwan

mean, with the really they I So out there. think lot very is upside heartwarming upside, have group very, are and And our rapidly. actually and that for achieved of justifies moving the they with this them. is quite there very investment I an trust infrastructure, a investor scale,

Thomas Flaten

the questions. Much much taking Great. Thanks it. appreciate for so

Laurence Cooper

Thomas. Thanks,

Operator

Thank you.

proceed next with Our Company. question. Yale Jen Please from Laidlaw & comes question your with

Yale Jen

for movement, taking the point. this glad and Thanks I the have two progress at forward questions questions, here. the

MRI as as Is to two combo that well as presenting in wanted the meeting as biopsy you clarify were is data that the well one correct, the of treatments. groups ASCO also first of The mono? of

Laurence Cooper

Yeah, yes.

well IL-XX data-readout at sort phase the have ASCO, cohort, readout of in with expansion monotherapy as So IL-XX main study along we Opdivo, program combination of the as X and of the as Controlled with Controlled the X phase program the yes. will

Yale Jen

on the be second gating IND they this Taiwan? which that follow-up factors is at what before an for And is one previous the in one, point file to might Okay. the – can Eden

Laurence Cooper

Thank Okay. for that. you

they’re FDA, there a my be if Yale, So, the TFDA, is one seeing. of understanding, first you Taiwanese, will programs this that would, to a CAR-T

hospitals and imagine the their regulators. the team investigators hard Eden and of working as education regulators really can BioCell Taiwan dialogue with to principal prepare been you with the investigators, the as – under well TFDA stage, with So in has and in

say good that, I say couldn’t will already wasn’t received ears. package, if it all this done. that not means it think to given will guidance now except open in in year. Taiwan. group with transfer in, the significant from United have specific on package is a the been date when us essentially here there we’ve news, then goes will in, a And because been I and be go be tech that preparation essentially, That the that to in process, That Shanghai the States, course, of there’s

Yale Jen

Okay, sneak one question great. I And more can here? in

Laurence Cooper

Please, course. Yale, of

Yale Jen

you which text Which that to you is in opportunities that you mean, – have contemplate. mentioned – I BD you the need always might the that there’s script

out So States, want the and for partner that in have the to one likely I’m just your determine sort potentially you or asset? Is there assets one rest the curious, as among we’ll any be the currently could United be keep China, the well be what any of potentially value you or X a world the except as metrics full go X house what priority have of can to of will through to you most will to the –

Laurence Cooper

which – my Sure. one best. That I asking of is asking like children you’re Sure. do

Yale Jen

And get they different… all

Laurence Cooper

We that’s GBM how operates. have members new how to friends that’s the all about there an So, built suffer and drug in and look, We company who family age. they I’m – Many are disease. this hasn’t they a recognize – have of all solutions problems. been for think from recurrent us, and

that our We using solve are problem. talents to

comes that you see such And weapon, for IL-XX development and potentially into platform, we for more, them more turn to hope and turning As intertumoral drug some essentially hot. guide at data ASCO, a a IL-XX more around data cold can that IL-XX you’ll do that GBM. like useful will of is the out, delivery since we of

Board bubble survival. asset] be our that it will entice ourselves with build the essentially to want around our really could That [IL-XX data around median prosecute the partners that overall and could we out develop [ph]. up to program something own that And that or

program, off abstract. For perhaps the all is about, largest to genetic goes to that’s has cancer, value of cancer. mean, I fundamental cancers, address that know, in platform technology the we’re you TCR Yale, that that as ability the causes the mutation insult, the the driver talking heartbeat probably the genetic

had And in now target to and commercialize that that business that major tumors. already effects know neoantigens up it. the have we’re We therapies solid in scale

say that comes data groups that indeed, as obviously, remarks, in it around we’re push activity. but that David and talked So, to, in, could BD we in heard And we would as prepared really as you his to like already aware as hard result of that. possible,

sensitive China, BioCell CAR-T, advantage with avenue the the doing is landscape, a BioCell Greater advantage own developing see spend of of that work Asia. for investors and the the then, then Eden really being new for you in taking Eden already whole to good our and us And can in partnering and taking

day, and think to great the going it at forward. partnerships I we’re of it Board as be hearing to shape and the the you’re ready So in that needed. investors. worth to do end the we’re team And has But the to to

David Mauney

Hey, I’ll data Yale. This clinical lot drives add is these a of David. this. Obviously, discussions. just to

We pretty CDXX increasing IL-XX behind time good during ongoing a a good during actually pandemic. to I of think our a an have keeping sooner has the these very worry, of and them. TCR-T data Obviously, assets job, fall dialogues with level done of job

a When solid we company company. Ziopharm as about about tumor it think we as think a though, focused

highlight that are to partnership for own as to point, add our Lawrence as U.S. there point so, working that efforts as Eden data highlighted drive quickly in hard so final just wanted as discussions with ultimately data will possible, exclamation an believing along can get we allo BioCell, you. we the that for asset, just to very that with much as And

Yale Jen

Okay, great. keep safe, lot everybody. a Thanks and

Laurence Cooper

you. Thank

David Mauney

you Thanks, too.

Operator

you. concludes session. question-and-answer This our Thank

turn the to to like I’d So floor for closing back any additional over management comments.

Laurence Cooper

and forward you call coming the today. virtual be you, you, day, and most everyone. thank as over everyone, months We The for that investor important well. part thank in Good conferences safe joining to August. earnings updating such us is look Yeah, and operator, on our next

Operator

for conclude thank gentlemen, lines this and We this disconnect your does participation today’s and may Ladies at you your time. you teleconference.

Alaunos Therapeutics (TCRT) 7 May 202020 Q1 Earnings call transcript