ZIOP - Earnings call transcript Q1 2021 | Alaunos Therapeutics, Inc.

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Operator

Thank you for standing by. This is the conference operator. Welcome to the ZIOPHARM Oncology Inc's First Quarter 2021 Earnings Conference Call.

As a reminder all participants are in a listen-only mode and the conference is being recorded. After the presentation there'll be an opportunity to ask questions [Operator Instructions]. to President, conference Communications. Investor like Levy, to now Vice Executive Relations would turn over the Adam I and Corporate go ahead. Please

Adam Levy

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

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

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

Officer risks time-to-time. and are may uncertainties have, who'll Medical will today our XX-K other subject we Chief in our on and numerous brief present from XX-Q Baffa, we filings an overview our that statements Officer SEC described On Dr. financial to corporate and the as Chief filings who update Heidi Raffaele within a present call programs. with and clinical and make Hagen, Interim Executive Forward-looking summary

our EVP Chairman. GM addition, joined Jill Groot, James our Executive Operations GM and Huang, by In Gene of and Strategy and we're and Therapy, EVP of Buck, of our de Ellee Cell Therapy

the formal turn Heidi to be will I'll whom please Hagen. over go by part of up the remarks of Heidi ahead. after we'll Raffaele All get call which and Q&A and the started, to Heidi, open

Heidi Hagen

our progress to pleased Thank on this update everyone. you, Adam, I'm welcome an and quarter. provide

focus, an we to we of shareholder prioritize portfolio, allocation. focus The long-term. over guided of moves reflecting achievements building strategically our first emphasized and give several I this capital made value would we've quarter and by execution as the one as like overview was

venture partner quarter, This providing This this the over trial TCR-T We continue important conducted own in forward made the look Eden expand by GMP be completed CDXX-RPM our followed facility trial control manufacturing the in GMP joint for year. to infrastructure trial work. validating our to expanding to construction first the the supplement by CAR-T the the and BioCell. facility was summer. the capabilities own We will our TCR to cell our and will qualifying updates partner's patient progress the being and during meaningful the the and Phase process our therapy I CMO of qualifying the the TCR-IND second our facility half We at Anderson. to During first adding will facility the progress destiny be on Phase we as capacity our of company I MD allow with patient infused in quarter.

accelerate complete We have made trials. today announced the to wind the difficult down existing and of our decision clinical IL-XX

taken that in deployed not decision believe have benefits board therapy. continue and this of management We resources But lightly. elsewhere. the and remain to this to potential be better capital partnerships the We open and experimental can team agreed

technologies, therapy IL-XX gen our associated XXXX of end evaluating our the and synergies anticipate represent program IL-XX total next of program. with we explore we have closure the of cell XX% These number headcount. as small addition, In the through layoffs a existing approximately reductions begun of We between program.

over Also, to CDXX-RPM year. I CAR-T of resources We will the clinical the we growing of be reallocating support capital program Allogeneic trial. anticipate the the closure remainder our Phase TCR and human

needs. the one million this and on program best investor should XXXX smartly board our and Eden are giving future with $XXX.X We Management focus conducted and of BioCell. in Taiwan two partner could quarter be and late us Our be our define our joint focus quarter working by capital being CAR-T diligently extended. venture into ended runway management to a believes approach further for cash

have we as can raising Other approach. and our committed consider say details today. during we and first We'll financial capital previously, have both found near in implement performance the on press As shareholder discussed on which our be in value were quarter issued to of term. this our are the XX-Q we more to release earlier

has Regarding I'm our continue progress execution our made an permanent the set identifying pleased a strong on Chief the board who initial a to all of search deliver candidates. seeks for report can for stakeholders. individual and drive Officer, success that Executive to board good

We will continue to it progresses. you update as on this

investors This over will Medical the that over now remind Raffaele, on Officer, we Raffaele? shareholder execute virtual participation look With continue to be to turn forward to want strategy. will Baffa. Meeting our Chief I on to our Dr. we hold Shareholder as that, meeting call a Before I will to call Annual our I we turn XX. May the Raffaele and

Raffaele Baffa

cell had our our me of programs our the from chance to Day detailed Let event by overview on have begin March. share posted R&D held to are in we website. pleased how during therapy saying Materials were that

the made are down event work [ph] increased redirect Sleeping to populations program. IL-XX cell the the give to on time existing update. our the neoantigens quarter, monitor T cells we to last on our us decision in provide highlighting transfer today clinical specificity of the website. characterize report of neoantigen meeting difficult in the evaluating the a and data specificity resultant at abstract the accelerate work presented and Heidi that appropriate continue will of patients the and and QCX the Beauty AACR our poster We'll deep company as and mentioned I TCR enrolled. the on KRAS engineered of At TCR-T system of Given dive transposes ability poster for back our confidence wind These available non-viral to brief a function. gene has very to already the

is anticipate our sharing potential Eden pleased patient our announced progressing believe Taiwan. in using note to our system were on, the that of we CAR-T us second first trial Personalized we Now of in year. It this BioCell We this dose CD-XX Manufacturing and to the This the data important half advantages differentiate have space. technology. of Rapid in is trial RPM

For after days refused cells. genetic two into T transfer patients patient CAR of are material the example,

Trial. our, TCR Library to Turning

making and activity Our good we now progress internal and team We're first manufacturing clinical pleased the the side both on are enrolment on is to have of of the in clearance streams quarter. IND the side. focused on

in half patients treating anticipate to year. continue second of this the We

we enhancements our technology to continue the TCR notably explore in-licensing the additional patient to of TCR we've this next on expect data in trial readout variety to the expand treatable of of our research IL-XX inclusion generation and area, our Library previously to As preclinical In we guided, population. first XXXX. membrane-bound would to to pursue a

questions. provided open that, that reflects for an the pipeline call progress I'll have as updated our in reference. ongoing With posted now We the slide materials a Operator? to-date

Operator

Instructions] Young [Operator from is the question from first Please Fitzgerald. Cantor Alethia go ahead.

Unidentified Analyst

This is on for Nina Alethia.

to in clinical Library So relatively as What get company tumors. trials steps start COVID? prepare solid are Anderson to at and remaining trial normally in running you Thanks. light that MD of are the TCR-T running up the and steady

Adam Levy

Thanks Nina.

Raffaele Ellee to one. and me comment ask Let that maybe on

Raffaele Baffa

question. Thank you the for

beyond prior speed. MD you tell Anderson the and that, fairly the us, can the what and at forward at the after sooner MD Anderson we'll enrolling hope I that's we're with is open passed. patients of COVID So worse we moving starting It's has

Let's say pre-COVID.

we're Ellee, as QX announced to So have year. add we we're confident the going earlier you want of start to enrolling in this do something?

Ellee de Groot

manufacturer team identifying of remaining our in Sure, - our to contract focus said, which being to manufacturing patients. really trial these final do at is that as two clinical thank production. then, for then are qualification preparation you. and stuffs to the complete And and The A; Raffaele able batches

end points we enroll are major of moving focal two and nicely of are able along team give by activities we'll us the those year as patients to confidence the projected. So and that those the

Raffaele Baffa

to that we this patient process add, for the for trial. like started pre-screening I'd already

Unidentified Analyst

Okay, thank you.

Operator

ahead. The Chris Jefferies. next go from from is question Please Howerton

Chris Howerton

can if As the the of there? any program, the expect this wind look guess of I like we year. line in to should the the rest terms over of R&D activities down basically, you IL-XX of some what about changes, the overtime think of what And we for

question TCR-T clarification. What is doing that just exactly than different manufacturing I and for facility a how So is, is now the CRO program that the maybe Houston? cells in The the second thanks. just is the have qualifying and

Adam Levy

then Heidi, and Chris. Thanks first Maybe you want take Raffaele the to the one second.

first for Heidi on the shutdown. the spend The given was outlook IL-XX R&D question

Heidi Hagen

question. the Yes, you for thank

and we've discussed programs. TCR really and before cell programs therapy as pivoting focusing on very we're our much So our

the that to some on we of So ready of from patient and to ingoing manufacturing steps first our dose appropriately towards are getting clinical as Raffaele a perspective. stated focused the getting

direction that in allocation capital platform really will that a attest our moving towards expanding looking us really feel we're we at so move like and And it forward quickly. enable and that speed

GMP where will opportunity past to focus you point. Ellee; manufacturing that's be just expect on is forward, question? in it put our the do can take Raffaele R&D program an focus you going talked and with of allocation we've our we've the I past in for some inconsistent and guess and that had other this what towards now CMO at want and the comment about to capital that So which

Raffaele Baffa

Yes.

so is that not the going the say CPU be CMO. manufacturing What first the name our doing CMO, can time of way? we're double disclosing this [indiscernible] is So at this [ph] I supplementing to we're internal

Heidi Hagen

will And go future XXXX. TCRs us that to expand want enable as and to do work forward how in think in about we we really

two of streams it us So manufacturing. having gives lot optionality a of

Chris Howerton

clarification. Okay add and if I maybe just could

put for described. this the we capital should or any obviously is that your towards OpEx point there'll is basically program you at significant done that So expenditures there be facility? expect as But

Heidi Hagen

Ellee. you, Thank

Ellee de Groot

now is that So complete.

construction as in completed Heidi equipments outlined of and summary So we have the earlier. the her and installation

for it clinical through facility perform of can that for We required will the we are and batches the be process that marching qualification trial. the the demonstrating the

Chris Howerton

There So this ask very maybe no question plainly. to at point? more ones for meaningful capital the just expected is or expenditures facility the

Heidi Hagen

say we're that I now, talking which about would I for capacity would Phase the for be trial.

our TCR where CMO that we that thus at hopefully years. have the moving if expand But the would point, and capacity and further. Phase facility We towards far look III will capacity Phase between so II be may we we'll the built opportunity We in obviously have you with qualifying. - our future amidst have partner into forward very at expect our we comfortable to program expanding this point, and move the we're

Chris Howerton

it. Got

very that's much. Okay. right, All Thank you clear. very

Operator

is Your from Raymond Please question next David go James. ahead. of Novak

David Novak

Just me. one from

forum program. based Could of for enrollment rates reasonable framing a current this like numbers you will March. this patient terms auto for the year? timing of you Could speak on since at something disclosure, preliminary ASH be guys of frame to I'll back maybe mean help leave that we're the in and look expecting probably the Thanks us just CAR-T help data? or expectation in Anything up On half expectation like I there. can helpful. you

Adam Levy

David. add want And Thanks that? then you Raffaele, comment to on additional Ellee, color. you can do

Raffaele Baffa

to is end I expectation said the the year. we the Day, actually have as Sure, by of patients R&D the five six

all ASH submit going want something? the patients Might Now, we that right the you going will a for going believe it to have. that's depends I good is a submission many place? Ellee, how It on ASH, I'm right add to I we're [indiscernible] to make [ph]. be after it's can. ASH not be conference be. sure deadline. will to for feat. But Definitely they we're

Ellee de Groot

don't I have anything add. further really to

I think you it. covered

Adam Levy

Anything Thanks David. else?

David Novak

That's so it Thanks me. much. from

Operator

Your from Laidlaw Jen & is Co. Please from ahead. go Yale question next

Yale Jen

In that possibility alternatives? would our next down. that the license be other CAR-T, you're What's close to allogeneic terms of potential going or

Heidi Hagen

ahead, - go discussed sorry we've and as think Adam. I I'm

really feel As really auto we of we where releases today in our of at and discussed trial we're of just are considerations the I that that We putting leaves focusing Phase direction. putting in the asking that lot to step and it's us of think I to But out CAR-T on the look effort there effort and so we're and a is options what us folks the in really some put future. our one that trial. towards closing like we for of most terms

Yale Jen

since the might status those Okay, just of one Library to the terms the what Library more and here. last R&D maybe Could Is time, at this been update added Day point? question you anymore be? of targets there us in

Adam Levy

want Ellee, about the Library? talk do to you

Ellee de Groot

Sure.

outlined of TCRs, will six submitted we started TCRs R&D those with we six the in that with have As with FDA outlined TCRs. number them promising we TCRs to IND NCI. a licensed Day, be for we initiated as and in our from But the of also and trial the

of over different working I we it' these that and and that working goal through through ones evaluations are TCRs we're towards IND to the want selecting year. XX next the so to So which doing TCRs anticipate XX we add and think actively well those against targets and

Yale Jen

Thanks great. appreciate Okay, it.

Operator

The of go from Thomas Lake Flaten next Street question ahead. Please is Markets. Capital

Thomas Flaten

the Asia. on those sharing patients follow-up updates data that? Any Do preliminary presented a the any those auto in CAR. was Or patients? Just investigator-initiated patients on There near how outcomes compassionate use faring? term respect you'll to from on Is added? patients some on the going anything have of activity and with you be most the there are in six

Adam Levy

provide do some want you James, on Thomas. to Thanks comments that?

James Huang

Sure, Thomas.

law last the year's any related at data have of the We working there We is. information some changes - genetic of under through to the We're moment. continue monitor in the law some to update patients. don't

process in order So adjust legal we're domestic in a that. structure up the of to setting

of on with sure data new or patient So to don't the you. have any we information share

Thomas Flaten

Great trial enrollment. over Anderson. up to respect and are how then looking Any MD are and study It and things update TCR over with on like going NCI at for what's clinical there? sounds running things

Adam Levy

comment Heidi, NCI then do want on and can Ellee, or Raffaele to you add?

Heidi Hagen

Sure.

Rosenberg. technical stated before, and think As think there. issues there. We're of a we facility back their supporter the facility we the But to or enrollment working that in Dr. do don't we their great on I still work bring, they're control patient

of talk our our and it. really the to and with technical protocol our process it's side So outside of and we bounds But advise. continue them

So it really within resides them.

hope concerns. with patients the our them in be that expect manufacturing and But it and up they'll We outside coming soon soon future. of is

Adam Levy

on you on that, want add Ellee, anything NCI? to

Ellee de Groot

with not the technology own our thing forward. are just, are issues regularly. those to kind to suspended said before only at I them to regard of in the we're being details the close NCI going is we're really But on to so that and with The would that really that and that add liberty of coloration trials we hopeful we're discuss unrelated speaking and at move have

Thomas Flaten

Great the questions. thanks Much taking for appreciated.

Operator

the question-and-answer to would the remarks. to conference Heidi turn over closing back Hagen I This session. like concludes any for

Heidi Hagen

We call. really and with to everyone next we Have a speaking us thank great day again want joining look everybody today our forward wish and quarterly you well. for to at

Operator

today's concludes This conference call.

Thank day. have your pleasant disconnect You lines. and may you for participating a

Alaunos Therapeutics (TCRT) 7 May 212021 Q1 Earnings call transcript