TCRT - Earnings call transcript Q1 2022 | Alaunos Therapeutics, Inc.

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Operator

Good day and thank you for standing by. Welcome to Alaunos Therapeutics First Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] I'd now like to hand the call over to your speaker today, Mr. Alex Lobo, Investor Relations. Mr. yours. is floor the Lobo,

Alex Lobo

Officer, today's Good results of afternoon financial me first quarter Alaunos.com. read release, XXXX. XXXX issued release on Mike Chief is We Alaunos available XX, the are encourage Research press President and as a release the Development the Earlier welcome company's with conference months call this Alaunos to and as XXXX, Executive website Therapeutics', SEC. morning results three March the Alaunos press be to well With Vice Boyle one Alaunos' and Therapeutics ended Deniger, and Vice XX, Kevin of for President Form everyone XX-Q quarter Wong, ended Senior, which press and quarterly report financial report Drew quarterly also Finance. audio today The at this Alaunos for filed the announcing webcast. March morning, will

or implied are call through Litigation results could only are that The no under certain the information on public call be differ harbor with to to like potential on required is said, materially future uncertainties the cautioned SEC Kevin? the safe our note archived Please may In Private Kevin most will XXXX. with Information of recent turn May addition, those time events Actual the call XXXX. obligation the date law. is or reference. today's or being business. broadcast there made XX, at and set statements provisions by after Relations this in of update this of today applicable webcast, of associated live Reform of as the contains over section Securities by to reflect the that that due and conference revise information the I call Act as that undertakes circumstances date website accurate would ec.gov. webcast be forth Participants sensitive is forward-looking except this this statements risks to the company securities to and conference for company's any of stated uncertainties covered Investor discussed forward-looking filings With company's risks Boyle. live from

Kevin Boyle

Alex. earnings the everyone you, Thank And to Therapeutics Alaunos quarter welcome first XXXX call.

successful team first of generating clinical We progress has since advance spoke. TCR-T I patient strategy delivering the the proud made the last progress Our and our and shareholder working of diligently been Phase trial. in our of we our dosing to am team X/X value. significant announced recently meaningful Library

our treat expect trial continue capabilities. We in this and accordance to to with manufacturing in enroll patients

details namely We also in been have today's couple both just additional later two today, TCR-T a scientific Drew ASCO on upcoming will ASGCT June. provide call have accepted would in on at posters minutes. of posters focus I that to conferences, Library trial. early and like our

cancers. a lung, duct solid As recall, hotspot pancreas, study Non-small you cell X/X six targeting this across mutations endometrium, and ovary is basket tumor colorectal, may trial Phase indications. bile

matching MD library. based HLA at one our available Anderson patients Cancer enrolling with these six TCR-T cancers are in neo We on Center of are that pairings antigen

weeks The reported cancer KRAS, ago EGFR. TCRs, dosed weeks consists non-small post four patient safety in XX that treated a patient was infusion. now targeting TCR-T is has at calls six Two first for lung clear cells five trial mutation. patient The the the window. trial. library and XX the imaging first The Our TPXX of with and day we KRASGXXD design the one we cell

with dosed the be at will decision dose made a consultation point that second be the trial study investigators. in the will later design, at level. in Bayesian possible With second it the is patient That the

the treated Anderson, patient, XXX have consent we first have or In we As with enroll trial. lung are screened patients to actively patients and we collaboration this and colorectal MD in to working both mutation excited tumor HLA. approximately additional as are for

X% TCRs the found in patients one of greater of library. the match our We than have

and initial expect not the from library first our ESMO year accomplishment We update medical the is represents capabilities. of been potentially or This dose great in has over a first before or out sixth manufacturing, by building the testament a at conference. in provide Immunotherapy product manufactured meeting cGMP second year, With chosen received readouts data to dedication a fully Cancer conference, using to to this the team's provide that suite. clinical AACR patient patient regards our ENCI CRI the last we annual report TCR-T the a the patient in-house half to trial by our do the International in-house intend

will noted we anticipated for We our product this be clinical support allows rest to suite cGMP of previous the one the efforts As in the on quarterly this per month. call, our sufficient current of year. throughout capacity our approximately believe manufacture

However, we we prong implementing we capabilities three we strategy of already working two. are we on program, expand recognize the a require do expand capacity. to additional as this, are which To the that manufacturing first will our

products. implement we our manufacturing cryopreserved First, introducing by working allow product. for This cell that simultaneous includes are further to production will process multiple SOPs of optimizing

third, to footprint. will to additional scientific we Drew working presentations. capital, now highlight shifts. multiple staff upcoming to expanding Drew? over raise to physically like support call I'd the And investigate we turn additional our hire are our as we to Second, cGMP

Drew Deniger

Kevin. you, for first us. mutations Dosing cells solid targeting the proud tumors is to TCR-T hotspot patient team human first step so us our non-viral this for helped in this point. just of I'm to in Thank who entire has of get

ASGCT the the half annual at most for clinical which to present to report to expect Later credible the a year the major initial today, in will meeting. our present data IL-XX at data. second continue forum we We of preclinical meeting, bound we believe is medical membrane program data

establish specifically survival other the to immune responses that this and As kill Overall, hotspot observed therapy support cells IL-XX this cells. advancing tumor XXXX. towards IND the you may a to the specific presentation clinical tumors. has tumors. poster TCR-T membrane T-cells ability the an IL-XX Furthermore, of we targeting in Today's potential IL-XX and potential half TCR- is deepen highlight forward long study the potential the TCR-T expressed demonstrated cell second in to believe to cytokine bound recall, to of will of mutations bound T has augment membrane targeting look lived of cells. We solid program filing been

The an our in-depth ASCO we a follow strategy. adaptive up design, presenting look dosing In look will to addition regimen and at Annual progress presentation trial ASGCT, provide at Meeting. presenting trial poster forward to the an and XXXX

respected a grateful We are to share able these details at to be such forum.

expand our hunTR. team and to progress look development we using to pipeline, research make continues in TCR our As proprietary Hunter our discovery

on the to Board. an to want Scientific update our call over Before I provide Mike, turn I Advisory

strengthened We have SAP realigned cell key with opinion and our leaders TCR-T and therapy.

Carl next significant and is scientist UCSF from involved therapy, Chairman been Kole of renowned sequencing single synthetic a and has generation in from cell Matthew of editing stages June brings technologies, who Roybal, physician receptors, expertise gene including Porteus in Stanford all UPenn, CAR-T virtualization Our strategies. cell cells. coming

cGMP, in specific has from substantial We manufacturing cells therapies, quality who experience and have TCR-T added also Stanford and neoantigen, Steven regards cell especially other Feldman systems. to in

of cell turn Board Mike? guide I like now call review confident will We along TCR-T Alaunos the cutting Scientific Mike our the Advisory therapy. that over the would Wong the financial quarter. results are to for to edge to first

Mike Wong

Drew. Thank you,

XX, ended our me March the XXXX. for financials months review three Let

net first of quarter the XX%. for approximately XXXX first and the loss a the the for XXXX, reported a million For approximately of million Administrative net quarter approximately XX%. same XXXX, compared approximately for $X.X loss quarter XXXX, approximately were XXXX, of Research net share, for first expenses or per compared to the period the $X.XX of net first of of in approximately loss XXXX. million expenses loss of $X.X a compared million quarter General to million for we Development million and share decrease quarter $X.XX first of $XX.X a per $X.X $X.X of were or $XX.X decrease to

As to to anticipate cash of of cash the second quarter $XX.X March and our XXXX, cash sufficient into in runway had operations approximately million Alaunos fund be XXXX. equivalents. We

burn of over $X.X decrease quarter to of compared first million like million, was XXXX, our Our for That call remarks. or of hand back Kevin? the $XX.X closing operating $X.X XX%. a XXXX quarter million concludes to for in to Kevin I cash the the would update. first financial

Kevin Boyle

of part our am Library transformed I be innovative Mike. and progress. talented Phase you, just honored scientific beginning. clinical the patient trial a work TCR-T that the research has is our a of first hard team to into Thank our in X/X Dosing dedicated

this enroll we ahead, to to year with trial. the As closely and we look in Anderson consent at continue work will MD patients

we to also well capital With we diligently working a our reprioritization a the right IND using Alaunos organization and to strategy The our multi-pronged steps are face to the ahead element success. XXXX platform. in pipeline took an in of strategic pre-clinically, effective conditions new manufacturing size of necessary use our hunTR as IL-XX advance second plan discovery critical market well the filing a membrane is restructuring challenging of the completed of towards We invest half identify as proprietary bound TCRs increase to capacity, year, today. last

capital be we as to to shareholder of We will continue work good value. stewards maximize

our on flow we call, million our significant last million, cash year-over-year. for reduction have mentioned reduced a and operating to As XXXX $XX I $XX between expected

will have believe I appropriately dedicated addition, the that focus to individuals us In our of that on we team execute sized pipeline. approximately now XX allow

Anderson partners, employees in our our I talented to support website. posted open team the our hiring join selectively this MD of team, and my journey developing are unwavering positions for and for on like the reiterate appreciation cancer We targeting tumors. on solid have to treatments shareholders our would collaborators Houston

to XX. on be like call our of would as the questions, open that materials our we I More XX, can proxy shareholders distributed information were of connection on place found record general meeting Before of shareholders April remind June our in taking annual to website.

the Chris? will We open questions. call now to

Operator

comes [Operator of Instructions] Our Swayampakula Ramakanth from H.C. Wainwright. first question

Unidentified Analyst

enroll? from good morning, TCR-T This Wainwright. completing of need the for study, to is X/X Kevin. questions Phase And Couple many RK do H.C. how you patients here,

Kevin Boyle

on be will on I we we design, number TCRs we indications. Good be XX patients say value part that a perspective, XX at total patients have And treating lot morning. XX is depend would dose And the solid enroll see. different There as levels, and TCRs. by determine enroll by a will gained of many targeting Directionally, do patients that of how we will information and likely patients lot levels. the with reminder, given be Bayesian find what would Phase at it'll as patients patients between a somewhere tumor early likely Again, this with we treating different Xa out. six given and indications. In the we is to there of of number learning also of different and a different indications a currently from

in trial. will this determine patients part we treat that well, early this So how in of as part many

Unidentified Analyst

that. for thanks Okay,

such So is the it is a indication, that all that trial sure of or with XX it's indication trial, comers designed patients to can of you of goal or couple what more hit the all irrespective part each evaluate is. TCR is at that the you goal an make least since the of

Kevin Boyle

TCRs. alternative there different in to by to treating Now, necessarily value patients be in is different not different use is goal TCRs. and indications But gained using the

these very we'll right we that progress early trial just seek trial. stages. the so learning specificity we it's But as again, well. too now all we move -- we because are to the say And also Phase for reiterate we to data will forward in determine exact appropriate be want to a this we dose in that. with need. do that safety learned X And will early haven't the this I will And us focused this through on as continuous clinic as with

Unidentified Analyst

and of does Thank in disease identifying for these dosing, patient well work, How manufacturing since you a are you, probably one can especially their since at the along the time manufacture of some per enough logistics month. terms drugs condition? current patients patient,

Kevin Boyle

the work talked the trial. MD Anderson we closely that rates, their a at partners the have are of or Well, to approximately Many timing not at with of these trial. those different determine we very have matching for patients placing protocol not patients on about our XXX this for looked Many progressing at clinical starting is requirements the are ready under just this that TCR patients. treatment patients and of trial. They're these journey met

closely working what patients at able we far. with MD again Anderson appropriate thus So at patients time put determine to the the to trial identify time. been appropriate on to the have And at PIs the

Unidentified Analyst

Okay, be the in done bound half and needs the IL-XX program, now before membrane what my second question IND between of on XXXX? last as the filing to of

Kevin Boyle

I'll to turn Okay, to Drew that. answer it

Drew Deniger

Yes.

our will have at cover ASGCT of data. today, we much presentation the So poster which preclinical

that. well. as we'll So And the it We runs manufacturing do the need our have to you towards point I'll website, strategy. on regulatory and

time we next cells, be But will data lived able second with very these year. of and on up especially is And the which puts poster can presentation, growing meaningful. as into half some share clinically take the you'll of so encouraging, be to that and TCR-T preclinical we, see our lion's is completed think us long

Operator

Abbott from question comes next Nick of Fargo. Wells Our

Nick Abbott

dosing patient. that terrific, our Hey, for thanks on And congratulations first taking questions.

we the those facility successful expand how Phase implementation could strategies? How So two for first the X/X, trial month should the do a you Phase current with about treat? think GMP to of many patients X, think the ability Kevin, you with

Kevin Boyle

Yes, what we And upon two successfully question, good is, execute later initiatives. those it's folks I will a we as update Nick. say would

that But with contract about levers have to ourselves multipronged do at And then the now. need how do I we we manufacturing to right think to a quite to other increase our expand scale what ready to capabilities, not and footprint manufacturing footprint. partnership look manufacturer either So up we throughput capability. existing or in our do our share

reiterate different in that position we our manufacturing an process, at. at to regards we're our to when with is play on that provide next to some strategies cells. believe a looking and And be the many is on these But like approach of ramping somebody, and the So plug of to especially immediate likely individual call there not learning that I will more color a would we hire facility. quarterly that increasing non-viral we it have throughput that existing TCR-T an I

month once So that typically there around curve six range learning the individuals timeframe. is of is do hire we a to in three

Nick Abbott

then thank phenotype. the Right, IL-XX alters suggests the you. that abstract, on And including T-cell membrane clearly bound IL-XX, the

central if of to there you'd be you have have IL-XX bound But which the to production a over want highly product move obviously of so memory, IL-XX? And you bound non-memory IL-XX? question, this you cells. think are is you kind would the preferred just these desirable think where do membrane bound over XX do a long-term situations membrane Or

Drew Deniger

it's a Yes, good question.

mentioned, both need have And as patients, so they we to in see which you types of TCR-T phenotypes, one better. cells don't know we is different

data need So show human. the but effector cells we are not cell to sufficient Clearly, stem mouse in memory better cells, way try than to in there's models, that both.

the extra cells So programs. we cells, stem cell our pools T exploring. we IL-XX, have think younger capability cells. both But we're that's to diverse the membrane of grow memory TCR- bound get we something an of in And the boost

decision, to have to going are data drive Nick. clinical that the so And sort of

Nick Abbott

thoughts you, should tumors, there's I that there'll And no Hey, then hunTR. output that also, your last is do that that you about output? begin about on see the but diminishing we neoantigen to point, probably of and think me, for how or also of focus returns. neoantigens? terms is How prodding on in there's so one and And thanks, at and neoantigens point be shared proven hunTR for on technology, then we really Drew. unique think some can the unique

Drew Deniger

Sure.

seen most of we targeting line and a in neoantigens of people tills So with have the other which program screened, the what hunTR. NCI able out TCRs to We're places. have successful in find patients we very from is

in house. do that to able we're So

We order with are on EGFR TPXX, especially to library, and focused grow in highly desired the HLA KRAS types. increasingly

with find to, personalized we to look is we're to our , you As close more more TCR-T. extended be that near may but also to a NCI Dr. plateau now. right we've there, at what that Rosenberg and towards I'll the TCRs nowhere there credo at points biologically

unique some as well have as the in we interest the hotspot So neoantigens neoantigens.

we're time. point think close diminishing this at returns don't I So this to

Operator

Cantor. Agrawal Prakhar And next have we of

Prakhar Agrawal

and question. taking for morning, Hi, good my thanks

So days expectations. up details have up. the for my to missed on that is, any was the XX had you the as patient can patient days first hurdles quick hurdle, any and further give details to on might lines that you dose safety you that safety based XX And clear I out cares of the had therapy given find more share. how a I follow passed the mentioned that And follow on. were can And I this you had a versus built think patient first what in question your on

Kevin Boyle

All for good them. questions. And thank you

are conferences XXXX. second half additional provide data here we of in to scientific mentioned, appropriate going at As the the

this X RAS reiterating So level the is at it's point, the that dose billion we And level. the first cells mutation. have, K was at we're which just dose first GXXD billion, X T

Prakhar Agrawal

And Kevin. now? XX you're you, of remainder right for you expect TCRS should TCRs we year, the of thank with expansion that Okay, further comfortable or the the have

Kevin Boyle

certainly Well, to we hunTR the determine we're our the to excited six having just gets in TCR library expand TCRs, TCRs expanded we December continuously. seeking will our it with from hunTR, XX based platform, progress to made that on

what The is will and certainly grow expand library. we be to find. continue internal of objective the exact based So to ours timing on determined

Prakhar Agrawal

of communicated if And $XX And to case. it. to Got is question, questions. housekeeping taking million, you million on the want one operating trying final just check had for burn to thanks cash $XX previously just that my

Kevin Boyle

increase get doesn't you range. if call on with first reiterate do, four, operating reiterate I it and you the guidance anticipate in cash $XX today XXXX. of for here the did million to $XX look additional throughput. burn the quarter at manufacturing and and that the them But the quarterly burn yes, that We patients year, of Certainly, times throughout between that do additional hiring multiply to dosing that million and

Operator

Thomas Street of Capital. Lake comes Our Flaten next question from

Thomas Flaten

morning. patients you for screened have a greater now? what help Or the more you little Thanks Do that could you taking detail just XXX bit of than Good mentioned have, in looks us I those pipeline fall but can patient the pipeline wondering you if questions. through out. was X% some patients in think characterize Kevin. a match like? obviously you place

Kevin Boyle

MD accruals patient concern Yes, would not site. do have say what single having I we is as with from coming a any Anderson

very through the that of we think that trials so seeing going various patients have screening we I a pleased the have have number we're we open trial.

So a with after as treatment both after that to be we TCR to be found patients on protocol. the we we of available information very in Anderson then been move and an and a the have match clinictrials.gov. to on screening more the find Again with to have clinicaltrials.gov and progressed indication that protocols our potential screening diversity patients treated library, protocol well. MD cancer they and on open at in types that pleased the can also and then And details then on have mutations

the very and thus So for potential in excited with throughput regards we're to XXXX. patient far treatment here

Thomas Flaten

you how anything know that? I you being share the able vain information sharing share around, screening, around might to And about process long on with the from outcomes, time patient can and was wondering if respect off I them something you to to for entire hold took want first be

Kevin Boyle

every is, trial matters little a on reiterate a through is Well, related what from how been insurance once bit I the when manufacturing I'll long identified patient various to days, different and matters. takes our they've approximately they work that XX get is say consented freest and it will administrative process

is ever you quite regards. in out do to world, not and perfect of in of make the want keeping manufacturing and order really next patient. of roll set you I part realistic, team So Where this sure done where to not quite you we're then and it's That's a where begin by our for good the needs to day have that a bit expectations that that manufacturing, there variable conditions do manufacturing. is be the good as documentation next

to about as not appropriate setting is XXXX, cryopreservation, the in of So other memory other aseptic I runs, we implementation process suite be need expectations manufacturing the that Whether rolling IL-XX bound patients for be of of it be and other we things or things, take think well. and place. runs suite. manufacturing number happening will look out as think our will will that There there for be that ahead are uses

going to a to for in to patient pleased So pipeline very with I patient do the month have the and meetings are data here would upcoming XXXX. with one that set flow want the expectations at September. But we're not here a present we unrealistic be excited that of

Thomas Flaten

expectations around from lack just of NCI? you quick question, flow better any final a news And term can set a for

Kevin Boyle

can't I NCI. to speak

appreciate I to So, too XXXX. kind him much all. back up asking be I know running your But of at anticipate and do in getting with would that question. not shared here

conference I on up seeing will all call. today's their And but for it'll queue. to you questions think it's in conclude the progress. Thank no NCI participating. I'm ultimately further This be

disconnect have pleasant You may day. .And now a

Alaunos Therapeutics (TCRT) 16 May 222022 Q1 Earnings call transcript