Alaunos Therapeutics (TCRT) 14 Nov 222022 Q3 Earnings call transcript

Good day and thank you for standing by. Welcome to the Alaunos Therapeutics Third Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]

today’s being that advised be conference recorded. is Please hand over with to would Investor now speaker conference to like Lobo, I your the today, Relations. Stern Alex Please go ahead.

quarter to Good of webcast. audio the A available through that slides, be Alaunos And the you. contains note results on welcome presentation webcast after are Thank Therapeutics call will morning. Please today’s third our copy which XXXX today’s and audio financial conference platform. call. the website available webcasting

announcing release encourage press results a SEC. today’s this issued Form Alaunos morning, the ended September the We this three XX-Q the XXXX. press as quarter filed ended morning on September everyone financial with months quarterly well Earlier for read report XX, the Alaunos’ for was release, XXXX, XX, as to which

report release will be press alaunos.com. website available lanes company’s and on at also the The quarterly

call to the there In being company’s addition, and Investor of for will website is this be archived Relations reference. section conference webcast future the

that live on note Act information discussed the are XXXX. date only XXXX. Securities information as Litigation is call time that covered provisions XX, this Harbor of sensitive cautioned today’s of Participants contains certain of under of this Reform Safe broadcast, accurate conference November Private Please the that the call

the sec.gov. Actual in with the with forth on company’s by from recent set business. today’s risks at results could on uncertainties and those most made are associated differ Information implied forward-looking public call risks SEC statements materially stated or uncertainties due and our to filings potential

may circumstances revise live of after applicable to no forward-looking events undertakes webcast, be or statements securities by this to obligation laws. any date update required company The except as or the reflect

Mike Srivastava, of Vice Boyle President Finance. today and Officer; Executive Operations; Deniger, Vice of Development; Research are Drew me Chief Senior, President of Vice With Wong, President and Technical Kevin Abhi

turn that begin. Kevin over Kevin, like I would to call With you said, the to Boyle. may

We you thank over on weekend, morning Veterans year. And country. to just past that the have served for appreciate folks joining we our made I finish an we want to us Alex. as everybody all have the this you you, Good today. Day progress those Thank remarkable to update

can you technology, and into development transform research diligently four, to meaningful see our As on promising team and clinical worked efforts our has progress. slide

very response are report the level. TCR-T pleased first treated with confirmed for more achieved patient our to response happened in-human clinical first We the in cells. we that at dose even that It a this Beauty impressive Sleeping is partial trial

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operating and In at our time, manufacturing products throughput our updated suite, standard increasing suite. additional hired we same the personnel can procedures in so we have state-of-the-art cGMP multiple our potential manufacture

successfully at produced high our dose level. the cells quality clinical second have manufactured have consistently and scale We product at TCR-T

add to to library, cell addressable continue TCR-T for We market our our TCRs program, identifying increasing hunTR advance thereby our new to the therapy.

compared engaged while to spending good to We our capital than stewardship cash to demonstrated of committed we believe continues year. remain have our as strategic our programs, with spend. advance last and prudent I being highly shareholder of our less team half employees

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provide Additionally, facility. also these KRAS can data concept cGMP TCR-T as TPXX successfully proof doses cells at for both our sufficient manufacture and we manufacturing that of mutations in-house

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that to ago, by team want good Kevin, months contributing be Thank to I incredible the I with treat to Having patients solid Alaunos thrilled part joined begin am saying use to and and everyone. this technology science fantastic morning, be the to team you, of how tumors. and three we

our patient to team, very MD Drew, a I improve trial. highly internally, are our motivated manufacturing are led product I PIs with engaged have NIH on who capabilities. as pipeline. our productive Anderson R&D to I patients the expanding additional and together to work by be am enjoyed I enthusiastic we motivated days working place from team my production and closely thrilled expand with And to continuing who conversations old and know whom have with fully our

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we manufacturing capacity. Now patients executing a as screen momentum expand our in builds, the trial, and continue we on additional to and enroll multipronged are to strategy

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Good have work morning you on to you, to Thank with great on call. the again. Abhi. and everyone Board It’s you

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was our Our goal hotspot that in hunTR and screening the we presented establish platform before accurate a towards to study is robust mutation focused move approach.

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KRAS, in mutations plan the more and EGFR First, mutations the we library. to existing add to TPXX

cell Second, patient this believe therapy. could existing will mutations. the we to more We population restrictions aim expand benefit add HLA the who from to TCR-T

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XX. slide to on Moving

of quarter, for the XXX studying. of interested are hotspot During in prescreened tumor mutations solid presence we over we past samples one the

HLAs, as also proportions We looked viability, of tumor factors T and prescreening -- process. and part other of at cell infiltrating relative screening the cells

are with TCR in samples under initial treatment comes indications we that an for are roughly a discovery diverse efficient set and of representative period. from samples, them possible populations. a pool solid best From continuing cost-effective group of find investigation currently our short of the tumor full to the way workup. The of This a quarter of was time tumor

lung are We based dominant cancer. tumors, GXXD their and and KRAS mutations, EGFR and gastrointestinal LXXXR two the GXXV which GXXC, mutations XX in on EGFR at mutations, deletion, in are lung in We looking GXXD, exon prevalence chose prevalent highly are four and especially cancers. solid

Given our KRAS early and we to into encouraged add efficacy other KRAS to our reactive signals clinic GXXD, targeting mutations in clinical program. the GXXD more are TCRs

TPXX focused multiple shown cancer, ones known highly to studies, genes mutated TPXX I in been though of in be commonly immunogenic there among cancer are the be is in number including will applicable the that that hotspots to locations, that is of types. to a lead of TCRs mutated We previous discovering broad TPXX they Even and large a successful eight reactive on be we will has we helped patients well in most range all in be NCI. mutated at were believe setting. to

mutations for in hunTR all initial personalized therapies cell saw their cancer, patients most response for suitable one of the had our a where expressed we As to be tumors. solid also may TCR-T set by data

applied system is could be time with Agreement rapid the discovery or treatment identification a our conjunction Cooperative to and of TCR pursuing in and their for Rosenberg under NCI the decrease from The approach similar Research leadership Dr. CRADA. Development to

cost commercial to of We Beauty critical further autologous for transposition that TCR-T therapy. Sleeping will the personalized be time treatment the could use decrease and of cell application fully the and believe

to the starting results I third call for financial now slide quarter would the turn to to Wong the on Mike? Mike over XX. review like

Drew. you, Thank

Let September slide financials on for the which me XX. three review XX, ended months XXXX, our highlighted are

net For of $X.X to the per quarter of or of for net XXXX. million loss per reported third third XXXX, compared $X.XX $XX.X loss approximately we $X.XX approximately of net quarter the share share or net loss a a loss million

approximately to to The milestones the Japan the third sales of increase Collaboration K.K. quarter was XXXX, million $X.X due of compared XXXX. approximately was for revenue Pharma primarily achievement $X.X of based million the in for third darinaparsin quarter by of Solasia

to million XXXX, to mainly development compared XXXX, decrease $X.X milestones for CAR-T a program lower and winding by Anderson in offset million the million were and primarily and The expenses by of headcount quarter of IL-XX the our XX%. expense of million, quarter for approximately a partially facilities in following a decrease third decreases expenses. one-time $X.X MD related were $X.X $X.X to down decrease programs, a million employee of to consulting Research million related $XX.X of due Solasia. expenses based and Japan related third costs decrease due approximately in $X.X of These the the to achievement our sales was reduced

reduced the approximately employee to General and in professional XX%. our a XXXX, XXXX, in for quarter decrease due consulting to was million $X.X expenses to $X.X headcount were decrease The million administrative period expenses. lower of primarily approximately third million the and and compared same of $X.X due services for related $X.X expenses million decrease of a

had As restricted XX, of XXXX, million and cash cash. September equivalents approximately $XX.X $XX.X and million cash in of Alaunos

million, of third quarter approximately XX%. third Our million a decrease operating the in XXXX XXXX, for cash was burn $X.X approximately $X.X of of quarter million or compared the to approximately $X.X

turn our to I like That for Kevin the to financial now concludes call closing remarks. update. would

you, Thank Mike.

company let’s the near-term. be we the slide the milestones expect drivers to about talk As in value turn for upcoming XX, will that we

poised made generating -cell valuable Sleeping Our focusing team is business continued team solid platform progress novel treating patients and on this clinical has progress targeting translational data. and TCR-T for our tumors across our significant additional year, more Beauty the

into TCR-T fourth the we patient towards quarter. next dose the trial and this of to enrollment our clinical expect continued end, patients Our top priority is Library in

the enrollment medical seen in have providing are and excitement forward trial. in have in trial on that major prescreening look clinicians additional tremendous consideration of at a building of dozens we patients conference. We earlier, mentioned this to updates we XXXX among we being for followed, As specifically

IND amendment a believe an fourth file in driver to value be the quarter we that big will for the expect company. We

increase IND TCRs number HLAs. addressable trial, clinical patients at of targeting the This will will two add frequent new the First, greatly queue able to in the our for we to our therapy and the will Anderson. increase market MD mutations and be

our fresh move Secondly, TCR-T process we to cell from as in the IND cryopreserved product. makes manufacturing an important improvement

As Abhi mentioned, scheduling XX will reduce for this add flexibility and from to time days days. patient manufacturing and XX treatment

go We expect half in this process of new effect to in first XXXX. the

briefly I’d touch the tumors, membrane-bound development cells. of data target ability on also presented the like TCR-T we to our of TCR-T membrane-bound to kill IL-XX and at also IL-XX program. Earlier cells year, this tumor-specific highlighted that establishing specifically while long-lived ASGCT

the this continuing in are potential We second to microenvironment XXXX cells of advance deepen filing in an harsh of and the survival clinical and tumor responses. believe has TCR-T towards the program the half it increase to IND

Sleeping field this and the clinical may broadly to to in T Rosenberg Beauty. Lastly, experts with the fully therapy develop cancer therapy. believe that a some therapy experience we using for work trials autologous bring significant in continue and are world’s be team with TCR-T future. of the proof Dr. personalized TCR discovery personalized strategy this approach to and cell concept NCI applicable cell the We with of CRADA and

our on business significant Our year-over-year. team this and simultaneously has progress made our burn operating year been delivering cash across while reducing focused results

team, our the for patients shareholders open gratitude partners, to we support. my their want Before to and call I to questions, express

building we our to-date excited successes to in remain XXXX. forward made upon about and look progress We have the

mission tumors lives of We as a the working expect the and for you in this tumor are being suffering treated greater cancers. of solid our our early year solid We even we transform are to thank being accomplishments patients to way success part improve the lead from journey will confidently continue to ahead.

open questions. now will We the Liz? call to

comes Instructions] of Our with Prakhar Agrawal [Operator line Fitzgerald. the Cantor first from question

open. now is line Your

Hi. and taking finishing my the the all thanks question. on the Congratulations of everyone, XQ. Good and morning, for progress

third six the is, estimate, taking So bottlenecks I why go of set my next dose first working through on to dosed And the if comment be -- talk about for almost will why months given? things had Maybe key in based couple are so patient that the also patients question along, a was could you you June dosed. and it’s on be what second the that of my follow-ups. patient

Hi, for Prakhar. Thanks the questions.

as at a of there’s in the response CICON with that’s early the building and So dose, lot this you data interest study. the excitement first in see lowest confirmed partial really

So talk September was for and the to great of CICON the end really proffered at a trial enrollment. accelerant this

more pipeline is and patient expand two to even and building. IND the funnel these the patients from just further fact, will was is presented MD the once the at cell And new recently, the that be Anderson TCRs over this allowing team stem by of all transplant filing, shared strong at data in adding even benefit was the with In on doctors it CICON interest tracked really therapy. and to and this

eliminate the to also increase flexibility going scheduling to any will enrolling patients on is whatsoever cryopreservation trial. and for The hurdles further this

to manufacturing as in that there in patients more many think increasing build treat capacity a enrollment we reason been is I XXXX. we So investing our have to and expect

follow-ups, Kevin. a maybe Drew, you, there and for so Thank was target not months. T are still patient for persistent the one, I cells at a six of couple think, And question lost Okay.

at So any higher for more color months doses? on six reasons from the level details on could could provide how stem memory work and cells improved with your PFS progression transformation if you of possible and/or

Yeah. Thanks, Prakhar. questions. the morning. for Good Thanks

taken circulation, of over which in lump. the cells, in was six high from persistence encouraged circulation We in excited quite tumor see were of see the are also this that months but from is to we XX% and to it biopsy patient up in to the their also this the very right not only

know getting harsh this into microenvironment. we are that cells So the tumor TCR-T

So it’s very encouraging.

positives HLA-AXX encouraged all in the also GXXD forward. so the they both that are present KRAS tumor, are going We were that and

characteristics We in are those some very data we on knowing going still don’t cells. of but what’s of looking interested in cells now. question the We for the are the your point, at this have at

had patient encouraged -- by We really that other are results the and to the treating the very results looking patients. forward clinical

lastly, Kevin, is investors. for it. question Got a key And this

and So the the I talk might company think this given for Thank the if about make runway, you clinical have cash can financing avenues missed possible you. you sense next might sometime and in XXXX? the catalyst

Prakhar. Certainly,

into always second runway great we So early and exploring available of lot and cash a a XXXX, our giving which biotech, of encouraging us. flexibility is the are is on based options is financing interest to data, options. quarter There still us this as

have who also and supportive loyal been a prospective power from our appreciate see TCR-T new investors base, the therapy. and potential our cell shareholder of We interest of and experiencing lot

Reminder, ATM we have in place. do the

yet worked in option well. hard this we very that’s So earlier the addition in to as have shelf place to year another

and be So we to ourselves have to fashions. have many fund raise different of options in able number up any teed

are in providing future. ability to we our very So in to forward runway cash and expand look our confident updates the

Thank you.

you. Thank

comes question Wells of from Shin with line the James next Fargo. Our

Your line is open. now

my Hey. Good for morning, taking guys. question. Thanks

and great. to go still to you present, sounds doing HLA back want like work one were things are it real and sounds Just tumor GXXD patient still on looks like number quick. It

to persist? current the you can that And from the say will the any is the maybe sort why relative be to you response exhaustion you then product, of that’s at going saw process when changes cells? related, looking guys what you move So signals suggest to freeze warm cryopreserved

then the first Abhi James. one Good I here. question. Drew Thanks, will manufacturing to and over take morning. kick Yeah. for the

are we infiltrating one, T encouraged are patient still encouraged the the to into that there, regards cells the very tumor. in target with very So

mutation, kind are are tumor their we of some only not are responsive -- at ability that at be system. of exhaustion alive we to to looking cells We and because the tumor that actually a they vitro but look to markers have from

looking are all we So at that.

use quite maybe when of what’s that get to hypotheses We around to setting. on encouraged we are clinical the data going the drive and kind clinical in

am going for cryopreserved I the So kick it Abhi question. over to to

I is saying our reproducible. Yeah. to Thanks, want and Drew. very robust manufacturing by platform that start

viability product. purity, have produce high We able high cell to and been high positivity TCR

in a from process done just what and that to manufacturing any not When we product. formulation, have overall is to run very a is we in not a it have as many we except we overall that have on there qualification comes And process based can formulation. there’s moving cryopreserve say product, fresh similar to added manufacturing our change cryopreserve process, -- our fresh the

Thanks, guys. it. Appreciate

Thanks, James.

Jefferies. Our Howerton next of question the comes Chris from with line

mute. you is now on Chris, be Your may line open.

We next can the Liz. move caller, to

Our question comes Jen from Yale line of the Laidlaw. with next

is line Your now open.

Hello?

Good morning, Yale.

Hey.

Sorry. name. be think level. we hear and XX question. my a is My dose We next taking patient would I that that next be you didn’t last same mentioned the patient you about or [Technical should How is first the cells. -- listed follow-up question ballpark I for that the was was the -- in then one, Difficulty] the I first will the thanks billion question. question just. and second have My

at Right. three That’s second number intend the Thanks, patient the will the Yes. dose level. to treat Indeed, be Yale. where we patient.

-- TCR-T TCR-T the to cells XX you approximately levels a the range so As and is billion are dose cells. for anywhere X XX TCR-T XX aware, there Level is billion from dose

we number dose level physician is. though not And guidance would are the that’s communicating on the that where of in treating the and anticipate the really we range, exact so

Okay. Great. of specifically get the TCR-T, I quite it question just new repeat dose you are the what configuration helpful. two That’s in of clearly, very didn’t is could One those added that here the that more two. terms

here. This is Drew Yale. Thanks, Yeah.

new library. the into very excited to these add TCRs are We

the that that As TCRs we part amendment are the those FDA clearance filing of we gotten just for haven’t yet. IND from

been they will to once announced we because year. we specific haven’t XX will already late from anticipate the library we and last expanded the six have cleared, be So they something, clear but we that identity have

so to here. can So enrolled caution it’s be that FDA, bring think do don’t the We with the we cell TCR-T say to that’s patients that want a move therapy expectation, the taking number we of but our make trial can of going as increase in bit and presumptuous that can forward. significant be we we a to in

this terms in quarter, of a the you thanks. That’s could or just this question to Do Okay. Maybe $X.X -- Solasia million very it have occur event helpful. being Great. last going Pharma. here, one-time we forward? revenues anticipate periodically this from And be housekeeping

that? you do want take to Mike,

Sure. Thanks, Yale.

company. of third Solasia anticipate sale over achievement that this receive We quarter first few payment the the received that next on in the definitely regulatory are in and of approval we the for non-dilutive Japan the of the and XXXX payment We funding from will first most commercial darinaparsin pleased was will upfront the be meaningful very we years.

Okay. Great. congrats the That’s helpful on very and progress.

Thank you.

Thanks, Yale.

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

is Your now open. line

that the genes the already there taking guys are TCRs, focused to safe question. am for on, it’s thanks back I Very just three within that assume to assuming the you right? Drew,

within within and is and correct, are or more reiterate mutations mutations. to be to Yeah. add again, add to KRAS, EGFR, existing HLAs we looking Thomas. more That that the existing will within TPPXX It the genes

those it it’s along same consistent will be lines. So that thesis with

was it. number Got it patients, that you pacing, availability to back two the at question sooner? enrolled, just first elapsed? of kind has look time has the frame way there since the insight been going into if trying patient am about enrolling that And in stood I another time enrollment of the a lapse that manufacturing some of more patient get to that

you assure never whatsoever. manufacturing can rate-limiting been a I has step that

a have throughput to manufacturing capacity building the and/or come. platform anticipation We for enrollment simply the up very strong of

level at data we are really momentum. release, We like. dose now at an with anticipated a is be that enrollment excited proffer the But would CICON, we partial confirmed until all at had we very the pace that early the lowest building talk long than response slower might

There with TCRs, worsening HLA -- fast patients their that, did been their mutation TCR and disease unfortunately, diseases that heavy were match just other but a are exclusion patients result, tragic these that there burden. pace. have the as criteria, health a at the unfortunately, few of because And patients declining have a had very

therapies meet one So the it’s they TCRs. not from even our them, perspective, failed when matched of that did they unfortunate other inclusion a health criteria though

with from cells be geographies, you [Technical that even I of we cryopreserved presentation we the will believe treat And about new so more a to, at we people two excited that case CRADA patients excitement, believe, studies we responding from product, allow inbound to which able coming [ph] the inquiries, produce of journey, we move the in the tell different to and to that fresh patient’s Difficulty] that the coming TCRs will people us with are what earlier a of our lot have and can NCI. mentioned in

So, again, partial a reminder, clinical three clinically have confirmed been different by responses. our TCRs now trial validated having on

more So to there treatment the excited dramatically. many in are of treating quite anticipate XXXX pattern prospect increase the and we enrolling very and patients about

to that dose me, missed And just all appreciate confirm for many or how and anticipate you assuming perhaps, I I color. patients Level at X do it, treating no ICANS? DLTs

there. the science to itself let for going speak are We

So we that. closely are determine to follow working very PIs to with the going

go So we we along. as will certainly update

the questions. guys Excellent. you Appreciate you. taking Thank

you. Thank

Instructions] the line open. line of next Chris Howerton Our question comes from [Operator your is Jefferies. now with Chris,

is Antea for Howerton. This Hi. [ph] Chris

you Sorry questions about on earlier. for the issue a audio and great quarter. taking Thank our congratulations

two We questions. have

dose First, the patient is the types be? cells TCR-T Thank and what viability what next cut second, And in expecting there your the differences purity to next any tumor you. are cryopreserved will the in process? and of data using you

Abhi?

you Thank question. for

based high two better positivity. purity see and and of differences on is versus in any positivity two compare not by of fresh saying maintain these dispositions, our cells, there with of we the terms liability, characteristics that Let patients, amount few liability, we when early do around. products we look cryopreserve purity TCR that really me start different TCR qualification first still We the same at

the time, not will additional share translational and we have do indication. major on anticipate And and presenting additional much from ahead. We data indication that patients those data have in the conference, are the patients medical at that disclosed XXXX at more be they what Great. a we information about

have that trial. Phase reiterate our are with treating X/X different we solid we do tumor six basket that we again, So, indications

you Thank it. Got taking questions. our for

Thank you.

you. Thank

I participating. queue no this for you at in showing This concludes am time. call. today’s further Thank conference questions

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