TCRT - Earnings call 4 2021 | Alaunos Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Alaunos Therapeutics Fourth Quarter and Full Year 2021 Financial Results Conference Call. [Operator Instructions]

I would now like to turn the call over to your host, Alex Lobo, Stern Investor Relations.

You may begin.

Alex Lobo

Good morning, and welcome to Alaunos Therapeutics Fourth Quarter and Full Year 2021 Financial Results Conference Call and Audio Webcast. of Kevin Vice Alaunos Development; President Wong, Vice are Officer; Chief and today our Deniger, Drew of President me Boyle Therapeutics' Senior, Executive Mike With Finance. Research and

XXXX, Form a ended well Earlier this the was months SEC. Annual as which read We the full and today's release December XXXX. on financial ended XX, everyone results Alaunos X December morning press XX-K year encourage this morning, year with for announcing press XX, for issued the Alaunos to filed release Report as the

company's will at on The press be release report and website also Alaunos annual the available alaunos.com.

of addition, company's Please Litigation certain safe Act information accurate In conference contains the the harbor time-sensitive Reform website information through that and is live XXXX. of webcast XXXX. as discussed date Private of on will note that is today's there is this under the conference reference. are cautioned this call broadcast, the March be call being the future of provision Investor Relations that XX, covered of this section Securities archived Participants call for only

associated after events may securities Information no today circumstances are company as with stated Actual forward-looking the reflect made by to applicable by from revise date obligation webcast, filings or update The law. and in our due or forth forward-looking with SEC undertakes at required set on to the any statements of be sec.gov. business. uncertainties results except to public those the or company's potential this statements risks risks uncertainties could materially differ implied and recent most

turn Kevin? I Kevin over said, to call would the With like to now that Boyle.

Kevin Boyle

solid X for and have Alaunos our XXXX that since novel program Quarter we everyone, the in time, TCR-T of months welcome, Full over I made has It Therapeutics Alex, advancing tumors. great Year Fourth been the joined and treatment the just you, company Thank Earnings Call. and to strides

team the have I'm Our meaningful and all capital and across about being of clinical progress for as pipeline, stewards good we is year all clinical execution delivering significantly spend. the made reducing preclinical our while the results. vision of proud very and both

the in TCR-Ts I solid we want confidence weaponizing that our reiterating to tumors. have by begin attack to

team of into and our value. generating to our motivated Our is the translate appreciate and create and treat importance TCR-T to expertise data scientific progress. patients clinical unique We clinical approach platform validate shareholder

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December, In additional further evaluation study's we to the an of X amended IND include application TCRs.

X market has library now for of of the the and XX and total library the pool patients Our trial. increases further X X The EGFR. TPXX addition KRAS, addressable TCRs: to eligible a

have infused recommended technology neoantigens. allow multiple in cells reactive is TCR-T design should against are to be this dose that clinic. an advance Beauty our rapidly indications at cost-effectively will X and patients believe mutated X with autologous it as to to transposon us that T dose enrolled, adaptive Sleeping been trial our the the approach advancing Library then Once optimal identify that of We such levels using TCRs express engineered

this in quarter. patient cGMP own be manufacturing which facility, state-of-the-art in closer built the The have step We our as our for value trial patient first the creation are and consented anticipating treating we one towards in performed study manufacturing second will we our at XXXX. first

is for and capacity entirely manufacture year qualified release allows has for staffed the this of current of in The Alaunos facility anticipated suite manufacture been personnel the per clinical cGMP by fully and approximately product. the This product month. X

Before Development, preclinical our programs, President Deniger, for for to of Vice on I like Raffaele Research our his and to update turn the Drew an I thank over to service company. the call Baffa would

amend filed application As update Phase success. per tomorrow. helped our the the role for position have our Raffaele trial and Alaunos as his contributions XX-K year Officer I/II earlier Library will today, study Medical clinical to over His design effective the depart successfully IND for Chief TCR-T last

wish a his shareholder remains the on him supporter endeavors. Raffaele firm best and Alaunos We future all platform. TCR-T the of

consultant development, Dr. drug of member, Chris experience have years with a engaged XX of and also we leverage will our Board Bowden. and over We expertise in clinical the

to now research Drew call like our to turn the to I'd efforts. development Drew? over and highlight

Drew Deniger

platform solid you, targeting to with development evaluating National agreement in will TCR-T personalized Earlier cooperative month, Thank this CRADA Kevin. announced the an Institute. TCR-T tumors. we focus on extension setting and a research our This our Cancer

research efforts to addition internal on our efforts. to are In clinical and expanding with the development focused those and our we NCI programs, advance our

areas cells supports and is of cells. immune One IL-XX, survival which of other T these is a that cytokine

believe increased in cell We this stem of TCR-T in product. potent supporting the augment We tumors. the deepen other potential have and has targeting of TCRs of memory especially more therapy with to signals, developed the cells translates expressed T mutations hotspot manufactured the and TCR-T solid proprietary co-expression IL-XX. in clinical present to absence in responses membrane-bound survival This a cells

mutations. We patent around targeting developments recently these international covering an filed this application hotspot technology, TCRs with

filing program towards new conference later As data scientific plan showcase major we a in this XXXX, year. work this an at preclinical we to IND to advance

or also hunTR, highlighted human our we our discovery platform, which neoantigen In receptor T-cell recently addition, engine. is TCR

killer X T-cells of tumors state-of-the-art create dimensions and tumor individual in-depth T-cells. to down on of focused bioinformatics. are by and which We to We expressing matrix, mutations can do then be using using reduced sequencing XX,XXX infiltrating thousands simultaneously helper XX,XXX hotspot

to is our our It addressable library. The identified further the goal and TCRs expand clinical the against therapy. to and year this TCR can cell library neoantigens be rapidly the market added tested increase for

to like results the turn Mike? Mike our the call to over of Finance, to now the VP year. for full would I and fourth financial quarter review Wong,

Michael Wong

Thank Drew. you,

me XXXX. review for financials Let months December X ended our XX, the

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

were quarter decrease XX%. XXXX, the for of XXXX of fourth compared Research $XX $X.X approximately and development expenses for fourth a the approximately million million quarter to

quarter approximately $X.X same million decrease compared million to for for fourth period of XXXX in XXXX, General and the administrative expenses were a approximately $X.X XX%. the of

results now And review ended will the I the December XX, full XXXX. year for

XX, $XX $X.XX reported a $XX.X or per for million December of a ended a year full net million share the loss net net or loss $X.XX of a approximately to we loss net compared approximately per For XXXX. share loss

XXXX approximately and the of as Research year. and million IL-XX controlled development expenses primarily prior This decreased winding to in million attributable lower was by compared of our X% result CAR-T a programs. $XX.X down to costs to the $XX.X in approximately program-related

decrease $XX.X administrative For to $XX.X The year million services costs. a decrease of were compared primarily expenses year $X.X and the XXXX, to XXXX, approximately for million. reduced was approximately attributable full the full general professional million

year cash cash Cash equivalents. had to was in cash We XX, burn December quarter second full $XX.X Alaunos and $XX.X anticipate into be of to fund XXXX, million approximately XXXX XXXX. the sufficient of operations runway for As million. our the

closing Kevin like call That would for to concludes back over the our hand financial remarks. to update. I

Kevin Boyle

Thank you, Mike.

progress. Our talented and working our dedicated into Houston-based hard clinical is to transform team research scientific innovative

of quarter to focused Phase of Over the this in year. our dosing first XXXX, on execution, course second we I/II look and patient we remain the trial Library the in TCR-T forward

later that are a IL-XX and execution delivering on this value to program diligently membrane-bound to in data advance creation. shareholder working result We an scientific filing IND major year. We believe will and in towards at also focusing expect clinical present our XXXX conference

evaluate and We our IL-XX CAR-T controlled for partnering noncore continue to will assets. opportunities also

in from of to when restructuring year, has approximately August strategic the today. team reduced a XX last With been people I completed XXX arrived headcount

XXXX reduction million, continue good of be expect flow million capital We be and to significant for to cash operating $XX $XX a year-over-year. stewards and between

over Recognizing months of X of role further the Board. has been made changed confidence, that to the the vote James his and last as a Huang has from Chairman progress Executive Chair

for I've ahead. appreciated year accessibility forward and and support. look guidance progress The shareholders be their grateful continued team, partners the possible James, and the not our to of and I am partnership in I would our without many, for made continued

call Operator, questions. will to open We now the Kevin?

Operator

first Chris Our with Instructions] Howerton from question [Operator Jefferies. comes

Chris Howerton

plans in question terms moving how guess how would you was all Excellent. of articulated on of one detailed under of that near-term that in being clinical kind development with the with the new a I would leadership of and may that the maybe be terms appreciate anticipate in be they high-level call today. forward CMO I future? the influenced So question. previously were Raffaele a progress

note, have if kind of really question helpful TCR-Ts. current be, it would I understand second Kevin, would The you better I the that have was to of possible in library terms

terms new Just of for curious bringing example. for additional HLA TCR-Ts, some give indication in if cadence bring example, of matching in up us could for you EGFR, to

Kevin Boyle

in a clinical Great. we very direction regards development. and very with, that to IND Chris. the development now you, We're assisted place and believe plan. clinical us with Raffaele pleased Thank with unique strong have I

foresee So not in a at with to that leadership changes level. do I wholesale regards change

much MD and on so accruing XXXX year membrane-bound Phase to enter and the in our very still clinic I/II can our with in going continuing excited to focused and Anderson IL-XX. focus We're make that's at progress, our this be we preclinically patients trial,

a very will So member. is who leverage to board very Chris CMO we active experienced Bowden, and a continue

And with read trial a in to clinical or continue Chris make data adjustments so any as closely and to we work on standpoint. comes pivots from to will the

With regards that expansion certainly, it's both mutations our of the of Library, to we're goal to the after. TCR cadence going the increase the

in library hunTR You to them to EGFR. program through is that really identify we TCRs highlighted qualify in continue that process, and get added and do This EGFR XX TCR currently insignificant is To X one months. take those targets our to new will progress of have TCRs we anywhere an say, program. -- or the exciting, order to particular, in the IND not that should something will and I

a with from stood not think cadence the TCR identifying an earliest. this I the say in to our expansion been second knowing the TCRs that we last Library few successful hunTR at just So the over our year until hunTR platform, it's up fair of would that having half of we standpoint, platform, months see

Chris Howerton

appreciate are don't know That's ask. I ask anyway. I right. All others Kevin. great. it, really if it to Okay. I I'll maybe -- going

any study, I/II I a to dosing of clarification, dose like So the those the constant kind as of levels TCR the across constructs just might be articulated of you've see? And kind respect in Phase rationale that around levels? different will dose with provide commentary different that a patient levels that you'd the to guess

Kevin Boyle

higher level, a because larger dosing. to with addition critical, well So with of we in expansive at very that did it a a was our did number course, general, as the we to try dose levels regards in to and historical of level dose very companies' set an of there. efficacious our dose which, data this belief cells looking before was levels It were reach to a we really is -- we in study, out goal review safety, other that wanted

] stages get to, gene We greater place dose doing Beauty also chance want that. early we'll we're Chris, that to we where and levels, a all, reason accelerate is believe and efficacy. a have difference unique After the a so We the again, to this through treat design of patients. we to do to of have [ are in cancer their make motivated the lives, the

we targeting really we to how is safe that a want we efficacious. product we that have, And came And the have levels, of result, and in our we that over would at with MD as that point, with PIs we're the dose same And have dose with regards this trial. range so dose level to working the as that's a would closely anticipate, very Anderson. both indication, the up regardless well at

So that. with we'll we from it very well. And learn feel comfortable as

indications, dose, As Phase that's Ib dose identify learn get trial. be different know, will dose we'll on as or Phase might II I, we Phase And level, we we from. Phase level this optimum it learning that I from the this the depending

Operator

next Our Wainwright. from comes He H.C. question Arthur with

Yu He

the to quarter. just This mutation. follow TCR up want expansion for the is RK, congratulations I on in the Arthur and of on progress He this Maybe

correct? So expand launching current mutations library additional instead flexible different Is that my to understanding is additional you that guys to study. including another -- the of are more trial into

Kevin Boyle

I'll pass that to Drew, Arthur.

Drew Deniger

correct. is That Yes.

Yu He

Awesome. agreement? color Institute, to regarding Cancer is that's extension appreciated. personal more the the National And commentary give the And on institution? if applied the you TCR agreement with could with guys the Yes, of the any

Kevin Boyle

Yes.

the for partner So is NCI, personalized with that to TCR-T. our going be

So approach, we around NCI be TCR-T doing be with our partnership coming will we will be be will approach our using doing. library is specific will year this later the approach personalized but more And the the out details with that. what

reactivated these trials. As you're aware, the NCI just

-- in be with and investors relationship time and have later look communicate more to able our that year. in to pass, trial, we'll we'll we'll as updates specific broadly we more So this continue forward be further some providing our about

Operator

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

Thomas Flaten

I with Kevin, as to Can of the that read per max about enrollment one I pacing correctly a in is an heard enrollment I to how can per month pacing manufacturing sure or respect study from patient comments theoretical one we make at month. capacity? as you point read manufacturing think kind I the should perspective? that just prepared product want Or this perspective, -- around from

Kevin Boyle

and question, words It's that's our capacity. a correctly great the in that read you did the sense

Thanksgiving you want the let's happens. could how going seeing a Not but a Christmas ill, matter between and infused, I that say, they month are no patients holidays. life think that very that ill up be end be many to it's are, to unlikely patient done,

want They with and their and time might last be holidays. -- what be There's things. scheduling with to families their for insurance spending other

quickly working preclinical GMP IL-XX. are appropriate the and advancing this patients So and our with be our enroll will it be our in it's best, also to goal for But that we safely trial. as program suite will

other be products. will there So

unrealistic our anticipate we full utilization it how that a would we patient what think have would that's XXX% is So I to suite I would just it a typically the be enrolls. But say throughout in GMP year. month, a presume not

we patient don't So both GMP progress continuing knowing this to have we activities month but preclinically and our we'll just but see at doing suite, enrollment this do in have we specific time, point, will things not other a guidance per that proceeds. be to at how anticipate

Thomas Flaten

I had data about Is know to being talked XXXX. way so given you a respect the data -- that And patients context perhaps that community? with only feasible? that, do being then And you see and investment that initial still in the for would to some the previously in we from -- of is there that releasing other scientific meeting? the have opportunity of Or

Kevin Boyle

appropriate. would about spoken conference conference likely the we September most Well, possibility might certainly, that think patients but scientific I credible indication-specific multiple a be before way ways, be most at is enroll, on an there's in the the conference. We've way appropriate that an there ESMO a being in depending

think in the work and presenting with just find appropriate We'll we'll investors forum where touch play I about we'll appropriately closely we'll as PIs well be our year. be to So data. that it with by

Operator

Laidlaw comes [Operator Jen Yale Instructions] Our question & Company. next from with

Yale Jen

Congrats for progress. the

The first has? the could us bit he more question of what patient, terms or in consented tumor is a she of you first that give color type little

Kevin Boyle

thank you I would and Yale, for your love interest. to,

The specific that treat safety patient that appropriate patient with more time about information be patient. up at investors with regards wait would information end that with for and the we our a that after We later with Street will communicating to communicate the point will we and period

Yale Jen

Two quick ones to follow.

you that XX have this so is many library that in HLA at far one types moment? first prospect The how of

Kevin Boyle

currently I we XX is And you question. list on deck, that good library the that. one in do to website on point thing all have That's want of are our the to XX our TCRs of corporate and a a of in Slide that

have refer tried if that and with So answer that regard. in Drew transparent there, you shareholders But we Drew? look just HLA do but question, let I'll to our be the

Drew Deniger

our X XX excuse different for XX it's TCRs XX misspoke, Yes, me, TCRs. HLAs I -- TCRs,

Yale Jen

is the -- the or dose? reason dose lower you that X efficacy that And last a safety consider could to want have generate cells. your billion Should simply lowest signal is for we generate maybe potentially here that question Great. just

Kevin Boyle

Yale. you, Thank No.

safety the typical of safe I certainly a being first sure of have infusing primary for think focus less we as any that sake mind would that inside quite kind both I product and on and up ours. product focused on We it's that first a wouldn't safe for we're ends any the a make Phase at efficacy if But we're as the for there quite to signal this having trial, that's is it at patient's time. human. point, feel

Operator

questions conclude Everyone, a for today. any time. I'm disconnect, have not the and also does this showing day. at may further now you presentation this And wonderful

Alaunos Therapeutics (TCRT) 30 Mar 222021 Q4 Earnings call transcript