Earnings call transcript Q1 2023

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Operator

Good day and thank you for standing by. Welcome to the Alaunos Therapeutics First Quarter 2023 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] Please be advised that today's conference is being recorded.

to Lobo. conference like speaker to now Alex today, would hand over the your I ahead. go Please

Alex Lobo

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

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

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

this Reform certain safe the Participants are due Act covered information with or that results call today's on business. cautioned from differ of materially under date as that the note forward-looking only this harbor made broadcast, the call of time-sensitive Actual accurate the XXXX. uncertainties May associated the could risks of and by statements is conference information that stated is Litigation of XX, Please those provisions contains company's live XXXX. discussed implied Securities to Private today

after by with be forth date The revise may Information and risks law. uncertainties public are the of any forward-looking at as company update or this securities except required events SEC our on circumstances most reflect recent set filings or undertakes no potential to webcast, the sec.gov. in applicable obligation to statements

Abhi President Technical Senior, be of Research and the Wong, session. With also of Vice Mike Chief available Officer; President Srivastava, of Q&A are Vice Development; me Executive Vice today will for Kevin Finance. Drew Operations Boyle and Deniger, President

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

Kevin Boyle Senior

cancer mutations the tumors. response disruptive Thank in patient you, with that the the encouraged therapy and patients cells are most time our high-frequency excitement. potential meaningful driver for that approach, has a need. high us. Alex. the clinical morning established our you Alaunos We're is patients and to The thank transform paradigm. the hope our everyone, TCR-T innovative clinical by treatment We targeting alone delivering unmet joining is technology to believe for first first Good we solid And to bring non-viral not fact for can treated had promising that

compared the Our prospective by prior accelerated the shared enrollment to highlights patients. enthusiasm the year

accelerated we manufacturing The protocols TCR-T data advance milestones. of to Alaunos and clinical to third ever. patients. a end XXXX quarter enhancements including our suite clinical start we implemented multiple diligently manufacturing X/X We've XXXX. on off last is amendment an productive library the to-date is have in our IND interim build data in as progress busier expect and our that a multiple that towards new encouraging generated screening enrollment to worked to report early at with we and We added have than through Phase from enrollment to aim team trial have results important the we update, the Since

of also full debt. by forward with we've strengthen steps taken progress The important our to addition In made, balance move unencumbered our Bank the Valley sheet. prepayment to us clinical to enables Silicon loan

Precigen. towards XXXX. of and corporate Altogether, recently becoming financial as obligations right by with are end royalty the agreement milestone that work company Our eliminates X-ready amended a and we the Phase Precigen to believe taking steps we we

X/X like TCRT I'd Phase to more library our in detail. discuss trial

this growing trial. We have and excitement to around capitalize worked momentum on the

cancers. ovary and this bile recall, trial is targeting endometrium, you solid six across driver As cell a lung, colon, basket mutations tumor non-small duct will indications, pancreas,

library. TCR with these and HLA a in both that specific a Anderson cancers patients on actively any our six enrolling combination matching at are to one of We is mutation based available MD

improvements quarter, the included operationalize quarter screening faster in IND. worked critical expansive this enrollment that These accrual. processes During facilitated fourth to were XXXX to the and enhancements first have manufacturing our patient we

treatment. We have increasing also implemented cryopreservation and patient scheduling flexibility manufacturing our to process, for

cryopreservation, viability, believe Since this purity products enable we patient positivity our comparable process. program prior to enhancements to manufactured these our TCR with that, have us meet and multiple We year. will milestones adopting

Additionally, our schedule generating, months. identifying this of have investigators booked patients coming MD been manufacturing at Anderson staunch the and fully promising through trial, supporters a

a between X poster data early June. Annual nine taking Looking treated XXXX the first our ASCO Phase be total highlighted completing from translational patients XX ahead, patients In of and this we Meeting portion the anticipate place at early treating will in three the in year, study.

this As fulsome the data we'll a in on we third quarter. multiple with milestone, important clinical patients provide readout more towards progress new

This use are to April, TCR our mutations. exclusive advancing amendment have in or of amend TCRs with our targeting and our tumors. Recent changes neoantigens, focused targeting Precigen. license on were to rights including platform. In our we Sleeping We capital belief platform solid upside corporate tremendous maintains driver agreement singularly this the Beauty, pleased supported potential

milestone of At royalties, In Precigen. all $XXX commercial obligations over the and the eliminates This million. to assets. return, regains CAR-T Precigen represents IL-XX our same rights amendment a due to and sales-based the time, noncore potential savings

TCR-T believe facilitate TCR-T and advanced Alaunos maximize have the been our further There As a several sign discussions. space, in transactions of that for allows partnering one targeting this is companies. to we believe is assets, TCR the and partnering announced positive our driver companies un-encumbering we us recently value shareholder most mutations,

decisive further also Bank. upgrade earlier like Silicon also with forward our SVB move fully us our and This under month, actions the owed highlight to prepayment to would loan our by loan to The with of Precigen I licenses, bank to to these this term allow depository us balance remaining we cash. obligations. that regards unencumbered protect quality allowed prepaid Valley the our

on of welcome Hoffmeister Robert Directors. are to our side, corporate we the Also to excited Board

in discovery brings and in of cancer TCR development those For expert and therapies, the experience know of wealth Robert, who an he immunology. of you, don't engineered is a

have thrilled and team on have We insights Abhi Drew him been to already his Alaunos leveraging the are and expertise. and

to and expanding TCRs corporate our platform. enhancements the to in addition making progress, In through Hunter of towards we're clinic our exciting the library industry-leading progress the structure, made significant we've

like turn now to efforts. Drew? the Drew R&D highlight over call ongoing to to would these I

Drew Deniger

excited Good you, to with an you including everyone. morning, Kevin. Hunter. the our Thank efforts I'm share R&D of update progress on continued

market library As a discovery the therapeutic foundation proprietary of our is cutting-edge candidates. the strategy, for increase our TCR reminder, and to Hunter expansion our addressable platform drug is two-pronged

current way, adding TCRs library TPXX and by targeting with HLAs expanding One mutations. are the combined we our KRAS EGFR is more

number these adding this can deliver Through pipeline TCRs our is way TCRT, patients. critical mutations, to strategy, a potentially and believe IP we families. we more Another targeting treatments gene strengthen bolster our portfolio, within next-gen of larger effective new for

We we the two the additional and we TCRs year, have brought last the to have to to that twice already structure our expand total manufacturing added TCRs we number regulatory library clinical of the When shown library. XX.

Our TCRs patients benefit XX% strategy as screening effectively cell our to our addressable over potential we rate result as the number has that match to therapy. to expect year, market. a grown part grow TCR-T from could of to This the doubled potentially XX total of expand library and the

the discovery. throughput expanded infrastructure of recently for TCR Hunter We to platform, our increase

have ramping and new tumor anticipate already success discovery pace bioinformatics lab rate. have been TCR samples processed, greatly capabilities which We high rates, screening screening Dozens increases second and the up equipment, while of quarter. our we in advanced introduced our maintaining

From up can as of each T-cells line simultaneously, individual we sequence tumor single sample, thousands them and cells.

clinical valuable a reactive specific to to TCR addition able make and ones We identify, mutation is the are combination. HLA are which to believe TCR than the We as platforms. amend then is a Once in markedly months our the faster identified in can new competing library, our, can to we I&D this we incorporate do think which XX to nine TCR. we

to it proprietary proud rapid are advantages significant methods. of and throughput discovery of We our We TCRs increases TCR the Hunter high company's approach value believe over traditional potentially pipeline. offers generate the believe,

Membrane-bound aim be cell therapies, generation clinical TCR-T, may and of deepen responses. further next multiplex TCR-T TCRs These the in IL-XX used including exploration to which

more generate we and or that to valuable be opportunities in TCRs will believe of over identifying Alaunos. We for the the capital. who believe proud that pace has partnering so doubled screening year also could out-licensing I'm the successful than team, in result has Hunter strongly non-dilutive past potential the

now would call the turn to like to I over financial update. Mike, a for

Mike Wong

Drew. you, Thank

with remain capital. our As intentional we an organization

of the patients people, to With less team we make to and our valuable shareholders. than continue for our fulfill to XX investments value commitments create to

be has promised We science continue recognized to by technology disruptive conversations that are solid tumors. will unique that be is what to and curative investors for a for it on confident, based recent our

XXXX. financials for the three me ended to our allow March Now, review XXst months,

per loss period of XXXX. million a reported $X.XX per $XX quarter net $X.XX For net approximately net share a net for a a in loss the we approximately million of compared same the first or share loss of or $X.X loss to XXXX

As numbers which to first detail, we the primarily for approximately $X.X period same in a were quarter million compared more the of activities. million an was look approximately discovery XXXX, the of research XXXX, $X.X and increased into for development bit TCR in to increase XX% expenses manufacturing due and

compared for to primarily million to a being of the professional continue stewards decrease prior quarter as expenses was million the of same General XXXX, be on we period of in approximately due and were approximately capital. first XX% the good $X.X lower which administrative fees $X.X year, to focused for

approximately had Alaunos million total $XX.X cash XXXX, XXst in March of As balances.

first million operating to cash $X.X of the same $X.X for burn million. an quarter approximately in million, of increase $X.X in Our was the approximately compared XXXX, approximately XXXX period

in activities our resulting Phase line in X/X increase active library This expectations patients amount reflects was manufacturing of as the trial. from our TCR-T it with the our in enrollment

service operating between XXXX to million costs to be operating million. current plans, continue excluding debt our cash $XX outflows our on expect for $XX to we approximately Based

to programs. a operations resources of have fund cash and the to quarter result, R&D we XXXX As expect fourth into sufficient

Silicon As the we remaining amounts million Kevin XXst term owed Valley fully XXXX. of this noted the earlier, our under with month which repaid as March beginning $XX loan was of Bank, at

of obligations restricted to has fully released million also to pleased SVB no report balance are been with XXst Alaunos. to XXXX that We cash back $XX.X of a remaining as March

allows markets companies of cash, engagement evidence biotech have us with remains eliminates additional encouraging Investor capital with and capital This and update. for our leave I'd science. control you transactions to markets a to over operational expense. supportive being differentiated points complete like to interest

raised following is biotech we to raised the has at prospective regional Despite to with this aligned $X.X by billion is a disruption year-to-date, have XXXX. continues $X.X from interest believe year. sign investors. for We this bank also follow-ons outpace positive compared the follow-ons XX follow-on in last failures, this the point which XX billion point in been market received

for the to like turn now to would call I Kevin closing remarks.

Kevin Boyle

employees hard-working tight multiple at buckle at and Enrollment ASCO be safety, translational committed seatbelt brisk say you, therapies data. waste Thank been low an in busy is to around your encouraging occupied. Things that will manufacturing have We've and and and an your need. our our most is for am team the and proud here. update getting manufactured has prepared exciting Mike. has been ride. suite same are told for time we share I The we to patients efficacy and products producing including persistence around data

providing the trial additional to an treated. third quarter, forward patients look We highlighting in readout interim

We enjoying new program. identifying our TCRs are in Hunter also success

seek disruptive to momentum us of our addressable in market this platform great and The TCRT technology our revolutionize the strive partnering as the gives generate confidence our will We position, tumors. building platform. in solid increase strengthen value we the IP interest treatment opportunities potential of to and with

thank colleagues the solid we immune system Alaunos, and at treat as like partners patients, their to as well with tumors. I'd shareholders as all powerful our support continued my weaponize of to for TCRs

the to We open questions. call will now Cory?

Operator

question Thank Prakhar, at At we Agrawal time your the Our session. question-and-answer Prakhar will Instructions] Cantor is conduct open. line comes first from you. this [Operator Fitzgerald.

Prakhar Agrawal

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

the for three whom there translational it update getting we any that presented seems is ASCO, well data question as patient have for at first seen for efficacy. So is not

only get couple follow-ups number translation be data a please. not if three? of patient? translational any for for you confirm third and data data I had patient would why And If presenting, could what So you efficacy you

Kevin Boyle

Absolutely.

May But So the embargo part will and in just patients. has the the believe that full in the will on unfortunately what come the presenting by in on start we're and you promised The with on two say will able treated. not that patients data we is quarter not previously that being since are afternoon. we've the additional What disclosed the we're is full with as ASCO. three say abstract I this that as time further of believe we lift we've been providing include look limited I But one, Prakhar poster third can that abstract disclose the released year forward out data to before we detail more can and data to say presented. any wholesale a we XXth,

Prakhar Agrawal

And Got heard by dosed correctly to to be the patients second lower to Kevin which the question, it. I XX year expected target nine complete Phase XX X, if end are patients previously. to seems XX noted of than

if the each have has X dose? dose a target a maybe will whether the could any call in there this enough you confirm first, Phase And reason for at So patients recommended enrollment been make to on change? for Phase change we X,

Kevin Boyle

the for Thanks question.

already same nine gets to treated the And XX patients. that adding XX math you range. guidance previously provided to three we the XXXX that to in XX patients add simple Just three patients that treated if year, we you last we the

not how slots get engaged So have literally encouraged trial. manufacturing guidance that quite to this really been, has in by enrolled we're over we their have patients changed RPIs fighting and

So further very updates. excited momentum about to have we the and providing look that forward

Prakhar Agrawal

for The close timing guidance. And until is guidance it. and the update the interim cash quite Thanks for QX. me, XQ the cash runway have of clarification last interim data in Got question you is to the Kevin.

stake So this update. lot of from there's a interim

confident than could avenues Thank You finance be visibility have financing explore are How the update you other the company? at this us. before interim meaningfully more to you. positive interim? you will And

Kevin Boyle

take to want you do Mike, that?

Mike Wong

to earlier With continue to capital and next we cash data plan Sure. dilution. perspective, inspection a obviously as and And of in that our we remain fundraising be Yes for the runway set important all our from stewards believe to Prakhar. which Phase good options mentioned opportunistic we remain is library readout we said, will us. trial, consider X/X an Thanks sensitive available Alaunos.

Prakhar Agrawal

Thank you.

Operator

next our you for Thank very much. question. Standby

Lake comes Flaten question Thomas Markets. your Thomas, from next Our Capital of open. is Street line

Thomas Flaten

dosed appreciate third in readout to I reasonable second well, guys. taking be been the or will as see is assume that the curious from at in dose question. I'm patients morning the it level level Good only? QX, that they we'll the have interim dose

Kevin Boyle

regards dosed at any patients release We're regards is by we as trial you with dose levels patients our how more many I we would will and quite thunder flexible when would and conversations to the can I update steal third third investors, and excited our patients. a speaking about if to update in to regards to say to Thomas, a the what just overall quarter. that be will PIs quarter gave prospective design they research insights provide with what an believe going multiple provide analysts. there the the we is level. is with we investors to the be appropriate to treating clinical to guided number with reminder get this with be reiterate will very we of regards cells What are those that

Thomas Flaten

scientific basis? in done be stand-alone release that that something the a will meeting And you just do context it. on or Got of a

Kevin Boyle

be to and options going regard. all keep in flexible We're that open

it's important just honing to What flexibility at this that in guidance say commit in third as think we to to point. the do quarter. to had I earlier have it guided want the be will is we just on

hear to with trial. We we think as So excited And connecting to I everybody an everybody hope be will we the on look are. then. forward update

Thomas Flaten

year But great expanding we guys to you with capacity for into for of done switching year was next wondering per I as And resources period a what us your mean time little maximum. the a what about planned have kind if bit X manufacturing having manufacturing there ago, Phase gears matter? guys And job I maybe patient over month for get one in capacity was a needs you capacity. you resources talking that were that do can you contextualize think be? move could and you current

Kevin Boyle

manufacturing he's charge here. Sure. in Why Abhi since to that don't I of over pass

Abhi Srivastava

Thanks, Thomas for question. this

excited about our are platform. We very manufacturing

we introduction run. putting the has calendar. well cryopreservation the worked after expanded is our upfront schedule As has pretty our us which Phase two helped out PIs, have the out I especially of That received per for manufacturing our into last program our which by we to time, really is well which capacity patients mentioned really

are manufacturing busier we in suite. ever than So our

or are one going far as of expand as in shareholders. capacity As CDMO our a we Phase the time the well we in the interest is manufacturing in multiple the going the increasing can the our as X multi-different the or approach utilizing We're comes. strategy. we're be -- we in in-house combination way be side those best as investing to capacity where for multipronged either And have a manufacturing to going of of to company whatever hybrid option

to it more looking into forward we II making very the and So Phase excited and we are are about cells going patient

Thomas Flaten

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

Abhi Srivastava

Thomas. Thanks,

Operator

stand much. Thank next Please question. very for you by our

comes Our from of Swayampakula HCW. next question Ramakanth

Swayampakula Ramakanth

Thank is morning, Wainwright. you. Kevin. H.C. RK This from Good

Kevin Boyle

morning Good

Swayampakula Ramakanth

third out the you patients put by you in the multiple said did manufacturing side, time? data to there many the obviously some you're you on you itself quarter also making additional the study. but to on Because expecting How you're that amendments. some changes think on trial only not can get So current do

are things. have end almost getting amendments is So there? we we'll more what One to a of feel for of seven, sort two talking sort trying get rate? the of Just like trial the patients enrollment helped to eight questions. And of like kind increase the two are data

Kevin Boyle

Absolutely.

last And Okay. you it was seeing great week.

adapted. in really quarter from XXXX -- and in was learnings our took of fourth amendment clinical I&D the the excellent. just we the It XXXX So trial

included updates the a combination quarter fourth things. the in so And of

that both entire lot treatment process really And what One separate a easier as we physicians. made patients and for that protocols enrollment is to and one. combined combining for under had screening we the

So in received PIs was I our think also interested by well who this are study. it by received well patients

we've more longer requirement mutation and a One the more we that months remained had biopsies early six in What learned between little the had for confirm we present. bit post-treatment if a what shared retest been required retesting had mutation than Previously, has the to details we we've we of in the a last of no test. is tumor able our is previously learnings mutation. the

mutation comfortable the we so cancer that driver felt going is at remain. core quite And since mutations to of that these are

so And and and also prior really eliminated we hurdle. a that facilitated eliminated retesting aspect that

our So again taking learnings.

a did that unfortunately great. me And thing the And predictability has we in that's of fail added that is patient that other other let The the treatment. you if and talked products efficient cancer the just cryopreservation. for ready journey. ability allowed for getting tell made are in about them products way, our to the us the their earlier freeze they cells and patients, down have very manufacture ready treatments We

so, analysts And are kind amendment really right. I'm learnings. that's figure -- update -- the detail and And patients to you we're in trying do to were us not has and the how you if treated the of those as all the to the going I and leave enrollment we've all the really applaud of out though morning buoyed many of at trying answer That's more facilitated quarter my more third that best in that's wanting early exciting. to

Swayampakula Ramakanth

of been would had helpful. this have wish it Kevin, coffee one less cup I morning, you

to a that Drew hear TCRs. can Hunter Drew, platform and to it's platform, you on for expand question produce So, talking additional the great to the

you the to non-dilutive us or So, you give partnerships, attract trying targets of generate some or sort process of additional you through to are additional in what you're attracting partnerships? are to as any can how color looking in partnerships terms at, able of funding

Drew Deniger

for question. you the Thank R.K. morning, Good

high rate Hunter We we very of proud platform success are and of have so TCR discovery. our a

believe that a KRAS we part same partnership targets. on we multiple as attractive partner. So to be really the exclusively targets and focused time as at would after by that explore are EGFR that or look PXX for our of owned library other modalities. At potential note Alaunos use We those as We're and discover are to TCR-T we opportunities It's that to we're could able different the do expansion treatment can needed. for go other we important strategy. so proprietary, TCRs

quite excited so of we're platform part that about as And well. Hunter the

Kevin Boyle

and there's power ability discovery. about valuable sort his nice these driver and implementations other has could to of as also recent highlight is for of this partnering that the many throughput. be just been increasing and that team identify think flexibility What's mutations, assets able you And is some not Drew over there heard Drew that, robust platform identifying but I fact the the

out team and some So you and and ways, quickly think two are with the or more it of processing the more adoption new -- adoption people samples can more that they be getting efficiency new AI you're can discovering processes. on about either more tools some all the things equipment the of of

-- amazing the So they the there. harness it's how bioinformatics over really accelerate is team to power throughput the AI of

Swayampakula Ramakanth

last me the Thank you. on question from cash. One

$XX.X So, that -- into this million or about, talking that is XX.X%. did $XX.X the the you're million. to in included XX.X% addition restricted is the the release that of cash, the Is

Mike Wong

mentioned thanks $XX.X we fourth which Hi is XXXX. the question. line of XX, The is as million that for previous $XX.X expected guidance. million to as the earlier, runway cash restricted quarter cash in balances total our XXXX, included with March is of R.K., of cash into And of extend had in the

Swayampakula Ramakanth

taking you questions Thank my all Perfect. gentlemen. for

Operator

and you you. now disconnect. may This We in conclude conference. Thank appreciate program does the your participation today's

Alaunos Therapeutics (TCRT) 10 May 232023 Q1 Earnings call transcript