AADI - Earnings call 3 2023 | Aadi Bioscience, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the Aadi Bioscience Third Quarter 2023 Earnings Conference Call. [Operator Instructions] Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Marcy Graham, Senior Vice President of Investor Relations and Corporate Communications at Aadi Bioscience. Ms. ahead. go please Graham,

Marcy Graham

morning, provide to review an quarter the Good conference results Aadi call third to operational XXXX. and you. the welcome Bioscience for Thank update and

the PRECISION quarter CFO; and results activity our Chief our update on trial Joining we David Itri. Dr. and of for our clinical development an today, overview will on Scott our CEO; financial provide Medical Lennon, an me XXXX and Giacobello, and President call going X Loretta and third Today, forward. Officer, the Dr. operational of plans

We will comments. the call open the of closing at lines for following end questions the

by and those other quick website the can section reminder on www.sec.gov a the of filings result forward-looking various include Risk results will events and statements or risks, A annual in today of be or Exchange uncertainties Factors statements forth implied that with could differ and Commission, the www.aadibio.com. which those quarterly any at call statements. Securities from Actual on factors our as forward-looking set materially found made or expressed at including our

subsequent forward-looking CFO, our Scott XXXX, views date. update statements. to addition, turn We any call specifically should upon made forward-looking opening this over X, call any not to Giacobello our only as our Scott? as disclaim today, November as In be or With statements. will views revise representing any obligation his of the any relied that, on of represent I statements for and

Scott Giacobello

quarter operational good review today results and the Thank us third to XXXX. you, for financial morning, you everyone. of Marcy, and joining for our Thank

of perfect Lennon, in activities introduce XX fourth in I quarter. comes than expertise the we take like us joined deep and the as underway, guide to rare the next Dave and Before of CFO. look global currently oncology President forward through and continuing Dave leadership us history working Dave this start to choice that in a disease mTOR-driven role and diseases the about more at with would background growth opportunity CEO I'm U.S. and as experiences of our my third our and with quarter Aadi years in with excited the to pharmaceutical future all him commercialization, strong progress in and development. to who discuss a and to phase make

the to his I'd Now call initial to turn for like comments. Dave over Dave?

David Lennon

also role Thank management all thank and taking the I CEO would joining getting the are their for like us warm my work for introduction. to Scott. you, team entire thank of today. welcome hard the where appreciate you and I Interim to prior we to in

in team class opportunity timing great The combination inhibitor and here success There to of cancer. Aadi. the is the of unique mTOR is to drew me technology, on build a what

deeper to Our more therapy, generate resulting hopefully nab-Sirolimus and groundbreaking the tumor us mTOR in the inhibition potent activity patient responses. of pathway better of at allows site anticancer

multiple sarcoma data unique XX We first highly from a a X. company have the moment to expect we our XX tumor-agnostic have indication where PEComa, as and study PRECISION months readouts this our of rare tissue soft very to anticipated in over next proven our

to and company. And team be performance the to oncology to over very precision share focused third excellent on fortunate Aadi strong leading with clinical a who ambitious an an their quarter. building continue joining execute also on commercial I'm I'm happy programs

to interim to we continues enroll rapidly, by early now data X PRECISION mid-December. Importantly, expect and present

and cumulative over months first the upcoming ] prior a and XX% more our XXXX. X trial the $XX We in sales at a third FYARRO million quarter, remained of catalysts sales [ moment. million in in will solid of year $X progress share the in growth

II development X in neuroendocrine studies strategy executing of agent other lung also our in single with tumors. other are care a in in ongoing in tumors. X combination announced Mirati's are with cancer KRAS in the and cancer Phase previously inhibitor of as endometrial the nab-Sirolimus, and of These We on addition combination with trials standard our solid initiation to

treat represent study cell to with of of cancers tumors an is sizable, based is evidence Symposium to interventional data whether The realizing mutations patients or the focus of look cancer in patients. the database. PRECISION nab-Sirolimus TSCX of types. of TSCX TSCX TSCX tumor on next-generation ENA organization about This that uncontrolled Foundation all TSCX alterations. of And all the key XXX,XXX nab-Sirolimus common TSCX either real-world need fall's of unmet our tumors designed types provides leading X This nearly estimate alterations. are best either of trial frequencies with mutated these These this at across date at TSCX considered sequencing the The our to Meeting, pathway patients thought with on alterations to presented solid together has patients or cancer the or growth. potential data X% or all mutation to been elucidate in potential large of and previous harboring TSCX our for independently. or corroborates activating genetic from activate mTOR Medicine We types Triple

a trial innovative that over wide of this a it With approximately mutation and types. , are difficult general are split addressable in types. between like a to further market with represents nab-Sirolimus, total our Our PRECISION tumor details trial for clustering the gynecological going cancer multibillion-dollar found cancers TSCX- forward. our tumor tumor-agnostic believe these patients will I'd in to speak mutations potential analysis and XX,XXX and range these gastrointestinal, evenly a Loretta, who We of turn of background, locations breast With lung, across across urinary to nab-Sirolimus. or to types, often are Loretta? unique latest therapy, variety internal indicates roughly X-driven plans cutting-edge treat. is X each testing genes, there mutations

Loretta Itri

everyone. morning, good and Dave, you, Thank

is agnostic. TSCX, This and PRECISION tumor mutations truly TSCX ambitious making study an elucidate type. of the of trial cohorts tumor to tumor nab-Sirolimus on regardless intended X inactivating cancers is noted, of Dave without expressing and types a by adaptive one it and impact specific unique As segregated

are pleased a continuing increased open The to than the study. community supported our the to patients an has are to X-week broad period. using benefiting with available sites Working effectively we academic has interest TSCX by within TSCX able just-in-time alterations our as with and mechanism have little participating in identify prequalified based, the and of trial. XXX We with our access sites inactivating sites our of very or allows from NGS more partners to us advancement sites open as patients with who clinical and both us that outreach track as in number

recently Accrual X predicted published between been by real-world at the as the Meeting. even Annual ENA has arms data the remarkably

to have other. date. the continue enrolled important We with It evaluated very assess each is PRECISION broad trial designed is to to the that more XX from trial, X representation solid of separately ability X arm in tumors a us single as is providing to with although tumor types discrete remember independently the than a arm

separate be Given its this viewed X own studies, as with each design, can outcomes. X PRECISION effectively

statistical in future, in of mid-December which at not X/X and analysis are report analyses near year. tumor-agnostic Consistent of the stand-alone quarter X the interim plan, to this another we studies. are X studies. to the just these in which at X/X enrollment, X expect Additionally, adaptive They are with enrollment, report preplanned XXXX. we X third there plan

early DMC modify safety the of The when this upcoming on the using will study, patients be followed and or each of primary interim file are investigator arm. tumor will performed us been of assessment protocol evaluate the patients response to study RECIST for will include and planned criteria We'll distribution, the analysis endpoint for to and with data year data XX analysis provide that evaluated early warrants. opportunity type months. on if X/X have accrued the approximately The X evaluable ORR interim from later

We expect representation therapy. and treatment of to broad reflect these results lines varied tumor histories of types, a

on great and to X milestones, We PRECISION both in look later program our have forward and year momentum XXXX. throughout built this delivering key

forward the spring next We our by few delivery weeks. excited a important promise the very nab-Sirolimus this the and the completed study year, on enrollment of ahead in have preliminary in over of XXXX. the complete by to Scott? well the remain end quarter to expect of now the the readout financial look about communicating third the We results trial turn planned study X/X to of interim and I'll call of of our potential PRECISION and for X progress. the updates Scott from to

Scott Giacobello

Loretta. Thanks,

the and the on year the On PRECISION the trial prior million compared organization. related quarter which in increased to the remain is cash, current for the we FYARRO quarter. operations short-term the is and of progress increase period into well development $X quarter in million were quarter, the the equivalents in XXXX representing to primarily same continued build-out This fund expected ongoing $XXX.X the third Research XXXX. $X.X R&D X growth financial sales $XX.X capitalized, based of investments, as to and in million XX% front, ending cash expenses plans. over million with to

loss was million $XX.X for million general increased third the to the expenses for $XX.X $X.X build-out primarily increase is and Net the third administrative quarter were Selling, $XX.X compared of FYARRO. XXXX. in quarter. marketing related period million due million company prior to This the and the quarter year infrastructure same expenses to compared in to for

turn on results closing be I'll information our comments. now this Dave discussion more third the for performance quarter, Form call the a our his reported provided For over in detailed on of financial to will XX-Q. call the for Dave?

David Lennon

Scott. Thanks,

to sizable cancers or truly said earlier, mid-December. sharing alterations forward lies defined planned in look with ahead. I We've and As the interim activating in analysis X for about upcoming TSCX TSCX excited we are X what PRECISION markets

excited third Beyond analysis catalysts including new interim that, in X/X up XXXX, the are about our we in coming the quarter.

reach to in next year, XXXX. of fully Operator? study trial the expect for can the line full end of open the completing the We questions. now in spring the by We enrollment

Operator

Cowen. question first Instructions] Peaker [Operator Boris comes from Our with

Boris Peaker

Great. me. for questions Two

year, second, XQ turning which to do is FYARRO, second the of [Technical the in you you First, any PEComa do early? interim therapy on what need Difficulty]? out that market have of analysis, be duration of estimate efficacy And of you what stop for kind to in sense next

David Lennon

Boris, thanks very for much questions. the

to what have a at efficacy rate second the course, that that comment in stopping this terms context of Obviously, and needs to arms time. be combination wouldn't point that have about we In think considered of running potential X about we needs of at the study duration and I within when study option point this But do early. for be. and response we interim,

I what side consistent seeing this that that's is we've in PEComa see terms would we can clinical point. at is the what I comment been duration think what in trial, On the of duration, with and

Operator

Our next Catanzaro Joe Sandler. Piper from question with comes

Joseph Catanzaro

for couple on PRECISION me X. a Maybe

So expected let the this. for interim hearing that you scans minimum interim this follow-up us months, first analysis, post the of what initial with of the amount the know just of baseline by second is think And minimum for then we're I ensures? can X.X year-end,

the the the look? second take allow So was analysis interim not, Loretta will this to these always along then heard of lines, plan? if decision And the to you right, drove if study. another I sort modify And what you

could by Just then? it sounds maybe wanted fully study understand you modifications enrolled employ given time, bit a will what that that like better little to be the potentially

David Lennon

Sure.

do areas? comment X first Loretta, to you on want those So

Loretta Itri

for your thanks questions. Joe,

reply. me let So

the one, a think please? have So -- of questions bit you I'm your repeat Do kind of the could I the -- first order sorry, little you got confused. I

Joseph Catanzaro

be Yes, yes, quick sure. I'll here.

the plans? have the you analysis, then post potentially And something interim the new? second what the is this what amount drove of Or decision? could And post-baseline And always would was take that's given by interim scans been analysis, point? enrolled that this insured of So months fully that follow-up. X.X the modifications the second minimum in then with trial

Loretta Itri

Great. Okay.

So the X.X-month at scans. post-baseline guarantees X least

the to approximately on design. or resizing. have that are X/X statistical ability you interim want question everyone file at always assess asking patients consider is will early and to have is The has you look interim second a when at analysis not the to whether So of analysis or sufficient might the a X/X the or common adaptive to been plan. have not that sample whether is an follow-up. It to about were very This least study analysis, in kind of size

scans an But -- occurs. So always that have would look those have this months interim options are and both will that we at by planned. X radiologic independent we will committee. performed be was this follow-up. independent analysis of analysis will when data the This of review And is monitoring

requiring have study, we even I we still by will cohort. be enrollment time, that questions. hope the the that your So entire follow-up completed addresses on though will additional in presumably

Operator

Song next comes Jefferies. Roger Our from question with

Jiale Song

Great. A couple from us.

interim we the which let analysis FDA all, you or contextualize been interim not to terms the care FDA understand But at X. against have going In hurdle standard providing now will are you the -- know the providing of to the efficacy the analysis, now. of statistical have you you Maybe I as at if can guidance the us benchmark. right

we know be the interim to in want achieve? So reaching or each you can will the the efficacy goal analysis ORR

David Lennon

this of we're assessed of X/X question, at follow-up. Thanks is -- The take point, of on interim I'll we the Roger. of second testing investigator-assessed statistics and is enrolled it minimum response ORR, based the note endpoint, this not It's so in the endpoint it's based primary one. patients and primary is for study, that And months to of rate. be against will which on actually the would that the is the this independently important overall the plan. interim also be X.X presenting December that

Jiale Song

Got it.

endpoint you and So know, for not in the us we will the Or the full let interim point the us you analysis okay, data? would let continue -- you will stopping be hurdle will that just the trial primary the will the that? second for do are what's know analysis,

David Lennon

that a at of probably the time terms we in review where are point the something a view sense measures wouldn't that efficacy rather about but with hurdle and -- be are give -- continuation. probably in We talk that Yes. of we're what and seeing the issue, to is trial is we whether

Jiale Song

Maybe follow-up. quick just it. Got a

David Lennon

Yes.

Jiale Song

And complete trial? a of Yes, the the the on XXXX. you we expect trial full when from by this quick that follow-up should is say the you data will end

David Lennon

the it's Yes. end It's still roughly XXXX early or of at XXXX.

probably this give We haven't the early we we'll likely once update enrollment. -- at more XXXX a it's we anticipate further but point, complete

Operator

Demir next question Ahu from comes Our with Ladenburg.

Ahu Demir

us. questions from Two

regarding how will And activity? more Triple to impact high impact how during other it trial observed disclose is in the curious deep frequently patients? the looks it the Meeting most that they First Or the analysis, the pXX mutations might level? be might presentation, one the is you like is co-morbidity co-morbidity, going interim

David Lennon

Yes.

tumors. co-mutations types very and of TSCX if is for correctly, across TSCX XX% high -- common About TPXX mutation in those TPXX internal that cancers. up analysis in data the a the that when co-mutation mutations. that first you you pXX look patients with is co-mutation XXX,XXX -- Loretta see take at. what recall, each indicate new So with those, cancer that back is the we there's types although and I'll different either overall cancers I crack of year across or calculations of had general for in me on this. potentially at common looked most XX,XXX distributions -- patients that consistent the types most tumor while and our all And we see all

context. And might altered that not to work believe what given with any and expect PRECISION from so expect anything TSCX that the retrospective impact we the add cancers and the don't know for it would you the seen it necessarily would and I it's that? X and past And within And overall. X, responses we we've in to analysis that in you or way, different if became negatively trial wouldn't to -- Loretta, TSCX basis PRECISION patients

Loretta Itri

I correct. the No, way. it same I think entirely have would answered that's

David Lennon

point initial at nature analysis in indicative numbers, terms be don't would be status would in won't trial determinations this on Yes. And co-mutation any the sufficient believe of really at presenting make we while The is going, time. detailed to an of robust we be then co-mutation of in do how enough this to significant point. the status interim, that a

won't be we So that data. sharing

Ahu Demir

on is endometrial second the That's my helpful. question program. And

sites expect many how enrolling, from of initial see data open? do study? portion is when the trial X And the Now Stage to are you

David Lennon

sites we've have we So on we're engaging an I study sometime the but study. have, we the very just study excited number and hope about in XXXX. started update wouldn't are in comment on of this community we we -- the to is -- -- that

Operator

questions showing time. turn over closing any Dave this to for further I'm like the not any to back at I'd call remarks.

David Lennon

Thank Super. and thank us much, for you very joining on Kevin, you, today's call. everyone,

X mid-December propel analysis As a interim to mentioned, the opportunities plan need joining We I the have trial on provide about with say. PRECISION and on additional for the or we in day, great Thank making to XXXX -- future we're that our I we're could for forward and should progress, grow. appreciate really the of and number to exciting for our the your time catalysts the excited everyone. look you a updates process call, progress

Operator

Ladies today's and presentation. gentlemen, conclude this does

You may wonderful day. now disconnect, and have a

Aadi Bioscience (AADI) 8 Nov 232023 Q3 Earnings call transcript