AADI - Earnings call transcript Q4 2023

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Operator

Good day, and thank you for standing by. Welcome to Aadi Bioscience Fourth Quarter 2023 Earnings Conference Call. [Operator Instructions] Please note that today's conference is being recorded. I will now turn the call over to [indiscernible], Head of Corporate Communications for Aadi Bioscience. Ms. ahead. go please [indiscernible],

Unknown Executive

morning, provide to review an quarter XXXX. the Good conference results Aadi call fourth year full to operational and and you. the welcome Bioscience of Thank update and

Dr. the our quarter some Today, financials activity Giacobello, Chief we Dave On provide and XXXX. full is Lennon, President year overview and CFO; Loretta and Dr. Officer, fourth and an for and our of Medical will the Scott CEO; Itri. operational call of

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

addition, today, In and obligation XX, made forward-looking of as not represent this date. our update specifically any to should revise representing relied views March be upon XXXX, statements. or as only subsequent any our views any forward-looking call We statements of on disclaim any

Dave to statements. With over turn for his opening that, call the I'll Dave?

David Lennon

nab-Sirolimus outcomes to deeper potent living dependent inhibition cancers for and that to and mTOR and unlocking the review inhibition mTOR on Aadi, Good and by has morning, full uniquely potential We are the technology At financial better pathway. today XXXX. believe fourth deliver mTOR you nab full patients of everyone, on are of we our with us the ultimately inhibitor thank results joining year for and operational potential for the a quarter combining focused Sirolimus.

and development a the delivered execution goals. for commercial year company progress and marked strong And against XXXX we as both was by increasing momentum

FYARRO the over a XXXX, cumulative $XX.X and and penetration First, for XX% achieving growth year. settings sales malignant prior achieved academic million the for of high year community a considered the is full FYARRO solid, preferred treatment remained PEComa. representing in

cell the nab-Sirolimus growth either key a of study of or potential with X nab-Sirolimus realizing uncontrolled These and in is PRECISION types alterations. tumors with all types mTOR to activating solid trial of leading either patients pathway an to for has our organization to harboring the for been solid elucidate the treat designed tumors Clinically, activate TSCX are to alterations of our focus interventional these of TSCX potential alterations. thought genetic

As considering a reminder, represents sizable, mutated solid TSCX tumor whether about the of together is or in need cancers X% all TSCX and cancer patients. independently and unmet

mutations with new across evenly Our between new are variety analysis in each approximately tumor alone. for genes, XX,XXX there internal patients represents these mutation types latest a market potential nab-Sirolimus. multibillion-dollar mutations year split roughly a addressable each U.S. of the indicates With

and are types. cancer tumor gastrointestinal, clustering locations nab-Sirolimus very to believe innovative our breast TSCX a often cancers TSCX PRECISION are therapy X range across in or types, and cutting-edge found We in trial is wide difficult these treat. lung, genitourinary, a of testing gynecological driven

evaluated from the providing X separately is PRECISION as trial, is arm ability one arm single to designed Although each with a independently assess us other. the

on both own X. patients top first investigator-assessed the data in be evaluation provided XX of PRECISION QX, in effectively X population viewed outcome. with arms. we line reductions studies, planned design, responses enrolled this Given PRECISION its the patients results These pretreated interim from a across XX In sustained heavily separate tumor in demonstrated first each X a can based

X the interim our within post-baseline XX the in scan. rate the at As reported least of overall was cutoff We arm, were patients who evaluable expectations. a TSCX for efficacy range an which reminder, for date of included had response the XX% analysis

and be durable. to with date to this heavily especially at noteworthy a early, was therapy. median cutoff. response appear ongoing lines a responses time Medium This Importantly, given X all X.X time is the that of deep prior of responses pretreated is months were population of and

Lastly, X these responses across tumor-agnostic indication. a tumor we're seeing types different supporting

results In prior given who to least interpret. the are were rate, lines a early including lower but of at patients pretreated, XX% TSCX therapy, arm, X had response we reported had, these these heavily TSCX challenging

to and continues we be now X fully the enroll enrolled to steadily, trial expect PRECISION May. by

in patients We who investigators total minimum December as expected QX planned responses. which study, followed interim have assessed of input primary are the for opposed overall readout readout, in rate on and reported next include we'll of This for months, evaluate been X our our XXXX. is response analysis, will a the which still track XX independently of to a

XXXX. We the of data completed early expect study the to full be in by XXXX with end

the to for Over-activation the pathway safety announced nab-Sirolimus of provides Phase cancers. single of excellent PRECISION X to various commonly targets. of addition for cancer is enrollment in previously found these and profile difficult-to-treat trials mTOR-driven tumors, is and underway dysregulation delivery promising X, both the In indication mTOR opportunity combat and II unique

treatment approximately agents had tumors, NETs The or today. nab-Sirolimus rate is and a with first NETs historically guidelines low year. have recommended oral trial clinically and which other to patients response per are treatment are with evaluating rapalog X,XXX NETs. neuroendocrine nonetheless in rare used

we demonstrated demonstrate in nab-Sirolimus' mTOR nab-Sirolimus nab-Sirolimus models, warranting provides relative type. opportunity exploration sensitive known excited suppression in leave trial best-in-class further target a mTOR animal tumor about to of improved as it indication. other We're this because efficacy this to preclinical what In the

cases endometrial letrozole. potential yielded endometrial combination XX,XXX estimated year to most inhibitors one have advanced EEC be we later There's trial the the of second with type recent reproductive in in evaluating annually tract cancer started settings. aromatase and letrozole in few of mTOR data potential the diagnosed and nab-Sirolimus cancers of for studies U.S. recommended The these of recurrent changes and common with mortality. is Endometrial of present therapeutic the in our is cancer for combination early-stage last studies a promising second-line cancer female the of an with increasing inhibitor, enrolling, this year. creates and of these combined used the standard Both in disease opportunity to first we plan actively clinical and initial are open-label care results Prior alone. the the

genetically-driven in to also of realize foundation solid Rounding QX well ongoing development development solid multi-indication becoming we and out of provided we precision with a positioned trial other our in an tumors our program, and inhibitor tumors. oncology cancer robust KRAS With clinical are bold a tumors a mTOR-sensitive program Mirati's commercial clinical ambition other runway and a into spanning CRO, combination and by lung XXXX company. cash have

I the for Scott call turn our over will on financial progress. updates now Scott? to

Scott Giacobello

$XXX.X Thanks, Dave. in measures head short-term corporate which cash we XXXX We ended early equivalents customer-facing and streamline in operations to implemented In had investments. a with and costs, count our our million reductions reduce solid cash, and quarter included fourth functions. and XXXX, operations

prior Full sales and for Following product FYARRO $XX.X these plans. will XX% measures, increase FYARRO sheet X% XXXX quarter. growth QX $XX.X prior XXXX we million, on of $X.X anticipate over sales year were QX million. were representing that our net an based fourth year of the over quarter, year the million into XX% fund sales over balance current operations

the to expenses million million for development Research year quarter. the in $X.X increased prior quarter to compared $XX.X and

initiation the For PRECISION expense million of $XX.X $XX.X amounted million X the the continued to and cancer is compared increase year, This NETs. programs to related trial last R&D ongoing the to primarily of year. endometrial and in progress

million $XX.X Selling, in million quarter general the to and administrative expenses for were period XXXX. compared in the same fourth $XX.X

For higher This legal and is the million in increased and $XX.X primarily expenses to to totaled expenses to year, compared company $XX.X infrastructure SG&A prior due marketing related the year. FYARRO. increase million costs

fourth compared loss Net quarter was $XX.X for $XX.X quarter year million was million the $XX.X year. of million Net the prior fourth $XX.X to to loss million in the XXXX. for the compared in

for our today. results will this For filed financial the reported performance to provided of be later on discussion a more detailed XXXX, XX-K in on information call be our

back hand the for to comments. Dave now closing his call I'll Dave?

David Lennon

in the sustained help valuable quarter the Scott. and study as remains as X alterations We're looking PEComa. TSCX I'm you, well progress progress we and our X/X proud TSCX and the to so of enrollment tremendous XXXX. FYARRO activating in the end meet in analysis accomplished mTOR-driven the with cancers. the needs inspected We're with sizable forward XXXX. a making from PRECISION by interim made clinical development markets with what team May QX against patients Thank with full completion asset in other demand in to sharing of in of plans X third

open for the line Operator? We can now questions.

Operator

Catanzaro the from coming question Piper first our And Sandler. line Kanzinze Joe with Instructions] of [Operator

Joseph Catanzaro

XX first characterized the very know Maybe being first one, pretreated. I were as patients heavily

lines, the or change remainder I if update the any you've look And you have in along And have wondering of trials what the dynamics disclosure? these seen interim follow-up. in whether like. one since any enrollment way So data any visibility around maybe

David Lennon

Great. We PRECISION appreciate Yes. about talking X. the Joe, more thank for you question.

entry design saw standard or right, being that the more first So and We going Patients heavily line all lines in get indication the is pretreated. prior -- enroll of in, patients number as a trial. the have anticipate, of X patients. that they late group. to prior trial with therapy XX treatment criteria received of that nab-Sirolimus to the XX first were by patients our for terms care We of to we're appropriate -- this their those satisfied have in in having enrolled

anticipate or overall the what XX the to of interim line We're this still next later year. the And continuing comment we're obviously the out end report we'll we nature I the and to in within patients patients enrolling total later at with. wouldn't X/X patients up trial, so on the enroll trial. going

Joseph Catanzaro

follow-up, could acquisition the I initial Bristol. PRECISION around endometrial if Okay. any are maybe the expectations been unrelated by there's or studies, when on early NET Wondering maybe those the combo the there are Wondering early you in from And days. still trial. to updates with there any data any appreciate then if X. then my adagrasib And changes report adagrasib

David Lennon

Yes.

So great questions.

is -- we I the share to do anticipate appropriate we later earlier how mentioned neuroendocrine We'll data and those studies, enrolling to patients trial data or opportunity Those and we that and about I year. potentially on think data those. enroll this maturing. we something is have the meaningful are have when sharing open-label that that Phase say it's think are data II single-arm endometrial

continues actively say and -- regimens studies are in is which that is patients, to on trials, each folks' community those a therapeutic great Mirati, for terms generating we BMS happy engagement the think of I'm on interest each of and the just there's then And ongoing. in those of good initially both enrolling sign these the patients in with indications. collaboration

patients enrolling into don't and are We updates any we at this point. further have that trial,

Operator

question the next Our with from Jefferies. coming Liang Cheng line of

Liang Cheng

This the have for X FDA guidance gets know interacting FYARRO [indiscernible] is around Second you FYARRO or about have year, about can any Roger. guys questions. I is you the I coming tumor us, Liang provide detailed question plan? from guess us agnostic. commercial more One -- in with we been

So what agnostics? tumor for consider -- FDA important to as in your and what's the most thing understanding, label it

David Lennon

and for for Liang, you, Roger. Thank Great. in stepping thanks

maybe maybe Scott just year? more. it about FYARRO on and little for Scott, comment a talk want you I'll question to So terms the coming a in talk that, FYARRO the of little to outlook, outlook your to then second bit do But we'll over about turn

Scott Giacobello

Liang. not Sure, going absolutely. mean, guidance FYARRO, for think Yes, this the for mean, question, I year. provide see, I Yes, to we're I you thanks as for

think $X.X million about think The there and grow there. or is $X last we the $X the stabilizing what quarters, so. XXXX. over the few above. I what that sales we But be think would continue range, expectation sales last to seen I that that's potential over to and stabilizing think excited I for you've million mark few to And slightly the quarters around you've expect in the seen FYARRO I million

David Lennon

important we tumor-agnostic for and here. going We're as -- has It setting expect a there. then market your reaching here it widely was job Liang, and when most on penetrating what the it just saturation very a in about be in on most over preferred the that population. view more what's the ultrarare give how tumor-agnostic thoughts recognized It think to important Scott. considerations guidance ultimately, to preferred Loretta first-line from question the an is think the out. And and her FDA's the PEComa I'm therapy available we is indication. market great turn team incremental -- second around we growth the on is indication we interpret for how And FDA's are may the and Thanks, on or to PEComa. done

to do Loretta, So comment? you want

Loretta Itri

Sure. I'd be happy to.

study thing in seen think variety tumor-agnostic what is the different perhaps What have that I do tumor-agnostic wants we from important a in studies a different tumor of study. looking is is agency subtypes want you most do tumor recently, see they patients. certain the that of to of concentrations They types. information to why see mutation not representation a for of of in variety a across so tumor-agnostic a the types, are

So for indication, course, think case, looking of single drug then, And I that safety or think of most population the closely reasonable a our approval. already their In have single whether are course, profile the approval in regarding element that already a terms see since that, tumor-agnostic to I not is rate. response perhaps resembles we determination classifies of they a they in we And in a looking important seen I safety PEComa. in the be agnostic what think have would good profile. for

David Lennon

Thanks, we I where follow-up, enrolled for tumor that have think Loretta. results to a to next. Loretta you the very saying, our add we think a early of what just was on of trial, shared Liang, we we can Thanks, population tumor even so I if saw broad what And in the within back the And no had there's questions. that December. saw and distribution kind we move in types far, diverse to

Operator

question next of line Demir the Our [Operator Ahu from Ladenburg. coming with Instructions]

Ahu Demir

little heavily cancer. that can criteria year? patients? patients? you of And X have exclusion a expecting this questions. question could sense follow-up If many are you sites One, to color, give for How A many what to they endometrial I of are open be provide regarding bit how us see inclusion would Joe's we Are the a the and pretreated? and great.

David Lennon

Sure.

happy going probably it I'll an update of wouldn't we Ahu, and give we're at that see it patients and some expect I active, sites to a answer Loretta Loretta I'm we're given to design we build later point trial, this over are think those the the in at questions. a in of for of and But time, maybe details. -- But so the to this to discuss or turn the where what trial just of number the of is number to kind story. continuing just might to year, let we you there. same

So Loretta?

Loretta Itri

Ahu, always great questions, as usual, coming from you.

of an So chemotherapy. either combination recurrent Stage no II endometrial Patients evaluate advanced be X study unresectable X or open-label basically, this Phase or in is will looking to patients carcinoma. with endometrioid letrozole advanced or would X nab-Sirolimus prior have of or who that the line received have and

patients we're is who So in population what of this course, is are which from a treatment PRECISION. course, early differentiated, doing relatively their of in somewhat

that this safe dose. is X-stage Simon I were much pretty nab-Sirolimus PEComa, that in think So is same of well-established study. they a a And patients dose the with are treated as and

to early an enroll being to Ahu, address open-label like the anticipate, since detail? and this report by or of more you the able study, is results So your would first that end plan year. Does we we out question, cohort, this

Ahu Demir

may. I is Loretta, question compliment have is And I conceptual very for you, you as more if thank This well. helpful. one your great. for This

other besides mutational So mentioned mTOR you could on you backgrounds mTOR to X, inhibitors? comment TSCX, sensitive tumors sensitive what are

Loretta Itri

that I many Well, targets. that provide I along there mTOR mutations may provide a quite may difficult because that's think think the question pathway -- are

don't any There those that of for of I mutational inhibition. mTOR are been think are specific as think any that has specifically identified don't proven. I target suggestions However, those a

Operator

further I queue the call closing see this the back in remarks. over any turn now for at questions I no Dr. will Lennon time. to Dave

David Lennon

the Thank call you, operator. And thank you, joining everyone, for today.

our X/X against later forward very which think this #X ability And is are look we confident on X the trial the have that as see, set update XXXX. We're to both we into interim our providing on looking delivering PRECISION goals deliver that within for year priority, and an XXXX. I ahead trial. finishing we XXXX to you and operational on

the We're the mentioned providing in both and our little got also about programs a Q&A endometrial updates and this new on we bit year. today to and look excited discuss trials forward to NET later

with deliver remain as confident update that time, to look Overall, making that the you, we continues same attention a the market. penetrated At indication, with is sales go all. your us for we solid to we Thank really otherwise, we're an progress for you the and in highly and next and you market thank forward we're have continued day. the within forward. PEComa And I FYARRO. in today, This ultra-orphan time and great all

Operator

Ladies your participation. and does gentlemen, that today. conference for you for Thank our conclude

disconnect. now may You

Aadi Bioscience (AADI) 13 Mar 242023 Q4 Earnings call transcript