AADI - Earnings call transcript Q1 2024

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Operator

Good day, and thank you for standing by. Welcome to the Aadi Bioscience First Quarter 2024 Earnings Conference Call.

[Operator Instructions] Please be advised that today's conference is being recorded.

Now I'll turn the call over to [ Audrey Gross ], Head of Corporate Communications for Aadi Bioscience. Ms. ahead. go please Gross,

Unknown Executive

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

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

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

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

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

David Lennon

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

TSCX seek fully is market. is to a Today, important milestone a of PRECISIONX a enrolled we This types. to with as an potential for solid TSCX of now I'm announce nab-sirolimus that harboring inactivating tumor trial registration-intended patients or array either alterations, understand the across pleased broad tumors sizable

internal genes. Our across these multibillion-dollar addressable there represents between tumor a roughly split Each approximately patients market with latest for XX,XXX potential types, mutation analysis with variety evenly total a nab-sirolimus. mutations indicates mutations of are

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

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

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

in of in reductions we noteworthy expectations. XX demonstrated patients be arm, for results which given investigator-assessed across to and the These in sustained lines this a especially which durable, within both XX%, reported TSCX of from median we first arms. responses tumor of the QX, pretreated XX responses overall pretreated of interim appear the population a deep based enrolled response our X planned heavily the note, range of early, rate therapy. with is As on investigator-assessed top a data reminder, line provided PRECISIONX. evaluation in patients a Of first heavily population prior an These was

view of in late-line significance patient especially tumor-agnostic ongoing reinforce different treatment Lastly, a conversations of to indication. clinical our the the with I reported responses the the we first were experts types, supporting that in both these responses groups. across X interim seen want potentially from tumor analysis, highlight

have TSC We and path a believe potential continue results of these group patients, for submission that approval larger hold to should in improve mutations. we to or

been overall the evaluate investigator-assessed opposed independently rate primary for of will QX of endpoint to and as include have now our the a planned assessed a is anticipated study, analysis reported next for we will interim XX analysis, months expected This response responses. trial which readout, minimum With which X of our fully followed on track total of patients, in who the highly December interim enrolled, remain XXXX.

we Looking study be the end XXXX the XXXX. data by of in full expect ahead, to completed with

promising In addition II trials for Phase the to PRECISIONX, to cancer enroll two targets continue mTOR-driven well.

annually letrozole. Endometrial Prior and of on the advanced inhibitors mTOR in second-line in female recommended cancer, and an reproductive in with first the estimated tract or the trials, for aromatase EEC cancer to the care endometrial the of diagnosed As EEC is one of the cancers disease mortality. cases of There reminder evaluating settings. a common with X increasing most cancer recurrent U.S. few alone. used the of in have nab-sirolimus endometrioid-type with these is potential results, or for letrozole yielded therapeutic changes standard recent inhibitor, combination combined early-stage first the and in the a opportunity of creates is combination be this XX,XXX clinical studies promising potential

a exploration oral is The NETs. tumor it best-in-class suppression neuroendocrine agents, trial nonetheless what are the we which mTOR-sensitive demonstrate the recommended target excited year. We're rare because mTORs, animal response nab-sirolimus known other cases in is in setting rapalogs NETs in models, with In evaluating provides other type. or nab-sirolimus efficacy NETs. NETs second trial low a nab-sirolimus guidelines. rate to opportunity are to historically clinical further and a demonstrated of have X,XXX the relative to for tumors, approximately in or used believe this about preclinical treatment improved treatment warranting clinically with nab-sirolimus'

unique tumors, these combat provides commonly profile of Overactivation and the nab-sirolimus mTOR found dysregulation safety various opportunity is the to the of difficult-to-treat excellent cancers. in delivery and and pathway

data indications from are are eager promising As studies this initial these think such, present to and we these year. open-label later

terminated KRAS-mutant That with to lung promising the non-small to At our today, solid for announced and BMS. supply mutually our in nab-sirolimus NETs. update with now us final a indications of cancer Phase which have a EEC As evaluating this collaboration and the our adagrasib, plans, phase selective and KRAS inhibitor, early to cell we ongoing trial, BMS and nab-sirolimus agreement of in its enables of that Mirati, the agreed was evaluation we combination other II tumors. prioritize we discontinue development request, trials our

to for product $X.X FYARRO. the quarter to FYARRO now net Turning with sales of well continues million. perform

For a new of Swings in we of than a current is to expect distributor this average. context, in this bit in QX QX sales correct growth will is from return may patient decrease and where quarters, small a accounts, reflects to top enrollment fewer year initiations what number we're historical patterns robust in actually in cannibalization very QX. changes and subsequent prior ordering a trials. in and We be patients clinical our believe due at into part seeing commercial itself

as treatment for X on the after the position has FYARRO years cemented malignant market. just preferred coma its

now addition We the ordering quarter, have across community high XXX launch. FYARRO new more penetration accounts academic consistent every of and since ordering have accounts than and seen with settings

We realize multi-indication rare XXXX months are proud aggressive our of well XX success to and becoming ambition sustained and cancer. the and are continue for impact ahead us, runway commercial with had FYARRO this will a of company. to With a have patients QX into positioned we precision oncology catalyst-heavy of of cash has FYARRO,

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

Scott Giacobello

streamline and measures from cash a decrease Thanks, fund and equivalents costs, in operations implemented the capital Dave. quarter QX plans. the XXXX XXXX representing including based current X.X% net into quarter, an prior continue to were that $X.X early XXXX first short-term We with balance for management, investments. sheet period. in support product our to healthy ended the will $XX.X cash, first reduce Responsible on year operations million sales FYARRO million

this well will in as As Dave QX, lower decrease quarters as in was ordering part in to commercial mentioned, patient patterns we which future due expect correct distributor initiations.

year, expenses in million operations. due quarter. XXXX. period was related quarter general million million for and to expenses increased the compared $XX.X the costs the first development programs $XX.X loss cancer to same NETs. decrease compared for the XXXX. related and fully is Selling, in administrative of and million primarily quarter progress consulting to reduced $XX.X million ongoing of is the This our severance to prior now in Research PRECISIONX continued to and year were for which increase Net in endometrial streamlining the prior in by first legal to trial, quarter enrolled $XX.X million to the the $XX This quarter the offset the compared and expenses of versus in $XX.X first mainly part the is

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

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

David Lennon

other as the with plans third this anticipated We already tremendous is TSCX of as TSCX trial clinical inactivating strides making our Thanks, providing development in in X a our Scott. X/X quarter analysis made proud progress forward II from the PRECISIONX look year. sizable I'm early alterations later and mTOR-driven Phase well sharing look year. cancers. an and this to against We're markets highly we've from interim

open can for we questions. Now the line Operator?

Operator

first question Roger from Song [Operator Jefferies. comes Instructions] Our with

Jiale Song

update the the NET. readout the year, Maybe quickly expectation we're meaningful and to much how [ initial versus on safety just particularly will patient ECC this cetera? and later data et efficacy data the Curious and (sic) numbers going How about the that ] become? into see EEC

David Lennon

Roger. you, Thank Great.

and the and trial, remember X-part able efficacy initial are in report on Xs XX enroll that early the out studies on the patients by Xs this So to NET Part anticipate initial safety end and data trial. year. those II these Part of each Phase EEC we'll be We approximately data

to would add you anything Loretta, that?

Loretta Itri

design. the well reaching determined that think that I anticipated, to we're problem the Only X-stage in going have and the been going Simon's have is ends recruitment as don't and any

yes, just on mentioned. as results, So Dave to we're target I report think our

David Lennon

by of in in combinations of -- exploring because then Roger, these interest we improve upon mTOR great to spaces. these seen what both prior the with been and trials -- encouraged community nab-sirolimus inhibitors both these there's the potential on we're Yes, has before in very been of both these

data. we'll we of out through that pull see as So first report parts hopefully, the this

Jiale Song

the maybe maybe in Yes. Yes, the that's trajectory, on parameters first-line for FYARRO bit XQ sales. and historical terms from off to the repeat field any FYARRO, also color the to some little maybe the terms as the compared sales to of from of the average, of curious PRECISION And what's very in seems helpful. feedback some your existing a use, kind results, around dosing understanding And impact the patients? but treatment duration those

David Lennon

sure. Yes,

X sense. So to parts in that a

as cover So data. of strong first, awareness, for those we've extremely we at uses, et me that were as let on adoption, us in physician first-line look terms looked of parameters, late cetera, the all at

FYARRO in real see attitude changes in use community's And the PEComa. no so we towards and its

some this expect -- little we a more And the QX, quarter-to-quarter for us in we variations with incremental lower are sales and we indicated We be situation a year. in bit think course could this QX of in a I to steady-state in occur. growth, quarter as expected

Importantly, adoption of half starts that we is very remain -- demand and FYARRO in impacted in we starts small the really it's swing About a what with some that in see patient by has of new here. our patient impact centers. driven robust, new remains largest

largest where patients the in large at usually with over time. to have commercially X XX the one any recall last number X last enrolled we drug trial. correlate centers, PRECISIONX on PRECISIONX over also the we've patients around of XX the of patients months. anywhere the a recruited And months, into X And we've that course These

distributor typically, in talk what just clinical side the this what's then responses the aligned to let Scott business. I'll same clinical like a talk case, on we're go trial a of and versus about commercial little So about scale happening more I doing is as But in the of -- that situation, Loretta PRECISIONX. commercial to to we're in aren't magnitude trials terms bit the would the to side. Maybe physician and

Scott Giacobello

sure. Yes, Yes. Thanks, Dave.

swings recent we're as On what at saw noted, at distributed an which we've in -- the level inventory unusually in QX end quarters. side, low quarter, on of inventory we is we some based the the seen in

that next going itself few quarters. that's And do so to we the out over expect work

David Lennon

Loretta, particularly from comment on investigators a the I then, through response that we And and just maybe led on the PRECISIONX want interim recruitment. what results how saw their and

Loretta Itri

had our patients. The of Well, more impact study. the this frankly, Remember stage given interim, no remains of saw beat. supportive the advanced these X.X, community very X actually prior was of median to many regimens. of responses miss with than a And first patients prior didn't at many that the having that We X therapies on we accrual. received very the virtually

responses the patients, these treats we that community that good. saw the to So looked pretty

so of have terms everyone we remains and our a accrual. And missed in enthusiastic, not beat

uptick. had fact, a small we In

I wanted to reality. that's say, know me So but if that's Dave, what you the don't

David Lennon

other always you I want Thank Thanks, reality, Loretta. say Any you. the questions? Roger. to

Jiale Song

helpful. that's No,

Operator

from Our Sandler. comes next question Piper Joe Catanzaro with

Joseph Catanzaro

-- have this cannibalization ones. up following sounds the Just you're I'm quick patients. I'm of understand enrollment of trying misunderstanding a phenomenon It first commercial understand the on PRECISIONX just sounds PEComa to case. the And and like that it Maybe guess describing. that's I into that's maybe like But dynamic. FYARRO commercial if sort couple trying case, sort away saying you're why it. I'm pulled of to

I'm misunderstanding it. think, totally I just maybe,

X So X any maybe help appreciate it. there, follow-ups. or And I I have

David Lennon

Yes, sure.

is level get where. institutional and highly What an don't with is tell hard was we it's the saw physician largest we commercial we enrolling but some we coming at our our this some were for product, saw business of level what IV in through orders sites, Joe, with So correlation our us to sites. -- what that accounts data end a often data, of therefore, and largest reductions patients get that exactly PRECISION between up correlated PRECISION

use, clinical into we a level, and don't maybe may enrolling opportunity that were commercial being that spontaneous commercial anticipate how but plays the physicians out, like that patient a them -- took commercially treated those patients enrolled few a exactly of would a in we patients, of non-PEComa At instead on those patients basis trial. the have that know were

an clinical exclusion PEComa this in it's obviously So into because trial that's case. criteria patients not

And we're that that gap XX about create or saw that in remember create QX saw gap QX. we or of that in patients that swings patients XX the last talking less the we

of takes swing very sets actually the so decisions that to And it way. business few

And to indication business. that patients so the enrolled, non-promoted for et would an now back that are be -- for a only looking line cetera, option to opportunity in with Precision in go commercial last that fully

Joseph Catanzaro

confirm quick That's know baseline would clinical for this it. Maybe could have but be X within the if you PRECISIONX, that just Got wondering features of helpful. said Okay. questions. your sort expectations, GXXC that guys the you set with meaning pretreated, had for out that aligns the heavily of trial? on patients, XX first any the decision And tumor data then was terminate population emerged types. of full that based to diverse that, I

David Lennon

Sure.

for the indications. Thanks, And -- what completed focus excited with that see, we with well we from and that, we on seen Joe. decision nab-sirolimus saw And fact, NET it's data as to population, other we're little that we in the do program that efficacy had we really the come very will before. baseline a in the program, much in potential on Any nothing we've set. safety fully very -- that to more -- as the so So the about it's -- endometrial The from and Mirati trial. evaluated decision, or we questions? that data it's obviously, fully far. and do to analysis decision consistent on only cleaned the can trial haven't data what But have strategic and when the interim financial on the those

Operator

question comes next with Cowen. from Our Bancroft TD Tara

Tara Bancroft

to just question on that asked. follow So up last want Joe the

how next in you're year over So savings or this much that ending the now we X difference expect can agreement? cost now

David Lennon

to spending? Sure. comment for Scott, outlook want you on do

Scott Giacobello

question. program. specific that we shared but There Yes, the information, for Yes. haven't thanks savings, on that we the information information. individual Tara, haven't be shared will

David Lennon

Tara. Thanks, else? Anything

Tara Bancroft

good. I'm No,

David Lennon

Operator, to other any questions. we can move

Operator

with Our next comes from question Ladenburg. Ahu Demir

Ahu Demir

us. from X

you this look would for to the follow-up in like program? Roger's are more interim success EEC the analysis provide a on this And benchmarks? Could one, guidance First setting? what What question.

David Lennon

you Loretta, comment would Ahu. like that? to question, on the for Thanks Super.

Loretta Itri

Sure.

that And give a study. basis response so the that kind of first will cohort the show in And course, exceeds of that it's -- a And patients a XX%. is is response. for think that accruing of may XX the XX along looking to design. looking is be it Simon's far you but this the -- designed expectation, So and in be -- the X-stage pretty second for. patients you're the patients, guidance I an We're It's total would of on additional be would our we're rate higher, overall portion for a XX folks. those

Ahu Demir

is great. understanding, That scientific albumin Based our nab-sirolimus sounds on regarding question uptake there's the second strong Yes. collaboration. My in rationale cancers. between also, RAS-mutated therefore, Mirati a uptake

So pursue RAS-mutated future? and to curious, do in setting the if obtaining Any side? be and plan you the you clinical cancers [indiscernible] any on that data will this

David Lennon

make time. patients and a have I how in at in data plans that later we'll into decision were trial see the now, no that comes think, Ahu, that area. on we in expand enrolled to the the Right point

Ahu Demir

Got it.

Okay.

David Lennon

Super. questions? other any Thank you. Operator,

Operator

at back remarks. for closing further I'd I'm showing to turn it to no this questions Dave time. like

David Lennon

joining particularly Thanks Great. supporting and Well, really to this. clinical Loretta the development the great Thank around everyone course our thanks, year, this you. And call morning. progress everyone, we of this for to remind and study Scott, over I that had Audrey wanted programs. for

We have our in and also opportunity for to interim which with milestone year. about where analysis this programs the early cancers, NET in forward expand now nab-sirolimus major look updates We're EEC TSCX the we and of X for our and look PRECISIONX this us which really are later portfolio. TSCX those determining really we've and be mutant quarter go to will enrollment enrolled next large on to excited seen forward progress trial us a fully and X/X year,

Bye for we joining everyone. go further in for we forward of we to updates And forward XXXX thank look year. the the now. look business. our as Thanks, updates and you through as call that then finally, today, we expect on and to progress growth return to QX sharing to Otherwise, FYARRO commercial

Operator

concludes conference. your program. for in This the today's you participation Thank

now may disconnect. You

Aadi Bioscience (AADI) 8 May 242024 Q1 Earnings call transcript