Earnings call transcript Q2 2023

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Operator

Good day, and thank you for standing by. Welcome to the Aadi Bioscience, Incorporated Second Quarter 2023 Earnings Call. At this time all participants are in a listen-only mode. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to Marcy Graham, Senior Vice President of Investor Relations and Corporate Communications at Aadi Biosciences. Ms. Graham?

Marcy Graham

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

Loretta CFO X call provide will update And by overview including plans of activity Scott Joining an CEO, operational an today our and Officer, and the Dr. our on President and the Giacobello, on development me our during followed and financial Chief update Interim who an provide is PRECISION be period, continued Itri, he commercial for will will study progress. clinical our who Medical XXXX. on

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

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

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

Scott? turn the I will to for opening With over that, Scott his call comments.

Scott Giacobello

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

clinical enter each on see half the the solid driving performance results and organizations the during quarter, we to focused year. We second of as from our continue commercial

Efforts and providers increase quarter the healthcare quarter. see quarter the we utilization previous key the our sequential teams the in as are XX% awareness over from sales pleased stakeholders, continued with feedback sales FYARRO driving field in X% of reaching positive in the setting. are prior marketing efficacy were growth and $X.X year we varied educating over by and safety the and FYARRO with and channels, showing a growth million, first-line on the for greater physicians

the X forward looking is to and Separately, with results end analysis year. patients well, an progressing follow-up interim XX trial PRECISION before of we're of on providing appropriate the the

tumor patient opportunity PEComa, much enthusiastic the a about We of of for significantly trial exciting application to future we are different broaden growth. presenting this population an types additional in address in larger potential nab-sirolimus across currently the than and many

have either in Beyond X the a the of tumors, the other we new target PRECISION study, potential neuroendocrine use as or continued pathway clinical further through FYARRO pipeline of investigation of our number we're the or in in indications, mTOR combination nab-sirolimus expansion with agent to and therapies. inhibition Today, single cancer evaluate announcing a of NETs. endometrial

with us value indications other of data targeting This new potential execution believe to defined of pharmacology programs promising, of mTOR fronts, that shortly programs. indications therapeutic launch year a many to alterations. which reflect includes benefit will these join to Loretta patients. now additional in provide preclinical a our pathway potential we treatment of clinical on the aspects for unique the enhanced in the we nab-sirolimus greater believe is genetically Our of the on cancers harness as these technology and of in will provide detail our and nab-sirolimus is

and PRECISION our provide X Loretta ongoing is activity. up on an update trial Loretta? our clinical next discuss to

Loretta Itri

of mTOR-naive is X in study patients TSCX inactivating the prospectively two This solid trial you, trial to TSCX. in tumors arms, or in tumor-agnostic our ongoing solid Good we Thank malignant morning, and TSCX continued TSCX Scott. one Throughout everyone. other tumors with one designed have with second harboring alterations. advancements independent harboring quarter, PRECISION the with evaluating make patients

relatively of observe the continue even study two rate a accrual to arms. between We

types We of than trial truly also expect continue tumor more to the fully have a very a and this broad tumors to solid represent representation results tumor-agnostic discrete XX of outcome. across

profile safety and and pretreated with the new enrollment increase this we seen thus have Importantly, signals entirely safety have the in is continues AMPECT to patients. far of population in seen heavily that as study consistent no diverse emerged

of and months enrolled. is the XX we first full after progressing patient by enrollment continue spring well, to trial The target next patient the was year,

when response end forward looking the the overall on are be further X interim appropriate of the preplanned investigator in sharing year, the assessment with to with analysis presented on XX of will information study follow-up. before We patients the PRECISION conjunction

the about the treatment this promise patients We may the hold that diverse and population study nab-sirolimus of potential of need. excited remain this of important in for

use and believe PEComa beyond potential We both in clinical indications, of also number to that and single and with therapies. continued we have agent nab-sirolimus the as TSCX other its in which extends is of a a investigate indications, combination new why X approved

pleased With of we we nab-sirolimus letrozole for multi-institutional with of carcinoma. on to endometrioid the of and advanced to with endometrial efficacy or is X nab-sirolimus letrozole endometrioid-type are stated, well are the more trial initiating safety advanced combination endometrial that trial or investigating a share patients EEC. open-label, evaluate track, PRECISION recurrent cancer, easily Phase and the II This in recurrent study or an the treatment

recurrent data Prior of there combination and this cancer. is yielded activity with for therapy promising antitumor potential inhibitors have endometrial we to clinical the patients produce area, synergistic with believe endocrine nab-sirolimus studies in mTOR with endometrioid-type in

patient We enrollment expect initiate in XXXX. of quarter the fourth to

may care letrozole plus nab-sirolimus a immunotherapy, which failure. in of recommendation believe chemo-immunotherapy be we that the opportunity standard change recent now for very to there treatment, includes in first-line following develop unique carcinoma the chemotherapy endometrial Given plus

metastatic the received lung no advanced, tumors, than pancreas, In launch fall, open-label evaluate tract, differentiated, II neuroendocrine lines or who functional addition, of NETs, well expect to two trial have unresectable to with of more this adult Phase multicenter or nonfunctional, single-arm a prior we or therapy. patients or locally GI

combination adagrasib dose clinically Mirati KRAS in historically solid The KRAS started, GXXC which the mutations able agents, with in to nab-sirolimus nonetheless, patients is patient of and with superiority patients of the clinical intended treatment and demonstrate conducted optimal first low Phase in with are this of and evaluating the I/II trial determine adagrasib in to this with the has dosing of recommended being Phase rapalogs nab-sirolimus purposes other tumor the The dose nab-sirolimus collaboration guidelines, future with tumors. of oral the and II population used study, and completed. mutant is publication. anticipate Given treatment in Therapeutics, response recommended the we rate GXXC now for to with of combination

many strategy. activation now back As the the of fronts. you new I progress. our Scott planned addition our of turn X, PRECISION of financial to are see, in call on Scott? over studies, will on can foundation we growth are progression updates and for The active to the commercial

Scott Giacobello

Loretta. Thanks,

our we of for continued with In commercial patients the addition to with pleased FYARRO progress are advancements, clinical PEComa.

XXXX growth million We than X% XX% remains second demand growth of which We covered. the are product a access seeing lives year-over-year more of commercial and very XX% on $X.X represents quarter, basis. of first sales and for in strong with over the quarter steady reached growth, commercial

to XX just market. sales months on $XX the have Our date in reached than million more

strong, up from consistently was we clinics quarter, first reorder sales The XX% positive more hospitals of had have XXX representing XX% than experience half of ordering end quarter, the and unique the the At been in uptake quarter. underlining approximately with community FYARRO. second the FYARRO The the accounts, rate in nationwide. approximately

FYARRO PEComa, a continues as approved frontline As to in the increase only therapy. therapy share

Our malignant awareness and the team continues in drive cement our as efforts to FYARRO standard gold education for PEComa. to

understand value PEComa becoming patients. and differentiation so, that clear do they for of the stakeholders As it's FYARRO

sarcomas. awareness patients. Our overall an specializing FYARRO of also significant a The for are shows those physician readily top providers their is FYARRO receiving tracking with of robust are awareness and feedback that treatment we XX% and choice as for impressive indicate adopting in XX%

short-term increased the million to to million programs which capitalized, XXXX operations cash financial On is current front, investments, the we This second and $XXX.X the for $XX.X NETs. $X.X build-out related in expected R&D is endometrial the prior the well based quarter cash, additional quarter. the fund of including remain expenses development equivalents quarter cancer in with plans, the continued increase progress and in on compared trial ending to to and the PRECISION of and Research million primarily as year X organization. the into ongoing

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

quarter. predecessor, The $X.X impairment year to license quarter to the for the $XX.X in loss million the year related compared Aerpio. included $XX million Net million loss of prior agreement net was noncash the company's charge Gossamer the prior

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

truly As I lies ahead. and about are with we're overall excited stated our progress, we what earlier, pleased

in and mTOR looking about high need. forward new to with We meaningful continue We're unmet end populations prospects endometrial for indications to are our in further and on our information excited PRECISION year. programs patient the the next-generation the and progress enroll X our the trial of these sharing inhibitor cancer NETs before and

questions. We can now open for the line Operator?

Operator

Our question from come first Instructions] Thank you. will Joe Catanzaro. [Operator

Your line open. is

Joseph Catanzaro

I what's follow-up here. couple. questions required a is patients have minimum the one that Maybe PRECISION us if Can cut the the have follow-up data a minimum once my there? on whether you taking you so, Appreciate everybody. remind just these X XX Hi, And first reached period? interim. triggered

these will on a I but the Thanks. you, not and And confirm point in data review will be this Loretta, at to be there just assessment study. that investigator-based think just reported heard central wanted I I interim

Loretta Itri

for subjected IDMC Hi, will you're investigator Yes, they Joe. not and These be be you your review. responses Thank will correct. questions. to

short. then will So months your first attempting few the six was that patients. minimum think question. are of we follow-up, And on A the provide of most fall follow-up to I

we months. might be about I think that shortest the will have Does help? X.X follow-up

Joseph Catanzaro

data included of NETs need you that That's you then guess, potentially that superiority just strategy and could then guidelines. Yes. potential if set everolimus, for to route? helpful. super that like is there get the maybe then think follow-up, there? what's would the And generate data so, and Got sounds pursue you scope it. maybe to set generate a I in over it the And to I correct Thanks. to published study, look a to a points am

Loretta Itri

don't So Joe, I numbers. have We better strategy you than could did. huge just need not I think the stated

numbers, are initially. number small We small going the study. do Two-stage exact not but a share it Simon to relatively planning be relatively I'm to a will

low very response rate look the And will that know, will if pharmacology is oral to markedly we you rate. see believe rapalogs rate. as superior show a We actually because, superior associated are our response response improved with

If study we small to the prepared will the in number. larger patients, see subset a to a of first signal we be expand

that helps. So I hope

Joseph Catanzaro

Okay. helpful. so that's my for Yes, Thanks much questions. taking

Loretta Itri

You most welcome. are

Operator

And from One moment question. question for our next will Ahu our Demir. come next

is open. line Your

Ahu Demir

morning. A necessarily quarter. questions I'll Congrats this couple follow on not as the it the progress approach like us next on well. TSCX/X Loretta, remarks, in of your up are Good looking based at here. on for sounded you study.

curious you population with prior would be could that could in yet? haven't patient you will there. that be provide more just So share What therapies? looking if Anything you the us at color you

Loretta Itri

the play onto good fact, to a trial not You're enrolling, not It's long mutations always PRECISION PRECISION, study. quite morning, TSCX And permit NETs hear Ahu. or correct. point in of as as does patients the NETs is with the good will X you. we from significant study. role And TSCX/X

study. functional, not medicine be precision to old-timey, So an all-comers intended this NETs. more a This is of a is nonfunctional

on data response show we differentiate to it rate literature a was in are to our regarding the the pharmacology. will out population a low very for be looking differentiate, oral we the basis easy the that previous benefit of to and us in And for bar, brought question, as rapalogs. superior think It's in relatively from

Ahu Demir

the on PRECISION you. helpful. other My X. Thank is That's question

to mean readouts? in XXXX, readout? for for analysis? for top the complete first that we line data for still should of we data expect you the what half top track And Given line expect it next Are that on what data would enrollment year spring

Loretta Itri

in quickly changed. then completing final months year, see data math, probably anything as how And quarter. Well, report takes, I enrollment to as end end that We having report early see an can't next time by have think have to on of mature, the by year. long have can by can. anticipate of will follow-up out exact I if you first last six we as commit we out the will line we do you end patient can of it because we results to of something but anticipate we the quarter, and first don't

Ahu Demir

And thank is question for Scott. you. Okay, last my

For market you we should penetration, quarters? FYARRO growth much with the anything communicate us, could subsequent how is there expect And Scott? for

Scott Giacobello

Yes. Thanks, for Ahu. question. Thanks the

We haven't PEComa pleased I we how penetration with physicians. continue and in from say market what with would to shared doing is information. really be we're that FYARRO hearing

of I think to we April and May actually quarter. followed bit saw had you softer a as a had June. far expect as we a up in from had and We quarter perspective, what the by move strong this as little X% that in a growth

of actually what We quarter So similar saw a in that was could last of the situation a reasons. for actually full year I launch. first think be number

it's for as the positive inroads continue we'll to has we to on half the first the into with bode not in think as I I how think for make but think well to able see of And mentioned I So move should my what duration I line continuing, continuing be really comments, forward. launch back year, -- guide we really gone.

Ahu Demir

much you Thank very my for questions. taking

Operator

question. next our for Peaker. moment will One coming be Boris question our And next from

is open, Boris. line Your

Boris Peaker

my in program? seeing comment it you first question in you're FYARRO. therapy how development Good taking to Can of and of actually morning, duration thanks you compares My clinical questions. on terms saw and what the for on what

Scott Giacobello

mean, duration yet. shared data I we the haven't Thanks Yes. question, Boris. for

I think out want we there. little a time more still

patients. were we As EAP, of first patients out of patients getting when and journey, we I've lot remember kind with previously, of launched they said coming then no approved also line you out so in a had where their and later therapy were patient there,

I quarters. more half seen the in should well, I read think duration, the bode first in as better year, move happen we've have we to in we'll this as which coming continue that a for line, and think I think of first I the mentioned,

Boris Peaker

second you're else? my PRECISION endometrial question mentioned something are And there's think indication enrolled. on indications predominant observing, Great. Curious, XX there maybe you is or any X, I that

Loretta Itri

Loretta. It's Boris. Hi,

be seeing a larger we're the are And are probably seeing common wouldn't see We what are ovarian, -- urinary most I a you a endometrial, most the is is which it GYN Bladder, subset. We're not smattering of you, tumors tumors. of mutations it's number because the bladder, tell seeing. the in we sarcomas from but one what which is where surprise as group, highest would surprising patients the one can TSCX also interesting. see player. sarcomas, We

everything. leiomyosarcomas. We one we small a have of And osteo, then see of group

that I endometrial, in. say the but So suggested, specifically would see is not but tumors -- group, GYN, of mixed as different we largest you as GYN types focus a

bladder, hepatocellular. We also large see tumors, of pancreas, a GI gall tumors. fairly of portion That's fair number another

seeing lung one to -- we didn't lung. much say up now more starting of Lung we're see types. I is as common come the follow beginning, we So well. as now that much would the pretty In

what pattern can tumors. I commonly that we we So help? are following of usual say observed is Does that think the

Boris Peaker

for Yes. lengthy for you very my Thank answer. questions. taking much that Thanks

Operator

And for one next moment our question.

Our your line next Song. question Roger, coming be is from will Roger open.

Roger Song

the taking congrats Thanks for question, the for Great. progress. and

the -- you're trial The some traditional histology-based more from the you strategy. mTOR first Loretta, validation inhibitor, prior maybe question trial. expansion towards the related to Seemingly, moving say be may of like,

anything TSCX mutation suitable mutation be any for for precision for X specific and FYARRO? continue route? or genetic the Just you beyond curious if FYARRO the oncology will Like may

Loretta Itri

interesting you. question. That's a really Roger, thank

take we direction. think I that will

and the will moment, of At perform look on co-mutations. those to targets the As two of data to is to the only well. you that we exploratory trial is at analysis with, that therapy know, compound, that are targeted are the the seem course, we other PRECISION work one combining mutation suggest there Mirati

very we potentially to PRECISION forward, us contribute think And other rich have that a would to important identify co-mutations that looking set from data help I X efficacy.

will now, data. think follow no. and be opportunistic I the think answer But I future forward, we be So right the would

Roger Song

Yes, looking you. any that Maybe co-mutation. I histology-based quick you trial, makes will some those other for potentially more you're mutation, for better And traditional just maybe maybe follow-up. strategy to implement FYARRO? even a the understand biomarker in sense. Thank

Loretta Itri

moment, this At -- think very got full at the kind a I very we've of plate.

immunotherapy. So be both combinations, I taking continue medicine study. would very chemotherapy, at aggressively and to we don't on standard additional look other think an But we precision

We to are opportunities potential always compound. expand for of the looking our

Roger Song

Thank Excellent. one. last you. just Maybe

initial you. the start study, the to For can Thank able and we NETs be little the guide to about data a would you bit ECC see?

Loretta Itri

Well, studies year. begin to anticipated enrolling are in. the Both in calendar first this patient is

two-stage I some time should next anticipate, would So studies out, data, have that since year. early something they to we even probably are report

Roger Song

for Great. you. it Thank Thank That's the you, Thanks question. taking Loretta. from me.

Loretta Itri

Thank you.

Operator

I Giacobello would Scott remarks. now to back like to turn the for conference closing

Scott Giacobello

the to today. Great. Thanks, everyone, call for join taking our time

As as you got to and we're year a lot see, updating on, you progresses. forward looking going can we've

Operator

today's concludes This participating. Thank for conference call. you

now You may disconnect.

Aadi Bioscience (AADI) 9 Aug 232023 Q2 Earnings call transcript