Earnings call transcript Q1 2023

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Operator

Good day and welcome to the Aadi Bioscience First Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. Instructions will be given at that.

As a reminder, this call may be recorded.

call Relations Marcy Aadi and the President Senior Bioscience. turn Investor of Corporate I'll over Graham, to Vice Now Communications at Ms. Graham, ahead. please go

Marcy Graham

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

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

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

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

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

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

Scott Giacobello

quarter operational We're this continued out to as well. to this you Thank first a strong first results quarter and performance closed review XXXX. Thank for off hello everyone. the you, our our drive the and financial for us and morning results to year start joining Marcy

the PEComa previous XX% advanced focus sales treatment over commercial quarter, sequential resulted quarter. during the a FYARRO successful malignant execution for million Our of increase on $X.X in of the of

The the market to driving expand our disease. We their continued efforts increased this in patients team the we're work. of to now and with from region to benefits FYARRO the of treatable and hard from success rare suffering forward resulting look visibility pleased our delivering continued commercial these our growth

exciting On we initial PRECISION TSCX or This tumor for X will today has the potential we to population and TSCX of future clinical the on in significantly patients broaden patient for opportunity types an in growth. for trial front, our an directed application much currently many inactivating than update tumor larger provide the registration nab-sirolimus additional alterations address agnostic presenting different harboring trial PEComa, genes. a

by in distribution are in share tumors details on initial We the well seeing the of are as PRECISION of conduct X trial the on the the Loretta as encouraged shortly. trial further two we types the arms. data enrolment will enrollment

intended X to Beyond the The the in Therapeutics begin initiation to the and recommend with X/X tumors. determine KRASGXXC XXXX. the in Mirati study, of dosing with KRASGXXC solid patients dose combination Phase is expected patient optimal mutant nab-sirolimus will adagrasib second and PRECISION quarter of with is with in the of evaluate trial first dose collaboration Phase the study in

this either for potential number use targeted in later new clinical or of to new therapies combination of single for other the continue year. we with nab-sirolimus clinical with indications, agent potential programs Additionally evaluate a a in as the

to several the executional goals are attain in working on for fronts a progresses. hard periods as We year, achievements are success aligning building prior our of the on year and key

update our X we to activity. operational is trial on PRECISION Before results next and discuss for and Loretta? an review financial up clinical quarter, Loretta ongoing the provide our

Loretta Itri

naive progress PRECISION X on first we far. patients everyone. are continued with our or to in Thank solid mTOR the harboring Today advance malignant we quarter, morning agnostic first update the you ongoing Throughout providing so tumors alterations. have good our TSCX Scott, trial TSCX and inactivating tumor

As study the is that balanced with to accruing a evaluate one reminder, the tumors distribution is trial independent trial arms, TSCX the exceptionally the of between prospectively the pleased TSCX, other TSCX harboring solid TSCX. with I'm one evenly designed arms. that tell study alterations and patients relatively to in you and of well two is two

and more solid also seeing of one than three histologies mix occur that alterations XX with TSCX represented. enrolled remarkably and thus prior are clearly We tumor accrual This than cancer type any across broadly tumors. diverse observations tumor TSCX far, of types no discrete pattern supports a more

have representation sarcomas Simply truly breast other no very tumors and solid results stated, we including tumor will that of a tumors representation a solid common higher have expect cancer. the Additionally, than represent broad of outcome. and the any agnostic bladder

emerged consistent safety very is have Importantly, pretreated to and heavily this the in safety profile that patients. new and no thus we population with have the far AMPECT observed date of signals in diverse study, seen

regulatory potential histologies, it binding trials of surrounding large integrity, believe to Given tumor including a the way trial in of we impact and environment critical the in accelerated to patients tumor we the variety is particularly the treatment a study with sponsor and report approvals. agnostic results, of of conduct this data a number preserve current

in by continue the enrollment followup. to first well presented was interim full the information, later year next in We PRECISION progressing months will response target including is Enrollment patients year, and patient with trial the look on conjunction sharing analysis spring efficacy we of be XX after further data analysis XX a X in the forward enrolled. appropriate with patient to when on pre-planned

working our Cares from matures, identify have at As place to during process. Tempus us recruitment to the novel and develop into benefit partners put are we methods and the Foundation consistently [ph] with U.S. in support measures our Oncology, Medicine and enrollment study we are seeing the trial,

CTOS, recently at ASCO of the multiple study, SGO outreach increase most our in have continued We including including to visibility soon others. broad the expand presentations, community the and meetings scientific among oncology to to order at

excited a patients for of diverse are study novel nab-Sirolimus of need. about of potential We very this treatment promise may important the group the and the truly and hold in

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

Scott Giacobello

Commercially, the steady importantly, Loretta. in demand to continue progress million adoption access are remains of FYARRO see with commercial further for and XX% with make achieved growth strong patients product PEComa, We to and the we over covered. pleased Thanks, represents sales We growth for $X.X favorable XX than of lives reaching believe XX% market. in on impressive more account addition driven million our which fourth $XX the orders. that months the last and been have quarter the over quarter, just continuing first new date sales accounts by of year, in the of with to

who their of the FYARRO PEComa the ordering It end experience by community conveyed rate XX% as of patients. XX consistent the accounts, viewing had XX% first prior The positive the FYARRO to was clinical uptake more of quarter representing is are with in in quarter, XXX up the see care than sales HCPs we increasingly encouraging quarter, those At unique from clinics for above underscoring approximately half nationwide. of time. accounts reorder ordering hospitals the the the first first standard for and

as gold driving in FYARRO awareness Our to malignant PEComa. cement for continues standard efforts execute and and a team to our education

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

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

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

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

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

the seen we from data interim As forward earlier, the and trial, I year. very have patients the enrollment stated we by about and with from information are We're overall are look encouraged really initial our PRECISION lies later analysis sharing we we XX what to further pre-planned ahead. X on the in what in progress pleased excited

we and value improve lives as long-term to for therapies build therapeutic Aadi Meanwhile, the by our focused benefits to of create that we is continue of further to the stakeholders potential oncology a focus maximizing and goal to who diseases. precision delivering those the quarter as from leading commercial the on clinical company mTOR on it to ability from on suffer patients momentum deliver our first strengthen will establishing

the now line can We questions. open for Operator?

Operator

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

Your is line open.

Roger Song

our taking from us. couple A and update questions. the for Thanks Great.

population in and the you the versus to the share the of confident therapy, comutation or XX the like be additional is the later year? distribution other followup XX readout, a just color enrollment and the Thank by the around initial have of related the this may any have outside this baseline from the us terms of you you. one you patients any first told expectation TSCXX, in the patients between PRECISION of disease, patient you will year can terms us? end also what data trial, the or So around are of current what how can data TSCX provide enrollment stage histology your prior you with And balance for initial

Scott Giacobello

to Loretta, one? want Roger. All thanks, do you right, that take

Loretta Itri

Sure.

the We the around baseline releasing details are not characteristics of population. really

have is be that out it disease and end. advanced that say third patients think we fair I and these most in patients, second and anticipated think to the will line borne I of

that towards there the I answers in of of followup definitely also XX the those number the be hope not have of will be to given far. terms question. that report confident only pattern your available patients significant we're reporting we we year, accrual will In will patient on patients end population for the very on, that thus the but patients

Roger Song

That's perfect. Loretta. you, Thank

Loretta Itri

you. Thank

Roger Song

the Q, then, us of it launch, pretty trajectory And you. for give the we first a of will ready you do admit and slow, the have just project you still How will bit kind context maybe account. of the first the a Thank terms Does maybe to seems how strong? little that, so beyond rest growth how have then Thank given and bit far seem you. the the to new quarter, sales, the data re the sales FYARRO first year Q the this the is the of little kind seems track? strong in a orders

Scott Giacobello

take that, sure. Roger. I'll Yes,

I So PEComa. we're the year, can been typical say would strong, we growth those in others. flatten growing indications slower few quarter, curves, that plus. at is first, think think, pleased XX% right? to start would and curves in quarter XX, as particularly over such first had in right, particularly of though, small pretty with as in I Also to say the that the think the last quarters, with I launch I the time would still And pretty be than that's I which tend XX%

that think we're pleased I with overall So, growth. really the

to rest going to growth XXX. But guidance the of as not in between XXX it's and look we're like I somewhere forward. what that's as the I always think the challenged, year, see obviously we're think providing patient we for with PEComa population far and strong continue don't, move we we'll As

Roger Song

taking Thank our you Excellent. for questions.

Operator

Thank you.

Our comes Piper. Joe from with next Catanzaro question

line Your is open.

Joseph Catanzaro

PRECISION so for two thanks quick questions. on from X. me Maybe my guys, taking Hey just ones much

you touched on you data? more you you remarks, around can received but like in this details elaborate whether the not received prepared saw efficacy or can a at First, bit the you you initial little look? any It on bit sounds Loretta, confirm you, safety, a some I data think but this

PRECISION to expected around ultimately And timelines think patients. XXX then second, here, trying X so to about enroll

If full you'll line around patients have end, ultimately at full interim and top how XX to should Thanks. year the data about readout? time we enrollment from think

Loretta Itri

question. Good, good that for thanks and morning,

now. the a to usual seeing fully upswing enrollment, next the start, So full be will original quarter statement in kind And so middle we we terms enrollment. and sticking the believe that you are end of kind that we're months of first of right we enrolled of happens trials, of of by that are XX of hockey year, in with and stick the we slow an then upswing see clinical our

not in a important to in very piece enough that in, allow having may question, which previous followup think enough getting evolve is whatever It's their that stated sometimes be. confident the the followup XX-patient our I we're it's with study, on to gets just I enrollment As really lost. patients them response,

So be as to we're quite able confident we to going that anticipated. are enroll

I think that you sure them. I'm both of another question. had I not answered

Joseph Catanzaro

the that relates blinded this question the you initial largely efficacy you on it safety. second got do to I as some fully whether you of saw or guess first you remain so around Yes, sounds at Yes thing? question. relates look, data Did to it like data see any side and guys

Loretta Itri

to gets remain we separately. blinded efficacy. Yes, know The to reported be it safety to reason we about that is us clear,

I Officer. as would notified serious So be event, if is Medical there Chief a

aware serious that database. that's clear. safety are issues hope separate during from any regular So occur we the study I of the

Joseph Catanzaro

for Yep, Thanks that's so questions. taking much clear. my

Loretta Itri

Thank you.

Operator

Thank you.

Boris question Cowen. comes next Our from with Peaker

Your open. line is

Boris Peaker

for questions. my Thanks Great. taking

The just do sense on any publish any I a the what answer first now curve, sense actual of uptaking you've us that while to sense that or of you the that want drugs one, for kind or to doing little starting been of you precise will a give to you're is, get more PEComa a size and market selling epidemiology, commercial better have question? and ask are work

Scott Giacobello

months that. and, that still thanks that work out the Right? real information the to challenges had I as the you always was now but we've have, [ph] we XXX out Boris, with working Yes, that, and any we there epidemiology for XX mean, Yes, know, had done patients. the been around there, XXX We've question. on just we're concrete not

bottom launch overall. is like XXX need going of since but we out idea can that be think I before that end ordering better we're unique we the we still north I it's we think more where feel a get with time accounts the what doing, of range, say of there to we're

Boris Peaker

my second you various exactly precisely what? And you presentations meetings elaborate more year. is, when Great. this Can later question at and mentioned multiple

Scott Giacobello

do you want to take one? Loretta, that Yeah,

Loretta Itri

the question. not understood I'm I sure

Scott Giacobello

ahead. present…Go The

Boris Peaker

and I what was we just going say to be presentation meeting the medical at. it specific expecting should

Loretta Itri

we presentation. be Oh, data that more meeting. be at It will will anticipate of a presented corporate don't these a medical

Boris Peaker

X, going No, anything, of you you general, kind do talk meeting updates but or I year? to other mean, any have presentations medical any in anticipate not I'm this about PRECISION later

Loretta Itri

we data, ongoing We, will be at ASCO.

else. at We what at to ASCO. CHIP will be [ph], having I'm trying remember

We CHIP we're to nature I the have I that so I'm many be presentations different, making at than the of [ph]. we'll going ASCO. just can't other at be remember know sorry,

Boris Peaker

thanks. Great,

Operator

Thank you.

with Our next question comes Ladenburg. from Demir Ahu

open. is line Your

Ahu Demir

three Good my morning. my have Thank very on side. much taking you questions. for I questions

percentage indications cancers is that give perhaps was you the the you did was one enrolled and is PRECISION for number are enrolled. any there could predominant First in on sense wondering trial? if X. Loretta, us XX if there mention a indications I endometrial

Loretta Itri

are So information, of specific there are publicly are than may there specific not to the How enrolled in type three released, you imagine we've morning. tumor releasing not, you? but of any that study as no are we date. Good more

type common there's not all tumor really preponderance the of that have representation the from. we any could to So We conclusion one not think much say. oncology there's of But a a major do draw GYN ones. types, of I

Ahu Demir

or expecting to changes are X to you. combinational tumors development PRECISION that to plan interim wait When are other Thank on you them see for or what additional Okay. the readout? My were is terms there the planning clinical of do you initiate? we going Are to in mTOR plans. question second to you any trials

Loretta Itri

We which have of Stay will We relationship the the near planned, study do release in year. some I'm sorry. interesting nab-sirolimus to some not are not But Mirati, in adagrasib sure at will the you're that just really will with aware I'm very have a I'm But with guidance of. have do that studies near tuned. we We this details. that future. be announced the we be probably combinations that anticipate are combination liberty point on there other future. several That but happen yet. released exploring

Ahu Demir

last or question comment can on U.S., the you side. my commercial of do is the Then you, Asia? effort outside Understood. on commercial Scott, Europe

Scott Giacobello

Ahu. the for thanks Yes, question, Sure.

think what down coming which is at I we're So as the into there road. have said consideration the we still we continue our we're, outside taking think of just previously, U.S. said is to of options then TSCX the evaluate we've and also I implications TSCX the Tacoma we what market and looking And

think I evaluation. it's something So under that's still

Ahu Demir

taking for Thanks good. Sounds questions. my

Operator

Thank at turn time. this for call Scott back I'd questions remarks. are any closing further like There no the to you. to over

Scott Giacobello

Yes, for you. call at time have look about to and thank progress taking today. Obviously forward you our soon. our the company, join the we're here updating we excited again everyone thank want I on to very to we on what going

Operator

the your does program. Thank participation. you conclude for This

You a may have disconnect. day. now Everyone, great

Marcy Graham	Senior Vice President of Investor Relations and Corporate Communications
Neil Desai	Founder and Executive Chairman
Scott Giacobello	Interim Chief Executive Officer, President, and Chief Financial Officer
Loretta Itri	Chief Medical Officer
Roger Song	Jefferies LLC
Joseph Catanzaro	Piper Sandler
Boris Peaker	Cowen and Company
Ahu Demir	Ladenburg Thalmann & Company

Aadi Bioscience (AADI) 10 May 232023 Q1 Earnings call transcript