Rigel Pharmaceuticals (RIGL) 7 Nov 242024 Q3 Earnings call transcript

Greetings, and welcome to Rigel Pharmaceuticals Financial Conference Call for the Third Quarter 2024. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce our first speaker, Ray Furey, Rigel's Executive Vice President, General Counsel and Corporate Secretary. Thank you. Mr. begin. may you Furey,

be third section financial results third press a on the and was our for the conference presentation rigel.com. our this quarter business Investor call. issued in can ago while The release & short along quarter to with and slides Events financial News update XXXX viewed of Welcome for site the Relations

regulatory ended regarding with update product obligation reminder, subsequent actual year today's of quarterly forecasted. These only subsequent that events and XXXX, on today's call SEC. or our with our statements financial QX our risks made these during forward-looking plans and for uncertainties December outlook the description be a no statements A subject XX-Q As including timing results forward-looking are found most make we for Form filings to development. on statements and file to Any those as circumstances. to in our reflect these and date, report annual may forward-looking the recent the and of can SEC, are XX, statements XX-K to risks differ cause undertake may report

the time, Chief to I this to turn would Officer, like President At and Raul our call Executive Raul? Rodriguez.

Ray, Financial Chief Officer; Rojkjaer, our our Lisa and joining today. Officer; Dave Commercial Chief Dean Also everyone, Schorno, you, thank Thank for are Chief you, our with me Santos, today Officer. and Medical

significant our of to results. business the of business. In oncology the we will quarters Slide I an progress strategy our and first begin on in quarter third our with made Rigel's grow X X overview year,

and sales these. expanding pipeline maintaining objectives: financial development; I of on X importantly, now increasing portfolio Our collaborations will discipline. growing our through corporate strategy and advancing each and main internal our and summarize one, three, to commercial strategic focused is product

This of product first a generated $XX.X net transition addition in Rigel Firstly, into the by patients our sales net commercial we as GAVRETO, with across driven for million. million the was generated of of was compared majority network. XXXX. in prescribers third $X.X to which third growth the up robust and the growth portfolio, total quarter our quarter, full quarter revenue the we XX% with sales of strong This

In addition, for we TAVALISSE REZLIDHIA, to patients for growth clinics. shipped another saw both record and continued achieving year-over-year bottles with and quarter

Taiwan. a expand in commercialize Kissei outside U.S. new and that to continue $XX as commercial this potential develop Republic agreement to $XXX our from We regulatory well Japan, upfront payments. product REZLIDHIA future presence quarter dollar million received up million included for milestone with development, This to agreement and Korea and payment the in and the of the a QX we

dual Phase development efficacy data data cut that our regarding Secondly, advance in an pipeline, we week, IRAKX/X additional published for grow earlier meeting at in to Ib objective olutasidenib. our additional we'll ASH, from sharing the to lower-risk continue from in Initial trial look forward inhibitor the a MDS. RXXX, in we study a abstract to our safety ASH and Also and data more recent December. ASH have this at data was

a collaborations time-efficient manner. well. us and to cost MD of progressing provide with strategic a are broad Anderson in the REZLIDHIA trusts CONNECT cancers Our These explore with opportunity IDHX-mutant in and range

with a earlier Our we with REZLIDHIA did AML combination in And plans will and in both discuss to first our from other evaluate in-license we IDHX or In in September. RXXX Anderson, year, lower-risk oncology enrolled and/or hematology GAVRETO acquire continue its expand opportunities trial MD our in with portfolio. to mutant late-stage assets olutasidenib. further development MDS this to XXXX, and first patients X with agents as the patient evaluating REZLIDHIA

are we Lastly, a so as we in business, doing grow our financially execute on our manner. strategy disciplined to

Our quarter in for third significant In us net generate the strong first while income business positive summary, time income. and to growing execution our net to enabled made cost-effective quarter, approach we progress year-to-date breakeven. achieving has development in clinical commercial the third

well drive value XXXX. positioned as to are continue we We into to head

with And the to provide Dave turn I'll that, Dave? a update. call commercial to over

Thank you, Raul.

the We in are very pleased with revenues strong in QX. growth

to sales our since how Slide Moving annual evolved X, and you quarterly see have XXXX.

first from grown growth the $XX.X revenue and XXXX with each over million, quarterly growth XXXX. quarters. $XX.X year That's particularly We reporting quarter that in an started quarter sales the continues, this million $XX.X last X We now million XX% representing previous of are incremental the and year, quarter year. to in third have of over

That and driving been the GAVRETO our has quarterly Compared XX% our XXXX, third The its XXXX. TAVALISSE line. of X through our REZLIDHIA top by our third for of strong successfully years to of and driven significantly growth execution broader expanded building ability commercial of transition demand launch. first in we consistently generated has of addition to the to awareness quarter portfolio also quarter growth and the

of record see, can you net delivering way our on As we're sales. year product to well a

My XXXX. team all entire for and TAVALISSE, thanks grow to and community driving to to both GAVRETO REZLIDHIA for focused is sincere hard team improving execution, commercial demand in their institutional business accounts and all successfully patients work on Our continued the for Rigel label our transitioning momentum product.

TAVALISSE to the thrombocytopenia, adult our immune performance Moving who for patients response with quarter. is an see have indication, in first FDA-approved X, I'll which with or CITP, treatment. insufficient X. previous discuss chronic On to you'll a Slide had our third Slide

our net X% with the X,XXX to the same the network consecutive our third period sold quarter, bottles last increase quarter XX% increase versus in Moving to shipped a third million distribution an clinics We quarter the during high. and Slide X. of XXXX quarterly report strong year. in record I'm X,XXX to pleased from bottles and patients TAVALISSE to eighth sales in third quarter, another resulting $XX.X product for

who through for TAVALISSE first patients the refills for prescriptions and both who demand, are stay for trying product TAVALISSE very the grow time. to continue on We patients new

Moving to Slide XX.

is FDA-approved I'd minutes to relapsed REZLIDHIA, myeloid detected discuss mutation take indication for refractory growing as Now susceptible a by our with our you'll with On like to which IDHX for FDA-approved test. or an Slide sales. adult acute leukemia REZLIDHIA patients see few the XX,

channel million again, reduced doubling to year by as third compared of We to XX. patients REZLIDHIA $X.X bottles. bottles This in in to sales, of resulted inventory Moving XXX and more REZLIDHIA sold to the our QX, We the prior net shipped in quarter generated bottles doubling product a demand Slide clinics year. than the XXX distribution XX same in period more ago. than

stay REZLIDHIA adoption, institutions patients of who failed awareness in on efficacy with improving both by community and have REZLIDHIA's the to venetoclax. therapy We focused continue raising in particularly upfront

Moving to Slide XX.

as to Japan license globe. about our outside U.S. believe bring AML to right further in We And in accessible develop commercialize make to these expand to other in REZLIDHIA to partnerships We're access a to the to excited in and goal and the opportunities the and We distributes olutasidenib our beneficial markets include in partnership expanding Kissei the TAVALISSE our markets markets currently are incredibly agreement need who in U.S. Taiwan. around with work is we is outside for Kissei this Korea continuing explore product to partner globally. patients Japan, other markets we're

Rigel. full age discuss therapy was years the GAVRETO, for the adult require I'll of begin Slide of through the third include reviewing thyroid are well quarter in pediatric systemic FDA-approved radioactive as indications adult with which for I'll quarter metastatic XX. now Moving as cell our GAVRETO, GAVRETO who fusion-positive and patients and which available to first non-small patients advanced with XX, On by iodine RET and who Slide XX RET treatment refractory. fusion-positive lung cancer older cancer performance

available GAVRETO note bottles full in count either to with quarter we third reporting resulted purposes, and in the GAVRETO. we for patients portfolio, net and in GAVRETO XXX sales. of XX product of sold quarter bottles first GAVRETO of that capsules. XX report Please XXX our XX total For clinics bottles number bottles. This count the $X.X million shipped or equivalent in And is

total now it [ sold million of since $X have GAVRETO X Link of a We ]. in transitioning

of patients, We GAVRETO net are network. transitioning to distribution Rigel's quarter successfully that both are full we accounts that demand and over very and indicate prescribers happy sales

insights Moving to wrap my with early up some GAVRETO. saw comments to we what during with I'd on like Slide XX. quarter full first our

we that the we've to prescribed their the continue can confident with Care we continue specialty have progress to distributors. prescribers current need. hub GAVRETO ensure seen many as transition without made shipping ] smooth [ feel of pharmacies on pleased had that the incredibly our in taking first seen network. expected those in knowing through are direct And of Based as X to accounts can and ordering getting have clinics, therapy they exceptionally specialty patients both solid our GAVRETO the interruption order we an access and patients patients to by our also through quarter patients full We newly Rigel well the have

business. And of distributors of coming yet expect accounts be bottles not expected direct XXX accounts. bottles did order. most top of would I've our placed our pharmacies handful of have an Our that accounts, more our making about we a Specialty XXX representing patients XX% have business up through shipped noticed shipped that to direct to business. there

a the particularly majority the prescribed data, of standard seeing and administration are the GAVRETO. in milligrams the of that once dose have and pharmacy dose below to opportunity day, starting indicating an may reinforce addition, In XXX specialty we are of GAVRETO patients dosing

to growing all move portfolio year-over-year Overall, GAVRETO, XXXX. we REZLIDHIA look forward to with our expanding as and patients TAVALISSE to strong on revenue impact our we our contributed forward have growth further

the your Lisa now our turn development to discuss attention, I Lisa? and progress. for over will Thanks to call

Dave. Thanks,

highlighting I'd a Meeting the presented ASH begin of to like upcoming posters that to Moving be in at XX. at the December. will by Annual abstracts Slide series

poster cutoff As XX a refractory of escalation with meeting. be presented using from of the X, the patients MDS data date or October the December Monday, Ib of part Phase the be lower-risk will in Updated will during dose session relapsed RXXX on data shared results Raul mentioned, initial study at

with presentations use are patients in Additionally, and planned [ related a number of AML ]. olutasidenib MDS mutated IDHX to

Moving Slide to XX.

to We continue our our strategy hematology on and expand execute to pipeline. oncology

role, alongside making either such Consortium. CONNECT. segments, First, IDHX MDS glioma, has continuing under as plays we're new net believe our partners collaboration, glioma mutated Syndrome clinical with and and progress we're where a MD cancers Cancer the in now into indications is additional potential One AML several in combination. in advance monotherapy or the to meaningful clinical We olutasidenib and advancing Myelodysplastic active olutasidenib olutasidenib Anderson as or

December. with RXXX level dose Xth DLT novel is is Phase in within evaluated observation is currently the a will patients being and relapsed/refractory in lower-risk ongoing, study Ib our expect the Enrollment that be IRAKX/X in dual inhibitor period MDS. completed we

focused or potential areas, in-license and remain looking oncology would stage, seem be for or products fit a to possibly evaluating also opportunities portfolio. on products We strategic hematology, late registrational infrastructure. differentiation in or registrational can with more hematology have data to the advanced our our related that We're that leverage data, acquire products and for products oncology

our and with acquisitions to that goal to organization execute. align to continue demonstrated olutasidenib with ability As of assets find our pralsetinib, and is our

an evaluate in with to and or transplant Center therapy an MDS provides more Cancer combination as Anderson AML planned evaluating [indiscernible] high-risk monotherapy monotherapy decitabine strategic of IDHX CCUS dosed Phase this collaboration with with and proud very malignancies. first venetoclax. XX overview a hemologic Slide mutated our HMA alliance AML, in as patients in It olutasidenib to September, was previously have maintenance for trial olutasidenib, enrolled IDHX-mutated MD a this the and MDS lower-risk olutasidenib also broadly patients shared beyond. Ib/II MDS in mutated pro that in We're and and into advance IDH a is of was the with

trials. We expect to to or trials conduct us registrational these subsequent a trial position

Moving to Slide XX.

XX%. have is in with glioma. gliomas year uncertainties to and a adults. tumors adolescents in Global and with adolescents II Neuro-Oncology XXX Gliomas are Despite translating Consortium children Approximately trial deaths account X-year Another U.S. Connect mutated approximately of we in available new Phase of young population in XX% is high-grade to each of IDHX patients are than the CNS this important survival young cancer-related the a and high-grade X,XXX development high-grade adults. collaboration conduct leading therapies, for cause the less to cases polyoma

glioma. II study that evaluating of umbrella safety a IDHX-mutated trial Based CONNECT's from heavily patients put Phase we glioma efficacy trial olutasidenib relapsed high-grade in clinical olutasidenib believe included and A or will Phase Phase pretreated called as shows on with clinical preliminary results in refractory Ib/II for Target combine has a glioma, olutasidenib II treatment a arm be temozolomide guided TARGET molecularly D study, and treatment.

are to by following progression-free of the and can study patients year. We, of this of prolong option underserved followed mutated monotherapy to given CONNECT, with much-needed the treatment combination high-grade goal olutasidenib olutasidenib patient radiotherapy. along this trial determine this IDHX to by temozolomide glioma provide the The is with anticipate potential be survival activated We excited population. about a end alutacitinib's of this will new when

to MDS dual as and development XX% progression risk MDS IRAK-X/X transfusions acute patients transfusion patient lower-risk in to high resulting leukemia. Lower therapy. like elderly anemia, some need facing population our of high on our more red risk will see a clinical program is than progressive I'd provide requiring XX. of infections dependency Next, which increased in novel supported cell burden information primarily the background cytopenias, unmet inhibitor Transfusion area particularly risk of of with and RXXX, you Slide is an on with

Xq are as patients survival as curative allogeneic other lack transfusion therapy eligible include and of rates ESA stem are The due a underlying to Del primary reduce morbidities goal burden than which of therapies Long-term due eligible associated and poor its Initial advanced options health minority cell of to for the transplantation, transfusion is X well stage burden. lenalidomide their treatment to and conditions. for patients.

standard luspatercept later lower There more DSAs patients, are therapies durable of toxicity post imetelstat recurrent patients. issue. MDS For are to recently and difficult transfusion-dependent for eligible ESA been with because and therapy, disease. refractory no patients or or an have risk and approved responses attain of for lines And

approved to by has signaling. address the need therapies RXXX in population were effective XX inflammatory unmet agents hypomethylating new, for this these the targeting patients. the fact, ago, about In believe years underscoring patient safe, needs for that potential We

IRAKX highlight and associated RXXX. why Moving pro-inflammatory to also immune the of involving regulation excited of and lead may and independent with inflammatory cytopenias. receptor about persistent This both pathways marrow IL-X [indiscernible] of involvement I'd signaling like to and to chronic of environment Slide XX. pathways the differentiation. marrow pathway activation is a MDS we're IRAKX, stimulation IRAKI X/X to leading this inhibition

restore in is healthy suppress supporting preclinical and hematopoiesis shown and inhibitors volunteer both may Cotargeting X to MDS. fully AML and modest IRAKX this activity far on inflammation and and MDS is to cytokine Clinically, MDS. have that and was to IRAKX converted gut oral previously RXXX in being an suppress in XX, dual a inhibitor studies IRAKX/X is shown currently the pro-inflammatory production. evaluated RXXX that prodrug rapidly lower-risk concept

Phase and XX our MDS, Slide include expansion safety safety. X open-label study relapsed/refractory a of standard rates are with of shows endpoints has endpoints the The a expansion recommended dose escalation confirmatory with PK. cohort and secondary and primary this RXXX X patients of selection design ongoing dose plus the design lower-risk for trial and Ib dose for for improvement the response at which

daily to total split fifth of dosing enrollment and completion. XXX XXX dose and cohorts study The included twice continues with levels. Based progress study, recently daily for the in additional well is regimens a X on we've dose of the level, from emerging data milligrams X dose nearing milligrams a

the We recently expect with will period transfusion abstract. December. burden published evaluation completed summarized this far the population DLT thus We're the patient be preliminary elderly dose as study from safety a in level and in of this efficacy encouraged high data ASH in

non-CNS-penetrant RXXX in progressing patients RIPKX rheumatoid Slide Ocodusertib, well in arthritis. an is moderate with currently Lastly, being clinical signaling. in severe inhibitor referred broad range our of necrosis our on with XX previously factor cellular to Ia/IIb a programs implicated tumor studied is to Phase and adaptive XX, processes Lilly. RIPKX RIPKX actins trial inflammatory inhibitor as are our partner,

patients enrollment Phase of is II preliminary within first half with advancing Phase approximately of analysis the well results anticipated XXX the IIa XXXX. of

other rheumatoid penetrant RIPKX for progressing of the CNS potential programs nomination. excited diseases. is broad and preclinical arthritis Our lead about in We're the and also CNS program progress inhibitor and our immune candidate

the the discuss to our Now Dean financial I'll pass results to for quarter. call

On Slide #XX. Lisa. you, Thank

shipped X,XXX TAVALISSE levels During at bottles votes patients distribution channels while to the quarter. decreased clinics, of our the specialty our we slide X third the bottles X,XXX the shipped and the of levels remaining of at were quarter, to were XXX bottles to while distributors. distributors. patients bottles shipped in of our to REZLIDHIA bottles We shipped remaining the distribution of channels specialty tales in of XXX to decreased end end XX at quarter. our clinics, the

bottles the of clinics of bottles period our million distribution same quarter, compared increase XXXX. to end at in our distributors. in quarter. to We specialty from X% GAVRETO and growth the $XX.X the were patients XXX sales XXX We the XX channels to in shipped of product levels of a shipped million bottles while GAVRETO the net remaining TAVALISSE of reported $XX.X in

We from reported quarter million growth And a net $X.X product XXX% the to of $X.X GAVRETO reported of in sales product XXXX. in sales we finally, the net same $X.X compared from in million period in REZLIDHIA quarter. million of the third third

quarter The GAVRETO first to sales. full

Our we allowances estimated slide returns, for recorded net other from net and chargebacks, of million. TAVALISSE co-pay sales Gavreto, from assistance and product $XX.X discounts rebates,

For XX% of for our and quarter sales, gross GAVRETO the respectively. net product approximately XXXX, XX%, XX% adjustment TAVALISSE, REZLIDHIA of to gross was third and

certain changes gross costs in distribution to or result We'd during like into to future. continued channel our arrangements fourth adjustment the TAVALISSE we the net to favorably reducing highlight access that high-quality our quarter, and made for will impacted distribution

quarter the clinics patients end bottles impact the our change the in see as inventories in distribution may quarter, is channels this to not to a our we remaining reduction expected While at of during normalize. bottle shift and

and XX% sales, adjustment gross XX%, be quarter, for gross product respectively. our we XX% approximately to of the GAVRETO for to fourth REZLIDHIA net expect TAVALISSE, Finally, and

slide. next the to On

and contract $X Medison. in from some sales quarter. revenues from license Kissei revenues in million Contract million $XX of net fee are and includes in an million million consisted delivery In million of supplies. Kissei, collaboration from from product related The were for addition $XX.X revenues REZLIDHIA $XX Grifols the to $X.X $XX upfront million for third our from the drug $XXX,XXX

Moving expenses. costs on and to

driven Our million of XXXX. third were million cost approximately expenses XXXX. for period to product sales, amortization to and the intangible royalties and product primarily cost Total $X compared sales, was same increased quarter fee $X.X $XX.X in due primarily product of cost sales format $XX.X of for paid revenue million higher increased in Increase the to by expenses was cost assets. million and sublicensing of a

In addition, increase was expenses. costs in personnel-related an commercial-related and there

disciplined quarter, in This $XX.X period the income a maintain We of cash, we into cash quarter in $XX.X from reported million loss $XX.X second million, to net XXXX. future. million the of as the focused of end net and and of to We short-term ended the financial up same the approach investments compared our look with equivalents quarter.

that, over the With to Raul? back to call I'd turn like Raul.

to time Thank Rigel. This Dean. X, for an Slide you, And is exciting moving on please. really

of goals During delivered in quarters we we XX, the year. our the earlier that X set on

another in on commercial $X.X sales our to net capabilities product, potential. we the with And for quarter focused business. REZLIDHIA strong record generated achieved of first in generated now our calendar and revenues our us million to year are year-over-year. product our We've First, deliver in leveraged with way expanded GAVRETO, for sales maximizing product growth its of to its product quarter net commercial We demand grew transition we our us. XXXX. full and our which commercial the another third addition We TAVALISSE and portfolio record quarter

development we in significant our Second, pipeline. made advancements

Ib safety progress additional we our month. to next MDS continue study meeting eps at and excited ASH and data from incredibly the in lower-risk We are to Phase present RXXX,

and and with Our with CONNECT continue we Anderson now underway. MD advance, MD have strategic trial collaborations to the first Anderson

strides And in great we lastly, focus as areas, continue to maintaining we financial discipline. made these on

and have third positive efforts these of year-to-date. to income the for generate All a net quarter enabled us

XX. Slide on Now

and our for progress line portfolio continued objectives: major strategy our focused to positions As growth, executing and expanding our on generate to and how about advancing in and us the remains in beyond, development future growing company own Rigel 'XX to top manner. and we our commercial in and financially sustaining think our development growth it 'XX corporate reinvest a will and internal will in a development to profitable olutasidenib be for plans and our operating outline our importantly, we in disciplined allow RXXX pipeline pipeline. And Becoming XXXX. us

'XX progress Operator? And you close Rigel. on focused we made and momentum your into that, your continuing in We've remain in thank and the we interest out to call head this I'd open Again, now as the will XXXX. to with significant year questions. like for

Our Pantginis question Joe from comes line Wainright. first [Operator with H. Instructions] of the C.

the Nice see to approved progress. products'

you questions, So if don't mind. X

between and hoping So to color can the any if refills to see prescriptions? more first, you or provide TAVALISSE regard was I new and with balance mix

provide do commentary that? David, you to want some on

for the Joe. Sure. Thanks question,

you as know, that are controlled TAVALISSE patients product and is a continue platelets their sometimes a that long taking take takes will As as and elevated while. are

stay say business with over the they in on the new seeing our we've that. is that go because business. grown of carryover to And majority think majority I will of on patient we're years, that and of I our patients that couple growth starts have is therapy, the Once So tend along carryover. last board, we

is I both new both from carryover, said what as that's was majority growth to well when say a but referring patients is to the our I meant So as carryover. starting

that to want clarification. Appreciate the have, second I that And make it. question heard if sure Got then I correctly. I

if to you top correctly, heard I see not that traction this based said still And just placed early really on it? have I So curious, was have just the orders. it -- is logistics, with would several GAVRETO. not characterize you how nice centers

expected to and be we And centers orders as of had direct haven't. haven't seen we see said, just a what we in prepared First clear, that to that, of top all, there's my said handful I I comments, from.

good significant specialty understand to trying the we're little portion a have But a through So about is our bit. network. we pharmacy that thing the data

they transition versus to and network network in drug filling are institution patients as seeing buying be there. the the the when it specialty could then the Rigel pharmacy So

my business QX. the direct at remarks to in But what said October, to looked through actually, I overall, just channel XX% was it's that up XX-XX. we of for was distribution When prepared this our accounts in

So like expected, our that Hope more I we and the business improving, through more Joe. what helps, think this is -- Joe. of is we coming it drag,

line comes with Our Nochomovitz next Yigal from Citi. of the question

This of Ashik for the of is least run the year. to on all at just phase of updates quarter similar this [ ] you GAVRETO for benefit on a with was million sort relaunch. much the $X launch, Appreciate follow-up in you last the a it's least of on last sort entity a stocking the there did like had Yigal. prior sales, How And I with initial reported guys? question on looks the on here. compared the what sort of at rate the

the we about sort should restarted? think here it or here of given more growth maybe So modestly more in trajectory how the way aggressive should we from be about a thinking

to you take Dave, want do that?

for question. Thanks Sure. the

would at QX, very It First to of sales. all, remember that what end to our of $X.X and at end, as that I orders million distributors, was the right about stocking. the was some refer in filled we

we just a have This bottles. we sold XXX-odd bottles And or sold. shipped XXX more XXX we quarter, slight bottles

were maybe up XX-some in another So there channel. built the bottles

demand. we majority majority in demand saw true saw demand, say just that account is that in we of demand, would overwhelming what our I QX patient the So is

higher as is in the to out quarter shipments ended patients we shipments the level say level that, more and with We clinics. will to of I people going quarter some with clinics over. patients started out going transitioned of obviously, a what And much

would more that, as we move forward. growth continued some to So I demand than any but can't really see comment expect we

bottles into described clinics. the and specifically patients full to or translated And our And of the that XXX then from of amount or in build bottles revenue. distribution in QX of that of shipments Dave an of increase inventory and the channel had we remainder essentially inventory was we QX, incremental that had accounts, bottle in

the question of comes Securities. from line [Operator with Instructions] . next Kalpit Patel Our Riley B.

abstract. Before these data dose that share the that XXX of events here that Grade in can higher? first, or were indication lower-risk adverse to proof-of-concept extent the I occur the X/X in MDS, listed in milligrams are any generally there the doses guess or dependent you Was

the Yes. Thanks for question.

we December. that think in detail will I shared be more in

ASH the poster meeting in the At presentation.

it. number terms maybe the data the Got Okay. expect of we ASH of should much patients number cohorts? and more at And of how in

Right.

we data July So cutoff and for we're date the updating abstract, XX. October of use the -- to that

So it's X of about or going be so months another to data.

So the the that. you'll beyond see little data patients from a fourth dose and bit level on

of Our the Haque line next Farzin comes question from with Jefferies.

X to in the RXXX what how with success off with about for start low-risk To program the -- advance the bar to in Phase would the forward? need we MDS think patients, should Ib you see

was a Rigel. discovered about comment data -- This molecule to We I would available. molecule inhibitor Lisa this this -- preface at full is the think that here most let me we're excited really We there rights this IRAKX/X just it. by own saying data. advanced that

good substantially to posters in data more where off And come. present low-risk the to MDS, you the we excited in very here are and the delighted saw abstract much in and we're here, really mechanism We study to a to indication. we're that detail see

you In terms the maybe to of bar, Lisa, want comment do that? on

Yes.

think there's afterwards I metal have patients. I'm for and until and eligible and nothing obviously, really agents followed we having talking they if ESAs, transfusion-dependent about If are luspatercept. treatment the the now they're kind look HMAs. of got lower-risk FAs landscape stat, we've the patients by MDS, These first-line at will

requirements, transfusion kind efficacy, independence they And them. reducing that's gap. of have associated with quite in So transfusion HMAs of improving a terms in or terms transfusion of

one So end. low that's pretty on

that previously as pet in it's study metals, cetera. unique is our then received And HMAs well patients have as et enrolling that

are said, So in it's rates unique patients XX%. settings. we that like that included that you is I including know study relapsed/refractory I for weren't line, the would first response first-line around say that But in those

So I don't number right know on put that now. it a I would

I what efficacy by the on we're far. safety and thus encouraged seeing based think we're data very

the new for it then be the safety the issue?. expect same risk That's do severe just of does for and for curious helpful. GAVRETO, the infection, has to to rate-limiting how you signal And program related to I federal competitive was

Lisa, on that? comment do you want to

I yes, say and that Dave then maybe -- from would can comment.

from -- new. So really the clinical something isn't this

nonetheless, off-target is This activity down Looking terms JAKX that in know targets, were treatment We are label and about increased were get inhibition of there the that pneumonias, a in XX% infections cancer of why there. inhibition for lung that we patients from cancer. section. happening. were patient the at JAKX, rationale made these We this in to with most off-target which know there's study, for common some already risk the safety ARROW is the the infections in that addition know receiving are this pneumonias And of lung of in reported. population, not in is of and which but the very we infections primary aware

is So oncologists that familiar situation this are with very a managing.

what do heard you from [ to Dave, on comment you've ]? want Simpson

providers. cancer. DHCP said, who oncologists line than regarding very said, Sure. send all we time. I'm that care XX,XXX our update. calls patients haven't more cell safety Patient is medical Lisa that any to And this is say as paramount, the to health These that And are we and the very treat proud sick non-small and received information to

RET on X of precautions the warnings with have different You market inhibitors and and precautions. extents and on warnings significant both

opportunity -- we for nonsmall at at this look moving the GAVRETO in space. cancer positive any the So RET lung cell forward how we we point, don't fusion see don't in any see

again Patel question with from Securities. next Kalpit B. comes Our Riley

that but an had same on one just lower indication. agent the withdrawn later Yes. for was IRAK another curious MBS more inhibitor investigator in was as study, There program. the started then sponsor I

if guess with what I a you RXXX versus the be? would to So differentiated others, factors few they had highlight

the comment to and believe an I hard I IRAK-X ours X that significant a say was difference. inhibitor people. on It's is IRAKX would inhibitor. is an there

bone think in cytokines and where in inflammatory this slides more inhibition highlighted of that inhibiting marrow profound a showed Lisa X the provides case. I the X presumably one of both we in

for inhibitor advance So said development certainly an development between believe I available. I as IRAKX X. difference in there's is important that and earlier, X And another not in those don't

first the X Lisa, we profound other on And So the was And cytokine X in any is and that work over rationale, more X, this of liked the to and comments? division reasons X. X. X

fairly summarizes that's No, I it, think well yes. pretty

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And this teleconference. concludes today's

time. You may participation. Thank you for this at your disconnect lines your