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Gossamer Bio (GOSS)

Participants
Sheila Gujrathi Co-Founder and CEO
Bryan Giraudo CFO
Luisa Salter-Cid Chief Scientific Officer
Richard Aranda SVP, Head of Clinical Development
Tyler Van Buren Piper Sandler
Joseph Schwartz SVB Leerink
Geoff Meacham Bank of America Merrill Lynch
Josh Schimmer Evercore ISI
Carter Gould Barclays
Emma Nealon Cantor Fitzgerald
David Hoang SMBC Nikko Securities
Patrick Trucchio Berenberg
Call transcript
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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Gossamer Bio Q3 2020 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. [Operator Instructions]. I would now like to hand the conference over to your moderator today, Mr. Officer. Financial Chief Giraudo, Bryan Thank you. go sir. Please ahead,

Bryan Giraudo

Sheila the Gossamer may making statements. associated business. Please operator, these information addition and this for afternoon. you, Gossamer Litigation Officer, statements ended Reform Co-Founder statements Act. conference Officer, with call Dr. news September and Chief materially quarter Report Earlier as on today's that We differ and forward-looking a risks Bio company's limited This filings. release to qualified period in for a caution thank or releases subsequent call, today under us joining Bio's will issued Dr. Executive providing Actual accurate Chief afternoon, for third Luisa all is on and press contains Form certain of Private statements are forward-looking management as I listeners announcing implied time-sensitive Annual be results including provision filings, the Scientific uncertainties the by contained its note corporate may well our call also the you call Thank Gujrathi; Safe this those update. am Gossamer Salter-Cid. the XXXX information the discussed by on this that stated of financial from in that Securities to by a SEC XX-K forward-looking and due Gossamer's be only time. results These covered XX, in the during Harbor joined

events affected pandemic. revise call. circumstances undertakes the conference clinical in to or by results of meet and obligation related reflect a after clinical forward-looking in ability any timely Gossamer our to addition adversely trials our our to Bio statements date the this manner COVID-XX to the to completion be of may that or release especially to from ability update no initiation Our studies, guidance timely ongoing

Sheila? over to to the like Sheila. turn I'd Now, call

Sheila Gujrathi

areas. and today's hear financial Bryan, afternoon, afternoon in you clinical its is Gossamer updates us founded research our candidates. who XXXX independent Bio history experienced areas in has on and development engine time you, of quarter to and oncology. pleased of several Bio of a collection as around related of the to inflammation, centered the therapeutic Gossamer therapeutic and team results of Thank announce made. this multiple the with addition efficient about need unmet to successful backed joining an the Gossamer that status programs to and appreciate be a immunology the We the the pipeline preclinical good of Each call. closely product execution This across is is and progress on everyone derisk was to these an taking product work to deliver and was pipeline focused engine from patients. for development value to meaningful and product areas program candidate would a understand third clinical innovative of differentiated regular to by profile high Earlier

two be into trials. to independent advancing different molecules two Phase pleased indications are targeting X We

our from and for appropriate through Gossamer data candidate programs a is candidates Phase continues in multiple create for multiple progress All the its clinical to immuno-oncology of to through tumors. value new the The discuss progress trial potential advancement development execution to as excited solid also purpose. shareholders. told, manifestation GBXXXX high experiments continual of are We it X/X simultaneous of

out October, the we briefly moderate-to-severe our read asthma. oral status review the treatment In I results once antagonist First, study. will of our daily line Xb top the for Phase GBXXX, DPX LEDA of of

asthma to consistent worsening XX% met, exhibiting proportion of three as across drug worsening, milligram did XX% statistically dose to first GBXXX a then asthma And reduction the significant milligram placebo. the in both improvement to a While compared compared we secondary endpoint placebo. as active asthma all XX of of XX time saw arms to groups the not primary the worsening key of and in was demonstrate patients endpoint

inhaler. Bryan pulmonary with arterial will delivering for with success GBXXX of with improve global concept further is through clinical programs, engaging SITC vasodilators two have a of from in was clarity quarter, and reported site that regulatory GBXXX which next of on GBXXX value-driving a the we our which partnerships this data convenient and upon treatment our week about studied authorities inhibition is After the patient upon a financial We update. GBXXX will pulmonary end inhaled candidate I currently of progress X potency hypertension forward. inhibitor to inhibitor walking an clinical in third will and an hope with have discussions of prior Phase to that, GBXXX by profile of alternatives. the the the the activated observed recent proof the by remodeling to outcomes. these are receptor kinase path We and provide help a directly strategic year, for inform trials touch at being powder vascular of the oncology from improves delivering new GBXXXX. of PAH. kinase dry before standard selectivity results in top designed half the care disease PAH of these Since tyrosine hope and or reverses PDGFR first potential optimized

Our we to experience an in in to ongoing Phase Phase two Xb studies volunteers patients. PK our bridge study PAH X the saw and in initial healthy results weeks PD meant safety is

in have option to forward to biomarkers. and clinical While the engagement information open December. event extension. label also important look is two-week We portion end at the before GBXXX too target on patients in focus have two-week data the the we These evaluate roll study six-month onto a of a investor sharing year gathered to short endpoints, changes

to new a patients adjustments, how well us as trial conducted And critical in this enrolled this the program needs helped as have onto by learned year terms a now was moving believe and while earlier that Xb the And COVID-XX in patients restarted, during investigator study. unanticipated, are logistics, COVID study's lessons this pandemic. the operations, conduct to has be trial We of patient the this reminder, inform forward experience As we here the the in interrupted PAH Phase pandemic. PAH. protocol

are excited to had We sites study. for our also announce that TORREY we X activated Phase multiple

study placebo. resistance from We baseline will XX-week functional distance. fourth is expect evenly the changing of week is patients. vascular multicenter to this The the this evaluate secondary XX-patient class study an placebo and randomized X III six-minute safety XX Phase to controlled, be begin double GBXXX be trial This PAH in The test study enrollment of and quarter. clinical for and a pulmonary efficacy II TORREY endpoint and will is patients changed primary walk the at trial in key drug and between and endpoint blind,

read GBXXX inbound Phase focus months, working webinar the to in over risk. to place protocols have X have In on program in the TORREY clinicians offline posed XXXX, will be half we few groups to coordinators study the December. we host from closely obstacles to the advocacy help that in investigators the mitigate procedures patient interest data study expect and in with investors, and with developments put GBXXX by able from subject of pandemic. past believe PAH patient we health, first response on received and the and further COVID-XX sites we a We're surrounding to the We the focus COVID-XX

this study PAH, During in our additional event our discuss you addition weeks. hope call on for that will lookout this advisors from surrounding the Xb and to details coming the Q&A. rationale Please GBXXX study join design to details external on call, give for our X Phase the we plan program. us more We in GBXXX about making learn initial Phase available of on be to some for results and key virtual

for HIF-Xα we is discuss treatment inflammatory GBXXX, stabilizer disease. Next, bowel developed our will of the which oral being

healing reminder, an life is GBXXX IBD. action gut-targeted impaired of monotherapy patients the oral disease patients in therapy with mucosa to burden has continuum. is standard clinical GBXXX the to across in patient the with care of deliver achieve mechanism meaningful that a and anti-inflammatory to and endoscopic to believed and sustainable the quality of traditional the approaches disease in benefit combination a potential intended a GBXXX as promote to Unlike of IBD, unique histologic, high address remission. is with both As

placebo announce pleased we active with controlled, of active a double begun to so is in to PK SHIFT-UC are Phase SHIFT-UC that subjects randomized, mild with PD to study patients GBXXX GBSXXX in blind, have and study study evaluate ulcerative efficacy, safety, multicenter colitis. We Phase The X moderate a ulcerative adult in dosing patients X the colitis.

XX. for endpoint randomized be dose with XXX of at The clinical patients two expect We this proportion primary placebo. will enroll about groups UC trial remission to week evenly patients and across is who

Secondary mucosal healing. clinical proportion remain in to week and XX response, Patients remission, trial. patients days five improvement of the therapy steroids will endpoints eight on including include background throughout at with endoscopic histologic

to as the working in the In TORREY I turn advantage of UC developments We pandemic. in closely a possibility to the we immunosuppressive a regarding what Also, first to out SHIFT-UC with GBXXX’s may disruption. therapies. previously, be are half there related subject mentioned able to line to data study non-immunosuppressive compared in in viral of COVID-XX believe we mechanisms expect sites Phase SHIFT-UC to is X study patients readout potential PAH, the that from mitigate the be line further top XXXX, COVID-XX with recruiting recruitment

mild positive in UEG X announcement Sandborn Xb Diego at May data which Phase section ground trial. our on us with publications year. University active Web of turn trial And these Dr. San UC California and enabling In treatment after and the four-week for and presented to the finally, KOLs to this to that hit in our Gossamer’s CDXXb of Week received Sandborn’s being XXXX, great with this line of We from our a interest the deal completed X top of following study the Phase presentation, moderate modulator investigators disease. Dr. patients commencing is Bill Phase of a October, tumors. in induction at Virtual will GBXXXX, is running following We’re having posters developed site oral we feedback solid available

KEYNOTE-AXX twice results being XXX, resides Dr. presenting in a from which data portion Johanna We the the with dose milligrams poster been as has GBXXXX data have XX from clinical X,XXX combination treat X/X GBXXXX monotherapy dose Despite dose Phase week. checkpoint is GBXXXX is in shared with at of pembrolizumab daily. greater pembrolizumab. relevant especially responsive of activity, toxicity that KEYNOTE-AXX alone now in tolerated. ongoing solid SITC BID. of are this inhibitors, be than from some suggest X observed. clinical details X/X also has escalation Dr. with and on in Enrollment Phase to clinical biomarker has and well no limiting Phase tumor up Wells escalation trial both phase encouraging number advanced that doses ongoing which the to Messersmith types is the poster used Oral XXX, GBXXXX is tumors. to been both known biologic studying and continues this or combination milligrams patients those in couple to which generated equal Bendell updates number cohorts presenting XXX in our less study to [ph]

castrate-resistant patients noted Regimen disease activity, B. and received treatment XX who disease, patients, Three clinical greater XX XXX.X seven stable with of cancer, of initial cancer these patients A therapy had disease these an in in of than stable those triple Regimen risk four colorectal, monotherapy of metastatic patients and combination was stable in received of terms of Among cancer. stable a duration patients negative median microsatellite days. prolonged gastric prostate XX breast assessment In days had

seven in Importantly, observed to was therapy greater activity at a an two the had disease than higher increased in checkpoint five suggest of doses. treated progressed milligrams the combination of mild and equal or patients doses who Stable BID clinical with XXX been previously also inhibitor.

tumors, Published GBXXXX that the disrupting in have previously microsatellite suggests received patient of an of combination phenotype. We T which XXX continuing with work converting cell BID myeloid have to cell potentially That more who positive with preclinical in by inflamed treatment. a received colorectal milligrams five response activation microenvironment GBXXXX immunosuppressive cancer, lines stable confirmed infiltration and biology, allows tumor is patient therapy pembrolizumab. steady one for seen on in works and

An show or increase changes with biomarker early of lymphocytes, GBXXXX in after signatures and monotherapy pembrolizumab combination of the pembrolizumab. in plan GBXXXX reduced with GBXXXX with myeloid-derived observed correlates aspects support also cells biopsies with as suppressor mechanism expansion evaluating dose-dependent Our action. both TILs, with gene T dose patients combination. Protein combination in blood to with combination in is of and tumor-infiltrating following Myeloid-derived cells treatment increased which decrease findings as treatment. up also in CDX or GBXXXX combination an well these dose positive in consistent cells manner suppressor to characterize in X We serial pembrolizumab. pembrolizumab. with next therapy the recommended regimen of Phase further the XX tumor GBXXXX T cohort

will be this ongoing free from to can data Giraudo, We clinical Bio’s as Virtual part of a hand it update. I The feel site Financial will Conference. Bryan entirety posters to for With on trial the our from Officer, XXXX. out over to site. SITC SITC accessed Web view financial that, the Bryan? Gossamer Chief on report their continue these Messersmith presentations Web in in doctors Bendell, Please

Bryan Giraudo

you, Sheila. Thank

the expenses million as third XX.X compared G&A XXXX. million XX.X were for were for review the in in cash $XXX.X as with cash quarter to We anticipate facility, R&D expenses XXXX. G&A of and our equivalents. access and quarter to quarter fund same We XXXX. cash to expenses and capital the into the for along second development and half third marketable XX.X of We Research operations provide third XXXX of quarter ended our capital the cash, sufficient to results period of X.X of resources million the expenditures debt the in million period of compared same now will expenses of securities, XXXX. the approximately financial with equivalents million will

Our for to quarter net $X.XX share. $XX.X loss was equating million, per the

in in to interest of XX.X $X.XX attributable million same to reported of XXXX, the which million, share. an The expense period net we For was a loss equated $X a primarily increase we over some a will million. back offer of closing the income Q&A. Sheila Sheila? call to for and turn before line I With decrease in open up that, the X.X investment increase to comments

Sheila Gujrathi

X want times. the has turn my and extend Gossamer, to clinical It of possible multiple helped will Phase our Bryan. team been partners to I and an patients, physicians activation to during we bring would trials and COVID extend to for the quarter who to especially us exceptionally Gossamer’s busy the you, have advance achieve appreciation Thank the as research and third programs year pandemic. at that, I best gratitude I go beyond fourth during operator sincerest date. Gossamer these Operator? and like my continue who to to the unprecedented With their over also questions. now selves call personal

Operator

a Ladies much. for we it session. gentlemen, so you and Thank will open Instructions]. up [Operator question-and-answer

first from Your of Van line Tyler comes question the Buren.

Your now open. line is

Tyler Van Buren

in just I'm Hi, GBXXX how the you that a And data imatinib see with exposure will data? the you taking a lung the data potent route I in coming Understand imatinib, GBXXX there questions. think could couple I ratio – we more OLE just delivery. than we from and patients? up. any that terms lung selective had possible Good [ph] can much guess did of Thanks could planned the and Can afternoon. been you for confirm has given you be you but see interested PAH on see data well? guess a we six-week speak specifically as ratio guys. exposure as it's of I when that of could higher data from of then to And mention and

Sheila Gujrathi

and Officer, start then to would our Luisa add ask Scientific I’ll Salter-Cid, I’ll she Great. anything like. Chief

in PK our we Phase this well our prior this they with characterization lung specifically adverse to [indiscernible] hematomas. that of normal measuring levels molecule because saw low as kinases, that So imatinib several of including as adverse in have serious events, having pre-clinically concentration, trials clinical number to study as effects as plasma. healthy full issues yes, we events, number have significant understand done well And PK Phase PAH [indiscernible] X have X subdural a high side and that the in do then that exposure It's imatinib a again we volunteer of hit GI the systemic PAH safety designed the in trial. Xb to tolerability, events, clearly CNS terms we around experience were important and what substantial if PK of have more was peripheral, and really you and in so

So would systemically that level this PK able low is again, in ensure, we periphery. really be critical to the

And so GBXXX systemically. cleared high rapidly is and level never reaches

and this So what confirming from population. And we've normal but you shown trials are then healthy in see profile volunteer the low the levels in clearance. CMAS rapid that perspective, we're our PAH

exposures you again, lung upon and to the very, a that's that’s this to manageable really component very tolerability. substantial want again systemic critical profile, where improve safety exposures So really

critical. that's So

to can So, to think into our touch continue that. upon on December we discuss webinar that. And we'll details in in I more that go

two-week OLE I patients have Regarding patients the as proportionately. again, COVID, do mentioned, had part come that the this shutdown available this Xb because study, study. really these to of especially we PAH in is of because year. experience, Phase a in for centers. six-month had conduct the We a early pause the OLE We sites, had to of they out the treating total for the at But given the

in be mainly on will December. we two-week So data focused

add? focused target continue biomarkers, have again, to With on and the Luisa, discuss PK, program. that, So anything engagement do and tolerability, you else safety, to

Luisa Salter-Cid

Yes.

a a but because have not duration you've but pretty of the think of high really on much time. we and that, retention think I exposure that also only lungs for one another has just period thing covered, I the in long the target sustained exposure, is, it's it’s XXX actually

the target. others And that on this the just way it's endpoints we XXX confirm it's have distribution, PK not PD. really but the the and as prolonged from data such binds PD that So MPRX also

Tyler Van Buren

you. Great. Thank

Sheila Gujrathi

Luisa. Thanks, Great.

substantial how really a think characterization forward molecule best look particularly. for of right the really I molecule amount further preclinical think share to we've class in and done that we're we it's with our truly data to and going presenting to patients, PAH So

Operator

comes question the of from next Joseph Your line Schwartz.

Your is now line open.

Joseph Schwartz

you you able about and my ongoing start GBXXX to also I of at in that I if think potential heard you that Phase seen could from wondering I some isn't thinking hope you say that. I'm point PD to and off bridge do this on signs? to a How for if expand gauge or what you misunderstanding. and some signal see comments taking look the effects some data be then per you've be if of might Xb was some to on about would might volunteers, question. wanted that guys. patients vasodilator doing? was start markers has would I in when you not Hi, at you one signal accurate, a just healthy see to are what ask And to Thanks to how since interesting how that terms in with the se,

Sheila Gujrathi

Yes, great.

the of points we Phase is really, that in with substantial where development. my to great look our of Phase across our SID, the date range doses at have think multiple Xb have experience were studies stage and of I the the are a we volunteers ascending pretty X now healthy PAH in normal in you we clinical patients, so totality experience. for Joseph, dose When a

trial. taking sure design right think that right the X I going the Phase to we're the we're all for with steps make

X in be So sharing experience. is our of think we'll I totality December Phase really what the

PK mentioning volunteers what information of also the Phase from I of to that that's seeing being PAH able bridge. but terms and like. data Xb, patients only to healthy consistency in it’s and the was bridging not the exposures normal generated look, terms in back so in And we what in And

changes peripheral points and the be potential would intensively proBNP able could as that efficacy time point to So time was I question such follow on your over our as on secondly, making. levels I readouts, echocardiogram. think some clinical PD, as disease for I well as And at look was think imaging for on changes hope such we in patients be

amount the in as that timing, able you asking is you're at know, data, of If of even study. X Phase see effects, study course, you But, look they me really XX-week some of were a about our if to XX-week timeframe.

PVR. – that's that's looking at so And and

looking some well So systemic and it well of imaging as be also as clinical markers will as for biomarkers. at disease these

for, So COVID the X. again, I robust And the program. of to think really pretty we have of we informative unfortunately, for Phase be more coming think data impacted got we the impactful just and Phase robust Xb or hoping nonetheless a but it dataset will because very pandemic experience out ability the were

Joseph Schwartz

stay tuned. we'll Cool,

you expectations are about or wondering GBXXX, then look give be response you forward trial? us to when if on the could LEDA your with for learning biomarkers a found So to was we I what might thoughts able better than associated

Sheila Gujrathi

Yes.

feedback for is that of I half to be that think of to the towards shooting seeking. next kind able get think year we're I us first budgetary we’re

to have being these are that the schedule therapeutics that We there COVID other meetings same patient out and in population. deal divisions COVID studied the with in

is mindful in that to and detailed then our But hope feedback in more So forward half. first data we’re of going that look very we'll forward to the that get our registry we're plan presenting that.

Joseph Schwartz

Sounds Thanks. good.

Operator

from comes the question next of Geoff line Meacham. Your

is line now open. Your

Geoff Meacham

had taking I Hi, for couple. guys. Thanks the a question.

as a in size, of on that what guess maximize you not types combo could then PAH concept proof for Sheila, resistance? XXX. that is the aiming example? one effect therapy, up would just And feel The a in PVR have study? of controlled well Is a on as then get I the one I for of XXX. like And – study first you prepare follow for say you sort the population maybe there on those larger you in differences you're

Sheila Gujrathi

going continue classes on therapies, patient at the not patients disease PVRs We're two Geoff. looking to population least vasodilator of symptomatology, classes despite at three vasodilator to and higher of have exactly and if being That's after, Yes. we're burden therapies.

we're therapies patients with adding are disease II So again III a they background they functional that on substantial are on burden class and and to. pretty

we're activity to which really population, a population the disease right for this Phase think X enriching we is of think in be kind trial. higher I studying So

compelling that’s So a very unmet I need. think very,

imatinib the as of the look distance. well as XX% XX% like from terms saw reduction in XX% at – six-minute IMPRES about they from improvement their trial, In effect to data about XX%, size, a walk improvement you in if PVR,

ago terms was or of was on that conducted, in were sick therapy. patients then also study when while that a classes how III were. those And of II done Now they vasodilator

That similar. those an that's therapy. So also design of was other classes study to add-on

So they vasodilators. that's helpful being added again, very saw that to know really to program. that a level of on rationale think improvement, our I compelling that's, for despite And

obviously, terrific that to be since going type improved that think, and about be are show be thinking talking level disease question how I talking the about to So to would the that efficacy. much their And patients ground. then similar is, control? we're Again, – of able off so study of get we more with more our that as

Geoff Meacham

you. Got

next But have for you. a then Thank you you're for Okay. do Bryan. clarity options you on first as sort getting That's feedback steps. partnering, or XXX I know to negotiations? have parallel on And still one to or Phase you X here design is strategic maybe when or a it absolute on Sheila. process step helpful, of about think

Sheila Gujrathi

very right, critical of regulatory Yes. the forward. path I engage discussions. for would course, It’s, to is understand in say because what a piece and us both, we development

we any to things information you natural on. that Bryan, to So get commentary? are provide obviously those have very do I want think

Bryan Giraudo

question, for Geoff. the Thanks Yes.

until we direct program that would challenges really to look our has investment obviously like, ideas what what a practical that X Phase through the weigh could let I in. presentation discussions to could to in X have while partner a that hard we And then the make substantive be. any really around commercial have read in engage and think potential Phase regulators

what did. those with the So working a able get the be a what is bit to chicken X and little and we're answers. Because real Phase is has as a market our egg strategic like at to DPX conversation, friends reference the antagonist diligently right now, of Novartis to only a point looks it

see And so efficient have any have really we're if as well that to on financial infrastructure obviously But regulators can to that, have more we and what hard it's commitment until in plan. about trying streamlined would to as partner talk a weigh make. we

Geoff Meacham

Okay. Thanks, guys.

Bryan Giraudo

Thanks, Geoff.

Sheila Gujrathi

Thanks.

Operator

comes Your of next Schimmer. the from Josh line question

Your is line now open.

Josh Schimmer

might at in the be question. a look Again, able the first to Thanks can right-sided you we PVR effect taking pressure that measured on in Is XXX, get on specifically? when heart for indicate going have being your or how have but going Phase Phase Bryan, I wait in Xb operating think for forward? about to we to prepared should that expenses it is X? remarks, missed might And

Sheila Gujrathi

Yes.

So pulmonary X our vascular from is comes trial. resistance [indiscernible] of primary right the heart and catheterization really the data endpoint Phase

Phase X. again, that's, XX-week endpoint So for the

And will will – naturally so that be that be robustly characterized.

disease imaging, data. is Bryan, ahead, go Phase really on when again, And that's then so the echocardiographic potential but Xb, hemodynamic expenses. And From more biomarkers, and you around, should activity plan that. clinical see to operating that not

Bryan Giraudo

Yes.

as Josh, pandemic, that two guidance of takes XXXX. we too on early based capital for that back the very say, us the enrollment my But shall into are available the us upon to that have the kicking backdrop totality at Gossamer capital important feel XXXX. of of doing said work, into of it's I in X good we're remarks predictions that the half to against we because and these of to off Gossamer book make greater just the I'm cautious Phase well trials we half still give So, than us all we second the takes the timelines costs. do thus

Josh Schimmer

Thank you. Okay.

Operator

Carter from Gould. line Your the next question of comes

now is line open. Your

Carter Gould

you X. guys the been the the a of And that on XX% I hurdle delineated how know and what's Can for for to of guess taking of XXXX, maybe to six-minute just sort bringing help do of term then to kind to just XXX. about reduction population think help of to back what appreciate talked in you either terms experience for the Thanks of trying biomarker in afternoon. first, or some that sort of I and put and kind Good the, come when this engaging floor, that meaningfulness, KOLs Thanks. clinical XX% up guess But sort see? think of sort about think Phase about lack distance, if you PVR, imatinib you of are in I maybe need hurdle some sort of context? in target on reach you. I the there's I you landscape. I’m lot guys of data? with MDSCs. And understand – better questions. there's looking walk guys guess Great. to a Thank you just maybe have a poster you

Sheila Gujrathi

think it achieve unmet we're here. to of really gets what your – the I Yes, first need to gets question Sure. really trying

two PDE-X, ERA And obviously, therapies. be So, on functional is treatment type earlier severe a And everyone have that of patients depending with most there usually really vasodilator like on these those state. classes improved of and IV. vasodilator PAH no some that combination. could other started are regimen those three of approved how there then the and predominantly even just are off been used the are a are of in class III added options classes in beyond therapies patient When in in combination knows reminder, as and added, II, processes disease are type

So high and therapies. patients rate with patients have mortality real progress, to continued IV to are functional heart and right who indication. rate a for for III impairment are failure, oncology XX% status, who deterioration morbidity class no controlled hemodynamics which or who there's rivals available leading mortality, to functional and any continuing is patients These their really – of XX% continued on the mortality and the symptomatology, those have and a in

we're measuring as will us and functional any especially if show get which is But on and information. this So looking And of to on human clinically our improvement. primary see is why can six-minute dynamic impact see put to as the stage the very we these classes of this be trial. we important by obviously to That's at that improvement for really add just of at to improvement functional important the Phase X very need functional really critical, [indiscernible] we looking of walk improvement, we parameter endpoint objective for well. measured obviously because distance, our also type as development

we're So to really to here. there such clinicians I question would available of the a what's improvement options. would and into sicker improvement any outcome level meaningful, be Because level what measures want looking. very to vasodilators answer being able show We the add argue population in from what hearing these they can treatment we're these on see. is obviously improvement about just any because like and our just we that's will of see aren't to

that them inhaler do. what another know this of type that they affording powder of is Now very that, person, logic before the pretty population be three and They're of to sotatercept systems. be well, bulky that's be our human because Acceleron’s into a all presentation having treatment different every said is you nebulizer for dry also with really could able remind these is potentially very really a all just And which to convenient with asthmatic type terrific an while carry live to given patients patients is commercial they that around normal you similar moving that weeks forward types just had this devices DPI patients. can monitoring. having as for life, in to inhaler injection But GBXXX designed familiar

very It's to presentation is the that favorably of appreciated presentation is received. Now delivery they're PAH moving to four had take a DPI a with by so community. times system a day, highly and more DPI type that they've a up and now to

showing functional symptomatology favorably to lack that, think then of this options really patients. treatment moving that given there's will I as very considered very, And on Luisa improvement XXXX, any for be really on these let on a and improvement So again, well. comment I'll

or I tumor-associated think or tumors is myeloid as critical TAM, really macrophages, to ability and shown efficacy. of granulocytic well cell T in pre-clinically suppressor macrophages both That so we've as the our in which populations, the tumor means reduction myeloid-derived cell we've monocytic, populations, preclinical infiltrating increase cell seen the biology. for disrupt and

infiltrating increase see the tumor- CDX you and in T So lymphocytes cells.

this So we've pre-clinically. seen

migration the the to increase by type themselves So immunosuppressive immunosuppressive in combination and MX translate then and to immunophenotype being that able an it's these from results the repolarizing cells the cell MX burden, and be to into response. to the of clinical T blocking showing really reduce recruitment – also biology tumor able them an is both and into

this treated cells. combination as and and seeing to. the the on as we the as in speak so at Luisa limited TILS, especially at proteomics peripheral monotherapy TILS what compartment influx granulocytic can the CDX, think in And again, in looking looked In we seeing of as have I biopsies in the more biomarker for it in patients. then we're themselves you well when the you the we're if in patients as combination monotherapy the look CDX transcriptomics see the both cells, treated arms, well and totality and periphery the seeing in the of as tumor granulocytic look at the see you samples data our influx monocytic of the at MDSC that this well both MDSC patients the combination And reduction

I to trying think get what really we're to. that's

get opinions Your if let of think T to get of to the But what about have Luisa show increase don't have over matters. great question. targeting turn of a these to, I data cells we informed lymphocytes? myeloid to more to I answer level are in we population enough know kind her it that's that. to question MDSC me

Luisa Salter-Cid

Yes, absolutely.

basically, have it down direction think So significant. to And the right in grappled a people has I is be what beyond most has therapies have just it all that people question landed What including going with. significant, and to very is so for is enough? us be that

[indiscernible] fact the in of day we end mentioned, the the is do, just Sheila point, see not at we cytokines, to us And Do the other biology. that think change CDX. and zeroed an observation. significant specifically into that much increase really seeing in cells, Sheila's the and with have you are here. it's You And And some go then chemokines, it? infiltration? T in CDX in proteomics that So really folks I which that are. including But have want as we the biomarkers then in you in tumor is about all

has it specific a rather is a to know So for think everybody totality That just than that not doing therapies. is what of to MDSC I else fluke. modulating with be data it's think the just us these number And consistent the enough number. that's I

Sheila Gujrathi

Yes. well it's that few biomarker us has this from derived the the a the genes periphery, want genes if cells has get for data you these interferon proteins, easy we've looking biopsy. a reassuring I And to the as looking I then as seeing biopsies, Again, well, actually our changes. to COVID which themselves. thank really able myeloid that been the and look been the at type looking our tumors responses, been to at team as we're looking at not inflammatory themselves, to team. great a pandemic during things so it's been And getting back clinical at to because expressions effort very noticed at the gene get

cells, cells of we validation incredibly biologic the of productive to again a – positive and and we that and critical see for And which So fruitful to the influx I able activity. think been are be for really are see then us seeing mechanism T see clinical this activity. that's

and remind everyone, across tumor lines know many also coming that And are shown inhibitors seen we're two either of five mostly then lines of checkpoint to good Most prior duration that. have difficult with responses treat – have with this, have checkpoint types patients of or who has in and who've lost inhibitors been greater then you therapy combination. patients we've responses least the two-month all treated to not that a about are to as very but resistance patients. Just guys secondary with these seeing primary to CPI of response them very therapy, at prior sick

– stable say. I So disease, should think that I in terms of

think I is that really encouraging.

or Just find XXX given a disease encouraging. Phase we're in just confirmed seven the to evaluable of at PR at greater, this in, And really about the again X again prolonged experience point, the XX milligram stable patients. we five including have that's

think I us. that's out for XX, So of X if really information you're encouraging seeing,

Operator

Your next question of Emma comes the from line Nealon.

Your is now line open.

Emma Nealon

question. taking the Hi. Thanks for

think So turning potentially to Phase see GBXXX, the is just the you physicians in future speak data, you fit in mechanisms then you are this so feedback some from to given work, to of there into it profile mild evolving can early X where combination landscape? would the any logical? recent could to exciting why moderate commercial the – physician setting? And be potential And of just terms that specific

Sheila Gujrathi

Yes.

such just – a really is think I it's mechanism. excitement the differentiated

are are So course call, there effective orals are therapies, on typical that the the of them but marketplace. immunosuppressant that not and entering into biologics of I've a also most mentioned as it's number really some of

approved. have We are the JAKs that

therapy this but SOP Phase targeting very that actually X the think focused in receptor system. exciting really be I both others for, of of that’s are looking terms think will the This is analog immune therapy those and which a I leads patients entering [ph] a to had of has focused type modular for space, on the potentially have symptomatology the clinicians And data. gut been epithelial being mechanisms epithelial and mucosal integrity disease disrupted the lining, continued IBD and mucosa kind differentiated able these that function and and that the heal repair on inflammation the further of barrier severity. lining to in have

used has therapies that that a of of potent immunosuppressant risk for other now to point, a malignancies, oral other to So pretty failure in alone, and progressed synergistic think that's a not as and patients could the and from because and especially and a population severe really of disease faith their terms that used commonly to who go on some is differentiated or monitoring again, are maybe patients generic may really to – that this earlier disease, have of combination to infections, I be very manner, right to mechanism have and then at or steroids that really in from biologic leap of required. take from the risk an big in immunosuppressant well and moderate exciting be X-ASA hopefully disease, stages other as in ability a as earlier immunosuppressants the safe more target steroid X-ASA that to as well especially moderate

So in be patients that gap such have And it's able faith. leap the really GBXXX. would of prefer be to jump clinicians a to use, really and could big another therapy and as to

severe area. tremendous sense that pre-moderate so think this the a biology you when again approach, look I as disease mechanism well positioning, really at as that to resonating is the type of excited pre-biologic, differentiated which so about it's really that of makes they're So And powerfully.

because think with really who understand are the design, capitalize the Luisa addressing add benefit. been could want we've I have doing of what what too. on about the about And this other so we with well, mechanism talk that's work as and her best the to And lot patients the And on to thoughts to we trial SHIFT-UC study combination really I we're on then a focused on mechanism. our approaches

Luisa Salter-Cid

Yes.

self are complementary really So – the we that the time mechanism because, spent some of standard is on mentioned, this do – their really we immunomodulators action of have Sheila is as care. to

specific well including So samples. as well lot and as including therapies synergy inhibitors we the translational data of but in-vivo have we JAK complementary, the as with combine seeing quite anti-TNF. really few synergy, not are patient with both in just a And when of as organoids lot also endpoints models, – cocultures out that endpoints on there, a a gathered you

seeing and come But these we two good the surprisingly, are not very I we data. think share will between absolutely to more So synergy approaches.

Emma Nealon

very you much. Thank Great.

Operator

comes line of from next Your question Hoang. the David

is open. line now Your

David Hoang

Hi, fitting in. guys. Good afternoon. Thanks me for

ulcerative colitis. had and then So questions; one just on for one two I PAH

interested something the be trial So X really drug’s or oxygen having Is additive for you would Phase testing do and supportive that be looking pursuing they for PAH, you informative profile? info a sotatercept, looking And that peak that to cardiopulmonary ever note would think consumption. XXX? at exercise at I that in have with Acceleron that's

Sheila Gujrathi

those a That's study them – Yes. we interesting measurements. for taking obviously of applaud very very types and

We have with as well. discussed our this investigators extensively

I in We Phase our of detailed in say, specifically. into and our of X in some intensive, type should terms built have rigorous study that trials not of assessments

we the as echocardiogram most as on on the lung the focused vascular think hemodynamic we're in relevant right ejection in imaging of getting of we’ll really fraction. function. well resistance and development the be measurement that again, heart again And I right terms stage think the through endpoints to data path that's, parameters, looking at pulmonary assess this heart at

think we are the those areas of that where we think we are. were I the think So some relevant that most for – I

also The at very again, important right about greater the those But depth, we be heart screen looking is I think other biomarkers and the potentially supportive studies. is really that we're important. doing assessing, in of in proBNP are over are BMPRX marker around and that levels mechanism would to think to time things

at other vessels lung. vascular in I in really looking are in some at what's try be imaging We to modalities to the the happening and that potentially think themselves the get structure will exciting very

I we best some that are to our of at the employing forward which are those in we'll so that things time. discussing, imaging webinar And are techniques other probably we novel think have at be look And December. in decided those program, our this again,

David Hoang

SXP modulators in interested paradigm. the into treatment earlier Got of ulcerative on I know are then moving receptor colitis, it. Great. the And that some just

for patients. that X trial example, Etrasimod And Phase so, I've in moderate seen has a

who with your score score patient I you're X think at guys X, treatment Mayo different X. earlier of X, in be in population endoscopic even a paradigm? they're or to or overlaps that least going the from Is maybe you will Phase that enrolling

Sheila Gujrathi

totality will endoscopic disease and scores. population I of if the would scores the you an at there look that the Mayo say be overlapping

the the for developed just drug. know term? obviously I Etrasimod know the well be will having is ozanimod. We long ozanimod we what very And question profile the profile for think

comfortable be maybe we drug, therapy. think think clinicians that be know uptake, that I up that challenges So, that liabilities can development the completing monitoring great it’s of I and clinicians, some how the potential can will there algorithm? liabilities because how think deal therapy, especially think treating they by question it's you community in how all SXP, to given number said risk, have Obviously, will of that With time within of with large the a safety circulating that have and move PML lot be clinical that always they therapies. thinking to over to a any will risk if with for for treatment their I abituzumab significant patients. targeting more alpha-X-beta-X is, with. their how about positioned TVO There it deal will with by liabilities of be that, Tysabri. have lymphocyte with be really reduced that gotten will the safety those scary the lymphocytes. the terms at see into the reductions, around programs other in and it's then we we it risk around question used had is and just which in I to terms potential they've SXP something have peripheral while when then looking think received And have a Having infection So, a will modulator be

by are clinicians those I be think So, always for and have and thought about managed things to patients. real will always

and population of they about how impair into to these we a versus that to to infection think be the in I moderate therapies when be of to time? type mild some the earlier potential of used those how will want the think system profile try have the move think treated therapy. question other effect, So are doesn't is, we about, that that things that ability risk and over that to lines immune really therapy So up

some thing. I orals great, coming in, so And one again, as second the then us. much that's this complementary them could other view these as of combinations for be synergistic So is competition really or thing don't

have to be on versatile combine oral-oral these we we focus think powerful combinations safely such other gut-targeted. because really think have with great to for are mechanism be able So And patients. to therapies, a should us I we will for really that, and also we

a have PK. very we So limited systemic

exposure. have We focused really lot a on colonic

combined with. be able very I be think potentially will could good mechanisms we for to to that have those us

just again autoimmune on therapy mentioning, combination to It's colitis any approaches one patients for No a is cure an going to or ulcerative the have with critical. work our was Luisa is started approach. combination As patient patient disease. any we really be oral going combination and

figure over develop regimens have also therapies out way therapies. to individual as time safe important us best our is the I for combination think we to So as

David Hoang

taking Thanks and questions. it. the my Got for insights

Operator

Your Patrick next the Trucchio. question of from comes line

now line is Your open.

Patrick Trucchio

Good afternoon. Thanks.

in that’s and the Just regulatory for recent on a seen years guidance and follow-ups few measuring the for of in IBD confirmed GBXXX. histologic by the PRO shift terms validated analysis We've measures. the mucosal of endpoints with preference healing

enrolling, fairly wondering IBD. or moderate in regulatory you have view then an see should SHIFT-UC how I to endpoints this believe we follow in and is So to do And stable study? still we endpoints population, more mild with eventual patient it with SHIFT-UC ups? bar the I'm – particularly shifting ahead we the is as look two the And update

Sheila Gujrathi

question. great Yes,

lot disease of been, an Crohn's there's the a think on course, has additional still I say does it to for seem of would then, dialogue I colitis, and proper example, ulcerative regulatory be which area is challenges. able But For evolving endpoints.

so is I importance think relevant. clinical of very the remission

be not really to clinical again, So at primarily, endoscopic looking frequency score that be able looking looking improvement at, that primarily bleeding, still Mayo signs the really is counted at to the as at symptoms, and looking remission only remitter. endoscopic but and rectal and

think a lot And there's of so endpoint. in that I confidence

it the say the spoken as the mucosal – medical higher you really here, And gets I to evac [ph] and is healing. is on has to to bar issue. our phone think the of like many tissue

a it endpoint. clinical remission can So really that greatly on to you Gossamer. such the histologic we remission mucosal meaningful we a do top of true, very that show that healing, that get say believe because is at just lot and if And that's

as define So it's inflammation, very, we resolution if histologic you of detailed. very can again show and remission,

have of have, colonic layers other types You absence neutrophils and again, of inflammatory the cell and multiple tissue. really to

again, Phase be And I saw out endpoint we'll to that measuring high Xb. something definitely It's data our able we to be higher that it's very bar. get coming the of closely. a is, think hurdle, where is best so really healing to mucosal And

the going in And so feel approvable the Phase of do that remission is we're I very our But clinical to endpoint solid. X think measure trial. I

will then that your could mucosal the secondary And secondary then remission healing to program. be very I so very I as having think and dramatically important ability clinical efficacy, going that's development also characterize think But important well treating very a and important to shift to as endpoint endpoint, will looking wrong. important remission our and and primary getting at I it be don't at histologic during the have your endpoints long-term to sustained clinicians be remission as to to regulators, patients. as

Patrick Trucchio

XXX Got disease, the moving in would movement determine what SHIFT-UC ahead it. regarding Crohn's potential And outcome from the Crohn's? would ahead just in to for disease, Crohn's or wait then if plan to be moves before

Sheila Gujrathi

in – the our currently Crohn's we we'll I based that and forward. right rationale, work moving colitis. will now for as But we be it get believe ulcerative based And there is scientific Crohn's that on indication planned lead have disease the think That's on more we and thinking rationale experience, the see data Crohn's disease.

Patrick Trucchio

you That’s helpful. very Thank much.

Sheila Gujrathi

Patrick. Thanks,

Operator

questions at [Operator are Instructions]. no There further this time.

You continue. may

Sheila Gujrathi

the these for so all much great you our us time Thank portfolio. around asking questions and taking

and speak We’re to forward and December more at in discussions you hopefully be to pleased all able looking to to again you the seeing webinar come. to

So thank Goodbye. again. you

Operator

conference does this gentlemen, Thank for call. today's and you Ladies conclude participating.

You disconnect. now may