GOSS - Earnings call transcript Q4 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Gossamer Bio Q4 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 speaker today, Bryan Giraudo. sir. ahead, go Please

Bryan Giraudo

Senior the and a am all subsequent by stated due joined Executive morning, company's and by Chairman, operator forward-looking Richard including or implied statements. Clinical Annual news results are forward-looking in Actual this by Gossamer's Report Earlier to on with release SEC the Aranda. and releases, Gossamer's those today Gossamer joining its announcing Private statements during uncertainties Gossamer Harbor information morning. Chief filings. discussed forward-looking certain this or time. Gossamer’s that only of business. period associated These Hasnain; Please conference statements time-sensitive contained Faheem qualified statements to obligation filings, note I on Bio any year-end may XXXX Officer, President thank the revise that you, Act. Safe differ of events Reform financial Litigation for this after the from a be the Development, risks these this the of results the statements issued you Securities date Gossamer call. us limited Co-Founder, or in Form materially accurate and information reflect Vice also may to forward-looking update press be contains takes is call Thank We circumstances for provided and conference no Bio XX-K today's call call This provision that under of a management corporate update. listeners making covered on caution will call,

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

Faheem Hasnain

II financial Today, progress Gossamer's provide the great We of product date as team that will made progress thanks and four call intensely of candidates, two continuing then of parallel the known to of us XXXX a you you into a as on an Thank also of as for this for treatment forward joining to to we in on lead inflammatory year-end view and us where we the GBXXX us focused line product year through XXXX all proof-of-concept our course, Phase we you, walk for will, and Bryan results. our execution which PAH treatment the and co-lead candidates seralutinib, XXXX, top have clinical our look data that update on bowel for share disease. trials we'll morning. Bryan GBXXX key will

share always as profiles. Both the could as unapproved don't need have unmet very of well using fact are tolerated programs severe underlying clean they're disease. mechanisms yet key pathophysiology obviously of address find indications, therapies to populations despite seralutinib patients Now current to of We in novel that in believe product and GBXXX treating indications to both attractive. that we different both candidates treatment characteristics the targeting where date paradigm been both transformative volunteers assets generally be healthy safety and have the

inhaled PAH seralutinib start let's So the currently ongoing TORREY II patients the an c-KIT, with Phase and in it's of and PAH. of is inhibitor PDGF, Seralutinib enrolling study. treatment CSFXR for

remain of for the although the change to go from Investor statistical the website page distance, of expect study of event at is section gossamerbio.com, to secondary a in walk changed half baseline in is December therapy, The XX with our seralutinib anyone at the walk key to who who trial at where Events to powered TORREY missed subject recording PVR XX II And Investors first are to that TORREY the endpoint The class results on XX is Day KOL-led in significance the a enroll we week in six-minute six-minute in reminder, X week endpoint baseline and approximately patients COVID-XX expected of PAH encourage trial on primary from top the not a distance. pandemic. developments As will functional of triple therapy. and like XXXX, of course, including line ongoing available. from our the I'd background

co-lead stabilizer GBXXX is of candidate, HIF-X call for GBXXX other for oral II of the SHIFT-UC who is IBD. treatment alpha Now an the Phase trial, the study product enrolling our colitis. ulcerative we treatment its

of XX-week at remission is Now line primary UC of trial shift study ASA including ongoing XXXX healing. half of GBXXX X study. is response, a remember, subject mucosal in again, recording as the remission, well Investors Day, XX. Events watch expect remain last endpoint, you to UC already. enroll page patients moderate section The of the clinical expected from at The week's the week UC gossamerbio.com. developments improvement, clinical event will also stable the week with endpoints to haven't recording the the are pandemic. you if seralutinib and shift KOL-led the histological on we first as these throughout COVID-XX the at The also endpoints the background event approximately endoscopic of also the mild available secondary XXX therapy to who Investor to on And XX, results will top I our website with evaluate to study to encourage

patients I/II GBXXXX, which we're Phase tumors. addition dose advanced Phase patients of through oral an and response with therapy, or I initial for modulator Gossamer to that in studying progressed anti-PD-X have microsatellite the in seralutinib And cancer XX treatment II also advanced cohort, esophageal Phase stable to up cancer. and is Now patients is rolling in GBXXX, in to trial the after gastric a solid expansion colorectal with recommended CDXXb currently hard-to-treat a advancing

once becomes data XXXX this We in further announce available. ongoing expect it trial from to

DPX product antagonist final GBXXX which clinical Now treatment asthma. oral for to moving an is candidate, on our the of

IIb that year. quarter DPX top a for or those asthma. there results we past the LEDA believe do As backup this you antagonist viable the our remember, with Phase FDA clinical may for related discussing study molecule of previously the path read the in and EMA, exists GBXXX out we fourth both treatment from of After the results line development

be that backup antagonist of being crystal ongoing either patients, without Now focused we're but a I will clinical execution update. will Phase trials. oral an can over benefit our in X believe make Chief partner. that, further Officer, Gossamer its DPX Bryan II advancing for not DP that I to With financial successful a Financial our or antagonist, said, the a currently trials on Bryan? it want it to GBXXX We hand clear Giraudo

Bryan Giraudo

end for the and cash $XXX Faheem. results Thank review now ended million year equivalents. you, the of year We'll with of the We year XXXX. financial full cash

maintain of we cash and equivalents, in us capital available capital and our into anticipate to a We our sheet, debt provide balance cash the to plus continue XXXX. half sufficient robust second resources a to facility

year share agreement For connection GBXXX, full a expenses in quarter million full R&D The December for ended million in XXXX, were with the $XX same XXXX. $XX.X million million to or the three of we for same approximately the million for ended compared compared or months XXXX. expenses share the a were Q&A. was net XXXX full of that, the million XXXX. to license of million the the in per Faheem million quarter $XXX.X the for compared back $XX.X year was increases the trial $XXX.X December in $XX.X -- to closing XX, milestone G&A $XXX.X compared XXXX for which II the of to XXXX $X.XX of million were from of XXXX. attributable period million XX, primarily to compared the XXXX, in $XX.X full the May we compared $X.X ARPO The to the for per for in $X.XX fourth comments seralutinib year million million the of million G&A $XX.X I'll XXXX, loss XXXX. of period for million were before amendment December XXXX. or R&D share call compared XX, expenses to were XXXX, of million quarter Full the $XX.X to period XXXX. XXXX. December Fourth loss Faheem? of for XXXX XXXX R&D in some compared year open $XXX.X The year clinical to to the XXXX. for the were for a the in-process $X.X full expenses $X.XX per expenses loss R&D $X.X year same accomplished million line expenses for $X.XX year loss million period $XX.X ended same With payment were $X Phase of in full in expenses initiation turn or $XX.X connection over with a XX, the million net share, net net $XX.X to per to to

Faheem Hasnain

Yes, thanks, Bryan.

solid programs pipeline be value, about. enroll alpha XXXX like and our excited all the of in or focused But trials. to tumors. most this also without patients stabilizer programs on with a Gossamer investigators, any very GBXXXX coordinators of that have continued who efforts our believe enters we But the seralutinib, preclinical that robust drive will multiple our we our our XXX, of we're study HIF-X XXX team, incredible would we do and unable So

the us, to within So Gossamer truly Gossamer, of have of the the been you team team supporting I'm who walls and four of all grateful. outside

to I'll Operator? now that, question-and-answer with operator the to the Session over begin call the session. So turn Question-and-Answer

Operator

Instructions]. [Operator

from Tyler comes The first question Van Buren.

Unidentified Analyst

for This Tyler. morning. on Hi team, good is Tara

give event there think us this clearance do the this Then in so of you is more regulators following is really see you recently, precedence you So pivotal was endpoint, to you like potential some think interesting for color any secondary how many for many in, this maybe to could a on Phase about meaningful? think to patients will as hoping do endpoint a expect part program, disease you frame do see need endpoint time and this? the be GBXXX II, which the I how how

Faheem Hasnain

question Dr. development Richard? heads Hey thanks. up our who over that turn team. Richard clinical I'll Aranda, to

Richard Aranda

Yes. Thank for the you Faheem. question. Thank you,

is relatively to on clearance As disease you know, would new to see. it's we sort concept, difficult put expect parameters a what of so

probably endoscopy. use a both some mucosal on extrapolation can and we think remission requiring I healing histologic

approximately could And then quite be that placebo. meaningful, a between so let's probably or difference so, XX% something of assuming north there's say, that that's

endpoints In in on remission and so far, that of within not by or regulators. terms of the and the more clear approval the yet required therefore histologic has context as clinical what the the histology there's has clearance of guidance disease the know, endpoints been value to disease for is on in addition guidance we placed concept commented

of what if it. and most see histology -- value particular including it be and of the all difficult that will obviously, they to data, think clinical see considered our discussions of it's although, have on on highest about totality the we would an So bar, being within the effect parameter, it would that we do and the

Unidentified Analyst

thanks. Great,

Operator

question next from Your Carter of line comes the Gould.

Carter Gould

good Great, guys. morning

are front? just case Just guess helpful but component study? we potentially lines reducing shift recruitment. lines, Crohn's, these just number such, there going two And you exploratory first for the as of to the doing guess, any guys me. I something you things do in -- just should you're on guess, time still around you you I to with effort UC terms in just time ensure calling anything the executing either parallel other But also, see, be on I ongoing clinical the just make on some clinics, I Thank background doing with help about non-immunosuppressant of as that to are reluctance hit you're you. in on the with in want and think understand if to maybe COVID think either visits then the hitting the clearly,

Faheem Hasnain

we initiating over last until to first then first, certainly, to the got take we've and results do interest, Crohn's Richard, question? our the study. first you Crohn's will of Richard. question but question contemplate Phase UC I'll to in before turn wait I'll view II will Yes. But be the be want after the handle would

Richard Aranda

II designed implications. pandemic we When Phase the Sure. C study, safety the and potential the we consider

several did we things. So

like and pandemic we First geographic sites, we have distribution and the of things sure of of that. sort the differences right given countries that in made all,

third, for for and site spearheading a trying we've we team great so protocol Second, is tele-visits, program. have have that to patients, and of drug made to And the medical speak, to operations home shipping their the etc. great as our user-friendly, the appropriate,

number a with globally with conjunction relationships partnership the CRO. great investigators have of We with in

of all upon accordingly. the so executed are that So, can program progress we these being

Carter Gould

Thank you.

Faheem Hasnain

ozanimod other course that one is is staff on and just the really the executed team Yeah and it our that point that The add and in. on program. depth other core I'll two team us, from tremendous expands in last and also has team on comment, apart is to pandemic, this Richard the experience something all clinical which gastroenterologists and new of was Richard's IBD IBD of operations of the team.

landscape, extremely helped So that significantly and Richard sites extremely and for said, really investigators, the as with program. the this the familiar familiar and with

Bryan Giraudo

Operator, question. next

Operator

next Your comes Nealon. Emma of question from the line

Emma Nealon

the for from potentially the maybe taking and pipeline? you think about later-stage want to months Hi, curious terms XXX move thank look into now about I of question. the pipeline in how you and that versus looking seralutinib externally studies guess, think your what pipeline XX XX excitement to how you in like potentially I guess, you preclinical for growing current do

Faheem Hasnain

line the now, If I we'll proof-of-concept for months XXX thanks progress forward on we our and to to top parallel two XXX. as programs, seeing XX from be question. obviously, looking of Yes, that kind data XX mentioned,

are to preclinical progress we our expecting Beyond pipeline. that certainly

a will our the more be that later and next that We'll spring We first hoping outlining so on We're actually have come clinical pipeline. be we plans program. on for preclinical the program. pretty target our doing to robust in

XX will that the continuing say program a then fifth be see at if the pipeline. the would to talked program we from to to of with about yet the to essentially include and what that XXX, programs advance entering XXXX, think clinic, XX our clinic undisclosed into that so now, preclinical into I program And we XXX at a point it's earlier, DPX fair in number I months hope

the think, founding about business the pipeline pretty the speaking now, team your we significant has we've I job great question really incredible opportunities for company done development, As since sit to, XXXX. an in inception a really it got relates sourcing as of of Gossamer

And of got a so our exciting perspective is opportunities. that pipeline we've

focus we'll in place entire development really be on business so now. organization as that the of got that down on time suggests really the the pipeline being, execution And that for standing we we've

Emma Nealon

you. that helpful, Great, thank is

Operator

question Meacham. next Your comes from Geoff

Olivia Brayer

this is Two the guys, for Olivia questions. Brayer. me. Thanks Hey for

finalize with in First, more that's that you're there interactions regulators a GBXXX and us is some a development Phase can something waiting just you III place give the potential that this around we there's or point, how going for is color at really to until been plan partner indications there some expand then I going see very second, What's year, in the there more strategy on positive Phase play? asset just development some later longer-term GBXXXX. data much. forward? quickly to And the that other this Thanks are with assuming into opportunities

Faheem Hasnain

Yes.

extremely to relates good, the been and with interactions As it the regulators, it's helpful. very very constructive

moving and and the as and in we So The the potential there a Phase of with of and program a our effort require That pipeline. being absence III having program that a between in view we -- of for excitement the is amount not lot that both our optimism substantial got a pretty mentioned, of rest we've III and EMA. plans reasonable the path partner. forward not said, is would I Phase FDA would with concurrence the path be forward believe clinical the

decision so this that Phase is XXXX we And without that a made our side. progress by in we a Richard, do want having our III clear would you partnership to substantive handle question? the view not

Richard Aranda

expansion the there's Sure. now explore if Right to is that obviously have assay. Yes, other tumor that immuno-oncology we always that types a studying. types think of we positive obviously, currently signal, a focus in beyond are possibility for I do the tumor

therapeutic to this our know, on at is As immuno-oncology we're indicates time, efforts. applicable perhaps that but you the the some other literature areas may molecule focusing

Olivia Brayer

guys. Thanks great. Okay,

Operator

from Trucchio. Patrick Your next comes question

Patrick Trucchio

Thanks, morning. good

COVID? if what and what top is data the post-pandemic initially discuss around impacted of environment line follow-up the on the if pandemic by particularly the pandemic any, wondering in on for And and the are Just at included lead having been I'm first integrity? which guidance for impact, pandemic. half least COVID-XX collection programs stage, or expectations in data at this data you PAH, XXXX, the one had can the assumptions

Faheem Hasnain

Richard? Yes.

Richard Aranda

Sure. I first could the address question.

no data there's impact accumulation quality. or all, of First data on

sort XXX We our program and of XXX implemented pandemic, from of you was XXX issues that programs. learnings we the and had and height that the in no program. recall took during with completed If them

we have collection with quality we So issues any and expect data and anticipate don't provisions place. don't because we in

Faheem Hasnain

at regional assumptions of trying And programs both ability, innovative our got access are depending the as both including kind the line, kind pandemic of locations as time -- enrollment beyond selection, be a best these involvement, where as -- really site been that And of think context global on just lines around of can of that terms of impact. chance patients, time to in and relates our about we it the looking and including our and we've in local the to to room in planning COVID as of of better ensuring we circumstances. kind better as trials to we we've of

ours, So been tell focus, the our along we're has not tremendous that a from moving continue entire laid But only earlier. of predicted we I this. out of hold to the kind guidance this at looking can and is is perspective, we industry as -- know to we you had I

Of have of But none hopefully, see how the see. we will next a have play XX X is to we'll to exactly but lessening ball, so will course, this the of hard kind what of in crystal COVID out. see us months effect to

Patrick Trucchio

few then just GBXXX. And a it. follow-ups Got Right. on

novel to response. compared with and [indiscernible] patients have to So tend to you those loss JAK inhibitors biologics see improved treatments responses

regulatory SXP expected in wondering earlier So also impacted, that's And the GBXXX, secondly, in all, ASA some a I'm biologics, more stages by to and in forward positioning endpoints I'm then UC earlier SHIFT-UC these including inhibitor these of just being could so population? to trial discuss competing GBXXX gut-selective are related moderate of to moving characteristics it related failures, could how patient an if if wondering the the with what patient population? and JAK prior efforts, expectations disease characteristics X be baseline and at positioning the in modulator you

Faheem Hasnain

Do Yes. first? Richard, the I'll take the to want you second question. grab

Richard Aranda

Yeah, ASA enrolling population. post inadequate a trial response the X SHIFT-UC Sure. is

Our endoscopic have a We than population more including with moderate mild. moderate they inclusion milder is require consistent criteria although may disease, more disease that's symptoms. activity so really more

post enrolling to anticipate population apply guidelines moderate classic that we is moderate X is that, of pre-biologic said have to the that of that population same net failure Having more regulatory severe, the of a So therapies steadied. population. for most ASA other which

we responses anticipate of the don't So required. on terms any differences from or of are regulators major in endpoints that type the expectations

Faheem Hasnain

like And about in and mucosa as your incredibly that, rates And this we it in to probably, relates One patients see are of that I in for check. oral out therapies a mean, I be indications question hopefully other still lifetime. get is need I despite and that healing this reliance therapies. view an trying they're other where the going see and kind therapy will areas orals these to steroids, coming to I agree there's there we've not all is patients that available And oral remission need. all to of I go Patrick, see of would think in off, and biologics, unfortunately, context patients, play MS, where oral we our of they case, the that multiple interesting of couple reduce are incredible mean kind over opportunity to suggest need seen rates that for mean, positioning, able that on to low therapeutic first offered still disease when In think to the be back dynamics. in, oral push on pretty kind that almost of the be, we to cycling an through available the the

have able of And but on there's as continues monotherapy, could an have a we the important try get would the management not with also to but mucosal out to not but to safety, integrity safety safety So that an play dynamic will next that barrier we endothelial only level dynamic, that attain. XXX to potentially think only and profile there's an also hope therapy allow effect be profile combination a if disease would to to us hope, of we agent we for here. healing that

the So for safer is need market the and is the pretty we significant think unmet certainly clear. need profile size enough, is a large

I us perspective, think our significant opportunity front with of in a we from program. So have pretty this

Patrick Trucchio

much. very you thank Great,

Operator

comes question of from next Tong Lu. Your line the

Unidentified Analyst

Hi, It's the thanks SMBC. question. for Tong David for from taking

the two We one for and have XXXX. questions, XXX other for

on readout do you XXX, have range be and there the would terms in and see in is what the give Thanks. see kind trial? For between competitive continue next would in is the target or that to development? vascular you'll comment a in the you minimum to to III in the be Phase and see question, test the for can resistance you what to correlation have of you For would into advance any inform results walk are around the decision how the space the any the further mind result order six-minute similar a PAH expectations pulmonary PVR GBXXXX you response

Faheem Hasnain

Yes, we able moving that to results, the for to in study. to I mean, of comfortable their be like see IMPRESS their III, and were of context imatinib seralutinib us would in Phase XXX in kind they to see order the of expectation results hope

and hoping Richard? out we're walk that be PVR. think on I would So both will play six-minute that that the profile

Richard Aranda

a Faheem. generally think correct, six-minute what on I around well. benefit some parameter, and I an walk if that was that should relationship that's you hemodynamic kind want there's just your to there's see as of add considered effect reasonable would question you is on you think relationship Yes, a And between -- have also expect

Unidentified Analyst

any steps? expectation And reform you. to next of the XXXX, around Got the color the the how readout about

Richard Aranda

Yes.

and looking we that. the the patients. decision obviously, PR of totality robust will as I expansion in phase, look three at then in expectation at would think the the result data of we're the a is number a on we to make tumor there And the two particular such -- types have -- that actually

Bryan Giraudo

Yes. at we update and to a hope trial have further the ASCO communicated, And we've SITC at as progresses. Tong, an update

Unidentified Analyst

Yeah, got Thanks a lot. you.

Operator

are remarks? time, do you questions no There closing at have this any

Faheem Hasnain

to the mentioned as continuing our patients. phone, you, And to for very for I everybody on We about significant just working than you hoping thank other on make dialogue. and programs we're Other to to thoughtful forward your we're importantly, thank questions. excited most we're difference a look that

I a thank hope all, So day. you great you all and have

Operator

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

You may now disconnect.

Gossamer Bio (GOSS) 27 Feb 212020 Q4 Earnings call transcript