GOSS - Earnings call 4 2021 | Gossamer Bio, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the Gossamer Bio Q4 Earnings Call. [Operator Instructions] Without further ado, I would like to welcome your speaker for today, Mr. Bryan Giraudo. Sir, the floor is yours.

Bryan Giraudo

thank for and afternoon. us operator, you, you joining all this Thank Officer, am by Faheem Executive Medical call on Hasnain; Co-Founder, Chief I today's Chief Gossamer's joined Chairman and Gossamer's Dr. Officer, Scientific Officer, Aranda; Gossamer's Richard Dr. and Chief Laura Carter.

caution Earlier Reform that XXXX a results from that year-end forward-looking will and announcing provision statements stated listeners SEC filings, financial statements. the discussed in subsequent Actual uncertainties information the business. issued results XX-K may the Act. risks on today, Securities qualified Please is in to and including statements implied of note safe call, covered a differ under Gossamer this associated forward-looking contained report materially update. release by these Gossamer its forward-looking news the on making press statements be corporate We certain provide Form company's those Litigation filings. the Private during These call harbor Gossamer's by releases, and annual with or due are management the

conference be limited accurate information only that call may a of time. period time-sensitive for also This contains

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

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

Faheem Hasnain

upcoming Gossamer Gossamer and year have and Phase preceding afternoon's II Hypertension. in thanks of Pulmonary colitis for provided. challenges that years X Arterial call. the the proof-of-concept readouts was XXXX energized on team, We and us the everyone this Bryan, you, at with enter excited to despite Thank execution ulcerative to are for the X XXXX joining

underserved. the alike view approaches, potential. treatment both product hold different Now we sense that novel mechanisms indications target And different be both while candidates, these using them utilizing that to believe populations in if shifting seralutinib we they're to approved, paradigm target GBXXX and molecules continue

with let's First, start GBXXX.

include SHIFT-UC second clinical in early point exploratory II this X as the placebo. out mild-to-moderate and of of endpoint patients were trial this randomized form is ratio mucosal healing. read between year. of tablet the active in in a to results remission, trial. the GBXXX clinical clinical improvement a histological during a GBXXX in treatment primary XX-week X-ASA top with Patients secondary global doses And are primary also end Phase SHIFT-UC safety X:X:X being end study on with line quarter quick assessed randomized, week And The is and Relevance is trial study double-blind, remission, placebo-controlled The points UC despite track endoscopic points studying and response, therapy. end reminder, XX clinical

systemic exposure, is as designed distinct and development. We believe therapy this and GBXXX's intestinal immunomodulatory as intestinal with gut-targeted to therapeutic as HIF-X We through has well patients. could date a mechanisms exposure differentiated IBD. function a of inflammation in or generated restitution support and to IBD therapeutic barrier mechanisms believe profile GBXXX data and for preferential late-stage clinical potentially approved gut-targeted be with nature from thesis. combination than The stand-alone of medications GBXXX outcomes By in a IBD immunosuppressive and stabilization reducing those epithelial and is may and higher improve local alpha. have mechanism restoring potential this preclinical other GBXXX the

fourth week quarter, in quarter the expected is early in XX the XX SHIFT-UC second end primary read of this the coming in out to trial week Now in addition to fourth quarter. also treat-through year, the endpoints the point

Now you Phase ongoing Ukraine a II Russia. know, may study SHIFT-UC had as of in of sites and patients our some the within number we and

our and our a we and caregivers, the else, hearts to safety hope Above for First, in all whole. importantly, horrific course, their go people Ukrainian coordinators up most situation. Ukrainian patients, as and, investigators, of health study this

In been we're and terms We of on of throughout monitor impact the has ongoing impacts Gossamer communication point. primary escalation Ukraine the to data Bio's Understandably, for no data clinical end team to of continuing XX-week our tragic operations our to impact our challenging, breakout been and and trials, into to vigilant has hostilities. set. proactive tensions XX-week anticipate

to Class patients II also as II's patients Gossamer PAH and Phase ongoing TORREY known its GBXXX. study enroll in patients. III Moving seralutinib, in on functional continues to with

As you COVID-XX related to in the Omicron COVID-XX of late Delta wave But raised related of we're may to at variant the say recall, barriers fall and to this has that, of to the pleased significantly summer enrollment. from point, that the data not developments impacted XXXX wave line ongoing study reiterate year, to to the viral out the we course, patient top further expect enrollment. of COVID-XX read ongoing any in second pandemic. we're barring half guidance in Today, our TORREY the current this able of variant

extension complete completed blinded part a continue should the and allow study generate to the see trial. to imatinib This valuable long-term percentage data XX-week we Now study period patients IMPRESS granted the are elucidating of option of study into XX-week very as they enrolling study, the the of extension, of elect to an us extension in to patients on who have similar the PULSAR patients. the once period TORREY and of open-label continue To study sotatercept. open-label date, to trial high

discontinuation the to study IMPRESS the X/X the weeks. has observed primary rate comparable study arm, pleased the manageable to to X that, PULSAR XX-week study roughly in IMPRESS in first patients study more recall, discontinuation we've dropping out rate And in prior rate The date, with point. more the the dropouts of the you the of blinded sotatercept. events discontinuation majority in occurred adverse been the TORREY in was due high to imatinib of very end these been see a to hindered by If

moving Now seralutinib. from on

U.S. global enter Ib/II been U.S. trial of to in patients clinical earnings year. our volunteers and a of in of that on Our a prior outside healthy had in expected and our happy call with CNS-penetrant Since the this half study FDA. today in BTK entered we're announced lymphoma Phase has inhibitor, announce first then, the by GBXXXX that We CNS the previously fourth GBXXXX accepted IND quarter to application clinical is XXXX, the PCNSL submitted

Bryan CFO Now with that, our to Giraudo, a Bryan? final over hand COO, I'll update. and for it

Bryan Giraudo

Thank you, Faheem.

ended the of million XXXX. equivalents. year-end with We financial and $XXX full year the for year We will now the review cash cash results

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

partially study increase related primarily million clinical of year GBXXX, study was preclinical ended R&D and and in due clinical For R&D associated increase for preclinical expenses of were The costs This increase programs. the $XX million GBXXXX December $XXX trial to trial XXXX preclinical and XXXX. R&D million compared expenses to compared were XXXX. XX, by was decreases XXXX, same offset for costs to to GBXXX XXXX. seralutinib the with an and $XX in for $XXX full million period the quarter expenses

year December million express ended the G&A loss quarter in compared $XX loss or to were for or $XX period the G&A $X.XX the period $XXX in X XXXX. $X.XX loss XX, share were same XXXX. was for $XX for for XXXX net XX, $XXX to the a per for net in December $XX net ended $XX million The XX, months the a the full for full share XXXX, compared year full or full million per million $XX the share net per compared million fourth to share per of million expenses compared XXXX. of of million December or million $X.XX in year ended the XXXX. The $X.XX XXXX, loss was year to same full

for turn I'll we Q&A. to over call open the for that, closing comments With back up before Faheem some

Faheem Hasnain

the to and please questions. ahead go Operator, Thanks, open Bryan. line

Operator

[Operator from first Cheng. line of the Our Instructions] Brian question comes

Lut Ming Cheng

I coming have going side a to catalyst. couple be that's the UC since on your next

be pretty the efficacy associated rates, color efficacy later have placebo will clinical and more X the It extrapolate remission histologic us you just the help -- follow-up. remission? benefits clear we're if of the should on specifically. also what the how we bit we I great on rate to if in expect benefits Can rates can more remind with can histologic remission on you how on? get a can terms early we perspective, to Just us

Faheem Hasnain

our to turn Chief Medical Officer. question over I'll Aranda, that Richard

Richard Aranda

in reviews example, results histologic challenging for responses. Yes. recently to clinical around at one Thank several a been stelara. specifically early X literature Yes. you, that. endeavor looked There Faheem. was It's later that have has to predict the reviews,

end the the -- early was review studies. one those was histologic they is weeks other one those associated points those what inhibitor time JAK looked VARSITY with they The clinical studies, in X. when around study. for And improvement third with which golimumab showed healing points, of And different mucosal at X robust throughout later at they programs. and and studies early, at fundamentally, improvements were more and example, be seem And the to

VARSITY For was XX. I golimumab, the in And example, XX. the week stelara think, week was months the X at trials

probably relationship, and the and end reflect histologic a that more not perfect a not clinical robust mucosal it's best later. it's the we have changes it's particularly early but perfect healing association, can potentially that So points

Lut Ming Cheng

Okay. one And quick then follow-up.

of And the how to think do assume level we on patient of steroid period? induction X-ASA patients? the use study, terms the the about steroids what these of in of in should on mild-to-moderate use background I allowed also, is and guidance that give uses during physicians you background intermittent during So SHIFT-UC XX-week to therapies be the

Richard Aranda

be be studies. as concomitant trial. all the will various X-ASAs That corticosteroids. look to to they XX% on you if anticipate background So enter Brian, XX% throughout could patients from the on background range the seems anywhere be We

weeks Once patients the weeks, have a the the of we that change any steroids able not background XX During of do they beyond go of they're at to patient investigator. medications, are trial, the instructed the provision and the to taper the the first discretion XX background

Operator

line question Rahimi. Yasmeen comes from next the of Our

Yasmeen Rahimi

the to regards safety gone then data through? did how see what monitoring And third the you in you discontinuation do is discontinuation open-label. your many rolling appreciate component beyond bit interest of that, current that, rolling really TORREY quantify percentage Is opportunity there comment patients study, over to like patients in into are I Faheem, at little a then lower the discontinuation into a it, that's And TORREY there's of rates high basically over? has this assume junction? And an What like on what type maybe of study? committees the rate, commentary guys it.

Faheem Hasnain

Yes. Thanks for your questions.

to relates thus the going any we're it As our anything on the be not That's around kind enrollment or of that. disclosing of to approach first question, specifics been far.

with saw with we else of level basically fact we as Richard, engagement have I a rate OLE, just do said, think really we're of we'll into the framework us. that reiterate kind for So we really kind consistent, that add that anything and think the of patients PULSAR it's reference a you set what study, at in to pleased the the is continued that? of and good to want that

Richard Aranda

much low Yes. we're as study, brackets our rate, a which had the very -- to trial, No, we're mentioning, And had a the Yasmeen, around retention. and it's was IMPRESS and PULSAR good think, the rate, PULSAR. I high which closer seeing Faheem

encouraging very us. it's So for

Faheem Hasnain

couple. DSMB, And think the a we've had then I

Richard Aranda

X meetings.

Faheem Hasnain

cover that does it? Yasmeen,

Yasmeen Rahimi

Yes, that's it.

Operator

question Our Schwartz. Joseph from of comes the line next

Joseph Schwartz

and all rationale know on the a I if the the the disclose SHIFT-UC in was higher to able are using doses on XXX Ib? for GBXXX, you'd once I milligrams higher wondering the day. you've they was wondering are was what the Congrats X progress. that said both I versus that you're Phase just doses study. studying be than what

Bryan Giraudo

but of are to middle Joe, enhancing position. we'll Rich intellectual won't let we in the disclose speak our rationale, But not have We we property the it. disclosed it.

forth come data to disclosure. which And rationale? around of that we our would But will like I levels, the time done those dose Rich, so with get before be

Richard Aranda

Yes.

think of Phase way it we is would I encouraged the floor to of PK, the that with activity good within clinical were call plasma our And our biomarkers, that gut of very hints as I'd exposure will. us floor well the signs I like the XXX-milligram mucosa within study provided in obviously, as we of, histologic saw it Ib you activity. exposure, and frame XX-day if

exposure there the you we II saw also within dosing by we designed increase the consider treating trial is So those that foundation, with if and, higher our was to as X a gut idea aspirations. longer the our would perhaps signal that amplify Phase hence, and

Joseph Schwartz

I you if be you're the similar how you range every with end are of studies, in the on are kind relate often about dose looking And dose healthy for could higher dose could find was GBXXXX. of a then efficacious? strong talk you're studying the some study that dose? of and you question And to I in doing, is the oncology push the range Okay. Or in you done volunteer that profile anticipating, doses they assessing? range the maximum tolerated a safety wondering you're order to Phase as where

Richard Aranda

volunteer our healthy study? Joe, about you're talking normal

Joseph Schwartz

Yes.

Richard Aranda

Yes.

to historically that's a just CNS penetrants done. what thing is target such believe superior about we our you, of think great assay is profile receptor our good I the And that relative is we guide to exposure systemic to opportunity -- remind an we to and use occupancy to going be. our BTKs been us, have have

And achieve occupancy receptor within maximal dose. above model the receptor typically, we're look dose going go push go above And XX%, then at so able utilizing we're systemic and the to to and our the and least to good you us for safety way a circulation -- helps above that go in pretty lower context. guide in occupancy, that that BTK a

there. plan. a then to gives dose with -- an occupancy our We're receptor that's So escalate start mid-range assumed fairly going rapidly us guidance that to at use

Operator

You are next, Carter Gould.

Carter L. Gould

just SHIFT-UC extension clinical comment to see start, committing only then, as I around release? quantitative what you in sharing you top can you the disclosures shift of to open-label And the weeks. to terms press expect about line, in disclose you Are Maybe any is understand, XX separately, the remission?

get around lengthening an So XX consideration or my it longer-term weeks. there expanding would any that thoughts understanding weeks to follow-up? Has and is there helpful. some Any XX been additional then maybe just be

Bryan Giraudo

robust the secondary data fairly be biomarker We'll in our and around end Carter. disclosure, the at certainly key have we Thanks, Yes. points primary and that time.

as Richard transparent and certainly So did, past expect the Receptos, Faheem as conversation. to fairly should back in and you a going

As -- to I'll far turn over Rich. the as it

Richard Aranda

-- is the weeks from I XX clarify, just to want you XX our blinded, double Yes, will. XX week still to if week

label don't their into the And just want I allocation patients XX at need randomization, label the assuming to on worsen roll again, after that, least and line So clarify extends their out the original the next steps to we'll extended. in. label. of then [ move our XX weeks look Once week stay over ] open to they be top on open at decide open results should and if

Operator

the Patrick next Our of from question comes Trucchio. line

Patrick Trucchio

is The seralutinib. first just question regarding

hit addition in expectation. looking program placebo. of can points you've to move forward that of give end XX% at to expectation data primary to baseline to I tolerability, additional secondly, from week be safety XX, what relative discussed an the you'll on in And to discuss point So III? in change the the past, Phase think you wondering an if PVR remains approximate the to improvement I'm and confidence

Richard Aranda

Yes.

changes clarify, trial the is be giving clinically from baseline bracketed recent -- effect to where IMPRESS the not improvement that's seem What from sotatercept, placebo. and in XX% PVR to on end guidance PVR totality at a from Just looking the as the and based points of necessarily the between we're to XX% we're the meaningful. data treatment those

that to evaluating. premise key the PVR, we is route other have will other the profile. addition a be in administration good And safety Obviously, we inhaled for the that's component

Yet, the for standard and other see we walk, heart hopefully, We a not as function. biomarker X-minute right we good will measure of do be we're but we'll are will -- NT-proBNP that. trends looking powered at

Patrick Trucchio

helpful. us the then That's describe just accelerated could for see as can Yes. And for described? data for path an the look is Or seralutinib you like pathway? what there an clinical you development opportunity approval promising if

Bryan Giraudo

get as and, Phase conversations efficient through foremost, study We have desperate before and the push as new obviously, have want right for can any can. be time that, we spend with we we would hard patients able plan. that And TORREY But we as the as hard we we with that regulators. I most push first Pat, would to premature. data, say the be just regulators comments clinical with know options, to to want to and are III for will really

Operator

question next Your Hoang. of comes from David the line

David Hoang

just had on and I I PAH. -- each had X on UC

week used trials, So expectations of the any the what based make maybe for responses have -- the other on which considering XX maybe UC. other design? Are we we XX the first at on can molecules see some and for week we and treat-through inferences

Richard Aranda

clearly expectation incremental ozanimod we better see that could we when that -- of example, There's worked on program. we for more is treat treatment Yes. sort longer. something That's experienced, potentially that -- one on as we effect

then they So degree to maintenance response, of we week for -- well at patients as at continue maintain into a as response certain look and they do that that they points, opportunity as also looking XX, have XX the example. time week have at X some

end will the give a the response. day, hint at to maintain a it of of us the of XXX So ability

David Hoang

in the comparable just how just sotatercept. not opportunity are their numbers not And seralutinib or addressable sizing there seralutinib? around acquisition in and for any if total Merck, terms think you for their the had would I wondering patients Acceleron, example, market that's if market with PAH, would think opportunity of might Okay. you that about sotatercept. or know I'm when that That's include helpful. overlap they then that, of on for in presentation they you some discussed

Faheem Hasnain

Yes.

view way market. our with -- think described I in pretty as the it's at has been it look addressable sotatercept is to kind the of appropriate consistent

any think we've significant don't got that. I that deviation So from

Operator

Clark-Gartner. question line of comes the Gavin next Instructions] [Operator from Our

Gavin Clark-Gartner

making Could to the on on protocol for roughly works mg XX had seralutinib. dose? like of And So thus what TORREY. one the explain I how you are dose just proportion far, exactly patients titration it

Richard Aranda

-- of twice the the They're trial, We're XX a X first Yes. out weeks and, we that? day. XX they of at that tolerability X Could X -- they in -- the question, escalate a XX. weeks milligrams start to profile the opinion during of first rapidly able they're de-escalate to milligrams once dose please? day, twice able obviously, investigator and the patients part reach de-escalate they you What dose dose repeat up of patient the to your the second to the

Gavin Clark-Gartner

Just roughly on proportion the [ patients your on mg of it what have study made ] dose? to XX

Richard Aranda

were to very, label. as It's are as we high patients over alluding very the into rolling open

And tolerated. I rollover. there that's XX well think reassuring since see day also is being twice it's a high very the So we dose that milligrams

Operator

We Instructions] [Operator this call over at further to time. the will have Giraudo. I now turn questions Mr. back no Bryan

Faheem Hasnain

I today. this Actually, want joined to thank to give who I Hasnain. is us want team thanks heartfelt also here Gossamer. at Faheem to everyone the just

professionals, We progress. dedicated have a really of group incredibly the and fantastic team and has passionate made

would honored that's with you progress everybody I as gaze thank with share move to just programs. our an our like involved we these to exciting XXXX. So We're forward towards

again, So thank us. joining you everybody, for

Operator

for again you today's conference participation. concludes This your Thank call.

now may disconnect. You

Gossamer Bio (GOSS) 3 Mar 222021 Q4 Earnings call transcript