GOSS - Earnings call transcript Q3 2021

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Operator

Good day, and thank you for standing by. Welcome to the Gossamer Bio Q3 Earnings Call. [Operator Instructions]. I would now like to hand the conference over to your speaker today, Mr. Bryan Giraudo. Officer. Operating Chief and Financial Thank you. go Please ahead.

Bryan Giraudo

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

to initiation and timely that completion the to studies. ability related Our clinical our guidance, especially meet of

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

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

Faheem Hasnain

arenas sites. care. Europe, of the XXXX. screening challenges the But our in were At and pulmonary treatment screening and of more kinase you for press Phase seralutinib top And discuss data believe all session. In end challenges conducting arterial on half joining are a conduct shortage guidance the we first, and for the we all Thanks, of call. update TORREY of Gossamer the the issued we clinical of line Bio's inhibitor Bryan, release pandemic seralutinib. the confident and We for At uptick a our pulmonary study and through of today spring call, question-and-answer today's we inhaled created for third of our U.S. COVID-XX sure trial. I'm this at unprecedented in given will both will with in effect we quarter earnings a the especially in we has quarter of in screening uptake were experienced many meeting lines, and impactful we Western nature we our U.S.-based with the the critical time patients started clinical full to COVID the leveraged the enrollment the meaningful enrollment December completed of learnings COVID call variant from our for Prior August and us the medical you earlier hypertension, mid-summer, and time X, readout in today, in of of thank Ib trials as our of shifted aware, in on expected on professionals, to delta that study second trials, the TORREY XXXX. these including second Phase for II and

I'm had throughout Moreover, national, on engaged, a that into the ground and we're essentially XX-week TORREY we actively measures delta trials. level second they've line enrollment back enrolled we're working say, all sites emergence Remember, of some A study back once mid-August on they're translate world pediatric investigators COVID-related the keep our in of increased variant, into specifically II, delta as to getting and enrolled. Phase work and were to half designed patients trials, obstacles in we we complete to the we with navigate the and created mind patients and on as and those issue, many the regional first enrollment. an investigators confident well challenges from vaccine COVID, while therapeutic seeing sites wards programs, passing, as western now first data screenings encountered these once nearly obstacle With nurses year top be lockdowns experienced of the many XXXX. OLE. protocol engagement Phase our COVID next into enrollment to a COVID gone enrolled XX-plus appears studies, to enrollment reach to the and and and with can their further halt. we're from in additional the to that pleased completed COVID-based municipal to and study, the of have our already COVID and of half we that booster the have However, September. of clinical research called and an competition also antibody in all ICU locations that online in the incorporated continue have Ib and patients some Despite of in with remains non-COVID

GBXXX. Now moving on to

commercial enroll of in action with number ulcerative immunosuppressant. investigators with to for target lacking an commercial from GBXXX clinical UC mild-to-moderate and focused the of enrollment distinct for buttressed molecule. GBXXX positioning concern COVID, of the active the perspective, And those in in COVID. we able on we X-ASA bowel pleased but fail to the patients bodes a biologics disease. for are that We make extremely believe throughout alike, mild-to-moderate with colitis are speaks trial announce potential group believe became UC Patients hesitant were dynamic And mechanism from patients trials therapies. pandemic ulcerative is of this in an severe GBXXX to who month, evolving are This it inflammatory treatment completed attractive colitis patients Phase landscape. are option patients to today with SHIFT-UC systemic that We and jump for GBXXX's despite this also the to disease. enrollment of study reasons. well the real options We well tolerability II last institutions a for immunosuppressive safety is inundated a

expect is additional team positioning The complete including XX quarter top global announce randomized from the After legacy as instrumental infrastructure, XXXX. from early primary of of remission randomized many therapy the expect stay patients XX the on we endpoints monitoring, weeks. results of for announce to leveraging After line the a of an trial Additionally, [indiscernible] will additional of primary XX-week trial completion Once members, the safety XX-week XX result this therapy, capable of in fourth building and all clinical Receptos to contributions for month successful endpoint, XX an XXXX. and the of after , treat-through a long-standing were relationships the in in second quarter weeks endpoint weeks patients we trial clinical enrollment. this weeks.

of patients enroll our the longer-term presented we completion option open-label generate with trial, the extension be in to will data. Following the where hope study, to

dosed believe I penetration and stage to superior intensive GBXXXX. known have internal behind-the-scenes pleased the autoimmune announce oncology to CNS quarter, to Gossamer before we unveiled including neurodegenerative results run multiple that next that to pair candidates that product and We inhibitors and these that the subject have clinical XXXX development candidate, listeners as in this volunteers wanted work. BTK product GBXXXX position properties, disease, remind ask financial through CNS-Penetrant, trial a also molecules Now sclerosis. brain primary recently Phase conditions treat And a of with today GBXXXX differentiated for These today our of I its month. -- healthy and candidates the in neuro are including I Bryan inflammatory lymphoma in we're the first

to next presentation back our to in it plans. first is turn Phase Investor the initiate gossamerbio.com these enter a clinical expect GBXXXX details a and visit to development year. Day in now to website trial We that Ib/II registrational I'll second candidates both Bryan. Please potentially half a next recent first-in-human of the see at year. half of our of expected trial

Bryan Giraudo

Thank you, Faheem.

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

For the to turn over which the net call period Faheem back in $X.XX that, I'll $XX.X equates we Q&A. same million, a also loss of share. reported a XXXX, With to prior to

Faheem Hasnain

my the excited like joining now the difference towards And with you. incredible just for open making you commitment passion We're progress for I'd share Bryan. questions. Thanks, a and patients. for team thanks Operator, like us to to you all I'd of to thank give our Gossamer to their for today. can line

Operator

Instructions]. [Operator

of comes the from question Yasmeen Your first line Rahimi.

Yasmeen Rahimi

on the open-label? that first in Maybe clinical of the are then many maybe for open me and one patients hierarchy so is I track line half the TORREY SHIFT-UC. statistical enrolled XXXX? on data regards know top secondary the have that the to And response with of you sort mucosal on to end you into is healing. then regards can have around planning additional study. question Have patients on about questions I the entered turn And for two of XXX% you sites point you we in provide about you. think -- the commented how are to noted label, as second is that second

it some color could if So you very around be helpful. would that provide

Faheem Hasnain

this for question. very Faheem. Thanks is much Hi, your Yasmeen,

into As patients it relates that to of the are number OLE.

OLE comment you're don't come is an numbers fact into enrolled to we now pleased the into we're said progress on patients we're patients have early that starting patients that sign. been an the and As of that, see specific encouraging have enrollment Having aware, with the or all I'm that entered OLE. enrolled of sure the

As it UC, to relates sorry... the

Bryan Giraudo

very put in results, feel subject to again, the changes with the timing be will COVID forth, meaningful on almost of that are we The number and reopening running the due our said are issues. of our as the of verge sites on we up mean or Obviously, deliver XX I we we good to we in COVID able landscape. sites Yes, that But is online, have, variable. board the that sites. that of remarks, all to the

Faheem Hasnain

over And that UC give you question. the some I'll turn thoughts. Richard to to

Richard Aranda

Sure.

in achieve powered endpoints SHIFT-UC end study and healing, our is our and to mucosal clinical endoscopic involve those secondary points. also The healing response, improvement appropriately or study

Operator

from the Your next line of question Joseph comes Schwartz.

Joseph Schwartz

It of to the of able like line disruption. expectation the data 'XX still second is looks subject ongoing in TORREY your to report being top of from half extent potential COVID-XX

So within that at question, if how could the half of I the a where if as half put 'XX most been you the as rate that 'XX? was characterize of data be? enrollment much then would have stretch release continues same second of of follow-up. can And the I it wondering second has recently, a And part

Faheem Hasnain

today. of of enrollment that while or seeing we're it's the plan rate to resurgence. again absolutely by COVID Joseph, the that delta, on I I don't next continue a after we see variant But relates -- rates think to we're declining to mean XXXX, put it we're As seeing we gone hopefully, that the we're have in encouraged

side apply again, we I at -- until only we're get with pandemic. to prudent to kind after of continue of to the it's to other can that the think COVID So where us for

Bryan Giraudo

and just going were put sat of as ferocity Yes. and the the we the here I of hit critical we in at end say, again, not we we we the guidance believe But care. as from the expect at year. that end Faheem medicine of quarter of would out could clearly conference just practice did to Gossamer, it same the did a thought ago, pulmonary we hit said, didn't And it. and to what wouldn't delta the Joe, the day, we

to to So ultimately, infrastructure is we control the that again. end variable do our of people, fingers our the us have happen a beyond are we got There that. certainly crossed won't summer and that's plan, have back the that that the the

Faheem Hasnain

believe that's guidance. on today, we our But obviously, where a and forecasting we pretty projections reasonable are based

Joseph Schwartz

you have things main making X-minute doing to if more substudy then simplify as for walk an be alone protocol a such TORREY rate PVR straightforward? the that's could considered helpful. more some study That's Or how the interim could factor, study? undertaking perhaps Okay. And example, a analysis amendments for limiting about -- be and the

Richard Aranda

Yes. study. We've designed the This is Richard.

our a COVID. As we've patients PH with in Phase reminder, of had Ib from the some setting experience

we not from flexibility the Phase interim mind is do requirement if something study, Phase because you So or to endpoint provisions for than the we an that the important size you that to several you had are do. a allow PVR and compromising PVR without for a the lessons demonstrate was plan our feel walk for certain II the study get-go, much We A to way or of quality from in hence, hemodynamic we and study. it's will, learned some that actually, want will, X-minute with integrity analysis, typical the II endpoint. program, designed, do changes. currently And if sample planning we relaxed, is to more that design not

Bryan Giraudo

Joe, got called impeded It enrollment. again, was that, of the work of in components just investigators And the the literally TORREY that to not add many ICU were our study what fact wards. I'd

we team management has of than not, have we All we our the And just investigators. often with patients, out been hear, nurses. have don't visiting more

COVID. more pulmonary to on world macro has do is we're excellence do the basis. treating starting and struggling TORREY really of seeing really about it of lift, but that just not just infrastructure So care at, to that, struggling, think about the what's centers engagement, and on with we're going with again, are around that patients critical We a

Operator

Carter Your Gould. of next question comes from line the

Carter Gould

like the be I to if the SHIFT-UC. level at clearly could helpful homogeneity, your start, in enrolled even of It population with the around, would marketplace. the satisfaction guess, were you I differentiated you just seems a guess you it in beneficiary comment positioning high

your that level, high moderate And early that so would population you some landscape, changed going intended. pun UC front setbacks just at even mild as shifted, the severe about you I I I at then be viewpoint guess, your have, helpful. competitors that's, guess, no but any landscape the given on a around around has be would think any to if forward. to efforts that of of oral the comments And some in the of moderate, recognize of sort

Faheem Hasnain

we're landscape Certainly, this the as of the in it's of of a profile UC, I of definitely position the a Yes. relates that There very is absolutely moderate it is you're think enrollment, view the mild shifting attractiveness right. to reasonable given segment some in drug. occurring. to And to and this interesting while pace

remission play potentially try through only rates we clearly, therapy to have later able think change would continues earlier this possibly out, even view in but use. really move the opportunity to not therapy opportunity up in and I to be to an the to as safety if combination

frankly, safety as profile the sits drug made the around is say, associated an that the this quite cloud think more attractive, JAK just now example. with class of with, I

a think bit -- to I this So for all speaks that's a tailwind that of program. of

Richard Aranda

enrollment to year figure out targeted half terms confident population, demographic line we target an designed a mild of what next the have the but till to In with Score to population. moderate we've patient have we of we're first the We'll get and that Mayo characteristics top to of right wait full X. based based on endoscopic population, on results our been, subscore it the

Operator

Olivia Your Brayer. next from question comes

Olivia Brayer

I of TORREY and to see sotatercept, about similar also for then at directionally. range. know I was in that improvement, And on I expectations walk XX% you've wanting talked XX% to XX reduction XX-meter on measures efficacy ask wanted PVR in to think study. X-minute to your the latest least that

that UC. is a I've looking to follow-up that to any hit? Or how thinking there on got So the you're bar then still about are updates And readout? you're

Richard Aranda

right see, hence, in to no We still and guidepost believe want are there's what changes been our that process. thought those the for we

Olivia Brayer

bit Got the landscape talked be development. but modality than there still XXX, on the of know a on oral and through orals it. number in I asset market. moves your by the more could there little Okay. earlier, And a development, time about guys you then are one

So for how question hierarchy where I treatment XXX you possible the those could is, about guess oral do the be agents? differentiated And you most think think different do there?

Faheem Hasnain

be we autoimmune patients as like viewed cures. And know, as So other are many going these none of treatments cycle often through indications, unfortunately, treatment. as

daily a -- is The large. So have market number of think pretty that incredibly I attribute oral treatment the an patient-friendly availability choices is of oral, of being of kind attractive. a

that's plenty that So the I of on a number there's are, think for but is is in patients, kind the also mention that first room great orals of context. market I to think, of

doesn't the unique level kind first the X-ASA I positioning think oral second dimension so is we to ozanimod, positioning same that speak. really prebiologic very doesn't other the a post in pre-immunosuppressing of words, the which failure JAK. that's that moderate play drug have to here least segment of mild does nor of that well, the a positioning that at course, know is kind competition, of that in In space,

element data bodes drug the So this that think plays there's profile of that very well I a I think the for out. future, for unique assuming

Operator

Your next question from Patrick Trucchio. comes

Unidentified Analyst

This speaking is Jason for Patrick.

question I I guess a inhibitors. about have GB the And X-part BTK just so

study give And on And expected study is, your for if question And question GBXXXX? pace your what GBXXXX. possibly, you future first so is enrollment in-human for is for the primary of can second insight us your for the your is, your your what first GBXXXX. endpoint some

Richard Aranda

Yes.

study. we're -- normal a currently healthy As mentioned, volunteer conducting So

the obviously about normal BTK tolerability. science and volunteers' lot a safety, healthy We'll of behind nice target And inhibitors, at so occupancy. pharmacokinetics. Our thing point there's biomarkers engagement typically look primary receptor for is

So we'll will assess those. also

around furthermore It's [indiscernible] question Your Yes. was normal volunteer. healthy a

units identified, done are and screened and put queue. patients they're typically, where X Phase So in in

would anticipate It's first-in-human it's I we similar trial current relatively -- think it normal question So anticipate quickly. likely that our question a doing about you XXXX. have healthy BTK, you XXXX. we'll design a given go And as -- a I that think normal volunteer also a volunteer had then healthy had we a

Operator

comes Chang. Your next Brian from question

Unidentified Analyst

for this the inclusion are patients criteria going thoughts Maybe CSF first have other just planning including you then you And are or indication. BTK any I one for from to on I'm be include inhibitors involvement? if GBXXXX. exclusion using quick curious or learnings follow-up. on early to have one you PCNSL, And with -- intraocular

Faheem Hasnain

CSF CNS we and we're our going lymphoma enroll patient secondary are to include our initial dose we in part with refractory to study of going primary dose that recurrent have population a intraocular recommend and involvement. on Yes, escalation a we then patients define Obviously, our or our a patients Phase then as PCNS Phase of component. part patient expansion once as -- dose, II population focus will II as and

Unidentified Analyst

on into -- the X if remodeling we from And And just OLE back Ib Phase be update the I'm of just the compound seralutinib. vascular -- updates you for X-patient you term, patients. if maybe additional started looking have would Okay. in and any hemodynamics we curious given last that those any getting wondering or I'm study near if quarter. I'm saw signs also

Faheem Hasnain

Yes.

extension patients we had complete Ib. the Phase the two of as recall, open-label you So

another as One of continue protocol that well. patient rolled do have this in. we in They continues open-label over experience those an to patients still

the other extension forward trial open-label and did go to The therefore, not seralutinib. decided go of in patient another on to

have not difficult. vascular assessments terms did of we remodeling, In It's of specifically that. any

continuing as we thing indirect walk example, X-minute and that such follow. is, only for we're to do the obviously, NT-proBNP So have measures,

Operator

questions showing time. am at this no Please I further continue.

Faheem Hasnain

updates we thanks no to my you to look If further time that We today. team, thanks being everybody. next everybody with to And us patients give the on in able the enrolled right. there's forward and thank all to continue for quarter the the progress. All spending questions, trials. Thanks, have again, to

Operator

This Thank participating. conference call. concludes today's for you

You disconnect. may now

Bryan Giraudo	COO & CFO
Faheem Hasnain	Co-Founder, CEO, President & Chairman
Richard Aranda	Chief Medical Officer
Yasmeen Rahimi	Piper Sandler & Co.
Joseph Schwartz	SVB Leerink
Carter Gould	Barclays Bank
Olivia Brayer	Bank of America Merrill Lynch

Gossamer Bio (GOSS) 9 Nov 212021 Q3 Earnings call transcript