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Gossamer Bio (GOSS)

Participants
Bryan Giraudo Chief Financial Officer
Sheila Gujrathi Co-founder & Chief Executive Officer
Jakob Dupont Chief Medical Officer
Luisa Salter-Cid Chief Scientific Officer
Joseph Schwartz SVB Leerink
Call transcript
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Operator

Good afternoon, and welcome to the Gossamer Bio Third Quarter 2019 Earnings Call. Today's call will feature updates from Gossamer Bio's management team followed by a question-and-answer session.

I will now turn the call over to Gossamer Bio's Chief Financial Officer, Bryan Giraudo. Bryan?

Bryan Giraudo

Thank you, operator, and thank you all for joining us this afternoon. call Bio's today's Executive and on Dr. Officer, joined by Co-founder Gossamer Chief I'm well Bio's as Dr. as Gujrathi; Sheila Gossamer Chief Officer, Medical Jakob Chief Bio's Dupont; Dr. and Scientific Officer, Gossamer Luisa Salter-Cid.

Reform its Bio September is ended XXXX covered call harbor certain and Act. update. safe press afternoon, information third corporate XX, issued provision a under Private note this for the the Gossamer release Earlier Securities of today announcing Please financial provided discussed results quarter the Litigation a the that on

that annual from listeners Gossamer these This filings. forward-looking obligation may limited reflect will news the of Gossamer's or the or undertakes Gossamer and in caution information business. risks call We conference events statements during accurate Bio results call report this SEC forward-looking period for date and company's management releases the to on after XX-K by that These update be contains circumstances by any this statements Actual only revise a or and statements statements. contained may call. time-sensitive implied with time. qualified filings be Form uncertainties forward-looking subsequent due in conference the to making those including forward-looking statements differ of to associated also materially stated are no

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

Sheila Gujrathi

diseases. extend I of of be immunology, us to year, suffering everyone to and the Thank February leader today's in call. that on goal you, such this our patients oncology to inflammation Since public Bryan, joining good lives and industry from in and initial offering Gossamer enhance an afternoon and is emphasized Bio's

I four updates will Gossamer's updates further our to remarks. product On financial each few towards ambitious candidates provide today's achieved then through the on following am you that walk discuss which clinical-stage will you Gossamer's a call continued of closing will for I progress and Bryan and milestones update excited goal. I

conditions, product clinical-stage and DPX nasal our are both will eosinophilic which most we for We candidate chronic advanced developing polyps; spontaneous antagonist, allergic oral with GBXXX, with urticaria. begin including other rhinosinusitis an chronic and and without asthma

enroll testing Phase Bio a of LEDA over background treatment Gossamer period XX-week asthma. study on global Xb is patients treatment the for to the GBXXX a moderate-to-severe therapy. remaining LEDA study continues eosinophilic with

the to four As weeks an have a approximately is whom completed measure the its population five first trigger composite an half primary of at reduction reminder, the worsening asthma GINA endpoint. is as eosinophilic of least in a of at count interim study per XXXX LEDA cells enrolling steps all analysis trial. on patients XXX a XX The once LEDA the and have uses in track microliter. study of patient two-thirds

result treatment In line in Madrid, presented the could Xb In GBXXX's the fractional second mild-to-moderate XXXX, response relation FeNO a half for further detailing to to for prognostic useful asthmatics. full in September we read out European expect FeNO oxide we or suggests the Society and The this Respiratory nitric Phase XXX-patient at in trial. that as top of International exhaled in Congress data described serve effect marker GBXXX. to poster atopic posted

currently eosinophil, are a study. In we is enroll the to using to LEDA which addition market elevated

our with parts subpopulations ongoing showed as FeNO or FeNO reduction per X mean placebo potential FeNO subpopulation high millimeter. also billion. In XX showed we to continue per study, FeNO high day parts versus at XX.X placebo a to billion, a of patients FEVX evaluate The biomarker. Phase LEDA a improvement for greater versus than XXX The FeNO XX equal of

Meeting Allergy asthma Asthma and related in American GBXXX. Immunology Annual presented the at we week to two past this Houston, of Scientific Late College posters

Pharma in mild-to-moderate baseline X versus Phase detailed met from morning previously partner Japanese Teijin flow The the its expiratory primary placebo. from asthmatics. study of in by The a peak endpoint results proof-of-concept change XXX discussed first our contained study run

that Additionally reduction overall the and GBXXX. in eosinophilic worsening reinforce to a showed the of baseline we in useful led in to XX XX% risk XX% a population our treatment that for poster, asthma the an These blood with eosinophils milligram the GBXXX elevated belief potential population. reduction data in response of are marker

biologic gossamerbio.com ongoing analysis second the As asthma in details of are commercial prescription real-world the GBXXX trends part market, asthma. of Publications the three dynamics and Posters related to All of the a available from section. our website these ACAAI for our at characterization usage poster in and posters of on

call, in proof-of-concept We X as nasal study. plan dose On effect XXX approximately in who patients first both we on the quarterly remain second Outcome the chronic We polyps this with study enroll of steroids. XXXX. to GBXXX the weeks for measure without the to patient study X TITAN out in designed Phase at XX chronic GBXXX of a after TITAN with read to Phase announced or and is on refractory to previously known are patients top the the for rhinosinusitis, study, which data SNOT-XX Sino-Nasal half Test, track proof-of-concept treatment line our in intranasal of rhinosinusitis score,

and CRS. urticaria implicated pathway there cells the basophils and eosinophil, Moving that or types, to of our indication asthma THX the are from biology CSU. as GBXXX, on pathogenesis is third-line CSU, the for cell eosinophilic does such differ But mast underlying spontaneous in and chronic evidence

translational a larger trial understand half prior of biology, of combines to we the Phase to with XXXX study. initiating patient difference To we right ensure in CSU targeting the desire our X first a decided in the are effect to have population, in better the initiate smaller

such of in as and We other GBXXX the to eosinophilic also allergic continue diseases, inflammatory evaluate esophagitis. potential

XXXX. about in readouts need. areas To look close are across unmet on multiple GBXXX, holds high DPX multiple allergic to that we reporting oral top antagonist disease this potential optimistic very we with the X And forward significant Phase once-daily line

to GBXXX unmet has be move PAH. rare as with to also inhaled potential a practice disease new and first the Arterial of therapies. in limited for the need drug on crippling destructive the now class will inhibitor, and high Hypertension, GBXXX, of the receptor approved known PDGF therapeutic Pulmonary our We treatment

Phase completed the serious volunteers and orphan studies events and in from treatment adverse been has with drug observed, designation X normal EMA granted for no GBXXX the has FDA PAH. safety healthy of the

biomarker commenced and Phase of Xb with patients in We exploratory target safety have data. GBXXX initial an engagement the transitional the and profile PAH assessing of tolerability generating and goal

extension, enrollment expected period. quarter six a XXXX, While study to the original two-week we protocol trial begin of we the open-label the originally include amended receipt the of in data, following long-term to toxicology third patient following month

working study participants identify and Xb been for Xb Phase with have investigators closely our Phase We to our site appropriate study. study

we XXXX, of Phase We enrollment in expect from Xb to the first in the expect fourth readout initial the XXXX. the begin half trial quarter and of

Association we a Sunday of at in the As present Heart excited American Scientific this animal Philadelphia, data Sessions Monday and models further distinct to GBXXX preclinical are PAH. coming reminder, in two

its in demonstrates delivery progression the in through lung furthermore, is Model presentation preventing disease-modifying Rat and treated GBXXX efficacious entailed first Monocrotaline GBXXX in PAH of the model. maybe on The that Pneumonectomy remodelling effect of and PAH,

with PAH. results GBXXX arterial and ventricular Rat pressure right mean In The GBXXX treatment and diastolic from the ways significantly of second pressure. of details this Model reduced Hypoxia plus model, two presentation SuXXXX pulmonary

biomarker were observed. NT-proBNP of levels heart plasma decreased failure for a Additionally,

on after these future presented of website the you sessions for at and data in our Review PAH. program by. And presentations, GBXX we currently of the in abstract are are the you presentations to in are website of become very available both AHA stop our Philadelphia, posters the will promising if both on the presentation. welcome The

Additionally, we the with GBXXX conversations are based regulatory of and authorities our upon KOLs, designing final study. X Phase in stages

and that data be may generated incredibly registrational of from plan in Phase year. we to initiate registration, PVR, six-minute walk We the for X test. cardiac study believe function this the by While valuable first this will the support by Phase study measured assessing half next study future X not study echo,

treatment HIF-Xα stabilize inhibitor GBXXX, oxygen gut-targeted will or preferentially the disease designed an a inflammatory UC. oral including body's GBXXX ulcerative hydroxylase of bowel stabilizer prolyl involved discuss HIF-Xα, in factor response low for a to the protective of we transcription is Next levels. colitis

that October, subject GBXXX in underlying is Prize to a announced demonstrate currently see of work physiology. and Xb in a in proof-of-mechanism very medicine UC biology excited Nobel in was are to was We that XXXX decided the it patients. this Phase

are mild-to-moderate one enrolling placebo. with testing UC which We active patients in four-week is versus this dose GBXXX study, of

and as target assessment tolerability gene trial by Patients Score UC endoscopy. inflammation and confirmed outcome engagement, plan The colonic as restoration. and barrier safety evidence expression and hope in enrolling primary to evidence Mayo in PK/PD epithelial have evaluate see to and of the must we is active of changes confirmed by

flexible will in effects including treatment clinical And sigmoidoscopy or on We colonoscopy. Score. patients also closed either the period information study Mayo the after undergo

top-line pleased Phase are we initial to that We first the results report say from on to the Xb of are XXXX. half in track

we tissue. designation the pancreatic, colorectal, an on new FDA product tumor an indications. tumor population and within GBXXXX candidate. is from prostate clinical And the being These present types the asset CDXXb immunosuppressive GBXXXX, orphan will on other is include treatment received pancreatic for Finally, focused cancer. immuno-oncology drug oral of which mileage our has touch developed as modulator addressing GBXXXX significant tumor

antibody in selected have supply agreement announced supply agreed a in GBXXXX they collaboration entered anti solid we and for of PD-X morning to we Phase ongoing or tumors. KEYTRUDA our X/X pembrolizumab into This their that trial Merck, clinical with which study

Phase study of with or And esophageal we consists dose and The several cancer. monotherapy levels, initiate actively is dose the clearing known will X as combination escalation triple-negative of KEYTRUDA colorectal, gastric, KEYNOTE-AXX of escalation breast of GBXXXX portion The monotherapy. pancreatic, study chemotherapy. now after dose patients enrolling

an patients. Merck, in improve work very excited collaborate of the are cancer to we We lives to cancer leader as with established immunotherapy

Immunotherapy team as for found study Cancer Society be detailing Our on website. Meeting, our a can poster also last of now presented the week design which

half disclose rights retains GBXXXX. to XXXX updates of the from as second Bio we initial Gossamer progresses. the study study provide and will expect data worldwide the to We in

over Gossamer financial update. Officer, Bryan? for will With it that, I Giraudo hand Chief Financial to Bio's, a Bryan

Bryan Giraudo

you, Thank Sheila.

and will results We quarter second We financial -- of of XXXX. the ended cash of I'm quarter the XXXX third equivalents. cash for the quarter review $XXX with sorry, million the now

capital of and provide anticipate cash the continue sufficient equivalents resources our It cash under facility. into debt fourth us will us XXXX. the available our quarter plus to We to capital

Research and G&A million approximately $X.X GBXXX, XXX, compensation. XXXX. were expenses a quarter expenses in stock-based the that which reflects with $XX.X development million total XXX, continued of ramp-up expenses in of for in quarter and million, were the $X

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

turn Sheila? Q&A. comments closing to to I'll back that, Sheila the before for it offer line open some With over we

Sheila Gujrathi

Bryan. you, Thank

trial clinical principles a we like invested investigators would call close, the the to of for who Bio As thank have and resources draw shareholders, and Gossamer betterment at our all time to we the patients. employees,

continually of we product in our possible While not our successes areas we shared and oncology commitment clinic, our through immunology inflammation strive candidates that are to in your the and without journey. faith advance know the

continued time your today, Thank you and thank join interest the for for and you support. taking us to

I that, to With the over question-and-answer turn begin will session. the to operator the now call Operator?

Operator

Instructions] We a from question of Schwartz the comment [Operator Joseph or line Leerink. have SVB from

open. is line Your

Joseph Schwartz

think kinds much. worsening in degree LEDA based the hope very understanding biology as on of study? do to of what to that on has And Thanks baseline the congrats progress. improvement GBXXX. in see enrolled the What asthma was rate your the GBXXX in to best of endpoint? wondering the I this you – only question then you of Great. What events opportunity my of as do show patients And reduce well expect is is the trial? for My the you've on you first the comment rate

Sheila Gujrathi

Thank Great. Joseph. you,

in So just to severity. we sicker are population disease disease looking everyone, terms remind of to a enroll

two respect, that preceding to after enrolling typically, the start the of have – in we'll patients an the the study year So prior going in average baseline. we're at exacerbations

see a asthma of terms is broader just in like what endpoint area, rate. again, exacerbation worsening, at would we the composite looking asthma for an that to is So than which we're improvement in

number a to range reduction. hoping at events. of So to see we a XX% are we'll looking the reduction in But of be XX%

proportion This of Teijin trial, is we in saw asthma-worsening who similar where about to a had we what an XX% in the saw patients rate. the reduction

study. the we too that's and the we primary think endpoint really So guide the guide really the what as at about we looking looking for endpoint when what everyone trial at primary LEDA patients for

score and the eosinophilic the course at our of endpoint data take then that X at And will when will component of to be composite this at Phase we endpoints to guide of and And we're predicated we'll also from of X that looking in exacerbations, what the reduction, trial. are be been look we've is rate – And our and an and population high guide ideal that we'll Phase the beginning. looking we that's all X planning hoping be five which exacerbation individual Phase looking we to course, using with the consistent been saying at population. see in to is the again terms patient

Joseph Schwartz

helpful. provide on you hoping has your can Phase That's And I recall more program. I was that Great. Thanks. the Okay. for color on then current Xb us plans this that two cohorts. GBXXX,

different to you now X you next any thinking a cohort, first from the rationale start based what might Phase start slightly Or a previously strategy were there other that on you like is So the year. Phase that – and with have for Xb/X a findings seems seen data?

Sheila Gujrathi

question, Yeah, great Joseph.

are looking extension enrollment long-term amend to include we to commence toxicology study We think patients data. did our I the availability to of the open-label yeah, again want quarter. the So of this given

we've so And that. done

are investigators actually excited Our treatment and the enrolling very treat them to two-week start period. beyond patients

we able half design first on report we'll study that very next the that of as so and Phase set. Xb the X to be be will And really out well. data be data will And informing from much in getting the year,

looking safety showed XXX our be show preclinical that So which looking very getting in our data model at in PK animal preclinical important We and that in the we're excited and biomarker model will models. data, reduction at we levels setting. we NT-proBnP believe nice information essentially to

can be looking data we we'll as what So clinically see well. generate to

cardiac In long walk we'll X and by think and as as the Phase on six-minute Again, function are other echo terms as be of we measured our proBnP thinking strategy, biomarkers I at levels – looking test. PVR.

similar is been the we all design along. study planning overall, what So, have to

lot Phase then that, compared type had will now approach. authorities we've on likely as I enabling regulatory KOLs with think saying this be of we registration and study based in it may of a a are be that a space X Xb/X to not as Phase well conversations

success Phase However, trial again the we really think us position future of studies. will for registration X do for

strategy what's understanding of saying originally been in what from really it's basically still on our we've again for interactions study just terms our of So out. strategy. further going and more overall been similar the is through But laid assessing and the we field designs in what

Joseph Schwartz

my That questions. sense. makes Great. for taking Thanks

Operator

you. Thank

next Markets. Berenberg question or comment the Our from line Patrick of comes Trucchio from Capital

Your line is open.

Unidentified Analyst

Hi. Good afternoon. This is Iris on for Patrick.

the on a have I So congrats progress. few questions.

GPXXX. on First

you. anticipate LEDA what we for we benchmark a consider to program. then Just in interim should we the in results. a Thank on the of And analysis? biologic the comparable should for a endpoint the particular should that tell to-date? data can expect mind trial be us study us in you follow-up when composite have the Can you And should particular generated to and you LEDA based what -- we a at data secondly, would what released on terms tell be

Sheila Gujrathi

so Great. Thank much. you

at interim the analysis the will reached looking at composite. two-thirds of which composite what at be and ensure of really XX five looking worsened the have about again consistency We'll at sub-components the looking the endpoint, the -- So and of with the is we're be endpoint, of looking that's with be primary time events. we weeks a to primary patients rate

endpoint so that really be that's we'll at the key for And the study. looking

we'll of looking at function at look as safety lung also tolerability well. and We'll course and be

into III this be Just of data think ongoing whether be we releasing Phase but moving initiation and will since an forward be data's we will any will indicating purposes. not planning in to be support the clear, this of study, we

what level that's all of of the is secondary looking with across we'll course But disclosure composite providing. of on what really data so robust we'll be be the And the for composite the and the very consistency consistency endpoint. subcomponents endpoint,

And type improvement feel at feel if the Again, a So of benefit Teijin of different in population. help the will we're that the comfortable in in that very X will we're for totality purposes, regard reduction comfortable we to be in benchmarking of our ballpark. looking of program from worsening we'll Novartis the XX% have seeing again trials. Phase for data, III LUSTER-X and of seeing data planning events, and will the that we really in XX% of this their the Phase the course which improvement aid including planning statistical that III But study. those

And guide in all look at and again, in Phase primary And well. of because these across of trials. we the very the correlated Phase we'll won't sample are just are they with we exacerbations And that a We one as at can't a course at number consistency a smaller events. study these of II duration to have again, solely looking the overall the really in need and in biologic will shorter-term these different their terms as the component FL-X II in looking of events be look But at size. Again But of look individuals I endpoints. II subcomponents. as all Phase -- event composite. endpoint our that's that worsening exacerbations at studies rates again just

we be indication will it a give a of how will endpoint. us very in primary exacerbations -- at fare III looking it'll we So good Phase think a

Unidentified Analyst

Novartis A III Okay. at the program. question on Phase follow-up

could pivotal to Phase patient the zero in would be avoided lung the So based trial that Or function asthma your your FDA require trial with discussions Do study and possible endpoint? moderate on is failure. program? run with similar that you III population you the think the FDA the in it a

Sheila Gujrathi

question. great its Yeah,

conversations Asthma in Moderate-to-Severe population patients. the in characterizing where interested FDA, We have beyond the very with Eosinophilic efficacy, they a were broader had

the patient for IIb, biology that, our wanted to We patients. scientific we highest in think lies, Because as for the those have population LEDA definitely of rationale where study. that's Phase terms the underlying

potential done mechanism. therapeutic quite as well for to a all-comers that setting in are effects But mild-to-moderate that DPX interested the has they the bit the And Novartis looking characterization. that, moderate, in in generate in in trial. as LUSTER well ThX-related the antagonism we now in asthmatics do as as know to data, And at

LEDA from, talk is the plan continue And to have our regulatory our dialogue. again to own plan, So, we're data see that to ready to what about study.

Of course, take Phase they LUSTER-X back all the And our discuss data and available. and we look authorities that finalize at to will X, when become sets the regulatory III to plan.

will we're that, a benefits Moderate-to-Severe other Eosinophilic lot of patient seeing I clear the setting in those benefit, say really and in populations. Asthma not

We patients. to of III also And best that's adopting that's for thing will think, streamline our try We use well. the Phase resources think the do our to program. right the we as

So, those intention. will be of some our

Unidentified Analyst

question another Okay, on, GBXXX.

line from perspective, top in Ib something study, de-risking should how the assess? safety both the Phase particularly data, to think the and the we difficult is So at safety about PAH study, really in

Sheila Gujrathi

Yeah.

is and I primarily, and patients. experience safety this the trial PAH think getting So in tolerability

this that for the outcome primary And is study. so measures

will helpful, looking mechanism. the we be can understanding activity, We very at these around be biomarkers clinical that think in

engagement neutralize which signatures, function, to right looking And be which the mechanism. really that measure of us ability direct right on target includes more gene-expression NT-proBnP as in levels and again at as is imaging, well And of our evidence stream. heart will parameters a heart

be into of will modeling, seeing finalize Phase the exposure-response digging trial. encouraging. But that to Ib the lot proof all reduction that we we of Phase concept our for want guide And So, to in dose be those will be II. will very don't a

be a information will do study. to II helpful us nice that Phase really So very for

Unidentified Analyst

Thanks for taking all questions.

Operator

management time. the Instructions] the this to, like I'm any showing in back additional questions, [Operator to I'd queue turn conference at you. no remarks. for Thank closing over

Sheila Gujrathi

to very and you, next dialing dialogue Thank Thank to very Thank your you we much, and the quarters. few forward much. the look again. over for questions. you everyone for call weeks And more

Operator

thank gentlemen, today's in Ladies for program. participating you concludes the conference. and This

a day. disconnect. wonderful You may have Everyone, now