GOSS - Earnings call transcript Q2 2019

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Operator

Good day, ladies and gentlemen, and welcome to the Gossamer Bio Second Quarter 2019 Earnings Conference Call. [Operator Instructions].

As a reminder, this conference is being recorded. I'd now like to turn the conference over to Bryan Giraudo, Chief Financial Officer. Mr. begin. may you Giraudo,

Bryan Giraudo

well and me all Gossamer on Executive Gujrathi; and operator, Dr. Medical this Dupont. Jakob Bio's joining afternoon. Chief as Sheila Dr. With today's Officer, Gossamer's thank you, Chief for Officer, you us co-Founder as Thank call are

this Bio a provided press corporate issued Earlier release results financial and its afternoon, XX, second the XXXX, Gossamer for quarter a announcing ended June update.

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

turn it like to Sheila. Now to I'd Sheila? over

Sheila Gujrathi

you, joining on Thank us today's call. afternoon good Bryan, and everyone to

inflammation in and focused acquiring, therapeutics and of discovering, developing immunology, on disease Here we the are at Gossamer, commercializing oncology. areas

enhance patients extend therapeutic industry such leader suffering the areas to lives be and each in Our the an of goal diseases. from of these and to is

Gossamer shots journey along by goal. the working focusing are towards past on has patients. meaningful number of development that immunology diversified building milestones delivered our this clinical portfolio critical few a To end, with months, multiple team the on vision a over on achieve We benefiting to

call, our today's Officer, I'm for financial of you our going discuss discussion Bryan our handing through then X and Jakob walk clinical of the programs X to to before Gossamer's clinical updates GBXXXX. for will update. asset, Medical a over On stage Chief Dupont, milestones achieved newest it

will I remarks. which, provide a Following closing few

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

patients testing endpoint primary the IIb of on as All worsening. may a once-daily regimen is the remain recall, began study, in moderate background period. enrolling of will IIb XXXX. trial throughout LEDA XX-week measure study, dosing a study, therapy asthma a patients is LEDA treatment asthma, to and As composite in our over GBXXX known you Phase known October Phase as the severe eosinophilic global

half of in We are IIb top remains in study interim After to this XXXX. XXXX. analysis, full happy to reaffirm out track results the that in line the first read on the of an enrollment second expect to Phase interim half we analysis trigger

GBXXX with is the II patients On population treatment patients patients update, effective unmet few as recruiting significant failing that have and effect the study. endpoint designed of SNOT-XX have measure our TITAN, score, without to enrolling TITAN. our for high to with of announced in need SNOT-XX therapy. represent indications with actively plan respond intranasal last there options into we GBXXX both has patients patient call, We both of are overlap polyps. in patients nasal in who in nasal steroids. are treatment XXX XX to begun rhinosinusitis, Sino-Nasal the study without which after enroll nasal TITAN and for Since as Test, a parties and of The Phase These proof-of-concept we screening approximately The to the is asthma polyps. on rhinosinusitis, we're with Outcome areas refractory known chronic or first the relevance chronic study weeks for

score endpoints line also polyps polyp-specific endpoint. plan in patients such secondary the We as of Based current II assessing this to a on subset half nasal for proof-of-concept track read a in second are study we trends, on out involvement polyp key XXXX. a Phase of with top on data

study a this proof-of-concept or a of about initiating CSU, II excited approved urticaria, existing CSU Phase regards we potential, forward to In an GBXXX's and later with year. remain to therapies, dearth chronic in look spontaneous indication we

In have nearer this Please meeting the term, a European in the in December, and annual be Madrid International at October. Society discussion have lookout Rhinologic American we we Society Orleans at the a this poster presentation the Respiratory Congress for poster those. on New

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

to activated disease provide candidate, serious occur an Now is class, GBXXX the GBXXX the completed new it and and therapeutic observed. healthy an stage pulmonary assess This orphan data arterial is of safety high expect year. and I GBXXX translational FDA Earlier to is approved this of engagement PAH the volunteers study first of second and b the developing known have limited believe no GBXXX. initial have to on target tolerability treatment a PAH. and in our potential PAH our the product effects quarter our adverse to unmet of third therapies. inhaled let's for team pleased Phase for study, PDGFR enrollment medical trial PAH our has of am as initial be for that drug classes is patients. sites to to biomarker report PAH. and is patients Ib we patient inhibitor with GBXXX devastating, designation progressive the normal patients drug events Phase clinical in with move I that granted safety and in patients. need exploratory disease-modifying could hypertension, our rare the we and we The Phase a this goal EMA treatment to also year, generate profile with in of

expect the Ib the Phase from We readout first trial the XXXX. in of half

an excited continue this with including X registration-directed health presentation. as authorities of the November Additionally, the X have of Moreover, and we more about data by trial at GBXXX presentation a to we conferences, in II/III presenting discussions the on about anticipate American this just medical acceptance of end Phase our study oral initiating preclinical notified year. are and Association poster who us two Scientific abstracts, as Sessions upcoming XXXX Heart of our

alpha to the in HIF-X factor stabilizer levels. the the low a other ulcerative gut of to treatment and will lesions body's associated HIF-X with discuss of preferentially protective diseases inhibitor colitis, the disease We response will disease, UC. bowel alpha, is this GBXXX hydroxylase lead inflammatory that believe bowel. including to we oral bowel the transcription oxygen GBXXX, involved of inflammatory stabilize preferential Next, healing alpha stabilization of prolyl HIF-X designed a or for an gut-targeted, potentially

The active of Phase mechanism our patients last demonstrate in we our UC enrollment is dosing with designed proof mild which patients call, announced trial to study to in we of On GBXXX are in of X moderate in Ib of half symptom commencement in the weeks. in expression, well, potentially going Ib expect and barrier the line UC improvement. XXXX. Phase on initial top to is engagement, gene and first changes Enrollment the target epithelial patients very restoration based we from report UC for results

Bio's asset, Chief Dupont, and Gossamer Now Jakob I who Jakob? latest Gossamer will the entrant Medical oncology stage to into Bio's clinical Officer, over discuss GBXXXX. hand our will first it Dr. clinic

Jakob Dupont

macrophages, of everyone. oral which GBXXXX you and cancer. as being modulator our within addressing afternoon, myeloid good populations to recent tumor Today, you, immuno-oncology is These such dendritic the antibodies. that types neutrophils tumor pancreatic, cancer expressed clinic, on of particularly most candidate to CDXXb, prostate colorectal, delighted biology significant checkpoint candidate cells, the other with the cell GBXXXX, and the anti-PD-X to GBXXXX broadly suppressive Sheila, resistant is an for This cell product focused developed some namely immunosuppressive advance tissues. refractory present and I'm subsets. CDXXb an therapy, including Thank indications. monocytes, types product is tumor into in include pervasive suppressive and on myeloid most as discuss are is inhibitor target treatment myeloid

CDXXb the tumor preclinical reduces and repolarized of of environment In into modulation pro-inflammatory to studies, suppressive from importantly, state. in a cells those immune state converted a suppressive also tumors, anti-cancer micro trafficking or these

responsive checkpoint unmet generally to seek we these inhibitor minimally are GBXXXX, that With address or medical cancers need not responsive to current of immunotherapy. the

made involved to potential and to a corporate publication, has X pancreatic Medicine. us to University Vineet of July Gupta's the that paper feature of this from a clinical clinical studies. that driven about The lab of authored be Science Phase of GBXXXX, published was our the discuss University lab edition Louis entitled by I'd to types, posted like Washington in Rush and like interest call KOLs that excited attention St. data the of of sensitize on clinical website Before our And trial institutions we as article reprograms DeNardo's your in top-tier immunotherapies. and was cancer in to July CDXXb cover at we difficult-to-treat would key David GBXXXX I/II the which Translational some on innate significant immunity outlines X, Agonism in cancer our publication

of pleased we esophageal in types to The patients triple-negative and in quarter study of I/II year. tumor we solid this third I'm selected GBXXXX that, cancers. pancreatic, to our begin colorectal, breast screening actively Phase gastric, include in selected dosing that With patients tumors, and are the expect inform you

were these mentioned, CDXXb cells prevalent. in As tumor all are biology expression types is and immunosuppressive

with the we initiate The therapy with II combination monotherapy reach chemotherapy. dose cancer protocol positive we test or And of study several or of and greater same expansion cohorts of second-line When gastric a dose efficacy of PDL-X cancer. the clearing monotherapy. second greater the Phase line or II with therapy in escalation anti-PD-X will cohorts. combination levels, plan stable portion Phase or in open after dose I of to in expansion GBXXXX Two recommended dose, colorectal Phase anti-PD-X GBXXXX proof-of-concept escalation we consists microsatellite X GBXXXX will gastroesophageal

and gemcitabine will pancreatic care, cancer. standard Abraxane third in with chemotherapy, test expansion cohort of metastatic The first-line in combination GBXXXX

expect I/II will and disclose We progresses. provide the from of half initial as study study to updates Phase second in the the XXXX, we data

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

Bryan Giraudo

for of you, review million $XXX announced second debt equivalents. We'll of with Thank We financial And MidCap closing to the Financial ended $XX million million of and agreement customary conditions. the May. cash led to the reminder, $XXX million facility the facility was milestones quarter past taken we at Jakob. certain Gossamer, quarter this cash the clinical that of results development the a now XXXX. as by available -- miles subject become and of achievement $XXX down and will clinical

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

development which to consist of were million, GBXXX, reflects expenses ramp-up the approximately $XX.X for licensing candidates, product GBXXX, and approximately and In-process million GBXXX quarter. quarter and costs for $X related which acquisition in expenses, Research expenses the GBXXXX. of the our were a R&D

million total stock-based of the million that in nearly quarter G&A $X.X expenses compensation. $X.X with in being were

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

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

Sheila Gujrathi

we've a are unmet equally within thrilled Thank assets, diverse candidates towards targeting enormous product take needs. portfolio indications you, with their those progress respective in made Bryan. the of high And the clinical pride program. development with We of we advancement building

taken caregivers, Gossamer patients, our benefit alike. purpose immunology, inflammation our physicians, and the to and expertise our team drive Our oncology to has employees shareholders vision positioning heart, and for continually in company of

the support Thank turn to join taking over question-and-answer time continued that, begin I you now Gossamer your the interest to to session. operator Operator? for today the for call will and the of us and Bio. With

Operator

[Operator Instructions].

SVB Leerink. with Our comes from first question Schwartz Joseph

Joseph Schwartz

wondering Congrats your fevipiprant delay their Novartis' I will you impact your how if and the I progress. interpret thoughts on all could on was III data how, get Phase all, strategy. at if of for it

Sheila Gujrathi

Thank Yes. you, Joseph.

year. would be had this delay reading this that X III terms guidance trials earlier their of out X characterizing currently, a there are namely really by fevipiprant function they Phase out announce quarter of trials they year, Novartis They population, will lung Phase and out and of year; will be with clinical are and conducting X, X, first moderate reading from more the reading end are the X of LUSTER-X to their X ZEAL that in X that XXXX, end which be reading XXXX. trials, their they year out trials of the originally did by reading revised be this the asthma line and of in quarter exacerbation So out the the really top would III that state will be a first data and -- are outlined in in

a don't to program, this we as in significant the frame. that is really view similar impact So and very time our much

think really, they going to really report less very lung And we together is LUSTER-X as trial out critical X most and data function are what I from to And I that severe to understand of very on think for focused investors get is the to the what's our from in are just in differences readout all earnings LEDA. enrolling to be similar wanted their the the simultaneously able trials and a call. population population. X X since we're what we're ZEAL trials patient and into those relay

So and we're X, in LUSTER-X the as well as noneosinophilic X are severity asthmatic is is terms the that everyone, asthmatic X to severe just the eosinophilic of but which remind enrolling severity same patients set disease and LEDA. moderate patients population enrolling in to

discussed the on very LEDA we're year. are very the So the hopefully focused really excited eyes really we've and the outcomes trials the on forward. which But all about beginning of LUSTER-X and progress think looking X, of be I at of focused happening We're execution program. of will next

Joseph Schwartz

schedule on see determining you dose there could talk the what plan about GBXXX, about very was optimal how then little And to a hope the Ib. you'll and biomarkers I and if Phase That's collecting helpful. wondering you go bit you level efficacy and to in be

Sheila Gujrathi

But and trial Very in we different we're something trial. of -- is which GBXXX. safety, Ib do looking initiating is to in registration-directed very we with get patients, our want translational that PAH very much a primarily running pharmacology. again, the course, trial at have at before Sure. will Yes. aspects tolerability of trial. of exciting lot that Phase growth to It's elements be, Phase GBXXX II/III a

setting we of looking disease PAH on III characterize very of We've of measures PAH and discussed very phone so as are models some animal really in as are in the already preclinical their patients. with well before closely something were changes in and biomarkers, imatinib levels we've trials of on the impact biomarkers that exciting you, mimic And biology. human also seen the exciting Joseph, that Phase many really those that with evidence with seen at successful those NT-proBnP have that

very are NT-proBnP able to we So excited characterize be levels. to

of other of actually And be disease. looking would cardiac at other of In engagement signatures get at markers expression addition, we've assays looking gene understanding at we'll other that that and PD we're the effects target our affects some imaging. even assays including GBXXX, outlined, that lastly,

will scans left assessing cardiac study. hemodynamic fraction cardiac be MRI ejection and the So really parameters and ventricular other from that echocardiogram,

as of this as anticipating it study [indiscernible] really So of But significant looking at we're a of we time. trial, clinical And difference. be with should lot imaging. rich given will really biomarker not effects the a the duration be short any course, at well

Operator

[Operator Instructions].

today. participation management, Gossamer for session concludes in ends question-and-answer Bio this On program. And This you thank the for Okay. your our behalf conference. of today's

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

Gossamer Bio (GOSS) 10 Aug 192019 Q2 Earnings call transcript