PIRS - Earnings call transcript Q3 2018 | Palvella Therapeutics, Inc.

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Operator

Greetings, and welcome to the Pieris Pharmaceuticals’ Third Quarter 2018 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Allan Reine, Chief Financial Officer for Pieris Pharmaceuticals. Thank you.

begin. may You

Allan Reine

and third everyone for us joining Good XXXX thank earnings our quarter conference for morning, you call.

Officer, SVP On of www.pieris.com. the and Chief for Matis, President access announced you page financial press Yoder, Steve be results Development Q&A. and this We call today, Relations CEO; release at we and on our have Investor who website available will can morning, our the Lou the

call may we and made preclinical conference progress Before and of programs. trials I’d during and related risks and caution like future statements our the to operations operations forward-looking comments that contain uncertainties begin, to of Pieris, the involving including clinical of timing statements this regarding results

as quarterly hand may such and and or those or our described SEC, Our over The presented position no our information annual, With Pieris statements. future partnerships forward-looking in being current Steve. only and the financial cause materially to reports. events our call implied expressed to I’ll differ differences any by and that, reflect statements including that of or Factors might circumstances. undertakes results events with are filings to from today, the obligation actual update accurate is

Steve Yoder

by and then everyone I this from discuss update Thank I’ll pipeline. third followed year. some today quarter introduction on quarter you, begin brief preclinical for earnings her over for and will by you Allan an our and next for corporate thank Pieris past to to call. us clinical joining this XXXX go giving plans highlights a

clinical in of are variety oncology. to Lipocalins small body having on pursue and proteins are to and like good whose molecules. data, therapeutics data property is novel bind transport stage developing also clinical respiratory drug which components structure, are abundant different today’s that the diseases we function lipocalins. proteins the one be across in As treatment distinct which biotechnology Anticalin are a essential These including on a multiple engineered of proteins have naturally and are allow indications size focused developing that two are successful through a monovalent to We us Anticalin-based particularly are Pieris drug and proprietary company and will like demonstrated believe good options. we they’re continued to of call. properties, drugs. They is earnings be discussing reminder,

over that is to Anticalin that other that To engineering biology differentiated informs drug, as are through point, having other such be entire The proteins is traditional respiratory our antibodies monoclonal injectable we monoclonal and advantage pipeline. administered from inhalation antibodies.

also are agonism. drive T distinct We engineering immuno-oncology platform, which on costim Anticalin foundation proteins agonistic bispecific our focuses to a activity, of cell

respiratory treatment Turning target designed the to FDA target the to core a the PRS-XXX, validated is antagonist an our asthma. asset, molecule as value our alpha same receptor in uncontrolled way inhalation. of addressing via drivers, a IL-X localized for dupilumab approved This inhalable lead pathway was

proof the be to concept potential of drug class. novel serves opportunity, addition our delivery commercial of as also in In high-value for it a

AstraZeneca, with co-commercialization the with States. retain United collaboration rights We in co-development are developing PRS-XXX and in

our of beginning respiratory overall engaging that than therapeutic with antibodies a providing a monoclonal pipeline and microenvironment other followed T now is tetravalent genetically are HERX. of give through an window mode update a bispecific fused targeting of to oncology tumor-specific larger of to targeted the antibody fully lead by in on PRS-XXX, immuno-oncology two cells X-XBB was the with Anticalin unique I traditional will Our candidate objective asset, This proteins that drug activate preferentially designed its composed programs. diseases agonistic immuno-oncology X-XBB. action proprietary molecule tumor and

to Turning respiratory.

candidate study in was was single tested X.XX ascending The We’re nebulized drug ranging milligrams. dose at in tolerated PRS-XXX healthy well and pleased X safe doses XXX a that Phase milligrams to volunteers. from announce to XX

protein by as the it’s encouraged from very Anticalin inhaled first time administered study the are to this been delivery. human has We data subjects via

as We of exhaled ascending FeNO placebo-controlled X study, subjects or evaluating reduce PRS-XXX. of with study, completion AstraZeneca of report with data established AstraZeneca dose an and oxide levels the year. expect co-commercialization studies, have at AstraZeneca with may United along which lung is X these programs. to studies Phase partner After to asthmatics. Xa X company co-develop additional an we capacity to fractional enroll additional this of candidates asthma its in this the medical which tolerability Once study two upcoming exercise a meeting. continue and States. from those program PRS-XXX is to part our and of one elevated FeNO, nitric options we the signed marker who We inflammation subjects drug Phase is we our earlier on to full moderate-to-severe we focus the X initiated program have our we co-development safety, PK have developing where profile Non for will are multiple mild-controlled Phase are with options separately discovery Phase at complete, in we for will which with one in programs in sponsor XXXX the PRS-XXX, and co-commercialize AstraZeneca the efforts of and Phase five the PRS-XXX collaboration, the

outside are the provide I proprietary to respiratory We on year. would now alliance this pipeline. efforts our programs of our two initiated developing earlier pipeline an update actively own like and discovery also immuno-oncology on AstraZeneca we

data year-end update intend first half now an We in dose would provide tiny guided study this I by We’ve the in continue to XXXX. PRS-XXX. like data a today. for patients record initial for We on enroll to escalation to our of and initial study previously had released

completing patients set prioritizing we to range from that this dose of tumor our provide a enrollment Although escalation evaluate will phase, a the more data potential. complete immunotherapy after candidates responsive a from shift while the which represents previous timeline, disclosing the across data of believe types, drug

In enroll XXXX. dose protocol cohort the per PRS-XXX initiated to to And this inhibitor cohort August, we we allows also trial begun in flexibility this from in up of initial As data atezolizumab. escalation screening the the XXth report patients intend XX the the to with PD-LX a a study. trial for and combination has recently company in for reminder,

Beyond are of therapy anti-X-XBB anti-PD-X PRS-XXX, immuno-oncology Servier. we this demonstrated anti-human in prospect we with enthusiastic with and investigating pair to effects of robust of of announced bispecific directed another antibody-Anticalin about of models combination X-XBB are to synergistic our activity antitumor PRS-XXX a targets. recently as potential bispecific the PRS-XXX. the have protein PD-Ll/X-XBB addition we a part preclinical collaboration is Published pipeline, that our fusion developing

the of present the program preclinical this Society will from Immunotherapy SITC Annual first week. end We of the data for this time XXXX for Meeting at at Cancer

expand Genetics. Servier pipeline continue this and both and proprietary IO to our We alliances beyond with our Seattle partnered with immuno-oncology in focused two

INDs partnered mentioned, file one two developing year, which be previously we programs to within we of intend other As will one our wholly of and a for next for Servier one are the program the owned collaboration.

dose from intended a to in to clinic. drug of regulator safety more issues, master patients Placebo. Finally, increase the hepcidin plan milligrams suffering patient consistent, We per lead the either like year that one The lead to end negative substantial no demonstrating tested, drive I the dose hemoglobin of due the versus example this hemoglobin PRS-XXX to data versus trial, Anticalin X to doses call has both inhibited mobilize schedule technical study hepcidin placebo enrollment to Phase was weekly drug an is placebo. suppression generated and was kilogram of some consistently and iron more dosing doses occasion levels more and the the a full To the believe patient in to metabolism. rebound, the the levels, is the tolerated dose transferrin soon, there dialysis-dependent To reduce wanted another from data to plan to drug this in anemia. earnings hepcidin the favorable stage. increased effect and frequent shown the would program per iron trial. present and to enroll been final well behind to We demonstrated also by functional PRS-XXX, Xa profile and at ongoing kilogram. as be of levels end therapy the at to similar in this near hemoglobin milligrams of use significant the from hepcidin trial enroll date, X both mobilization antagonist known study versus the may opportunity could The an of hepcidin unrelated we that of of saturation, hepcidin date at change two not hemoglobin different to of drive We could levels. at additional study. Phase the potent nearing safe highlights in product to evaluating this the quarterly appears This deficiency believe XXXX. our completion what to weekly which discuss iron set may Xb levels seen suppress changes is for Due window five to We of iron disclose which fell antagonist dose single-dose conclusive potently date,

PRS-XXX and Asian share develop Pharmaceutical, ASKA with other right Japan whether to to territories. plan point also exercise ASKA to decide will We which at the commercialize its dataset and in

with dataset Additionally, outside potential ASKA’s we share partners of territories. the plan to optimal

are Scientific of most the would Moving over Peter and our pipeline, Officer Sherman, most our now members recently I served of of Dr. to the you welcome to through Chief concludes new Allan executive Keener President Directors, Officer remarks, in third Sherman, Board guide to Executive Sucampo quarter back we has multiple results like This as hand Kiener Dr. beyond as Medical and the my roles, Pharma. and and served Dr. the excited recently who of Dr. two financial to to Matthew for XXXX. prepared Chief Vice Acceleron

Allan Reine

an quarter for XX, were of to in increased a for Thank February primarily across the advancement with respect for collaboration our increase pipeline last recognized in costs year million the This quarter XXXX. This to $X.X increase We support $X.X the in net and G&A development ended of level administrative XX, $X.X quarter quarter, company. as early which loss well ended and audit of G&A as Genetics, compared for compared million $X.X advancement personnel Steve. were $X.X The agreements programs of in as XXXX, quarter compared $X.XX in quarter is as or $X.XX ended Seattle This as for June increase September the in the increase revenue well AstraZeneca, commenced ended both costs and our ended and XX, million year. of General the $XX.X the as cost of expenses reflects for per our million R&D which higher expenses an earlier. XXXX. September services million compared expenses in year or and activity quarter clinical legal to for you, per September growing to quarter of XXXX share the study. business $X.X expenses million professional XX, as the to for commenced XXXX, million preparation revenue to $X.X to was for September Research related XXXX. the million XX September share, with reflects revenue

was XX, and With will from out Genetics cash, paid the payment million driven XXXX, February as by milestone and The balance operating December end investments as September totaled the million the $XX.X by achieved expenditures of XX, back quarter $XX.X turn payment to upfront Turning call part was $XX the $XXX.X sheet. from offset approximately offering. the immuno-oncology increase of the $XX.X million compared of million in year. as cash I that in the AstraZeneca the million equity Steve. year. of during as of Seattle XXXX primarily to quarter equivalents quarter this This was cash proceeds XXXX. to fourth the the Total $XX.X over net of This in XXXX first collaboration that,

Steve Yoder

collaborative, and Thanks, we our Allan. proprietary novel the platform. assets developing summary, leverage focused on continuing a clinical benefits to while having of In are both

the to dataset you clinical inform next with would We class, us PRS-XXX. of the open pleased sharing forward Thank properties the are program. year drug PRS-XXX We of today. once look clinical Anticalin good-drug on like development to data are your to data data another we have comprehensive believe of that the from and on continued example PRS-XXX a call better call for that for questions. the We joining more the now we like

Operator

Umer Our your first the conducting line question. [Operator Instructions] At Raffat proceed Thank you. a with of question time, this with Evercore question-and-answer comes we’ll Please from session. be ISI.

Jon Miller

Jon a Hi, I have questions. guys. couple of It’s actually Miller on.

is data meeting’s. wait that this XXXX the or Is year with it’s still medical readout? going data an expecting upcoming is a next? start this We’re this you say this PRS-XXX Let’s to till still

Steve Yoder

Hi, Jon, Steve here.

upcoming guide opportunity. single-ascending the we dose on haven’t to ability We be, trials the multiple-ascending given about medical specifically So conference will liked talk which fact both that the we and that like dose the that together.

should general got with XXXX. to a people you thinking something respiratory I two prominent beyond And think, be that I there just this about say, use. reminder, typically are conferences as

and American Respiratory have Society the fall. have in European You Thoracic in you the the spring Society the

Jon Miller

you. Thank

the to approved there, seems PRS-XXX that that. like is For seeing figure this now cohort actual how into to data It I’m you’re on dose. going trying herceptin out interpret out to the push XXth

all have at any might way that to doses? herceptin at responses from the And the So a relative responses responses have expect to you differentiate does? do your we you lower if seen molecule

Steve Yoder

a question. Yes, look, it’s fair

think the mentioned, have to for PD we’re I when quantitative think a not we where drug completing done, not our here comment to thresholds release we I saying enrollment yet. to we it’s is, deliver, we’re as goal there prior we’re a And any what and qualitative trial. data set practice, set What far. as we data simply in going want thus good trial the on we to

a we that to in there line are setting. prior right cohort at And screening even cohort, And dose XX your can dose well of enrolling metastatic I then you cohorts. in as influence be which the able is that number indicated we trastuzumab noted, think with we as the level. that factors will be will the a as are probe as

Jon Miller

a right. All Thanks guys. lot

Operator

Thank you.

your Our & Chris with line next proceed the Company. Cowen Shibutani question comes with Please of from question.

Pam Barendt

monotherapy mentioned around release this types the Can or rationale in for you focusing Pam study? is the in Chris. on now Hi, XXX provide tumor press of some immunotherapy-responsive on

Steve Yoder

Sure.

talk I enrollment think maybe Lou trial I’ll strategy. the clinical to let

in to particular at gastroesophageal context want the from those the in in been cancer. bladder tumor that. as to number of we, to HERX and we’ve at some escalation those with have the the – it enrolled activity any as So as type explore And – that continue allowed pathway outset, part go to those do of the will kinds more explore shown the detail go to would way we phase cancer we forward we, outset. that be dose course patients with drug we’re on types tumor tumor we’re escalation. different we able in what that a of types. And cohort But to do with number seeking to with each activity forward the depth of tumor. number inhibitors the subset dose in really a that We such have enroll look we tumors like is PD-X of patients can as complete to in patients go patients now subset focus a of HERX-positive large of HERX-positive forward to of HERX-positive And and

Pam Barendt

very another me. patients types you quick of How for just we Can for Thanks helpful. tumor most prevalent except much. many tumor how And distribution on the comment the you. in That’s can ultimate type, look will follow-up example. Thank so generally?

Steve Yoder

Sorry. what something I the missed – thing the distribution. you first said

Pam Barendt

monotherapy Sorry. The the XXX types ultimate tumor of distribution study. in

types? little Given immunotherapy-responsive bit the a on that tumor focusing now more you’re

Steve Yoder

on time. at the comment to this going not we’re So full distribution

types. we we HERX-positive I have road think disclosed That different broadly back XX to or XX across where several data come approximately the distributed the you was when can in patients. tumor June,

time. specific what As to at to not specifically disclose we we we’re those bias present tumor forward, are where will continue the types, towards going as go we said

Pam Barendt

helpful. much. Very very you Thank

Operator

you. Thank

next Please comes line with Our of proceed your Amin Biren with Jefferies. from question. question

Biren Amin

for question. Hi, taking guys. Thanks my

how on Just to plan many this dosing start maybe beyond XXth cohorts on XXX, additional do you cohort?

Steve Yoder

question over Yes, Lou. let pass that me to

Lou Matis

Yes.

which highest factors with we we very safe with As outside cohort. will occupancy through determined initially tolerated if bioavailability written that trial well prepared through cohort the explore we side in cohort patients XX, now dose doses, cohort, – drug receptor it. higher design the at go the the of to tumor And was such XX at is screening be and protocol, we’re up will as which be the to the and

So decision date behavior given the to I have coming we of make that’s in that – the once drug the of we’ve think mean, that that I but out. would optionality drug an we cohorts seen activity initial the the

Biren Amin

or PD-LX high it trial, about, amended patients to inhibitors include patients PD-X Got patients then on it. I have we current population that immunotherapy-responsive effective? just enroll define what with this you to talking were talking or are Are the And more tumor you’ve we are is? types. Can about, mean,

Lou Matis

we the way. in that’s didn’t our describing were trial, the amend forward. so Yes, We because It’s actually strategy speak. formal to moving

but for – measuring not we are immunotherapy go no, inclusion will those not programs are And whether biomarkers in criteria. we’re this tumors terms are necessarily advantage conferring So at most measuring criteria of as certain not – inclusion responsiveness, we’re we’re looking we’re positive as biomarkers forward. at any that as time. Clearly, development those including as so biomarkers PD-LX we look that

Biren Amin

HERX the looking And all you tumor types Got in XXX it. study? then at are at mutation

Lou Matis

of activate of the No, HERX be immunohistochemistry. by drug either the how think mechanism has cluster immunohistochemistry anti-X-XBB surface. elevated and Anticalins FISH we action that the cell drug [indiscernible]. to the at expression works And on the tumors were of or elevated that looking actually HERX-positive actually protein I the only T-cells levels nature requires That’s

we we’re course validation biopsies, is possible. is, of The are doing, collecting where other longitudinal thing

that those we – able at activate meetings X-XBB presented HERX X-plus tumors the equivalent immunologic was what less the we we it it for X-plus in exactly confirm drug see to positive X-plus tumor trial our would restricted shown patient. levels X-plus or HERX initially – the for by data to HERX introspectively levels. that HERX far were a of read HERX be express the T-cells the to status of But patients drug be to criteria than can concerned, the And can as was the be that have as the shows that tumor. from longitudinal this biopsies Retrospectively, status enrollment be and the have So standpoint will enrolled administered time should positive at IHC.

Biren Amin

question asthmatic It last be considered? be on reduction FeNO? just mild as what terms of maybe type clinically of And ongoing, would in result it. one XXX that’s would relevant a the in currently Got defined study in

Lou Matis

Yes. at what The require we’re population of amount in move study consider meeting benchmarks. The mild they to course. studies and data a consultation were asthmatics patient at the from And was presented previous actually of who reduction FeNO study chain to we of that terms with FeNO reduction decided single AZ XXXX. doing variable American some are positive of closest looking in we Thoracic used the forward fragment and came in [indiscernible] from in May Society and outcome

we from And data we statistically whether drug with of of the reduction efficacy, versus – significant one that that was well. that clear reductions correlation of placebo we achieved were as course benchmark in reduction in we trials patients what the and some also – FeNO looked of of FeNO with the analysis moderate-to-severe benchmark. overall is So asthma at move forward. the a But in believe some have

we’re the in reduction FeNO Xa multi-dose there asthmatics. in And so, dose be dose the at as study levels dose current able for looking the asthmatics, multiple determine multi-ascending appropriate the and severe – mild from at of Phase we’ll the to part trials

Biren Amin

Thank All you. right.

Operator

question with the Instructions] question. Our Phipps proceed Matt Please comes of your William Thank Blair. you. from [Operator next with line

Matt Phipps

Thanks guys.

game how you between at formulation. one ability inhalation anything PRS-XXX, bit IV powder this And say of the then from point. about preclinical can little studies bioavailability a maybe nebulized that might serum much But the you and by can a sure mention the above nebulize even anything just dry in formulations improve is half-life. the I’m First not

Steve Yoder

here. Steve Matt, Hi, Yes.

study. any data terms ongoing the either single disclosing not or We’re a be multiple-ascending – dose in dose of ascending

nuances we I for that, size. is say think lot powder nebulized what by to driven the formulation a this of can dry particle

that the the think generated, capabilities there extremely our have so, at which we’re the what for the the disclose particle we’re part be based and be that And resolve good really powder, right study. with dry of into deposited of have we I would think need in understanding to the we airways. to a size way of formulation very that Until size drug on not have AstraZeneca’s we Xa Phase formulation particle to nebulized and I we’re we world-class in right that confident today, liberty the be formulation which the confident we’ll data

Matt Phipps

benchmarks in I’m Thanks. you not you heard kind those correctly. if set yet? you sure you haven’t said PRS-XXX trial Did And I boundaries met you clarify you have that there? Steve, and then, Can the pharmacodynamic say what of or

Steve Yoder

so. Sure. I’m happy do to

data, that look see enrollment. the was prior think what whether I that thresholds data achieve interim And disclosing many to order enough the also yes, we types we done what that our I good said well on wanted qualitative we’ve want program. all said of to do when not quantitative saying would different as then as like we PRS-XXX, of the disclose declare is initial data criteria, we’re – context for be said, we’d completing was yet. how before activity. we And success programs, biomarker there to results to we And for like our to as for we that of in in

we way data this We’re to dataset. data right to right on disclose would fulsome to these a the wanted terms of that all a in respect set having of benefits the fulsome IL more more now. comment not to programs are And try think at going We the ongoing be time.

data more to within higher cohorts to thresholds enroll But recent and justify yet we escalate And continue these the to enroll continue are the data and to from coming on over with we there set. to continuing so out correct, we’re the cohorts. quantitative were you we continuing generate we as not saw,

Matt Phipps

seems obviously with IND-enabling Thanks. have maybe X-XBB some guess. additional That’s mechanisms. it exactly, last different on were when maybe other encouraging the something thing, or of to And proprietary then seen platform not ones you’re but the I support this studies you’ve of like style disclosed working biospecifics

Steve Yoder

Sure.

Matt. I think, yes,

have biology showstoppers have considered we seen ladder is their is than the PRS-XXX, PDX be benefit to PD-LX a access properties still to X-XBB by will double the PDX a drug, things stake there’s disruption. a biology So not PRS-XXX. good which drug of where expressed. biology. of that given need for different specific the the one for IO that any lot a of you the part on have With PD-LX like be benefit and stake the on localized And PRS-XXX engager And is where

there is nuanced between programs. significantly biology those So

get of a of again, PRS-XXX, in escalation to PRS-XXX. won’t there. just reiterate mean continue yet IND-enabling and the as But for I merits, fact programs totality. through every certain activities back a the we to We’ve on go doesn’t got at think I we’re moment number to it data not continuation including work that there look

Matt Phipps

Excellent.

Operator

you. Thank

ISI. line Umer with Our next follow-up a proceed with from Raffat question question. the is Evercore of your Please

Umer Raffat

Thanks to around. time it question. on Hi. taking beat me much for the first John my so

my questions asthma had minute wanted a And may. maybe if I twofold. program. on to Novartis follow-up I the inhaled spend So were quick I a

how your that And sounds IL-X at First, claims you’ve well? comprehensive also their program. completed inhaled preclinical so tox to T Phase on secondly, all as say significant Is is tox they’re they’ve preclinical on fair inhaled X. the management tracking like fast a Novartis that It competition? cleared it slip

relatively understand to because wanted appears timelines stage. the just to I getting So early this competitive be

Steve Yoder

a take I’ll Steve maybe maybe Umer I’ll here, So, take it out. cut – this

different aspects I think two question. your there’s to

I let tox then slip I’ll alpha. considers Maybe biology and one. the second take Lou take IL-X specific I one the second versus can overall And receptor the biology, one guess hand. first the in The on T maybe the first the drugs is and

move we’ve Xa that tox and Xb to to our the have We Phase completed PRS-XXX allows study. a us four then for the Xa drug currently through weeks

studies the that Beyond then Phase will process longer later development, along that with enable we parallel tox a development. stage will Xa

tox by, receptor say when are study, tolerated looked we biology where IL-X which escalate for the at well from and alpha data intolerability when encouraged in we antagonism you database data we at have, that think dupilumab. I Xa the look were that look continued very and at the we safe overall the we Phase the study. significant multiple-ascending we does fact safety the we the with to And of safety

by the We’re properties data biology date tox generated and like overall very to we’ve of encouraged drug the specific PRS-XXX. considering the

Lou or that. beyond would to I absolutely there us is will in beyond with to I’ll tox then necessary preclinical whether versus to that comprehensive tox, one. development carry through that say, let further would And done handle if it respect T slip IL-X I alpha, not Xa receptor what call and So to Phase we’ve we needed program this do take be

Lou Matis

another X benefit and depiction a And broadly for similar Xa obviously published type. But a target is very show quite data. that The that So aware that we in was more Phase study. interesting asthma. T potentially Phase slip data Xa are the Phase that mild-to-severe from was of [indiscernible] were FeNO quite

plays how mean administered see addressing in we’ll So but out piece more population effective that that’s the systemically and patient it has Phase with target X, doesn’t in going be PRS-XXX. that we’re to

extent. see capacity, of atopic market and the did active inflammatory the in surprised significant dermatitis. And was to for see the think in active found to [indiscernible] mechanisms because, a we where we but work the energy quite that atopic we course in were dermatitis dermatitis did example, I not off he that, we’re

for data are as a there target we and aware bullish of and IL-X we’re very their out So delivery. the inhaled

Umer Raffat

Thank you very much.

Operator

Yoder, this final I’ll time. are Mr. to turn you at Thank questions the comments. for floor you. back no there any further

Steve Yoder

attention for you great the comments. and your thank a No, at Pieris. wanted to you further to everyone again support day. no We’ll your continued our for call. I look keeping forward have joining And today just Have thank again on I for updated progress.

Operator

today’s concludes teleconference. This you. Thank

time. line You may you Thank participation. this your your disconnect at for

Palvella Therapeutics (PVLA) 7 Nov 182018 Q3 Earnings call transcript