Palvella Therapeutics (PVLA) 10 May 192019 Q1 Earnings call transcript

Greetings, and welcome to the Pieris Pharmaceuticals Inc First Quarter 2019 Earnings Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Officer Pharmaceuticals. Financial Chief Reine, for Pieris Allan Thank you.

may begin. You

everyone. thank Good and joining us Thanks. corporate for call for And conference you morning, XXXX first update. quarter

CEO; Steve the Officer, Development be our On we Q&A. will Matis, have for today, President and call who and and available Chief Lou SVP Yoder,

released access website at release on Investor this can You press Relations the www.pieris.com. morning the page our of

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

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

inhaled abundant At body Pieris are engineered develop serves which the in are human for Pieris us as to year. extension, various They as to are that And naturally before to transport Allan. a more treatment the because protein to capacity and bind locally Anticalin And or biology unique and respiratory discussing immune-oncology. stable the to begin and thank lipocalins and formats earnings pipeline treat informs engineerable overview strategy. growing Thank delivery that more by now you, call. typically remainder creating turn will introduction options, disorders inhaled offer advantages our the specific proteins brief drive technology everyone antibodies. are such we a our today and Anticalin's by I'll delivery other for in the respiratory you proteins Anticalin XXXX joining proteins to for for are I to quarter respiratory our Anticalin smaller, and giving plans complex desired our are to first call brief of franchise. we molecules, leveraging progress are doing proprietary our by therapeutics. platform lipocalins, of

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multiple to X nitric ascending levels present first patients exhaled elevated Looking meaning human AstraZeneca, validated study this fractional PRS-XXX an FeNO with XX. of placebo to mild of we inflammation. alongside plan and pre-screen than asthma medical look controlled dose marker controlled levels in from with FeNO our or PPBs Phase ongoing trial, beyond, data We upcoming in oxide a greater with forward elevated meeting of being presenting to partner, present -- lung this at we the

of in locally receptor dosed As FeNO IL-X could evaluating a PRS-XXX or with candidate for we the this meaningful placebo. ascertain reduce the better X with regimen. the target dosing of its capacity along to demonstrating objective mild PK reminder, therapeutic patients and to potential of safety specifically, to FeNO drug asthmatic the Phase lung, study in tolerability pharmacokinetic reduce More are pharmacodynamic and engagement the in profile a candidate. in alpha PRS-XXX effective is PKPD forming profile reflect versus The PRS-XXXs ability a drug

of dose AstraZeneca complete, co-develop will forward, has the an dose multiple Xa And Dupixent, And study As IO our our reminder, EMA clinically X injectable develop same a or on biology been is that point the successful basis drug by approved which of FeNO X options the this this States. in of we And course. first great in Phase which severe create will completion multiple is made to strategy. reinforces PRS-XXX exercise asthma either available may due ways new study potential asthma for an co-commercialize with could for and PRS-XXX in biologic, this details high strategy knowledge PRS-XXX United Dupilumab. differentiated ongoing alpha molecule Once this FeNO as its our antibody, this the time lower to an this example a the receptor week targets inflection was in our a sponsor [indiscernible] reducing ascending engages FeNO. is is is Dupixent therapy. Phase program. ongoing risk high patients that that study the the or looking study, be Pieris in conviction to with approved focused R&D of assuming earlier believe for separately addressing Phase significant In respect, of which the for the to PRS-XXX validated a approval target relatively ascending first-in-class drugs

discovery like advance proprietary two discovery stage we the plan Additionally, stage may year later of two we year with we AstraZeneca to this our immuno-oncology up programs. which our to additional pipeline. turn continue last programs part respiratory continue initiated also proprietary we respiratory now to initiated to initiate collaboration And as programs and year. last initiate we two I'd AstraZeneca, programs under to to advance additional

a activate the in tumor-specific lead our a to is preferentially As bispecific tumor PRS-XXX designed asset reminder, T-cells oncology X-XBB/HERX proprietary for fully microenvironment.

response. our trial to to dose as escalation patients study dose HERX-positive also X intend and of objective trial exposure a atezolizumab, candidate agreement for in we we with data for that in from the combination our the the PRS-XXX to year. Phase dose study supply We X inhibitor, drug escalation X as solid escalation continue Phase from enroll report an comprehensive tumors data We continue drug to intend desired patients monotherapy Roche, Phase well. enroll ascertaining appropriate report later with approved by year PD-LX the in this of later And PRS-XXX under measured PD levels a this

Anticalin this plan Beyond PDLX/X-XBB a program is an year Servier. our is lead bispecific five collaboration program with PRS-XXX, IND molecule, which later we antibody in for application and to immuno-oncology file a PRS-XXX,

the drug at candidate recently American a Cancer GPCX/X-XBB a PRS-XXX, at Meeting. Association presented bispecific Annual Research data preclinical also XXXX session We poster for for ACR

for finally, Seattle We study optimized dose a or is the our multiple intend XXXX. life collaboration Additionally, to brief And half at advance Congress Hematology Xa immuno-oncology ascending anemia. June to this according Genetics on antagonist on hepcidin a XXth continues update plan. report provide I'll from to program the results European for PRS-XXX, EHA Association XX, which Phase

And sharing first concludes Pharmaceutical an who the develop financial of the to commercialize XXXX. guide for Asian ASKA back with data territories. be other over to Allan set prepared have in hand often you my PRS-XXX I through would This also like are quarter to right now our results to Japan and and remarks. We

and Thank everyone. you, good morning Steve, again,

million $X.XX million and for billing the $XX.X of partners, $XX.X compared March million million R&D ended development from million $X.XX net increase the March in as for with compared ended such XX, fees the we amounts payments quarter revenue, March to service administrative our to professional of revenue to XX, per share reflects increased with expenses The ended For upfront milestone to expenses clinical, were ended expenses and revenue our March a higher XXXX, as for salary quarter compared compared for quarter in quarter and were This quarter manufacturing the increase clinical loss or $X.X for expenses was XX, G&A and $X.X and General from per and services costs is XXXX, attributable advancement ended quarter the or both for $X.X the recognized quarter as the XXXX as $X.X XX, of to programs. reflecting net supply, million costs drug the earlier. personnel March million higher and the XX research a for year audit XX preclinical share tax. benefit quarter March ended in million XXXX. along recognized development $X.X XXXX. cents This loss $X.X and associated for

of $XXX.X XXXX. as balance well $XXX.X to March as the in million as This reflects first increased made expenses to the quarter as turning investments December total the XX, equivalents and XXXX, total compared of cash are cash, ended Now which cash bonus of sheet, million XX, payments, as quarter. annual operating

payments the strategic of reflected on over partners, ending by million $X.X increase turn impacted quarter for $X.X quarter With call cash sheet. the which also balance balance will higher receivable our of accounts in the Our back from is Steve. million to I that, our and was in timing prepayments

Thanks, the the in Allan. coming we PRS-XXX weeks single of say, data dose ascending from multiple forward meeting. program And study upcoming sharing its the that data to and medical the conclusion. I'd ongoing look ascending to at dose like of the at from ATS, study just in

monotherapy data We Thank now also for PRS-XXX like on and the to for this would the we open combination the And joining call today. of you year us your the sharing questions. later PRS-XXX. atezolizumab in filing to of call studies forward look for IND from the addition to

question of line [Operator Raffat the from with Instructions] Please question. proceed your Evercore Our you. first ISI. comes Umer Thank with

quick some for is question have I on Paul Umer. on program. [ph] PRS-XXX the This

about single And you powder dry inhaler. informed dosing X, the also to residence the we this formulation is going ascending to And ClinicalTrials.gov, that? ascending the bridging should we the Phase comparable assume you on think that device the drugs on could beyond? your on Should And of you should the be the to in what the on in we -- the dose, you're think about also dupi? in the the some inhaler have multiple Phase of systematic this? time ascending monodose what lung using doses? how going And mentioned are use the how with -- and us to the in PRS-XXX, BID and dose is what exposure, First, use what single for confidence that? this dose Thanks. level device X And you terms approved remind of

We're there Thanks all scribbling to furiously Paul. catch those questions.

one mentioning the take long is So statics question. happy infer from Allan information the dosing what around the you're the the first data residence to the that and what is ascending we'll single from dosing, to and dose regimen trial And dosage start of about time. with

Yes.

ATS, see from public abstract so you'll though weeks. a our poster of the So -- far what's honestly, the in is couple is

to look like exposure. we systemic when to get we're dupi exposure, So not trying systemic at

when answer see The drugs? we of Now, doses the can. is set, can data high we there with enough full our we get

a would can time you, inhibition, therapy a is, As a we drug. But dose statics you show believe is think inflammation. local see address pretty get abstract, to we consistent knockdown that asthma you of remind significantly And in local again, very you lasts to local disease. systemic the robust that, is long high this that this there again,

necessary saying efficacy to here. is with our We're not drive drug. So that's systemic that exposure our target

we'll efficacy from systemic exposure and the at different looks And up we study Now look Phase and be depending in Xb at Phase the with Xa as population to seeing again and we where multi-ascending reduction. FeNo levels. like exposure the systemic will moderate both then the looking And those the some what on dose, dose able test that can mild to well. the end in that asthmatics get in the can severe we that to dose compare we

to it's And our level more that said, a formulation, previously, is In present use Xa said taking after and a all the and one us I out formulation study developing terms determine When today. residence using was monodose to of gives think the the dry that, to there's going there's attention a we doesn't long why study, think bridging I'm as be more need. dose on at of the go InnoSpire the will not and It you or same is powder ATS. We've to idea on time, and the bridging this disclose from ones that. way if nebulizer, dose to the also the that Phase day drug. potential say, efficacy. idea anything information look you [ph], some study. DPI [ph] time, BID Phase that Xa the think we going we're to And as which at day is always coverage that ones the rule that inhaler. the BID going work. know is we believe And an that our dose reasonable we're a day, AstraZeneca lead effective But as about

So not time. that details getting we're additional at this on

a according to progress it's plan. it small the continued to DPI study bridge formulation, to However, and

are not for do that. add? that's going more want drugs that, any sorry or AstraZeneca [indiscernible] or Lou, that question, you on device I'm next the So in that like or used once anything With have comment to been to approved

the target. that with I show well. of we're drug And to were a of very really stable. its demonstration like we another inhibit just fact even the it's to add direct point condition also drug the to And shows continue that ability that because inhibition it's to remains [indiscernible] pleased demonstration stature IL-X able the as

a studies. it's So very proof those in nice concept of

Thank you.

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

started Barendt differ and your discuss them I is more Chris. a respiratory Thank and the to this the program follow-up. morning. stage strategy discovery aware for of you Good then at least And you. your How Hi, proprietary Pam between us little programs? does a program have making

take want that that we Pam, it's out discussion across Happy to morning, not one. engage, a the Good stab alliance types with on Steve form of biology. respiratory part areas crafted also asthma, would to all AstraZeneca, set that had a what the drive just again. operations but disease, generally part as going forward. driven outside within targets the of by yes of targets might here to And to When a we that's respiratory local we of of guide at the but ability we discussion Alliance, set

XXX% that AstraZeneca. at one, really that two of the structure to pretty And been of that on working didn't programs. the way four positive. years. programs target those what stage as And data were. was these know, PRS-XXX generally expertise all It in we Phase we priority which we a are able a you of are truly biology we're advantage Alliance. Xa co-develop list, day fine a in have we limited we Now collaborative the to informing co-develop because with together ability as if those degree to the are high has put take targets had on cycling. how to of some Those going early Those of of but same is wanted And largely AstraZeneca are that have idea for lock targets target at clear we with

advancing on own, validation our rigorous a As target for programs we're that through process. go we pretty

literature. Of course, we read the

We opinion have key an extensive network.

reasons is in today clinically, systemically two published prepared say, locally, intellectual not they number validated right locally; with advisers. to way now, which disclose have property targets the engaged for them targets points: the we is leave we I validated near-term like it we're our one I the the strategy to asthma. And addressing are, maybe would constrained reasons the world go two, after competitive targets, to of respiratory to are best and being more very of one that not adverse for really well think enthusiastic, I in think

some with Asthma longer and times large comes diseases. other development in respiratory

And that it's And forward on this of mix, disclosing what Astra of we're some you our hope of more how year, then we're that what its a so balance with comfortable gives IP working in working balancing. a striking probably we're portfolio we between I from targets part And look those flavor own. not the our a and an to competitive on future, feel once and of intelligence perspective.

question my follow-up Thanks program. so the IL And much. on was

you're that the send to that. mentioned you IND So hoping

you So read the to competition whether any year a that if collaboration there so this regard with in be Thanks XXX? this be be potential any in Or you a necessarily direction, there Can you'd different in provide any mentioned overlap your Servier. wouldn't you're through? there with would with or completely into hoping IND insight philosophy lot. submit indications to looking

Pam. Sure

going to I'm So take answer question. on and let Louis to Thanks. this

Yes.

is PD-LX/X-XBB as as that address bispecific quite as not we tumor on in is this with is range tumor One different microenvironment tumor activating So say we're expressed molecule that cells anchor which bispecific can't cells the a BB tumor microenvironment binding disclosing can on well. that's PDLX indications. really large. that the thing drug PDLX with The is for both the within the tumor molecule, myeloid lymphoid of microenvironment, well both as with types one and a

address. larger what ultimately with it and a this, now. a so in of partners that we're go mentioning we And tumors think but And first, I in not discussions -- our to us are about strategizing to make the tumor that, will landscape does give in our decision

you. Thank

of anti-tumor immune abundant stimulator evidence combination raft a that checkpoint us in in with one pathway molecule. immune attracted inhibition combined certainly a the a generating As X-XBB literature quite response, far preclinical from and only activation PDX but it's and is there's as to as not synergistic, well. per combination, anti-tumor generating very activity it's And to because inhibitor in

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

on Thanks. should immunogenicity anti-drug Just how asthma the about measuring we you Xb think antibodies? And drug? Phase Are with this trial.

is Steve here again. this Biren, Hi,

So yes, liberty we data simple there is not us to Yes easy for the about talk a are we an maybe from trial. and ongoing this. any are at to measuring answer

once an is a set We obviously AstraZeneca a information it forward Thanks. look medical upcoming reminder, meeting, under presenting to at is a comprehensive trial Alliance. As complete. really the data confidential the

respiratory start to guess -- in. I additional about interested collaboration we proprietary learn the that think well. when then, I And some on also as would And in-house with programs other targets you've have you

So when well? about targets we learn more those as

this is Allan Biren, here. Hey

concerned, as the So really AstraZeneca those that's disclosure is on targets AstraZeneca. far is of as dependent

we're what So disclose developing. they're not free to

tuned to for either their and pipeline you'd So meetings their presentations things disclosures, have and that. medical like stay potential --

we've already top PRS-XXX. As started talked about, additional on two programs we've of

likely initiate another year, have the programs from that'll We this program. will that which out two total round five

pipeline, as the As it's far proprietary think I same thing.

for preclinical earlier, discovery I with good to target get about think feel we're and our to in-house we'll we along said that data reasons I the those at what presenting, everything point that think, area. for excited file comfortable want and guess, get the relating street we'll are. more our some very, IP, targets and some data and about I don't efforts respiratory Steve text. IP get, further within disclose competitive we As as reasons, But we And

at from asthma like proprietary could Is And then, orphan that targets? with or I indications standpoint, a you large looking their pursue pipeline those a that respiratory company they indications just -- could guess Allan.

respiratory is many we everything there. When out Yes, there are the about it's think diseases diseases, on table.

obviously, after asthmatic a -- drugs there, targets out fruit when within disease. said, about can of at lot and indications there's of is a as Asthma both on go think that orphan blockbuster respiratory. hanging of you larger TX we one you And for there's just can plenty But within indications asthma other There's that asthma, we of low look the block them. paradigm. lot

respiratory [ph] we've KALs said Board. earlier, broad, Steve Advisory a Scientific really network As up impressive really of built in a impressive

we think scientific In our work in in-house bought about addition, we've with expertise really when translational respiratory up diseases.

gamut full of the at respiratory. looking really anything we're So

you. Thank

of with Our with question. line next Matt question Blair. proceed from Please Phipps comes your William

you I the guess previous same of the of last is of Anticalin to enroll you types? the more some this seeing is with Anticalin there. one since that continuing kind And wondering, what at other XXX full approved definitely I you BB levels the believe point, at tumor so confidence of tumor updates this of additionally, kind response projects, are in you say are was Or trastuzumab dosing above level. this or then PRS-XXX, I dose from dosage were this IL backfilling but active that? you can you're patients I getting that are mean, your on using micro-environment? and really

Lou a to Thanks, take Matt. going Again, I'm stab. to let

look to as Yes, as the as on well to complete presenting We a we're both comment we set really said, the monotherapy a for by not going end data. data of forward the year. combination study

we've a into BB one targeted very FAP, And patient from best a had Research very escalation to American seen activation. think at can actually meeting BB protein, a presented in X for target is fibroblast has a say is we who response. Roche, that Association whether they partial over Their plenary in which What plenary to elevated found ago. from a continuing similarly levels clear determine partial little -- session, tumors. is Anticalin different storm we single session designed a in dose the we are of who the that was the activation see which AACR, tumor were Again exposure for pleased patient bispecific the We their say the Cancer for molecule. trial month achieved to liberty drug. a tumor a

the can tumor a their targeted basically X-XBB activating respect a the that tumor work validation of micro-environment and objective-response bispecific to with itself. both was tumor eliciting that fact So of the

that those, Next data presentation. public public that's

our presenting So we to forward looking later are well. this data year as

levels, different. you'd that, doses, and asked are the they around to And indicated to Matt, Herceptin just them add are these

would than exposure of that our target would that be trastuzumab, are with stake. higher bispecific kinetics levels you drugs dose exploring what are to given at probably we So

to there So I would that. ways say two that are do

absolute as amounts, dosages, dose do frequency. could You well as

looking And out we and arm. backfill to at patients so protocols at of continue a XX we our flexibility per as have also you as the things to course, we're are But lot escalate. has least to go flexibility, that mentioned of to those

so are and also and And way from by totality we of exploring in those the arms a escalation. that guided properties of given PD like drug are on through any patients data of

you. Instructions] your from Thank Wainwright. line Please comes Our with question [Operator next of Joe Pantginis proceed with H.C. question.

Wanted on for XXX. co-development to option focus question the my

us First from to co-development, can to regard even with also if with front? a remind long the a logistical number it's your but standpoint, have from stroke, just two, on make just milestones the you how net decision co-development, expenses then you your increase And answer the broad there offset effect for meaning, participation obviously AstraZeneca. of financial would was maybe be your

if participation net So were to your for might Thanks. co-develop? be the effect general maybe you what

Joe. Hi,

add So I'll to to cut take free. it feel first the anybody if out wants

the function path. are of two decide being there. as investment and to share questions co-investment the second there down So data part opt-in. a the the of to is to look able return on our the And choose if whether then share, that mechanics we It's at go data, maybe

all contract are -- point, terms first So on unless disclose. the under otherwise the these we confidential

are data precise Phase the Phase is of Xa timing the available the the which, forthcoming opt-in from So decision, trial. Xa again, after

time period. disclosed a haven't We specific

forward to have those able disclosed they to essence capital be go important we Pieris so. it that to are positive, to to if potential data them, However, the for get do for be to order was disclose access of in for drug necessary to forward co-development if then order in the able to is inform credit choose in we going what the the

leverage function or we those the to in investment a royalty So if impact, the sitting understand opportunity milestone or to go to there at again the our with specific the on on full for able as for just going of to will as what and milestones and the return disclosed be want to co-developing understand were basis Number co-development data forward co-development. moving time. for are be back income of that at move we we two, royalties street the on enjoying an versus AstraZeneca, haven't details if full threshold forward forward

And with multiple as of on what stream say a the continue. threshold, sitting to the to dollar we basis in into some royalty However, enjoying instances, convert long and investment. a return on us each split investment, so peers and we certain, allows income gross would the in back the as on allows invested milestones some as beyond no continue. investment just long and sales, in in sales level for the sales And highest at can the high-teens. for the would we that program we can depending invest we And the royalties we global leverage more profit royalty in can of that royalty that in again with can continue milestone structured beliefs the is increase deal that take, our

can believe number best really function improvements. the I Today, fact think the we as in way as And that today, return much if that's so we long-term. we data FEVX for positive, at the program, to were significant because would be lung of the able here said the mechanics would I two, Pieris for as contract that like are a invest to again shareholders the looking And in point de-risking be program.

floor turn question-and-answer back Mr. concludes for Yoder that any the to Thank you. gentlemen, session. and I'll Ladies final comments. our

data to We you I everyone again day. just about progress to of look you continued thank and call forward two again want the and your disclosure the keeping today Thank updated and PRS-XXX for joining have in on great a attention for for support. your weeks. our for

Thank teleconference. you. This concludes today's

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