Palvella Therapeutics (PVLA) 12 Mar 192018 Q4 Earnings call transcript

Greetings, and welcome to the Pieris Pharmaceuticals 2018 Fourth Quarter and Corporate Update Conference Call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Allan Reine, Chief Financial Officer for Pieris Pharmaceuticals. you. Thank Mr. begin. may you Reine,

morning, everyone. our joining for you And XXXX conference thank year-end update. for call us Good and corporate

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

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

to future to statements results during this the contain forward-looking involving Before differences including and made operations operations statements we as call of comments and today, begin, might information of described Pieris, no reflect position caution that update progress the timing Pieris today. the and that undertakes any filings with anticipated annual, such position. or our to regarding events accurate I'd those forward-looking including year-end regarding The risks current recent preclinical are future and programs, reports. like uncertainties results Factors and only our of the we related implied cause circumstances. actual partnerships and SEC, is in cash our may an financial of our or and obligation company's clinical quarterly events materially future And developments. from such presented providing corporate expressed trials and differ or our are being to by update And may statement statements. But

Form XX-K, anticipate audited year full we financials will report be which XXXX on our by Our XX. with Monday, released filing March annual

German auditors investment from cash investments analyze with process, cash as would XXXX. update tax of owned XXXX, subsidiary. optimal that impacting At as $XXX.X million taken can, the tax matter our this with $XX.X provide U.S. Pieris year-end position, associated prevent as treatment for year-end ensure tackling wholly regard reforms we to nothing to an group. As advisers this importantly, unique these our time extra have December part of regarding derived filing. and a income would of a we see balance we timely and which XX, tax matter efforts are And and close a was and of to addressing and blocking December additional a our licensing XX, recent our We juncture, compared million

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of We the we program bispecific which first February evaluation also with Genetics. anchor other by strides signed further development Seattle they regulator negative date, tumor-targeting We're make of give those brief collaboration conclude. XXXX. our our which we on to for the a is partnered and master to programs progress forward To as alliance, pleased Genetics, have like continue generated three reporting advancement a of And meaningful iron would PRS-XXX, in I on to to the with update now Seattle and programs mature. characterized a hepcidin, immuno-oncology continued potent and metabolism. look of in antagonist

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

may. Thanks had I questions. if taking Hi. much for a so my couple, I

will Allan, could was expect a FeNO First, perhaps that environment changes be we know if if and for that four in Steve speak don't in patients the first the in. Australia, should to it's but these controlled I question. one seasons kept you

parts more really per is bar The reduction probably on second would and/or in specifically you controlled number in that expect there placebo FeNO, are we the patients an for a And one I that the absolute you. percentage would obviously, us was of would placebo-adjusted in as certain again up contextualize helpful. if well have you billion? context the be you to success That Thank could given ask FeNO thinking decline for that of environment. mind

of this those the work space relevant how So a And looking are parameters of Yes, lot progression for Allan and questions. Umer, frame I'll thanks at the the done PRS-XXX. for as great of particularly biologics. in third-party has all looking the - current questions know, at you we're molecules,

asked. going So let all of to those you've I'm answer him questions

recent the reductions they arm. presented that And in gleamed remember, that really placebo about at about from - look you show adjusted of treated which in And be you is fab and IL-XX if think that that's that data allergens like assesses UCB, so I it of can What their Umer, the reduction Vectura down in Yeah, variability XX% a a [ph] controlled was asthmatics, reduction eliminate FeNO of that's study at to the on and that in placebo FeNO actually did the environmental the reduction benefiting high tested, reason powder are XX% XX-day did goes out there XXXX, placebo group. mean over also in a XX-milligram FeNO XX% a AGS what because versus demonstrate is where in May statistically this hoc dose at trial to they period. and an a a exposure at take level measurement. patients facility, dose XX-milligram dry done via significant they post the inhaler fragment, the

placebo expect to drug difference those obviously, testing placebo. come And we're we'd So versus for down. then in

stay kind do FeNO asthma or looking baseline see in of at the where moderate-to-severe, mild in the you a of it you measurements is group. around trial If at placebo actually normal FeNO kind

to that is this a different at So measure. way look

at terms what of trial. partner in this going have that time. success predefined to not threshold on that In of success AstraZeneca is what our that we We're looks criteria with like, release

if study, they see about range. where look relative saw that study - you low statistically placebo Vectura the relative a of However, - they in a UCB, - I XX% at difference would say for the significant did versus reduction,

So that's look at. reasonable to we a think target

asthma in that minor Allan, in of begin, was include continue And criteria protocol to - patients, even to to with clarify double know we steroid. just been one but patients study mild though low-dose exclusion a and/or case this point the changes sort having there Got that noticed amend for of data they was any that Has ended be there, was did the up I trial in enrollment? things the it. a to the the Vectura went they with to

protocol therapies there have Yeah, we changes - our been background do with trial. having in no to

not issue has been for us. enrollment an So

it. Got Thank you very much.

you. Thank

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

Can this you. pace or Thank is Hi, year? Chris. Thank for set the program of data the you This PRS-XXX the Pam help results later guys. expectations [Barendt] release for following you. on

conference to Thanks, medical Phase outset, know, I'd a disclosing as And about the as a the data trial at the kind as to detail. Pam. Look, a manner. data contrived is specific say, not were AstraZeneca, rapidly last partnered of you trial. a say This the was liberty in And an the forward Phase as question. we as Thanks talk program progress at ongoing year. the are for far with pace, at line lot to of that, we population. the disclosure Ia top it enrolled completed upcoming look Ib those patient like is, I'd and the in timely And

intended-to-treat for derisking Phase in a PK/PD great really going way not mild early to and the target get hopefully, be is dose Our to asthmatics get process. with engagement to IIa This obviously to a FeNO. optimal very elevated the is short-circuit real, perspective on population

is doesn't multiple I every that I'm would working sites. population, well. across broader have about Ib Phase despite been Phase happen that Phase study, I very that sense. And the Ib, in "contrived" that really say we For excited day. a going enrollment

have encountered the and reporting timely committed enrollment trial medical timely to conference, together have AstraZeneca investment due everything on with sharing the here not as with timelines schedule, final upcoming forward AstraZeneca. results to we an sit the we with remains the subject set We whatsoever the at to venue community We on issues we look precise complete to But that today, remain any alignment completing course. and the details and in the messaging.

Thanks you particularly similar pace the much. you. color and can for a And on so for question XXX, XXX some provide XXXX? Thank there,

Sure, I'm going timelines. those Lou let talk to about

going it Lou I'm that. turn to over for So

stated, is well initiation this program towards clinical Yes, and XXX. moving the single-dose enrollment study. as presenting with with IND - continues to out I'll so this later well go year. respect that be That Servier. year, data We the with XXX, year, later And anticipate, is to the escalation an in trial we we start will of calendar this this in filing together

the cohort, in respect And exposure As effect evidence exposure. a to with and of we these looking, go course, we're by drug changes looking microenvironment at through patients looking of the with each drug of the that at at dose time of clinical correlating same time immune and the all pharmacodynamic activation evidence same response. for at in tumor

be as will we well. so year later And reporting this that on

similar to form parameters a synergy with also at tumor-targeted PD-X, looking our time, same activation enroll be trial pathway with At obviously being combination together and drugs' fashion, to inhibition. PD-LX the with that, Beyond atezolizumab the very we'll well. continues evidence

very much. you Thank

you. Thank

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

a taking assets. guys. similar you if little morning, Good could targeting moving about least for There's you the quite question. a - pretty path. my talk about PRS-XXX, enough few program. seem On development Thanks I with similar excited other also this clinical forward companies wondered at obviously early

on often into those determine you go maybe refractory to PD-X could don't respond looking benefit more lung, tumor do added the melanoma types to how signaling? decide of Or you of that very monotherapy? if Specifically, PD-X X-XBB at for you indication the amenable or really plan

let I'm morning. to going for one. this tackle Lou Hey, question. the Again, Thanks Good Matt.

Yes.

Steve. So thanks,

that really the in PD-X that no a means synergies it's exciting due particular fact - fact significant the by X-XBB to tumor I there X-XBB any that pathway an there's reason preclinical there's think is only of inhibition. this One that not PD-X and scientific is abundance bispecific. And that are evidence between models we that's very is evidenced combination pathway very very, doubt developing the exciting targeting simultaneously. the activation indicating bispecific that this and by company synergy a

basically, addition, I of this type in subsets tumor question, single implied every by - has patients. PD-LX expression your almost is think amount a In there certain are of

with across different this look going or amenable have the to not have of the range as in to types development how to to, drug clinical clinical And may PD-X clearer. trial to become particular so tumor information in at is specific particular wouldn't to move alone That initiation pathway patients wide an year, seen on a previous benefit you said, this tumor in we're either alone. we're development at initiate we you will the therapy point, with that liberty types. that respect and really that of of for But toward this of forward evidence had second co-stimulation half a inhibition give

is I if it's of and Number very particularly around local just reasons XXX remind that why And one. levels, the the remain this. we Servier blockade intended [ph] believe get yet expansion as of inhibition data also I exposure cells cells, PD-LX of at such everyone, also around dendritic we one there to we the inhibition. through that a would in we're a with T-cells enthusiastic X-XBB also of there drain - for local a nodes the we lymph good think like of may, why just XXX, get we expansion disclosed a also to in local approach, a PD-LX-based is XXX. be follow-up, able couple by to tumor-mediated checkpoint have could cross-linking, think Number course, add engaging number believe activation since XXX, appropriate immune I time this, a to And enthusiastic not although is are for two is

multiple there and clinical activity of PD-LXs are other PD-LX with the on indicated know, we a market antibodies. As lot

extra the as for we mentioned, that's that tumor, we And front a an course, lastly, what is, of on focusing we're I-O PRS-XXX. have much drug. Lou So could synergy the on solid beyond then HERX-positive tumor which population probe same within broader

in collectively, that approach. the powerful continues then powers for because companies remind to of And the would formats. those And are number to it the We on that. biology, So technology have this given the bodes that of three the of there I - biology XXX. compared very number validate think have. of drive interrogate at techniques are looking type a of is space the make mentioned, one bispecific a different that working aware to as everyone broadly formatting those of desired we you things We're preclinically. well different specific approach we that approach. for And we believe think us we for that our types we properties of And drugs more optimal screen a flexibility for after to able extreme the could

the for that's helpful all. in strategy think context you XXX that development I biology vis-à-vis we hopefully So addition outlined clinical to

Thanks.

you. Thank

the with comes of with Our Wainwright. from next your question. Pantginis question proceed H.C. line Please Joe

for the guys. question. morning. Good taking Hey, Thanks

Just question don't a quick on XXX, if you mind.

cohort mentioned of it's a earlier as synergy maybe rhetorical, with to can the atezo? potential detail though Thanks you atezo, study? monotherapy you somewhat disclose and at more this the Lou mechanisms with First, with regard now secondly, then little even dosing to right a what can in give lot. you're And synergy

about two dosing the the atezo current to Again, and synergy for then Lou let that - I'm there. mentioned. dosing questions also Thanks Joe. the strategy talk combo Sure, you going

Yes.

with this I say year, we're this purpose cohorts very are high excellent forward. the within dose drug very, to while - evidence And we the level to exactly different the the analyses, very been activity we're as an biomarker dosing and example, the detailed at the exposure of And the immune as respect tumor time. earlier. well. these And data present during at cellular the this especially as microenvironment of within said the certainly for moving very for say higher in earlier, including microenvironment one we continues cohort period dosing analysis, of correlate point go tumor we'll CDA at, genetic indicated which position well. where tumor is basis, at can't activation at to again, major which tumor activity, we tumor as same comprehensive a of at is at be in the response T-cells, to well. recruitment I analysis the microenvironment, go very going marker nanostring And the correlate and is things dose, can time, both again, So through microenvironment, of doses doing very we're with has the an of that later do

there be atezo, Now atezo are PD-X/PD-LX one And obviously will of is there. there as blocking expect pathway. reasons number as far synergy why a might that

checkpoint T-cells one for with is the microenvironment also express tumor population is tumor-specific For within on actual expressing T-cells. the tumor - micro expressed thing, are - microenvironment cells activated surface, a and when within marker the their PD-X obviously an most which engaged inhibition enriched cause tumor of within which tumor on or X-XBB, T-cells

and in of of So multiplicity brakes if of PD-X pathway activity, mentioned basically the it expect at would beneficial T-cells, that as very the a which [ph] T-cells inhibition so antitumor take and the for X-XBB, effect with responses. been to on you're you including both times signal, on in same taking a of tumor-specific of enhanced co-stimulation through the I off you synergy. models earlier, And of tumor gives effects cytokines the where inflammatory co-stimulation multiple has PD-X reason dramatic demonstrated, example, away concert with X-XBB generation that's forth, the enhancement checkpoint preclinically, activating time cytolytic block T-cells, basically enhanced you inhibitor the stands

might - because bit comment on more Thanks, little the to going haven't I'll give we also be it - think I not actually, to question specific first Lou. color happy on be we're And details. a

beyond our our - of to XXX, is multi-ascending or which is have minimum single to flexibility trial And course. a protocol remind more ability to current the doses in patients ascending levels. everyone, patients. However, great to And dose, of escalation also over-enroll exposure the benefit what wanted we see different in three do higher of in we explore for I there's enrolling the as dose written the

commenting showstoppers data on have we And no dataset And there far. are the so totality based any comprehensive said, so not of on until while this as later data had generated XXX is the believe to to exposure date, these we mentioned. it investment Lou ascertain and PD clinical to of continue levels we're a year, a the potential we as at reasonable various

Okay. Thank you.

Thank you.

question David comes line with from Jefferies. next Please Our the question. of your Hoang proceed with

everyone. Hi, on is [ph]. This David Biren for

few a is just XXX have formulation the some first. presentation I ready for sense the and whether make terms what Can us some maybe you - So logistical II data when of dry Phase of mild in question, inhalation the II Phase might commence? logistical then ones powder and asthma meetings remind

general, not the only in Sure, general, for the and conferences. the medical late meeting, The ERS, I Society, in two Respiratory in the the the spring David. that this September. European there Thanks fall, year May ATS, calendar of year. Thoracic in for space they're springtime conferences then They're but American two major September the questions. is which the the are specifically is kind year, fall. for respiratory two, Society And in think, is In bookend major respiratory medical of disease, the

I pipeline, general, data. thinking general conferences disclose think, in conferences target existing strategy line about in their think in should corporate to be with you I as AstraZeneca those respiratory communication for

the study study. concern, that strategy DPI And Phase the Phase remains our IIa the trial, as Phase formulation. AstraZeneca sponsoring initiate remember the far DPI sponsor with current will are As IIa we while to the Ib

the only to those study. As has plan first practice, the we our patient been in disclose

be able this on the that. time specific actually disclosure of of to However, as Phase we Astra. trial. not the this due are sponsor that in IIa the ultimately more authorized be we charge at And the will not collaboration with start We're they to fact the have

forward push asset we companies. that And continue about I both this parties remain excited the However, very to program. high-priority as can a say both for

Great. And just I follow-up. think one

reduction In on patients. terms achieve to based which activity, read-through hope any mild see to population the that such you're to And the FEVX? to of able outcome? FeNO signal there of the other as endpoints Is in moderate-to-severe any read-through you

So thanks. yes,

on that's the So great biology. a question fundamental

And to Lou then that, if wants add start. Allan can so well. he do So can to on as

of separate thinking are this. populations. and strategizing these we've done bit Obviously, then on But a Yes. quite

that in very a FeNO long-term a think it's severe asthmatics therapy, of disease, for asthmatics, I quite if and progression in new very function, significant correlates remains even well portends current with such example. inflammation that marker pulmonary that, the is severe such FEVX, FeNO elevated pulmonary clear in of example, decline as for

severe we in a asthmatic And of cognizant that's be for think, careful generally populations, progression of different population. to these marker that general, is we're very So are the of very although a It's good FeNO fact predicts the pulmonary inflammation. continued asthma. elevation

decreased. - sense, being evidence block way to has to significantly the information a due - FeNO within in to well, population, this levels So in treatment line our in think reduce such that drug that is clear it's we receptors working able four receptor that particular is the

look liter PRS-XXX, that of improvement alpha if a has program dupilumab, meaningful of FeNO. clearly I about think probably going Phase look those FeNO-high namely out, at And kind even plus has significant in neither is after with if I in very on clearly just XXXX, of superior pitrakinra, you IL-X the kind patients that seen receptor then substantial. And look we're studied very of function, of lung function, drugs patients guess, the in approved best was asthmatic actually far that effect are which which on FEVX, lung an receptor you the on four and if clinically normalization that's saw none that any X.XX then expected, one X.XX But the have inhaled in XX% alpha. really reduction approved, you effects Xolair, you about in back mechanism you using a their those we exacerbations target, severe nice I it you to III that, in effect alpha, And the mean, in at especially that eventually a doing the in of would And tested of result on have the at which back FeNO. lung doses to to see in did Phase an in were – have receptor doses, of effect compare did If populations, same see we IL-Xs drugs, But Yeah. given IIb population a IL-X on on has they FeNO. a so or reduction them with looked which anti-IgE, not have action. at add and did that XX% FeNO - study which asthma, effect study their function, lower if at nice although the very that mild high exacerbations. we

function exists, as trials So think lung FeNO we that and well. really dupilumab seen especially the correlation been in

see moderate-to-severe So excited reduction the of even to patient that of we're importance we're in really that to if able FeNO translate may population. and how the mild patient a population

That’s it. helpful. Thanks. Got

further back questions I'd are time. comments. Mr. over to at Yoder floor closing turn this like There to you. Thank no the for

a you We today support attention want we look for Thank to for day. and on your forward continued and keeping thank everyone updated of our Thanks. your everyone to progress, wish you. only Pieris. I again great

This concludes today's teleconference.

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