Palvella Therapeutics (PVLA) 2 Nov 222022 Q3 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Pieris Pharmaceuticals, Inc.

Third Quarter Earnings Call. [Operator Instructions]. At this time, it is my pleasure to turn the floor over to your host, Tom Bures. Sir, the floor is yours.

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

today, will available overview our Chief call and for Chief Scientific pipeline; Q&A. the we Officer, Shane Yoder, our Steve On Olwill, and our Hitto CEO, Kaufmann, who outlook who provide and corporate Development Officer; a on our have President will be

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

being expressed to might information including forward-looking to quarterly caution those the such SEC, call statements actual like programs, current partnerships of comments made or our statements may data, Before related risks conference by trials I'd differences from we our our with in The reports. progress Pieris, such anticipated materially described and cause differ filings regarding implied results clinical that results our annual, reporting our that Factors and including position, statements. financial during this and or of timing are may and involving including update begin, presented now preclinical reflect operations over statements Steve. of future accurate forward-looking events is events and I future any that, circumstances. or With to turn no obligation and the the contain of the Pieris timing and and will today, of undertakes uncertainties only call the to to for operations the as

progressing, to exciting how we our announced quarter you, an on will earnings programs recently. I for programs us are call. give Thank joining today for you thank XXXX new what our expect third Tom, and have everyone catalysts to update and upcoming lead Today,

we More year known readout for numerous the within of pipeline initiated points inhaled collaborators AZDXXXX, We IIa PRS-XXX specifically starts are Phase for PRS-XXX wholly our IO, co-development clinical we of for the which I'm the of overview franchise. we will year, expect X I development. of before for In fusion respiratory X, are asthma, Xb, inhaled X-XBB placebo. there which catalysts across respiratory, products. continue realm and go these Part inhibitor franchises. IO and has is Servier as developing alpha differentiated, powder next decision elarekibep, will I mg on subsequent in to inflection XX Phase have are or our also Pharmaceuticals addition completed with advancing in Seagen AstraZeneca expansion preparing AstraZeneca active the of Similarly, leader bispecifics, targeted respiratory by the expecting a driving Part IIa severe to and that receptor costimulation. to dry in-depth of both or IL-X IO that safety moderate the of Mabcalin, a more report mg of over the By clinical a be elarekibep, antibody-Anticalin details, versus towards pleased X-XBB Boston be early next trial and cohort into in highly within we in treatment as enrollment assets But anticipating give the owned, to while X an formulated the respiratory the is of X-XBB-based the cohort, with to we are continues while efficacy opt-in enrollment

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franchise. now Turning our to IO

including programs. exciting also program trial partnered Our program first-in-human partnered -- has Mabcalin and some starts bispecifics new upcoming pipeline updates, a for announcement multiple

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this next medical study We at for expect from to program. year data present the a meeting

we U.S. will rights on and program, retain any reminder, a ex-U.S. full As this for royalties sales. receive we

bispecific PRS-XXX, Servier is is SXXXXXX, which has PRS-XXX, or rights. global OXXX/PD-LX of continuing for Servier Beyond which development an

continue week. on first the to which IO number unveiling the those a to of announce work programs of collaboration the also the also plans the and bispecific receive will SITC a and upcoming for compound. am payment of our SGN-BBXXX, study known of next as The Seagen, at as is program PRS-XXX, Seagen. part in pleased conference for Phase I which milestone this with Mabcalin coming programs, is initiate we months, at SGN-BBXXX We Seagen a IND has I accepted, from been point first-in-class to study X-XBB/CDXXX the recently

Beyond initiation to recently program this continues has program collaboration. develop program, Seagen a undisclosed and second bispecific nominated third the within bispecific the for

X option X we for U.S. this in collaboration. program As a program co-promotion have reminder, a

developed excited in program our these partners compound the have Turning program most our to a clinical collaboration technology. target recent discovery the or X-XBB support broadening of advancing X-XBB/GPCX is X to in year tumors. bispecific footprint Among in X and which also immuno-oncology, PRS-XXX, stage and the we next we Pharmaceuticals, last Both ophthalmology expect licensed I the Boston for are of X to Boston of with months, many respiratory Anticalin Genentech, Pharmaceuticals of and various In we study several BOS-XXX, signed the a represent Mabcalin partnership. being progress. of the applications IO whom continues partners and the initiation is by target which which is Phase the a Seagen solid our

these importance to Tom. important addition our of served as capital, cannot like now and non-dilutive over continue R&D overstated hand back partnerships call source concludes would in to resources, have remarks, prepared current the markets. to my and This an contributing know-how and the serve be which In of I to

costs in again, XX, and XXXX, stage an and G&A achieve for make lower programs investments September company's million, operations $XXX.X PRS-XXX, a largely by to higher balance cash for The December lower share, or the the funding you, demonstrate million lower XXXX, of $X.X September XXXX, inflection PRS-XXX as million million compared XXXX. ended program I cash respiratory preclinical Steve. programs for compared million quarter And decrease anticipated offset clinical later the was XXXX. million morning costs prior $X.X trial quarter share, for quarter loss $X.X September was in the to compared $X.XX Steve, for costs to and grant September in next or milestones, the million, XXXX. related on ended million points were in of well for September lower for With costs primarily stage and $XX.X finally, to our the the costs, XX, believe $X.X cash in by was over partially respect the $XX.X commitment XXXX. The Thank consulting the into the pipeline ended due to I $XX.X and decrease in work loss partially and per September million a for expenses. due of provides quarter to period-over-period The the net net to R&D ended and across XXXX, balance multiple Overall, XX, costs equivalents quarter Phase driven continue higher we year, personnel ended quarter second quarter and elarekibep disciplined September the lower everybody. $XX.X Including that, to $X.X a ended XXXX. were loss due $X.XX year. the to year. professional from XXXX, The higher the compared September recorded a increase will near-term sponsored call we costs. clinical costs. loss XX, costs for XXXX. ended quarter completed decrease travel same XX, were ended quarter for ended immuno-oncology expenses to quarter lower and decrease this turn to sufficient ended incurred will costs SXXXXXX, September to as all the our offset cash program to million to was earlier good overall this across XX, service is other the lower as due XX, manufacturing the compared income, XX, XX, quarter with of equivalents income by proceeds back current for compared investments to Cash These funding expenses or is quarter for is XXXX per PRS-XXX the of totaled for facilities cash that XX, quarter

to like call We the for questions. Tom. you, would your Thank now open

[Operator Instructions].

Miller Evercore. first question Jonathan with comes from Our

your to couple clinic, the enter housekeeping programs, Congrats really level can on to collaboration you the especially middle opt-in of said -- wanted clinical quite slated runway are all that guidance you especially development easy you've And year, internal fund. all the the risk to are fund include? sort you funding progress. there to just whether development, given, ones that a through The I what what is -- that about opt-in those any of next runway thinking does progress, maybe to the that things. clinical Is the Which for runway? level? or you relatedly, higher PRS-XXX that that afford are you ability you

Thanks over in cover it's questions. and anything Jon, questions Steve. with residual fill I'll these, that the it for can to I to Tom you turn then on. have

Yes. Thanks, Jon. ongoing so the XXX with costs. XXX the includes and Yes, XXX runway along

and there. So continued clinical of to so primary those have, SG&A the those key are development that our are the sort and assets we playing

books XXX that's there's a all again, because by being right reminder that So on costs limited our funded AstraZeneca. now, really

received, we to, that's Bavarian of we clinic that pushing government the just we For the into really terms been our getting in the helpful XXX, that as that by are forward and announced. costs that grant supported referred and

So their and that's with we And then XXX progress support. there, great appreciate partnered Servier. also

just by about funded So Servier XX% under there.

So efficient and very to that's cost this out. how budget we strategy, continue

For are cost those those. have related licensed, clinic, that out we moving obligation we into referred to to assets those in the other IO no so

those just the cost. partners' be would So

stage opting could question I to X. opt-in the mentioned, paying about I have We X your about, continue going that to we quality the something based of believe again, be, PRS-XXX. second I of us, clinical going you think clinical this So that's next focus to year, it's related and And assets, the the we're think are, for about to total like if right, allocation across and be really of level, think think to for externally our we're on our sort affordable. for do share relatively to credit at opt-in thinking upon good meaningful higher a along And that manageable, that moving with course, is, that top development XX% at we into were that that those of able the line and spread we results I program believing, would are is the think get be again, the programs. hopefully the the on to -- in I and capital that milestones how to costs, again, of we that the that given think program get continue the of readout.

or the second would discretion that. question I for to remind Tom, we have do, budget. decision Thanks, and that color can to or and as Yes. XX%, revealed well The be opt-in only which want at them, is just as after do add talk that about which at to have, that everyone not we a we the not top are line the is data our would make XX% to and not could until we all, plan go-forward decision

appreciation are could could basis us the to for value in And So data the a Tom there have in That's in of ability higher that. partnerships. reasons, multiple allow franchises would have all independent, stakeholders XX%. external alone there will a level why the as PRS-XXX the extrinsic said, and course, of certainly be things multiple digest create value be to company. at we that that to opt several And than programs,

ability beyond. to we about are several whether potential opt when the PRS-XXX XX% year, we Phase very catalysts and things, that's So the the consider core but at other of IIa, encouraged next being in, or landscape

perspective? study That data other a there's makes not target that you ability in I can volunteers, really Great. good your from to on expect good PRS-XXX, from IPF. some Great. biomarkers, of get in maybe targeting that we out sense. give healthy what you learn will understand the for confidence year healthy next then And get just you that Can to than measure patients? on PD? Can deliver volunteer other translation

the next healthy we question. -- At Yes, that particular I looking And have data. at high I I mentioned end SAD/MAD wealth not we're with Jon. data to Phase of a not year would generating, will that a great in biomarker going know going study which intervention. be we've data -- a frame the be challenge is It's the subjects, is that a at already have we're level, of the this set of to think that what

data The to X One I we that important data. the in trial. However, FibroGen data that will is other want sets out. mind. have enrolled pamrevlumab know We keep the read they've

relevant And same with We of data are expect lot about of and study from data preclinical line year. the the mid III benchmarking parallel time, Phase hard next pamrevlumab top our other in against generate to out to come controls. working own the we program probably a

So we Shane the that our very Shane? more make nuances I Phase confident be when on the we and would that a safety/tolerability And is hope, one SAD/MAD beyond also feel, and looking comment Shane II from data the for with online, into bit study. we of types also goal forward the can that, have dose. all will might moving on of

Steve. Thanks, Yes.

things of So things in understanding we at the build that we We'll of also they're but II can what most effective but some at differentiated we'll with then readouts confirm fundamental we starting modeled. efficacious we'll taste. things, next see pamrevlumab like Phase this on most believe exposure what on And will an build of -- wanted design. the keep as look based the we the it's PK of look as eye any also, eye mid to study, the just that data support set, doses those which understanding molecule said, And mechanism And we inhaled to continue course, come consider in or that of trial we'll to of line the be to support such preclinical out also model course, to data emergence Steve on have to keeping year, one, Anticalins medicaments. an as action, the as study to occur. that additional the our course, our

Matt question next with from Our William Phipps Blair. comes

I far levels? there you'll next as tumor do from next you escalation, start expansion is guess just just types data dose you enrollment data for remind then curious just also into year. be year the some or Could as us on any or will And think get preference expression to for XXX cohorts? PD-LX

on detail. Thanks, Matt. more your before to Shane in turn have an I I'll question overview over here it

For the we're certain as so We're based we still go see the we in pleased escalation time range pace And far with That's something -- there's lines, And next be next to escalation. we're year driven we as that depending late of a expansion, we would to be want beforehand. on initiate that that's reminder, planned. that currently set, want to on a data to signals early predetermined doing on of a would based really be on the to believe important. corridor year. there's that. mid, generate sets that And data would going could and

year, So the have that to you still to when ability thinking be about I should backfilling, utilize would go we options. I would we backfilling escalation allow we about that though, note, protocol for data as does data. think would expansion, next think as and the

be think PD on -- us. indications, and nuances when for would as nuances they we can meaningful those have certain why clinical Shane, PD-X color into preferential time, the be tumors enrolled? have being mentioned. specific meaningful acknowledge on why to And in going expansion a data well we're as at So certain any we So a first mean, some there as put inform trial. indications you any on some time of emerge there you would expansion. into those expansion, I to in place tumor Shane us the also turn made to Are a that I'll comment the why for priority PD-LX we're announced would why in Are cutoffs? a potentially that go for it types over cutoff more data, of that rationale would good I go for we a picking

Matt. hi, Yes, Steve, certainly. and Thanks,

do of in escalation, not from the So a -- we dose perspective. are that so we have cutoff PD-LX terms not

We are comer also the tumors into enrolling solid study. all

selecting don't study. purpose are why in terms indication Now doing for want the -- the we of We picking that? be to stage overly of for or this sorry, an -- prescriptive

We be moving want of also to terms in through efficient cohorts. very the

well. As Steve said, the study is going

also had biomarkers. meaningful terms these all We're benefiting knowledge certainly are PRS-XXX. that on regards set we institutional from in of modulations We Steve backfilling the all option. to several our biomarker the of knowledge mentioned on gained are from benefiting With up, assays having what of

from So are those the expansion, will with the in into We optimal for those of towards range warrant to that. see if say terms dose have know dose. is competitive choose particular there selected. a And to options what we're move we as that which backfilling you here going in can, we bit of predefined cohorts. expansion Steve speed we predictions do escalation is indicated, have With in our would to, regards we conditions there looking from And bias we there is that the that, we indications. there programs, will a biological indications -- one have where would as

initiate that BLA some a know these we the a of path were selected strong of filing. of We we expansions, But essence, those concept here? but escalations, probability out want we proof in let was the want when success can you what's and guys them. of things thinking why in the to we we expansions also indication-specific about As

most consider the were we have regulatory we of considering once for priority perspective, there were expansion. discussion happening and some to risk/reward when when high path of in knowledge competitor the of go and biology, things identifying come a programs, from what's the indications the into So that our the some we also financial

mg in check okay XXX. the box Just XX we that follow-up just been level. yet can those? on the being on if Thanks that, guess XX Completed Has safety I Shane. the cohort. at mg of for completed one on kind the safety question enrollment wondering

the it's there remember, treatment -- Well, is follow-up. study, there enrollment, is and then and period after blinded there's a

thorough and mg that same will go the X it through So through. the we put X the cohorts review mg

safety would still and as of to course. similar that an analysis we year, gate to But get that dosing expect mg earlier do a cohorts the and in the has mg the announcement follow-ups. through expect for X we So would passing the we X had the due and had and announcement this review

So will the will the the although cohort high beyond that very mg dose we having not drug want safety one, And to if it XX the will X relevantly, confirm be confirm really mg whatever will is into allow at efficacy will for valuable do -- IIa it reason. it that will two, doses. phase, number safe quite moving because data it Phase we to XX be pass gate, if flexibility we beyond mg

There's And for XX stay X unblinding mg I process would mg say tuned. and did X would a thing the and an we would with assessment. the we I do mg. expect and So that same process the that

Roger from with comes Jefferies. question next Our Song

around over ones And for Congrats kind of particularly progress. quick the since or still follow-up. for to amendment you can the enrollment provide One see XXX. is AstraZeneca, improvements? A color living Great. the some so all by we a quick And us, just as efficacy few but the for you do gradually COVID the protocol Maybe one, people masks it's changed of less wearing see normal to last kind and just start with start people time? less. portion,

safety. you Steve, is for XX mentioned think, I mg the

to you possible is possible a for the But what IIb this you to signal -- that to confirm, III not decision? the in You're is kind for later? Phase you Phase that to do of Ia that's for efficacy. or If going need Phase case, just go up mg that XX make for

Roger. Thanks, Great.

first again, mg from mg X your factors factors the XX Phase enrollment other mg would second around could beyond question IIa the could the beyond and what So and inform was, data one we -- and do dose. then the safety -- was other how trends, what XX

going say to specific out I on numbers. first For break not would enrollment the enrollment, question we're

done haven't to going not to that. do we're be We that, and able

impact X However, factors enrollment I there probably say would would are that rates.

You of that just drive people exposure is overall throughput challenges, If up a more normal throughput and and mentioned more higher. if coming masks just off the lifestyle, opportunities broader viral for back if incidence environment. one presents that to would then more make are the get

So that's one factor to consider.

number think, And of just been be is the them quarter. just per do have more improve rates. We have amendments. address site se, have about parts into screen the being enrollment now help we talked implemented. of Second that's the which one go pretty the I the don't and third process in details. of last is been study. all think the said for lot through the squarely is thoroughly we filings those amendments a impact and point, meaningful, Remember, And to to to And engagement. of But review a as will those we going they're funnel. most will I accepted, broadening one the that believe early failures were that We reasons those the filings been made, the

will So the that the site next amendments more the on would bend and to be engagement accurately they But I getting say we able need of over gives then, provide that more assess enrollment much be just able on we whenever have course, visibility meaningfully. to is that curve. too to be deal then early implementation to lifestyle, time that. reason the that. back -- us an that given due normal of how the more doing, predict to and months, course up will the good we the and collectively it's hope would AZ additional to And couple of And move believe we that to more of in a update committed

do the going question forward, XX would second the mg the XX safety mg, what data. On with around we that

at look safety confirmed the at it would one, mg XX we is, way have cohort. to wanted the think I we

to what really will the think potentially than the good. so could border readout. in would that, would that, with through decision. that's to coupled for if think and go And going think placebo, down And as then better I against improve mg what's be FEVX about that its We've assessment, going on to Matt's bogey my X the useful. efficacy push safety beyond very the how would it's and be to it's that we important being clinically come to the then efficacy relevant process, we want answer And efficacy terms that even talked govern question. than mentioned in factors to, I particular, be dose X of should more, better be much And in of we depending

we to have So data driven. be

what on mg could to have And We course. between, we have would is in XX to think on if and that's with first X want will we make AstraZeneca than go an that able that mg I to again, confirm decision It something mg of go that be to before mg. to be. It higher parameters the something dose to XX But doesn't we enough have X that forward safe. intelligent then opine be we would, in co-development. go

runway, very a the payments. potential milestone Maybe one you have given for collaboration, cash Awesome. just quick the lot of

to runway, runway? do So meaningful have XXXX before extend early cash you cash expect milestone just curious, will you this the

to Tom, over one that Roger. turn I'll

Yes.

the and some So call cash we've near-term about of runway, talked of talked some partnered do into assets include that the in that we confidence increasing our in today. we Roger, on we milestones our have visibility

included. those So are

though, past. of modest milestones the in the probably nice context, AZ-type to they're more think just They're have. some we've recorded than in I certainly

were into meaningful AZ and because just the the that asset clarity, later for it that they're cash a time. So are level stage we at But us. not that these that quite balance. clinic They at putting for was to modest help

you Thank confirming it. Got for that.

final looks Yoder was closing it over our remarks. And to like back it I'll question. turn Stephen that for

you, Thank your everyone everyone. support just today, of I to gentlemen. thank day. want a thank again for your and continued you Thanks, Pieris. for great attention Have

concludes participation. today's We Thank thank conference you you. for This your call.

day. at this and your time, You lines may disconnect great a have