PIRS - Earnings call transcript Q1 2020 | Palvella Therapeutics, Inc.

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Operator

Greetings, and welcome to the Pieris Pharmaceuticals First Quarter 2020 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 call over to your host, Mr. of Pieris President Vice Bures, Finance Pharmaceuticals. for Tom

Tom Bures

Q&A. and Clinical and Development; Ingmar available of Bruns, Shane of SVP our for be will SVP [Indiscernble] and Head Olwill, Science, who Translational Head our

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

to statements operations caution and and of begin, forward-looking clinical and risks differ our statements to made or due the or and results this of and operations that trials related the of future we including Before our may like statements. conference expressed timing and our progress implied preclinical programs, during Pieris, forward-looking by materially involving events uncertainties actual partnerships from those comments I’d position, such call contain regarding financial may results

are accurate cause The and current of and circumstances. described our might annual, including events future only filings reports. Pieris SEC, statements no that to such or is with as our presented in update the Factors any obligation to quarterly reflect undertakes today, information being differences

will over to turn call I Steve. the now

Steve Yoder

you you, everyone thank thank earnings for to quarter and Tom, today for joining call. our first Well, us XXXX

the an business. describe therapeutic like our update the provide on pandemic pipeline, would effects I I Before on of COVID-XX our to

remains despite limited essentially with objectives on achieving of continued track, for in Fortunately, the research laboratories PRS-XXX this corporate has PRS-XXX, challenges and towards our our programs, core numerous pandemic execution and two our disruption. lead work

will ways what the at to working predict pose of new third for and to currently year, adopting disruptions, supply among we COVID-XX-related rely who and pipeline, on number risk It’s of to the We, this surprisingly disruptions. the the parties corporate helping not of disruptions difficult chain will course, highest feel crucial other priorities. impact significant managing themselves but alongside for our around are of our experienced and actual rest advance have pressures continue threatened juncture this a

of and both in various include of all across we’ve facility communities. the employees our sites, implemented at staff measures R&D our Hallbergmoos, U.S. and safety and company, lab non-laboratory a Germany. work reduce within research our to number These protect our remotely to and measures Meanwhile, the density to German employees requiring health

the situation, very we’ll adjustments, as continue we this fluidity Given make appropriate. of necessary risk update frequently, reassess to and publicly

in Moving beyond developed on proteins and serve we’ve and and like antibodies, update Anticalin has provide Pieris, they’re naturally are our Anticalin, abunded body called brief on that the impacts, of which proteins COVID-XX-related class background I’d these the now to proteins, proprietary therapeutic and are pipeline various an therapeutic know a human next-generation bind you molecules. to engineered lipocalins, various transport that a

more and advantages can antibodies, As doing as other options, typically we unique and as a such more such locally the biology engineerable treatment Anticalin proteins offer stable are ability or molecules, treat they in as to formats drive are large to desired delivery inhaled complex immuno-oncology. bispecific to other than disorders smaller create to respiratory

respiratory to franchise. our first Turning

This is PRS-XXX. We inhaled are antagonist moderate-to-severe we for start for the with Xa collaboration asthma preparing have in the receptor the for Phase IL-X AstraZeneca. of been study alpha developing

doses. of controlled nitric placebo initiated, on to in PRS-XXX the Because the disrupt having additional for we FeNO by Xb a year-end. administered believe will last AstraZeneca, by While delivered Phase sponsored presented details fractional initiate that reminder, reducing addition to cannot elevated lines this of FeNO, study run potential and mild time in track COVID-XX oxide study as was Xa to exhaled and of program, results are from year, time the safe the give levels and relative PRS-XXX doses Phase impacts demonstrating all we with well significantly the tolerated this interim we positive continuing we the at at at subjects or currently study all asthma but have be to

this of completion have subsequently, United forthcoming partner, will sponsored States. to co-commercialize co-develop PRS-XXX options which our study, Xa in we Upon and, and be AstraZeneca, Phase will delivered and by the funded

beyond year. alliance and Our AstraZeneca we expect continuing already PRS-XXX, will we three AstraZeneca fourth that on with program the the are work have includes later four programs programs initiated, to we nominate this

stage timelines Although, a we There are chance fortunate affected by that PRS-XXX our been respiratory COVID-XX. the might have of become programs is affected. that earlier for to fully date, proprietary advancement not

Last this is proprietary being plans data in several for to in to able that disclose studies advancement possibility year one programs the IND-enabling later quarter, we of the a that affected had for be we Because originally may medical COVID-XX, we later by laboratories year. disclose not announced respiratory into our that and rationale planned. set third-party for meeting part this at generated there details as program the is data

the end update of to this continue We may appropriate and more year disclose are that to nonetheless publicly hopeful the by be we on program. details we’ll able as

Turning fundamental a to and in update proliferation, protein. collectively activity. cytotoxicity memory PRS-XXX lead durable of focus provide T-cell a our are clinical IO to a Anticalin antitumor PRS-XXX. X-XBB leading Both on bispecifics, play I use X-XBB driving agonism which PRS-XXX to believed a would and our like PRS-XXX, is time for role but our to asset, on assets, continued development brief targeting T-cell plans immune-oncology will my also

demonstrated a escalation monotherapy study in drug supply with tumor under solid studies, provided is a X-XBB/HERX objective clinical in escalation designed drive atezolizumab study positive combination achieving environment agreement responses as with Roche. of agonism clinical avoid dose observed in the while HERX bispecific dose has which a unwanted micro and peripheral and a toxicity, was PRS-XXX, ability both to our which was tumors X-XBB the to

ramucirumab the reported on year, fourth last of the escalation Based proof-of-concept Phase we in combination to PRS-XXX we half paclitaxel. the what positive decided In which have from with year study data collected, Phase X second X totality standard presented current quarter for second line dose and the have the additional PRS-XXX. for including interim year, gastric a care data in is beyond initiate monotherapy we in of study we treatment of data the of the cancer, last this of of

like well you thinking, Today, with has informed the additional our rationale for announcing some as as that we to clinical the path seen of share today. data have we’d we’re the development

given we through QX the cohorts dose and X X.X to data Turning weekly weekly. X last XXb being year, at QX being XXb mg/kg the levels which for namely active interim given presented mg/kg cohort X data with

stabilization an or ORR and which patients disease of We control XX%. a observed partial rate of response XX disease in also objective response patients as observed or seven this and these DCR three responses three evaluable response cohort XX translates of translating out to patients, in objective in cohort. in disease rate All out of XX% were to XXb, three and in observed of in XX% stable an of XX% cohorts was patients best evaluable in DCR which patients, ORR

additional observed the benefit, which also cohorts, for response complete dose are enrollment. open clinical higher in still including We

these plan is enrollment trial the a to generate use While the set the according data progressing larger to plan, started cohorts. in will time X Phase we until

on depletion We anti-CDXX the to plasma to of cohort PRS-XXX. B-cell also enroll assess exposure pretreatment continue levels of a impact

medical to with atezolizumab this a at We and conducting meeting mentioned, data Additionally, this been of atezolizumab. study escalation study year. we second study plan dose have in a combination half detailed the from present as the monotherapy both

Now line focusing cancer we’re HERX PRS-XXX and of multifactorial. enthusiastic treatment positive our for for advance path this to the is second rationale gastric on

component current VEGF with our the to standard chemotherapy. of the a literature Importantly, and evidenced There agonist antagonist it combine play, PRS-XXX at a regimen. data as prioritizes scientific with of a a myriad potential by benefits combining an action efficient points decision suggesting path the also recognizing is to of mode registration care X-XBB in key cytotoxic

elements More immune in the that we and an and see tumor of specifically, could provide. other vasculature between as and tumor antigens enhanced we release T-cell And response IO potential an synergy paclitaxel. a debulking ramucirumab advantage X-XBB drive both can tumor normalization that of believe of based the result activation favorable

considering addressable gastric an both of world. line HERX the represents commercial rest and population in U.S. opportunity the the also positive the Second attractive cancer

Our and will endpoints both paclitaxel, include in between of which effective planned targeted PRS-XXX of patients, enrollment study Phase and will combination with the to sufficiently single in ORR XX a allow a primary PRS-XXX us believe cost we with X of and arm of efficacy DCR XX time ramucirumab and interrogate manner.

year closer formal endpoints details provide half we'll statistical and that We our justify of as the second can are very more mode the action plan and in expected get further endpoints We on duration to this the plan, to including the start development. of study. synergies confident the matters on to of detailed based proof-of-concept initiate study PRS-XXX on commentary that trial we further continued desired mentioned just clinical this achieve

will is have as the an bispecific, for the in as PD-LX/X-XBB XXX, Servier, in during program is IND would quarter original drug We PRS-XXX to like encountered our been peers filing update PRS-XXX, I of mentioned, beyond holds which product which a manufacturer and of scale-up Turning a guiding. our of end learned exclusive challenge also this with affect for U.S. by immuno-oncology recently give we collaboration for rights commercialization on the that timeline which lead the

activities this to Servier jointly and CMC Pieris additional to remain importance. strategic and have decided program in committed both invest its given

scalable The on now robust timing can scale-up expect filing overcome are IND modalities anticipated application process manufacturing that provide IND anticipate an visibility quality we high have of this As can we filing, year. pose year. later improved the Once be that we of issue a confident processes for challenge, for which standards an by update an implementing will sometimes biologics next for a we we will PRS-XXX but will we complex result, more meet this manufacturing. the

with targets are developing we and expect for over to the that PRS-XXX, to non-GLP our we hand to are preclinical complete work addressing later part of undisclosed PRS-XXX, we that as Beyond stage working Servier this also Servier collaboration program year. a also

immuno-oncology of we on that we alliance. In to make of collaboration continue also antibody-Anticalin as development bispecifics progress Genetics an to Servier, addition part Seattle and with have the

serve pleased from And us experience. pipeline, that oncology Dr. to years want to years lastly, therapeutic Bizzari will I'm development five Dr. quick Directors has of Board strategy on many and we XX our continue invaluable over more well advisor Jean-Pierre for benefit to provide update than has did a last for Board an company. insights as oncology these and I our of moving from transitioned on been with the the Bizzari resource the development an beyond

to concludes to prepared guide my the back you hand now financial like our XXXX call first through remarks I This results. quarter would to and Tom

Tom Bures

of annual expenses, X totaled cash capital the $XXX.X PRS-XXX. and to investments equivalents move both in operating ended decrease million Steve, good XXXX with we for next XX, XX, was cash, We for cash study Hallbergmoos. and morning, one-time $XX.X to a balance compared a points, year our million the Phase and inflection bonus and you, cash expenditures equivalents to payments, Thank due The Cash, quarter us again, believe XXXX. cash the position investments everyone. support sufficient December have ended new associated to of and facility including to the March

were manufacturing for our R&D programs. offsetting million The spending expenses and ended in quarter the expenses new $XX.X of R&D facility this to reflects associated $XX.X XX, both due the due Hallbergmoos Partially decrease in XXXX. March site, headcount PRS-XXX. increase million personnel for lower to overall the clinical compared in to R&D costs preclinical expenses with ended quarter March higher was increase the advancement an XXXX, on allocated and decrease an XX,

in expenses fees. ended million audit lower quarter reduction personnel the and expenses XX, tax $X.X a million G&A in $X.X for costs XXXX. March quarter the reflects ended compared G&A XXXX, to XX, decrease professional for were The and March

to million of quarter loss loss for March share XXXX. ended for $X.XX the $XX.X million per compared XX, per a Net or XXXX, was $X.XX XX, ended a $X.X share loss quarter or March net the

will I the Steve. back call With that, turn over to

Steve Yoder

are but everyone, team's of we in important stronger ability today times. and a through this, and all Thank few these new am worked to listening more have And months will safe other having ways exercises of focus and perseverance healthy. and who end staying to adapting deliver trying I'm efficient These on you, our grateful the I are tough Tom. you confident working. I come prioritization hope out for for been

the thank call to the call would questions. on you Thank joining open like we want us now and your I to today for to you.

Operator

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

Jonathan Miller

guess I I taking guys, Hi two much my have so for for here. thanks question. you

the Phase Let’s about PRS-XXX as you’re into that dose X additional be noticed those us forward? the much little dose X, and haven’t to give higher Phase complete I more move where start in anticipated where what a the is on dosing with are Can response. on moving in color cohorts what doses But you you the as level said by saw congrats you responses, way. you

said which X, you I runway PRS-XXX Secondly, would about Phase do talk our well? goes the point to you PRS-XXX that have value inflection that as cash through love through Xa Phase runway, through cash

Steve Yoder

Thanks, Jon, for the questions.

then to I by what your help recommended X Phase answer that. R&D I’ll Let answering And answer me turn to it goes question colleagues color start dose over after there to – second first. the more

won’t sheet balance runway say we into say, of PRS-XXX a that today. we So in Xa runway, with the to PRS-XXX mindful is timelines to do in should Phase can have plan readout course, thought and the on I readout the for a anticipated PRS-XXX thought deal resource being has guided an of we a gone the of of – Xa FP&A the timelines. on align great go-forward and cash to as for a pipeline. deal our Phase respect start great that And assets past, I for not position within for or other managing allocation

We we company. be the plan. from make PRS-XXX to ensuing new mindful the making, largest prioritization PRS-XXX’s this While investments the forced to might we one also value is decisions within according potentially as we’re for partnerships advancement opportunity existing ample realize to our to to be opportunities the protect that quarters see from value-driving well of And both in additional as partnerships. believe

And that has manage of so spend. about our our into to all gone thinking how

I on now and first question comment to we going dosage would Phase additional the Xa although turn Xa go Cohort around of start start the details, it be the going inform not between we trial. be Phase will of details said, interim how the beyond to XXb, to we’re using your the Ingmar to over formal To to study, for the regimen better actually dosing to that those closer specific we’re providing period the into

with to I’m going color. it for a So bit that, Ingmar to hand more over

Ingmar Bruns

disclose XX I the data about mean, Thanks, already we’re the Yes. and hi, trial Steve, today. Jon. not going Steve to reported ongoing Yes, as patients beyond said, the invaluable details from

earlier At as Phase on the general plan comment complete well described earnings the the higher guide alternative going schedule, not mentioned. or the that this there in will on earlier, additional we already where reported schedule to point, I’m this levels. cohort closer dose objective dose get and the weekly and trial. at B-cell As call additional have to remission happened. we as response the of like are Including biweekly on higher and next depletion we as a doses start Steve the schedules, X

Jonathan Miller

hop I’ll much. in so Thanks back sense. make Okay, the queue.

Operator

Thank you.

the question. of Jefferies. your Chang Liu from comes question Please proceed next with with Our line

Chang Liu

our Chang is taking one the this and is two, Biren. you Thank I PRS-XXX. is questions. for one Hi, PRS-XXX have our for

we on how what So combo you would patients meeting the for you. PRS-XXX that? is where additional the specific color and mind additional medical the trial was what provide you’re facing data therapy? many And wondering have on PRS-XXX going I like question expect on to both the now challenging, mitigate the for strategy from you the and manufacturer second Thank story, challenge monotherapy for release I’m to should to

Steve Yoder

the today how in suffice can the put at for data, higher patient guiding question. set on for is there the to additional combo we the some not cohorts, the question, our Day. And cohorts disclosed for Thanks and all data numbers cohorts enrolling PRS-XXX are would design. to that patients into are Chang. there in monotherapy based And – R&D SITC protocol in as as these in we atezo the disclosure additional across say the the say on we I of still flexibility think first the since trial. protocol the the of I Thanks, specific Sure. we’re many

And we I disclosed respect the have a clinical date meeting, any initially the tuned would the combination an totality party time. the say, in out the the not in allow data, of of the for since to coming investigators, particularly program for stay investigator for or want we medical of that a that context by trial by appropriate at trial, that put investigator

your would maybe back Hitto not Kaufmann for PRS-XXX, on can that’s we to PRS-XXX if sets comment that. So data come ask I enough or color, patients. on actually to additional question But

say manner to a as now committed of that programs. highly the in parties I PRS-XXX. both the which these over both I focused we it relationship remain a on most very two still the what and a and Pieris pipeline Hitto, value advance turn to relationship capabilities, as the Servier, well very advanced would complementary think, asset, as And I now as includes very is are to Before reminder, committed two bispecifics, focused parties

with on to bit a over what working we’re more I’ll it So Hitto that, provide to through color there. turn

Hitto Kaufmann

you, Thank morning, Steve, good and everyone.

GP are you scale. substance as It stage or occurred a has step the product then seen this. later establish to initially in at as last Phase unusual what go before not that technical is require The which likely of can a we manufacturing. your an this occurred process we product. and projects remanufacture. have wanting right really of many scale the our to challenge typically world, scale It to drug typically confident you our pretty the biologic X. process up manufacturing solve drug global adaptation start ahead most that has called so in biopharma a will this, occurred on problem you the scale, of in as manufacturing Unfortunately, a typically now then manufacture we other of smaller final in see topic the product And and we is is As initially that drug drugs biologics and and that, that

Chang Liu

you. Thank

Operator

Thank you.

the Madhu Our Kumar with of Please line next comes question from with Baird. question. proceed your

Madhu Kumar

that. Sorry about

So expected thinking is and of and Phase second-line with the trial benchmark cancer, VEGF that paclitaxel, do in rate X the you paclitaxel in this is this gastric HERX-positive what population? ramucirumab think combination about for drug response specifically, kind

Steve Yoder

question. great of the as team consider Hi I One, it like we course, as Madhu, with but of provide Ingmar care, to standard not our there more that, today. thinking bit imagine, analyzing our would standard on you can been we care. a emerging that’s vigorously over at to just has to look of hand color And a

Ingmar Bruns

Yes. Steve, Madhu. and Hi, Thanks,

– So yes, as the fully response rates on our the benefit line to I say clinical point. steps second as the trial much can PRS-XXX, including clinical mean and as I to the in registrational for then focus as durability. we at of and PRS-XXX totality primary a with single-arm evaluate development define plan efforts data from well next That's

closer study get we to you the start including design, study, with study the statistical additional of the we endpoints color provide plan. on the As will of formal the secondary

Phase for to reasons. reported the a rate they has And and obviously, the in the landscape been therapeutic encouraging and as X of respect more the response We care the we've and on durability, both between and can effect we there cytotoxic profile has care, with PRS-XXX achieve said, the Steve several the in seen ramucirumab landscape of of therapeutic and then provided of are detail differentiated in and standard for the mechanistic that standard current confident emerging debulking and competitive knowing today emerging X-XBB that some of agonism script. synergy our chemotherapy, PRS-XXX the some and particular,

with involving to a small Phase note important hoc immunogenic X And care was and driven that patients that effects. could tumor of including cell well death established analysis I the enhance treatment. as prior as both the very also it's the RAINBOW a will tumor the current about subgroup study standard that then post the of immunogenicity of of XX cells T-cell trastuzumab tumor of say from

the that component of would our have of a we And of in ramucirumab of limitations plan can that designed more real-world with estimate chemotherapy study accurate these can of the for actually have planned light the efficacy be data and regimen. we to efficacy that backbone so PRS-XXX, more expected that from the include accurately that statistical single-arm in gauge

will statistical future outcome real-world let's the robust a study. XX%, In addition, powering And what the said, level plan our retain allowing the context also, registration study thereby say, I as of of to inform expect meaningful above within to we in of also the a see data.

Madhu Kumar

as And of to about thought also end, Great. – cancer trial later just running PRS-XXX you gastric like monotherapy? kind what your gastric HERX that have the are line with thoughts well

Steve Yoder

go you just with do answer Shane, an there? want to to continue

Shane Olwill

I moment, line, activities get Yes. the This I just, second our close the we which plans, can stage mean, the think, of we will any that there. includes next when we we attractive. this really doesn't and -- preclude inform at this you about additional we find

Madhu Kumar

of PRS-XXX, through the part kind guys -- run conversation right is Okay. so has this a Or that's of regulators? now? progress in this been And last you

Shane Olwill

currently progress. in That's

the the we we detailed you a And So give we'll as use at next to get closer earnings time. call update will this. more

this generate ongoing to X. Phase While the team preparing hard, is data on additional working the

Madhu Kumar

very much. Thanks

Shane Olwill

You’re welcome.

Operator

Thank you.

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

Chris Shibutani

Thanks. when line. treatment about regimens can see weekly, little what bit in Can changing to of or expecting in talk of related between have about remind also, Hi. Thanks you is you're very setting that your us to what durability a et bit with a terms regard about thinking benchmarks PRS-XXX that QX existing what cetera? in dosing we comment the patient much. your you And little weeks, with kind just question, second you

Steve Yoder

Thanks, Chris.

to then PFS with question can first second was regard X-XBB the recommended why cohort go be I dosing principally the to that's frequency for rationale maybe may and on is a durably. more suggest one, on And because the dose. the a the again, briefly that's second get I over talk benchmarks XXb the OS would about maybe think and to could which And biology absolute adjusting the I X or I chain suspect line. suggest you play the two-part relevant at there. would Phase Ingmar either of dose question. into wanting on

with more over think So the you back over rainbow analysis want relevant other gaining Ingmar, X-XBB HERX go biology Shane to thing to intent-to-treat maybe before our why to to start about it is talk driving we on any retrospective the don't you turning and additional escalation strategy.

Ingmar Bruns

Yes, sure.

terms you I the know, trial. the will I benchmark, as mentioned is then see there, population, higher benchmark if will So as mean, rate and in registrational before, it's – ITT a at or a HERX-positive think, And months. look five talk you we The of, PFS durability analysis but regulatory shown overall you still RAINBOW very of XX% about meaning, small pull population. response the and remain population if a the ORR,

to the estimate, think something estimate, second as say data we also accurate in but more we that more three direct so about terms We're, get to emerging you're that's in to we and that closer data same we utilize of population. has this the the confirm on durability world that reason why been with definitive can far an study this as the still standard a start this of population care, mindful see or of will the we overall actually It's PFS, have wait for more referring of setting probably watch will to in course, to I the color we actually come provide while the trial. all of is up line, context

Steve Yoder

a you synergy And comment if endpoint again, going high do on nuances want meaningful again, conviction if also of time you well, achieve would of you the that further care, to level give any the us escalation, standard on our into Thanks, to want of that can before of to. take of to Ingmar. Shane, belief top

Shane Olwill

atezo sassing Maybe components of about that the lot just line a X-XBB PRS-XXX the there's of to look feel of types very And conviction for said, the sure. when synergy We what IMpowerXXX where therapy second the a can we in carditis real gives component agents Ingram and IO what as cancer. part these of clinical lung add worked through well line therapy, infer chemo trial. is combo us non-small with of first complementary anti-VEGF the an and between opportunity for this and there. mechanism in agonism opportunity approval see has there the Yes, we play we to resulting in for

anti-VEGF and we've recently, you've indications likewise, And modulation T-cell other benefit seen real where it tumor again, RCC, of a a with seen where in combining more that in help debulking. in an therapy with chemotherapy can

on program. fundamentally, or the looking is the of sort optimally of community not first understanding And X-XBB you second the the had And a for to stimulated. a certainly out takes question, some cohorts, terms activate by about to do so of it this need we of plan obtain X-XBB, program question will the this our think you would the continuously PRS-XXX. In we're of as second give activate stimulation want of of additional T-cells out what are we to -- that the lucky dosing X-XBB it's much different that help the in there's we schedules was, But go-forward what holiday one continuously to on. to And rather franchise. get T when an certainly cell, information that

to dosing information. been the That's sort behavior disclosed at able in increase what mandate therapy. plans data. of totality biopsies. between cell looking of as as do allowed of fold activation, that also out SITC weekly our to that HER what certainly microenvironment of so facilitates T us at for trial already QX, PD that trial, And QX, we've across part at correlate, molecule And to we've is Looking of start got additional we've a the looking post correlates also we're the tumor this

So that confirms the when also on our pipeline. for PRS-XXX follow informs go-forward sign

Chris Shibutani

the Okay. for additional Thanks color.

Operator

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

Matt Phipps

taking my for Thanks questions.

types First, to be I trial XXX additional responders disclose tumor you'd in. don't for what able came suppose the

Steve Yoder

the going conference additional that. to But beyond of thanks on or the a We're context tumor feel you appropriately is the data for the not types expect, out most in coming we by comment question. That Matt. investigator as might clinical

Matt Phipps

XXX, on AstraZeneca, on been looked this activities some were to your I being have Then year. wanting levels completed was end just transfer that believe have and dosage all of Okay. kind at lower there earlier to

Steve Yoder

Yes.

do Xa, think clinical an from progression But defined Xb who go-forward support Phase support AstraZeneca. currently this official progression would our question, and interactions So we active which to activation. for and Phase drug clinical data believe all Phase plan, Phase including is we according Xb X accordance to data respect with I Matt, is have program needed COVID-XX an readiness generated trial manufacture, decision delivery like to processes active activities Phase very an is. our AstraZeneca partner, of with inform role with yes, trial who At also playing role all going their has from the with believe the in all a I are inform your Xa specific regulatory we say in where juncture, course, we to governance. standard caveats, in that's related a of We're to product in site committed necessary to are the program

Matt Phipps

the last down the manufacturing – could of XXX specific additional quick one something be don't or I mean, the kind the of I to Thanks cell as or know, work, really just Steve. future line. that products with And to beneficial line manufacturing, XXX protein something one then

Steve Yoder

expertise can engage on we're expedient the work over say can. confident XXX. the of the advisors, PD-LX that's both Anticalin parties and attached in to is our finally we again I linked Hitto’s COVID-XX our the this for the in through would have that same an HERX is would on and manner, that say Hitto. block building based vendors would under committee. Anticalin just our team to X-XBB the turn that based this leaderships, I back that the We to commitment we just antibody antibody I

in block think ongoing if positive same. went common and bispecifics the gives forthcoming or that the to also learnings are through Even read two So hope. question building well, also us – a here. no some the work But your having through maybe work I

I'll to so turn free color Hitto, over Hitto. provide more with he to maybe that, if So feel it do any can

Hitto Kaufmann

Yes. Thank you, Steve.

just all, that something differences reminder, that at or it of was drug product we what – manufacturing. as happened the of part what First a observed scale-up the

far – from for away cell was line it part. example, the So

step of drugs me In manufacturing sensitive are and every drug actual it these single mammalian manufacturing by facility Let even process the the from by systems the every influenced of of component this. the like relatively also but frame single manufacturing cells end, setup.

say, view So the will positive effect we particular specific something is a currently the as combination be to for this would three. there drug. I it of that mainly learning

I say will start issue beyond X will So can that of at more have probably, run into. the would we don't there We we much see. we with you Phase having knowledge to that? have the learnings typically that at that think be moment. because than Will stage,

Matt Phipps

Thanks. Okay.

Operator

Thank you.

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

Jonathan Miller

me Hi, with letting a follow-up. happen guys thanks for and

you I activity sorts accomplish As you Is taking Or XXX facility? is both to Servier a which by scale-up this get question this a did that goals? mostly of on those and of the last them said, their – the is just required with follow-up you for to is What manufacturing partner the place the something of challenges, to that sort doing something material? activity? to you're that's those want is provide fixing responsible investing in sense in both and CMC issues. sort of what views just are manufacturing the

Steve Yoder

again plan product. discussed, thoughtful that that jointly multiple team Servier, executable with release this it's up mention Jon. hand the get back that specifics. very plan, to aspects thoughtful more it again, at both now, vendors for involved collaborative would a why with probably process to with come I multiple Hitto And both on internally I are parties just But and has the drug would vendors timelines. and overall and – I Yes, right in is it's one looks our I reviewed involved that thanks to realistic effort confident a I at in think

But able mention comfortable. to in to go might technically I if just outset. Hitto so feels he And a little more wanted be the at detailed that

you maybe if say everything can or said know anything don't more there's you've I already. Hitto, So

Hitto Kaufmann

Thanks, Steve.

CMC development much has this. network and just is manufacturing will manufacture confirm be other happened the for vendor that The said. comments with gives between in to joint this use to just that two maybe we Steve is Just very able project the has the campaigns something we every that step component third to and solve that. adaptations other conclude, us what part that And drug of aligned drug in at drugs the before the to is it two confidence course parties of

Jonathan Miller

Thanks, Good. guys.

Operator

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

Steve Yoder

of for of All We progress on want to for and their And thanking during great our right. stay continued Thank for Melissa. to you day well. again the just the you, updated you this everyone forward you thank much. Thank I a conclude and very joining your company. look by support and all call. attention Have keeping time. process

Operator

concludes Thank you. This today's conference.

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

Palvella Therapeutics (PVLA) 11 May 202020 Q1 Earnings call transcript