Pieris Pharmaceuticals (PIRS) 6 Aug 222022 Q2 Earnings call transcript

Good morning, ladies and gentlemen, and welcome to the Pieris Pharmaceuticals Second Quarter Earnings Call. I will now turn the program over to Tom Bures, Chief Financial Officer.

Good morning, everyone, and thank you for joining us for our second quarter 2022 conference call and corporate update.

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

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

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

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

I updates biotech Before to companies diving small-cap detailed tough the like for acknowledge into earnings Pieris. from would climate, least the like economic not release, today's

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vetted a expect have of to We indications inform number on expansion the by from study to select year-end. jointly data

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receive full ex and any reminder, we this on a As for we sales Servier. retained U.S. by program, U.S. rights royalties

is Servier an PRS-XXX OXXX some bispecific. PRS-XXX, our other our of continuing with the would within end oncology or S-XX-XXXX, I quickly to also on collaborations development update programs on like other Beyond PD-LX of brief franchise. a

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which We first of would trigger begin in half payment. XXXX, a milestone X expect Phase to the

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we last investigating additional to investments. new discovery-stage initiated year pipeline Genentech a in bolstering addition to platform application Beyond technology ophthalmology while oncology, continues us, source for respiratory for of excitement a our our in further collaboration be

like As wish to Company, Medical I Dr. who in his a leaving contributions endeavors. final update, Chief best Pieris Tim Tim all served President Senior and the that be to would as future will to to Demuth, I Officer, like and would mention has his the for him thank Vice and

in which through and solid PRS-XXX, enter the talent As partnered will call a remarks, XX to with months. we Tom. Phase partnered within a advance like study Pieris the fortunate my base This over stable PRS stay AstraZeneca, programs healthy to volunteers, multiple to concludes at partners several to we're would XXX, prepared focused of next complement hand on PRS-XXX, and have now to great I readouts Servier, I a clinical soon with

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

our deliver on the commitment managing coming wanted program providing Before sheet our update important reiterate results, our to months. balance to an financial I updates quarterly to in

believes equivalents Cash for of of XX, along million XX, quarter in funding CINRA and into ended II near-term for trials, compared ended operations With the December first the a quarter half of million the June operations of due $XX.X Phase down and $XXX.X across This equivalents a to number the the cash XXXX, XXXX. decrease programs, cash development now totaled quarter modest sufficiently to funded wind of cash the XXXX. milestones expectation of is balance the XXXX. Company second are with

XXXX, lower costs trial XX, related quarter the the work was well sponsored R&D June This compared to manufacturing to XXXX lower for June Phase ended to Our quarter largely were I in costs $XX.X as ended the for million due PRS-XXX manufacturing as in decrease $XX.X all were costs Company's is and lower XX, of preclinical expenses for as XXXX. million program across partially programs, to entered higher PRS-XXX license and increase respiratory costs finally, collaboration with into in due earlier-stage XXXX by costs. for partnerships personnel offset and lower new clinical an These programs costs costs. later consulting immuno-oncology Servier fees stage and partnered lower and higher complete

for for offset was were of XX, facility the the June This Our to costs, G&A million costs period-over-period expenses some by primarily partially compared lower service XXXX, travel $X.X expenses. lower quarter ended million the professional June ended decrease XX, $X.X XXXX. and quarter return driven by

For Phase net loss back XXXX, a net grant a XXXX. quarter And for the million And June or due loss loss call the share the share of I of compared of income to PRS-XXX we will $XX.X finally, is the with trial loss compared for per XX, XX, turn PRS-XXX June year. higher activity million quarter or per to this June June quarter our $X.XX was for that, initiate for of $X.X to as ended ended I over the plans XXXX. a levels quarter Company the $X.XX XX, XX, for XXXX, million a recorded This Stephen. ended to increase clinical $XXX,XXX ended to $XX.X

us Well, now thank for for and would like call the to joining Tom, -- you open you you, of all your We questions. for thank today.

It of looks from like Instructions] Song [Operator first will Roger come our Jefferies.

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may be So as the them data to the the process is efficacy make along design, have help AstraZeneca reevaluating they optimal of and decision for been study readout? the seeing what to kind enrollment the X-milligram and

Sure. Roger. Thanks,

for AZ in maybe trial inform and So the X-milligram is are efficacy that view data to dose your is on our optimal correct? using the the dose portion, focus what question totality to

that's Yes, Yes. right.

Yes.

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Okay.

-- I'm two So general questions Roger. great, are Those in hearing. there. so

concerns data, positive are the in after line power that one the these study, first of thinking the the And how top what happens The the dose, of about Phase two, particular, X-milligram view in of we're totality. IIa assuming modifications. FEVX in data number on

have study up So included the with deal to alpha say, information the wealth study, IL-X interventions, AstraZeneca receptor when designed a AstraZeneca and there designed the backing we other great including we was that of from assessment of dupilumab.

and roughly for endpoints is study. improvement placebo appropriate, a the very patients FEVX in proof-of-concept So the of Phase powering that confidence other robust treatment arm that targeted And included there very to data on II AstraZeneca, great the of of on deal the there cohorts. achieve a is then proprietary totality the based data study the the patients based XX in XX that to are

and size So we X-milligram maintaining of are the of group placebo group. the the the stands, as size it

XX look We be is milligrams. well will to dose, think we is in patients but X patients in X and FEVX powered the the be of milligram the fewer as targeted very that focus milligrams. at would placebo. far clearly in relative endpoint that improvement XX So to There mentioned, placebo X

good that. And we feel very so about

prior made general current And any of in to is talked any trial. other finely well with more time. We as size any treatment. it calls, to there. or enroll increasing trial anticipate about placebo cohorts or COVID we placed has interest the company at the not for masking, do that the we recruit result, the we're asthma a also and as So of And the think in the with challenging

of the deliver as improvement we really I it's four think steps, likely III over it's a currently Phase the endpoint publicly either I over and time be FEVX and BLA part than good Phase importantly, as assessed to is budget framework, would would everyone mean be co-development think triggering need we at We you weeks. is which since of I to Then and that a that. any strategy, So co-development respect able and the up exacerbations data. this have more part remind AstraZeneca about is endpoint communicate XX-month of feel a all with and period, to probably plan part a through before materiality to to possible. Phase will AstraZeneca, next straight to than is at which probable level given III an the detail would IIb appropriate going option different there.

before will co-development go-forward our So analysts, be the that would would understand plan external clear? what investors, any we trigger Is stakeholders option. clearly

very, very, helpful. that's very No,

think it's clear. I

Okay.

question Phase So just both you with see see that's you Phase is Maybe benefit the your seeing what of the elaborate and clinical your what you just X-XBB Phase mentioned II, ongoing reduced also, have what will one of which generate for XXXX you on And data I from in since in trials? in general. that for the you XXX. other kind from benefit. clinical in consistent you benefit data And confidence you I? CINRA Maybe enrollment? program just IO IIa, the been the gives kind still Phase program the the Can

Sure.

Okay. Yes. questions. Great

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be The next person in ISI. Evercore queue Miller Jonathan of will

It I be to expecting knew the here there is folks than feels though sort going even were longer we delay some was think Pieris-XXX. start like let's recalculation most with here. of

a couple be changes to which a all accelerate So whether which attempt to could of is this enrollment indicating maybe mentioned give an of enrollment. a you to trial color You enrollment? least seem bit design, more at us faster on or little just --

lower that dropping dropping substantial is the milligram you're and XX-milligram that is -- program? so a to for the you're that us enrollment. try is square down efficacy, given in X delay How much why So it you can circle efficacy

on you I in well, temporal, leadership masking. ground a not if was It chain, the supply sites now. as can world candid the impacting focused John. making, boost respiratory eye? just but third Look, but why for the three to fact, The what priority has, say, still the we And lines ago, everyone's it AZ. COVID Great the down still is may seeing, we And the time not the enrollment It's finding capital in quarter immense that amendments the to The team, human skinny-ing not trial that and is changed that is for AZ, bull's years the put. the This trials. control of fact, based at enrollment just on Thanks right think is I rates, question, fully manage with the very everything element appreciated masking are are it's also high project. say, don't we're it. question. rates. CROs And the is the of It's is think happening disease [temporally], also that. and to impact simply same project

very the and deliver think and that I with is as dose. accurate piece, and all X-milligram deliver that it's the would on is what the to in So characterize based changes, the to thorough pragmatic AZ a going trial, assessment we going these essential which trial

feel we that good changes, the wait sure decisions and other to as this And the we other adequately that now. AZ's going is just XXX in we program, wonder for have we're and good like if the morning So wake about made making and to programs the these capitalized to we're about make committed do feel difficult But lines up time I data don't our to to investments other XXX. program. high-impact while like that on priority

commend for acting their efforts. entrepreneurial, they're think them resourcefully and and I very I

need and on change that following around opt-in? still conserve your up various maybe I XX% reprioritize levels? Are opt-in think that, you do your least to does at money calculus the delay this expecting to then and

little Yes. I'll more a color. let tee that Tom up I'll and high provide at level, a

the overall overall because way the and us patients number it cap in take stratifying number two, intervention know the affordable of appropriate XX-XX, at that. the think about of significant current itself negotiated co-development have economic it's of of opt-in market several the environment the to years trade risk-reward that from XX%. very the ago, one, what I keeping benefit to would we we structure; a advantage the be even to pathway, could this that And allow event itself, criteria we're how value-driving

I'm play, but also be and remind confident and XX% could still many that confident scenarios, see, always we XX-XX wait we're maybe that. will back reasonably to be very And say and can in in why Tom implied. have we'll go So that everyone

Yes. Thanks, the of agree I those target overall for that's that And comments co-development Steve. why opt-in. shoot in we we'd terms about with think

sort along the reiterate we're And no that to XX% milestones here, just of way meaningfully clinical the opting so that, or immediate of have we carve-back of the stages costs milestones there's sort anything of or development we're again cost offset going cost entitled to still future in, in. opting for do When that some development the of of that to have incur. to for

also show is data and that is cost very milestones this. valuable we We going we help along if expect would level, the being there a the help I of again, it's we at to Again, get would data and program we again, development to with opt-in XX% the that credit think burden a going plan that, guide be readout decision. if higher get ongoing quality important. that because and from the positive, inform guide getting the think be is opt our that the on decrease. be will basis But that of development to dictate We able in an for do AstraZeneca

I didn't And maybe Makes sense. for that say XXX. that. IND on an noticed Great. then one you

filing. you a said regulatory have You

making why development a talk geographies bit and the about in to choices the you can do So you're more you're there? making for how starting choice where about -- developments XXXX what little your program,

with and are mention CTN filed really Australia, a what We in we didn't we XXX. We IND. repeating did Yes.

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cash turn I'll Tom some some about I'll to it our we over talk as of yes, did forecast modest let Well, I'll talk -- about milestones and for that forecasting Tom.

Yes.

we of would and Steve word that So with in did and agree we're say how about I it, the thinking used terms modest, that.

across pass for Boston We into expected, we would some there are would program have some goes If So we gates. be some milestones AstraZeneca. that of these would milestones helpful program. example, the I us, with like of again say, the that -- that for support But sort the not clinic earlier Pharma. discovery we've seen that not, partnerships, different early as stage as they're magnitude just but they're and characterize mentioned,

help have comparison to milestones development recorded past. and bringing we've to is shown just and partners they're these just and cash us, to the put modest continue think our it in in in -- it perspective, they're committed a does programs I So but meaningful from perspective to them forward obviously, the

Matt Our with next from William question come Phipps Blair. will

you've longer-term an assumptions would patients more impact therefore if to some number and mean in what type that then criteria? require happen does maybe placebo any changes kind to do trial impact also I has that of you trials on a Steve, versus of moderate the impacted -- meet a FEVX the do broadly, think qualification? that that kind empower of on just exacerbation side severe you wondering, mapping that control pre-pandemic? think historical need patients that more arm FEVX in And certain of commented in might has is Or asthma. disease on And how would finding I'm of of still

Matt. Yes. Thanks,

think trial. mandates, efficacy normal impact think us and think masked. eventually. I here on return just the I we so. people So I I opportunity our maybe during the enrollment last happened a asthma. the part of first It maybe don't question And there's I'll address will just if That's that try for don't think to love being timing. to hit unfortunate of was to long-term

efficient, So remember, is if likely a -- higher-cost control, upstream is benefits of play were overall of to ability biologic intervention injectable lead to to, the more inhaled better patient it the -- we I say, have think of efficient classically we that one more biologics. the even say

if positioned think of I So than that that biologic be like better will something happens, XXX. to no take advantage there

-- considered exacerbation respect compared or So at from comes potential something There that good the normal how to that's masking power well new weeks. placebo certainly and obviously be four a that's and how study, improved and feel to when a powered, to arm, data. and be epidemiology is about say masking by really I With that, the how would a of the and informs we is FEVX would navigating there the the the how I looking period running control study. severity it historical might around of of AZ it's power

we really good we'll using that trial. the baselines to the into about be feel go So

we making. the criteria we inclusion actually address think criteria think we are I about AZ When spectrum. amendments exclusion of maybe that the both control ends that is talk making or the

example, So we're XX% XX% modifying the criteria to from for FEVX XX%. to inclusion XX% to

general. could were do be come think the will be allowed opposite dealing or who have And in come the to to reduced that would patients much into then trial. trial. They we actually with patients controlled would less more able into what then currently you I suggested So happen function if control of now the

We There are [temporally], other are we the years either and powering is getting really maybe change. combination. maybe But retrospectively high as also, back last Typically, years. also that a like or in about screening a are masking reflect LABA forward, like which rather other five that think, demonstrating changed exacerbation things or lastly, now than I where within you good in the exacerbations. things mandating of combinations errors looking rid how how dose more to that -- are devices patient things couple of medium at dose a feel then allowing look shows ICS has you study. what at maybe unforced an control, the couple at of that well see two And vein, trials a allowed going things separate year another we're as reversibility ICS/LABA

year. one years within the three amendments, With the to will be changed than last exacerbations it rather

are, today. allowing also on masking be get who worse allowed us those in based would think, the control the allowing patients collectively had poor be enrolled than I trial who before and patients have to control so enrollment to And historically

Okay. the data you any you Thanks cohorts? last move additional details. expansion will the for the into XXX, One present before on one,

on We estimated in, a to on it sure to, aligns we're environment compared on that timing NTD. given in that find we can't is into sound that that expansion. likely move because if We all dose, investors depends like the why analysts rationale might medical an It say also say, would depends which escalate. forward optimal there with depend ourselves biologic biotech certainly with want to make we and our be understand capital-constrained definitively or for scientific and how conferences going that would

we where some that's way think clear conference be look I of remains But escalation, at that, hopefully. end is plans year, and when that the to line finding the I have the going to to So is whether towards time top decision otherwise, to able which with right, communicate well forward continuing we to to determined. be that beforehand go make or would description a quite on medical or Servier say the

All questions right. no further And time, [Operator joining gentlemen, at are this and I the Instructions] in nobody there queue. see Ladies queue.

So Yoder over now turn remarks. Steve closing it for to

joining Pieris. your continued and thanks, I and just a today Have to want your everyone, for for support attention day. to great say

gentlemen, Once and again, ladies concludes your this call.

disconnect thank your lines, you for us You may now today. joining and