Pieris Pharmaceuticals (PIRS) 11 May 222022 Q1 Earnings call transcript

Good day and welcome to your Pieris Pharmaceuticals, Inc.

First Quarter Earnings Call. All lines have been placed on a listen-only mode and the floor will be open for your questions and comments following the presentation. [Operator Instructions]. At this time, it is my pleasure to turn the floor over to Thomas Bures, CFO. yours. is floor the Sir,

Thank you joining call thank for everyone. corporate good for our morning, us conference And first update. you and quarter and XXXX

CEO, Stephen On Olwill, outline and our and will Kaufmann, pipeline. Chief Officer, our we our call our our provide also have Chief Demuth, for Officer, the President corporate Development today, on Q&A. and be Shane Medical who Tim overview Chief will a Officer, Yoder, available Hitto Scientific

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

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

funding. will our back before developments our significant to markets, turn joining My first-quarter everyone earnings our two capital the our us We'll first alternative from speak key our grant the for as for support sources today on questions. to to value with such Thank In will the we franchise biologics most within inhaled having of our which update call our of two to four and your who assets, then funding, context resources open quarter, advanced of our financial respiratory the focused present a you, partners or biospecifics belonging XA XXXX in moderate is our Phase access respiratory across I lead Tom, Biopharma study reflect The PRS-XXX believe the where to AstraZeneca. AZDXXXX, and R&D franchise thank we capital to our Tom, results immuno being for within call. the is crucial pipeline severe and other in franchise. by alliances asset you driven -oncology asthma in and address

first-in-human high continue year fully Next towards is a we later program advance which our study as this proprietary PRS-XXX, to pulmonary a fibrosis priority.

Our two study initiated cancers. known as IO our Phase both biospecifics II we CINRA, stage HerX of the clinical in expressing program, Cinrebafusp the Alfa, quarter advanced targets are most gastric also and which first

IND our program by now PRS-XXX to Servier, holds in coming followed our second of for going momentum progress enroll assets. together with in building continue SXXX-XXX on ex-U.S. within the snapshot programs further having with co-development We partner U.S. the patients a beginning for our IO this acceptance who respiratory received I'm our or program. alongside to rights anticipated these quarters details provide catalysts assets, our

three Phase moderate respiratory the efficacy alpha are the initiated for of AstraZeneca PRS-XXX, XA asthma. receptor uncontrolled in day care we milligram is formulation developing lead quarter, with the IL-X medium twice of given agonist or and to randomized is standard one-to-one-to-one asthmatic first and the with treatment regimen a three ICS/LABA inhaled top moderate corticosteroids that inhaled study the Our inhibitor the inhaler program on across which patients, long-acting of both on XX milligram data of one powder dose placebo moderate completion dose the AstraZeneca In of of safety dry and portion an the the formulation in milligram of severe controlled therapy. DPI one treatment of enrolling cohorts established dose the the is announced We one previously a of levels, the which portion plus asthmatics part consists standard asthma successful arm. placebo. safety study, dose the milligram of Having levels care which dose to the is at safety of XX and the of portion AstraZeneca the milligram also the three randomized level, one milligram two-to-one milligram

for the Our reporting included year. the of study this by readout end earlier data top-line efficacy guidance

ongoing Now, year. given deliver risk end the to broader be the along more that time results the heightened pandemic, there situation, a the the challenges by of is required the geopolitical with midst will study top-line

re-forecast, of process the receiving in potential any opt-in trigger of program with this timeline, along announcement a formal from study, An Pieris. on currently strategies and plan conducting thorough from working would top-line AstraZeneca, an a is and budget development AstraZeneca by for decision delays. to mitigate results

that exercise be would decision opportunity. fee. lifetime this level, of will cap product, cost opt-in through development the first includes At our the represent Neither attractive the XX an costs predetermined also of the high-teens, to We approximately then single-digit We receive levels. for we have co-development plus milestones. approval XX% responsible of making of the will will this to to investment cost potential the for affordable stand we share multi-billion At of dollar would which cap. make days level, this regulatory at up for option a from two an half for sales development with one and receive sales royalties milestones

mid share a would a enhance be for at in range receive opt-in cost to economics, second in of our but The co-commercialize without XX% cap, mentioned, the States. gross allowing we just the have reminding us worth to, would also the it share sales. XX% cost it's and level the a this lifetime option of everyone I've independent the in to options that United addition co-development product margin program And

two the beyond our alliance, wholly-owned co-commercialization continue asset those earlier respiratory to three AstraZeneca co-development we for of to connective for for or encouraging idiopathic protein preclinical tissue PRS-XXX Looking this And enter IPF, work an retained on jointly treatment or X AstraZeneca factor advance options on moving of towards year. programs which respiratory discovery our clinic, continue is we we with inhaled to which last pipeline, stage programs. data reported which track and our targeting pulmonary for remains we growth PRS-XXX CTGF Phase to year. fibrosis anticalin the

fibrosis. a treatment of As the Bavarian support evaluate government a the post development the reminder, to we program COVID $XX grant million early-stage also from received government for to pulmonary of PRS-XXX

a evaluating X-XBB in -low We HERX of and disease II IPS the also at our tolerability, better is is year. with X to is benefits are a of is excited options in on HERX Phase had treatment cancer. in the HERX diagnosis and gastric this treatments with for to patients for different II Ms. the in Phase treatment two-arm give Phase of past subjects settings. development enter bispecific state, between two study CINRA now effective believe hosting years. substantial an Aigner later The X with HERX pipeline. President effects. of facility this Bavarian study which separately, worldwide I pleasure the we We a mean -high update association grant. quarter like this survival pulmonary than despite PRS-XXX to patients a wholly impacting development modest have would our devastating five greater from why time these need in CINRA own -oncology billion Ilse more side sales, German healthy and I million achieved immuno $X just available Currently

XX paclitaxel care The in of standard the evaluating patients who cancer. CINRA gastric -high of in first ramucirumab regimen arm is and combination have HERX with

and an objective in to Go/No-Go this further For this arm, development safety response clinically addition ORR of XX%, we and of continue of at response program. a have least meaningful good of rate criteria clear duration to tolerability five,

this expect the from to in trial arm We XXXX. report data of

in arm -low second the with Tucatinib is gastric patients. inhibitor in HERX The HERX evaluating cancer CINRA small molecule combination XX

would For continue an and ORR of see development tolerability this with clinically of further to like this at we XX% paired of response meaningful least safety and arm, duration program. good to

for the data XXXX, year, low of is projections arm our XX top-line arm guidance, enrollment in initial our provide targeted classically on HERX is now cancer, education therapy properly the Because revised is gastric address we clinical HERX as this the required and this to guiding of community Although arm. data patients. HERX are time HERX-low high of to the what to we needed have sub-population first for more negative patients be CINRA aiming will engage emerging for the included this

candidate working and closely are in an the of to sites need. unmet truly drug this of medical area great interrogate We potential investigators with

next patients X-XBB solid open-label our in progressing study X PD-LX also advanced known program, X, Turning our in PRS-XXX, to dose enrollment Phase tumors. is with escalation as SXXX-XXX, a IO of bi-specific global

U.S. from ongoing to X we than as FDA engager in as clinical As the shown allows that for as CINRA, study PRS-XXX a activity our enrollment Thanks which for higher U.S. X-XBB patients originally Phase outside learnings received single-agent studies. to in and authorization ex-U.S. in dose a Phase uses was manner those a data emerging same reminder, and at from the sites. CINRA, the has seamless CINRA, X in PRS-XXX permitted well study across the

for Servier. we commercialization ex-US receive sales to reminder, exclusive stand our United partnership in on rights a And royalties with PRS-XXX we have through the potential As States.

AACR also we and pathway T-cell potency an OCS-XX vivo. pre [Indiscernible] PRS-XXX month. like in last OCS-XX drives PD-LX and jointly antibodies in PRS-XXX which has demonstrated antibody in therapy vitro anti an for superior different assays Servier to development benchmarks PK anti-PD-LX PD-LX in ex the at is to XXX, specific Beyond potency of continues both or combination to data and with CDX PD-X, SXXX-XXX, which PD-LX assays. by mono presented - comparable demonstrated vivo stimulates -clinical T-cells, human monkey stimulation inhibits PD-LX It

we Fc-gamma improve that limited by at activation shown design of rely for OXXX a cross-linking effects activation. upon agonist believe currently OXXX which development, OXXX receptor reminder, anti-tumor in the the PRS-XXX on may pathway As antibodies

to is specific Boston X-XBB within VLS-XXX, Tom other the clinic expect update this Pharmaceuticals continues Before to the GPCX next turning filed financial be update, for IND of to call program. months which PRS-XXX, like collaboration's. over we some to the would for towards or and a our brief I on advance provide a XX a

ophthalmology locally pipeline diseases well and with discovery applications for year collaboration for we on technology therapeutic development therapies our continue to platform. for the announced last our our multi-program execute anticalin of while Genentech further Additionally, respiratory and bolstering expanding and respiratory commercialization delivered the

our back the over that over I programs phase. concludes prepared to turn active within my SeaGen two a in would that remarks and collaboration, been like has to hand one one now collaboration have call including to joint This and ongoing SeaGen successfully Tom. We is

are down very recognize good to continue We it our mindful build capital in program been Thanks, has continue of the capital across-the-board. everyone. sector deploy value that we Valuations with significantly again, markets within based morning Steve. biotech how be And time a upon pipeline. to And general. and we broad that, challenging to

cash, balance the wanted of $XXX.X to first compared totaling course, December year million quarter I attributed equivalents for report for that cash to we quarter. The and a equivalents was have cash a to XX, ended cash funding decrease, and $XXX.X First, March XXXX, the XXXX. ended of in XX the a million investments operations

Next, I that in spending. of wanted role play and everyone remind structuring government of the efficient partners our the our programs grants to key

XX through more the to cost subject readiness the opt-in forthcoming have are Alfa and and funds the AstraZeneca support we funding of where development retained arm PRS-XXX. from PRS-XXX is Phase the Phase is efficiently Servier only per US the least fully the and X grant same XA study Cinrebafusp at study, arm of funds of funding fully patient we generous decision. than ongoing we development for that study the utilize to PRS-XXX, Bavarian the half of rights program government clinical approximately designed XX% the sites. our to the

for program. of lower Phase to lead lower we set was on into Cinrebafusp XXXX. sponsored development quarter operations our decrease XXXX costs Pieris ended a higher fourth R&D costs XXXX, that the as The clinical cost go Cinrebafusp plans for offset includes reduction million due XXXX. PRS-XXX the structures in cash the offset to is higher and the compared assets, to I reimbursement sufficient -- March clear March for and costs. work-related development. clinical largely costs which ended high XX no the headcount both expenses reported Alfa believe into higher for bars cost decisions were XXst, quarter in cost some personnel Phase other moved commitments as for costs partially manufacturing million govern have to on we I Separately, our by professional and complete and higher trial quarter due Alfa, is further for fund Considering XX, partially and consulting manufacturing was go just to $XX.X $XX.X by service Additionally, II that development we described, and of ongoing to program

onto million $X.X to primarily Moving quarter ended The for revenue March legal XX, deferred were quarter audit for by offset partially of higher ended was million quarter, the costs collaboration amortization G&A non-cash lower the driven March this expenses, earned XXXX, $X.X compared those and increase XX, costs. related period-over-period to XXXX. slightly by

I'll ended the March also XXXX. $X.X over that, or $X.X XXXX, quarter PRS-XXX. loss was million which March the a a call or March Steve. income net grant for a ended XXXX, And per share $X.XX XX, loss XX, of compared For to share with loss of the quarter was recorded million the turn back quarter net And to on $X.X XX, per $X.XX million loss for ended finally,

you, Thank Tom.

capital We fully innovative programs questions, as PRS-XXX Before the forward advance like to about to the to while current this of most. without proprietary therapies leverage not significant in now challenges readouts us looking would your getting the the a rights landscape mission. commercial The adding fourth and open and reiterate right who to those taking closer our non-diluted stage broad believe these later of we right our on us and to amount a call to for a and we partners, everyone's We for we data pipeline, clinical the now, patients retaining on today will to forward and are thank our points our is us apprised but continue right we enabled advance you programs, or in pipeline diversified them believe which the and bring significant to need programs have biotech with procurement, to year. deliver upcoming progress I these people keeping grant our has to that, look that you joining we call right partnering success questions. to our like ongoing pipeline

a Please now floor with today open for hold while go ahead. Thank poll question take you. first is [Operator for we questions. from The Instructions] We'll Evercore. Please questions. our moment Miller John

on Hui Hi. Miller. This is John Two Jessica questions. Hanitta for

is of or for there the selection given site in lack HERX for a function next you. milligram see Phase another of of given more portion PRS-XXX one, First slower the demand pushback the X trials there the is any And What how the these possible Put Thank the this the we'll data trial chance Phase underlying combo X space? trials Phase with from and that of of is XA -low way, landscape secondly, then HERX competition XX a conduct, top the year? PRS-XXX, the more dose? is year, portions the enrollment about development? of patients,

Thanks for the two questions.

the it and Demuth to the answer turn more the over highlight the So question. I'll HERX-low question details Tim second and first high-level maybe on start to with

Your study concerned safety first that's think parallel being AstraZeneca, for doses any data, trial. first I data particularly data in for with or the PRS-XXX high safety the the whether the in timing efficacy to dose the two on efficacy cohort enrolled that's question the

safety entire for the both we trial. that arm, efficacy the Part communications and them as is in would quite AstraZeneca Ukraine lot Part re-forecast and mentioned Xa rely the Xb. relied of the arm safety we on undertaking we This mentioned, well currently thorough part did a for we on prior a As includes have for had

knows situation that everyone can't so obviously we Ukraine. do And in the given the something about unfortunate that

mind. keep in to update one August. board thorough be earnings and thing at an corporate to AstraZeneca that's able let orderly we'll through work that We're expect a So very will be going just across which in re-forecast the next next in would the update call, provide to

about question second For the HERX-low.

being As been arm is ongoing with enrolling the this otherwise we environment, the pandemic a do we negative. in time -low in that emerging as to have challenges mentioned, sub-population just long addition characterized of is HERX that an for nuances known patients HERX in

the level so to, we're as in to through working two or we delineate HERX high bit Tim, also calling board at we're additional can and a the different it's sites of color, provide factors. beyond on which who between -low, what best bin -- go you on -high, U.S. one bringing that's we're into want arms. a working of if composite of Tim how a education HERX more And but on haven't of plan patients as well heard

Yeah, maybe.

reiterate, great, defined is medical is as HERX Steve quickly really if a are reported we're make score HERX-low is it's piece we unmet definition score make of education pinpoint that negative looking IFC very particular gastric And population IFC and the to of study to HERX a pointed of that that negative patients that them etc, of and Just if by aware the engaging want this you by need. And HERX-low actively -- to aware out, sub-population just talking cancer the investigators, great currently at standardly trial. nurses, with clinical them and in, patients help pathologists. by

good and who adding and deliver we're add expanding sites efforts So about these patients geographies education help spam that we gastric need feel that in to study cancer. about to

Thanks Tim.

Please to For our Jiale next go Roger question, ahead. Song with we'll Jefferies. turn

taking you Great. Thank the questions. for

first to the So XXX. question also relates

will [Indiscernible]. the your will the later cohort, everything readout XX that the [Indiscernible] initial on, I they of around dose for you readout you from because one think consistency time versus Is this plan readout three, current possible Given that is separately together. your

potential Thank curious you. read-out about there. data strategy just the So

Roger. Thanks,

light question, potential top-line to to got efficacy. in wasn't a for I sure connection delay of in heightened were readout per your asking make the just risk Your you perfect, maybe but the

different waiting one were all as Is I if to separately in of You efficacy there's asking, think for to potential goal. correct? a portion arms readout opposed the that

right. That's Yeah.

No re-forecast going jeopardize ultimately but think is options act will again, anything then we're of high problem. them very we all the collaborating a say, of that that just thorough say and with for because this of right we to advantage course the reasonably a will trust our going priority in do I want integrity final don't from open I to they to course and point. leave trial. I Listen, has the closely AstraZeneca for would the program wait now that be

So we wouldn't that study meant it of efforts invested rush it priority to by the great want are going compromise this if being significant with anything will very large that a all Astra as into resources program. global

we'll I we set but So an would see, to wouldn't That's what expectation. do. want

have what as wait risks. re-forecast to and of outcome the see We is the

That makes you sense. Demuth. Thank

Thank you, Roger.

Our next go ahead. Phipps question Blair. comes from William Please Matthew with

current there's I multiple of but late sites There Is or up-to-date, then since it's out in sites there as doesn't a us on realize success Good Steve, fair warning are like is the the obviously been give is at morning, press the quarters does March up-to-date. it quarter recruitment the recruiting. you countries, And geographically? But again, across number that a began trial. always this statement? new the on spread the looking about guys. release, how little contrast, that geopolitical most in not any that language trial, additional did it then around risk seem like were a fourth stronger seem which recruiting

So based environment lot of of environment across Ukraine, enrollment where ongoing post-COVID still first say be it's would still in I geographies may many is a is. to was, of again, given the first Matt, last yes, there general earnings the some assessment say quarter, fourth-quarter and in a the that's and in challenges a COVID on year fair of those respiratory risk And between situation a quite of call enrolling appraisal there different masks pandemic. ongoing and there's change question your you in studies real-time

respect definitive risks risk, call. later guidance of better is a increased AstraZeneca many a the in in is sites So the re-forecast use waiting more not recruiting basis. again, to ability. yes, the continuing trial, activate and an ongoing driving With very inform and operations thorough there a just earnings changing, confident of probably for the be we're we're next to very we're on They for have their uprising to that that, they'll global

the real is it's they on As monthly say less CT.gov than are in necessary we or by a regular AstraZeneca. working constrained in environment. I really elements hard place, supply a through that would is have time. a bimonthly supply There you update which to onboard chain But sites to and mentioned, all in chain isn't work updated approximately something no typically cadence, also get

real-time, general. as or eyes So on basis not about think that your a I'd keep but we CT.gov. active say can monthly on It's in being bi-monthly

Thanks. Okay.

which CTGF, to we're antibody see very to components have IV in non them. endpoints, from Speaking pancreatic IPF and different different readouts clinical obviously against but indications, - cancer, do the CTGF are of fibrotic going FibroGen's DMD, first diseases,

from you mechanism waiting think the more any CTGF So really for are guided trials these I think proof readout. on just do to, they trial, IPF which next inhibition until just there's year recently through mid you really read or of

we a from real, the as study in really fully pamrevlumab to through the our where believe trial clinically areas the with relevant think studied. meaningful data points us point large, Phase is was And at real. believe that all don't talk is we looking we enrolled key most that the people continuously are And advisors vantage it that has and of indication of that randomized. being read pamrevlumab been in will was to available expect also, would I the are pretty to be out I IPF of number rule And what through, data are the pamrevlumab next Xa from data be IPF from indication, year. or that to now two it a want read study we're in very

that I we'll wouldn't patient pamrevlumab. and XXX able say that from of beyond that And certainly other would low I on benefits we're that if there meaningful and our impact, keep today IPF, say important potential we be including the the answer eye are such but of within returns, even selection versus working you tell we'll there assess also even no. on. benefit it convenience is is think engagement potentially a to many still I think many nuances,

Steve. Got it. Appreciate it. Thanks,

Sure.

now question-and-answer our to I session. concludes back would like turn Mr. call closing to This the over for remarks. Yoder

have you so I great Thank really much. you add than say, support bye. day. us everyone your Bye Thanks attention to for other today continued joining for today of Pieris. thank a and nothing and your to so much for have

This participation. you for does teleconference. conclude again today's We thank your

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