Pieris Pharmaceuticals (PIRS) 1 Mar 222021 Q4 Earnings call transcript

Greetings, and welcome to the Pieris Pharmaceuticals Year-End Earnings Call. [Operator Instructions].

As a reminder, this conference is being recorded. I would now like to turn the call over to Tom Bures, Chief Financial Officer. Thank you.

begin. may You

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

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

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

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

bispecific of collaboration R&D a year our us collaboration our XXXX collaborations, ophthalmology Genentech further for busy today year-end leader several the for Tom, you, X-XBB joining entered respiratory Last to thank and and and year call. for Thank a partnered expand including us. with into was pipeline. everyone you earnings to We execution

unveiled our first-in-human clinical trials, studies and PD-LX our program respiratory in also proprietary bispecific new for We multiple a X-XBB franchise. including initiated we

XXXX. like this to from these I to of have now exciting year you through for of last year. what expect set the to for highlights some take would these and an All stage discuss

cohorts program multicenter safety moderate treatment respiratory a IL-X this formulation. our that and you X in The developing the is asthma. the study, the XX asthmatics X controlled arm. AstraZeneca the dose many weeks, dosed randomized alpha portion over asthma the inhibitor the changes year, standard Part ICS which severe were of of are or aware, X:X:X in portion is we of placebo receptor pharmacokinetics. daily and inhaled such MAVA, to study levels In review conducted on a PRS-XXX/AZDXXXX, for As mg DPI The currently lead are program an dose included as AstraZeneca mg successful of of study. in Phase completion we markers, safety Xa, as that the across X Earlier incidents placebo-controlled in measures of of consists announced Xa alongside the twice of that dose X therapy, medium care with events, moderate laboratory FEVX adverse

dose FeNO or X:X:X randomized microliter are or the to oxide nitric per to and equal across equal a cells X parts screening, greater then positive for asthmatics is a study, AstraZeneca levels. review, the of now efficacy than and this the enrolling Following the on of a moderate billion or placebo greater XXX X exhaled dose milligram at blood fractional in per eosinophil and the safety X XX In of uncontrolled with X ICS/LABA milligram count portion a part arm. study than cohorts

the of safety highest relative at placebo point to portion are end the to at now study. dose X:X level, enrolling AstraZeneca In of primary of this part improvement X which We the parallel, is weeks as looking treatment XX-milligram FEVX is in the randomized placebo.

orderly update are study in actively year, time of course the geopolitical will and data if results we Xa of Phase this guidance the line business, lines environment, top current the in our we to guided have feasibility we needed. evaluating Although from study our

plan we a AstraZeneca. possibility with being to this of the a of XX of program from forward, budget, into opt development for the This of At first the which enable PRS-XXX days cost cost opting readout would Looking cap. co-development alongside we level, for a us, study presents we royalties. from with a one of study co-development considering be share still Within in neither and predetermined cost made opportunity increase of sales a XX% the second the trigger our when of responsible meaningful choose includes this cover without cap. portion a to top be level, would for positive us cost option would the can share exercise future development share the XX% be line the milestones in proposed our responsible at milestones levels, X would and that an fee. to share At of available of cost X data of potential a

gross this we it we margin share. the to milestones continue co-development the to in If receive opted this would in PRS-XXX, attractive commensurate opportunity in more had opt-in participate to choose receive Although of XX%, sales we us would require royalties if first would lower those the not to tier. an at than be ongoing milestones would investments, development enable although

will we United we a in at co-commercialize to co-development options in have to As all, the option the opt choose beyond whether reminder, also co-development program the States. this and to

discovery collaboration Beyond remaining with the programs AstraZeneca was to PRS-XXX, the and X We able stage the co-commercialization an validate the programs in options exploratory in X not discovery retained collaboration X X in AstraZeneca. jointly discontinued for We are co-development for advancing which programs collaboration. X target. active of we of

briefly grant that this starting program fibrosis, encouraging reported initiating our we And advanced program X pulmonary idiopathic to for program connective a year. also we our I or in we we Phase post-COVID that data study targeting received the Bavaria from pulmonary year, announced which an healthy in discuss fully When preclinical fibrosis. from this with announced of anticipate supported such approximately the as on also for last grant State for factor, PRS-XXX, growth is cost manufacturing unveiled clinical CTGF, to moving This and clinical evaluate We IPF, year. and very last making inhaled has GMP for anticalin clinical the last near-term volunteers. activities this year, since development, apply program recent we development a respiratory X proprietary $XX protein investments of want effective. GLP for most plans Phase Germany to the and will tissue readiness asset, Now million treatment tox to

and as addition target, about offers. excited we validation reminder, in Given to the this committed that Genentech of last to activities signed respiratory inhaled and ongoing an the collaboration clinical initiated ophthalmology a the X antagonist we year the benefits which have have are this with ongoing of for program And programs. an discovery CTGF, also we joint of we part potential opportunity as

more alliance are We as it on give with that enthusiastic to progresses. about hope updates Genentech and partnering

to like X update clinical give I'd currently We Now, an immuno-oncology have in clinical pipeline. our on development. IO programs

is HERX-high those gastric single-agent announced X Cinrebafusp patients the kilogram an CINRA supportive activity weekly month, in patients. drug CINRA CINRA tumors, in program mechanism is X cancer are ramucirumab with need. Last as maintenance both the with safety this second X IO showed dose. with which the arms. study acceptable as dosing CINRA studies, we per bispecific arm, HERX-low an HERX-low CINRA PRS-XXX are In loading data or gastric for and combination XX short. a in In of QX study well first a program. high in In we of with the gastric evaluating in we includes of profile. paclitaxel immunologically milligram expressing HERX-high X-XBB/HERX and unmet first patients. patient of in represent its lead dose arms, showed both for Phase CINRA cold we In tumors XX-patient action arm, with medical This the or activity, developing cancer. biomarker Phase tucatinib the a dose evaluating proprietary Alfa and per includes for X-milligram Our kilogram are HERX-low separately also combination cancer

to for data expect arm, from this arm report We report year. And next HERX-low data year. HERX-high to we the the expect later

we XX% XX% arm and guided, the in arm. the least set both Go/No-Go have objective for or response a rate, our high for in arms and of at HERX-low ORR, HERX-high least at previously As bar criteria of

safety will at looking of we be course, duration arms. and both also for response Of

in Phase X/X Now, open-label safety tolerability the antitumor addition escalation activity dose known global to CINRA bispecific. trial, we to Phase the initiated also of also study X-XBB as the evidence PD-LX preliminary evaluate of SXXXXXX, a PRS-XXX, X and

PRS-XXX evaluating peer-reviewed recently in patients solid for whose on standard journal currently in tumors preclinical We we also care treatment. cancer the Research. this program And data advanced of with Cancer published Clinical are progressed

sales ex-US X-XBB. within would to continuing for reminder, PRS-XXX, an IO with ongoing States PRS-XXX is royalties have update a which United we for Servier on Anticalin-based receive develop I our a rights As the the and in this beyond bispecific update IO end commercialization will other quick undisclosed also the on to alliance partnerships. is like program. exclusive

additional collaboration Our have those Seagen this to progress, programs and updates we on to hope later with continues year.

of to to IND-enabling potential the the to necessary back the to roster are progress my is toward a hand And I be concludes with partners. development bispecifics in Pieris-sourced have prepared continues remarks. the soon Tom. they call bispecific to Pharmaceuticals like rewarding GPCX/X-XBB It multitude licensed or year now work Boston of over Additionally, This see clinical great would clinic. in the the PRS-XXX, last X-XBB that

equivalents Thank the million XX, The to and to from everyone. collaboration cash year ended you, Steve. agreements, due received equivalents and existing $XX.X was And year million December including cash balance a December and ended XXXX totaled for cash new milestone for $XXX.X XXXX XX, since morning of XXXX. compared the achievements. again, increase Cash December cash good

end qualifying in the Bavarian was of cash fund to an partially were planning development per CMC of also the include total XXXX, to right share. million X we XXXX price will ended the net $XX.X during year, ended does XXXX. activities be clinical million that R&D The at incurred advance by average of in required to noted to $XX.X initiation the and of the are trials impact position relates year-end addition, year were of utilized ramp-up These In The during costs PRS-XXX XX, the program this the for for later cash not $XX.X XX, expenses as expenses are proceeds year. government trials, in for R&D proceeds grant raise for December compared started of the which increases reimbursed cash million in of starting period. those operations PRS-XXX year the offset XXXX. December the program around Steve IO ATM used a $X.XX

were expenses incurred offset on the December increases G&A These manufacturing XX, PRS-XXX, million we costs. December clinical to $XX.X ended higher employee-related XXXX are XXXX. year for partially for compared addition, and Cinrebafusp million costs were XX, year Alfa ended lower higher fully In $XX.X which costs on by reimbursable. the

year-over-year. of insurance leverage that management our such compensation We spending costs. continue consistent accounting and to offset were G&A by legal, total was project XXXX, higher capabilities In lower fixed functions higher and the variable and G&A costs

office also the costs prior of costs and year. as R&D We the were to to Hallbergmoos, move new incurred lower building related number in there facility one-time in the a equipment Germany

share million XXXX, ended announced XX, loss year the that $X.XX XXXX. With or in turn I the XX, or $XX.X compared year Bavarian Steve. back December the for recorded Net for will December was XXXX reimbursement million income that year $X.X million was for For costs program to $XX.X XX, the ended of of loss share per under for December over other to the qualify PRS-XXX XXXX. of June net a was $X.XX that, call loss per ended loss grant

initiation. I our initiated want We There a We characterized Tom. we closing, up partners you, to trials new that's is to set new necessary well was and key points heavy-lifting an I and upcoming PRS-XXX just for added last and eventful healthy clinical subsequent Thank by catalysts, to maintained those our CINRA inflection clear from keeping a as and Phase the In and as year execution decision opt-in year sheet. this us the look say balance later updated XXXX. roster. on as forward PRS-XXX focus progresses. our you to including readouts our PRS-XXX on year clinical Xa data

call you we now thank today, the for joining your like open us So questions. and to for would

Instructions]. [Operator

the from Jonathan of Miller Evercore. come questions first with Our line

the way I Let's heard suggest opt might softer. maybe PRS-XXX. time was your that feeling you start I've the first not a really all that It's little language there you on in think or body

are what leaning going way good, option you Assuming still all feeling data are about towards the drivers of or here? Are different opt-in still is maybe the how not the you full there? a the you X levels of

educate were to around should aligning as those what the choose detail as doing milestone milestone on think we start opt-in royalty we've discretion not the on through or we want to opt-in I other now opt as could after then be what able which AstraZeneca And with contours, to is of the value with could decisions our that baseline the to and we means been investors distinct And in on we contours in communicate financings. how trying well the the streams at unfettered such X make whether funded, income traditional equity all.

a opt-in color to turn on is it's provide we the over rule fund I enthusiasm of think good much particularly So, be But bit and in certainly everyone Tom affordability go we partly little not and is I'll of but will to attractive, sure for and more how level there to understands a first little other cases. to responsible out data for think the the I want XX% how to it make this bit would going example, this. we're one, deeper why, all

meaningful, So, royalties just And expect our nothing, do right? we that are the levels, clinical we I to if development. so phases then, think we we development various milestones sales will you'd clarify, in of normally of milestones different milestone that are did get to this we is XX% the for the an we here any would So get those traditional a because attractive milestones the opt-in, opt-in. development think that us to for the if for move from be type get we similar on for product. collaboration could of co-development commercialized If option that co-development the nothing

have XX% we royalties would development share, in on would and ongoing a opted we milestones. of upside potential the to at to XX%. milestones much here, So, then that And a greater from have sort we the be offset entitled sales cost if we significant

option. we of in really ongoing co-development can At of that we the So of think development this. an we're for and something this we development meaningfulness how that's, attractive would the again, XX% think terms to share. the milestones makes And again, have forward planning upside, we our sort look a

would upside in program, on the that margin even doing we But of would Here, would be -- we than would be the a gross from first milestones there be lower the that development would which scenario. share step-up by sales would the further the that, get the we milestones again sales get. co-development royalties commercial and

saying, decisions to results, going obviously, and think be the upon itself data to going I without we look good are meaningful That post our Phase goes that those right? any take is based that how Xa the us. be it most of to

a be it's important other that piece this but not publicly And and component then, communicate data just is, a also have the we'll and of the budget. have go-forward to able we'll plan,

here. thoughtful accordingly. and and will a like It be FP&A will be won't black put be able informative, to we'll box an be it So there very

the the structured to And So think, in, good we and well. and lot would plan of investors, a in as the data XX-XX there we the option, a are viable eyes then sense I And going wait at rate. the news given good we're even pretty lower believe, how if very the is, opting about feel of it's also makes see. be our

tuned. stay So

is, companies not that we're sites that The result from right the I Obviously And geopolitical that would noticed time to meaningful the in the a are situation on PRS-XXX got what your to one site one just now. Ukraine fundamental thing the this Ukraine I on very the the all your you've only touch environment. impact on the here other watching of wanted of in But perspective line obviously carefully, on commentary itself? in circumstances one trial, thinking obviously. given about impacts the is study

Yeah.

role are The safety played over And a used the efficacy had the we've use Ukraine safety So role, the for study. portion. a nuanced us side what and fair portions for fairly we the a of safety portions Australia study. in for the important Ukraine would little different the

So efficacy we're doses and in as enrolling parallel the the also X cohort, cohort XX-milligram the cohort. portion, we to highest the mentioned, in safety the

a involved multiple study. and the this So, lot for They terrible development not our on notwithstanding, involve would something the timelines access be it could as we safety but used you on we've Ukraine that We're that changing know, used have impact anything does depending them letting on are program patient we're just portion in efficacy the as sites. cohort, well, because Ukraine, safety in third the today. that know investors directly

ways to portions. efficacy So, certainly that there's the for around navigate

really housekeeping, to we is to with looking not, good orderly And this timelines. thoughtful letting this be through investors going will of business, we're CRO corporate just is discussions the an us able we in So And as is mentioned. the update very something in that the course AstraZeneca know at. reconfirm make if

today So for no changes sure.

And that that obviously think makes we're all very dragging sense. closely. I situation

come next William with from of Matt questions Our Blair. Phipps the line

First that later Part target kind just in that from progressed clarify again, this on exceeding that guys that or year the kind would larger of Two-Stage to Part you had have B just patient in and, update to wanted A design you to then of out, laid a CINRA, the Simon HERX-low, confirm population. of be

meaningful very industry. eyes in hit HERX-low patients, the in both a that and, you bars I to that community think patients. particular, right. to we ability into we really in be as that XX regarded set think ability the And the we ORR will them we having if investment for that and meaningful of be we in achieve mean, XX think XX% achieve have that high if would bar, that's Essentially the we --

a go open that up And should of so, options number forward. then for

I course, year, expansion. that for think readout the and the progression aiming end ORR. just But into is, patients data the it patients we're the consider one at for progressing as at look totality the natural But forward data we'll, to after stage what the of of of XX that's broader clear. options course, of partnering XX even well. make That's

-- mentioned the this additional milestones much to expect the from year. you sorry, you this know Seagen can't too year? take do I an Are but disclose or -- continue later progress Seattle targets collaboration those You any update

we're but So, milestones have again, some And a a before at probably we can [indiscernible] remember, with can this. with way have can with say, than which but the to year program, entry milestones a updates color great to the progress are I this And point, there of the I are we can't expect program communication here. but partner, also a color year, we is might that provide deal, us. clinical look and of milestones, -- more of more is structured exactly the think development the not would align really in public, more would There there clinical pleased was bit from progress we them and would that share we could around forward to we still align subsequent Tom partners, you we that providing one Seagen I making Seagen a able imagine itself. would just little be our and with we anticipate say proprietary front to lot color what with program. lead later there's be

all more milestones. Seagen add And wants and I any the align know if don't Tom here detail. on to have that We color with to

they through mean, I to you're Steve, clinic progress into would as and entitled right. milestones that. enter be the we

as to benefits those forward program, only just we that So not some the the development things obviously well. look from the are but financial of would

lastly, first And following of Jon's on question. kind

higher all that now from safety or maybe the Xb that was trial. mentioned portion done Does is can be you Ukraine in coming dose done of or So, whatever and mean the the near-term of risk getting the Part that Australia real that Australia? -- there's kind

very we leverage I practically many COVID. and most I locked last ago. certainly But the than that a recruit. think where implication. is that's that think, it different could The country various was right we for certainly than COVID around down was states mean meaningful. I year, normal last rely Australia. jurisdictions, we're back could that Australian was Definitely now on potential that's of year year, And and impacted now the Australia Ukraine evolved one maybe across in to had getting kind And more of we feel geographies, ability we to effectively situation

[Operator Instructions].

with Our next come the Song line Roger from questions of Jefferies.

just already co-development because gross option sharing. of margin So, improved curious the this

what can if you core on be PRS-XXX? to comment the this additional kind So upside -- will you options? the just of commercialization decided Just co-promote

to Tom. going to turn I'm over this

especially color say Tom the not AstraZeneca before lot entails option. there's Just more maybe just the provide provide a that. bit But around communication a that right at on can more kind with outset, around co-co a what of we on can aligning co-development color now the versus

into to I think once we co-commercialization. about funding how when that to going of want obviously alongside that's they us this think for so would -- a we at we're potentially AstraZeneca, is something this, we're and have decision the X clearly later, this of where be commercialization looking be sort Phase point

a giving and nice that's days sales a about able biotech something perspective, I But early as the commercialization it's of probably develop terms that have in very saying, of think lot moving from we're a potentially again, to sort being sales integrated we of it's So and force. think thought. being into to us option the aspects

how think company. forward now, of have we and can the co-development to focus meaningful for as a execution right be I looking the that for those options on to sort want us and we

to of foothold forget, function to economics And explore co-commercialization structure that I fixed here, as XX% Those really been around like there us integration. the a the to we to. commercial the able opt-in. or would the and The not think I are XX% itself. to whether be about, is getting co-developing the we But all the wanted Tom to it's or not. facilitate think, able do also Roger, we And independent if is not I we've of opt-in co-development for what are a in help would the option said, the say, as that mention, Tom to shared fair is talking That's that if that. we are we would co-commercialization do economics mentioned feel we that be or we as spectrum, key really

so, And realized all of ADC. of program, therapy, recent in IO next-generation the for -- we the aware particular kind HERX-targeted

the gastric the kind So breast exciting [indiscernible]. some X-XBB from but news reissue cancer, of cancer, not bispecific kind for necessarily those of curious versus around your your thoughts ADC targeted HERX

you are Roger, the to ADC low in recent HERX-low? study, And HERX referring data from

Yes. HERX-low, yes.

Yeah, it's good.

really announced from -- there's in HERX. So data some that was

We've you the think talked about relative Shane, I And that think Shane want fundamentals it do of immuno-oncology back HERX-targeted agent is could for now I the a next-generation to an antibody X-XBB that's within or major joining to next-generation thinking the we share this to probably sentences, but Shane's one? take in he why in treatment And this. couple we're paradigm, placement the or about and have about with scripted to it best think change ADCs. a can goes maybe And of whether that either past, again, fundamentals a really IO ADCs. talk agonist person of the or think role alongside a call, I how doesn't a the TKI great of patients. toxic a X-XBB. classic X-XBB therapies, payload bringing

the for thanks question. Roger,

there. targeted mechanism environment pointed of space. action T being the exploited a fundamental advantage here. The is in from Steve opportunities cell now as differences nobody is agent there's taking this fact others But the HERX-low in by just shows out, essence, So, our in of perspective, that

of coming levels X that a manifesting a perspective, Phase induction manifesting? It's lead immune X-XBB in Our showed quite the expression. how T cell tumor. that destroying elicit strong on us study X-XBB our memory of a it will is And microenvironment data preclinical can by agonism. data that and favor you're of HERX of we And expansion. an out based will going response to From to tumor believe response. expansion, cell NK We change elicit low

a X -- response. And see Those CINRA to responded study Phase as that durable lead we will You durable had well. in impact. will the to patients that a that

facet profile. here the key safety Another is

profile with very we about, safety to So, combine have either a them with as it's other agents. with going instance, a to to and think you be combined ADCs, work agents. pretty for allows CINRA, And monotherapy acceptable that difficult us other or if

So, we in terms a data of forward space. position HERX-low HERX-high both a the look arm give strong very to coming -- biological X HERX-low our plan will and different Phase and it very HERX-high both but asking questions, us out as go-forward of in the

no Steve like at questions this to are There turn any further call over the I would Yoder closing back for time. to comments.

I a your attention Thank All continued other right. Thank everyone wish you. great support you. for and for Pieris. to again of your want No other comments than to everyone thank day.

conclude appreciate We does This your you. Thank teleconference. participation. today's

disconnect your may lines the your of You Enjoy time. day. rest at this