Pieris Pharmaceuticals (PIRS) 4 Aug 212021 Q2 Earnings call transcript

Greetings, and welcome to the Pieris Pharmaceuticals' Second Quarter Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tom Bures, Vice President, Finance. Thank you.

You may begin.

Good morning, everyone, and thank you for joining us for our second quarter 2021 conference call and corporate update.

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

just line the will who introduce later in We the our Medical week Tim also have Officer, this Chief call. Demuth, on who joined us himself

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

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

welcome development Tim Medical who joining who quarter today call. begin joined with earnings Officer noted, by a you, to thank Thank Chief everyone to deep Demuth, comes our our for I Tom, and Dr. second clinical XXXX and just to warm experience. us Tom as you want for extending

today, Pieris. he recent Kaufmann, on novel be will Hitto to Chief prepared who that provide appointment some Anticalin our Chief what also Development call, great Officer. years, Shane, whom you before position will patients. Tim the and call know, terrific want his a doing Tim, quest platform the and While driving proteins of this all attracted in they congratulate in science Q&A innovative past listening into are him complements on I Shane to been job session remarks for during has able Q&A be mode understandably the therapeutic to X in translate transformative medicines Scientific Officer, also the perfect our on our for as

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focused Phase disease, the of on Moving for AstraZeneca respiratory our in patients are severe inhibitor to multi-program first asthma. DPI part alpha IIa jointly enroll X-part an of those formulation, the AstraZeneca partnership study of continues to Anticalin which on inhaled the or moderate inhaled IL-X to to receptor we treatment that in is treat developing PRS-XXX AZDXXXX,

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initiation, TX X whose publicly, AstraZeneca FEVX uncontrolled In will being PRS-XXX with the primary we endpoint and will to weeks having study, a of safety X announce the improvement evaluate compared asthmatics the endotype moderate of over in efficacy, Part pharmacokinetics placebo.

next time are co-commercialize We and we options the will at States. drug study announcing the separately which looking this have to in forward of year the results to codevelop United the

we programs In addition AstraZeneca, about early-stage with advance have XXX, on which time. and an provide to are working to which appropriate continue we updates will X at we

in to immuno-oncology dose the that Alfa are am II in the Turning trial coming first planning the pleased I we franchise, Cinrebafusp weeks. patient now to Phase to our report

II HERX-high The cancer. a activity supportive with high developing single Phase bispecific are agent which an drug of a profile. safety we X In CINRA or unmet of I cold X-XBB biomarker is CINRA with showed involve data that mechanism of with XX as needs. reminder, showed high the action represent those and currently HERX tumors in also acceptable patients low-expressing medical as As Phase with Alfa activity will for low HERX patient and HERX its X HERX study patients. X Cinrebafusp patients immunologically studies, low gastric and well tumors, arms, both HERX design

Seagen. for drug molecule drug supported in The agreement is The regimen, tucatinib small supply with and the a CINRA arm current Lilly inhibitor of a and second-line HERX supply CINRA combination by is standard HERX arm high of in will HERX agreement HERX, supported combination with evaluate and evaluate ramucirumab by paclitaxel and low with TUKYSA, with ramucirumab. will care a

cancer Asia, prevalence we be Korea Given study the of gastric in the high the U.S. will South in in to addition enrolling

particular evolving analysis and this bar closely, setting. landscape to continue of monitor high in HERX the will maintain the for go-no-go each high in We planned the a study in will treatment landscape

achieve of will a these setting remain number evaluating in and ORR I are we be safety. minimum duration a the standard efficacy benchmark arm, XX% the settings. at low ORR XX%; Both of Phase these in the high we We minimum the for at data established confident by we higher response we are than in of In studies arm, of HERX that ORR based can ORR, on a and measures, our target generated target are objective the HERX response of care the rate, including targets the We have goals. XX%. setting

second asset, and we, IO Beyond PRS-XXX, with most S-XXXXXX. Servier we CINRA Pieris advanced Servier our or PD-LX is full X-XBB codeveloping hold PRS-XXX rights. a where are bispecific U.S. is discloses

the PD-LX or tumor-specific we with with study patients We open-label to study avoid tumors expressing treatment. of year, thereby the X-XBB this dose bridging the activity X-XBB is tolerability the draining lymph in of within global in will I and first when the designed of are previously reported Phase safety, whose tumor standard other to microenvironment continue goal. towards evaluate T patient progress antitumor care Phase preliminary on I of dose planning escalation PRS-XXX great on progressed to cancer advanced to activate bispecifics. and toxicities PRS-XXX make this the cells and solid cells systemic nodes, evidence This XXX

power, optimal considerations several Given therapeutic the this critical of achieving window. to IO-IO intervention, an are

bridging I upon believe X-XBB this looking in remarkable immune target PRS-XXX which forward development, before would this Over disrupting it low immune through to you the valency to allowing to are of has Third, you, the remain peripheral to our second, several to undesirable concludes by potent a clinical is bispecific antagonism himself agonism of to important Tom Tim quarter PD-LX hand I like we believe beginning blockade; complex who improve formation; surveillance yet has and driving reduced PRS-XXX compared let then some PD-LX, locally. financial the on activation while X-XBB the to silence given already and remarks, IgGX-Fc X-XBB prepared the fold inactive when introduce guide avoid to XXXX backbone Overall, and positive this, soon. This cells, potential yet avoid X-XBB affinity will has benefit over it combination my second Tim. peripherally engagement by study peripheral a back is potential call a we First, potential versus to PD-LX there exists to shown nanomolar X-XBB we for bifunctional results. now potency

thrilled data very I I'm the the Steve, and for platform potential programs everyone. the the to and for as This warm well drawn is speaking. be company the thanks the as joining novelty promising generated. Anticalin Hi, clinical to already Pieris. Thanks, and has for the company welcome. Tim vast individual of was

As immuno-oncology these clinical trials. franchise a the lot scientist patients, in towards assets spent a I approval particularly assets and been is and oncology, believe these bringing focus. opportunity its I have and a of some am by I clinical into here excited physician there his who industry tremendous bispecific for progressing intrigued of earlier career X-XBB-based about

with and I much over Beyond the proteins. There's shown convenient proteins I and for early like everyone, look and to forward would solution. Thank application you, team respiratory patients. now the Anticalin need working I promise to in of administer to medicines immuno-oncology, interested Anticalin pipeline great I'm inhaled bring has to advance to also that of hand to therapies believe Tom. a very needed inhaled a the offering

again, Tim, million and the ended equivalents December Cash Thank cash cash for XX, morning balance June $XX.X compared of $XXX.X XX, quarter a everyone. the and you, for good XXXX, and XXXX. totaled to equivalent million ended year cash

amending the have $XX increase, more of balance existing Of or sheet in million XXXX. partners to half than added $XX agreements. existing milestones We achievement the this through of million first our from came

than continues second quarter, $XX those new proceeds was million price the ATM raised upon more And the upfront of The $XX $X.XX. of an facility, as average be use we of of our obtained million company. partnerships. the at through targeted operating entering payments funding to Another shares needs primary in selling use

programs net associated new higher are million to the reimbursed ended new agreements. G&A million the be onetime June The XX, the related funds include for balance collaboration over quarter our a quarter, funds June million approximately cash Bavarian ended $X.X incurred loss $XX.X loss stage be PRS-XXX or project on was ended received that, XXXX. R&D and legal $X Hallbergmoos, achieved I'll costs for With for ended XX, increase with reflects $X.X for R&D not costs lower manufacturing positioned XXXX. With June amount June the $XX.X non-dilutive costs our PRS-XXX, $XX costs XXXX. of incurred. loss current entering and call turn the government royalty and clinical equipment and announced The to $X.XX million June for preclinical XX, programs. per were for costs million per compared as higher from we to the program a the reflects share or this office quarter loss of of Additionally, to programs decrease are XXXX, expenses grant quarter facility immuno-oncology with along in that share in into Germany XX, year. to compared XXXX, the over across execute we million move quarter on were ended in our discovery the in Those for June $X.XX for to XXXX. the XX, well quarter of and to expenses XXXX, million XXXX, the an dilutive back a prior ended quarter the the half time first XX, management to Steve. in $XX.X activities increase higher Net will compared spending funding does multiple

last X that healthy second Tom; which Tom. heard top caps you clinical for that driven of us, according I it have we proud from made highly clinical recruitment Q&A, and And the next of significant up year progress you, the as before year, really this advancement wanted while will to half stage for fourth course a a Tim; to sheet successful includes of development the half you've quarter, we opening capital, first a of reiterate of just enrolling as pipeline partnerships; year. from with new the we're planning by actively Thank Through have balance talent, plan. of continued enter asset assets, heard to non-dilutive our

we'll lead key keep are points, beyond year. to We get way. data capitalized our for and readouts about And be and programs all next you progress including respiratory IO inflection to happy along our the informed excited

now for So questions. like thanks joining open for the we call today to And and listening. would your for

ISI. the Jonathan question [Operator line is Our Instructions] first coming from Evercore Miller with

I'd like program the to new XXX. focus on

in going point. Phase Is X the in then of than proposed is this that have this year, I And run as the a really different forward separate obviously, possible you post-COVID see work think, your competitors, talk Looking shared? at to coverage Or be regime be secondly, will data for But can I is comparable? to into be hoping path with to that made similar you to you or for later sort fibrosis strategies about target we're preclinical should clinic with good systemic lower formulation IPF? indications, clear. isn't expecting X Will we delivered much this think XXX? early this and doses indications doses How

high it at Thanks, on details. partners Jon, then on X can and for XXXX. the kick level, there color off I'll it Shane some a

think ranging populations I X lung respiratory -- be accustomed relevant think, differences an from on commercial on as notable asthma seed. to compromised compared fibrosis And today inhaled needs be that are pulmonary the in what settings the intervention program actually functions patients considered its for different for to the as to lung we feet. each there very would independently are, own well

drug-like week that the poster. the formulation, or that's true out what a any touch but because we'll the and asthma So will best we're we on have will that for talk going engagement data about fibrosis. patient are hold in that, intervention, on COVID we range path way you'll as for the a clearly long population we target first is see whereas and of that's is limitations we the also think that And in there mentioned, pulmonary that come address the would of of Not for on a that we down. won't in better nebulized post-COVID ERS. an beyond formulation eye DPI think September, details formulability but because our And be properties, patient to

program then and around -- which are of And there path fibrosis. clinical post-COVID say the would to for there I is a lung early point, in IPF the second the high and development degree on clinic the path, this is clinical the both efficiency

envision to also in strategy. later the We put clinical on color year more the

the do with leveraged, So that to detail pleased grand I for fibrosis, clinic that we'll want in highly the but be grant more today, for everything that that for much but long stage using clinical we leveraged we're can it and really the say on into committed the funding it we're putting although IPF. COVID development highly into is pulmonary gets initial us to is

about enthusiastic of to around really around do stages that the other and cover color? formulation any add to clinical the you we're other path to any free there through So nuances the or feel want leverage. Shane, development, initial

and Yes. for question. Jon, thanks, Thanks, the Steve,

So with learnings and perspective, a delivered just from in nice as what terms can and a course, lot a and a preclinical a clinical there's we the we data body certainly, of got a from of formulation. from take dispersion perspective the PRS-XXX, that. data delivery lung, formulation PRS-XXX learn the into from of can from or -- We've nebulized

formulation we're is nebulized heading where said, PRS-XXX. Steve as for So

to the data actual we understandings are fact need that notwithstanding with there the molecule. can take So there that generate we

how going we're use can color the moment. study. the that piece will said, good at put perspective, to -- Phase a behave there pharmacology species, into safety go suffice the there's in that to piece, about be both a dosing PK the But from lot to a of Anticalins a simulate from class efficient drug that's to want in a strategy as and indications. have I model we as Steve not a We clinical in be we on And dosing piece, of preclinical how utilized opportunities say, perspective can way to it explore a understanding

Great. glad think this for you go/no-go about to Then I see bars the really Makes on pretty XXX, explicitly. talking sense.

little can HERX-low a But aren't positivity will given, standard to mentioned, you make of said, stratified care HERX bar about patients? I of talk you more sense a you XX% as folks, the high HERX XX% -- in think As a the of competitiveness pay the lot beyond really indication. bit usually. comps

So how comp for the population? low right are you HERX thinking about that

Well, can as Shane a at you some level -- this I'm happy feel again add high to kick free to then and off color.

-- HERX-high think know, more space. -- the classic as much you is space evolving I HERX-low and the than HERX-high dynamic

this So number ramucirumab paclitaxel care And still ORR and population tried the HERX standard ITT a at of X have to X into space, care move where XX%. the trial. of it And the really or and not with there is of wall, examples hit been whether with have showed therapies or and a they targeted clinical placebo was kind standard underperformed sometimes plus. plus-ish benefit about of the negative

think standard over engagement is we synergy the relevant at through care we partners. use pursued X-XBB a we exciting really activity drug either our further example, looking biology XX% make being biomarker to meaningful evidenced for data is as or on of drug either on with X-XBB, improvement to the are would improvement the merit own what that be of investment, that this so And related based a the assess, that a able by clearly meaningful Soluble or that of would and our that the to bar think

or fundamentals, of to fitness metabolic only we're of they really to paucity how in is engager immune And durability the that looking terms areas. But biology a in it are that's competition, compared HERX other a low. maybe at space, X-XBB the So cells. drives back HERX of this high is X-XBB and

perspective arms. in coloring overall also both how this so about of And we're our that's thinking position

asking again, Shane, free what that's any HERX then and particular So around depth Jon add was about. feel in to low

have generated of the showing tucatinib benefit Yes, some low with certainly. compelling and in Jon Cinrebafusp data just to HERX And the preclinical listening, remind those Alfa we combining setting.

Steve combination, us is benchmark As be and meaningful believe around tax is we ORR, do if path to us indicated, we the that will it give see forward. a on that going XX% for clear key

from is with question next Our Phipps Matt Blair. William coming

else? starting Shane. handle the you still on sounds you think can It maybe patient of trial XXX, Europe of Tim. positive with is just most analysis? screening start you who escalation like Maybe plan to, Welcome, final XXX. us if And on where in obviously the And say, a test a disclose protocol remind escalation to or kick on how the give like off that maybe U.S. to that the enrollment surge. trial? you dose Delta during able did be the you kind track maybe in And recent wondering the if COVID-XX you'll level? then Congrats, dose despite would in a or But sense dose somewhere could relative label

Matt. Thanks, Okay.

Let's XXX. start with

pretty I one and can we bit about little we can talk more handle then XXX. that think a efficiently,

Although as otherwise we say a at could partner as it's much CINRA. not liberty say as we're for, to project,

screening throughout So for as COVID-related XXX screen the study. do we as COVID-XX far goes,

performed day end confirmed And but visit. the as of before diagnosis at continue of to test trial And is study there of positive at randomization, the be So the during patient the it's the withdrawn, is they the on indicated It's monitored. duration a is it's follow-up a there study. minus they If -- at X a excluded if screening. the performed also, get trial. study, final and from drug will

relevant question been different pandemic. a have persisted, the view off of are that guidance you phase. the But yes, and safety the then As in of is efficacy job data which say, I And in on around and again AZ regions of know, and an Australia. on as look, the lockdowns noted, you through of trial, and in pass a again into we the announcement efficacy terms have execution great we year at of phase are gate it's next would reiterating again doing the of navigating the when conclusion

the working is the done managing I geographies also a the And pandemic. Ukraine. AZ in. chain to very from we're well say, amidst supply one of We're patient great doing in job Australia as recruiting has things

we've that remain able the to abreast be I hold imagine, we've from overall, program So lot including guidance everyone been we'll largely really the closely with XXX. you XXX, forward keeping working dose on at as and to developments. And a escalation the confident what as and aspects, where it Servier, learnings of can -- and look for we to recycled relates are of

us, As you broad this X-XBB only us a XXX agonism about low what body a localized that multiple have ahead we're starting know, gone of including clinic in started differently number bit before is, I that also color X-XBB/PD-LX there a very bit to now safe. of started we little bispecifics evidence, the dose. that X-XBB not XXX we think is CINRA, in of been because thinking a bispecifics mean the in And and have we safe a a dose. have U.S., helping and fact, and we at is

science what we even rights us. best and out before U.S. are honoring for bispecifics that for but also have the we with scale. was what's safe looking coming ex U.S. doing are we we've the seen that And the collaborative it's geographies, rights, very though is we of think has a on at full is trials global patients, So Servier multiple patients,

we've yet get really we X-XBB field industry the can where yes, years maturing really, as where, that but general won't started -- several into that doses and in are we were progress start can't to probably into So the I the ago. get we made the specifics relative pleased -- we at with reflect bispecific can of we to X-XBB/HERX think when

call So the I color enough that's hope today. for

might one XXX, to that want you guys that is On have or exclusive about the there how has programs that Servier program? at Servier, I non-X-XBB kind management are you -- bispecific, thought classify XXX a that is that last whatever find to things Yes. -- in for agonism something guess rights one. that of what you're or proprietary maybe other -- looking it, be

Yes.

of a basic so couple -- with points. So

the XXX, a So we now XXX within alliance is program XXX we programs, have codevelop. and Servier, of and X have we

full Servier U.S. has XXX rights. is program have We global rights. a where

we milestones will So enjoy and royalties.

are not target the disclosed immuno-oncology the said it's blocks specific bispecifics, X-XBB. that and they We other thing than these way The not that are our exclusive and good partnered is blocks we specific building our the we've remember, is combination. have building -- on platform

so X-XBB/HERX doing doing also other on we're own, with with with X-XBB/PD-LX we're Servier, we're And and things while working our Seagen. X-XBBx

can other we So combinations, do X-XBB with or pretty different freely. immuno-oncology bispecifics

potential the And able were underpinned to is forward. leverage and going learnings so we from other that with XXX there bispecifics biology

So thinking you shouldn't just just be about this as X-XBB.

Our next question comes from Roger Saul with Jefferies.

thinking the provide XXX. some for benchmark you -- details for the Great. -- I the around is one So And appreciate X

how that XXX. would duration in stable decision? would take of program how for one of the is curious, response impact that go-no-go durability the account for terms disease, kind impact the the you and Just into your second The -- of

safety passenger the -- next efficacy safety announced I announced the So know, year. and this year as far you as

of the safety efficacy dose for et expecting year, terms what next So data the patient announcement, there? and in we And the should the how cohorts, number should like cetera? we much expect

versus that you of an move trial. your type XXX, the Roger. of safety question data Thanks, should the efficacy had from the first. in at would when disclose phase we end start On expect asked, Maybe we Yes. of announcement terms the into the what I'll last with we

think your I question. that was your -- the was heart of that

we the get through data be trial. disclosing won't full So we until

we really, sites, after an which in then safety study. course due will And I say, moving more we're and announcement phase," a through truly gate be the global you so would efficacy the more expect, into think, patients, through pass many the gate "Hey,

a what's as reminder, portion, placebo. doses to XXX on X patients up think efficacy I in and ct.gov, And is including is the which

so number data imagine respect co-develop on it come study, year and large year used and top first on we the expectation our and any were top disclose be want to line of if, our ORR, example, opportunity the the but I out have want. what is specifics And will would durability because of we at more line think, high, XXX, next durability. you data we a would inform and certainly give on thinking composite we be to I back there's guiding intend factors. going the I color want plus to with fundamentals share community maybe So on patients. more would rate. of meaningful data, to of inform isn't in today. and you we conference, co-development, that Again, we're an asking don't let improvement, practice to add be in rainbow a of fact, terms the AZ to in plus to be next we response, share think option the so we've maybe I other we durability, to would would improvement And when the an going disease safety our data to the targeted disclose that or what which or a a we're can in about know you to our of what at We're ORR, upon at color in positive they're haven't practice be of able for a our X-XBB, to to it's isn't if that's for and out PFS we be on data least time would But that good control period but forward details co-development if a I seen go Shane, impressive consistent want response. dependent that looking medical therapies want then triggered, an X-month intentions to sufficient -- will think much durable with ambitions. And XX%, broken see key going is beyond HERX opt-in them. I be

thanks, Steve, Thanks, question. and Roger, for the

again, is, of remind add would bulk I what our here. mechanism to action Just of

Phase our we response. patients. was to what these end-stage to reinvigorate immune system. of agents. So stayed study going that when in T time a the as a for I really patients agonist, given They X-XBB good on We're cell memory the to drive study we're responded amount that And going saw are

to So we ability. the X-XBB impact that believe your potential do has

of have modulation getting also ensure that we're Soluble pathway. We to that good X-XBB the biomarker

to So emerging very said, the of as also analyzing data standard to really offer a assessing what and want look the the of versus have we we totality at Steve approach care. rigorous and

It time. no we this at questions appears additional have

So to Mr. for will back over Yoder closing floor any the I turn remarks. additional

everyone everyone for and attention you support very closing remarks the I than a say company. continued your for great much. to No of for thank your wish again thanks other No, day.

you gentlemen, disconnect Ladies and We does conclude lines this your for at teleconference webcast. and and thank participation, may time. your you today's this