Pieris Pharmaceuticals (PIRS) 4 Nov 202020 Q3 Earnings call transcript

Greetings, and welcome to the Pieris Pharmaceuticals Third Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. of President Vice Bures, Finance. Tom Please go ahead.

Good us for you. corporate morning, conference everyone, joining for update. you thank our and and call Thank third XXXX quarter

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

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

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

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of States, alongside have AZDXXXX co-develop will or completion AstraZeneca. Xa, co-commercialize United Following the options Phase Pieris to and the to in subsequently PRS-XXX

to commitment agreement available the of to clinical market continued with starts Alliance AstraZeneca’s key last with to AstraZeneca all be the Pieris, AstraZeneca And progress we additional and given driver our we AstraZeneca happy as Apart this terms PRS-XXX, tangible of program. PRS-XXX four are able AstraZeneca. from an partner. the appreciative to full highly for of report a to new the consider are advantage pleased remains programs, includes programs. potential, collaboration differentiation We’re And reported for engaged beyond value our communicate initiated taking continued the opportunity, and fully PRS-XXX, a the quarter development collaboration and we also in fourth project envisioned being these additional we just that The collaborative potential the of have of collaboration. with committed one,

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increase to T in our the phase driving the at to of a bringing cohorts, of an and rationale Additionally, tumor is mediated responders of the look in in proof the target cancer benefit. showed in drug and patients substantial presented that few of options, PRS-XXX conviction the program observed in the a next in action improve with treatment concept PRS-XXX line in candidate. combination of the into the potential expansion of reinforce of studies, of each significant CDX+ soluble forward active clinical dose with fact development doses for engagement mode schedules tested all and cells microenvironment data lives and newly profile of X-XBB reinforcing of these and acceptable collectively suggest the gastric a X-XBB significant study intended These we ramucirumab second safety paclitaxel.

trial a quarter with with Lilly us signed under, Lilly we Company & As previously ramucirumab. Eli collaboration will indicated, clinical agreement which supply last

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patient the agency’s of the the stability that of excipient supporting development the in today of during to level As FDA could now XXX to stability PRS-XXX to enhance stressed real Type of initiate adequacy results completed excipient, meeting We data used and the PRS-XXX. to the administration administration as proposal occur well existing preparation a of the under these setting. the have studies, of an the world prescribed submit for PRS-XXX we on of as request, existing conditions of use list preparation in part continued A to process for the plan optimized in clinical the form co-diluent a clinical feedback as the

complete hold that We meeting. considering we forthcoming which pending positive in submit response dataset, A our will letter, we allow are to lift FDA December, which confident to generated expect a after the have a Type robust

paclitaxel, Phase of decision expect a to combination PRS-XXX a study FDA of Type ramucirumab via and meeting, in now next year. formally we this with As engage result initiate A to X

this as In clinical X-XBB Although forward most receive appropriate Type an PRS-XXX, a tirelessly advice not that additional our this matter a program, from provide look the update view this which team bispecific able we PRS-XXX, entails planned. to development providing year, is agency in path progresses worked we at we of are forward. to agency appropriate originally this on viable advanced is through trial future to the our second as through believe substantive time. IND stage, initiate readiness I the has meeting the the to expect complementing on engagement A intended, process. And

for We PRS-XXX for is a next X-XBB/PD-LX this with co-development continue rights. an together where ex-U.S. program, under hold our rights to alliance who holds our anticipate Servier, partner this U.S. with program filing Servier, we bispecific year. IND

the the stage is Additionally, who for second our Servier collaboration, undisclosed would this preclinical be the Servier, of by program intend to responsible handing preclinical PRS-XXX, alliance addressing work program, within before a non-GLP immuno-oncology. over targets development for program for complete PRS-XXX year, program. biologic further our we in to

collaboration, payment Seagen advancement Servier continues alliance, Seagen our last our program previously planned as communicated. a where million collaboration successful $X to handover first the of milestone within following generated our the as also Seagen the which continues Beyond quarter,

our advance clinical results will him the new new regulatory of third shareholder, raised advisors dedicated offering objectives during the the equity have an the our block In detail. And $X.X finally, have to to provide this concludes meaningful drug facility. all senior venture. Senior to at Ingmar clinical through resources I’ll our Now, has you our support to with for These years execution This executive wish another moving call leadership amount we strengthening my further for the we while Pieris. through we an near-term Head development we moved beyond rest transaction quarter, base. conclude to search believe Development Vice at back to or development Company. our Tom yet remarks. coverage while to has team corporate hand teams. more like I his interim, Ingmar the affairs together would proceeds on a The guide XXXX provides continue Tom. used Pontifax, date. in Clinical million his I few to best been Pieris, with in an third ongoing operations capital Over the focused offering you, financial the updates. clinical at-the-market and mention net a of quarter ATM the on represents pipeline, we time full me and and Bruns, of and working execute needs to that drug And invaluable would to like now the development accomplished accomplished President facility shareholder the was three pipeline, at our prepared opportunity. to the In trade the And in of only in with pursue We resource

of IT milestone. for R&D the cash $XX.X everyone. Thanks, from good IT XX, ended morning, of the in higher Steve, to restrictions. XX, due turn XXXX, The quarter in balances was to XX, professional investments the and to XXXX at inflows and the compared for million ended Net restrictions. offering cash quarter by million $XX.X move cash, achievement XXXX. and compared was spend, for lower and due a September to the of due totaled million and With overall for R&D the to preclinical investments offset again, the September XXXX, ended equivalents call ended $XX.X and XXXX, decrease I million the equivalents, was a the million The the to $X.XX G&A quarters offset decrease third consulting $XXX.X travel-related Hallbergmoos, costs. higher the to XXXX to of the loss December an audit ended respectively. and XXXX. decreases facility. expenses costs, move back ended as was allocated expenses or allocated for These proceeds $X.X collected will in capital, of prior ended a and by or decrease the June quarter partially new million manufacturing quarter quarter facility first Steve. and G&A The million loss per to for operating loss $X.X due mentioned $X.X costs $X.XX lower new expenses cash the XXXX. $XX.X $X.X over XX, XXXX, quarter September in were manufacturing million personnel with and associated quarter facility due since an were primarily increase XX, was COVID-XX expenditures fees, by lower lower PRS-XXX, year-end $X million R&D year-end ended net facility XXXX, The costs, one-time primarily expenditures, in compared a Germany and expenses Steve new for spending lower use expenses and license in to the expenditures loss million the due to quarter partially move XXXX. XX, that, as XX, were September share for September September cash offset XX, decrease to costs to ATM that to and facility, well per and primarily net period compared higher for Cash clinical million year-to-date was September quarter for lower to share due travel-related the $XX.X and on COVID-XX XX, partially Cash,

during these the of patients includes with hold committed constructive the Thanks just studies Servier. data satisfaction by progression to COVID again, we at I remove PRS-XXX the communicated pandemic, this for new of are clinic with do well the PRS-XXX, as have disclosed with dedication AstraZeneca our to our ESMO, recent Pieris’ as be closing, to and developing Tom. and In the team unfaltering future remain advancement the which progress for to the want reiterate for completing without partial pipeline, wouldn’t of engagement the FDA together and today recently continued the this ongoing who treatments. deeply whom to We PRS-XXX we valuable the able current clinical

who are for to team, We now like you questions. our to call shareholders would to joining open as your the call as today. wonderful the us thank well our So, on

Your Joseph comes Thank proceed first of Thome question Cowen and Instructions] with Please you. your Company. line from with question. [Operator

Thank and you Hi, congrats on progress. my taking the for questions, there.

to A stuff give that First potential can implication XXX kind the Type on then, little possible, for of make pipeline? indication, that meeting? is the of on or on when the the you do kind outcomes X of of specific XXX, collected, go-ahead was how they kind begin? be better on start to will FDA tangential sort a the this or of trial, you the and did needed Thank this us timeframe bit all of specific broad you. give information if the just If earliest that, to you that did, Phase an be the could the that a that point changes And the

for Thanks Great. Joe. Thanks. Thanks, for questions. Thanks the joining.

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on of Happy and comment the to first the question. third part the

of FDI of the first did So, we very all study FDA type on closely work the with far, align to specific they alignment so design. on have the

very what the study we just broad the data seen detailed reported submitted, ensure the us a the events clinical to discussion administration that FDA we sense, and design have but has with during the study, can very to apply us discussed much. cover product. which they actually call do the before that in to yet not asked to before study, And handling with want Obviously, to itself in FDA. we’ve intend have We FDA do the conduct occur very resulting we FDA what a an to additional that do and to our thoroughly the stress had are the was

about stage, question, a do at of this platform would it’s you for sense specificity second is that say, I clinical a a regarding not broad and subtleties, not drug something platform. the what And in adjusted, we this is this the really approach. really broad specific. On Because

these And in evolve you So, administrations, manner. advance studies, specific the drug the clinical we appropriate. very it’s in adjust a for more and age further

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

day you second of for election. how’s drug hosting First, a But thank Presidential earnings that, an impact that are frontline the agents effect use combined to agonism ramucirumab the line like I call in the the thinking setting? IO cancer want how in gastric X-XBB with the going about of guys after beyond and you

Madhu. you, Thank

agent I on didn’t repeating frontline in But, mentioned right type the And fully gastric now. Would clarifying? on question? question. the of we’re question, hear breaking any hope timing. specific you would not I welcome mind You’re cancer. mind you your -- news the You

Oh, blockade. PD-X

has blockade study. PD-X X in efficacy So, frontline shown Phase

do in how X-XBB for treatment that in So, second ramucirumab you setting? that think agonism landscape line changes the

which brings And it the of HERX reinforces but therapy, gastric have what the settings some a PD-X candidate agonism, hand relevance early is care also, as again principles frame with and can examples in through mix, with developing there. which see benefit what maybe the context. PD-X see and of And really, biology I we have our for we’re our particular under the fundamental showed in line that as is great So, that immuno-oncology is I regimens, would we cancer, things, immunotherapy HERX of it as registration immunotherapy own And study, gastric this potential a among we happy case to adding over study. XXX that we particularly earlier in off, blockade the the great actually I to lines in enthusiastic more that benefit known One now it that think between particular really other And of to standard in even of detail. Shane actually blockade who does, think including does, cancer, KEYNOTE trials. shows the the positive of to cancer. positive also gastric X-XBB patient twofold. And drug synergies

to say, is have would in only specific actually synergy brings potential Shane ramucirumab, I new, that So, turn that. what the stabilization something general through it framed but talk details would, about which that not both, and over have to vasculature we are that disruption. excitement angiogenesis I is which we with adding But

patients prior know experienced I of a bit already line on can those our been in been PD-X Shane And show why top about blocker have adding on we more a little enthusiastic, a gastric candidate will second that to provide are color in therapy. with lot and prioritizing he’s so, drug that likely he chemo -- thinking who that would

little will. a you to more bit for you detail, So, Shane, if over

year, of mentioned, cancer modulation. to observed benefits So, blockade you been for early in and is opened who’ve part on who from PD-X they KEYNOTES see study trial a our that we Again, gastric common pembro and had we last and validation who presented disease, They durable. our have indication study also and we come been study. And of patient had verification experienced, is remember have in may the involvement by lines very the stable was and Steve mentioned, trials, further combo checkpoint patients the reiterate done had went that and this also in do they response And a our on on response, with what trial. they best come as study. just on Steve had And And stable partial which well. immune disease. to

we baseline. low often activate of and from very something our to do PD who a that our checkpoint is ability stats responding inhibition. X-XBB CDX We’ve different engage also feel drug base the demonstrated have to through very have several started So, patients we

as So, and there core study. some be patients patients tumor be are may our defined who would typically from benefiting still

you in that also Phase a rate is rate. X have our we increase healthy QX disease interactive study, off and if dose response XX% go overall weekly our very dosing, about monotherapy As know, in we to control range,

lot scientific from there’s to nice going perspective, monotherapy. as And for Steve a got we’ve is So, and rationale a agonism why X-XBB say, [indiscernible] said and combo. of I’d

and cells to base. X-XBB being educate facilitation them will active an agent help also which T debulking, So in or come and make and that in an like that pause the release the antigen spread, tumor agent chemotherapy, anticipate we

we in Steve facilitating in X-XBB in the response agonist As rates impacting second beneficial. where microenvironment. there’s ramucirumab and And, a observe clinical said, be a think as components and the there line, well in monotherapy going first I seeing inhibitors And, line, feel normalization we first And And the to them really is studies, of additive that is to vessel potential line. as our and a tumor couple very the notwithstanding opportunity we significant. second is also we environment just strong of we non-redundant of the are action terms say, real synergistic in clinical in again, component the to synergistic there’s in with mechanism we feel in paclitaxel Phase what macrophage about checkpoint X that feel regard as terms landscape, precedent. here when

balance other asthma great. about more And in Okay, respiratory idea kinds the of respiratory you how generally long the I the versus guess of beyond Anticalins of targeted inflammatory PRS-XXX development space. then do the in exploring franchise, indications PRS-XXX and other

Madhu. Thanks, Yes.

I atezolizumab think about a with So, candidate see we one, the certainly AstraZeneca is, huge clinical influence a these opportunity how and that blessings a focus, outside. it benefit way remain to is of agreement will with all would we how answer [ph] asthma appropriate focus, in and all in of success drug will collaboration and the of have that manner governing that and we how this been or actually candidate datasets, local that -- TX nature its a to on has commercial And assess still continues the endotype to delivery we always biomarkers asthma intervention. of has stratify based develop lungs, it. respiratory forward intervention has the the severe wake This it the that been drug moderate the by in for going ThX, a phase maturing a key

So, I de-risk with target in we the for of clinical another ask terms potential molecule. and more the of than that differentiation could of don’t think another

for opportunity as look ThX served will that’s that, that to blueprint in a a obviously will field. intervention, require develop, uncontrolled And asthma. potentially atezolizumab COPD But moderate the perfect to further continue that. the severe particularly again, Beyond something serve for local at that something how has we in could things to pursue for on concept with But phenotype near-term, data proof from certainly it’s focused announced analysis. in in look But AstraZeneca. we’re the ThX the today. It aligned further quickly. watch it would potentially we things closely of getting require forward as alignment and the we asthma will It

Your next line your Miller Please question. Evercore the with of question proceed with from ISI. comes Jonathan

question. for thanks and guys, the Hi, taking

Can to want thinking great with potential asthma He Company. Sorry what any on that than I patients decision third, that Is then, XXX. little moderate it more change made was start to merits moderate what studies, on change expected, bit And patients? a looking we you potential Thanks. meeting to could in it again. And and have to at there? and for powder know a eyes you as maybe cohort, color bigger and only that And was to that given a how about with safety say the Xa the leave. timeline? severe guys only. as your clinical noticed for that us and A we were our love and you XXX, you should see address moderate just to and fair patient Phase addition I’d decision I means -- a formulation, ought we Type look what nebulized excipient to initial we then, remind in delay the to also severe open new be the formulation it from should you in move hear Ingmar I’d that give a population. move to the is PRS-XXX, about Astra’s forward for

Sure, John.

thanks So, three the for questions.

XXX. were third and first The the

initial and And for of severe, on So, FDA you’d then, study go maybe a around include might the to XXX safety as Hitto to to be that the adjustments excipient, Alright, questions. I look of two-part ask engaging XXX questions meeting. to those which the also cost to population in benefit XXX opposed will color I for Type the controlled moderate, as moderate patients. patient a over next to back little the those which then, the part perspective, this maybe in so A with for moderate to is more to from the together, choice and what

we consider mind to the reflects uncontrolled what’s I novel trial now data. of think, program, from is totality the design in inevitability organization today’s keep which And important strategy for The -- which us the that is here large on this that dosing near or sense really considers progression. distract this the outset, moderate design overall the patient a impact I itself, of the of certainly powder. term strategy ultimately think, at itself real BLA dry the force inhaled program, doesn’t certainly we to ultimate biologics severe doesn’t timing, is for achieve to When the objective. the announcement either is approach, asthmatics. that, behind objective But AstraZeneca of have in development it

happens, study, due the I as that course, comment I would expect clinical these I of until detail. two that as include I and think formulation would lead patients, safety also four-week appropriateness, this yet having said phase that includes phase registries given variability more dry number parts Recall the market study publication think changes and And process, opportunity, typically them makes look screen sense. in called that Phase moderates, tolerability measured a -- the in say of And I X in stage. detail. -- powder that I on screening of is we I it that would and it that say on we in will move I X that Part to then the part, be submissions. forward appropriate development, in than given in But, And not process, that as study, would much had in but smaller can’t And stage, provide variability first would that part there’s there of forthcoming this comment this is and substantially we overall pharmacokinetics. would on in second underway follow-up haven’t that terms mean, regulatory a be it’s lot period. and still detail felt of my process view the for you just dosing at the asthmatics two-part appropriate focusing again it for think submissions

think looking the there So, the when parameters and I classic this, come practice. out of registry be that’ll you’d course, at in clinical consistent I published with think is due

the in think In terms was look -- about other for, that of to I what talked terms that. I of moderate --

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from your Blair. The line question with Phipps Please next with proceed comes of William question. Matt

when an the happened, Type to give on of adjusted submitted question. disclose when you that A the response Thanks the guys. the A be would in then, the Jonathan’s remember next concentration clinical this guide you [ph] you update letter? follow-up expect seems I you’ve minutes more should that just us A you guess what question. you be excipient when the of And or the for the -- the request. Type back hold it for steps, we get would adjusting for meeting the having outside said, -- my Obviously could Good hold taking morning, formal meeting. I

the Thanks Matt. Hey, questions. Yes. for

with of the and we terms year. filed In the December, determine letter, intend on mentioned further approach, on envision, would believe updates, that earlier, timely what’s I our something, meeting that do full the we as we view at and response be which are the itself it to response then currently then before the look I complete in that’s going pretty the and end right of then to

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would that So, be the timing.

not I informally. and for formal to bang-for-buck with you to to has however considered get communications manner us both the minor aware. to a and with them we’re as going adjustments efficient Type FDA, to in thought hold. the to these We most of, we So, level been constructively time, once provide with this much operating out very community make wanted are we FDA off request, are think plans would formality, XX-day it disclosures in clinical if of specific to any resume respect Then, are, investors engage additional activity they which overall, our we turnaround then A order commit than of And other just lot in sense a formally with the we’ve and possible.

we very the that’s think overall So, justified circumstances. under

it this to Are data studies in would COVID related just it? guess, the inhaled a you go ready into you could proprietary you Okay. disclose what to IND-enabling when by question, still delay. disclose have is time delay at One give the some it it you generate will of to other I be if that? -- available program, on be trying guess, terms or more stage enough pre-clinical than earlier I details

Yes.

that the to but an do why to would work be local that we offer also what disclosure would say, rationale. with publicly, and provide here’s a just said the more why want here’s We make than a So, have sense we target would line would of high-value to intervention attached differentiated comprehensive very clinic. desire clear have it to the would a and dataset to the value when candidate consistent envision very in proposition of a and a the sight it past, as opportunity, name, why

that did timelines vendors, primarily these have in there we a those would whether impact studies. of driving it’s the selected Specifically, it I development a was related activities, studies. vendors, the And delays, you of COVID-related to or call, that see some last want there’s alluded some in strategically. on more make ex some which of is the vendors, could which we vivo that’s we’re were complex with some working number even which timely vivo, particularly an for fits to there. candidates actively pipeline think range And we complex worked think in when flexibility how across happening But, ability also disclosure, our conduct engaged. be we delays into the some particularly with COVID once It’s of I the what studies, in so the today And potential meaningful that. enabling to declared, very it of change more given that vivo IND

path of a COVID. that experiments on I that the of path potential in conducting confident we are near planned through ongoing in the feel on the term, the we and based We’re the generating ones types we different to to to that But data -- waves working near-term. are studies, very have generate are want that on the

proceed question line instructions] Fund. Sharon Sphera your next Ofer [Operator of Your comes with question. from Please with

wanted PRS-XXX, of from be data if a on dependent first will expected on the time. I maybe trial your give similar part to the timelines, you So, the ask because on us color could second

how take? and that? like long like your of what design maybe for So, begin, before that can evaluations for are expectations any And study anything each sort COVID-related might at-home that the way, enrollment then, flexibility would part just along allow

maybe we questions. with And color Thanks, a far. these again, and approval little Yes. answer I Sharon. to those could But can did to address more I need so you that align questions try are on the of AstraZeneca. I than

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Okay, great. you. Thank

the Yoder turn the Stephen I’d session. to Mr. question-and-answer the closing to remarks. of call And have reached we for back gentlemen, and like Ladies end

Company. call. Stay support look thanks want we forward end continued updated to great for I Thank attention our just by the everyone a keeping to safe. for you. again joining We day, and your Thank want again to you on today for you. progress your and the of And you wish and thanking

conference. This today’s concludes

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