Pieris Pharmaceuticals (PIRS) 10 May 232023 Q1 Earnings call transcript

Good day, ladies and gentlemen. And welcome to the Pieris Pharmaceuticals to host First Quarter 2023 Investor Call. [Operator Instructions]

At this time, it is my pleasure to turn the floor over to your host Tom Bures, CFO. Sir, the floor is yours.

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

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

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

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

over to I call that, turn Steve. the With will now

and Tom, thank everyone joining you, Thank to today. for us you

the for diseases. advance and pipeline our update I respiratory will to be inhaled providing progress we making on are an biologics

believe transformative months for modalities. the in programs, potential We XX versus our to which key current continue preclinical to catalysts towards XX drive clinical carry and we next

completion and which receptor antagonist study also to the remains PRS-XXX priority with Elarekibep is Phase as referred AstraZeneca. readout is Xa from IL-X an alpha top inhaled partnered or oral Our AZDXXXX, the in asthma. Elarekibep study

that and Pieris will prevalence treating the Pieris's Elarekibep. high is respiratory a proprietary Anticalin commentary respiratory programs our offer advancing platform to PRS-XXX targeting fully on by inhaled In approach addition, two may alongside tissue. diseases provide I PRS-XXX new fundamentally lung relevant directly

pipeline Building the effects, convenience. provide of therapeutics upon side increased biology, and validated benefit, clinical to improve reduce clinically potential our has

opportunities the large be industry. that target need continue programs to significant underserved with unmet biopharmaceutical Our by

first turning Elarekibep, And study we to the ongoing who top Xa enrolling our to closely partner continue our for sponsor. with study priority, asthma is work as Phase AstraZeneca

additional than clinically study As we several across have new additional previously bring including sites total to the clinical more achieve of would completion, AstraZeneca communicated, focused to countries all adding committed has that number geographies. a resources sites and XXX

impact track We With positive uptick into on this in new the plan patient randomized amendments the is footprint year, that study. and became we three result important of a this anticipate are quarter. to the rate this witnessing AstraZeneca geographies this to the act protocol earlier clinical broader patients this effective screens. in with in meaningful

focus endpoint on be placebo. improvement line measuring the middle anticipated milligram will This versus XXXX. reported dose FEVX Top placebo of by at the are the adjusted weeks, study's efficacy primary to readout X X DPI results

dose in improvements the efficacy study, the have received was asthmatics study the placebo safety that which therapy, the top of twice That either moderate to or Elarekibep was Separate on milligrams all over of X from patient daily these milligram were enrolled who portion review completed. we enrollment portion successfully comer, of pleased of weeks. XX XX the announced controlled DPI controlled ICS/LABA in for asthmatics of mild cohort background

has higher needed. doses multibillion the in when to asthma commercial This the but dollar considering many provide the Elarekibep patients would Elarekibep tissue not lung targeting current offering only a route therapeutics administration product directly profile superior market profile, the providers by potential prefer. if of healthcare evaluated future substantial a opportunity provides that a to additional and administration, safety data Elarekibep enables The through route of supporting remains be also convenient

are studied to Elarekibep development opt-in drugs a priority managed. address With shortcomings believe commitment a and we could of important top results. positive asthma If AstraZeneca of obtaining for strongly AstraZeneca's our currently to is and approved opt-in the how alongside the we trigger the increased company. a are in transform in and will our This co-development important Elarekibep position by Being delivery data set forward we supported decision. with plan look resources if successful, provided, we data that organizational being is

two Next, forms inhaled like advancing an of anticalin proprietary. PRS-XXX of connected lung best-in-class has idiopathic or targets respiratory are which growth PRS-XXX, that fibrotic both and potential. fibrosis, and differentiated IPF other programs CTGF fully the inhaled highly is protein PRS-XXX discuss tissue other to I or for factor of pulmonary treatment would that we disease are

compared in lung and intravenously potency a antagonist is approach administered in pamrevlumab CTGS superior to route demonstrated believe an stage exposure to we Preclinically, Critically, an has clinical late lead PRS-XXX systemically superior to administration a compared that which infused outcome on for provides target this development. may inhaled pathway. superior of clinical

the for believe potential to with potential current for have on care disease. PRS-XXX these serious of of Based the we could via IPF, best-in-class delivery at inhalation, convenience combine the as as standard home potential benefits, well PRS-XXX

that company. PRS-XXX Elarekibep, our with could believe represent we a tremendous commercial for As opportunity

pharmacokinetics is in continue We the to X subjects tolerability administer healthy that Phase plan in PRS-XXX volunteers. evaluating safety, study PK to in a to or according

government. ongoing along year. We grant report expect of in the from with the This Phase to a results study supported study Bavarian X meaningful this by other activities is half second

post-recession, deposition also ATS preclinical fibrosis be the data XXXX significantly by Conference. excited This a to presentation when data reduced will May new In presented XXst. on at International show model PRS-XXX present in We lung how silica-induced will PRS-XXX are a inhalation. Sunday, delivered collagen

for being want the to treatment antagonist of on I update PRS-XXX developed disease. Jagged-X Next, muco-obstructive an provide lung an inhaled

opportunity respiratory lung. diseases driven production mucus this large supported represented and on for by by mucus Our is can PRS-XXX that data enthusiasm showing program is the preclinical in market based regulate the

the via JAGX objective burden, of the reduce increasing across in action patient broader ciliated locally oral cell signaling the PRS-XXX's hyperplasia the lung PRS-XXX mode to metaplasia, other cells. and Notch of as stimulus well with to number a is block as reversing applicability aim independent mucus we goblet inhalation of that offers Unlike plugging mucus of is interventions which believe population. designed

JAGX-induced Previously that ERS presented cells, PRS-XXX data can drug in at XXXX mucus-coated thereby inhibit showed reducing European on lung or penetrate in Respiratory preclinical epithelial Society potently expression. Meeting epithelia signaling mucus to vitro, candidates the

month, PRS-XXX will Conference preclinical presenting the at reduces nomination metaplasia we be that a inflammation-driven PRS-XXX hypersecretion development May towards cell ATS International data mucus advancing XXXX clinical therapeutic on this and is year. model. candidate And later later this disease in demonstrating XX, goblet

with the Turning to advancing. several support they programs partners now to on remain we that and our delivering our committed immune-oncology pipeline, are

the cost our promising include multiple generate pipeline manner exist With and immune-oncology Servier, efficient in and data. value is Pharmaceuticals, clinical on advanced which we preclinical of existing benefit believe Boston portfolio a this collaborators, being Seagen and based our opportunities from to

Annual The alfa gastric from enrollment study to April, in in PRS-XXX response five clinical highly AACR beyond been Meeting. the presented XXX% the these that results cancer the results at showed study. First, objective HERX-positive the being second Prior there in of discontinued available, and results cinrebafusp unconfirmed study company's an presented line were durability patients and reasons. enrolled emerging strategic in for promising rate encouraging profile a into have promising

activity partnering to potential transactions traditional in HERX transactions and generated considering range from focused Pieris an to given excited of is continuation the this spinout immune-oncology a program emerging of now cancer transformative of other program the in gastric this studies. the facilitate

solid the escalation study to we of which portion of collaboration with Mabcalin Moving tumors. bispecific or is in for in a beyond PRS-XXX dose X/X the progress PRS-XXX, treatment our the X-XBB/PD-LX SXXXXXX, Servier, continue Phase of

a bridge USDX within the the costimulatory a million T Seagen earned a CDXXX-expressing of provide to in tumor potent a tumor-specific SGN-BBXXX for start antibody-Anticalin XXXX. payment compound bispecific study collaboration, when PRS-XXX SGN-BBXXX Next as known was dosed and designed at between first-in-class milestone Phase patient also X is first cells. cells CDXXX/X-XBB we

to BOS-XXX reimbursement we for lastly, with And And those delivering immune-oncology the external PRS-XXX, Pharmaceuticals known on spending X advance with beyond on Seagen programs. clinic, in the to program, which within two towards continue fully compound, Mabcalin and franchise, the to as Phase begin which also bispecific is we Boston are internal committed this months. received for other a expected X-XBB/GPCX programs coming

dosing payment franchise, the this upside. upon receive are human believe in we offers this will first entry clinical eligible from stage long-term of that We X-XBB program. fourth on be bispecific the clinical program, And modest which a our additional milestone to

Tom. concludes call I will This prepared the to and now back hand remarks my

Pete. you, Thank

and $XX.X to and December of cash decrease equivalents during result with for quarter XXXX of March XX, XX, cash being ended Cash, a investments quarter year cash equivalents totaled the operations year. million first of this a $XX.X million compared XXXX balance ended the funding for the a

in decreased Also, compared higher to more cash cash the operating frame bonus than XX are due for million. sufficiently burning annual by to and that is the $X quarter XXXX, that more time payments operations of months. company first historically our next this quarter the than a first insurance burn occur and The believes quarter funded

future study benefit of taken X we certain obtaining for Phase of for Xa top are activities and include actions Phase for our in for readiness the As priority the PRS-XXX to the interest gate and plans we already achieving the including enabling data and investments on PRS-XXX PRS-XXX noted, our IND activities previously namely, prepared operating Elarekibep asthma. current year cost in have saving PRS-XXX

cash and are Elarekibep the decisions, pipeline making the this equities achieve the from readout. maintain investment objectives Based will modest the while to we we market to able to discussions assessing our opportunities by milestones deliver of anticipated will existing AstraZeneca progression collaborations, current timelines we and using reach continue confident pursue on partnering appropriate to leveraging awaiting be for study,

discovery alfa and and software higher $XX.X Research ended for March XX, the XXXX. costs, the for compared personnel and proprietary. offset $XX.X ended decrease for lower lower due costs partnered clinical by to partially both investments development costs XXXX, expenses XX, for lower to program million costs. costs overall primarily fees programs, stage March These PRS-XXX quarter license were cinrebafusp was higher and on preclinical The quarter and million were

ended professional and for quarter decrease ended were and XXXX. by insurance administrative lower the period-over-period March compared the for costs $X.X $X to primarily - XX, XXXX, was consulting million driven The General services quarter XX, March million costs.

For was with cost overall lower ended The incurred XX, respect $X.X for grant recorded to decrease $X XX, XXXX, March PRS-XXX. to the quarter in million March PRS-XXX slightly million XXXX. quarter ended compared due income of the was

of impact In interest the quarter to rising the approximately months for March addition, interest March minimis XX the $XXXXXX the XXXX, income was de XX, compared ended XXXX. up a amount $XXX,XXX XX, rates over in ended quarter given last

share million XX, And XXXX. finally, the $X. the per ended loss compared March XXXX company's net quarter loss share $XX.X XX, $X.XX net or of quarter per March million ended for the to $X.X loss was for a XX loss

will Steve. And with back that, I hand call to the over

Well, the you call for thank to would all joining for like thank today, opportunity you Tom, take any us call questions have. we open now you, the might and on to

you. Thank ahead Miller our Go from Jonathan. from first question And Instructions] Jonathan [Operator Evercore. comes

to Thanks so much ask my love would question I program. XXX about for the taking guys.

off X supportive? looks data rapidly given of constraints half, supposing other volunteer path again, for is the study on What's FibroGen's great. second bandwidth? XXX that FibroGen looks forward Phase coming your healthy the How you suppose can Let's advance good,

for Thanks John. the Thanks, question.

by continue that So, of we FibroGen upcoming this cost middle the the readout we manage progression the year. the that believe data And pamrevlumab. through of be guidance of to that that. and that beyond will very are of mindful PRS-XXX presented be mindful time can effectively we We for

can our has of Phase moving any and are of for ongoing modestly activities As and to on this to announce plan Xa, the continue will the which clinic. this the anticipated and Phase readout, those a a that leverage to to forward cost do we very point advance that and will, soon, story we and year intend data the the and budgeted that for continued could keep the lead believe near PRS-XXX by second year pamrevlumab finish believe towards the reminder, X effectively gating that and we inflection term that strong to top half inflection end program related line we and is point if we be positive for

things all done, to have the weeks, we possible see to that access as months or always looked we whether couple of look particular. different balance leverages in we continue couple at we've of sheet, the ways partnering. capital will And And over as to those and that equities next of it's continue

So for we that further forward that are the we to think validation IPF. to locally. superior treat be we program. look we point we of watching and be CTGF And go a for approaches it And and will will closely that alluding to intervention think

And for making options PRS-XXX? sense. supportive. now, And different I I with a for some about AACR data any give know how that strategic although what's different your in then us if you having agree Makes timeline remarks discontinued guess look of again, any you've sort But Okay. which the sort different to color look the program. PRS-XXX about the would respiratory targets, mentioned Can top you decision strategic focused a bunch more prepared seeming relatedly like previously of for been already? had of conversations the for I advance really you program, reasons, direction you're in -- you

most John. Sure, patients were at the just blockade, had of set, had what small data. those therapies seen one I'll rather in space sometime that heavily had in the they the the multiple all within HERX, all five responded. HERX and is we start advancements data data albeit pretreated, In had patients AACR, of Thanks. with a amazing mean, patients HERX therapies, were our who checkpoint half progressed I as striking. presented

of durable the responded, this all top around just with line second of regimen cases Not on had but in benefit [indiscernible]. standard care

small, they're So although compelling are set data the

of ranging small. from talked that as groups we as pharma, investors, X, number think option appreciate potential [indiscernible] that investors a we private large and about and

time. things take These

belt the right no knows isn't better think I than company number and has Pieris knows its a partnerships that deal who that under rushed. of

our P&L characterize under very program. going And we continue continue the so very respiratory previously focus enthusiastic balance real, interest franchise sheet continue we as what our will I given will on to in communicated and to we will our use strategic to as focus leverage That had would pursue to forward. and

on I patients discussions in additional it's there interest those to Pieris be just not Inc. But that comment advancing. will that I is believe I'm the drug won't with future. going the be that be real, So specific will appropriate. wouldn't And reiterate it And this

I able good Again, of XXXX to say about no stay of deal towards So And I be back tuned. to would is rushed, terms but talk sight the say in of half that guidance, more a line would is program.

much. Okay. Thanks so

Thank you, Jon.

question ahead. And Blair. go our ahead. next comes William sorry, from Go am Phipps, Matt Phillips from I

No problem. taking question. Thanks for my

pamrevlumab itself? maybe if that Zephyrus-X secondary the if would but would with maybe you indications what endpoints endpoint no [indiscernible], curious well? be Just you lung you in the at other fibrosis the any primary in else are some fails there as there's might obviously mechanism, that I trial. guess confidence just of looking issues pamrevlumab give consider the like Or

I'm the over would to we to to Zephyrus-Xtrial and a course, level that mean, Phase negative, I trial pamrevlumab for high turn reason happy the I of if just say a Shane bit X, add want endpoint. negative, the the at would color. is of to missing if Matt. Thanks understand start is I'll it

a So for expected see with an example, Anticalin better the we targeting be the actions will believe lung achieve than of to not stop inhaled lower development CTGF. reason a that of directly as may efficacy inhibition

of at access the level. be will function could a So it deeper when a data one

for CTPF other validation data we that that a and priority as of lung that high be including that pretty IPF disease, are is IPF showing fibrotic do believe relevant, While indications intervention. a indication the the there are could Pieris progressive beyond interstitial compelling

remains in indication that's top So to our pursue. the still view

will press detail approach poster week with data course ATS, support think, wanting the at We and local that this release will be scoop being we the again a due for have two not presenting we with will conference released on to that later will -- preclinical caution in next in a, data will that that's compelling rationale news that coinciding month. a in or weeks but I additional

color hit to for outcomes welcome on a pamrevlumab. provide zone an additional positive thinking are that not other grey FEC you're how we'd or line through a be Shane, more on top

thanks for And Sure. Matt question. the

pamrevlumab in remind Pieris striking just show that Phase So study. people activity did X to the

at They So there level. was also assessments a lung significant FEC had quantitative including the impact some additional fibrosis.

So reducing another slowing progression. actually you're measure down disease that the

the of When things endpoints. any We'll we in believe don't placebo plays but consider behavior we differentiated. the look the certainly will role fibrosis. that pamrevlumab study point lung We system. at that data, feel the CTGF out secondary a the within few look that expressed has just the those primary at where high we to and are we in levels also

However, administer the if of a a target large its you administer portion only systemically will disease. a of pamrevlumab lung, way like make sync size there be there. And will with drug the to actually drug the actually

By very administering inhalation, we better lung important. we're going drug feel have it's and exposure to our by

One population of they FibroGen where things is may be a study that by the under admission sub they own feel their after presented is some dosing analysis patients.

So identified felt would level, trough efficacy. give which they maximal a they

dosing receive However, of current with only will actually that. half the patients about the regimen

So for the it's higher more molecule, a by got our targets. affinity potent

drug more the more pamrevlumab. route, dosing. we our what is over also potent are ability to By that administration we we and can ensure than believe regimen, effectively our dosing optimal it's deliver So have the by the we

are think significant some I there differences.

strategy there's differentiate clinical from opportunity the to Along with perspective, that a as well.

to have pamrevlumab see go with of things with opportunities So and we that is without decided care of the standard care. the do one of standard FibroGen go

in in phase. that We to the believers else the big the of data through the that year. we're X Phase have that, of all and Notwithstanding everyone when like just have in generated unreview from there. it, pathway X wait it comes FibroGen decisions the middle strategic data Phase some and So

is is plan And just to Yes, me nebulized that X Phase you take quickly remind what forward and thanks. well. the as

within So our study The I nebulizer. nebulizer dramatically. is technology moved Phase on has

is So the minutes. pretty delivery these time and are portable matter a of handheld devices just

talk we nebulized primary appropriate when IPF a and to key So believe for opinion the that leaders delivery is population. the consider we research,

to you shake if landscape last on one I'm about some it. collaboration missed targets I Are planning you from I see of question. waiting sending kind results Servier. know with Are And programs? sorry those competitor soon? also you the anytime Great. XXX out with mentioned

It's thanks again. Steve here Yes, Matt.

you've points around decision on time. data, your an I RPXD for before, I biologic two And maybe can had escalation question think think when timing, timing dose. one gets to to an predict hard It's Phase for as or the I timing said expansion. to X take optimal

RPXD We as data at Servier over will inform year look continue this budgeted OBD, potential continue and to of we the and expansion. to program with middle second advance and to the half the as planned

There prioritize the collaboration commit parse-out is could and expansion, flexibility how in to expansion around whether one expansion.

of we out come the firstly expect will And year. additional looking be we secondarily at we medical to be looking our also over or of course data landscape and the will competitive half the second importantly so at of data conferences

our we look strategy, to whereas we And to continuing prioritize we said, course, our respiratory have are of overall franchise. at

through out in the will once data will, to medical Servier. talk likely about be escalation of we're put conference a think and together I and we're first context we part of work publicly. we not can, we But good ready the data to yet all-important rewarded that with So continuing and will

Great. Thanks Steve.

Matt. Thanks

closing back last turn That for Steve Yoder it remarks. any was question. to to the would I you. like now Thank

and your remarks other company. your our of other again continued to everyone No for support thank than attention for

patients look our biologics truly and pipeline are respiratory on improve to the outcomes have great the to go day. as excited and of diseases. for with we We promise progress Thanks, forward you by a forward. opportunity inhaled updating We everyone, our

you you. Thank today's This for We does participation. conclude thank conference. your

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