Pieris Pharmaceuticals (PIRS) 2 Nov 212021 Q3 Earnings call transcript

Greetings, and welcome to the Pieris Pharmaceuticals, Inc. Q3 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Tom Bures, CFO. sir. ahead, go Please

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

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

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

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

I will now turn the call over to Steve.

Phase PRS-XXX/AZDXXXX, asthma. of in of XXX to for Dosing today which Thank in Part is milestones on with alpha alliance top balance quarter you of Phase several pleased a the powder study, uncontrolled X Ia endpoint partners, we will The USD which dry great everyone through asthmatics our as of XXXX to that Phase PRS-XXX. controlled we I has dry being objective million, developing us Part with is having our in inhaled the evaluate Data the will care moderate evaluate weeks. over and FEVX to pharmacokinetics of of over standard asthmatics in efficacy, and formulation and placebo. XXX with safety X review moderate endotype, on the unblinding pharmacokinetics powder the sheet the global for milestones own treatment weeks will TX AstraZeneca data discuss of compared a with most the of formulation primary are completed greater study have outcome disclose the us uncontrolled our Part asthmatics. and later the will important quarter IIa safety line inhibitor, the continue part you, of improvement the moderate third pipeline from United jointly ended healthy of the of Tom will which moderate-to-severe AstraZeneca line Upon IL-X detail be assessed of study very reporting together to IIa progression thank the year, these co-commercialize of the an call. of entire receptor gaining follow, now will where to to In next and year. over joining top exciting II we entire and am the study study, the codevelop report options Tom, will in for key and second States. publicly the advance Among separately been we in efficacy results next earnings IIa PRS-XXX I we get the to a

with early-stage X that programs AstraZeneca. on are we PRS-XXX, Beyond continue together we working to advance

presented fibrosis. protein inhaled program for We data development connective treatment to Another against CTGF announced forward on Congress recently supportive preclinical the we are for PRS-XXX, a of lungs tissue respiratory growth PRS-XXX. our targeting reported for proprietary Data data respiratory idiopathic an clinical and September, the is for to nebulization, anticalin program, looking delivery its next at local rationale as International the administration the factor, the or advantages Society of intended properties in via suitability Respiratory CTGF, catalyst route. drug-like the PRS-XXX initiating intervention demonstrated the pipeline fully European year for with the pulmonary for providing such

patients. showed target mitigation engagement greater monoclonal clinical head-to-head to same data antibody in more administered preclinical has inhalation validation fibrosis our which administered via studies, that administered like IIa antagonist. a in CTGF These that PRS-XXX lung a approach Phase study pamrevlumab PRS-XXX the randomized of may against systemically inhibitor and Additionally, through a target achieved efficient a a support systemically thesis locally the IPF be than data and provided superior

a pulmonary activities for and fibrosis also post-COVID GMP tox of be Phase USD for in support Bavaria initial this program, Germany. will clinical The XX development. the state will readiness support with development approximating GLP clinical of studies, including the evaluating the grant clinical and I manufacturing We program grant from million

this pipeline, our briefly progress would we earlier Before mention immuno-oncology I also of year. moving collaboration on to signed like the Genentech to the

committed initiated that for X in proprietary in Anticalin X to ophthalmology, the We our part commercialize and leverage activities X delivered programs, discovery locally and have platform. therapies joint the develop as collaboration now of respiratory discover,

are an we We on these course. and industry excited to look leader, programs, due their updates forward in additional to with be progress Genentech, on giving working

immuno-oncology like cinrebafusp now an with give With that, update beginning alfa. our I pipeline, would to on

small cancer patients to HERX, supply regimen, is II. currently as with the we HERX-low ramucirumab, ramucirumab developing in the design with for are a X while bispecific standard HERX-low HERX-high arms, PRS-XXX, arm current a the study tucatinib. is Lilly, agreement and HERX-high with The reminder, Phase arm which also cinra X by comprised be be HERX-low drug The with is gastric of evaluate combination molecule supply Seagen XXX with will supported tucatinib, a known with drug a combination supported care of HERX paclitaxel, and agreement by a and in inhibitor II of patient entering that to and and evaluate HERX-high As cinra, patients. for X-XBB/HERX cinra Phase will

the next we are initial higher reported, from the HERX-low to XX% previously setting which we established by arm than of for of ORR, which bar a benchmark rate, response objective report least As XX% plan care. is the at year, efficacy data standard significantly or

to ORR, evaluating control addition we of In be duration rate response, safety. and disease will

arm, treatment a progressed a enrollment the landscape, have homogenous decision just one patient HERX-high population, of after more have made to evolving the focus those For who given strategic we therapy. on recently namely line patients

includes change, we safety well response, Given rate which to and duration this from as of tolerability. control arm XXXX, this as now report data expect in disease ORR,

our for a with XX% an HERX-high of ORR We profile an cancer. represent a would durability measures, previously and believe response bar As a we composite attractive our with gastric arm of have advisers good is that go/no-go option rate for patients for including least guided, XX%. and HERX-high the this important criteria safety at

our next program. to I-O Turning

tolerability rights holds collaboration evaluate of cancer ex-U.S. progressed advanced clearance evidence We patients we of rights. preliminary X-XBB/PD-LX dosing regulatory have a U.S. and will received open-label patient treatment. program study antitumor bispecific, number escalation SXXXXXX, conduct are with the global of in holds in first the this with in activity dose on nearing full Servier in or solid Pieris care for The who the a safety, of and I/II the PRS-XXX Phase of to standard study tumors study jurisdictions. whose

initiated part with co-promotion that bispecific program is Seagen, in immuno-oncology And develop update, of States. the United undisclosed a continuing within Furthermore, second Seagen immuno-oncology option includes bispecific. collaboration to we Pieris I'm program, first lastly, as program a have an our the that the pleased to for announce the anticalin-based

Officer. I and Tom, the to like markets-related at back hand now recent whom treasury, oversees Tom matters his on activities congratulate to procurement Chief financial including call relations. would Financial and would the to over planning, investor company, all financial like to I also tax, capital promotion

strategy to as business promotion would in Site and Counsel to I like on Business congratulate lastly, will Chief Mousa In and recent Ahmed his addition also to serving development Boston head new Ahmed General Head. And Officer. role, his portfolio

ahead. please Tom, go

milestone Thank the balance for December XX, year a good quarter cash over The ATM and again, X.X period. by our compared development XX, gross we XXXX, The increase used ended increase months XXXX. cash under September clinical the government proceeds equivalents the XXXX million offset $XX the grant to ATM new PRS-XXX of costs average December sold collaboration ended since first of qualifying use balance existing XXXX. you, received the include and along Cash fund XX XXXX, our the will The program X XX, Steve, for for not the agreements incurred stock million due the cash totaled September of program partially shares of and and was $XX.X IND-enabling program. achievements, million cash ended price cash from cash September morning to be including to million is for at proceeds $XXX.X and equivalents an everyone. reimbursed early does $X.XX. as operations Bavarian impact quarter those of third for our of In with

expenses higher compared million the XX, for and ended an increase These partially clinical AstraZeneca. in are alfa reimbursable PRS-XXX on increases employee-related higher preclinical The XXXX. increase quarter higher for offset ended lower $XX.X by spending September were programs, were manufacturing costs costs spending XXXX, manufacturing by R&D which costs. in September costs to XX, across on PRS-XXX, on fully for manufacturing $XX.X the quarter million cinrebafusp activities reflects multiple and immuno-oncology

and $X.X spending million XXXX. quarters to functions ended were for leverage the no in G&A categories G&A significant our XX, to incurred Moving efficiently the There as company to on support of overall September XXXX needs. expenses. changes both we continue spending, We and

was June ended grant, under for previously of XX, for the $X.XX quarter net announced to was September or For was per ended loss a program And September net million ended the recorded loss finally, XXXX. XX, the $X.XX costs or quarter the compared XXXX, loss of PRS-XXX $X.X qualified million income in a of $XX.X million per XXXX, share share for a loss which September $XX.X for other XX, XXXX. that Bavarian quarter reimbursement

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

we before sharing you to filled compelling and conclusion, and us and to lead been our I'm looking progress therapeutic overall to Thank year-end. respiratory eventful forward with and goals on continuing additional our look one programs programs say immuno-oncology year. key an programs, on I with partnerships, to next far, executing new for clinical execution year forward of want Tom. In you, new this has several that advancement just so

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

comes first Our question from the Jonathan Miller with of Instructions] line Evercore. [Operator

couple a have just I here.

expecting I to I to think very results IIa, what clarity of want the Phase hear the communication we I'm of should that be obviously get X part on but excited from XXX more portion. some safety from

tolerable already a investor expectations profile. are for think I

eventual the patient from So while comfortable what that be we us we wait population? should in gets that part for expecting release X

see some it's to sense there very Secondly, things the I what early are in interesting latest on development When we get the time were in thought here preclinical very to but humans? nice versus data. the path antibody clinical and line? systemic a thoughts especially your differentiation the presentation, XXX for could start U.S.

Steve take it I'll Jon. first at question also try before Thanks, the question here. over Shane. maybe to then frame more to handing Great. cut and second a the to depth

gate we're through. the Part and to going safety we PRS-XXX part just go to what think efficacy it's I on study, of So Phase X need look into the Ia where good to IIa from are

there tolerability dosing is So safety, additional doses X in we completed part, noted the the safety goal safety that and first placebo pharmacokinetics. where part, to and assess of the we

study, So particular. review review process and unblinding calling this the then blinded AstraZeneca data an within data and a a in then and governance, as is there's

and forward So the move meet or time to committees be the IIa there whether the not into review a and portion portion will of conclude or to then the data efficacy Phase study. for

to from will the working data so going through next previously, what that AZ any as will guided efficacy have portion, we we part, announcing And will data but trial per the which still for complete efficacy to are we plan we with won't we do, se. the closely will that is gate present that the So this into data going full we we're go be top be process. be to through will the be first and line year. study, guiding part safety The we're announcing the be

year-end got the can. dosing review we So process that here. that that specific officially then motions of forward soon to haven't we question? as And we we go like would address sort that of progressing. on looking into weeks it's anything has reporting. that that's look as AstraZeneca we your that, we're and guided for would through something announcement on I or some an just that And unblinding given doing completed in now align with we're but note and as to will say, Does And the the move

And sense. XXX? That makes perfect on

Yes.

we're we are we to normally with the preclinical in monoclonal -- of studies is that presented IPF antibodies. drug R&D shown to with we put engagement. antagonist on believe remind able PRS-XXX, number our that address We've So pamrevlumab. we in nuanced strategy just already targets trafficking that benefits XXX, over CTGF start what ERS. approach validated already shown a the doing I clinically forth already again We've pamrevlumab in to dupilumab, ostensibly as think through And superior against validations vis-a-vis studies from did ways everyone, over with target at

setting, we of pan ultimately that of show will a continue will course, preclinically will So the techniques is but local to ourselves the in the potential clinical this approach. benefits way avail to out,

going And other approach we're for also that and a ways continue, prepare specifically clinical the going go, right to to is to only look development, that we mechanistic and way not benefit. preclinical pamrevlumab also against have so we to translational as a local but reinforce we're why at

that's in with development towards what to work tend we clinical program. generate. what course, we disclose we as to That's so And intend early this due

we've already to over articulate we there, said add done, want if of I everything particular, a to and to beyond else is Shane, anything say benefits you would maybe in how give you pamrevlumab. over what also, benefits but plan there systemic terms that to in specifically I comment chance

for thanks question. Jon, And Dave. the Thanks,

clinical So just Steve and as data is we the are how pamrevlumab, how going And in route perspective, we feel facilitates The convenience pamrevlumab, got of better see Jon, terms of differentiation over patients. early we've should CTGF. target out? that better better the said, for on administration demonstrate and flowing from a question, of target. the from also, based to an then engagement we the really course, target coverage you've We saturation for fact got feel that a differentiation

it of data year In to did that, IND-enabling the share of ability and showing there's terms our at parallel in to as to areas further ERS. We'll of said, characterize to to And a models right of the lung. clarify preclinical you this evaluation utilize continue the our we that, we number our methods can preclinical deliver drug that activities. and characterize

at lung things of that pamrevlumab drive there's to with going to some in the start IIb Initially, target the is decline as In tolerability this. that clinic, components those and And in study. be us CTGF we terms to clinic, excited of the very the standard registrational in a safety clarity reduction their the has have towards one endpoints. to then of function observed from -- about Phase was made look

clinical to that what So we in terms we some real of as components in there's of give in have certainly course, standard to initially. date, we'll it. meaningful And on approaching quicker -- from trials the manner readout we aim want color closer how And essence, to possible. through, will clinic. And get get initiation the more as as we're see in there's to markers get our to of that that

Your line the Song comes question with of Jefferies. from next Roger

Great.

X for So from me, XXX. maybe X

doses, X that if mentioned So enrollment you correctly. the I just completed I for you think, already Steve, remember

something up is X if in of kind Phase of kind think is said for X will you that You enough already you II? do dose that And still just will to the Or you sort of later? the dose the curious place, levels. doses dose

and part additional Phase as is well. AstraZeneca conducting the doing study MAD also I study DPI understanding you're second the XXX The of

we Just curious X -- will expect should some data of from we those when kind studies?

Roger. Thanks, Yes.

So of your X across first question part cohorts X. sequence was, part both I think, the and

in after by would remains so the and then that parallel low and would Pieris had in efficacy low would mid the X group then third the also, data X, are the and of aligned then on guidance the assuming and line year the and be portion to the the in the that efficacy mid of completion of following complete safety And highest dose, all the the our and And part all for of which dose at who what the then both patients and the AstraZeneca that top that, efficacy. would the next through the enrolled the in design, high first part, part. dose the part, those initiation randomized study, was and once run placebo so doses, into be data justified and safety and going dose efficacy gating

your answers sequenced are things and staged. that hopefully, terms So how of in question

AstraZeneca second availability the from nebulized asthmatics the pheno-high formulation asked bridging work was We're PK bridge question done, we to the in manuscript and formulation had Phase additional where DPI submission the around and together in done I work enrolled you get therefore, finalization And had with on think, a I read better AstraZeneca. study, controlled to those process, DPI. the MAD any nebulized working in in then that from of the the that data drafting and we order mild on

out the is the It's part that publications data So all comprehensive of course. in in our review due of will process. more peer-reviewed form intention come these

published. And studies, separate so will But process. separate Both that's those we -- all they're know manuscripts. you'll whenever of have in

That's great.

question to last is XXX. My Okay. related

you slightly changed very of HERX-high this evolving mentioned you Just and kind the interesting, population. landscape

provide you're just the expecting KOL, reasonable Also, population. I be DOR, remind XX% of the the very should the mentioned the us differences this clarity meaningful population. for around what's key a Just what ORR some for DOR population? think this Maybe -- kind DOR and kind just for you curious of HERX-high

Sure. Thanks, Roger.

what isn't engagers. and in is contextualize to it's to good of I just relative terms cinra it again think HERX

think And that be of generated opportunity we great mediator. based for so this tested we a primarily this And to low we're has HERX show immuno-agonist rationale on a immuno-oncology progress we such there. going there's remember, today and some hook a And for a and HERX agonist And the uses of just a bogey given or reiterating we by standard And dearth a X-XBB in targeted X-XBB preclinically XX%. in for see program quite for a low, as cluster care do high. think time. XX% ORR, as of and that as been of we the can been primarily data our T-cell that the second-line clinically, benefit meaningful at HERX separately in

Now HERX disrupters other high, very been it's all of disease HERX intervention, mediator HERX, space, that uses and in because you players aware. of antagonists primarily the a it's as space, dynamic the are HERX that all a as in the and number space are for there probably

do we this cinra though even modalities the other in agent, an So development. is with HERX-engaging contend primarily that I-O are

the looked out as we a think than landscape benefit are second offer still relevant. with And of bar we intended do And line, a different remains setting number so something two, number that, there. immunotherapy, composite that still other we at we in that think engagers durable setting, very one, XX% that the ORR, the an that HERX very of plus is, in HERX-high

or this way part or to second patients over that concluded his And do that of difference words the he can so can right get Officer, Tim as it with second good what and is own last why evolving the maybe here, of of coming the we've types couple our in would nature only. him will some Chief the in few adjustment is care the discussions good, only. various to enrollment advisers go with be words, I as Now and share year standard geographies. his and that think we and had And is how months tightened to Tim, we've of now last making in really the to the second-line in we Medical or impact of here thinks line line right focused

Great question. And thanks, question. for the Roger, Steve. Thanks,

We know patients in principle less gastric oncology, that lines obviously, of as heterogeneous rate population a general yes, a later cancer is with a begin So to response with. of have treatment.

And dove on KOL RAINBOW the would we road the up when realized population, our into robust data. that most is the have tightening XX% data, those the down to and publication. really rate. by the mentioned we second-line we benefit deep and interactions high the where have decision-making the population Steve really really the program focus so just benchmark response Obviously, HERX that's we

published With months. You of the response. it's asked about RAINBOW, course, X.X at duration of

when add cinra So be we and have I investigators to Phase we that's at a to that the able year, this ram/pac that and at we've with benefit shown anticipate based on think And deliver shown we our over believe would that, reason I well. is we significant data before to that as AACR confirmed that [indiscernible]. will

cinra conclude, different very It's patients. we to landscape. an just has mechanism yes, to to evolving be a ever-evolving strategy adapting this So of second-line for envisioned our option are an It's landscape, action. and

Instructions] with comes Phipps Blair. next of [Operator line from Our Matt the William question

So is period. of on dosing in-house? blinded X-week you follow-up kind mentioned There's the Is data done. a also XXX,

just Phase XXX X next third us do least we would know year, dose is then in or II Ib the it So that in timing, on will doses lastly let for at And then doses? portion? you to when completes the X data before period for Phase they that X-week the wait that safety any the will on still unblinding. we get if follow-up all wondering first And be

Right. Yes.

Matt, for thanks, So the questions.

XX-day the Part question that based timing have was passing on all the on the that gate fact announcement in Ia getting into of both been we've announced and patients the -- So dosed through or first a your not process out. from you of no period. remember, But And on there comment guiding is aspects the don't want review date. know, Tim, on data. we're again, to on I specific follow-up a the

question your top on in a Phase come then second. back And to IIa we'll line

Great question. Thanks, Matt, the for question.

a being the X-week as safety enrolled we And follow-up of part X-week for be all, there well, actually be first out, of patients the The data is of there It's first And data completed the first a will set fashion. follow-up Steve yes, study. this we data Steve a of Safety in -- study. be enrollment the mentioned, So as the pointed part period complete study. -- Review speak, is the analyzed, later in-house. held on in coming There Committee for up. as available will blinded will the to

available efficacy, right for So safety very soon. come patients data all will Follow-up now.

add to your a just question. Matt, color final little on And

So the Part Ib doses of was it earlier, the think the safety study would will, run be parallel that question, third I X as first I the will and Jon's in highest dose, mentioned which efficacy to in part. from

I X-part everything. that entirety that which to so of course, top that that from current and the expectation. in make power of line crystal study, meet the Xb next the match intend of safety. clear, dose number entire to And jurisdictions And any bulk to in just everything the objective plan And the Phase think the of the disclose Part which the to the efficacy right, line, the IIa not together it to of include just AZ, be plan, will top able announce study. to with would sites, passes to we of our the will results study again, was is is that -- we number currently enrollment is year, the

Yes.

high combo Or or Is strictly this that XXX, low tucatinib -- the the line for I and little understanding second bit On that that seems is for HERX HERX combo the line reading chemo Okay. still second it a like focuses as or alone. was well? correctly broader? one -- if

it's great to Yes, turn a Tim. over question. that I'll

manageable of that I of because we'll high, the of comment is Tim that. HERX emerging care, far let one more standard is but dearth on think this than

some Steve. the arguably new in higher in Thanks, a a Pretty world unmet indeed, eastern equally, the part even on well population, medical very as entries of as argue the needs. the is part, competitive a speaking and HERX-high regular Yes, lot of western Yes. it's external with low, basis. might obviously, space, consultants

regimen. So there clinical approved even is trials beyond outstart for much chemotherapy not patients the in

therapy, So it's third not even let second-line an a established line. alone

that a for population, HERX tightening So we the to high we as feel of pragmatic indication while is most the same the at at time, really discussed for HERX-low part this have point, line-plus criteria it second the earlier, study. the

last one. quick And Great.

IND that XXX, that approvals there U.S.? on trials start Are a ex in trial? countries. the an waiting in U.S. getting clearance Or to will congrats start So you for couple start to

guided haven't We specific jurisdictions. on

filings which course. as of will into, think space, filings look disclosed we given allowed I haven't escalate. and course, say in and in that refer the in to our that, we to did way what jurisdictions for due we of we accordingly with we'll escalation with But regulatory most from past, that to in is have nature ct.gov yet the lot efficient we And other cinra. initial the a the U.S. back competitive learned the us our gone calculate but just engagement FDA that come has out

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

everyone for your again your support continued for And Thanks, Have thank to other Pieris. right. of Hector. attention and today a add All day. than to nothing great

conference. concludes This today's

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