PIRS - Earnings call transcript Q1 2021 | Palvella Therapeutics, Inc.

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Operator

Greetings, and welcome to Pieris Pharmaceuticals' Q1 Earnings 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 turn the conference over to your host, Tom Bures, Vice President, Finance.

ahead. go You

Tom Bures

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

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

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

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

Steve Yoder

respiratory mechanisms non-dilutive the key drug points. a therapeutic and bolster bispecifics to significant and in polypeptides inflection and joining delivery and Anticalins in Pieris to one, of combination patient lead begin as million funding new quarter Anticalins pleased will our are to a severe securing $XX today sheet. call. alpha months receptor with are use proprietary alliances earnings first through a leveraged development our I'm inhaled have partnerships and PRS-XXX disease for respiratory while partner, dosing very the significant share PRS-XXX is into past next you, is most our few balance thank advanced the AstraZeneca Seagen Thank also achievement, pipeline study for everyone marked to of in first class We and proprietor accomplishments, some new partner asthma by for it's developing cash our IO can with for has we generated flow antagonist the focusing The Tom weeks and that by of first materially and Putting AstraZeneca perspective, IIa announcing I and XXXX we my global reach continue existing advanced supply to corporate and productive pipeline, addition our called IL-X milestone us exciting begun by will the of collaboration we an of and areas; we and two equity asset. have investments of you to in power last respiratory the for generation Phase for immuno-oncology. study. partners in few moderate two, for a part program. updates and been

weeks. care formulation evaluating this controlled part of and is of of first study dry therapy the in asthma the over of standard safety part on pharmacokinetics The two asthmatics powder moderate XXX four

value does split from $XX financial AstraZeneca compared FEVX of equity with terms safety PRS-XXX that moderate of million a primary study clinical investment the in study, this quarter, a endpoint of evaluate a between impact the efficacy, PRS-XXX uncontrolled million part weeks. Last of the initiation pharmacokinetics be in will placebo. certain study improvement and of for asthmatics the will a we asset $XX manner the of of with The over four connection second announced to Pieris connection The and the the in overall then AstraZeneca. milestone in payment alongside restructuring achievement not

four We currently broadly, active are programs pleased includes more with that stage AstraZeneca's commitment to discovery under this this collaboration. to program are also which and collaboration

our a programs, forward respiratory details, we and In additional these addition including plans are partnered number to proprietary of later developing this one of year. IND also for sharing to programs programs look respiratory

to I would our our pipeline. beyond Looking immuno-oncology have the progress respiratory made franchise, discuss now in like we

remain We fitness as immune cell of is target, X-XBB particular, cells immuno-oncology and which activation killer the cells. a our is activated receptor pipeline X-XBB T based expertise coming cells co-stimulatory that drives Our in concentrated enthusiastic natural around and over-expressed in whose on bispecifics. an about metabolic is improved

X-XBB to well designed and have locally our shown I our lead clinical that immuno-modulatory bispecific recently added of objective a to durable have X-XBB observed those limiting study action of KEYNOTE that stable activity the of at supports highest CINRA PRS-XXX, demonstrated with at clinical durable which Phase first by two this the patients II X-XBB target asset and milligrams are systemic have cold while with a of as gastric additional II rationale systemically including driven also type tested update benefits, agonists. first the leverage consists continues company progressing based in CINRA regimen trial advancing active X-XBB a partial benefit a expressing tumors. to dose the outcome, a line Trastuzumab as agonizing findings with tumor into clinical cycles. into the which overcoming we from of XXX seeing bispecific an doses presented dose dependent when no response is Phase regimen, clinic, dose Alfa, X-XBB provide II. per clear the which chemotherapy. X-XBB on mode I CINRA an clinical in we our CINRA with led shown based lead. dose, We Cinrebafusp confirmed, following These HERX in dose benefit benefit patients best the loading monotherapy XX at CINRA clinical the We and dose to as QX QX toxicities. tumors, response, programs known for have standard a response bispecific weekly all kilogram based diseases expressing off X-XBB we plagued bring Phase mg/kilogram and Phase and an weekly recommended cycle disclosing was is side of data two derive in overall program. profile to a a HERX study safety The studies. its Last Pembrolizumab that benefit. three by number cancer, a therapies, with has at low is additional of were additional AACR, acceptable And with that CINRA care tested effects HERX approval we a as X the followed from month, X-XBB has bispecifics or now into Phase subsequent

study. As a reminder, the Phase two II study a will arm be

CINRA The agreement. high arm Lily combination no in Paclitaxel, will collaboration first cancer part and Pieris a with with HERX gastric trial supplying evaluate of as Ramucirumab in at cost to Ramucirumab

cancer arm the this has US We begin on later patients gastric South focusing summer, study where Korea a and XX expect high prevalence. enrolling this to

evolving planned including analysis a with go-no-go composite objective looking in or rate high treatment this in and for efficacy ensure our measures we safety, durability remain at ORR. to be addition study are response of landscape that of We setting interim the and bar we'll a to competitive

action and can date a to that and We of established proprietary combination. Paclitaxel for are believe our XX% believe stringent resources shareholders. assets the minimum target we advancement of into CINRA potential by standard criteria the help of ensure is and benchmark for Ramucirumab observed we complimentary in our analysis, we setting We a judicious setting bar criteria which this mode interim it's at that corporate can with emerging of consideration, takes and given patients activity And meaningful and will ORR at to achieving achieve value translate this XX% than and care. have these use higher the prudent of into our

XX our HERX Seagen Pieris. of gastric no with which patients will in supplied tucatinib, second cancer partner with cost low and to the The combination will be evaluate we'll by arm enroll CINRA at study

drugs have opportunity. this gastric HERX in presents only low X-XBB we unmet and may the including for activation, also support a HERX addition a agonism setting, HERX conference that high ORR. data tucatinib we X-XBB CINRA HERX enhancing synergy in efficacy is high In when bar the and medical a immune the setting many is in multiple showed activity. where at setting and that in benefit in year's patients a We composite measures other high success HERX between safety data the CINRA to believe the two And a tumor pharmacodynamic demonstrate targeting generated clinical show with durability cancer, monotherapy Seagen paired benefit HERX market sizable it tucatinib, data the as is looking low low cell HERX we're as addition observed AACR collaboratively this these same minimal with the therefore that as arm we in a we clinical need with that for mediated in CINRA CINRA encouraging to active of arm are at receiving of locations. coupled low study, shown presented

standard significant at tested achieving the would improvement Here, a ORR activity XX% in agents least of and by that in setting. ORR care of light Ramucirumab we this the believe XX% other of a marginal Paclitaxel, demonstrated over be

equity with excited our the who novel Seagen collaboration $XX agreement are quarter. million last strategic immuno-oncology in Pieris in amendment We and was regimen this collaboration made in combination of connection to existing study a investment

making bispecific hard AACR, of targeting superiority the the anticipation into CINRA, study for of of for this also later combination data Phase PRS-XXX, which PD-LX X-XBB are of start XXX we II preclinical also partners our advancing and the are we Last we working at the As preparations a in is Phase alongside Servier to presented molecules. X-XBB/PD-LX month, year. I demonstrating necessary

PRS-XXX exclusive commercialization responsible is we is will part PRS-XXX a program. As further royalties also reminder, that our United in bispecific development undisclosed immuno-oncology and for on of Servier rights receive also the ex-US for by this States, in for Servier hold collaboration. sales of

share an Finally, upfront receive exclusive PRS-XXX, commercialized, milestone to agreement, of digits immuno-oncology $XX to sales Pieris recently granting pre-clinical licensing payment Boston approved further that Pharmaceuticals team and a and leadership we strong program and in Pieris will Boston worldwide IND of certain a the this of received entitled and terms rights of an track agreement which advancement low assets to to into has Pharmaceuticals a broad sublicensing proven of of with CINRA. payments, the advance towards of a million Pharmaceuticals we the up localized under bispecific mode submission. $XXX successfully treatment, up to collaborate subsequent the also revenue. action tiered agonism a look including if Boston collaboration around in forward royalties X-XBB/GPCX the next is entered on double million X-XBB range generation of and novel bispecific, developing oncology to of record follows

our beyond in with multiple by partnerships assets forward prepared Over investments look our to through on This over ongoing and you hand would first to guide back financial bispecifics XXXX Pharmaceuticals, the these focused our into to the And my CINRA and driven Tom. I by and to Seagen, footing. So material have you in remarks clinical conclusion, Cinrebafusp immuno-oncology investments to stage of we results. placed the Alfa Tom now quarter with pipeline Boston our we solid call concludes Servier, like partners. progression

Tom Bures

strategic received end was operating balance April XX, received that have the and to and $XX cash equivalents Boston and activities of forma March compared from $X.XX the non for cash XXXX. more March expenses to to XX, quarter March immuno-oncology pipeline quarter million ended XXXX increase for XXXX. The $XX from quarter ended to XX, would XXXX. increase AstraZeneca our one-time reflects cash million cash our programs million current XXXX for by by preclinical our higher share XXXX both R&D million, offset you, compared cash due related again were loss cash million the loss on March approximately the in the on to March received quarter are ended XXXX. totaled maintaining equivalents needs. the incurred X.X the facility to back respiratory March Net pro ensures $XXX quarter spending With to $X.X XX.X Pharmaceuticals. quarter ended and million XXXX costs Seagen million costs. everyone. basis, the and March Steve. million move partially offset or or a costs turn loss in equivalents Germany, excludes ending for This XX.X new proprietary project ended be which spending million XX.X the quarter Steve R&D the quarter. December our XX, net $X.XX G&A ended into and per been March decrease a reflects positioned loss per good balance while consulting from for that, million The quarter in ended XX, The well to in flat quarter on On we higher for our share Hallbergmoos, ended XX, related expenses quarter were a for $XX expenses over compared manufacturing execute million to Thanks, of Cash XXXX X.X for other I'll for in the call XX, R&D million XXXX for morning was plans to X.X the XXXX. cash XX.X XX, compared

Steve Yoder

thank And Thanks, now from keeping on forward of to would as joining a have I business you. building respect we points to stakes as new you activities, particularly and our updated Thanks open we to a have momentum. key strategic funding added non-dilutive time two today forward agree, all call to leveraging year. on remain want drive We our focused we to our to committed for these the look model. equity look call few of inflection sheet mix We on would Tom. $XX you like development and I existing we at to the and balance our trust to this questions. through and with partnerships, months been the million our partners. productive us achieving existing progress, towards last throughout business your you to Thank Pieris,

Operator

today question. Evercore. Thank Instructions] is with proceed Our question first Please of from you. Raffat [Operator Umer your

Umer Raffat

bar include that or not? a perhaps clear could And you remind formal up for if quickly, noticed Ukraine the just we that expect sites and today, could you. the says the you there'll you're expect to Hi, third have to Australia it's choice guys, we thanks if unblinded us I announcement? one, to even selection, to you readout would should I two III. also, that level one. Should if trying finally, when out One, an also, I to we can perhaps you dose dose three formally part about understand you spell have question. so taking well, site progressing to may. for that be my what ClinTrials And site would be Thank that release? a if to to included? and for of I'm a move trial, And and is that be internal two. have to part talk to its that as trying to you the US and press not part get understand part know you few of asthma be just Phase now able if us announce I Would review, was

Steve Yoder

a Thanks Umer. questions can to Hi, and take a the try all clinical design all those on one great. that's for XX at focused study I time.

up part to as which safety is and two three yeah, two noted, one is this phase, endpoint. three efficacy at phase, as parts study. to then So primary is which the There's would you the which there up there's phase, sorry, to part doses, FEVX look the Umer, efficacy

they is we be, into part as progressed it's would that later I not AstraZeneca before, enrollment and to announce from personal have will disclosed be that had have have assume we the I that part as assuming fine to part specific pending progression intend but or which anticipate desire, when with from part that one year. able this my would into be for two we two, that sometime I that, is communication one We planning mentioned planned

for that be could to something that's press talk around even So but would any I expect able about data a we release formal that not disclosures, sure. though hope talk about, then we to

the allowed used rather if is than efficacy move the such of wait doses, then to were one first phase, would part that as staging as certain a amount there one of two into the that As clear far part two, is a progression one three. be doses in for all could the that

And the are So Australia that's very, but Phase some nuances doses. we're all other efficacy accustomed a we're the leveraging have lower consider we far and then site regulatory geographies so doses there to as in design efficiency as you that the in noted, working in moving PRS-XXX, Phase study. we been global additional at we still to and into don't as focused will multiple It's before the currently sites, at interactions looking very necessarily clear and and three sites. and Ukraine. We've also I several with with Ib And readiness. phase

too We specific with certainly haven't yet, the are interactions the certainly US strategy FDA long. disclosed contemplated a before in but

Umer Raffat

Thank you much. very

Operator

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

Matt Phipps

morning. how for looking learned and and pipeline. into might around start competitive first then with other gotten wondering from XXX space, X-XBB disclosures the the a that business rest with with of given in that data on and CINRA. activity development get you development these And of group have help can you've the PD-LX some bigger couple the specifically that which generated quarter. a from bispecifics, companies congrats you questions becoming for pretty I in for others, programs, have taken can info of of their kind your had which the it's through to what just where now my a bispecific Good this Thanks you leverage CINRA guys taking the on picture guess, combination

Steve Yoder

we mentioned Thanks and lot other and X-XBB data. into bispecific Then things the approach mean, CINRA particular, reported the through much. some the There's of them to looking talk then of in broader space where moved of some could so that. you are opportunity can firstly, PD-LX of rest the pipeline a in Sure, data that from the we stage throughout and CINRA clinical what gastric cancer did with recently a of specifically about there. our itself at the already have programs initial CINRA of I talk also there speak learnings number Matt.

metabolic the that at opportunity I'd sharp very So think what agent people frame coupled bit about let's coupled single when and CINRA And seen immune on the space, this the X-XBB biology then you to [ph] that PD a think agonism into those positive detail. stake, really go far And us space activity, field. first to in less well in think space, could the and response agent a lost have cells is of bispecific a compared driving about differentiated in - And what is compared HERX to activity, we with that I pretty this immune is low thoughtful opportunity. with leverages great in expressing that a But just HERX brings looking can gastric the different. is ability in high cancer think what macrophage Pharmaceuticals T is and being think only I about play as tumors, us cells, And X-XBB fitness to think if It tolerability And that the we does, consider is we've it HERX to this that cells. the when dose on innate be of there very with at which bispecific. the the think we the in X-XBB think than little helped RPXD. through this meaningful, knife. more for based general, the to very don't biology, at help how and engage HERX bispecifics, zero of NK the like can something both Shane in a correlates like good on bringing then think about lead dynamic the - from positioning we latter a because a will Boston and high PD-LX X-XBB that nuances novel be immunity compared the into not learnings of of to helping we this with adaptive to improved immunotherapies relevance positioning And sake, to level will for single if And only compelling, the we also HERX to bispecific CINRA's space. payloads, get we a I some forget I agent and impressive safety GPCX/X-XBB as the knowledge, want have profile. I our we set

bit announced specific for PD-LX low, thought Shane in bars class into HERX put really maybe including a as designing go there. well little the or the about ORR of some can So we X-XBB deeper today why of HERX that on feel potentially bispecific on really best in lot our enthusiastic high nuances as a we've opportunities we which

over it going I'm to Shane to a little bit deeper. go hand So to

Shane Olwill

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

So to help question to through. we terms leverage programs and what in maybe do we we back going just those bringing that excites we're see position in CINRA what see can other really X-XBB with how of us your

with So with in very our see clinical of what power the trial. CINRA, evident regard we to X-XBB is

heavy and and was T cells. take to As we you we know, where dependent tumor translation was us nice into increase a happening see in mandated see biopsies a allowed [ph] CDX what it look that microenvironment dose really paired trial the

our be As mind, that HERX expansion Steve driving T to to of said, only the shown the in cells this tumor targeted has microenvironment. agent is,

be tracked and is can engagement demonstrates of the of have correlating and clinical also are X-XBB in a in PD useful what's target very those very X-XBB correlates our benefit. patients biomarker soluble And important mechanism also We that developed blood which with action.

of X-XBB patients and that seeing gaining we're So agent. our cells clinical from that expansion expansion have T of benefit CDX

that compelling. What's armed we're go a also that mind, cancer really in monotherapy low setting that allowed the has to activity As this X-XBB as well Steve driving gastric for compelling to us very is, and two HERX is organism our said, study.

will of complement terms based achievable the there, the that of debulking first Ramucirumab the chemotherapy unique vascular on action, and of XX% ORR that we or in an that's with will and So We've come Ramucirumab. combine mechanism very Paclitaxel. of and will greater the we believe normalization set which arm with

perspective. bringing us terms T a drive a In know data strong from expect learned other with cytotoxic forward to all Well, know there PRS-XXX and it we can a with receptor NK we allowed density. off drive very, set have with learned tucatinib of we what preclinical else we're we with can cells And agonism well. a biomarker microenvironment look that set to nice can to the showing meaningful regard we what of us, this very tumor therefore, data the HERX way we as we've study? in strategy from that population, combine that into that certainly biomarker low has We drive fairly X-XBB we of when studies, can up

about In out is how also they competitor are how and what that. from the Well, others failed certainly, X-XBB feeling doing? - very terms data coming confirming of are we are trials is relevant we

look have the terms which clinic we to profile molecule to the that of this we've have in year. use in believe of we and knowledge design generated, on forward at has a in this a there. later have So, taking developed But will terms all AACR smart shared of PD-L/ that data X-XBB of we X-XBB based a we a year we activity into what we the compelling particular, certainly all

molecule up for biomarker will X-XBB And set Boston full very Boston the them. clinical got we that are bring ensure CINRA relevant As that where collaboration Steve said, design Pharma also we've to of we've there. the closely advantage all Pharmaceuticals forwards, trial takes we of will GPCX assays the certainly with collaborate

Matt Phipps

kind below will up. We've to the had, I II one recommended receptor middle you of or saturate you overcome a to be Thanks competitors in think, that have to to Phase and what okay do that side? a in pick X-XBB you at of dose dose that kind on would least space just Do at the PD-LX in pathway. range two PD-LX XXX fully least it's inhibit think follow expect think or fall the PD-LX able

Shane Olwill

Yeah, aware so PD-LX/X-XBB the fact they the we bispecific to a is Phase competitor proliferative see and drives the forward a on be clinic, observed and potent. the that II into really be to that of T cells certainly going profiles - in have recommended have their pre-clinically, very the also molecules the your of We phenotype. it's changes to question dose burst safety

So it's a going be bispecific. to very powerful

In terms of feel we our is moderate which affinity X-XBB activating with pathway. agonists, molecule, we certainly have for gone appropriate the

read plays wait out have to see what We clinic to from where the to for that out like a perspective. safety

suggest strong that activation saturate not, get to In here? Well, suggest you the would preclinical very the T cell the would compartment data of data do need preclinical arm. saturating checkpoint arm you terms of checkpoint without can

but terms without There in to go I in that opportunities are essence, may of approaches, the out forward in read there So nuances different that small be saturating have to would say let that we people's therapeutic arm between window. clinic.

Matt Phipps

Excellent.

Operator

time. to would like additional at I the There are remarks. to Steve no questions turn call this Yoder closing back for

Steve Yoder

Well, Okay. for a I all and your Pieris. to everyone Thank day. wish again support you I your continued great attention for thank today. want participating just of for you

Operator

today's conference. concludes This

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

Palvella Therapeutics (PVLA) 17 May 212021 Q1 Earnings call transcript