Earnings call transcript Q4 2022

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Operator

Greetings, and welcome to the PolyPid Fourth Quarter and Full Year 2022 Conference Call. [Operator Instructions].

As a reminder, this call is recorded. And I would now like to introduce your host for today's conference, Brian Ritchie from LifeSci Advisors. Mr. begin. may you Ritchie,

Brian Ritchie

for Financial PolyPid's Results all Full Quarter Year XXXX Conference participating you Fourth in and Thank Call.

Operating PolyPid; Joining will me PolyPid's Warshavsky, SVP of Jonny be today PolyPid's Chief Ori Dikla Akselbrad, Finance. operations; on Chief Executive Missulawin, the and Officer for call U.S. Officer

and company's the copy Earlier press of today, X release PolyPid website, Investors December ended is results financial months released in section the the on XX, www.polypid.com. the available for XX XXXX. A

call, this federal on will that you remind to the the like forward-looking making of within securities management statements I'd be meaning laws.

provide making patient For SHIELD the example, the line D-PLEXXXX, recruitment, use wide management of discusses statements the potential II the is submission results top the the including D-PLEXXXX. goals forward-looking the including study, I for partners results regulatory opportunities, of the for potential attract timing and for financing support, the SHIELD NDA regarding resumption, D-PLEXXXX, the completion to of the pathway and of it timing and SHIELD additional to potential enter process design when study runway its and expectations packaging company's interactions and ability regulatory with for and for thereof potential to of and manufacturing timing for authorities, revised expected European the its commercial XXXX, collaborations validation respect with cash II

to described time and of are which from control, in filings. many the numerous uncertainties, statements are subject risks risks to Forward-looking beyond our our including time SEC

not differ. you those actual should results place including, or these risks to uncertainties cause the statements. with and in events which materially and you or the results described reliance Exchange encourage Form Our without actual forward-looking to material I that factors review the XX-F, the on may results materially differ materially that to those Securities cause company's from may projections. limitation, filings identifies specific company's Commission, These undue from involve statements statements. differ events could Accordingly,

intention or XXXX. because or conference any projections the X, only by today, to required events update statements, disclaims whether information. contains new call obligation, speaks or This of It law, future financial February broadcast any forward-looking live PolyPid as of revise information, as time-sensitive except or otherwise.

of remarks, to the Dikla? pleasure to call With prepared is the it those turn my Dikla. completion over

Dikla Akselbrad

Brian. you, team Thank earnings at I and full our of XXXX quarter welcome On like everyone PolyPid, behalf call. to our fourth would year to

thrilled for U.S. Before meeting details discussing our pathway we to Phase on the following SHIELD like the clinical I the have clear I for U.S. now X data. D-PLEXXXX positive how in to a Type program, the submissions FDA NDA of potential would a with regulatory C reiterate are the communication

evidence colorectal the currently D-PLEXXXX a FDA As in the Based data, abdominal available meeting, advance analysis particularly study D reminder, p-value surgeries. on potential FDA that Type centimeters surgical an company compared the a NDA SHIELD supportive The acknowledged recommended may results X.XXXX. also study standard than I care, that of to in data we in a I SHIELD support the this a in these prespecified XX which evaluating patients represented incisions on submission. reduction with XX% greater The provide additional the endpoint of observed population. agency the primary to from of XXX of conduct provided the subgroup

could a such with to confirmed II incisions approximately date, potentially that as serve study. has which study, patients ongoing surgical the appropriate SHIELD large FDA The enrolled the XX

for wide D-PLEXXXX that this use. has for also Importantly, of proposed prevention the FDA the recognized potential indication is infection, since

opportunity wanted some look to expeditiously patient to design working currently to like. will of trial QX the are take provide this around quarter, finalize study we the today the what next recruitment and resume expect color revised we While to

we of the tight duration SHIELD highly will were throughout have given within view that place I I. derisked the in which positive be fact Phase restrictions not in in a data more patient it as already and we the SHIELD trial, generated the pandemic COVID-related III that conducted II and population First, SHIELD focused the during

to Moreover, notably with including gather feedback approximately study, patients last total of site Advisory in In specialized conducted surgeons and recruited properly U.S. meeting into we specialist. additional the from opportunity SSI, to Clinical learnings, specific year key SHIELD We patients key the clinical infectious subjects key leverage the XXX to both an patient the opinion ensure XXX already learnings leaders II. have order countries these or regard intend leveraging to SHIELD-X we recruit disease a and behind to XX from Board are and profile. late we a

approximately Total I. the study enrollment. I II would seen XX be resumed one next in months to Top from is is months line SHIELD X are the expected of into we from time recruitment that next mid to line enrollment results SHIELD expected anticipated completion year time similar quarter. this the time highlight

conduct total unblinded to analysis once of plan also follow-up. approximately an XX a their completed patients We XXX interim days

took To during to that challenging period most will it COVID us you the it put recruit in I, XXX pandemic. was months this and patients XX recall context, into of SHIELD the

a defined in SSI, control XX initiate time the to to index days Importantly, standards II care of similar surgery the alone. combination will of the design ongoing will endpoints leverage the new and SHIELD standard post the and patient top of very with to secondary intervention having on in trial D-PLEXXXX and and receiving of subject The primary of at The will primary reintervention rate resources terms of endpoint SHIELD guidelines. to ability II compared significantly the CDC SSI study of needed a and care the arm be SHIELD mortality trial. receiving study the arm I trial reduce as in be

year the for interactions the place in we be Pharma the Patient to U.S., the near-term of done regarding for in U.S., authorities EU the the the take will this add also EU an Israel. first European as strategy are closely pathway will should FDA D-PLEXXXX. with and The we days. regards preparing XX on this Europe, that study have working regulatory safety anticipated are In monitored with we regulatory and are additional European partner, in with fully for expected region. half aligned with our I Advanz

to that our we a balance fund in financial expect having and number financing cash QX In continue quarter to enhance compelling well regard XXXX to we position, of extend this third our our sheet opportunities to successful With current a anticipate the into completion. year. to to runway of said,

shown shareholders. We institutional by largest are continued for grateful our support the

Ori will those. operational Ori? number Moving to review a on, XXXX. have we ask of I goals in now

Ori Warshavsky

XXXX development not year, but the on fronts. China. territories in view and like focus and first, We intend to Dikla. a development strong as in for a U.S. business different clinical geographic also you, business transformational potentially attracting additional From we perspective, manufacturing Thank on D-PLEXXXX and only areas, regulatory partners

validated over directly I as platform and of technology at a the platform-related target for predetermined a time. SHIELD the providing collaborations. trial, disease Second, PLEX point This large local of drug organ serve a clinical can validation in the platform starting period molecules controlled release of

new into is in-house partnership opportunities. a manufacturing research Importantly, potential encapsulate API proof PLEX that our it of support the and months various to we capabilities, platform Using matter in-house GMP development of achieve only can and have concept.

X on will areas. PLEX platform key collaborations focused be

systemic for or the is delivery The delivery delivery, local of toxic, too effective in oncology. specifically drug first, where not either enough example, innovative

technology Second, an and an the drug, approved local significant is leveraging product clinical differentiate life PLEX always accomplish Specialty where provides benefits. excellent to cycle management the looking portfolios delivery prolonged are of existing companies to this. way their

the although Our discussion partnership is in is pace objective planned to X XXXX, difficult predict. exact to partnerships inherently formalize of

my year. On of for needed support this having in the it process our the validation data the year. to manufacturing first and pleasure end half that, expect we commercial operations financials. the the We to over review of plan side, call submission packaging to Jonny NDA the CMC the preclinical and to by validation to With Jonny? D-PLEXXXX current complete turn is an on

Jonny Missulawin

Thank you, Ori.

to deposits end million of XXXX. million the equivalents cash, $XX.X As XX, the short-term at had XXXX, and $XX.X of December as company of compared cash

Now let's of R&D in the resulted The million clinical XXXX. period the trial. Research the expenses of XX, $X.X to were from expenses income months compared ended and the December in statement. primarily turn same the Phase SHIELD X-month development completion million X to III decrease our XXXX, for $X.X I

ended full year million $XX XXXX, For XX, XXXX, respectively. December R&D were the expenses $XX.X million and and

year decrease expenses, the expenses million period. development $X.X of for the $X.X of recorded business administrative General fourth XXXX and million $X.X prior the the Marketing during of and $XXX,XXX, fourth same XXXX. were to million period were compared the in quarter XXXX X-month the for quarter from a

as million the of loss the company XXXX, million For to the of $XX.X fourth had to quarter ordinary fourth attributable shares $X.X net a in the quarter XXXX. of compared

XXXX, a loss year had company to the to ordinary of in year million a attributable the full compared $XX.X shares For XXXX. $XX.X loss million, calendar of

We will Operator? open the to now questions. your call

Operator

first [Operator Instructions]. from And line Brandon of Fitzgerald. the from comes Cantor question Folkes your

Brandon Folkes

incision me, think potential we the I'll mind. the Congratulations how SHIELD we don't mind. how the are SHIELD about as think -- just just for just lower then rate do health similarly, of assuming you when for successful about of control a arm? of on you if infection ask hospitals upfront, about larger in pushes maybe just So product economic a there? surgeries? pulls also few you And if the you Just this Maybe the and any the can think And progress. commercializing in sort II, we in we Maybe II, elaborate benefit? in comparator do to terms proposition then how don't

interim early? should stopping there? Any expect On analysis, of the what chance we

Dikla Akselbrad

and So will of first joining in the question of health cover will II. economic aspect let I the Brandon, and the and And about how interim. SHIELD us, then it around with first, we for terms I'll start look Ori infection the you I elaborate rates the thank also at

data So what we now robust which we've first have assumption. all, done, our for a of is very to close X,XXX basis patients, the of

rate. mentioned this all the was times and conducted an it COVID, several during Although has on influence that we infection

the in We are taking a of that our during rate And this there as are that this also we are and was were might plus, a are obviously, the reduction it X derisk assumption. derisked conservative this is is infection although number when be why is period, Because papers another think infection talking is years time what perspective, taking a assumption our Phase under we've showing this in aspect taking. of baseline we this There we a this we're COVID. of a program. bit that seen From during X. about

at remarks, lessons them. learned as in patient many be the evaluate were but population, that, end we we've than trying Clinical both as the Advisory done a to referred many year, it had also last that evaluate and adviser. parameters Other internally, Board, briefly at a of and today's to that reviewed with process external could We to prepared taken look

them of but in potential specific economics look and future how centers. the also specific also surgeon are product, and the looking at the health hospital at countries, Some would

now as protocol the All as of are into parameters well operational the planning. these into

interim, things expect, are not has, possibility also an the stop a efficacy, to obviously, fertility. well sizing interim modification as to we for for so if As due stopping as the early as

did aspect that it's And entry, economics? health go the things blinded refine -- as do have assessment the I, us we of we in prior we along. full a SHIELD to help also some So Ori, have you entry. to touch want the as we -- can also

Ori Warshavsky

Brandon, defining what surgeon we a make comes or changed from clearer just it understand is, factors, the will think a hospitals. surgeon we to as the trial a anything, itself I hasn't story patient the easier risk economic. in bit for we I D-PLEX. better is can in even risk in with this patient-related the a it and is If procedural-related If risk health little a this more population, they think apply the We're potential flag patient issue either where now to right? see this made factors --

we're is the we should hospital a problem for I when where think where kind more making them. of bit -- clearer it factor -- a little assesses So risk the

And from is time additional in on. as there before, so additional right, an infection, the when hospital, there's reintervention, costs and readmissions

anything, if just the hospital. the a little bit -- clearer story just we So made we to

Operator

Barclays. line Prasad . And your Balaji from the from comes question next of

Unidentified Analyst

for This Balaji. is [indiscernible]

could patients mentioned You XXX and it the recruit timing SHIELD for SHIELD for is the to your that months criteria took for for given II? expectation of eligibility I SHIELD that on the trials. What II XX patient different about enrollment patient be X

Dikla Akselbrad

that. question. clear on So thank We you were for very this

is this I. the and we that expect the recruitment will XX we months. are pace rate. the got So was SHIELD pace and SHIELD what more recruitment we've looked numbers patients -- And in of Those we'll specific, also to here how I of focused also population, be those way, a By we've from faster during time the done that we what have that. extract fast at hopeful

Although, the seen laparoscopy opening because we've slowed processes again, in COVID based in well our obviously during assumptions SHIELD as centers what I down to then terms were remember, getting when and needed. we patients and going on need conducted was surgeries which of completely SHIELD surgery time, as having and taking test I,

centimeters. patients all quarter XX end incision had recruitment, slowed of and the the have XXX of patients of to still, out were So length at points down close XX% over of those But per patients recruitment. with we around those

was a the terms So this you give our of recruitment of what at can expectation in sense peak.

Operator

your the Buchanan JMP line from from Roy And of Securities. Instructions]. comes question . next [Operator

Douglas Buchanan

the just a few follow guess I up last on questions.

make And think to then the what's I I endpoint other centimeters, of there said, missed the it. just on over want in you Incision criteria? clear any are the kind patient I'm Just but group Dikla, XX primary II. prespecified sure -- SHIELD for

SHIELD you Is the about II so about I XX% the criteria? So that incision, in think appropriate accurate? had XX implies patients XXX it and with large with

Dikla Akselbrad

I'll right. first, broader had that II but remind open prespecified also So SHIELD is or population II criteria. minimally had meeting eligibility colorectal, this focused XX% that originally yes, are everyone more of the targeting just It SHIELD SHIELD in wasn't invasive. a criteria II. we the We abdominal about just

based And in patients see II, growing. are XX%. the SHIELD is XXX, that sense we incision. around the we FDA So it's wouldn't focusing on you now we number see I. it this that having XX% large we've And about trial in with longer SHIELD that I, of ratio makes the expect the same to feedback, of But in why the had incision this seen SHIELD

get you you you to wanted Now another it? point had [indiscernible]. Did that Roy? cover,

Douglas Buchanan

Yes, exactly.

Dikla Akselbrad

data add group. SHIELD longer type So the had focusing are had incision of on this and recommended where the p-value just data view of SHIELD that and focusing group the subgroup, FDA the with we we prespecified in discussed population I, a that FDA a we received we same and X.XXXX surgery, also that II, as on additional which sub the supportive same in this it we patient was

Douglas Buchanan

the Okay. enrollment SHIELD Great. you I, the couple sense unblinded when you the to assessments mentioned to a On assessment. And interim. blinded that prior blinded assessment then on you SHIELD apply II? does first of threshold, the you interim occur? in had have for Do expect a max And also can unblinded some a

Dikla Akselbrad

can in to in ongoing done get sufficient actually -- -- first done are real all, I the and something we no was there until those is are blinded that SHIELD where the blinding SHIELD is will something ongoing but assumption, this are and the management It's that here, on the us done see plan, we well. within II about the nothing going overall that But there the basis. idea obviously, be things effect. trial an about helps are within underlying no is we point that on So internally is an of assessments understanding, have do patient statistical point There so of basis. the that some an

have, to With have sample the in interim, reassessment. the possibility regards size a do to we interim, the

is the how or, a primary to the versus primary those are around what endpoint, would go endpoint I the the because understanding blinded details think we bit I of it is into SSI the assessment, early doing start say, but sample more to can see in underlying a -- we reassessment. detail, do our needed, assumption. is progressing, discuss And a once possibility, versus if to the we size we'll have this overall have

Douglas Buchanan

guess -- more. I couple Great. Okay. of a sorry,

or I what that with about way be OncoPLEX, any partnering partnering seems data? much the had true hold D-PLEXXXX on like you of more for reset with Or discussions You Is Are to get going that about SHIELD of to It ongoing previously. deal it's then expeditiously? what kind pretty hit D-PLEXXXX? to those more have you a that? maybe And for continuing? kind do advanced as year

Dikla Akselbrad

the with question. start latter of I'll Again, part your

very Our begin other we have intending are but asset development developing D-PLEXXXX, our effort this And obviously, top also done priority continue to and a until as will products clinical up get be priority. we the in of now fully now it's this is to What the pipeline continue right CMC is, we to processes. valuable potentially development, stage. and to OncoPLEX our remained a

a package. on thing in decent obviously, this our invested need preclinical another the a quite resources the clinical priority. a that D-PLEXXXX, into I in OncoPLEX think is is near But stage the before, terms limited. study focus good so said to right, that will go But as we I Obviously, is you're are is in stage. the are

Ori Warshavsky

Yes. D-PLEX And on partnerships. add I can the

that in There's the geographies new the all different showed still other contact partners. in conversations a of for we're we these in with interest had potential partnering that past, territories. few ones from All of actually

So lot and one the trial, the depend Obviously, stepped product. of this it but all lost no interest is ongoing. back will in really a on

Dikla Akselbrad

that -- is us. robust is it additional different or I some platform, are pairing areas, we with better the this from the understanding known around around with is clinical and molecules that we around thing, collaborating, add for very have which and novel in the our one interest new PLEX thing platform the encouraging seeing would data I robust a to SHIELD that data,

Operator

currently back the I are no further you. questions. hand There call to will

Dikla Akselbrad

their like goal to our forward potential on remain bringing We candidate Financial late-stage long-term our towards we care XXXX in Year-End continue you Results again speaking our promising product believe especially emphasize with and Quarter of external patients D-PLEXXXX. our our the quickly mission of Fourth D-PLEXXXX in all PolyPid's and grateful to to I joining their call. Conference for partners to of would firmly, as our to team members to next health prospects, and for commitment advance support our you and possible. to achieving our look Thank We as continuing providers Call.

Operator

today's you. conference for participating. you This concludes Thank Thank call.

You now may disconnect.

PolyPid (PYPD) 8 Feb 232022 Q4 Earnings call transcript