PYPD - Earnings call transcript Q4 2024

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Operator

Greetings, and welcome to the PolyPid Fourth Quarter 2024 Conference Call. At this time, participants are in a listen only mode. I'd now like to introduce your host for today's conference. Brian Ritchie from Lifesci Advisors. Mr. begin. may you Ritchie,

Brian Ritchie

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

I'd Joining me Missulawin, months on U.S. financial a Czaczkes available the and Akselbrad, results statements And the Warshavsky, the of call today Executive Ori X PolyPid XXXX. will of copy will to www.polypid.com. in company's Investors XX, press PolyPid. Officer management is securities for of Earlier federal that December release PolyPid; released within you Operating the ended on Jonny the Chief PolyPid today, section website, Officer; Chief Financial call, Officer, of on be like remind the its laws. the Dikla this meaning forward-looking XX and make

statements recent is the it cash the of of results accelerating Management potential efficacy of forward-looking company's the and line that SHIELD enrollment runway the expected beyond the the trial, timing quarter example, trial, II top the II, the from regulatory financing for making D-PlexXXX, from of discusses probability XXXX, success third the company's expected into proceeds NDA timing when the gross of for SHIELD the potential submission, trial, results expected from of II line prelaunch for the activities. preparations submissions completion SHIELD For top

for the from NDA the opportunities United long-term full and in warrant additional if opportunities, from exercised, in D-PLEXXXX result of market warrants all States, proceeds for with pipe the gross prospects. D-PLEXXXX of procedures benefits would capital the ImmunoGenesis collaboration in use with company an million Potential would $XX size that company's clinical that in of potential additional proceeds, pipe provide of the approval, benefits partnership potential the beyond in the the issued D-PLEXXXX, in the potential exercise

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

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

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

over turn call With to of pleasure it Czaczkes remarks, PolyPid? those CEO the completion to is the of my Dikla Akselbrad, prepared

Dikla Akselbrad

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

or . size notably efficacy assessing III DSMB prevention to is the the pleased with II it by the undergoing patients the reassessment of enrollment patients. XXX infections the the of colorectal surgery planned abdominal patients, D-PlexXXX of minimum surgical lowest for site of number upon in which sample Board after Data Safety the critical the in Dependent recommendation are to as most Phase very business, our We relates trial Monitoring advancement recent conclude SHIELD

We suggestive favorable a patients enrollment is of view CLX it signals outcome from D-PLEXXXX. as upon XXX DSMB's the recommendation positive as efficacy conclude the of to

date SHIELD top remain from As to results II and outside to the data fully generated others PolyPid line blinded until valuable. of the reminder, a DSMB are

a a for securities institutional we private in $XX.X proceeds. that agreement led purchase announced concurrently financing shareholders gross we million by reported, previously placement into for As entered existing

quarter of transaction the in third the financings from from expected II. proceeds on line result top gross The XXXX PolyPid's moment. SHIELD this into beyond the a extend runway More cash

our this the of Most we enrollment confirm increases study recommendation month. of treatment over some the power that expect and patients DSMB to around to XX has probability planned next believe the complete to enrollment we opportunity steps. to roughly ensure success. study trial's First, week, And importantly, D-PLEXXXX discussions reassessment patients The the next overall CLX has enrolled sufficient benefit. date the further conclusively however, and current XXX is rate per sample an size of

top Phase new with breakthrough anticipate a drug Fast potential NDA, in XXXX. positive results the and the Upon reporting or advantages second of designation. quarter application, expects data, line submit Track We III to of PolyPid therapy

to in outside Ori? over turn We and on our forward are the recently John financial thrilled completing Ori partner to member and partnering United expediting to chartered He Hopkins Mr. affiliates lead a Capital I Yitzchak analyst and care to company's States. is for prelaunch from the market discussions a look Management focused are welcome partnership Directors. the a the Board at Jacobovitz and our technology Jacobovitz the submissions, potential, the to Mr. and and MBA preparations discuss financing. AIGH of a his and from is We health is analysts. announced Jacobovitz call investor University Inc. at activities earned December efforts collaboration. of accelerating regulatory Mr. also trial now lead Board Myomo, will

Ori Warshavsky

approximately data. partnering both like on invasive procedures, for to Dikla. believe patient the market and potential would addressable XXX surgeries over D-PLEXXXX procedure provide is minimally for on and appendectomies per the related in our you, total D-PLEX surgeries. annually, colorectal prescription There some industry principally hernia Thank just additional soft surgeries color on repair, discussions. year market XX comprised of based IQVIA open We leading data, million abdominal the U.S. and are I X.X million source and our

and an We believe the X.X including opportunity procedures. in is urology D-PLEXXXX of an related additional procedures also million use for and in there that abdominal gynecology hysterectomies

and if includes sternotomies According prolonged which have cause either replacements. mortality. high and joint surgeries, high hospitalization relevant an SSI financial have develops potentially . or to are the D-PLEXXXX the substantial a infection rates of and CDC, SSIs As costs morbidity, clinical

accounts for It is the by the XX% risk more infections associated deaths hospitalization most per to is extends attributable by the with mortality costly cost an SSI in SSI to and of that is a reported $X.X hospital-acquired directly with days annual all cost infection hospital of with X- associated and acquired stay of XX% XX-fold type of increase with SSI. SSI $XX,XXX increased length than admission. billion of estimated hospital X.X of

D-PLEXXXX and subsequently, a and for data an in SSIs post of reduction If in Collectively, confirms postoperative without unmet the XXXX. infections transform as commercial in D-PLEXXXX hospital-acquired our significantly November all tracking have CDC the over where surgical showed and could X% costly X,XXX increase market. even in XXXX a to across outcome SSI opportunity surgeries a SSSIs of landscape the we COVID what published the potentially large in A approved, broad data SSIs this own in hospitals global The more compared XXXX in considering in market years an report increase need U.S. coffee. seen reflects in clinical program. report this substantial remain

in for Europe. agreement already in exclusive Pharma of remain We U.S. the efforts. our with for with the discussions priority after regions D-PLEXXXX aligned Advanced potential different licensing active commercialization partnering being our to with Turning several partners the

seen uptick just interim discussions in partners potential we recent as results positive recommendations, the of and shift the important, Following an in with tone have conversations. DSMB a and those

drug prolonged technology We intratumoral enables drug proprietary are delivery. focused centered delivery partnering also controlled that efforts on and on our

development half-life As advantage for potent tumor ability short candidate but such, last limiting goal to Immunogenesis, administered our solid aims biotechnology December, shrink PolyPid's prolonged delivery of with tumors. treatment enabled to relief agonists by focused microenvironment, potent research with This or antitumor in when combining STimulator an extra very drug their a and STING and have technology of STING take are of and Houston-based enhanced a the alone. clinical-stage PolyPid collaboration technology collaboration STING a announced activity. tumors the INterferon ImmunoGenesis, or Genes on company,

microenvironment. will opportunities of that, challenges and it value exposure call This and create distribution the a my uneven now enhancing the infiltration Jonny? in could financials. tumor innovative is limited cell pleasure turn believe collaboration strategy dense overcome immune activation We With within tissues, tumor to could to potentially while cutting-edge bring immuno-oncology to existing partnerships. approach the and through additional to explore to review over continue to Jonny this

Jonny Missulawin

Ori. you, Thank

thrilled to a financial each are significantly from initiatives position. We advance enhanced of our

equivalents had As XX, of $XX.X the XXXX, of cash million. and cash December company

cash of XXXX. We into third flow be will quarter the operations fund our expect to sufficient that

of earlier days briefly which of months also me announcement existing investors gross proceeds. private issuance let following will with entered we of into our top investors XX placements the highlights trading in $XX.X warrants, the received from results. million line upon and of for expire recently the The the Now date review X

substantial full in life believe We an is warrants of potential Proceeds a NDA that from the leading participation in the beyond with transformative of proceeds. would exercise in indicative D-PLEXXXX. the capital million warrants the would this of transaction in of investors approval. issued Exercise provide this of in old gross transaction group additional sciences-focused result company $XX existing

are for demonstration grateful and support. We continued this confidence of

to income statement. turn let's our Now

driven most of by compared Research in X-month were and XXXX. recently XX, the trial. SHIELD ended period million million $X.X II development XXXX, expenses months ramp-up the fourth expenses in of to quarter ongoing Phase X completed $X for the were III the December same the R&D

$XX.X December R&D prior to For during and XXXX $X.X fourth and XX, million, Marketing XXXX million were year $XX.X the $X.X expenses million compared for the were expenses respectively. of full XXXX year business period. quarter ended development and million the

were of to fourth and same the quarter in for compared expenses General $X.X X-month $X million million the period recorded XXXX of XXXX. administrative

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

With Operator? your company loss the open a a net XXXX, $XX $XX.X in that, had year of million calendar full the net XXXX. to to will now For compared the loss million questions. year call we of

Operator

Instructions] [Operator

from Buchanan our We line the will JMP. now of Roy first from take question

Roy Buchanan

and think expectations -- commercialization plans. but then how Ori detail, just your pretty expecting TAM start, readiness over label, I guess help just target the your good to the is segments data to just expect the about positive, in different you're for just Can and went which wanted those assuming know you and we us I

Dikla Akselbrad

Thank you.

our see -- we expectation the that that the the how product we say, we have of It focused is both Europe in will that. very U.S. a have call detailed terms be large But nominal. or on, of to expand things stand X we on and this is plan like it, we could stage, in that. in a is let's surgery. first the general where let's abdominal expectation, more incision launching and This area at our ourselves labeling in So is with how

So that's with label. the

You about commercialization effort. were marketing the . and asking

Roy Buchanan

Yes. Yes.

Dikla Akselbrad

Ori, the you want part? to take second

Ori Warshavsky

Yes, Yes. I'll take it.

is So in half kind we I X like about some numbers reconstruction total censor, market there, soft to urology, C-section over parts go of in can can tissue, breast the then the went abdominal, the go of addressable to related gynecology, of the have, said, there.

our pharmacy disease directors, with strong the point think finding these I -- these that with drive have from an perspective, partner infectious a is with conversations can specialist. both really is, surgeons,

partner think I complex for find really kind for is and need understand us top is me partner at mind, that, conversation. a right deep this we the task, for to -- that selling all we this is -- really can hospital have that. the of least the that it's And of it's of for right into and

will colorectal just gradually, foot formulary anecdotally you in our the starting heard expanding. or incision speaking. XX be and not if is million the right? made just what a abdominal the or is all that X, in I door day tell made abdominal. an on the broadly same the with once my product can for conversations label, a expanding an these for like the it surgeons, way incision incision is It's from understand but in is in even Dikla on resection I -- mentioned the colorectal It's then We're they appendectomy. So surgeries gradually

will on more get formulary, product. it they with experience use and And the the once it's broadly

Operator

Thank you.

Craig Hallum. We now from take Knickerbocker the question will from line next the of Chase

Chase Knickerbocker

analysis patients, subsequent characteristic So of are trying patients the kind are et can start, give -- cetera, I kind a baseline interim similar these when the you compare XXX get of general a Just it just kind informed that been to of geographies kind of of facilities like of perspective. to how to a you baseline us how guess of a analysis? these XXX patients sense patient from these of kind similar perspective, have to XXX the interim that enrolling from idea

Dikla Akselbrad

question. you for Thank the Sure.

is really how But is it the we've geography, in interim and we also seen see since the that us and divided centers expectation we again, recruitment outlined the the a up similar in of it until not so is what interim. in at recruiting infection now overall. with that all expectation. or our don't our We was were rate along blinded, for arms. alarming the that the recruited we the interim with terms And is in patient sense very open in but it's don't So X line between time the the know anything it data. Again, line

centers also So we so new geographies this new is continuing. don't have or

will And last that we be I are the a We weeks, pleased very announcing recruitment. of the team. few expect patient within with rate

Chase Knickerbocker

Great.

-- on enrollment dynamics. yes, those so that And

So And then And and per holiday the XX seconds, second, the then kind time returned just of call of that, after timing. Christmas month. to patients time on just kind you it, slowdown slowdown. readout

should Just a so of all cleanup kind kind month and the for understand or things. on that, of of we a think and XX-day normal primary, then data follow-up obviously, the kind post X we

next So top read of late talking, it, finish on confident kind out you if the enrollment fairly enroll -- line? that month we're XQ call

Dikla Akselbrad

a confident. exactly, X X of expect for be data. primary follow-up the last of first that Very will the for cleaning said, Yes. months sometimes in. Yes. patient that at or March, I announcing point, half for the follow-up hopefully, you we from the for of month would March, And as and in the beginning

we top line from be we quarter a So announced is will in, the last time that the this that results. patient announcing time around

Operator

now H.C. take Ram from Wainwright will We the & question next of Co. the Selvaraju from line

Raghuram Selvaraju

wondering you D-PLEXXXX. an us commercial between the Firstly, us on what in more if if insight think U.S. for commercial ideal might expect give and of some specifically properties about if the the also, divided I give the was could responsibilities you front, partner be could you yourselves into of ideal be the how to a sense some hypothetical And scenario, we could which you and extent Would have U.S. And and sales commercial for specific D-PLEXXXX on promotional the promotional potential you and also, if have involvement supply to what If be specific control expect any market. sales partner. activities in manufacturing to over for activities? a example? subpopulation targeted in sole would prescribers, so, to you elaborate the of of to expect the

Dikla Akselbrad

Ram. you, Thank Sure.

are the can -- very I looking years, can ideal the the way the speaking them, device frequently partner them suite the in the at Both way, site for the at a their companies. is with arms. look the are last they're of the pharma partners within infections, a the within frequent partner sales that hospital, And in the and a So few good has has the surgeon. and companies it's other and broader they looking the are divided to in suite of -- the companies force med the large presence surgical are hospital large area presence surgery suite better the part you you could this tell of strategy. visit pipeline. surgery surgery that the that expand in their where to that has of part into and It's One X many that

that new After tell nicely of when adopted didn't you I can looking in the very this site were portion a see of not And by see ourselves SSI. being in drugs that many hospital-acquired of were hospital-acquired you And you where were we years and and of you necessarily there. those area clinics are that the site at approved things, those hospitals, general, infection post drug And other in that infection, being COVID, surgical we new surgical first look the have launches at the area infection. any is days approved when the of infection. subsection look at products alongside

You asking were manufacturer. about also

we the manufacturing product. So see ourselves definitely

that and that getting and for product solution, get to we manufacturer, we this the And after of ready had bringing is it's efforts submit did is a things all that being lot inspection of here. stage. efforts of is that strengths. our touch be briefly commercial part and our aspects biopharma a to -- is X know-how and As X commercial-stage NDA fully on integrated our bringing fully we also what something of -- the We X.X lot be days understand a strength, this is health This unique ready what end this review we to the in a will in be something European very partners. There is ago stay will of manufacturer partnership, believe around we think we FDA want and full will these It's fine years on spent order unique. for advantage by and maybe the in care, to and the Israeli requires investment review of one in that of stage. GMP our of company. ready is this septic, time about a and are responsibility believe we the Ori, discussions, is the our GMP the important you -- obviously

Ori Warshavsky

I'll Yes. it. take

and boots more will ideal scenario with the think activities, ground, the in preferred I partner. meaning capabilities I in right, And looking a do think the of the global has partner lot the depend the the our kind sales day-to-day global activities, what or publications, the HEOR, think expansion first, that we on brings, -- the national the of so the into of . that reps, partner looking into accounts global medical on I MSLs, into everything activities review. of the indication, is what this do view but scenario by to a hospitals the global go

that be can else prevention of done -- product. done can there's a quite D-PLEX with the forward, looking what with be that And lot prevention of beyond

traditional of terms stay and of global partner. fair if the marketing medical it kind will So ground on ATR the us, global be kind us. look day-to-day the with the activity with the pharma you will in at with of the stay global will

Raghuram Selvaraju

helpful. very That's

and half-life, broadly technology development platform ImmunoGenesis your been for -- pairing as because treatment drugs what you checkpoint that asset tumors. actually would develop with candidate for plans combinable that in to approved existing is approved those of to expect evidence more remind monotherapy existing some quick they beyond could Could optimize items, combination be you able potentially specific with already your Just just APIs X to there, example, previously with be into the how ImmunoGenesis, you what candidate? have you modalities short solid deploy integrated data think approved elaborate to of other and potentially you you clinical with other I on knowledge, you do effectively to future difficult candidates respect the if front. currently ongoing may, And would that the collaboration the for that inhibitor have that your of platform and the and has R&D us reposition historically of which if development activities perhaps but are reformulate, also the D-PLEXXXX also how enable be their agonist expect what it with STING that then to for in mentioned API

Dikla Akselbrad

Thank you.

relate with can in But disclosed. chemotherapy around compound. tested have complex known doing working worked chemotherapy. been In do and vitro. can not that and past pipeline were and we in only are with we have and some on do with with have with, factors preclinically terms we've I that all approved that the as that and have the programs I We've past growth new work disclosed well in our approved in steroids yet vivo, been the been of to We have PLEX drug mention some on, those drug as analgesics in platform worked

be literally, is only we're we've think And the beginning done the not the disclosed. potential is touched this around of here And what even that. that thing could I

did as We specific. SiRNA, not as are that with well some also some proteins to work things be peptides, for yet example, prove,

new also for have of to some those kit waiting terms the terms of been are all things the we working last are this that looking top the So we've platform, at -- develop in X of in PLEX. that in line so the tool are that of very the years, we capability are of share collaboration with investors capability and on and to in our in do the of areas and hopefully there continue that that and that in lucrative sort some

and a most but will efficacious, tends STING quickly. prolonged said, terms agonist, having -- it of to both have, modalities is avoiding on other locally much response other this together together of to at with those very also challenges but think has could the very general, be overcome basis overcome those potent the we thing the also good that thought the this, tumor immune challenges, make be a deployed being the agents. tumor that the in short with you drug drug And In able therapeutic so that the from site, approach with more potentially and always continuous that is deliver systemic and think with to as ImmunoGenesis have lives, exposure overall this

-- only As combination good with will drug patients the as immune think that with will benefit be, something checkpoint. I

model definitely that be get preclinical the best that's show stage, together as efficacy of combined will product. that the to So well, on ImmunoGenesis, to when with we we something the the looking what's

Operator

from Folkes . and next now will line from We Renshaw. the Brandon the Instructions] [Operator Rodman take question of

Unknown Analyst

how in much in the just possibilities? you incisions. you II different of abdominal results much going color maybe you on right, get and the Maybe pushes Shield surgery just and the where you just terms on language may terms should post Is the Can label. all the II regular that language, label sort of firstly compelling this talked the sort label do you about the for me, potential pulls are color large get it or way, broadest label about how just expect the just how talk whether progress. we the Congratulations Shield process indication of of of sort of partner think the you approval during of sort NDA submit you way may regular or versus color get that's being be kind posted for being to

Dikla Akselbrad

sure So I'm your had that. the missed points, in we all there some got gap not please anything, of Brandon I line. repeat But some if I -- add

is that think obviously, and I thing Phase efficacious the -- data important will how most the it III be.

this recall, you this the -- now in II, on on an subgroup influenced is way had that -- If an in the also could SHIELD make the the influence agency see we basis be and effect prespecified reintervention That also I SHIELD mortality. of on data.

had in have not that smaller primary part incision. endpoint the also of that but this are patients We study of group

They on of Shield primary. patients about out of had are are not that So of the II the are incision. smaller primary that top XXX part the XXX

with plan So together but agency, once label discussions the also label the we'll to to to immediately And FDA data obviously, the the start we agency, will look pre-NDA the expansion. need with our we meeting. at meet is and around sit

Unknown Analyst

across strategy? we do those new you you've stage future Obviously, platform? would given earlier sort bring the out. a process D-PLEXXXX just But how of you deploy to do partner you maybe think to perhaps post expect that the into look and approval then a Or And the platform, indications development as through bit the the do development about partnership, strategically, of we sort molecules you secondly, helpful. D-PLEXXXX? funds take PolyPid's done capital more just very of strategy validation with allocation approval partnering to look which That's at

Dikla Akselbrad

in it's -- look because the this. our a much -- also pharma obviously, disclosed at but D-PLEXXXX, line, that partnering are because have thank that next earlier as that stage. We you. in at those we partnering partnering because the of earlier disclosed question, stress We and we company good validation that for That's look those area have just not the from where we've we important to a very are are of not that choosing yet and area at

So of terms partner with the look in or earlier either . the by the partner lifting to and than have the partner. heavy most of clinical we development together

Unknown Analyst

all Congrats on the progress.

Operator

closing like now I for the Thank Akselbrad to to turn remarks. you. conference back would

Dikla Akselbrad

and Earnings for joining Conference our promising PolyPid's our XXXX you results. potential completion product confident Fourth of D-PLEXXXX Year We long-term especially to and remain the Thank look Quarter enrollment highly Full Call. line top candidate prospects forward and in late-stage

conference and with again of call. D-PLEXXXX team we members on our advance commitment partners to We As are continuing and . speaking always, grateful to patient and our providers you shareholder in all care to next external towards goal as to support quickly our for mission their to health our bringing possible. as forward look

Operator

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

now may You disconnect.

PolyPid (PYPD) 12 Feb 252024 Q4 Earnings call transcript