PYPD - Earnings call transcript Q2 2024

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Operator

Greetings, and welcome to the PolyPid Second Quarter 2024 Conference Call.

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. Ritchie, you may begin.

Brian Ritchie

participating Second for Conference XXXX all Call. you in Quarter PolyPid Earnings Thank

the be Chief today Chief me Officer, call Joining on PolyPid. of will Ori Chief of Jonny United States and Executive PolyPid; Dikla Missulawin, Officer; PolyPid's Financial Warshavsky, Operating Officer Akselbrad, Czaczkes

to today, its section is release like for federal will this www.polypid.com. available the Investors financial Earlier the on the months company's six I'd press and laws. PolyPid securities within of you XX, June the released on call, website, forward-looking ended make the XXXX. the results that three remind A copy in of meaning management statements

SHIELD are D-PLEXXXX warrants For analysis, drug timing example, number line of the and all statements to when is the cash of forward-looking new top submission for trial planned unblinded the through it application issued II the discusses its of the and company's expected funds interim runway and recruitment, PIPE making secure the centers, exercised. expected from if the management additional potential for recent results

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

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

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

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

Dikla Akselbrad

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

extends the We site it are planned SHIELD financing of our our and patient cash year in study continued trial Most to XXXX. through completion interim in fourth our infection. analysis clinical recently. colorectal expected Further, progress recent for quarter full and operational of abdominal enrollment important achieved II as relates early thrilled the the runway the critically, with results this pivotal D-PLEXXXX enrollment successful the surgical prevention of for the ongoing in

In will addition, assuming the II cash line this beyond the the runway second the of be our further results. of of exercise financing, quarter top XXXX for warrant anticipated timing extended into SHIELD full

today of SHIELD And the report subjects. including to with centers Let's and I status the begin am XX in approximately Portugal, Hungary open study enrolled countries Italy, world Israel. II. around that has multiple now Ireland, the Germany, U.S., the currently pleased XXX approximately are

of patients quarter conduct line Top a of interim follow-up, XXX are complete XX-day analysis quarter for subjects As in the results to an in expected the anticipated the intend next XXXX. XXX is approximately planned the we unblinded to occur reminder, total year. first fourth once approximately which of

full interim II enrolled than analysis is and the for to three planned enrollment. quarters SHIELD Therefore, more now halfway

I in to and female pre-specified key and patients the all II we significance, large median have robust call SHIELD the pace. enrollment at are incision suffering Importantly, from percentage last in the on subgroup. male, patient identified split Of continued. age, enrollment cancer enrolled of a is SHIELD consistent progressing The trends similar patient our

in we have SHIELD demographics focused I. patient positive This data population the in similar generated observed being is which are more these in important highly because already

tight infection strongly place continue enrolling currently being that a clinic SHIELD during will under SHIED that is by the II key is the pandemic. in believe Phase as Later not observed restrictions site We the which trial. conducted surgical SHIELD III to the I, the further opinion viewed COVID-related derisked II were the in being currently call, the in a field. Ori leader discuss in Unlike

Of we this the related learnings are course, involved leveraging key I also from in sites to SHIELD study.

on II identified to sites essential safety the focused believe prior of without to practice Safety II recommended SHIELD around conduct execution data safety charge in terms Monitoring the Committee to countries countries As are the we for Moreover, from in in in and of review continue patient no and the sites issues for in good SHIELD SHIELD have I, recruitment, Data has II II. call, best clinical in earnings study SHIELD study this that centers in while of SHIELD observed and discussed SHIELD SHIELD same modifications, XX be performing targeting accumulating have these Xx date. number approximately I to and been the We D-PLEXXXX on we meaning of the related monitoring II.

in have on. for submission in the D-PLEXXXX sufficient of NDA a the II submission. previously, what only acknowledged for surgical not NDA Last FDA support evidence U.S. if we that is and have large SHIELD safety but result I to potential To said may efficacy we the Moving reiterate confirm potential with a incisions D-PLEXXXX the provide patients year, supportive also pathway SHIELD successful, the clear of regulatory

existing participation financing company's beyond XXX top-tier fortify We of a profit. investors, comprised XXXX the enrollment of the million analysis interim runway sheet our was completion balance gears. closing U.S. to of multiple were expected quarter patients PIPE of pleased first results successfully expands into The including life new PIPE II. SHIELD for syndicate Shifting by approximately and gross the investors. cash in of $X.X recently science-focused of The and

in recruitment secure either of in due resulting potential top D-PLEXXXX the into and the if issued its million XXX trial all has SHIELD problems the to interim efficacy, to the If warrants trial exercised, second up of $X.X subjects. an continuation quarter the this results III Phase the plant stopping be of PolyPid in additional XXXX. of financing of line unblinded recent oral II funded to to are analysis will company patient beyond

company loan with addition, has In announced secured deferred Kreos over that will the agreement from million XXXX onwards. with of $X existing April paid its it restructured which be repayment

I'd like who to investors thank take the all support. confidence and financing the for in opportunity their to the participated

our pleased role am instrumental been clinical company's EVP, and Affairs. of FDA commercialization and Ms. today the authorities, Clinical European D-PLEXXXX. Dalit Affairs to I Dalit to Clinical strategy EVP, to CEO, with Finally, has been look R&D, Regulatory the announce promoted our R&D, Hazan, has Regulatory and to her that in we the forward of of potential of contributions and execution advancement R&D PolyPid and and approach the as the regulatory planning we strategy, Deputy continued

review PolyPid Now over turn KOL to Ori Charles to with I'd the event recent the call Edmiston. Professor hosted Ori? to like

Ori Warshavsky

Thank heading several last be We virtual and and replay topics page infections. the Events June, of key Surgery, A surgical Investor company's Professor webcast the on can found type conference Professor discussed prevention Division of you, Presentations featuring E. website. surrounding the event Dikla. This Emeritus of College of under we this Edmiston key the of opinion Vascular call hosted Charles of Wisconsin. a Medical leader Surgery,

surgeries site in type normalizing rebound procedural a Key to missed Three, rates and elective to and patient-related when have pre-COVID surgical infections due site colorectal significantly of in of surgical suboptimal and surveillance infection, back factors possibility takeaways up to to number patients strategies. a possibility to increased factors. infections with surgical widespread infection is the levels due XXXX. multiple XX% found risk from heightened the one, of surgical this this the the to developing XX% prior risk compounded Two, to increase of conducted call included: environment underreporting

patients the months $XX,XXX over $XX,XXX single $XX,XXX payers long-term from of and ranging Edmiston care cost the clinical economic Four, risk the superficial to concentration of prevention undergoing takeaway, commented site using for surgical antibiotics high benefits event the to And D-PLEXXXX the Dr. infections add deep remains infection surgery. from and to ranging bundles. infection additional $XX,XXX, that when of colorectal site release respectively. with and of the reduced a in has cost surgical final commercial substantial, is sixth XX in achieved to infection Medicare XX-day bundles infection period in potential to colorectal surgical the

pleasure turn call is to Jonny the over financials. the my that, review it to to With Jonny?

Jonny Missulawin

Thank you, Ori.

of had million. the As closed of of company XX, million PIPE not gross the $X.X deposits generated include approximately short-term cash, June from cash XXXX, August. proceeds This in equivalents financing and does $X.X the

forma all the additional pro be our balance into XXXX, $X.X from that not operations cash first if of expect are the fund recent financing exercised. to sufficient warrants will including potential a quarter million We

most quarter million business driven compared increase were XXXX, year recently R&D for expenses development Phase were and Research ended in statement. X-month ongoing income compared the XX, Marketing $XXX,XXX of million of expenses three our in was the period in during by the to the and $X June the June SHIELD development XX, ramp-up trial. months $X.X III The XXXX. prior $XXX,XXX XXXX, three II turn ended completed let's for to same the period. Now the months expenses to

the XXXX. efforts. in our compared million cost for $X.X containment three This June same of to reflects expenses administrative and X-month decrease ended recorded General $X.X period XXXX, months were million the ongoing XX,

to a of For in million $X.X $X.X the quarter the the net as had XXXX. three of months XXXX, ended million June compared XX, company loss second

With that, to will we questions. Operator? now call the your open

Operator

the Buchanan from Instructions] come of line from The questions Roy [Operator JMP.

Roy Buchanan

first coming I quarter. analysis the one, next interim the guess up just the in

I the going trial the what of infection expect the options disclose the can are should are what results, if announce? rate? continues guess to we What Just for you you final

Dikla Akselbrad

start I'll with latter. off, first the So

be not will aware the of infection. We

of get only will endpoint study. the We the

interim, several the data come also of So the us back options one the who safety will to with of DSMB, is three the monitoring options.

but that the that rate. us can point need the can of say is option the futile, they number of say a required to or will upscaling what say will the that of data, They overall have study, know send can the reach the which are because no expect, point. hoping before fourth stop they to the due just infection study, we study end they the do which be And reach we not which at end they lower study stop end can need we actually they not point, also the to is unblinding we to then to us study. at obviously XXX. is patient that, tell the the below the Either the efficacy, will is that we we And expected XXX

Roy Buchanan

still goes And XXX. the milestones exercise potential can are recommend you the that then above And us the warrants, size advanced point, they they on the I remind if eligible any for guess, interim? that on trial

Dikla Akselbrad

the within for either two years. time So sample or There if exercise the we to a coming if any warrants early are shortened due that event study the time is the sizable at triggering efficacy study, that point. are we stopping which a within are end size the from lower up XX is sent be to which to we is of will the days sent the XXX. minimal there If exercises number, to

asking So about you ADVANZ, yes. we're

So positive several the top have the line results. agreement being in milestones one, development ADVANZ first and

Roy Buchanan

you then about geographies know partnering the are in you platform? last broader I And the or say anything II progress one can in SHIELD focused But additional guess, XXX% interim. on for with I just me. with D-PLEX guys

Dikla Akselbrad

and in in expect in and have the has coming that as we commercialization on focused we are So year say been sign agreement. I an we being on on part also geographies than expect discussions. the data. sometimes early progressing previous quarter, XXX% we that, discussions that commercialization focusing We've D-PLEX are XXX% deal this that that indicated something and we still are we've in see said We on can year to already Europe different that more this to before that and of also

as the You I asking another of This a objectives. that deals. year is in our activities platform deal development progressing. on of said the we would end also expect before were aspect our is see Again, business to

Operator

H.C. from from [Operator line Selvaraju questions come The of Instructions] Wainright. the Raghuram

Raghuram Selvaraju

Can me? you hear

Dikla Akselbrad

well. we Yes, you hear

Raghuram Selvaraju

wanted I provide completion if bit little a more could first So around all, you timing of the granularity to, analysis. of interim the of the ask

it the you and to interim a you So how once you share process if conduct can are with in that you later us you have first the quarter that juncture position in when XXXX, results? the when to on Would long analysis, sense have quarter you start this take expect in of quarter? in at approximately the a might depending earlier process, the be or

Dikla Akselbrad

try me the clarify let of So to points. some

The interim very You patients. XXX raised on good is point. a based very,

that expect months XXX, the reach about get we we two we that XXX days patients for it days once until I for approximately recommendation DSMB the the and will the So patients, DSMB for that Once once of -- two we interim and for or get patients. announce we've then is a to and reached XXX XXX XX data it's and top or the the cleanup months. getting follow-up It's point, cleanup line another XX recommendation. data full

that time. will that we be we expect And clarity fourth on So interim give said better is that data would you at year. quarter of this why the the this

With It's top data the is unblinded to back position the data. we going that. continuing little line because closed full end the taking year, data regards are There that terms should data, is to And to the the we've top line, longer getting cannot be raised the go then you towards also to the the cleaning in XXX the since after a in we of bit patient unblinding. recruit no data a back you of and patients.

So It's said that. quarter next the longer bit a first why year. of it's is more and a quarter, we this than in of

Raghuram Selvaraju

with the going implications if for In this. will all reporting perspective, And market can situation? market pre-COVID every a the the specifically intents from way all expect you market target the your situation line a return for you that to nothing the maybe comment underlying for be on and And words, respect dynamics demand extent forward. a environment you top purposes, pre-COVID-XX question assume SHIELD and the what at to like essentially should to I into that had that if effectively second for of the data seeing you this to persist II purposes other which intents The and we, for are a in changes resembles point, that respect that to what product with market environment are indication. was

Dikla Akselbrad

days COVID. lower reason a surgical with not site a the of out rate what to the COVID give we on hospital are the the really reduce and perspective part you're hospitals, seeing that educate specialists we Edmiston hold on try Professor to is and site the COVID, try wanted teams his rather infection but to what with how within to opinion prior with our surgical to this So and Charles to what KOL baseline infection working event give to with working rate was during teams infection these when happened of someone

specific be we regards is To that will be we more are on assume we be your baseline when prior data, that publish study to what to to itself, Obviously, more close to rate being now infection question, we will COVID. with blinded. at similar do observed the we the

call that said thing continuing. we and are So cannot presentation key the say we last that to data we formal are enrollment exposed We large to of and obviously this the our identified encouraging, And in in only incision can us, not see the demographic, population a and derisking patient large -- that this is, very comparing II comparability we view the as on we the in we trends for study. today's this SHIELD the incision. between the patient the and SHIELD is I

Raghuram Selvaraju

expect Can you to G&A of G&A at but a the market is expenses the I prior after modulated obviously, any market. ramp until you give I'm going assuming all in more the going a words, me rate then analysis preparation top to asking you positive do or to line interim after are product to run point? which words, keep evolve other interim release the results when G&A you think, into activities final a introducing from the expect we possibility positive. is, to that you contemplate your last how as other is, data And up sense hypothetical additional engage are effectively In question are the that of analysis. top release analysis line of spending really In what for the of spending expecting the you situation, us

Dikla Akselbrad

the from either start interim the participated stopping good or interim last very saying would also investors the point. This I a perspective at why round, is our is and to with that by on going a size is positive the both good XXX in the be the that and this warrant. patients, is the event our will view the triggering income of minimum this a interim, how for defined is

substantial as the and ADVANZ, we not D-PLEX. additional we the there. to responsibility with the around on the looking affair, on is as -- to hospital But see expenditure medical foresee to grow we at deal again, out G&A, that in have With Obviously, some marketing, sign agreement we on partners. the do will regards do there be continue the increase on of collaboration most modification the the we reaching not

there not do change P&L. significantly will we but our So will be some that foresee immediately increase, something

Operator

no have closing at hand Akselbrad for remarks. Dikla time. back Czaczkes further I We now to will this questions

Dikla Akselbrad

Thank We you the Second in joining Earnings our promising Conference confident PolyPid's our for late-stage especially Call. of prospects potential long-term highly XXXX Quarter candidate, product remain D-PLEXXXX.

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

Operator

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

lines. now may disconnect You Thank your you.

PolyPid (PYPD) 14 Aug 242024 Q2 Earnings call transcript