PYPD - Earnings call transcript Q3 2024

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Operator

Greetings, and welcome to the PolyPid Third Quarter 2024 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. Ritchie, you may begin.

Brian Ritchie

in Quarter participating Call. Earnings for you PolyPid's XXXX Third Conference Thank

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

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

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

example, rate, when the potential For management recruitment, the discusses is runway both for in financings of private timing II expected trial additional are company's statements secure making top D-PLEXXXX, to exercised. SHIELD recent and analysis, potential the it the of II if expected results interim all warrants from forward-looking SHIELD benefits patient cash funds placement line company's most the infection the the the expected and of unblinded issued the

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

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

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

Dikla Akselbrad

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

the position for very are our in prevention relates D-PLEXXXX as in all we private advancements infections. Moreover, the analysis with the upcoming the both colorectal we pleased in in issued XXXX are SHIELD from funded into as most recent exercised. significant our for our the critical II We surgical are a it warrants most business, acceleration of if trial of pivotal are ongoing of beyond to strength enrollment operating site financing recent interim financial abdominal notably and placement

our SHIELD recently further with that the interim planned runway study We analysis. unblinded cash enrolled patient last to discuss the We status II. shortly, I'd will like begin of to the but required announced a conduct

will have the analysis patient the completed. last We follow-up the for that been has the now days during XX current quarter the assessment of outcome

to continuation analysis unblinded due size efficacy, up XXX sample As which to may a futility. subjects, trial allow or early to patient planned the conclusion interim for positive recruitment, reminder, is reassessment

Israel. around U.S., I'm Germany, XX Eastern approximately pleased opened Portugal centers and are to that now study in approximately multiple in in the XXX enrolled today Europe, report has the countries currently world subjects Ireland, the and including

of summer the has the majority are achievement, of slower are This recruiting the the volume to recently. substantial conclusion procedures of and patients. increase with the now vast ramp-up open, months, surgical following centers currently All led planned in along in recruitment

quarter. progress results the the should month enrollment to This in line full the with the important since In summer. of fact, than December for trial coming complete were top subjects every XX us more allow enrolled end anticipated patient in

have we we derisked on SHIELD Phase said calls, as view III II prior trial. a As

population SHIELD this we data first primary in of view that our SHIELD is recent trial Surgery. the positive, patient a statistically focused I, by with being regarded D-PLEXXXX. conducted One significant This is further International have of reasons in set Journal data already which in the for journal, the the was in generated full the study I supported peer-reviewed the Phase III of highly of highly publication

to I publication. will this now Ori? turn the highlights for of from a important the Ori call over review

Ori Warshavsky

journals results safety compared medical of arm SHIELD resection largest is alone efficacy trial SHIELD prospective of is you, infections. of a to which was the XX, randomized, prevention designed administered of out of trials were surgical alongside included III in for decade. to X,XXX note, and in abdominal in Phase in post Of care I Thank the over Impact surgery-focused site SHIELD one infections October prevention Dikla. safety D-PLEXXXX care surgery and Surgery, assess published the standard III International of and in Factors colorectal total multinational, XXX I close On III the patients Phase ranked a including incisional standard the conducted Phase to double-blind Journal worldwide. the I efficacy by of the second a of trial

The a incisions SHIELD data informed of patients XX the of analysis improvements or with than patients were greater subgroup less in which paper endpoint, of surgical p-value a significant of in combination than D-PLEXXXX highlights observed incisional mortality with centimeters. in SHIELD execution all-cause patients, takeaways was compelling II, treated X.XX. from generated I the of SSI, including primary incisional the the that the key prespecified these the reinterventions In

was reintervention in SSI, statistically of than in additional or secondary mortality, outcome incisional to analysis value time deep XX-centimeter intervention of Exploratory efficacy the show seasonal X.XX. D-PLEXXXX any than In adjudicated superficial less in SSI efficacy incisional addition, all-cause including greater outcomes, p a in reduction the SSI, length key of a differences subgroup. surgical SSI, observed with significant also favor secondary

infection in restrictions rate, I that risk, D-PLEXXXX benefit baseline COVID-related may limited, unexpected difficult to would the currently with add that overall study. different In study territories including post types, inflection see not and under infection in I, Overall, safety the I enrolling SHIELD setting, extraordinarily also although rise conducted pandemic SHIELD colorectal place being SSI increased we were change that different to suggests unlike [indiscernible]. the and what impacted SHIELD in the surgery. pandemic those meet. became in COVID-XX the published during primary and the is the analysis surgery post-hoc SHIELD rate the II the Due is significantly above during outcome I with of data prespecified in the patients the tight rates they were including this

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

Jonny Missulawin

Thank you, Ori.

As and had of cash and $X.X of September XX, cash equivalents XXXX, million. deposits the company short-term

cash be sufficient the quarter balance operations of current expect We first that to XXXX. into will fund our

of pipe However, the in expanded. August I'd take to like the cash January transactions which to opportunity a two and financing the our significantly for terms be closed provides to moment of XXXX, review runway

the pipe, the efficacy analysis Under potential are the the million additional the of exercised. $XX.X an results positive all secure II the due terms have of to warrants stopping we XXXX and trial study interim of to January if and SHIELD unblinded

funded pipe, unblinded planned due patient to XXXX the continuation an million In the in the all warrants additional be pipe addition, analysis If and to are be efficacy August the pipe all would the top potential stopping results would If under positive or $X.X interim the trial have exercised, recruitment company January either to we line all warrants if the the funded August are August of issued terms the in company in exercised. issued are secure until both the of beyond exercised, results. warrants and XXXX.

For mentioned. XX trading outcome both transactions, to have following exercise interim their investors the I as days just warrants

expenses X-month administrative XXXX. X XXXX X-month $XXX,XXX compared III our General Research the increase $X.X expenses and months by XX, for ended were were the X in the of period development of XXXX. ended the Now let's million million, September September in XXXX. and the enrollment for ended R&D X-month business the SHIELD XXXX X development was XXXX Marketing to $X II expenses were months months $X.X expenses of to XX, in same turn trial. for ramp-up period same similar same The million XX, $XXX,XXX statement. patient to the September compared to period in the Phase driven in and income

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

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

Operator

question first comes the Your Instructions] from [Operator Buchanan of Roy JMP. from line

Roy Buchanan

on you a achieve just just the maybe bar couple you give remind sense is a of expectations Can your SHIELD II, quick efficacy need that us is? just line and sense for is infection us with of to stop the that blinded in what rate, you to the interim? a Just of what ones. can

Dikla Akselbrad

But it Roy, with thank know we you a hospital that which that could give sense line a the section change for from is see infection the in of two week, expectation. expectation. two acquiring our how you. covering with infection sense is report divided really that report the just the don't is ] rate well, our by line anything rate don't maybe can we I first looking blinded I allows in not between [ published in are -- it's from But you But the was CDC XXXX on give arms. so us last we all, XXXX.

obviously we they still all of And this it measures had you there that in surgery, indication interesting we've overall. COVID this at rates were X% the was look SSI first COVID is gives XXXX, And And increase is when [ the the in still a times. on U.S. for indicated the this that years seen was increase. isthmectomy in with and X% they in because adopted part in go there specific place. were that some on infection to that report post-COVID example, other then ], And an report,

week Phase have It So go we say anything obviously, we this blinded. the was I interesting really the -- encouraging slightly is II ago. are up. we health, think will of -- a for study. this infection this to see. is eyes But not what SHIELD about of can't very III this encouraging But in because And that is encouraging the rates light public us, expected, this gives but published in

Roy Buchanan

the what's breakdown the ex in And Okay. that, on maybe just of U.S. patients just U.S? That's heels then versus helpful.

Dikla Akselbrad

U.S. So most are patients ex of the

was needed of less. is of a is is kind you create You that or for gave an so long an SHIELD had what of XX%. alpha an high-risk which level value X.XX criteria it I about effect interim were interim patient the same size was look p-value also a or doing QX, I p population, analysis effect There, X that And are of didn't of if that lower. is analysis. at we and will the now, incision we the We of But patients. asking, what the the the XXX X.XX X.XXXX overall think, indication or at

more the of or same less So size study.

But is And you this early can X.XX. sense -- a give of kind the you lower can on effect I at give it imply think of will obviously, [indiscernible] interim. what stop than

Operator

from question Knickerbocker comes Chase the Craig-Hallum. of from next Your line

Chase Knickerbocker

of on the that's Maybe the December? efficacy path XXX just early there's just be we higher? that here, a to as resampling. interim overwhelming we that kind or expecting or simple stop set or forward, the expect Board's on kind of expecting Monitoring what be fact press analysis level statement investors that later month this kind Data as of should of Is far for Safety just to resampling recommendation should Should with whether it release resampling

Dikla Akselbrad

we've hearing joining they the are should should with unblinded or committee, to the DSMB Committee, Chase, we forbid, issue we come for study thank Monitoring will continue the And will from XXX plan we heard give or, trial we upside possibility -- press we God reporting Data is we exactly we release the up but -- a have futility. They as still but be formal a should whether that. possibility, hope quarter. -- which from to from are you of of [indiscernible] also think can we due a It's are this what very Committee this Whatever we to do recommendation the indicating not DSMB us. efficacy, will blinded. clinical we -- stop are -- they any

Chase Knickerbocker

that from reason Got then of fairly patient robust to enrollment you've outcome, of a continue see Any of accelerating got regardless to to kind trends. nice kind it. where expect of the patient kind pace of enrollment not And here?

Dikla Akselbrad

clinical and a nothing We see to here the did is of per mind since see comes not all the be month. year. all any to expect recruitment And in see about regulatory are that the recruit are get XX point on about not will centers patient of change. the open. No, to since vacation running, here team the expect open us. for all summer the the that now where we end efforts, that we us. we've very encouraging the the per centers also lot last And indicated December, with team of we XX stabilized month. We patients the end patients This and to impacted to to of we the do hopefully, And

So goes us if will influence well, at this stage. everything not this

Chase Knickerbocker

abdominal? of kind unmet guys well last interactions the to for the again helpful and kind as just in need space Any for hear be of on of just color of Maybe commercial on. broader in conversations with towards Great. surgery colorectal of some would KOLs and Any outside you me. incremental elaborating and it the there kind opportunity kind

Dikla Akselbrad

basis, are, on ongoing conversation. there an So

reporting Some of of are Recently, U.S. and about from what's better in our them done broader the do also colorectal to as of that allow see are We open about unmet the colorectal, need, from surgeon the -- ours part being hearing centers We like will experience that abdominal was and they and infection others trial. in areas where the area clinical need general. director medical surgery. in product the a perform them visiting hear a see. unmet director their specialists

that aspects hospitals the too like of ago, interesting We penalties and some health that getting. also the long conversation not are product a had economic on

usually, tell against do can that my were MD. an doing something hear are surgeons. that due said, that views diligence, we candidate that I views recently really and that interviewing, due his with supportive. and from heard, he when you I that was a I are diligence And I He's he

is could says, a that a terms we level see the the that is change anyone some response orthopedic developments is significant in also are adoption. hear make the nice getting that operate. this in are didn't the needed. I that way of not we conversation not of to This Here. market this in something And There area. actually recent very

encouraging us. So this is quite for

Operator

Ram the of Selvaraju Instructions] comes The question next HC from [Operator line from Wainwright.

Unknown Analyst

of I you This is approval. regarding size had in even have you any Eduardo that Ram. partners? a commercial or to question plan on for for put commercial Do the assuming place infrastructure D-PLEXXXX idea

Dikla Akselbrad

you. Sure. Yes. Thank

results looking commercialize said that. will potential line are that top first the in we as So the are that And I those D-PLEXXXX have the There commercial potential U.S. a in have strategic the quarter, with we we potential will have the the once that assets partner that -- many bring. past, like and substantially. in medical that and accelerate product we discussions to us, we around not in expect discussions are

So to is partner. our strategy with D-PLEX commercialize a

of could discussions And be in also the before it will end are mature year. the well geographies. and some We in other that of this areas other

Unknown Analyst

speaking greatest And other areas do markets value? U.S., you the regional principal think helpful. really what of the are That's Great. outside of

Dikla Akselbrad

that interesting it's asked this. So you

plus huge South a battlefield, site, opportunity. product Africa, think is market drug countries Africa. the a is a global for infection market patients. make India, a like at those where can -- could global aside And D-PLEXXXX and Surgeries problem, problem. Those market infection Vietnam, a Canada, think even like are trauma be areas is difference to and . also during at a like China, immediately holistic -- -- the is a the I Japan, administrated -- infection are accident that solution, Obviously, the are a market America, problem. I But Europe largest South U.S. market. there surgery a largest the due from are has

Unknown Analyst

line regulatory great. after is have you FDA, And submission That's you do the regarding a to could think do you that? submission time for this your complete? quickly How trial complete

Dikla Akselbrad

from be what we We the get the stop for the get that designation line, date. we first closer will quarter, yet our slightly, to efficacy NDA, that if generally, not we when get do line assumption as that have that we day details plan is at or should We results within for XXXX. we say, the the we with going that breakthrough getting expect are if increase but therapy need But the top did that is a disclose top let's at the the assumption will XXX we breakthrough be results have again the are with did the the time designation forward. have with or we we more say during the submitting we NDA we give to detailed But -- have line if we and therapy depending top that. that we been

Operator

further Thank be hand at you. closing no There back I will questions seems for to this remarks. time.

Dikla Akselbrad

highly you Thank in D-PLEXXXX, PolyPid's promising multiple potential Earnings forward for XXXX our long-term upcoming catalysts We and look Third remain prospects, candidate, [ our the ]. Quarter Conference Call. joining potential especially confident to product of late-stage

for team support all As D-PLEXXXX providers health our our in are bringing toward care of their grateful quickly possible. commitment to goal advance and always, members, shareholders and external as to our to patients to and partners mission we as continuing

you speaking conference look to forward our on We call. with again next

Operator

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

disconnect. now may You

PolyPid (PYPD) 13 Nov 242024 Q3 Earnings call transcript