PYPD - Earnings call 3 2023

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings, and welcome to the PolyPid Third Quarter 2023 Conference Call. [Operator Instructions] As a reminder, this call is recorded. And I would like now to introduce your host for today's conference, Brian Ritchie from LifeSci Advisors. Mr. Ritchie, you may begin.

Brian Ritchie

Thank you all for participating in PolyPid's Third Quarter 2023 Earnings Conference Call.

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

evaluation factors; pediatric D-PLEXXXX benefits SSI patients increased balance. the when For SHIELD persistent example, have the the potential prophylactic potential in management conduct it into timing is discusses recruitment results cash addressing total top of company's making XX expectations company's the the into to population; forward-looking in therefrom; to patients the and intention the and statements of centers D-PLEXXXX risk with additional total D-PLEXXXX advantages; in competitive regulatory time study clinical U.S. authorization open recruitment II, analysis XXX the potential filings; D-PLEXXXX's line site to in of D-PLEXXXX an commercial potential approximately II; its follow-up; XX-day end marketing for a patients the for of of infections; of SHIELD new execution their provide factors of the unblinded drug surgical the in challenge submission efficacy expectation essential the XXXX, demand application potential interim of and regarding EU application complete once by its its

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

to XX-F revise speaks or statements. PolyPid place those with company's cause events obligation, or of results required not results to Our differ and events live the as Accordingly, call forward-looking reliance that disclaims Exchange new and that I Commission, materially law, review statements, encourage or financial events which update and uncertainties material from or future the the on identifies filings including, conference could the only to information without because or those you broadcast by projections actual of except risks you statements. described contains cause or to the specific X, any should Form actual differ. materially as undue XXXX. differ these limitation, factors projections. any today, These materially results forward-looking whether involve in company's intention time-sensitive November information, otherwise. This statements from Securities may may

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

Dikla Akselbrad

last or To of to in to of so place I SHIELD on Thank our your our SHIELD acts for of ongoing II. on impact XXXX and colorectal material On the has PolyPid, the trial extend abdominal remain continued surgical I our took health their to date, on infection, express the call. families, you, for ensuring we, and pivotal II many our of behalf to gratitude D-PLEXXXX there who October you third like concern of the horrible us have begin, no prevention at site would To given our that to employees earnings and been on weeks, of to progress reach Israel operations the SSI. our quarter PolyPid, uninterrupted to everyone out X. Despite news safety focused violence the over regarding Brian. like would few terrible welcome team at specifically

results to and that factors, incision factors, patient believe the it of while study, expected of efficacy either of could with only antimicrobial known in of X.X of have approximately specific. Patients the the have candidates give opened, enhanced the patient subgroup opened site having a surgical a XXXX. To their SSI centers procedural currently procedural approximately the with Based Israel. expected open, we is approximately into by benefits also risk patients outside these such we both XXXX. I anticipate To at several of be you The only better majority particularly, is centers and the surgeon in the these in pre and case centers intend in COPD. diabetes, in expect total unblinded time SSI top effect surgeries, provide there trial patients we complete intraoperative be add easily the the for enrollment, second obesity, risk positive XX widely the this post-hoc a these ideal XX which In D-PLEXXXX have are we approximately up once of weeks is increased by and per the half closure, its and conduct approximately potential analysis factor of of should month. line fact, recruited of we currently vast XX-day sense which of has abdominal patients expect incision one. for recruited XX are results, being to per when identified a also as we of said independent end, pace enrollment once by categories majority observed would for an XX the on to is and XXX In while we the D-PLEXXXX be time, prophylactic shortly. risk ramp of the running, the and patients We following formally prophylaxis. relatively this opened SHIELD end I as into we analysis SSI to hypertension risk last takes few center up patient-specific follow-up in need II periods not interim weeks. fully trial, SHIELD Therefore, are D-PLEXXXX

Moving on.

safety result only Earlier the FDA year, As you to NDA not potential efficacy in submission regulatory patients we evidence also for II may submission. NDA D-PLEXXXX that and I surgical of the if potential U.S. but know, this pathway with a the acknowledged is SHIELD clear confirmed have support in successful, incisions, SHIELD provide the D-PLEXXXX a the for of that supportive large sufficient

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

from the We also learnings in SHIELD are I key to study. sites involved leveraging the related

this SHIELD for be countries recruitment, around knowledge the I, practice. from approximately sites the and have and are II. targeting II, centers to now SHIELD I best-performing in monitoring of patient execution While firm terms in We we XX SHIELD of we same clinical SHIELD essential the numbers good believe of

successful We supporting have our team, also enhanced clinical a study. key step operations towards another

into recently D-PLEXXXX company. we integrated helped on also While into several SHIELD we a milestone have enrollment manufacturing-related fully have that II, achieved focus biopharmaceutical key evolve PolyPid

completed up EU result EU and filing. of the release the First, a production the scale capacity tripled manufacture of This markets. validation that company's substantial of process to of production and scale we submission process successful global application, X I more expansion the and U.S., our D-PLEXXXX the a is than commercial authorization D-PLEXXXX. ventures D-PLEXXXX significant facility that validation significant NDA requirement at should for regulatory planned of marketing and highlight successfully the towards accomplishment completes

GMP key major Good in-house by us facility, Our control competitive the audit GMP as state-of-the-art successful also of a facility supply completed This stage going Manufacturing manufacturing regulators. sterile full commercial findings. manufacturing D-PLEXXXX production advantage valid our of Israeli European Practice, to a with critical we or recently, or clinical provide any for forward. Most of serve is Health from audit Ministry and without

at expected now commercial D-PLEXXXX produce to for scale we demand order product. the can in Importantly, the fulfill

Moving on.

end, in in result technology demonstrated the support To population. the a results augment and also We highlighting of PLEX preclinical the profile research Journal the in Toxicology. D-PLEXXXX D-PLEXXXX. time, International in pediatric for support clinical presented safety continue to to published of juvenile paper first evaluation and was that Journal the positive peer of the review published the D-PLEXXXX the of These platform have potential animals this

D-PLEXXXX Boston. I like in am report III not addition, gone meeting, selected part American as G&A to best like XXXX place month biotech of Clinical and overall of will last first momentarily, the Last the I emphasize presented took In which which the ongoing for gears, pleased has biotech XXXX, recently science Year services. Shifting to unnoticed. of including and we as the recently bid Phase Surgeons annual Congress to our and price. month, closing our progress the products D-PLEXXXX with financials we was at clinical advancement medical in regained the NASDAQ's Biopharma of in Also, Jonny breakthrough a efforts recognize SHIELD that highlight of that the awards manufacturing. of College life cost-containment business, time I'd result world's PolyPid's companies, the current the Solution I'd compliance operations, winner review while trial the minimum the throughout third

XXXX, first months used to by of X the cash activities net the XXXX. first For of X our operating decreased XX% months compared in as

to practicing expertise. distinguished the XX D-PLEXXXX. On PolyPid, Dr. Tsour Board physician Anat is We her like commercialization who industry to express like future for would Jonny. at thanks to the investor that, of approach appointed the our XX is I clinical Directors. with expertise of critical development, potential has Nurit extensive turn was of leveraging R&D following all would PD, retiring over We R&D executive to call across and to of take as an forward best critical years pleased initiatives. With over to clinical, functions veteran Tweezer-Zaks, PolyPid's our helped has advance and counsel milestones Board business Tweezer-Zaks grow Ms. our sector best and Segal, years is opportunity to and from well my this a I wish biopharmaceutical also provided welcome nearly behalf who to experienced regulatory Jonny? Finally, the look and Segal business. in was am we a as everyone Tsour Dr. that service. recently her clinical financial as years. She I

Jonny Missulawin

Dikla. you, Thank

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

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

September of impact of ended XXXX, the months Research compared expenses I the reflects decrease in the Now XXXX and a $XXX,XXX compared the completion from quarter administrative of R&D for recorded period. General X-month let's during and quarter trial the to primarily XXXX of million million turn statement. cost-reduction million that decrease to plan XXXX. for year Phase of XXXX. Marketing in $XXX,XXX, of $X.X and in the clinical were period the from income $X.X quarter XXXX. business were third the for the period was and SHIELD same XX, prior X-month the development X-month expenses resulted million the expenses executed $X.X $X.X same development the The fourth expenses X in to were our III third of

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

execute Finally, noted, we cost-containment as Dikla to well initiatives. on our continue

net months our questions. first of to such, compared period now by XXXX activities decreased your from used XXXX to X the cash call As will in the million million. With as that, in Operator? operating to for $XX.X we the million $XX.X same open $XX.X

Operator

line from from [Operator comes of first question the Barclays. Our Balaji Prasad Instructions]

Unknown Analyst

for is Vishal Balaji. This

road be XXXX, upcoming should we going the the of so down highlight As you milestone could are that we key and mindful events those into events? catalysts

Dikla Akselbrad

Vishal. Yes, you, Thank sure.

the feedback interim our of towards months III second analysis, recruitment early XXX quarter, -- first that, have milestone and trial, II this from will that I expected looking the for committee the be So almost trial, end our SHIELD obviously, will analysis. on X after the XXX first of the clinical at quarter. completion DMC think the should And interim patients, be we Phase the

And line our we're the shortly patient investment the So quarter the and patient assuming July. And about -- our patient this last And around obviously, of after talking top the main from from the focus today interim, actually. last post recruitment, line I. company. main as is that, we geographies. in. a last top we for clinical different closer continue have trial expect, All to should is we towards had that the D-PLEX are previously And SHIELD is get and in to that, in everything said, on similar associated company we commercializing with what parallel discussions to as would interim targeted we different we the the with that. In in

deal. more signed we top shortly publishing were interim, licensing getting As closer were line to and discussions the robust. much European And our data, before we

geographies. And is other is we there. expect the exposed front also do done investors would what see we to These to in There are lastly, discussions that we're this everything once our are stage, our But Obviously, of share, ongoing. also done. work that obviously, at on that share. deal, So platform-related have less will is this looking to we are OncoPLEX.

And this obviously, is looking main that for. the that get other there will commercialization. to as mainly be data, So related we will be the catalysts interim catalysts we are

Operator

line from of Your Roy from next question JMP. the comes Buchanan

Roy Buchanan

one, -- the potential lines the for first interim. the providing guess thanks and for I time time lines for the

Just is the the SHIELD I trial remind the the can with II? potential as for us interim? case the again, you was potential resizing outcomes potential for SHIELD And in

Dikla Akselbrad

thank you. So Roy,

had on patient remind we same the that p-value be, potential reduction if the everyone in with infection you patient interim outcome of focus of So X.XXXX. I, want would population, XX% I XXX to remember, SHIELD of could the at and

with see with want potential stop FDA much very in So early to line efficacy. would what the for the

option the stop for an for obviously statistic early are than I, what is efficacy. enough. is if we in the for sufficient and first SHIELD efficacy, So this should stop If mimicking more early be the plan saw robust data we

and the the And with and always, sharing DMC trial as overall succeeding is clinical can resizing, the is us fatal tell get room start will well. to infection also As trial, we as the that for yes. other we understanding no data option there chance that rate, and that in clinical there's

Roy Buchanan

blinded question, infection next my actually That's the Okay. it's rate.

line of with if expectations going you in it, it sense a wondering the had into your is trial? Just

Dikla Akselbrad

definitely have to pretty recruitment per quickly. up another patients an and we more at average seeing point, patients start center, line trend spread geographically X.X expect XX. a now, XX. where year, So from in the as we be believe XXXX, XXX have coming line. think imagine, the start the of of experience, from we first the I we need it And a that are to we see our is But saying more infection much are there. rate we see more will trend. Because in ramping of XX. we By centers. of with But we our will to now patients centers, for with will have And recruitment opening And you recruiting, have much indicative. center-wise, And that handful patients start as can end and the rate visible we that beginning expectation the rates as

Roy Buchanan

mentioned elaborate Okay. to looking internal Great. there little a cadence out just are be data? capital And could potential I you partnering on your OncoPLEX? unclear maybe guess, bit you to a the just the, get And you doing to bit was the then just runway Or of OncoPLEX, discussions. And are partner to to it how are present potential actively the broadly, more that. you work able need partner, a and about with thinking addressing on

Dikla Akselbrad

that, discussions and internal as collaboration, we what our supporting platform so is we asking the an our said fronts, also will this II we were is And a are work are focused you but runway. or I financial the coloring on from promote we investment potential that we is requiring more a obviously, in is on and program in program be cash give to potential of those not, obviously, order at on are to discussions all top have needed about also But internal partnership. And stage, SHIELD do targeting, getting line, So program. believe front D-PLEX needed that we both what on are hearing the to say before, can't well we as maybe because, the much that bit heavy related/oncology partnering. doing --

with you've indicated, through $XX toward million. take that So way first we've And as us we've the to quarter ended sufficient our cash, seen we've that the is the over indicated end of the this -- quarter. the all

from all so III should line that -- recruitment the Phase the once from it running have have Advanz trade, top trial, I Pharma. our remind trial we takes we potential everyone results a the With obviously, full full speed milestone ahead, that into consideration. with

that must largest support are on And of very So immediate different has is have III looking at financing encouraged once trial. we And an is that what say the in alternatives this shareholder is data. we I shown us that makes obviously, and expected Phase the now. milestone past level showing the our are

Operator

question Wainwright. comes next Raghuram Your the of from H.C. line Selvaraju from

Raghuram Selvaraju

on at for this time? us give of in Firstly, XX-day an number all I patients update follow-up the if was possible be completed SHIELD who it to just II at would have wondering their you

Dikla Akselbrad

Right.

do yes, we So sure, could that.

center remarks, we around -- And the enrolled. that has days. XX XX about say As have XX prepared would already finished in XX their I I said patients

Raghuram Selvaraju

working discussions, just Also fact the us sense to scale-up partner preferred manufacturing. something bit could if or a significantly respect might potential is plays you in the licensee the that increasing the potentially a to maybe tech a future already extent asset partners? And comment you work this to in doing If that be future? like arrangement that context something the a you in give of transfer in-house would with of the your potential of the partnering if what a on attractiveness it's in you to for on with which maintain have you commercial continue this can little anticipate distributor accomplished or role

Dikla Akselbrad

we has. line you partner, discussions trivial, the seen that all, belief, and They So this the trivial. essential. discussion, going of believe question the was their the building it to manufacturing this European thank our it that facility, and Israel, that in obviously a years own really of adventure obviously, we X, essential It ability we with was to that partnering, came it's to investment our would to just we a big enough reviewed CRO in that the us or And discussions, first we've our was essential to manufacturing suggest, facility integrated for not it essential our of to good get because make additional something going a CMO. this maintain. Pharma. on is X approval is diligence. the are because we own partner into the the for our from of not it's not of motivation manufacturing is forward and a pharma not forward build be understood and and facility triggering the And is due think reviewed biopharmaceutical our The process, this see ago too It's reviewed Advanz important. And I to solution looking that fully we all going facility, was believe

I is that the we years sufficient have bringing. of several facility added an it's think are value first we commercialization. that the full And for

manufacture the So ground solid we to a partner saying open the that, you can facility, some motivate control that. and full geographies, sell, us, us to to portion and I tell But of and obviously, something our maintain. -- want this the are a margin would in we have that a there. on different that we are different of larger is will gives if the

Raghuram Selvaraju

And lastly, enumerate global with partnering just from Europe, perspective you can the again, commercial D-PLEX? noncore for us might the which economically to be and broader opportunity other regard territories interesting U.S. outside of for a

Dikla Akselbrad

margin obvious America we opportunity, but So South that and or a also Korea. countries, Western-type looking definite of structure obviously, infection of India. are an -- Canada, level and of obviously Japan, market there South countries, is are China, the This opportunity, Australia, on is repayment, payment the obvious seeing

all so that reports are as of potential the cost with territories. here. it's really on So margin obviously, those and East globally. there, We've part discussions Middle some also seen our potential But

Operator

remarks. I to to would like questions. seems closing for further be hand There back no

Dikla Akselbrad

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

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

Operator

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

may You now disconnect.

PolyPid (PYPD) 8 Nov 232023 Q3 Earnings call transcript