Earnings call transcript Q2 2023

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Operator

Greetings, and welcome to the PolyPid Second Quarter 2023 Conference Call.

[Operator Instructions]. 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 PolyPid for Earnings Quarter all Call. Conference you in Second today's XXXX Thank

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

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

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

two discusses of partnerships is of of total For forward-looking study the attention including its example, management total making planned approximately challenge regarding cash balance. by the prospects NDA into Europe to the conduct a results time quarter; XXXX; piece once and of XXX its technology compelling infections the complete statements expectations have plans, in end and II, when SHIELD XX-day opportunities; U.S.; line flex essential potentially II; it analysis interim its timing SHIELD of its top in recruitment for objective XX unblinded into submission its to their the potential in U.S., positioning and and in the site the execution the additional follow-up; strategic therefrom; objectives, recruitment to D-PLEXXXX the Israel potential addressing surgical in expectation formalize open D-PLEXXXX the of well patients centers a persistent factors an number the of business pursue the of to and company's company current the

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

that differ may projections. statements and materially materially results risks events to material uncertainties cause results actual or from differ. These could Our involve those

Commission, described reliance filings place the including, Accordingly, the actual Securities any you I identify XX-F, Exchange results company's or PolyPid which forward-looking factors forward-looking update otherwise. the new undue required statements. events differ cause whether and any any events or with you company's information, projections because specific to by materially or from those future Form except may to of intention on review in statements. as financial not without law, statements, to or obligation, these should the that revise disclaims encourage limitation, or

contains information of time-sensitive This the X, speaks August call as today, conference live only and XXXX. broadcast

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

Dikla Akselbrad

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

trial advancement for the III product infection. To we announced evaluating begin, Phase we our to achieved candidate, we our that are abdominal agreed surgical the lead SHIELD thrilled in have II D-PLEXXXX. the of prevention This of progress FDA with May, recent the D-PLEXXXX colorectal promising design, site

includes trial patients revised large abdominal open undergoing colorectal with only The surgery incisions.

population. recall we SHIELD will in from generated data positive this very you Importantly, more patient focused previously that I

XX intend is and study We are surgical statistically time in Specifically, this anticipated to mid-XXXX. line additional Total infection II. enroll patients significant approximately to showed of SHIELD recruitment beyond reduction XX be XX% into estimated I. recruited patient expected in patients results into in population highly the an a months, already site SHIELD the XXX top

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

were recruiting trial. recruited have patient June, was In protocol and the recently approved II several revised in centers now late the opened. countries trial SHIELD first the Multiple

quarter. XX the We open the expect to and have in the end of U.S., by centers Europe Israel current

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

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

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

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

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

on. Moving

We progress also development initiatives. continue to our business

mentioned, areas. focused As previously we two are key on

additional targeting strong U.S. are with geographies, partners we First, different and Asia. like D-PLEXXXX in the

would areas, that oncology. specific focused as pursuing therapeutic be are we Second, on such platform-related collaborations PLEX

positions number well technology potentially pursue of PLEX proprietary compelling us a opportunities. Our strategic to

significantly Over the big across have biotech we last quarter, and both up activities development our business pharma. ramped

varying discussions to evaluate or D-PLEXXXX PLEX than partnership are the to of more with levels codevelopment with at related technology. opportunities partner We whether XX to companies

strengthen the recently a and key this the in capabilities consulting company's area. we addition, to business In company development retained goal firm focused support further

partnership predict. in previously, XXXX, two partnerships said pace the objective inherently planned is our we of to exact difficult As formalize discussions have although is to

broaden argument of research While D-PLEXXXX. continue to our activities, the in also we we support development published business

infection, persistent an a in including resistant significant of of II the era clinical site strains, activity of especially preclinical studies surgical Most of The multidrug-resistant D-PLEXXXX surgical Phase the Sciences. European the potential data addressing antibacterial paper range in This against in in including recently, increased bacteria. D-PLEXXXX Journal and bacteria of the antibacterial potential challenge tremendous the prophylactic published its potent an a Pharmaceutical D-PLEXXXX infection, and as highlighted effective paper bacteria was causing against drug resistant of of wide the activity prevalent ones. highlighting site showed most tested,

generated in like we our efforts I'd containment inflationary momentarily, Most and a challenging review including while to financials in Finally, G&A have Moreover, first operating compared cost X our operations, the the year-to-date. highlight environment, in used activities will first of significantly clinical throughout months net in in year our XXXX, million to decreased over the in business XXXX. manufacturing. of cash as months cost X by the Jonny current savings XX% $X

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

Jonny Missulawin

Thank you, Dikla.

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

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

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

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

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

containment well executing Dikla Finally, are initiatives. cost our noted, on we as

decreased our period $XX.X $X.X to million in the of in the by to net as $XX cash million. million same used such, operating for XXXX from activities first As compared XXXX X months

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

Operator

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

Unidentified Analyst

This is for Balaji.

product or pursuing, can the you across that you speak of are the partnership whether the and So the candidates? technology licensing opportunities

Ori Warshavsky

In a terms of partnerships, different things there few D-PLEX that stages, of side, number conversations in and are Asia. discussion. at looking Latin in both are the a U.S., on One, America

-- take what of and looking think some conversations, I more say, -- less, some now is to to really, more and data. I of the some are advanced, some they would is interesting ahead more waiting see more of something the want are some data, in are

committed I signed, type think is which is results, some regulatory the payments will signed sort sales and incentives on of of the ensure will most an backloaded, sides line both look look then advanced just any initial at to the And milestone-based we that top to the are the be based deal milestones. of align at milestone for before deal really a is and similar we really that that payment we when structures, that product. deal

So very team. advanced the to similar

a And acid, mentioned delivery in I there's past and of bench delivery buzzword the in right? interest animal just RNA both in And side, quite have this delivery, a -- not platform the looking anywhere increased that's do data and companies can -- RNA the That's nucleic in lot data, happening day. from the RNA. I wherever conversation general, we in the data, the products, innovative I at there's On highlight. is needed, think from with pharma delivery local

around that delivery. patents have We

-- this new, any -- technology, RNA. are it's where something with looking we we with let's more we're where Companies There's think are learn are in this say, open is [indiscernible], open. there's window So that to I and this always is push to on.

So try as we we -- as much on RNA push the as a we'll company, to can delivery.

intratumoral local addition, post-resection, into OncoPLEX, OncoPLEX, adjuvant injection In the bed. the delivery whether [indiscernible] or tumor as around delivery an conversations of

Dikla Akselbrad

what into not think prepared I in to obviously, on we for today's probably. investors going what's commit specific, probably I remarks go -- in think trying the important into cannot and in that, be line time without emphasize to we were to

first the time are in experiencing interest. a such the For we policy, of life robust

agreement something parallel believe lead So I to this is, discussions. is we this are new, that companies many think, that year. that And still will and in is

Operator

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

Douglas Buchanan

is if the can updates expectations inform blinded one, the Or trial? the the And each progress going about first expect the design And rate you us the SHIELD based you can remind guess infection through quarter? we're on your least trial? rate? the can at us I of you for what expect baseline II we what as enrollment infection rate meeting for

Dikla Akselbrad

for thank you us. joining Roy,

updating in hope XXX And issue first which You will be report on the next or definitely, could I be I -- will quarter. this a will around eyes, release milestone recruitment we around press to that expect before And expect quarter. we able in that progress, probably would the we every is patients. either our

judge quarter. We call we've it is and milestone, the can next in -- we the this point. this reached So this next if the

not focused the the we I something be overall What that for that is of in because the patient can SHIELD unblinding to not we In this will we we've obviously, used since population. terms this do tell rate, able jeopardize assumption I any that you way, want baseline share trial. to, infection of experienced

this And this seen than -- lower we've literature. is in is generally, what generally not

was that that are infection I rate open example, patients abdominal but presentation, our our experienced large for X.X%. the SHIELD open we in is in with rate that So around corporate incision infection all in -- presenting -- is

So we reduction. as what the we at are this from baseline. is see And substantial looking to that, expect

seen Our reduction. is the that And at we've patient Phase as the assumption least II. in in we've in population focus this III, Phase XX% it seen should be as

Douglas Buchanan

and incisions? a settings, centimeters Okay. beyond I. Great. work quite of just limited the let's ahead XX to, what And like then research that in outside market you you of incisions would us Can that's maybe guys in say, can reimbursement how surgery? smaller assume know about remind continuing. large a get you -- did event usage that colorectal I of you And bit suggests incisions above the potentially SHIELD label I

Dikla Akselbrad

Ori, first take my part. second the on take part I'll side, and we'll the

open clearly very criteria to colorectal meet risk showed that surgery, XX% to research factors. market and either patient the due other high-risk surgery the surgery-related open of or factor risk our of abdominal So

this is substantial. quite So

those we incision. a of with I, Just SHIELD as XXX out our large had were And in patients. reminder, XXX

patients at the personal even this look with risk of trial. more -- you If risk XX% factors, or one was

is So with I data. SHIELD this our also supportive

Ori Warshavsky

Yes.

patients. D-PLEX", would start, Board, the across I'm into When -- them of we product add ago. we So you I point reimbursement. I and you show calls the the -- few to use this, patient using asked these which that to "Doctor would going back the surgeons, and TPP they when really the asked get where But a high-risk would when before we ask

terms meets of next XX% of general patients so are high-risk it you tell it, patients? the from XX% know the question so colorectal gynecology in really BMI, the then of terms And surgery, is, us think population kind we and varied how fits on. anywhere And what in numbers. surgery. to that smokers okay, in of when general of -- And about And we terms meets many split surgery, diabetics, it your into with numbers high of these really, of it

the for across point all this product a as a good think abdominal is So starting surgeries, I assumption.

here. reimbursement, things terms so In of two maybe

in not hospital paid planned is is a money. the on really went -- time, First, product, inpatient the per if way, and A leaves then the lump hospital the then and if conversation our payers. with sum with they're the if efficient, surgery DRG. a since an the this get And makes hospital they're as patient

If there days, infection the the is patient the now hospital another the in money. hospital XX for an and -- hospital loses stays

conversation reduce that infection preventative is the here. piece there's hospitals an to really showing our patient here, So has additional that economic but measures outcome also piece

separate cost Infectious up the Now are XX% reimbursement hospital the payment. said, drug. eligible NTAP, criteria Product the Disease And that fit NTAP, we the we and from Qualified for went new the through for and we of technology a the of to because have Designation, to NTAP QIDP, we all CMS process gives the add-on

we with hospital the get the So can direct the have payers, although reimbursed don't product. conversations we for are --

Douglas Buchanan

Okay. yes, helpful. last you, Great. And That's then thank one very maybe Ori.

you about it the interim waiting anything around interim, a around the for interim? I last the any on good have the what like the share assumption? Is of call as for such the were think Do the can FDA you're implications On feedback and announcement. probably upsizing FDA XQ trial. you sounds nature you that interim feedback maybe were, on a track

Dikla Akselbrad

Sure. Yes.

getting The totally and centers of that, quarter. end end of from month actually for end this the are opening We approval May. patient. by correct. by FDA an So recruited in after point, the received waiting you're countries to And and the were June, the target the from the we feedback overall we approval XX of have approval on protocol, we the first multiple current by that with the centers from

we as increase recruitment. expect see, seeing would quite to I investors in an So progress, patient

first recruit from interim, the year. interim the X.X next during months is, XXX of about we And aspect once have the quarter patients, the feedback the should patients expect On the committee. recruit we we the XXX DSMB to that, after of

So early entries. should either or have end of quarter we QX, the first

what of patient robust for around focus made to patients interim of It quite, in patients. SHIELD in an obviously, statistical say, analysis. the set just And the interim patients, this data in the and everyone population, our an reason XXX you terms around could the expect the would number XXX was XXX significance. we criteria analysis remember, I of of to was statistical would have suggest [indiscernible]. also interim is I and line Again, have of part This could an early

Operator

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

Dikla Akselbrad

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

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

Operator

Thank today. does you. participating. you for our That Thank conclude conference for

You disconnect. may now

PolyPid (PYPD) 9 Aug 232023 Q2 Earnings call transcript