PYPD - Earnings call transcript Q1 2024

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Operator

Greetings, and welcome to the PolyPid First 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

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

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

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

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

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

or any intention or events forward-looking projections or new revise whether financial obligation, by PolyPid or information, disclaims because except future of otherwise. to statements, required update law as any

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

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

Dikla Akselbrad

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

about II our excited for the colorectal Most trial relates business. D-PLEXXXX our in SHIELD prevention ongoing to it are surgical the momentum enrollment pivotal of importantly, for We infection. substantial site throughout abdominal as

this Importantly, progress is a recently sheet. clinical being balance with achieved fortified

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

more intend subjects interim Top patients II Therefore, As now more occur in the the to of results the and interim mid-XXXX. analysis a total reminder, we once this conduct year. complete is second of planned the half line for XXX is which X/X SHIELD expected XXX than follow-up, analysis an XX-day enrolled unblinded to anticipated of half are in than enrolled. fully approximately

robust to would Importantly, indicate, recruitment rate. the with is current progressing expected space constantly status at a at the respect now enrollment

fully up a per recruiting is running, opened, and this weeks month, recruited we trial XX formally its As following patients. and expect X.X into being being center to approximately site and of opened call, anticipate once takes last on we which our patients the centers have approximately per said several we total

derisked we'd SHIELD to because population we subgroup. This SHIELD large to enrolled are which that SHIELD highly is cancer is we we to that XXX strongly pre-specified conducted III demographics within is SHIELD data peak thus With we place already we patients on I. have II duration incision male/female trial. some we population, with percentage in similar believe several in continue another Phase rate, not II recruiting COVID-related anticipate had were subject the patient I. month. in patient So patients more enrollment This the at trends I generated having crossed observing being during pandemic is involvement fact positive the the color are seeing. split and Of in far and Along are age, II encouraging this note, significant median SHIELD I. the period, in that of SHIELD in focused restrictions thought yet the the similar Similar a XX we of threshold, of per throughout the the the provide the enrollment said, that important in reason SHIELD tight

learnings knowledge as in sites the have believe the I be this best-performing end, key centers also monitoring the targeting the firm clinical we the leveraging we from approximately essential are to SHIELD sites related I, Of recruitment, of around for involved patient we II in course, SHIELD while from SHIELD II. same SHIELD practice. I and to of To are terms number study. XX in of this SHIELD good execution We

our towards observed operations to enhanced another meaning key has supporting also have no data SHIELD the D-PLEXXXX twice to without recommended of to date. SHIELD in II monitoring the clinical the review safety data accumulated study study that has charge II and study step the continue Moreover, study. safety issues for of We modification, related in been successful committee team, safety conduct

clear regulatory for potential D-PLEXXXX reiterate for submission we a have NDA U.S. to pathway we have previously, the what on, the in said Moving

large to only evidence take aspects the D-PLEXXXX acknowledged safety of Last year, supportive the And that submission. product key property profile. SHIELD the also of D-PLEXXXX successful, NDA support FDA compelling is I of is intellectual I'd and sufficient substantial with its foundation. overlooked to provide confirmed patients to that moment may efficacy if incision, SHIELD but a often the like in results acknowledge an surgical a not II potential

with the surgical pending the infection. protection method and are patents platform of indication. for of of long-term our patented we D-PLEXXXX uses granted patents significant approaching number Specifically, for of applications different the Among for site fast and its XXX treatment for PLEX those use prevention

patent XXXX to effect until expected D-PLEXXXX worldwide. in remain example, more SSI is For XX than in countries our

for late-stage Shifting gears. strong us. the value IP incredibly candidate this This only position of enhances product promising

II from continue a gross our private PIPE to of placement million advance XXXX financing We financial position or January following proceeds. for strengthened $XX SHIELD

runway year beyond our the Importantly, now this planned the timing extends analysis. cash and SHIELD anticipated II's of of quarter into fourth interim unblinded

secure exercised, Moreover, a $XX PolyPid million interim financing the issued unlined for potential company all to positive warrants and D-PLEXXXX. of the has the the would if an start to result the fund NDA planned additional the are which in rolling submission of of analysis the are

from science-focused investors, the Rosalind syndicate life DAFNA new reminder, of a including Management and and Capital comprised PIPE was As participation Advisors. existing investors, U.S.

call a Jonny turn review IR let convenience. you a the your look our I revamped to presentation We on we for that encourage Before recently at posted to I'd take of like over have would all you corporate newly know to website. his the of financials, all

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

Jonny Missulawin

Dikla. you, Thank

As million $XX PIPE $X.X of at deposits the This compared of of million the had million XXXX. to short-term $XX.X financing in proceeds XXXX. March XX, XXXX, cash the generated includes end as company approximately of January from closed net and the

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

X-month to months million, March for turn $X.X of our the were ended $X.X XXXX, let's XX, the period income X to XXXX. Research million Now development and same compared statement. expenses in

recently SHIELD recorded X for period. the million, reflects This the and prior year of to the expenses quarter The containment completed business the expenses in period $XXX,XXX months General was decrease driven ongoing months and $X.X X-month the R&D administrative ended Phase Marketing cost for III XXXX, in most by ramp-up million development of were $X increase the our the March compared XX, were to ongoing II expenses XXXX X same during March XX, in trial. $XXX,XXX, ended efforts. XXXX. compared

the $X.X $X.X quarter company we XX, X the months For XXXX. your of call With now million first that, the loss compared net XXXX, million of to a March in to will open questions. as ended had the

Operator

first the from Roy We first from line your JMP. comes question question take our Instructions] [Operator of and Buchanan Citizens will

Roy Buchanan

review, you and review ones I a the line breakthrough expected A plans is couple the bit NDA II. successful? Dikla, the guess, detail, Europe in little more can XXX(b)(X), time you just the the for what for SHIELD II time line? quick Then I submission what are far Just as expect we SHIELD designation? I as assuming can have just would guess, on say,

Dikla Akselbrad

Thank Roy, question. the you for

assuming maybe I design, will the for we to recruitment. the or it SHIELD finalize for we -- So the And to this should the stopping XXX is are the around -- are interim patients, is continue need II study expected quarter XXX for for analysis there with minimum patients which mid we to -- fall. another say, that the and year the readout this is assuming

the done we we will the -- during well. the the be of end that which towards XXXX, is at have to first of as of So And half get expect end the of end we should towards at XXXX, NDA, means that half XXXX, of that get the that the understanding submitting result. we the first year,

continuing recruitment, this This is this leave then our that to If decide we it and let's stop recruitment assumes we are way. well, -- assumption. the

to It the bit With continuing Europe, assume into XXX approval are as of get for looking strategy. NDA. at in this XXXX we the up parallel takes it end this to Europe. patients, to recruitment So the and a regards us the longer a takes

procedure, centralized the we submit approval get for so beneficial. Europe, once to an which entitled can are we very all is Although and of

get let's the FDA, as we Phase see if end to want tactical. the be submit to with readout -- III tactical whether Europe are meeting these We have making more, to but we before we will to decision, to say, the really get of

will of So our is that NDA. assumption U.S. in after follow terms shortly Europe

Roy Buchanan

countries X breakdown just in sites? a those the elsewhere, U.S. cetera, more Western et I guess the be Great. but Okay. the detail Europe, predominantly press then where of are in you expected site. provide listed bit added? know on or additional are XX geographic those for sites, then And the the release, the I to current the and on can XX

Dikla Akselbrad

Sure.

-- -- release that in participated, list Israel. of examples actually listed little Germany, countries we that So we listing a related that U.S., Hungary the countries to the are Ireland, the and bit are Portugal, that press Italy, there

X -- countries, added. say European X being countries countries. around additional I that that countries We between are European also have Eastern to per between the Overall, some it centers is in would

the about in that we In II. SHIELD Europe SHIELD more, also similar. SHIELD Many bit have are didn't that. in have Western U.S., We I I. that's spread, It's much and quite countries that were in a

Europe We bit which and have see we more a good repeats more of see is thing the we a because clean now, data Western little as itself.

Roy Buchanan

X then Okay. I last X can. Great. if That's And maybe helpful.

but advance II think guess pipeline. you you I pivot Just or SHIELD pivot, do the assuming soon how is not can -- successful,

I How have of, the fast You you what get can that plans? are the OncoPLEX kind waiting, guess, in going?

Dikla Akselbrad

actually So this now we lot a are that is into. effort putting something of

top D-PLEXXXX. our looking pipeline. are is priority previously we obviously, we But as said, So now into right the

The for OncoPLEX, second in oncology which program, is the priorities line us. remains a priority the

U.S. we the clinical Phase If with successful a FDA meeting had supporting you the remember, pre-IND I/II trials.

is top this additional SHIELD that are in milestone expansion II -- be sure direction in ready we looking strategic, I potential our are for of of of in III SHIELD line. also for the We of we more make this are this also important -- pipeline but prioritization, in order once a very to want to on with sorry, first some D-PLEXXXX, the So we Phase that, prepared pipeline. looking the pass priority, time broadening in

top I in some depth these This are have after think we we line, will days. there. at looking to news the something share very also So is

Operator

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

Dikla Akselbrad

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

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

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

Operator

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

disconnect. now You may

PolyPid (PYPD) 8 May 242024 Q1 Earnings call transcript