PYPD - Earnings call 4 2023

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Operator

Greeting morning and welcome to the PolyPid Fourth Quarter and Full Year 2023 Conference Call. [Operator Instructions] As a reminder, this call is corded. 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 Conference Fourth Call. for Year and all Earnings XXXX you in Quarter PolyPid's Full Thank

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

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

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

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

These may statements. events cause statements Our those undue that these on Accordingly, place reliance materially material from differ you uncertainties results differ. actual risks and materially to involve or projections. could results should not

the including, without may company's forward-looking in or review to that you materially to results from the the company's Exchange filings limitation, encourage events those Commission, Securities XX-F, I specific actual the which with Form statements. cause factors identifies described differ and

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

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

Dikla Akselbrad

Brian. like our you, PolyPid, including On I would year shareholders Thank team quarter to XXXX call. our fourth full everyone, at welcome new to and behalf of our earnings

with throughout thrilled a are We progress business. recently our significant achieved

enrollment infection colorectal our to for prevention begun trial pivotal ramp the site abdominal surgical of up. As ongoing SHIELD in has the D-PLEXXXX we expected, II for

investors. greater highly $XX have of status generated its this in SHIELD with preclinical that but sciences-focused a data the also participation We robust to some I from with of U.S. clinical potential new that successfully development compelling we support oncology. begin financing million II. demonstrates efforts, OncoPLEX discuss our order Moreover, in detail multiple in included all new life shortly will let's completed

The enrolled open. XX XXX study now currently approximately are subjects has centers and than more

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

X.X patients once weeks the center respect opened we into month, overall to we and centers have rate, patients. being anticipate takes following per being as call, recruitment trial to and recruited up XX its formally recruiting With approximately per which running, said our site the last is on several expect we approximately fully opened, the expected and

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

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

While we the in SHIELD patient number I, are best-performing SHIELD same knowledge practice. now as XX monitoring targeting of approximately for SHIELD clinical sites II centers recruitment, good from we the firm and have I around of terms

this essential to in II. SHIELD be execution We the believe of

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

Moving some on, data today generated our candidate. excited new preclinical I'm to with product report OncoPLEX

[ ], ability OncoPLEX prolonged be and of antitumor effective having We to impact. intratumorally the have while recently injected demonstrated

injection and melanoma has and growth OncoPLEX CTC murine is it a bed. has and adjuvant models tumor in the it's A X via murine been injection of or an used therapeutic models, tested all post-resection in survival and intratumoral Either various now across neoadjuvant application in tumor tumor approaches. the via single intratumoral carcinoma. increased a animal shown OncoPLEX well-established colon significantly commonly reduced

date, X The been has To of models attributable results. of the therapeutic chemotherapeutic the technologies' and of is with PLEX docetaxel. effective mechanism unique that all release prolonged OncoPLEX action highly drug, in and constant to different applications, OncoPLEX tested effect allows

into with injection The release systemic exposure agent. be or PLEX promote [ chemotherapeutic acid. of antibodies, used the nucleic not treatment the but ] prolonged T-specifics with to of docetaxel, intratumoral constant such the the as additional The types platform can an other the tumor locality, it only as with interventional and with deep combined penetration to rate oncology and drug also molecules, of minimal enable chemotherapeutics could

balance including or sheet for Capital proceeds. The closing of prodify gross investors, million participation new and Shifting successfully existing placement $XX PIPE gears. comprised PIPE Advisors. We Management of syndicate was were ] investors, life Rosalind recently U.S. financing [ pleased science-focused a private and by to from our DAFNA significantly

for $X.XX of But proceeds PIPE, X,XXX,XXX share, in an exercise price up company's gross share thereof due million same to of received purchase to purchased prefunded price investor per million. words ] the [ $XX the a ordinary all of the of shares stock Lea per at $XX of with $X.X of price exercise total purchase for warrants a and amount share common to the of

X The warrants efficacy. of and III positive safety the announcement earlier upon XX trial stopping regarding positive unlined of the of PolyPid's due analysis years in trial the expired monitor trading from issuance Board interim recommendation the SHIELD data D-PLEXXXX Phase company's the days a by in of the date following resulting II to its of

the If The XXXX in initial unblinded the PolyPid the to million of fund anticipated drug third positive start million extended exercised, for quarters II financing analysis. of cash analysis would result of late SHIELD and runway $XX the D-PLEXXXX. and of interim until additional are interim $XX issued the all planned the warrants planned unlined the new behind the in submission are application timing our

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

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

Jonny Missulawin

Thank Dikla. you,

XXXX, end of PIPE December include of compared XXXX. net XXXX. company closed as As of at This January approximately to $X.X in the million cash does financing had and XX, not the generated the million short-term $XX.X of deposits from million the $XX proceeds

late expect will third be As that balance our into to cash forma operations fund sufficient Dikla pro quarter we of XXXX. noted,

$X.X and most December XXXX. for months R&D by period Now of ramp-up II X million income quarter the development trial. in Research statement. the the fourth recently let's of the were X-month were ended XXXX, the ongoing III turn in our expenses XX, compared $X.X expenses completed to same to driven SHIELD million Phase

during to prior $XXX,XXX $X.X of respectively. administrative the in expenses of for million, $XX.X fourth Marketing $X.X XXXX and the For same XXXX, expenses and million and recorded X-month development the expenses compared year to XXXX. ended $XX XXXX were period. General fourth compared R&D full $XXX,XXX were the were quarter December and year for the period XX, of XXXX business million million quarter

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

For XXXX, the to full $XX.X XXXX. net the a had loss of million a million year calendar of in loss compared year $XX.X company

initiatives. to continue cost our well execute we Finally, on containment

$XX activities calendar As such, used to million. million operating year our XXXX million from to net compared XXXX as $XX.X decreased in for $XX.X year by full cash

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

Operator

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

Roy Buchanan

had SHIELD the couple on a II First, interim. I

remind is the what of outcome, the efficacy powering stopping successful for And the the spend efficacy? can i.e., us a for then interim for alpha interim? Just the you trial early

Dikla Akselbrad

of will get tell should the on should to us alpha robust The the itself committee the penalty we in depends order stop, data. the the -- overall interim in to alpha in an that number trial powered overall alpha X.XX. The the The on that be overall of the for trial. depends the stop the size general order early

look of XXX, at end to gives sent the the If the an day, very because will have of into I patients, you the And minimal. the the We I XXX interim overall I, XXX. to sort tell we recall, it earlier the is can we if alpha had powering interim was an whether the and be that very, or you sent in was are of data. different it very SHIELD on X,XXX XX%. alpha So minimal.

Roy Buchanan

for on the to clear early trial exercise, to efficacy a unchanged, continue warrant be And need is to be to again, considered a correct? recommendation just stop Great. then interim potential You the success for don't Okay. to be the success? considered

Dikla Akselbrad

data. effect all if The the the rest study -- this is at we period have the the at for XX-day an So warrant will overall year other the scenarios. around stopped positive is time, -- plus for the only --

Roy Buchanan

it. partnering just progress other PLEX or And D-PLEXXXX and year? guess, pipeline, the the, for have for technology planned you Got outlook a this activities then on you just can then Okay. of bit outside development just I on discuss the

Dikla Akselbrad

Sure. Sure.

potential the to what would those additional or we're discussions the part from in data and development some published of that our be next of research input to the continuing getting internal efficacy obviously. the also see we new referred part of want development, that what should discussions to or are initiating we and terms step OncoPLEX So today helps of direct or platform the partners some product today of understanding around is

as -- our And Obviously, cannot that, of discuss cannot some very are part are of we and discussing predict ] as that are conclude discussion interest within of the is with that companies to and data maturity And in us. both we encouraging. OncoPLEX. The well discuss, from we future understanding company discussion, [ collaboration. platform-related this is of of discussing pleased timing continuing with robastically animal we of but the the the and are approach collaboration are showing something D-PLEX potential kind that our of level these

Operator

Balaji from Your the question Barclays. Prasad comes line of from next

Unknown Analyst

XX-day their This Balaji. the time? to completed update number is possible for follow-up is it patients this I'm [ wondering at if Shaun for an ] on who of you on provide have

Dikla Akselbrad

Thank Sure. although indicated have recently days. think, you you more today's in your we've than XXX we XXX patients, press passed, for X our -- only recruited that And announced the we in We I X or patients. already if question. have days noticed few a release, that

and quarter, patients -- things we're the the follow-up. some looking XXX into the recruit had similar we finish started of most break. But obviously open that and if of additional do the we due the start tell up. can we finalized see I the trend you ramping that specific the centers only patients of at end we around and So at were expect to beginning to We I but to we SHIELD are patients XXX see Most have recently of the year saw in next that XX-day see started winter of -- progressing not did of numbers, go to open of up of follow-up some the XX-day. both centers the year, the holidays ramping most the terms finished having that recruitment in slowdown but significantly to the

Operator

Instructions]. [Operator

next line comes from of the Wainwright. Boobalan from H.C. question Your Pachaiyappan

Boobalan Pachaiyappan

our So a couple questions of side. from

production. First, about as think batch we commercial

So I'm small involving expected molecules. how to to or curious the polymers technologies lipids compared attached other platform COGS D-PLEXXXX of

Dikla Akselbrad

Health full manufacturer for review facility, commercial because also see So own a that we ago, we built for have is by time things of a actually control few now We and just on authority long stage. applicable we've the the for -- Israel manufacturing. the and cast the as a Ministry European months our Ministry GMP

to now approved commercial less the should know product this. be GMP the price final the should Again, stage. less of specific be we because X%. all a be the but indication than that price our facility shows it's will is product, the COGS than do not that early COGS bit very have indications And So -- be of for -- exactly of selling X% the it all we

Boobalan Pachaiyappan

positive carcinoma and data in models. Great. melanoma And colon preclinical about animal then mentioned you

these can associated the So and behind rationale discuss you D-PLEXXXX? I'm just choosing opportunities indications also curious, commercial with potential tumor

Dikla Akselbrad

are pursuing this So at is are that the it's look an we because to but -- that approach. was intratumoral these not for idea clinical,

model. the effect. We our sales also we adjuvant. post saw approach released X neoadjuvant saw bed was we for the adjuvant approach, is into the that the an as tumor directly also very was resection, similar were as chemotherapy results look And effect the approach, And This as the tumor fast-growing with see have repeated and at in the an injecting local similar that that pleased approach. tumor. prolonged results look animal applied here a are they is environment tumor an We OncoPLEX into within the models the local to weeks. The at the and in the idea

here neoadjuvant approach So a sales into the data idea preclinical fast-growing a our was to in model. expand

Operator

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

Dikla Akselbrad

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

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

Operator

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

You disconnect. now may

PolyPid (PYPD) 14 Feb 242023 Q4 Earnings call transcript