PROK - Earnings call 3 2023

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Operator

Good morning, ladies and gentlemen, and welcome to the ProKidney Corporate Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded. At this time, it is now my pleasure to introduce your host, Dr. Glenn Schulman, Senior Vice President of Investor Relations. Please go ahead, sir.

Glenn Schulman

Rob. you, Thank and everyone, ProKidney's update corporate Good welcome call. conference morning, to we the updates. press after evening, issued market corporate Yesterday several closed, a provided release that then financial quarter XX-Q our morning press filings. release and And XXXX this released results, third note available the be approximately after Investors call after hour website on -- our a X replay of its Please today's X will of section completion.

Tim this Co-Founder Bertram; of the Advisory Legorreta; ProKidney's and Joining Executive of Bruce Chairman Board, ProKidney's Officer, us Board, Culleton. and ProKidney's Dr. on new Chief morning are the Scientific member call the Dr. Pablo

Dr. Following Officer, REACT-XXX, some our Chief introductory on Dr. Bertram, clinical open comments Regulatory prepared James and your Officer, results Financial call by by development on today and Pablo questions. Also Culleton the call we our us Chief will and Darin up the Dr. is the Coulston; program, remarks Weber. interim for joining

to revise today, disclaim statements lay obligation as by specifically subsequent SEC are required Before could statements statements we as forward-looking conference that like will results any results note qualified this from just future also other and forward-looking annual risks XX-Q uncertainties reflect including we be filings, except may statements by with statements XX-K remind events. to our the and or filings. Please differ during materially law, by that our the uncertainties implied cause about to materially these forward-looking those due cautionary risks update forecasted. Actual and stated opinions our everyone begin, and statements statements on forward-looking November subject contained to XX, I'd or release, in business. today's that company's filing to These the making associated press of company. and forward-looking XXXX, call, report only to are by those These actual these we these or Form differ

conclude Culleton. the all Dr. a Legorreta comments the Phase Moving our including today. -- turn from your objectives We'll of Phase to with call our questions. and REACT agenda our call up Bertram, milestones. Afterwards, the providing discuss the incoming program Data, and then opening to RMCL-XXX and the comprehensive remarks hope Dr. open review I'd plan, few of for open the Pablo? introduce we'll Slide We'll Bruce X II with for like Pablo for to it Board. Pablo With III ProKidney's clinical over that, call Legorreta, now Chairman our and CEO,

Pablo Legorreta

joining. you and Glenn, for you, thank Thank all

vision the landscape. partnered known As you truly know, CKD to the the future Bertram Cell chronic kidney believe our potential Therapy, disease support that treatment may all therapy of the REACT, I has and to for the Autologous as I also with disrupt Tim Renal

first to we development REACT I Bertram contributions dedication moment introduce to and Bruce Prokidney. subsequently Tim review emerging from program, Before to the a all clinical for thank take data Culleton promising and want his of

and into As function REACT, to human has and kidney with disease, a for Phase one technology XX development. this approach III of those advanced nearly [indiscernible] the of novel truly years into REACT, preserve Tim invested advanced chronic kidney clinical inventors

Tim, when impressive left has Tim believe for accomplished development. clinical the speak future. have ProKidney human you ProKidney well company here. and for technology has that say I job inception I everybody an thank into REACT all his for tenure, During the done Tim at here shepherding positioned from this I you,

role. a well scientific we're with his advisory us to While have future Again, be in we gratitude very that in that him to you, happy you deepest and our will he Tim wish say all staying endeavors, accomplished.

worked hired for ProKidney. ProKidney Bruce together and excited X with treated the to a I Both Both team, with have and and Alan at several he about around years, ProKidneys becoming felt XX companies of for directors, new will around of and a about patients various X we him and background am bit years, a why Pereira the roles space that as have respectively. Lotvin had Bruce worked provide him in ProKidney. but really ideal the renal suggested background closely briefly that known Bruce at Bruce be him known Brian the top CEO forward. now nephrologist, to like ago Board would in and year leadership of that our both I having ideal on having have take ProKidney I

school like details X improving year So than Massachusetts. about to dedication we Bruce's a about years kidney few medical training ago. and training disease. XX share Study Bruce Bruce fellowship in I'd and in with now Epidemiology the world a ProKidney Heart patients at more of Canada. He Internist an lives background. famous at the in completed completed as Clinical a to months Framingham about after Bruce Nephrologist of courtship, hiring succeeded of in had

where Nephrologist services President was XX as by Manager a oversight Clinic. Bruce to who he leadership medical Tim, therapeutic pass area. After as now Bertram. worked PBM I development Clinical the Researcher of of share to of clinical the the a XXX renal patients clinical direct where call famous Baxter, Kidney trials, Calgary holding multiple epidemiology, He have like at has moved and he well. and he roles For Tim Caremark, words to with of director spent Director will Alberta, with kidney Care, on -- of running has renal for the Lotvin, sure patients as of products published General Medical Kidney largest including recruited papers and kidney including I'm one health then CVS you the Bruce then scientific the within University CVS outcomes that Chicago and Bruce global join to provided would and of Bruce disease. country, CKD Alan cost Vice studies to few the close Progressive acted in years, effectiveness. as to than global in provided X to Canada. oversight at Baxter research care Disease more and all Healthcare, years,

Timothy Bertram

Since Pablo, focused patients journey. the you support importantly, that of And late-stage ProKidney, thank of have walked step your on with CKD. to vision founding possibility we ProKidney. with bringing and living dialysis-free have the each us of you been for of on mission

REACT Now hand, firmly data our kidney and now leadership excited the going to stages forward with will we each of the we forward over look I'm I patients turn you step potential to and on real the journey that us dialysis. Bruce, to to to increased next bring an to I mature therapy will about it in take you ProKidney. bring take. our failure advanced possibility to to end-stage for facing mission

Bruce Culleton

placing you at the present want warm want Board Dr. company. in to contributions Dr. Bertram of Directors support to Thank for Bertram. the ProKidney and time for welcome, very to RMCL-XXX for over and II me the last his exciting provided months it's our their me he's trust to genuine Phase Pablo X data since I evolution. Today, the all really thank the in important joining pleasure this company's absolute from to study. the I also my thank

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Operator

Yigal is question [Operator the line from Our Nochomovitz first Citi. Instructions] with of

Yigal Nochomovitz

I had bunch order. no particular a of

secondly, are to were XX, not they XX included -- And First already them? the of mean, though bound you've lowered I enrolled they XX down proact the the to X, the delay even XX enrollment what to -- you're already for or X all, in for eGFR analysis? from enrolling then to XX. the happens regarding upper patients above obviously, XX that XX anyway, in proact Are in

I'm enrollment. the detail I on comment why will whether XXXX. that So if was are still mentioned could in there given already that, delay Could end open then for wondering that proact end, studies more interim explain think for just in originally, would analysis, that the the range be per both scheduled a you se, completing the you little you And X I interim was believe, of XXXX. at

Bruce Culleton

inclusion do in that enrolled, as patients your we're the criteria study I for forward. We have think, meet may you questions. I'll Yigal, in already not that Thanks, moving order. them, noted, XXX address

protocol will be those be a We to will as of obviously treated analysis the and and we submit they'll continue part patients per final set to follow FDA. that

the we delaying As while enrollment program here. there's we're our why study, with patients in for really CKD, execute on enriching risk with higher of twofold

patients criteria. and do the enroll is The and changes protocol any ensure want be those we to in don't further modifications who we first that do we really may these truly the outside response that complete of enrich subjects as

of as the outlined. that we're you over to that also The period manufacturing think, would pausing improve analysis, Phase in we all for here, interim an we're I finally, XXXX. you think complete a that systems XXX from the interim to pausing And that our will in we XXXX. previously is, our manufacturing, III same pausing study perform second then data, communicated question time. And did in studies I around reasons I've We

an yet We that performing get to perform modification on will interim analysis now our we're haven't Phase see you when this we future. we'll for committed in program the III but back to

Pablo Legorreta

a to filed Bruce's study, modify excellent enter you to couple answers. One be you FDA. comments in a of if have additional with criteria So is,

resume going year. said, will of time, So take that's we're bit a to next And this it why as doing right, little but we we got we -- and a much, time. actually not to little take

about that the there's the population think kind the talking The to other patients, these mention thing kind seen as study thing in this clinician is many alternatives. XX, this really where that of function. is highest or patient telling patients because data, that preservation that are with the and of that in XX patients, which is really of what's have is evolution to stream as But fronts. It's we're beneficial we sites of the -- have the never focusing I is sicker that's injected on function XX patients of data the XX to patients we to concentrating that risk close what disease to us the you exciting the out there's to study that important the other remarkable you enroll see preservation have huge no patients patients among is interest is and is saw XX from about

So patients about harder XX stage tell patients few, you to little excited have, go at that Xb XX. when them a in But and about enrolling you it's we bit it. are There's a get them, for to focus is when had talk of example, a on interest XA, going which from stage X the big to to study and that that. them

doing So us change by it's going the making to trial the accelerate the enrollment criteria. enrollment the for -- of to

Bruce Culleton

Pablo, to study that option a are patients for may a receive do close cared a have an reach patients told just where my enter for a meaningful. being stay period become around Having do they options. And And very discussions whole patients we kidney on a -- thing when patients dialysis. for lot when GFR patients possibility for preparing for for that's period my benefit. one for about time, patients And some those look of that. There's there's professional that clinical a into also more to when and -- that's XX patients career. of also

Yigal Nochomovitz

follow-up. a just And quick then

to then So maintain the the that regarding have the take interesting how but the probability internal I proact kinetics the them success of debate end is with XX I maximize the retaining Pablo, terms and FDA commercial was just your with of clinical criteria do optionality proact had setting, as you much or the the of have both you outlined, enrollment an in benefit. to modification having for likely in correct regard for not to aligning to there most X point discussion wonder respect X both at to slight the and for be XX higher XX enrollment to with secondly, had one? the And

Bruce Culleton

So Yigal, I I'll if could. address your second question first,

believe we across that first, that So see, upon different groups. we works REACT based the patient multiple data

even we eGFR so And that patients up including those might a to possible see benefit. we XX, do believe an

the notification XXX reasons modification outlined. And FDA second, perspective, a we based the this -- we to were So to this submit to will as do to a the that specific in-person not then We study or plan modification letter want regulatory that to require change or them significant an for being our we did we modification. the include not study, our see from do an discuss believe meeting feedback and a internally, FDA. upon

risk can with letter. lower managed be a So we think the and it's

Operator

Zelin is of Our Justin BTIG. next with question from line the

Justin Zelin

effect I fall here. the data X about that potential thinking into And treatment. of I to does have years? hear just the And follow-ups. your some latest of thoughts durability on wanted the after your Congrats on redosing how

Bruce Culleton

about a data, a the have control after of come have for first REACT. And benefit Justin, durability to may at tail insights but keep on confident mind need can't that REACT to your the -- some months. control more our in towards quite data based a the showed may We There's program III XX Thanks, upon that that get today program, in on -- II end. question. XX this suggestion XX of months see some parallel we to that we or group don't data. you XX likely from more XX, be that off We We it's to point, there's we out and the suggestion, we future. Phase durability But that, a do Justin, think the Phase with we'll injection. we'll redose in that group

Justin Zelin

XX could X I data that whether those into if fit they enrollment as you for as And CKD. stage criteria patients far had looks ask, XX eGFR. the XX you like Great. Of new preservation do XX, of it here to of have

Bruce Culleton

already are XX, already you group. I a it's of with those those of included that XX% that how off stage up in patients XX Xb think are And I don't of Justin, but on hand on X. to in can of in data question. We the many category have majority Yes, follow that

Pablo Legorreta

X declined XX are it's standard relative by points, care, XX a which of actually stable. the of greater than actually pretty see impressive. that those, group XXX you actually the it's with that the stage maybe of slight ACR X I decline. are But to quite similar in mean some But

Operator

comes question line the Kelly Shi of from Jefferies. Next with

Unknown Analyst

This is on Clare for Kelly.

the premium the trial enrollment mentioned [indiscernible] landscape CKD is as evolving. Phase for So III you

kind patients have expect as for preservation. So to of coming GLP-X more REACT GLP-X would activity drop therapy. treatments on received you impact cell having before would What such REACT kidney

Bruce Culleton

Thanks the question, Clare. for

program so you're Phase about several understand we the -- changing and III landscape, asking our GLP-Xs, on that. CKD including will I So points

is that practice the us guidelines studies for perspective, standard care make as to happen. and will be first, from we're to defined across it's we study by important that, working ensure just -- sure will clinical think of instituted So arms extremely that those a we both of

it's study was FLOW this to was stopped It's I -- the to study -- small me based the amount FLOW GLP-X the the hard with study. of space. with that patients some comment kidney do study, understand the in disease data of on early know efficacy. the rest with, percent for stage what may regards compared the effect familiar chronic of to FLOW within disease the which point. And included CKD X that upon actually second, a published kidney We in subjects think that The I this you be at means for

that a until that event question. is profile. do we'll actually answer have to have GLP-Xs do to We wait But me published favorable your for have data a know educated cardiovascular more to

Operator

from line Evercore. with the comes question next Jonathan of Our Miller

Jonathan Miller

analysis how on are noticed start with presented I get stage little patients I want in out the housekeeping. getting the be maybe that most already none baseline, in a endpoint? probe are love you're going -- that primary the for compare the that a enrolled to to getting sense that at pulling just maybe deeper bit secondly, aren't total patients to benefit. I are assertion the subgroup. X the of not How that let's And to the benefit criteria? to it's many that directly severity that new meeting then analysis but patients the final many some into FDA, Okay, in would the are the folks

looking they and stabilization also like So stabilization cohort entire I'm X at stage seems deferred of similar I the -- see that it guess cohort.

deeper benefit. bit is getting love dive little underlying most X the a what's to I'd stage into So the assertion that

Bruce Culleton

Thanks for Jonathan. your questions,

to new study or an Aetna is option having and day-to-day stage data some X a because understanding other basis the proact that a feedback, from ongoing we of part So close of XB our that very a slippery and sitting for approximately and I'm also clearly not in patients how options who say nature tortured and space on we received advanced and you a patients program. sure we of our over III forward. injection. We point. population data, of -- out appreciate X confident eGFR having need based plans not can are based out that that X being CMOs believe And it that that as it analyzing these we their months, it move health focus on it do word, their we you part forward you this XX We're our disease point of is within group. the dialysis saw XXX stage patients X for desperation better program. and out that subjects react proact after an CVS which Phase X. And other very at that upon were based -- could of it finally, understanding criteria. is And part over see in is the crossed can we're group as like, with this have meet for know rightly how to and and recognizing other They the decision we've to the first subjects. you space. want payers moving on enrolled worked have in And that medical if XX blinded, REACT also III upon treatment to here inside is in Pablo is subgroups, you think stage XX the inclusion to these react And of mentioned I to the that think about on the say about works groups. What different believe information other question, then, that upon we based today, data access this will lack is of those pain And an large impressive upon your around Jonathan, patients. Part Phase can are nephrologists slope we stabilization you preservation for of but kidney

refocusing those And so it's for reasons, all proact study. X our we're

Pablo Legorreta

and stage completely stage that cover cost Actually, what stages, get when you actually collect do X they Xb it when hear patients. the the that X, not X patients paid the the are talk premiums that changes patients cost premiums are of but into less that they where is you stage get than about different in

enroll thing creates it I we're the other quicker that but we than but because also. much having study good X X patients. events the stage key patients more interesting that confident other because the think in the we quicker are this quickly also us. But data hit going is for do the actually events must But So to -- only is opportunity responses quite other see stage feel from patients not patients,

Operator

from coming The from Instructions] of is America. Bank of the [Operator question Jason next Gerberry line

Jason Gerberry

won't And actually proact XX confirm sounds it you right, enrollment, of heard you will that. enrollment. out I the to slow new target it for speed criteria enrolled even just if XXX, that think a wanted you X with enrichment I like So

make talked sure, if of financeable you not What just an interim you I'm follow-up it out. about think catalyst question about the financeable out? on to And your don't just is catalysts cash question before are ultimately a cash wondering so if? We a runs an interim you multiple when, then do offer before get interim. more the runs

Bruce Culleton

think people XX clarity, new Just XX not we over there's enrolled XX -- about for we've X, proact that meter inclusion criteria. in

We'll will believe offer our and earlier, think a which look later our who the the kidney financing final of product. We for patients data study half stated III injected diabetic contralateral at closely share catalysts. commercial going biopsy we to Notably to that happy first you think final into and of is, of next that with months Second more catalyst in first to injected the then X biopsied, we We XXXX. half you XXX multiple interim believe, the have in kidney our and we're potential XXX, we program the mid-XXXX. are is data also be as bring year. that into results with mirrors an in Phase

present interim it, So to you letter some thinking continue a do will years. With multiple and when data in from I we says, to move benefit not is we're to would approval. feedback to be forward Phase bigger able even We're share endpoints analysis, it in endpoints with all feedback interim about IA, everyone I someone program. the from with share studies our you some given is regards inhibitor committee we'll the that for the Phase how you and of early essentially decision who are nature than expect. But of that FDA have the can make into will we different the said a program publicly trial, eventual couple next III III give opportunities want I you want safety insight what may clear the chosen been analysis within to to the that adjudicated this that you the analysis at or the about global that to we the case And were any in haven't we think get -- not. But led IA some several decisions received an SGLTX in future. that's received made,

Jason Gerberry

if just And one ask could here. I follow-up

the versus XX the XX. mentioned You

the you to have Or patients does is adjusted new -- XXX criteria? do meet the criteria? need So that patients inclusion your meet that to to have XXX that

Bruce Culleton

XXX targeting incremental we're patients. Jason, new

Jason Gerberry

Okay.

Pablo Legorreta

changed is us us Phase discussed that XX, the label, of that that is give patients. it everyone worth what's that to X And that will is think a the what here range has to right, XX topic proact One with broader of XX. going a of of to study all will going of on XX, actually just been study, possibility hasn't that Xb lot XX which III understands we from the because see criteria, have mentioning other not stage the to stage really I here range Xb having other so and is have enrollment positive it's XX the having enrollment

beneficial. think studies by that enrollment slightly the X different I see having ranges So we as with of criteria,

Operator

now end for this to At of question-and-answer turn we reached time, over And the I'll the the have Bruce Dr. call Culleton remarks. session. closing

Pablo Legorreta

in just all what over And benefit. X been treat with you perspective get that, to has before on inhibitors, I And decades. I'd many to investing have Bruce, the very I've life look happen. I do like patients and the for and at get things going it's what's more about than many, arthritis, areas. sciences is, history over Crohn's, share and to super investments investment many reflect have you different areas my sclerosis, I difficult see seen of things for so because half other how back therapeutic of I've hard in again in one theme here. that history, in It on many when in in -- patients doesn't just are product. And of in the drugs cases been view psoriasis, in investing when common multiple of a rheumatoid many in and is my you can that so our TNF benefit a that this those

of we certainly, responding -- XX%, patients actually So take it's XX% get and example, cancer, right? even get excited very excited. we for lower,

meaningful in them, X what we're excited. SGLTX. And very that at of and somewhere patients seeing the is certain year eGFR patients is go that doing SGLTXs was about showed that on patients have a drugs time, of get I well, per when at And was Royalty situation X I points and which in of I was per one respond a time, So the those at the the in when we several great where decline what's you actually decline, about inhibitors. actually with [indiscernible] at exactly through see number looked of I about here Royalty work went but it we a that with would Pharma, think points would treated of slow hoping actually what ProKidney and year Royalty and

not is preservation followed is function, And of really only seeing and there that we a today pass that from and And unprecedented. of space is But I which back we're a closely. in the which unprecedented. decline of a of really what's of function is good but it's So what perspective, REACT a patients, patients I what slowdown it function, think with XX trial, exciting preservation think seeing to we're but you, in this today stop I'll number small Bruce. unique

Bruce Culleton

today Sure, tell where to just everything Bertram you've are the for XX next like today. we Pablo. years to ProKidney that thank everyone call, done, I during joining phase forward interactions. your that Dr. I'm the this questions. last And to excited Tim, for to get for look you you lead to everyone us on our future Thanks, development. thank I'd can A and insightful for final of its to

Operator

will conference. today's This Thank conclude you.

for your this time. We You at may your thank lines participation. you disconnect

ProKidney (PROK) 14 Nov 232023 Q3 Earnings call transcript