MLYS - Earnings call 3 2023 | Mineralys Therapeutics, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Mineralys Therapeutics Third Quarter 2023 Conference Call. [Operator Instructions] It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Please go ahead.

Daniel Ferry

Thank you, operator. Good afternoon, everyone, and welcome to our third quarter 2023 conference call. closed, XXXX a updates. financial market our release the quarter third results after we press issued providing Today, and business replay approximately will section call completion. of on A Investors the be of hour X available website after its our today's we prepared up open remarks, Q&A. the After for will our call

filings, as by these Before law, or everyone today's X. light differ These forward-looking statements the this that to company. of the forward-looking results report would new our required these could annual XX-K conference of implied Except or forward-looking call revise reflect as and disclaim remind events. I with Please in specifically press statements update our qualified forward-looking on opinions we contain in about our to and contained today, from or forward-looking by note release statements stated these those future materially statements by SEC begin, like November risks associated only including to obligation any that and webcast and will are we due cautionary statements Form subsequent Actual the information uncertainties filings. business. company's statements

call of I'd turn Jon to the Executive Officer to now Chief Mineralys like Congleton, Jon? Therapeutics. over

Jon Congleton

results up Dr. for our Good Levy, review our David, Thank Officer. then Rodman, will programs; will quarter Chief clinical I'll Corporate XXXX our Financial questions. and financial discuss and Financial the Update to and business recent milestones, begin a everyone, Results David who afternoon, your you, before Adam our followed the by of with Officer brief Dan. Business open and today Chief overview joined Adam Conference call welcome we and third third and our Officer; by quarter Medical Call. Chief I'm

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on both pleased CKD also and the treatment knowledge and to continue company the will Daphne bringing bring that our be depth with and Directors, add members new to Karydas targeted path We're Board Glenn to to X expertise of Mineralys independent to we beyond. patients of as beneficial Sblendorio experience, hypertension,

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will Mineralys Chief Medical program me call of David for Therapeutics lorundrostat. turn the Let our now Dr. details over Dave? clinical to who on provide additional Rodman, Officer

David Rodman

the II everyone. give afternoon, chronic Advance-HTN program I'll provide the we've pivotal clinical subjects. and Explore-CKD. Today, lorundrostat, The disease good planned ongoing to then and Jon, enroll trial for an summary kidney you, of trial update I'll for overview lorundrostat Thank a of on named continues that Phase

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Adam Levy

everyone. Good Today, XXXX will of portions select Thank you, third I our financial afternoon, quarter results. discuss Dave.

expenses cash, will of December the through found planned Additional sufficient to compensation allow costs equivalents XX-Q, our R&D headcount. compared initiation expenses be XXXX, were equivalents corporate for third filed quarter in and clinical today. XXXX, ended operations $XXX.X regulatory be pivotal as XXXX. driven the XX, ended the details program cash and and costs primarily cash quarter can with clinical We to $XX.X due for a in million XX, as that $XXX.X $XX.X believe investments higher in will of supply, September XX, manufacturing XXXX. be cash, later and the compared September $X.X XX, in increase million clinical our the to $X.X million preclinical fund of trials increases with Form by of investments ended additions us September in of to as as was R&D mid-XXXX. quarter well We in The lorundrostat million expenses $X.X which as million to our of XXXX, support million and SEC result million to the

earlier. to September the to interest million income in and $XX.X Total the $X.X $X.X as of XXXX, earned headcount, money expense compared $X.X to $X.X ended officer call and ended in for expenses for G&A million that, compared The investments fees in company, with XXXX, operating operator was million was company's open were million in The professional which for U.S. quarter to for primarily $X.X $X.X compared was XX, factors to increase to director due XXXX, other public the compensation million treasuries. Operator? of the primarily $X.X Net associated and administrative was XX, G&A the policies expenses. higher XX, described primarily XX, September a associated insurance I'll the With attributable the additions ended higher as higher million for to the million questions. September for XXXX. attributable XXXX, ended market million quarter funds on XX, expense XX, $X.X ask ended result quarter loss quarter for the up million expenses XXXX. ended quarter September higher a to September the in increase other September increased with million insurance quarter was $X.X new

Operator

question first from DiFiore ISI. Michael is Your Evercore from Instructions] [Operator

Michael DiFiore

Congrats on for progress. A me. all the few

be many On how the had were And I have and already to patients Advance censored? withdrawal XX-week endpoint undergone treatment follow-ups. study, just passed then and curious hypertension therefore, the X not would, need

Jon Congleton

Yes, appreciate Mike, this is Jon. the I question.

enrolled at We of different haven't points. or number disclosed the subjects

this So haven't at point addressed that's just time. we in something

Michael DiFiore

Fair Okay. enough.

think Zibotentan regimen XX% to the I plus of said which reduction, XX.X%. reduction at Phase conference would that for on to was weeks be the call, XX% bogey potential regards last plus alone a in around -- weekend past over CKD XX dapagliflozin with the trial your the I weekend and II SGLTXs So trial, past met that you proteinuria by think reduced combination around XX% ZENITH the ASN AstraZeneca's this and

anticancer cardiologists aldosterone synthase as on your based appetite with what's this use an market treatment over KOLs, and in So research or to conversations setting such amongst lorundrostat? like the an effective willingness inhibitors

Jon Congleton

I Yes, appreciate the question. Mike,

inhibitor. seeing our an SGLTX confirming. profile informed in weekend, color their data talked using an ASI about the top before, we've not I think don't like From of of thinking. It's anticipated what It I was think something in on lot in I safety Ingelheim. think Zibotentan. interesting we've gotten or was both on a of agonist kind we mind. the data with that. interesting well an of ASIs what know XX% was from would Boehringer have that's figure say endothelin our we there Obviously, from BI reported for as receptor ASN standpoint, what lot with a interest we that this has BI as physicians I

KOLs I talking think we've takeaway need the just benefit. have the for is main one been is more Mike, us, than to say to

also focus several has unique about while So hypertension. benefit innovation in profile drilling words, hypertension really those in have as That's months that rather the benefit the that's we've have as can having done on that and than where opportunity have significant on disease, in benefit our CKD, overlap progressive spoken but with we've other benefit And those provide proteinuria. on providing just our new we also for a kidney pretty to there's then research, on we've been KOLs concomitant last think a X. unique between has market spoken where past, really a provide lorundrostat and a patients as

And of a made full is so think we really what trial we've needs because complement cardiorenal why the in our that's the disorders. really did in we market that's benefit adjustment

Michael DiFiore

preempted Boehringer helpful. That's question very my Ingelheim. you on actually And

the trial which long XX% your can, wasn't in any I you there's you UACR. that that a combination potency and drug, any color extent only To fundamental improvement empagliflozin, bogey explain XX% why may provide weeks on which if about in difference between was met? this think that with could XX showed drug

Jon Congleton

to A you Mike. that on into little Yes. dig I you that in XX% interesting look study, you reduction couple if would about if data, better is that, actually about at made thoughts XX%. equivalent to when of I an inhibitor. presence thing The what be was of typically performed aldosterone right? comment a less and think the think, think, than thing empagliflozin seen, was from not had XX% aldosterone a empagliflozin the note You And which probably insufficiency, as the to that delta Zibotentan. that bit inhibitor, maybe the synthase could related UACR of our was selectivity to The so interesting a than standpoint adrenal performed bit

As may Target-HTN saw even testing, insufficiency at we did study evidence when recall, dose. ACTH even doses of the at no highest in we highest the you adrenal the

was that interesting an finding. So

I challenging. can trials think be across -- somewhat comparing the

think final dual as proteinuria to innovations study. this of of puzzle us, interesting lorundrostat component we into see with I both really thinking as a kind are we're And again, think reduction progress of be for BP but very the benefit a development. the informative in to all excited could systolic the data, it that know Explore-CKD into of with I our story. as of the we well further piece was of move

Operator

from from America. of Bank question Greg next Harrison Your is

Mary Davis

do how anticipated in terms highlight lorundrostat Kate your ASN potential analyses of these Greg. anticipated population target for Mary market and impact? and if presentation recent guess late-breaking I also at target with on is the AHA, approved And This presentation for here

David Rodman

is question. the this Dave. for Thanks Well,

the to was really -- highest the that hyperaldosteronism. of really with more It's and complication what obesity a visceral the, beginning theory a was unmet the actually Our used from populating are people that call need we obesity. more

Target below up the And the the the the XX% looking the linear greater from just in continuous the was so above and really at BMI in of evaluation where what to In we a we did XX categorical. line paper gratified trial true see we poster And our at was analysis did that recently -- was a categorical relationship in saw a we to higher BMI that presented, BMI. we were XX became presented the was a like BMI, the and of there regression response prominent it XX%. we

But was or extent, what good a other showed exceptional overweight, that, drug, about now, achieve to of the practitioners subjects to we using response, trial XX people people exposure it in of ultimately, the XX responders. hence, more up to was including but that identified have factors down, And dose plan the you who now artificial intelligence to mercury techniques, don't driving there are it up toolkit are in obese goal. responders. to out we're lesser when truly to is equip to And is that's paired other the know X/X who who when are. figure our factors. who people a these moving key are why also found its XXX we we're the what we responses not take deliver of of also median exceptional really Right had millimeters that obesity one And

Operator

Stifel. from Your is Jack from next question Padovano

Jack Padovano

Annabel. on Jack is This for

do of the were primary lorundrostat are published overall? level have meetings, this for aware importance that and how than now And interest before? they had data has presented aldosterone multiple that of with exposure the the and at you now care cardiologists So class think more helped ASI providers has targeting medical

Jon Congleton

appreciate Jon. question. is this Jack, I Yes, your

seeing in I think absolutely increase awareness. we're an

of and it's appreciation. I awareness whether focus really seeing think in it's whether a aldosterone hypertension, growing groundswell We're there's whether more grow of as and CKD, heart this interest and failure. driver on that more disorders, cardiorenal it's

of data compelling that's really I put certainly tied some the out. to that's think been

data mixed effort with was in of showing earlier our Some a BI. with of some been targeted and robust by bit a even that's I baxdrostat. very data it recent the mean

data an It's nephrologists as therapy. see from And I and to continue just it's in there's of interest. that more So to across spectrum. will increase class the think continue think and I definitely endocrinologists, studies grow certainly, published from And more cardiologist, primary it's this subsequent exciting care. we new

Jack Padovano

given this not reduce a a Great. and been their how I And cardiovascular be obesity in themselves insignificant on they've to longer-term on amount? factors market, shown as changing then a pressure blood the if do see GLP-Xs but opportunity the may, follow-up, shift you you and by impact may for

Jon Congleton

really Yes, a point you I think it's interesting make.

past conditions, and profile a pressure see going and certainly be we we'll show a the very relates side, that. that. responses ASIs on of you in we key and the cardiorenal, market significant it's have again, think we believe having fact maybe GIPs we alone, think CKD likely contributors SGLTX what the of to As if a a focus at and blood think about with this on on that the and just to across robust seen or where benefit there's the metabolic we diabetes syndrome blood obviously GLP-X, that have lorundrostat across not on I GLP-Xs too robust be part that on combo in factor aldosterone after those GLP-X broader growing the having Jack, not inhibitors, pressure with potentially this effect on insignificant not just one syndrome not beginning large that's to of of this are but on all and interplay recent beyond that a an as and that's hypertension doing hypoglycemic is And And while writ differentiating as true drug approach. conferences, an targeted they're these reduction that there's just would the a proteinuria, alone, say probably track failure, may a cardiorenal it frankly, what not we're as stage some heart conditions. But to the can

Operator

Fernandez question next Securities. is from Seamus from Guggenheim Your

Colleen Garvey

This on for is Colleen Seamus.

forward secondly, amendments increase some to the these be And changes little if Launch-HTN then protocol taking Advance-HTN design a more mentioned rates. on And of lorundrostat of Could be you provide you'll CKD or to trial there? in too? some are But these design any as you'll learnings trial leveraging there? we've considerations You trials patient take readouts. forward randomization touched color you that from there competitor to are terms the population

Jon Congleton

Yes.

take of to that Advance role turn maybe saw on on being the CKD over first a me and conditions, in to one in frankly the was I of I'll to what We prior the launch. Let anticipated. the one of as plays implications them. alluded data changes with the and BI Dave learnings, we it questions, The somewhat CKD, I aldosterone CKD one know again multiple think,

the the that planned saw profile time think to have the within duration respond. BI fits data we of as we I far our as that within study

I inhibitor program. think the we additivity why with was it within our an SGLTX built That's anticipated.

was into presented ASN put week saw to say we affirming past at this what considerations So the Explore-CKD. I largely would design we

me Let question your address Dave have and Launch. about Advance

David Rodman

hard If Advance design that so this a been Will we resistant treatment had you the question. you Colleen, want do. to what end the seldom trial, definitively for control on went at have and as hypertension was be absolute always When the and execution hypertension. used, acknowledged design but a trial into only is able ideal that design. to was good to say a

were to and committed it it. to remain committed we so And

be we that, enrollment, though at to Now going on we just we're an that only estimations understood made whatever estimation.

that we what so the to and that's And we And really time place here. agility to like evaluating was in plan in always justification. real once amendment be put happened felt protocol a have there

you give me examples. Let X

on it includes a unanticipated regimen, and a called of put sort rigorous thing one was people So diuretic we Indapamide. very

didn't Now probably very most it's admittedly so that Indapamide we chlorthalidone, It's guess the one. why potent. they neither And doctors entered I like were used to even sole people was they powerful what stop it's the consensus is found trial. was be actually want screened their though is somewhat or not the many it's that that, and often hydrochlorothiazide reason did want it on to in and didn't the and

learnings maximum are that to of we people trial. the allow tolerated be the And dose to of if hydrochlorothiazide, the just willing so of to significantly number increase had one screened was we fairly use who could we go the in people

that's and easy change simple have it effect. pretty should we one So made, positive a understand, to

the next a everybody date control at regimen, We few their look on even an you quite here, like under they regimen you will. this easily what comes and if on prescribed with put okay powerful very looked medications. if these people, though hypertension Now were

Now we is monitoring. the thing do way, adherence we by the do, other real-time

prevalence But to So in better getting of mercury we they systolic, a take was higher people everybody lose the hypertension they and control. pressure has randomized or of we still if a start of then millimeters having they noticed a had out their Between become with blood adherence regimen, under much a drug and know historically it real of what trial. XXX into because we time. over lot

examples. wanted sites just you our the is a on second There and the to Those pressures done, to rate. others, randomization a prescreening have put those side So to expect our only know screening screening Yes, are effect we've for and whose understand, X are easy -- and protocol. screening into on strong standard to but about I them forgot. and regimen fairly are are that the records provide that's Launch. which pretty we thing to the increasing guidance blood to higher people stabilization start

real I'm essentially Colleen. last your to question, validation, be quickly. a Target-HTN. designed is trial answer a me Launch The Let for sorry, confirmatory trial

possible. inclusion/exclusion this randomization on -- probabilities to close to good we it keep really the there have Target-HTN we're So screening trying as a database and as criteria, there.

and few trial. now learnings, same challenges but Advance handling the in we're trial to expect that seeing of a we're the in have spectrum So XD don't that of we the using in

Operator

from Mohit is question Fargo. Bansal next from Your Wells

Unknown Analyst

SGLTXs, is Serina with to impact for be kidneys of diuretics combined you're ] benefits how maximize whether on on pressure? blood confer beyond [ would or to wanted This kidney and reduction on which the would about thinking pressure Mohit. lorundrostat best CKD I ask about the

David Rodman

Dave question. a care again. an is the standard ARB be they right? this a a What for drugs diuretic, of be and an complicated, often for Thanks everybody but loop that now But ACE on is right to It's Thiazide, diuretic. should So sometimes on? or

given. things those They're of be a going used. sort are to So

And approved pretty add known expensive limited. effective but is be to would still now, on are kind so and that. Right they're our be SGLTXs to access treatment and of

less. people of on somewhat SGLTX is an percentage the So

much but in they'll we -- more standard the also So and prevalent anticipate of by be we time care. launch,

trial diuretics. we're have running either on ACE, those will people X just or and the ARB on all So the of

we'll able that your to forward with mention, So thing the I data serum though, SGLTXs potassium. that at and answer point, lower data to we're those will point. looking is your be at One seeing question

is so although risk, have that because No? advantage And that second Was combination there lorundrostat. yet we question? problem with an hyperkalemia haven't to really less there your as seen you a a to even a of part

Operator

to further the call time. will There Congleton back hand questions for the are closing now Jon this at no I remarks.

Jon Congleton

updating upcoming rest Thank XXXX. of forward the With into year close and to milestones in advance. very we'll thank We Thank the enthusiastic lorundrostat progress to excited about for thus about you as that, made our we far us for you. our the you, joining everyone pivotal look to call. in advancing and and clinical XXXX programs, for operator, the today. the program we you continues remain We're

Operator

gentlemen, you. Thank you for has Ladies now Thank joining. all conference ended. the and

all You may disconnect.

Mineralys Therapeutics (MLYS) 7 Nov 232023 Q3 Earnings call transcript