Mineralys Therapeutics (MLYS) 7 Aug 232023 Q2 Earnings call transcript

Greetings, and welcome to the Mineralys Second Quarter 2023 Earnings Call [Operator Instructions].

As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Dan Ferry of LifeSci Advisors. Please go ahead, sir.

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

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

with on and quarter Adam discuss by I'm aldosterone milestones, call driven renal Chief before David today Officer. followed our open financial XXXX that and begin a Financial quarter and epidemic. will your we up CKD. or well, biology prevalence hypertension joined is therapeutics We levels our and that the Dr. disorders new welcome disease cardio circulating to abnormal a kidney review aldosterone Levy, linked difference business Results and clinical selective, Financial David, chronic and aldosterone. second by shift the Based focused second Dan. Update Phase as hypertension is and Mineralys recent who questions. of for Chief now you, we of effective in in addressing Rodman, to lorundrostat everyone the results, our will of then Corporate obesity growing underlying Conference programs afternoon brief data, Medical lives Officer; believe Thank both CKD Call. and and our Good our requires highly I'll Business include and our Phase we aldosterone patients. Officer Adam synthase This in Chief in in the believe rise have we reduce preclinical well X the X of the make to and growing this believe meaningful a tolerated on millions of inhibitor need overview address

half or uncontrolled the line of and half of program trial first this been second hypertension The the under lorundrostat the initiation the to during safety most is pivotal XXXX XXXX. first second we data team the and for trials quarter. have The planned one continue the and expecting of XXXX. expect of productive through Mineralys to the resistant for first two to in the of has a recent into patient very and amongst significant of the our year is for the Advance-HTN momentum we're milestones half top efficacy the clinical of This evaluate treatment dosing

of to uncontrolled second will resistant half or XXXX. second of begin The a population the Launch-HTN subjects pivotal which in trial, larger expected hypertension enroll is

mid from in expect Launch-HTN the trial XXXX. We data

trial, of set. begin in open label suffer trials, end from In participate believe out disease. United extension than anticipated lorundrostat in of of benefit to million addition is expansion Roll to QX which kidney is pivotal has This with opportunity trial after the be XXXX begun safety of therapy the States enrollment of stage completing the before will we X kidney that enrollment. then the stage our study we is many XXXX. This clinical line progression chronic these long-term the clinical disease the given data for lorundrostat readout potential aldosterone already QX kidney in of of chronic has plays to XX month, data significant X patients the established. disease. an offered we'll development to in adults role a this provide our well to chronic progression aldosterone More will disease Last either to the to have and year contribute subjects announced treat and potential the of elevated patients this abnormally top and

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

you, for track. earlier lorundrostat the and planned trial an Today X disease. everyone. Since on overview Advance-HTN pivotal clinical of Phase the summary remain initiation Thank I the the as Jon commenced touched of on has lorundrostat afternoon chronic I'll for Jon we a of will of then program provide overview good that kidney provide trial, enrollment.

we on-board sites into and have additional subjects continued During this time, randomize to the trial.

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squared, the or be In either than per meter X,XXX stratified less squared XX manner will Advance-HTN kilograms milligrams line randomization equal trial. daily to will versus -- daily with expected mid data in the body placebo trial, lorundrostat XX Launch-HTN XX Launch-HTN The to be per of mass index, randomized milligrams meter trial by option in one-to-one-to-one XXXX. subjects greater in to XX approximately to similar from or the top a of the titrate milligrams once a lorundrostat once are matter

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evaluate for benefit of subjects lower trial A kidney the alone of part Part in be function. of population. trial this in profiling lorundrostat As B I with proteinuria and combination will mentioned, the will on the

four of Part in is weeks. of once dose approximately an will increase moderate weeks chronic XX a another open-label, of of severe despite XX to kidney ACE second Subjects daily of trial profile the an population. an treatment will with the single-arm, an enroll escalation to subjects lorundrostat more by disease safety dose milligrams or XX renally characterize the milligrams inhibitor trial four hypertension for without trial that ARB. with compromised receive lorundrostat treatment of The part or B with will lorundrostat followed in

analyses of interim points. we As one this an more data exploratory is or time may conduct trial, the at

of XXXX. between data to members have We importantly the trial quality progress most XXXX sites the fourth trial journey quarter quarter new speaks trial team [that] expect line of to to and year and cross-functional at of we of make important you treating and hypertension landscape subjects look program who anxiously disease any progress of their transform aldosterone chronic complications on forward to We as appraised mediated unfolds. failure. that our hypertension wait heart a keeping and The equally the directly this our for to approach top associated teams our continue pivotal the our to status like this from first kidney

will who of a will Now review provide quarter second Adam? for the to financial Adam, XXXX. over turn the I call

Thank select will of results. Today quarter our portions afternoon second you, discuss good Dave and financial I everyone. XXXX

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

associated last for the insurance $X.X was primarily compensation I'll period on higher higher XXXX to in the The and call interest quarter with attributable ended during described expenses. new The funds as of associated increase for million $X.X million quarter income a year. XXth market XXXX expenses in increase G&A ask to administrative was officer $X million months with million factors million year, higher earned period to the primarily the the due million XXth the headcount, professional to that, for June $X.X of XXth, in which $X.X June to three other insurance same open a loss XXXX for public and expenses the last policies and questions. US company, was fees as result same operator $X.X With attributable was money the company's to Treasuries. additions earlier. and million operator? expense for primarily to the was $XX.X Total Net compared investments in $X.X ended compared director other June ended operating

Evercore. first Our Instructions] [Operator with DiFiore from Michael question comes

Two for me.

that Just, in Phase Phase background as regarding the capped hypertension to this trial, patients X that five design Phase are instead of the again, trial. is except could be Phase X. on launch X in meds first It's similar three much they one as the X the

placebo smaller, we that Phase could regimen have much up drugs more to cause And think follow-up. five background here the placebo tele-controlled should non-standardized trial? the a versus effect And greater about this could a effect? X include then how I So

Mike, me try you that. let to give on background

allow Launch-HTN five to and meds. Advance-HTN two both background on So patients

and standardized Advance-HTN, them on prescribed them we know treatment Now their off in we're a taking treatment. of putting

period. we of Launch-HTM, meds, regards be on two two laid points will prescribed that they a run-in it should run-in care question As placebo out. week them that through placebo period five stabilize what could background to your we've on largely week And take two

AI two the criteria cure, if point, they're sure three, we is at true we on their we'll the longer randomized. no pressure use regimen they will But XXX the make than millimeters they give on whatever So of to technology And whether will four, be that smart they're to sense mercury it's five, that randomized. being hit would of be five on compliance. background compliant above blood of be continue meds, stabilization compliant to two, a they hypertensive think not that our and I and ensure us a that may think

that's overly than concerned if a odd was not two I'd be the the of we that's to placebo similar Target. I about background we're number very with what group. -- meds causing didn't Mike reaction And greater So say within remiss had and Target meds.

on or know two, we three, five four meds. background in so patients had even And that Target we

the the Advance-HTN or at X real-world of Launch-HTN evidence, real-world of feel. the it's So bit Mike, Class kind end a generating more similar of little a a And it's probably curating version day, tightly construct. very has

Second picture question big one. a more is of

With as X's that and Phase longer X certain to it Phase is you're that will support the the purpose hypertension goes how be CKD primary XXX% on to it the indication. dedicated recent CKD dependent this a if trial, update indication separate be seems this pursuing no that you'll

change Just what in expand wanting the trial? sudden led to the CKD to expansion,

filtration really I'll first the CKD targeted the clinical how decline has genesis a solution and response that's that for cardiorenal. In our our of such a proteinuria indications. Dave slowing we is know is is beyond of you the the CKD step to been fit say, change indication CKD, us bring to rate marker that as and and of into glomerular cardiorenal And both from the beyond natural predict hypertension beyond focus beginning, the the clinical back broadly reason good in is And a do of case heard to world go was really that company we a for rate. of response.

the better on in of XX% role for that marker we could get aldosterone. a plays good a sense also us give We a aldosterone know based derisked what keen that add. really a proof-of-concept really can for lorundrostat based study XX% the purposes. CKD that and to reduction view one to I'll it's So benefit lorundrostat know CKD. research on the circulating has do that us two And out to lorundrostat serves is point therapeutics, in

qualitative of it indication proteinuria will potential an but nephrologist, chronic to research probably because significant pressure blood us the safety, us and there's done and in attribute large third next is show endocrinologist, on we disease, We've at value give it'll with in So for rated also physicians really of value cardiologist the proteinuria. benefit reduction the know kidney overlap. reducing from the the hypertension population

population real antihypertensive, be inform in to chronic two disease. really serves of think it us basically kidney CKD gives study of this so also attributes purposes, development a And benefit a as bolsters lorundrostat an I the would the in clear it but what sense future

with Greg Our Bank America. next of Harrison comes question from

getting that in With and CKD. over are how be now could that later-stage would a trial into affected little by you on see CKD and that of that to proteinuria in expect how interim you And some One terms kind to from would eGFR benefit? of affect that, meaningful would reduction BMI looking then think looks what hopefully, year and you you translate development? for the starting there be related efficacy how your

says, you let a not the a do for if see to with that, see proteinuria XX-week evidence circulating lot XX% study. aldosterone, reducing our in mitigate talk duration What you the there way to aldosterone the a a more is part maybe range, to of about going I answer think have BMI component and question, an a to the complete you it. inhibitor benefit over typically can out that there's with proof-of-concept which it. appreciate Greg, is first period, I'm SGLTX a of I'll reduction XX% me Dave guide

want a beyond meaningful we're for to looking know just I don't that reduction yet. So to that that. clinically guide I

benefit adopted directly CKD, are inhibitors being Dave We treatment turn well, remains unmet your SGLTX to there can even there's though of BMI. a eGFR, the need significant a quickly I clearly would with But in to to opine even think that need that their the remains we're far let it's on think premature find in me looking how to of addition. over lot and he advances. as As that question but on translate as meaningful it address

question question. do response. see where results expect better interesting hypertension larger and was, to aldosterone more to your It's a in So something similar BMI we an

Now this obesity. is a Type of are patients of X often group diabetes, proteinuria typically, in going have people to who have product which

And a very so to therefore majority probably we as are opposed the I think classical aldosterone opportunity of subjects statistical Also, an increase often in response. the to a non-obese are whether won't different chronic disease be volume to related more obesity. and the have much obese going it mechanisms have patients the pathways that just renal of to test level through

So We'll let be for and know. good question. that looking you we'll

question with from [Indiscernible] Jack Stifel. next Our comes

Annabel. is for This Jack on

BMI have are the to better if XX in pressure XX analyses that necessarily patients in So benefit trial out to HTN, systolic BMI Target patients turn in BMI of to over the a even firstly, BMI, powering enrich reduction. study have the you identify blood you the patients advocacy hyperaldosteronism any Do prespecified for link? less the doesn't sufficiently reach static not with XX? And lower to Advance-HTN but have

question. Well, another great

for a at aldosterone, understanding look because the for X it's the in are third and as X in we So with is to stratifying we're able BMI are reason has not effect? for place was, high as we're to whether since hypertension obese. believe the often BMI, we going versus for drug just chose to who stratifying So your clarification, be do you question drugs it will mentioned this line and critical agent people that we

have as greater XX versus looking we'll squared and be XX again, that. a looking than for meter we per pre than BMI So at planned equal categorical analyses less BMI do to or kilogram

trial. which it of the a to powered as as size we last for your was, question, that that? is much question has great the with And do effect do to with Now has are size

difference for it's So if size But a we're a similar HTN, we that. it's in not primary, secondary. powered effect see yes, a Target saw what to we

And I you you talk scale, more be then a a will you to monitoring might be the follow-up, if a to can Would anticipate monitor anticipate to that of for On their MRAs hyperkalemia? regarding patients? may. burdensome level broad lorundrostat required compared for about physicians

blocking No, won't it the period. is entire see -- excrete instead whether than more XX-hour aldosterone is of MRAs to can in our we'll be that milligrams, do of we and strategy, production later be XX looking potassium a subjects burdensome that for any so which the a window there have any evidence day with the to bit

eGFR, that, an the burden that there's happen I no or think and it in blood unless another be So that be weeks a on the optimistic very care, -- drug be checked. a they back And will after they'll are thing and burden. what standard serum time, pressure. that be will put two patients change unless there's pretty than as to this we would What have low four come They have certainly will at happen for be a small, will low MRA. they'll and reason titrated to worse of then is same thinking potassium can we're

next Fargo. Mohit Our comes from with Wells question Bansal

questions. two have I

of your in I'm having one, asking data helpful overlap first level is because launch marketplace? between CKD what ahead the proteinuria of hypertension? the hypertension be some So it's could this and

a appreciate there's Yes, as the there's question you -- different lot of and of cuts can imagine, data.

and XX% I it population have probably probably X/X population for position we've conversely, XX hypertension And it's of we to call CKD CKD. think to a look of kind the market, a at the some XX% the X/X reviewed of -- the data the that hypertension. form have broadly then of

-- either way. on profile overlap I them to hypertension, very with that's add think as critical is significant of did why we significant to product pretty an initial And overlap. target be So physicians focused research the proteinuria our because was

base And half on comment the then about feel front? comfortable something on progress 'XX to how that do especially you time? Advance-HTN in in touch just first far, at this the And enrollment trial. you so point the data wanted readout Could

first about to results Yes, to of we're as half and that's progressing line continue why mid-XXXX XXXX from to are for readout first Advance-HTN. we continue for we the to feel continuing confident anticipated half in top Launch-HTN, Advance-HTN, feel things data good about guide XXXX

Our next Law Credit comes question with Rich Suisse. from

to with approval also discussion need in to far, I for your your the of And on the design? based is couple also mg arm dose? And higher more do Based the what what get questions. so XXX comparator FDA that for you order demonstrate on have

your the the so be based approval? last dose of discussion XXX-milligram the say on what question, what, required for Rich, part will for

mg XXX that dose? comparator for and for approval the also so arm Yes, what dose

So everybody escalated is arm doing it or we're dose either the get is depending on placebo with in. to they're drug going which way

know the the they'll XX-milligram third same group escalated active. where XX what they're two And arm get arm placebos. at in thing milligrams won't they placebo four the they weeks, to for and get in and on dose they're if only So

that's we So blind how it.

XX-milligram milligrams, Now anyone And And be and arm label part the common a the And won't there reason range obviously, you do be dose-escalated. hyperkalemia of a question the started mild develops benefit risk. there always registering the who say, opposed greater was, very thing. normal set benefit, your -- is can exposure is it's arm? when sort this above of the because as the XX greater is, specific of this and isn't to second your that guidelines -- for to is

on have trial people -- the saw So milligrams. be also where the as some XXX responded milligrams to everybody those be if not same same the essentially XX started safety similar profile to would as won't Target XX of in because we we will It milligrams.

go will people no to XXX. And those so longer up

and -- it milligrams we So be course. think be will safety similar know of will same for don't rules our more the thought, is I XX sure, to

just to XX another you that XX-mg have mg then with so -- is arms, and confirm, up different two gets want one one to placebo. two the titrated So placebo it would the guys is

there's So basically, two...

let explain I it, to weeks. study So two and arms. it There's me looks I'm tablet for the all weeks for clearly. they sure explain the this on same the is go in Everybody same eight didn't X then that one three only tablets that look last

people on one tablet happens other the placebo, same to tablets it's at group. go then of same placebo same in So arms. but two are The the placebo the and thing

way X I in along, it's the the X arm and for weeks do each better? any So each arm pills eight arm last one all then for two Did pill weeks. in it's

many Yes, sole proportion I patients the the And important is you strategy? think? or then get other do get clinical it. patients no, think second couple How dose or commercial I in of in questions the more commercial would trials too. How

This is Jon.

a just dose. higher for because response to great react believe a and I importance We how some milligrams we was patients, know both the in clinical lies individual think metabolize efficacy patients, great the dose, and subject it's the from that exposures can variability we standpoint. them to a drug from and other next need that of in it a that at they HTN Target they're what XX that an change one give going level, safety

dose. in important that that becomes in to patient address to it paradigm to and hypertension, an so existing with titrate And fit to is variability frankly

to the The question, remind again, And providing so think the your the that me proportion. acknowledge is individual part patients we of latter of individuality and it's clinicians subject. really Rich, invaluable -- flexibility

can... That

Yes, it's Rich. hard now, say to right

to size able -- to see for and the they it and right The don't got XX us patient right patients the wouldn't that I hazard I want matter. pivotal higher the right a getting third obviously those guess arm know response. we'll the communicate think We'll that I for get we'll of that. to now, fundamentally run that right go even is with But the that a just key right to be required safely that and dose. dose to scale will program, for

And me. then last for question one just

other particular think do do partner. then is the agent? agents? combo you any guys select I like Is potential or guys there partner you there mentioned like [SGLTX] -- how And to

evident we Rich, similarity been level with been became seen that conical really responses very worked a our the have [dapic] us whether to episome, but CKD, of epical there's very have it As KOLs, there positive, it's episome, in consistent. high episome,

for pick let's has good so profile, matter of evidence the was that a it us, CKD. a just And a in molecule safety of body has good

field writ episome also one one the an for picked And so on to more large. to SGLTX dapic the sure was we make And we background to open that studies standardize inhibitor be us. needed response, future that may become

be will constant evaluate down road. episome. for something of epical That But be proof-of-concept and they background this the them. like meds, we something could any chose it So we'll hold

to for sir. further turn go this Congleton Jon to no time. over There ahead, comments. at questions are would floor back like Please closing I the

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

teleconference. This concludes today's

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