Mineralys Therapeutics (MLYS) 21 Mar 242023 Q4 Earnings call transcript

Welcome to the Mineralys Therapeutics Fourth Quarter and Full Year 2023 Conference Call. [Operator Instructions] This call is being recorded on Thursday, March 21, 2024.

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

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

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

by now disclaim light of we required call John? Officer in or events. future of Chief Except specifically information Congleton, to statements Mineralys to would turn Jon I any update revise over the forward-looking new as Executive law, like or these to Therapeutics. obligation

welcome and and Dr. I'm David full Corporate our Update our Financial Officer; Thank joined Levy, Chief Officer. Good morning, Conference today Financial Rodman, Results you, Dan. Chief everyone, fourth and Call. XXXX quarter to year and by Medical Adam our

the questions. before recent our and the of quarter will up and clinical financial our Adam overview milestones, then will year by and review brief a full open business call with begin results programs David, followed your I'll who discuss for we fourth

Mineralys. we've much be Looking to back proud of so at had the year, over past

and We several key that common kidney XXXX, pursuit to elevated expand tightly to approximately dedication clinical expected are is the achieving to who has Our clinical achieve driven to heart working our also all the and to potential both speaks I lorundrostat. programs patients level. significant team package and syndrome treatment by target in approach thus an we're milestones hypertension, team the aldosterone a targeted is aldosterone. the disease. entire disease by our the In metabolic is obesity. believe events, this diseases success which aldosterone believe data abnormally and together a on worked hypertension towards benefit cardiorenal, Aldosterone of is driver corporate of contributor linked to exciting and significant millions of are that of access has impacted XX% patients of several

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the the our trial these an on on allowing detail to but provide participants changes, trial the us participants of ensure Additionally, Dave BP benefit lorundrostat reduction all evaluating to SGLTX kidney objective that disease. remain while inhibitor design will access conduct throughout treatment achieve will trial the changes all of more SGLTX in have trial. inhibitor on of

We of anticipate QX top from QX XXXX trial line continue stated this data prior XXXX. the to within guidance of to

As of in track earlier, brings ramped value Officer. new I strategic a business research. mentioned Business appointed growing our as for our our We activities. we been leadership up multiple of development, recently Kim, team past companies the brings Chief experience X decades more scientific generating year She solid record and has than clinical and Dr. Minji over

the broad therapeutic has she overseas with across technical areas. companies in U.S. During and biotech worked career, and her

can well clinical you lot on of see, to past momentum the and strategy. As are in we've clinical our our over executing continue year, positioned built a up program

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

our the and the to and I'll John, had clinical were the the at a we CKD. very you, Phase trial good We're pleased pivotal announce and for give Today, lorundrostat pleased summary program of on lorundrostat, subject -- update Explore-CKD Thank I'll quarter dosed everybody. pivotal morning, on then provide for update fourth an the that revised II in of first very end we trial. Launch-HTN hypertension

X,XXX As clinical enrollment Total pivotal treatment approximately for Jon program of is for part hypertension. to lorundrostat mentioned earlier, this our be is expected the subjects. of second

the be milligrams a will trial. is X the enrolling to The is endpoint the who milligrams to for proof-of-concept change pressure that Launch-HTN their relevant prescribed this X:X used reflects after randomized to care either be trial X week will once-daily in Target-HTN. as automated this placebo, primary similar lorundrostat same primary placebo-controlled we titrate We Target-HTN daily milligrams systolic this endpoint of of double-blind the lorundrostat, office as or randomized, option the trial, XX X. Subjects anti-hypertensives. on of to but XX blood XXX a to with measured to in to X-arm design real-world trial regimen be primary previously daily which subjects once remain provider believe The up background X pressure, by measurement will targets. endpoint blood needed once will was

over trial trial. offered extension to addition, will subjects open-label roll ongoing an from this In be into opportunity the

Now in turning track and XXXX after on operational We're QX discussed Advance-HTN pivotal protocol implementation our changes enhancements the we progressing of trial. to earnings the call.

hypertension As the at and Jon rigorous noted in extremely with Advance-HTN collaboration trial team in very the a is designed state-of-the-art, his comments, research executed cardiovascular Cleveland experienced Clinic.

We AHA on placed a maximum regimen directed trial doses. tolerated treatment all standardized at guidelines participants

of -- BP whose of proportion any ambulatory XX-hour way, time resistant medications utilizing blood extremely This trial doses pressure real uncontrolled poor or real-time inadequate pressure have used In gold ensures the that truly we or we're using adherence choice control background subjects hypertension. and exclude we assessment this is monitoring addition, blood measurement. hypertension. standard an high to due of participants white-coat or noncompliance, In

our broad of more prespecified between overlap hypertension last paper to and given targeting other in hypertensive believe, hypertension, that supports aldosterone-mediated enriched JAMA the mechanisms obesity-associated derive mechanisms data year We is lorundrostat. believe subjects also standard will the population aldosterone-dependent Target-HTN benefit randomized analysis hypothesis. fundamental trial presented likely from with We be the of that and of our the

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predictive benefit. individuals plan useful the targeting to we lorundrostat clinical to In for unbiased likely drive tools to most repertoire artificial addition, to an explore model negative to positive other long-term tools using and continue intelligence of expand

data Launch-HTN in of of and from XXXX. announce the Advance-HTN expect data top in fourth trial We quarter line XXXX, from line to top second the the half

and CKD to program. hypertension on Moving our

X.XX be We all limit we're mentioned will Jon I an original of earlier, trial, inhibitor. to believe trial. eliminate trial minute to allow the current have our approach from subjects baseline have to the participants reflects XX modifications access Explore-CKD to us eGFR squared amendment who CKD. reducing of SGLTX B which lower Phase treatment ensuring this We'll As per profiling Part ml the XX better portion making for this per some meter

by demonstrate The of as believe treatment ample clinical pressure, progression to benefit reduction with assessed kidney periods is important provide weeks reduced objective systolic into from believe X renal which we elevated contributor to insights we benefit be blood and individuals syndrome. primary the remains cardiovascular an blood weeks, CKD, time metabolic well on in Lastly, pressure particularly still to X albuminuria. as which will will in obesity

maintain treating the to top our expectation and offered trial analyzed of we'll separately will terms be in first fourth the enrolled In of We how XXXX. contributing long-term subject characterization quarter the participation of quarter in be extension date, announce this they data to of the year safety. line to open-label or

turn apprised financial to lorundrostat Adam? of of will We I look now full provide forward the for program. fourth and development will XXXX. call over you the quarter to status a Adam keeping who year the review

Dave. I Good morning, of full select fourth results. year our you, Today, XXXX Thank everyone. and quarter discuss will portions financial

Additional ended found We today. was with Form in December which equivalents of earlier cash with details XX-K, our as $XXX.X XX, can filed million million investments XXXX. compared cash, the of be to $XXX year and the SEC

expenses sufficient to a $XXX our trials deducting be expenses. of R&D private proceeds as approximately well prior were $XX.X for cash, December and completed for placement support year. R&D cash manufacturing supply additions the we development to annual XXXX, million XX, that achieving $X to of XXXX, XXXX, The stock-based in million in R&D was $XX.X resulting primarily million second clinical and due from other the compensation, million upon XXXX. of headcount investments $XX.X were ended us February for planned $XX.X development license expenses increases fees and of $X.X fees of gross to clinical lorundrostat XXXX. of regulatory research to quarter in financing driven expenses million the $X.X as program in The into preclinical equivalents costs, our expenses quarter believe XX, and before and same by will higher beginning quarter compared $X.X fund and We and for allow December compensation million million million to the $X.X year expenses. for lorundrostat milestones in million in compared clinical in initiation ended million XXXX, operations the costs the pivotal in increase corporate XXXX, In the

to million December for $XX.X for to in in the the associated G&A XX, resulting expenses for was operating expenses. XX, and year. were year million expenses company, G&A compared and $X.X $X.X new expenses, XXXX, as million stock-based headcount associated XXXX, $X.X primarily primarily quarter year. of million were officer ended expenses ended compared in compensation higher the insurance with additions the of due in December million the public million compensation, $X.X in higher a annual insurance $X professional same and prior higher to with prior million fees expenses G&A $X.X to increase from $X.X higher million The administrative director other quarter policies,

the income million was Total ended other to other Total in to XX, quarter same compared money primarily $X.X million compared December annual on funds U.S. was for December to the interest our ended of $X.X was market year $X.X and quarter the XXXX, The increase treasuries. the investments attributable for XXXX. increased earned $XX.X year. million XX, million for for XXXX, income prior

December million ended the XX, Net XXXX, same million $X.X The the million for XXXX, year. attributable loss increase was $XX.X loss was [ factors was $XX.X year described for earlier. to compared quarter primarily million the the to I prior quarter compared annual $XX.X Net the for ended XX, XXXX. ] of for to December

the questions. I'll ready Operator? Operator, for call operator to ask that, the questions. open for With we're

first ISI. Our from comes question the of Evercore Michael of line Instructions] [Operator DiFiore

could Congrats background for millimeters regimen, placebo that on all on mercury literature trial. what think view millimeters Any Advance-HTN on terms me. the want one, given background expect Number mean effect on for we just drugs. in resistant hypertension X the amounts patients of I the the we progress. nonresistant just X of will to standard around X X A here, if suggests but of patients, versus color get few assume equal in be versus your regarding I that.

X I And have questions. follow-up

So to then those enter regimen run-in placebo-controlled period just same both to background on medicines. a so that period on And new a due page. the which the There's comparing is we'll establish I'm sure baseline after they'll during when we're lorundrostat.

expect So the in talking be full of don't really will run-in The we you period. is were weeks. effect be Most to manifest. placebo period X that about running that

what I And Target-HTN be mercury. so -- much the there'd be under little that our effect, And residual ABPM, from we think will study change placebo a don't it it could saw. X effect but was using of in millimeters

range you that will it not for that likely, in larger X-millimeter the be So under I most mercury numbers think quoted.

Very helpful.

label week, a treatment drug roughly benefit this to given recently a warning, approval having Another all the risk got how only on lorundrostat? want get views approved a a approved question. anti-hypertensive notable having and in a Earlier for just its black REMS of this box this appetite X-point this drug Despite X-point with the its your drug and other competitor program and -- safety for population, effect, was seemingly CLO warnings. bodes broad profile

Yes, this Jon. Mike, is

a kind treated means roughly any approaches. innovation of space. not with new an for in XX% getting We the think over population know need seen little of is We've we of of new thing. absence introduction years bad to unmet the this not the have that goal, a need the I modalities XX

unmet the of need As interesting, it's But appetite KOL I bit the haven't creates into details again, with far for around and broadly, think I interest the dug more it, as innovation. we a a was met the in really label new [indiscernible] challenge. that think be

a by toolkit not we be how do first targeted for prescribers. in to think we do always our category. But bring I on for that probably how line forward that's the been approach, has valued focus going KOLs, us, certainly bring

identify have to response subjects lorundrostat. those So enhanced an that they really will can

in date right I safety lorundrostat. need tolerability we've to relates doing needed pivotal a innovation that unmet to the lot and seen again, doing as of exists the of we're why the profile it what on fully that. to characterize We're very where That's the confident that's broader space we're in program think cusp given of we're now. this But

it. color year? Got you OpEx Any guidance on can one this question. final provide And

I'm sorry, Mike, guidance. OpEx

Adam. Mike, Yes, is this

that We runway have us year. We'll forward going cash on expenses. be this several haven't running clinical on into is provided brings any said trials our we What guidance XXXX.

ramp So to to is expected up. burn continue

of Our next America. of Bank Harrison Greg question comes from the at line

This on Mary is Kate Greg. for

expected maybe are top the year, at this data And expectations Looking line what you would advanced line what later a for the readout? for success your top be here?

Yes. It's Mary hard Jon. is Kate, to forward. this forecast

X across in think whole to back XX-millimeter systolic diuretic for BMI. saw the look Target-HTN, we enhanced I with reduction on and about -- an BP increased if the obviously, We population. response those saw a an those we placebo-adjusted at

framed mitigate reduction. have guiding that a to think to to the similar is XX-millimeter risk way X- that we likely both programs the I pivotal the response mercury

mind a that diuretic we know Advance-HTN Launch-HTN in enhanced with Bear background. as response of part and diuretic lorundrostat. both saw that an we And have required and

think that's I and exhaustive primary amount a done So of through. well with specialists. market pretty as care we've as research The a positive we've read that done, that

or to that's in don't an with XX-millimeter that about fourth add the a to reduction you're population, currently meaningful. you're that access X-millimeter when added you mercury at what's fourth currently based third they meta-analysis. on mercury agent improvement have or a or X line when something being extensive looking on third X- get resistant available If to agent, uncontrolled typically That's extremely you

study. subjects that's an And so can that's XX- toolkit see to those to and going replicated improvement We'll if like a Target-HTN. prescribers. we obese saw mercury subject XX-millimeter an that in enhanced And the particularly, if mercury X with to have within again to bring forward hypertensive XX-millimeter we why response, this resonates identify that's

replicate we're right of questions we and compliant at that the why truly around upon we a for the data are then resistant data gives lorundrostat Launch-HTN it's saw proper conduct that to proper hypertension. uncontrolled that identifying any study standardized and clearly that's Advance-HTN rigorous and really doing are in possibly kind a set on right dose, uncontrolled subjects chance to more particularly white-coat that without a yet improve And with but population, rigorous drug, still compliance is that specialist in or point us resistant. and and Target-HTN, the dose, or a applying think a background I in

Securities. question comes the at of Our Seamus Fernandez Guggenheim next from line

Congrats on all the progress.

I the going of impact importance ACC one Just guess, within investors the endocrinology the results in some enthusiasm X of from at the FLOW on think presented be and disease there's there. for to is the, questions milligram is one, those and that and of in I on getting with cardiology its trial of limitations community we're things. and specifically patients GLP-Xs Number the X Semaglutide, impact outcomes

know thoughts patient a the population. weight in on to both loss and wanted on are what Just GLP-Xs of CKD your impact

hoping And pretty the you'll baseline second I baseline most could reveal really important patient question are assume you just us feel be then prior that measures patient a kind share And shaping of analyses. publication? that you'll that just you've the good is in maybe on characteristics the characteristics for are to. looking you up got Advance-HTN, patient the the in to what with think what exploratory baseline But characteristics at

and you The surprising GLP-X, renal full are really that the obviously to health. if we, comorbidities, weight the GLP-Xs thanks see in Seamus, then benefits interesting I interested see see corollary and loss it as improvement set. others think cardio reduction, you the the overall it's are weight like relates for as don't metabolic And to relates loss. data overly GIP GGGs to all presenting it Yes, data question. the to

long diet, known think else. everything for time and been that's through I a exercise

addressed. some point remains the -- have the [indiscernible] residual data X still I we've risk a of what this prior presented, seen I'll to in through there last think with the think Dave of of X add the and from needs that was over to it maybe some to I at be data months, significant

you what heart decades renal to in interesting going residual of addressing significant get component driver is you a CKD, disease. of We heart risk to Dave, much any think failure and But really lorundrostat additional have that that's to like of And is We we hypertension, frankly, research becomes to cardiovascular thoughts broader a possible. broader treatment that think do ASI of of risk the as know and from be that of that? reduce aldosterone add that want multifactorial. as

a second then that, Jon. and bit your following part of your thanks, Well, add little I'll that. going to I'm question to answer

question, be a we this that a he to to the referred trial loss So weight that risk. going translated get major about events. Jon reduction But from lot. cardiovascular interesting as cardiovascular is question spoke right, this, to in in really really It's incidents a But reducing XX% important going X.X%. what reported that events, X%

in XX%. real XXX and per upon. to more per X% that there's rate of X than it's So that's versus But X.X X.X%, improve hundred, still the world,

by mentioned, a Weight lifestyle, loss These weight you replacement alcohol. having together part to not healthy for exercise, is of add all only all is and tobacco, just Jon that. things a avoiding of drug it. that these things, itself lose allows

what see X component there's difference. to changes. to that. everything as The We look will cardiovascular, time so this believe be X is room be lifestyle would renal we'll our what that reality, multifactorial of be the people we're important in these a drugs medications and And for that's seeing at metabolic. idea other in a But treatment. an making combined. is together going And in drug over

risk. a reason have aldosterone-targeted We potential to of like are the in loss, cardiovascular useful There's will, failure. therapies regardless heart things all lower why weight

to drug that. approach Our is a next-generation

focused are So not we're this GLP-Xs you we I in either/or an forward. think gives just some for that going very that color with and obviously discussing on going it's hope companies to interested be where

XX% second XX% really we what XX-XX the you I'll I'm African-American, in X is in drugs. I drugs, profile a -- male, had had to that What into about question we not demographic on but characteristics. go that about on XX% X this going tell your Target-HTN was nice Now trial, female, deeply,

is range. be in aspiration our to that So

see reason the that no we And to we we criteria using think won't in be inclusion/exclusion range have. so far,

could Great. And then follow-up. if one I ask

from the XX, to talk in a bit reduction criteria? of eGFR about importance XX little maybe the more the down just that As inclusion baseline can you

Sure, I can.

from for with this sites patients the to the sites trial care that a primary are more trials to kidney So practical go centers chronic disease. where referring specialized referral standpoint, like have we doctors

And so people see enrichment they tend to GFRs with with below XX.

Stage IIIb. So

so And efficient more those the instead a different X arms be of trial. will it to much in include of arm X

Now though, -- one since B Part also looking it ask is question, a had might at the dose dose important ranging. range to we discussion, be are us for

everybody Boehringer at One an of looking is in the the And is the combination. sure why say, lower who CKD committed X space, SGLTX advantages and are competitors our of both trials to let's on making potassium. SGLTX are that Ingelheim, now that's AstraZeneca your

And the so doing be we'll thing. same

recruit be a practical Those a SGLTX broader it's going thing. practical a much to safety, and way information combination. more XX of down looking same trial will trial the changes. for is population, EGFRs on X the an So Everybody us to were the the much to terms just we allowing the in of inhibitor in give and efficacy efficient

from Wells Fargo. of Next line of Bansal question Mohit comes the

single-arm OLE for My to a withdrawal questions treatment Adam David, February understand, Mohit. are that X firstly, [ study. the in a is ] OLE for This trying sub I'm with study. you're pursuing, includes to on regard

inclusion the this around CKD from of important then reason? another in kind drop So does to could for you pursued OLE give the secondly, risk? patients approach I hyperkalemia And that Or wanted there. of was what ultimately understand

the for thanks Well, Okay. questions.

its And so break just it down component parts. in to

The question first about the randomized withdrawn. was treatment

who and obviously, extension benefit is has -- blood a means we And on that they're drug So withdrawal. treatment the FDA that requires active who open-label pressure. in randomized is a the what anybody on do active on

will go be of So it don't have to on they're that tell how stay -- They informative, or would be in drug you that. subjects on hundreds many, through placebo. either go the randomized then but

cetera. would like it, rhythm. an course, words, go our in on has We certain go and then off see meaning circadian refer on-off quickly, a advantage drug you on are come -- we The know they half-life is purpose also drug, as things, things hyperkalemia, what approach. reversible it. to we XX-hour on time just XX- other got to a they can what that very amount of these In it's to in of restore on how How back et it about off they that can but only turn normal major a

So Aldo goes up it's the and to. way supposed down

And what for. that's so that's

we lot So a learn as primarily, a because but it's to expect well. it's those details, requirement about

So let question, your that answer there me Did for a second. stop just part? that

Thanks. Yes.

Okay.

of was have part from a separate that's omnibus What another the that. that, they're a going integrated safety having is -- be logistics But dose have cohort of who question So database in included we But within analyzed patient CKD don't every single X to your putting about patients got in. an X to trial. we're even extension. of standpoint [indiscernible] doing open-label drug and beyond we

they're important They the referral what deal to about And They worried in with these at eGFR was I be at we'll because in potassium. so that of mentioned, use to sites, talk subjects started all not want blood center potassium in bit relative instance, able the go risk it experts they a least binders, very when change that's we the And XX say, XX, to whose just and potassium. down. for time. to their pressure new

they're an XX, threshold docs space they able really patient's care because see in different be who in primary and with go potential that don't a eGFR we'll in terms somebody to for may a then to management. those provide that subset data certain of want So up over

very this profile and very, good we're this subset, the profile. have safety to going And subset, so here's safety over in the other here's control saying

high don't warning It's a getting about opposite. We're suddenly of a think that have have to get the So fact going go label. just we into informative I very you potassium. concerns might the to a set in data

further time. And there at this questions in the are queue no

the for to session. And call the I'd remarks. back Congleton concludes this Jon closing like So the turn question-and-answer to

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

you Thank all you. now Thank attending. for concludes much This the conference. very

disconnect lines. may You now your