Earnings call transcript Q1 2023

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Operator

Greetings and welcome to the DURECT Corporation First Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Tim Papp, Chief Financial Officer. Tim. you, Thank

begin. You may

Tim Papp

and earnings welcome Financial first afternoon DURECT of to call. This XXXX conference Chief quarter is DURECT. Good Corporation’s Tim Officer Papp,

Safe to Before you would begin, like we of I our Harbor statement. remind

the financial forward-looking regarding make results. product our DURECT’s we clinical future expected statements development development, of plans, call, and trials During course benefits, may this products or projected

Further risks results in filings, statements XX-Qs involve in and regarding statements. to such Factors. Risk materially forward-looking can found actual the uncertainties under other These cause including and those differ from forward-looking be and risks information these that heading, our can XX-K SEC our

To financial begin, first our like quarter review results. I XXXX would to

million $X.X due Our This R&D prior total higher revenues our for year. expenses to compared were the prior primarily quarter contract expense quarter and increases primarily in for collaborative $X.X to for trial the for manufacturing increase larsucosterol. clinical was with million the million year. first R&D AHFIRM was were increase trial compared first an in due expenses the revenue. to $X.X The million, ongoing $X.X for

quarter, first $X.X for was were higher as prior $X.X SG&A million, million expenses, increase higher compared primarily expenses, year. with This market to well as expenses the due research the audit-related For higher employee expenses.

XXXX. of as compared million $XX.X to March of investments at had XXXX, XXst, December million and As XXst, cash we $XX.X

in direct a completed raising million net offering registered XXXX, We $X.X in February proceeds.

into sufficient our believe operations the cash XXXX. quarter approximately We was the fund our quarter from first of financing, is $X hand proceeds cash burn first the the in Excluding on million. to

City hosting will highlight that New event Lastly, I would XXth. May in we a be on KOL to like York

of and hosting are Department Dr. from Medicine College in Columbia to from pleased be Division University, Brett of Hepatology. Fortune the Department Medicine, Einstein Medicine of of Paul Dr. Albert the We Gaglio

and Gaglio Dr. Dr.

or the medical AH. alcohol-associated We wealth about hepatologists highly treatment and disease. hearing this Fortune their insights in of current look with the unmet renowned experience to need a AH, are forward hepatitis treating lethal both for paradigm

our advance of discuss Fortune from members top in and the larsucosterol AH of join Gaglio and Several Dr. readout commercial the team landscape ongoing in AHFIRM. line to leadership for development will

webcast find the from in website. the details event can You for April the press of on release our our XXth

Now, I an CEO, Jim the update our programs. over certain our like would of to turn Brown to for on call

Jim Brown

us quarter Thank you, Tim. joining Hello, update. first XXXX Thank everyone. today our for you for

is treatment the filing. a for to has the top we for reporting lead hepatitis. support the to alcohol-associated We’re believe XXXX to year. the by continued and successful, NDA of for If end excited of progress poised significant our be trial our AHFIRM the we potential look about program. an data year completing AHFIRM forward clinical Larsucosterol line as DURECT

the of approval to focus effective in potentially gaining no this primary company remained treatment lifesaving therapeutic for patients today. Our larsucosterol options bringing AH and with

We to-date. more are patients Xb patients of in dosed With Phase target AHFIRM trial. XXX our than our nearing enrollment XXX

We quarter. enrollment of expect continue of the completion end by to this

with study multinational active patients a arm XXX double-blind, placebo-controlled, placebo two of XXX-patient, a arms is AHFIRM reminder, dosing a As and each.

at to in with mortality Maddrey for We’re and greater liver Discriminant MELD XX XX function patients XX from endpoint enrolling to or than AH, is reduction patients scores AHFIRM days. which are ranging severe equal scores The with or XX. transplant primary

leading global US, sites, enrolled UK. of in network through the including EU hospitals Australia, clinical a AHFIRM We’ve in patients the and

need that preeminent we of include are program in where this the an The for renowned there working NDA these FDA Fast treatment are granted thought to world’s with and potential be Track substantial sites some the FDA-approved liver in we could in a AHFIRM has mind, centers, AH, the AH unmet first Our our has hopeful support positive patients. leaders AH. filing. for and result With is larsucosterol larsucosterol Designation, a

on the data, that trial to encouraging pivotal a days. our Phase potentially results XX Xa patients survived XX be approximately days and based AHFIRM Xa announced April, Phase An our designed giving We published patients XX on been based trial, open-label all of Gastroenterology. data of online the we die AH historical hospitalized within In by Journal XX% Phase American had Xa our data. that

cross-study by This severe well-matched Steatohepatitis the contemporaneous DASH conducted peer-reviewed article the with trial comparisons or Defeat from AH Alcoholic patients includes Consortium.

of XX treated patients patients with statistically these milligrams and including AH controlled has that small, were standard-of-care a XX significantly comparisons scores milligrams steroids. sizes with larsucosterol sample lower part Lille to compared of or these study, a were the severe While not treated indicate patients either the

patients, In decreased these including larsucosterol-treated We as for evidence significant rapidly statistically of believe treatment potential levels for enzyme ALT. AH. in addition, provide larsucosterol the results the in a further reductions liver

the profound trial successful of driven Xa Our recently comparisons, into be compelling confidence that is directly and the study multiple study, survival mechanism which ties model. of will action we the preclinical benefit relevant the and multiple injury of where AHFIRM the larsucosterol organ published by our data, including biology observed AH, our Phase animal acute

to the market opportunity I’d to for turn AH. briefly like

over $XXX,XXX In hospitalizations AH significant between at of addition each. cost rate, to to a AH $XX,XXX this system, mortality cost attributed to high US with a the XXX,XXX healthcare represents to

opportunity savings potential a simultaneously represents could alone, in As healthcare multibillion dollar the it result, to States United system. and overall the a substantial provide larsucosterol cost

economic KOL opportunity We event. during further larsucosterol the our for upcoming discuss will

commercializing hospital-focused begun and potentially We’ve modestly larsucosterol groundwork product effectively US for we lay in the believe can to sized, the launch a the Salesforce. to

of around awareness AH. build acute like to epigenetic regulators continuing also the in diseases role are We

additional serve from filings a healthcare patients market system. AH a a concern, to ex-US may believe and attractive These markets larsucosterol Because the allowing our other support patients potential AH we in represent ex-US and the global is regions. we enroll positive opportunities. network, AHFIRM global their result regulatory site EMA also from

have and strides AHFIRM enrolled we summary, more XXX continue In to-date. with than great patients to make

the which support we would quarter, has year. potential this track patient of AHFIRM the enable NDA the on top filings. trial an this We AHFIRM reporting half second the results are to believe in to complete last line If in dosing of successful,

now we’d that, questions take like may any With you have. to

Operator

now Thank [Operator Instructions] you. We’ll question-and-answer Thank you. conducting be session. a

is with question. first with Our from proceed Kristen question your Please Fitzgerald. Kluska Cantor

Kristen Kluska

afternoon, much Hi, my for everybody. so taking good question. Thanks

The the in for first are this how one driven you of that I to I often had guess cited this prepared us if in that $XX,XXX break $XXX,XXX you the remarks. just much of days. a patients down is by fact for couple is, hospital could cost your

be because to payer understand, guess even related your this endpoint statistics and the XX-day important respect the you hospital, successful? FDA. number of for didn’t in that Xa second how to like I drug especially obviously, should dose. going to But need patients the those conversation be know And time are to I

Jim Brown

to I’ll It’s from then Keith a Kristen. and great little issue I’d it speak question, further Thank you. like start good this on to and a well. you hear maybe it’s as

I literature of is, stay days. think patient around we’ve I’ve typical most in six hospitals that from seen the there seen

that For live $XX,XXX those that don’t. it’s those those that costs. and And live, longer a about for for

Keith, want die a of speak drivers care. you $XXX,XXX. pass away them of it’s vis hospitalization that going that the in they out a majority to But those actually, to vis move maybe some do And they’re costs? the to the For hospital hospital patients hospice pharmaco-economic

Keith Lui

the question, Kristen. for Thanks Sure.

observation. driving a the most higher course, the stay. research in continued that a doing good as die time it’s we’re of hospital that I and of $XXX,XXX and more amount cost, patients care of end far while the are the this set. diagnostics, ones unfortunately mean that are up belief, I the our take the as length NIS is expire And intensive data that, are in utilization hospital. HCUP from those folks healthcare is that This unit of and think unfortunately taken

the had And you Phase dose. you severe our that know showed study patients required that Xa one of only cited two-thirds

be the However, AHFIRM trial. in different that may

So interpreting all budget length together and of we down And impact of be payer results, stay, a and our step be important models unit, value time in market stay. will we’ll put the those that and overall prop time environment. ICU for length of all access as

Kristen Kluska

been failed appropriate other believe of Appreciate you. it paper might conducted? a And and what that is getting thoughts diligence just, And do this Thank especially setting, some have space? mechanisms the in question that the be more you’ve we’ve this you larsucosterol’s is your in recent mechanisms about deeper there. why with

Jim Brown

That’s line as a Norman see great WeiQi question we’ll and we as because well. and the both we And I’ll more, then address it on well. some have have if

failure. off, a of number I These to of breakdown it’s patients eventually dying complex a of the leads unfortunately first think AH, are disease, systems. multi-organ that

disease. So just actually the eventually die kidney not them most it’s of liver, from

liver, liver the or shown dosed humans cell organ systems up and were these larsucosterol with these the of chronic protect in care multi-organ protect models. failure, of the the it shown in And death. we’ve reductions – against disease, that And disease who when kidneys, numerous we chronic in we showing XX and set as protection have we’ve in of the lungs, markers seen kidney

a of have and look those to the was there apoptosis AH of been the work. in couple one also one inflammatory focus, didn’t also really against past, the been tested to we trying and If and of that at And tested system drugs drugs and been block with the there reduce antibodies. there’s disease. address two cascade drugs areas more unfortunately, the in a of couldn’t And looking note have breadth certain then monoclonal were main

we We in there molecule levels With in have larsucosterol, that a we elevations wrong. patients. is are know DNA gone changes that DNMT methyltransferase or these know what

membrane’s we the know there that And of damage. mitochondrial a from are We against within damaged. cells so, protects hypermethylation different larsucosterol know and host ongoing know patient data, we is systems

and there’s additional give to components host addressed. component lipotoxicity inflammation, got you Any this and are But start as then, different cells and maybe WeiQi, Norman regeneration a it – reduces that that know reduces wrong cell maybe And so, have of we’ve increases and well. can maybe that on just survival it. thoughts? I autophagy it finish enhances gone of the of We

WeiQi Lin

would have quite thing, I well. you one alcohol, have they because Jim, think, liver I impaired do alcohol-associated No, add particularly it more subjects, just also hepatitis regeneration. covered

and regeneration So, liver acute failure. then resulting liver acute very in the injury, liver is important overcoming

little certainly the well. regeneration So, that’s important. a promoting larsucosterol did Jim liver as mention that bit also

Jim Brown

Norman? And you. Thank

Norman Sussman

add pathway. to very much Yeah too the that. big part – because with of the to dysfunction mitochondrial is me, the a I stabilization, impressed mitochondrial pardon was apoptosis

also was steroids they affect regeneration. And you the liver know, inflammation, important. that So but probably interfere with quote,

As WeiQi pointed in this improvement to recover out, you need regeneration without liver order broad inhibiting the sort from of this.

that data as the And even mechanism broader that. saw time, have of the you is trial. need impressive thing than is is the if more feel one empiric impressive. much I what addressed prior action at we But and a treatments So, really in Xa Phase something

Jim Brown

Yeah do sometimes you Great. mega interesting think thank histology is they patients, you, there Well, I of biopsy, see both. mitochondria. aren’t you it these when but see often the

there’s a So you of. stress in know now that that anyway organ sort

Kristen Kluska

half anticipate are your place that because you Okay, really more second of kind thanks. release? data preliminary for plan thoughts year press you And through that on endpoints then would of readout detailed then assuming this, for close first timing? to goes maybe medical we’re a getting the do And certain save with What just now, the the share presentation?

Jim Brown

timing. and know depend the important you this Yeah, to But, wait, will too is on wouldn’t. we it

have enrolled, we obviously, close, know, which now over XXX. we we’re when last the we’re patient getting So

so to patients left. just we few So the go. or A this dozen have

And we the countdown. and enrolled we can so, start people then that, will last when that patient, announce

the be great they’ll a done know last then from patients. job and of And last three patient team the So keeping it’ll Norman with until up have months visit.

been out closing gone we’ve we’ve centers can. and as patients closing we As out through, can we as

get that, you up have last XX patients so, clean few you the so hope And last, months. we is know we’ll to know, our or to the just as

So the visit. data patient have hoping months last team so within or That is last to would after two wonderful. be

So the day hope with when just trial, report few when we when that comes unblind we whenever to happy But it a comes. we’re days. out

have we’ll I’m sure call. I’m objective. press sure release our and be a would that so, And conference

of certainly I anything We that meetings. know that at timing hold versus back the point. about don’t wouldn’t

add – we’ll to publications in about more think you want fashion in to And broader then through I it. eventually Norman you know do present talk we’ll meetings. a And, and anything that? the data

Norman Sussman

you know excited I to and the line important presentation No, as unblind on things a see we’re as Clearly, that’s top anyone strategy. publication correct, on most and think decide then what too, data Jim. the and

Kristen Kluska

forward Great, to New thanks. seeing Look next in you York week.

Jim Brown

absolutely. Yes,

KOL our do I New me. so you Tuesday And York. reminding in have thank Yeah, event for next we

over guys you have and to that’s happy not be So, would online. great. It

Operator

Thank you.

question your question. H.C. from Please Our with with proceed is next Ed Arce Wainwright.

Ed Arce

everyone. Hi, Jim. Hi,

Jim Brown

Ed. Hey,

Ed Arce

last was to at to thanks hi, see I your my you Thanks week seeing taking for event. – great also week you forward and questions. look for next It

timing just more the Beyond had of I the couple a questions. trial,

as this ultimately, and explain and pencils go think two be you statistical on the investors are arms positive get why to seek two is, were readout, would this them would I actually for know over of – the on there start important you And are label. their significance, both just to both study. dose sharpening are powered if there both in

to be other in the commercialization, the Salesforce, you and pivotal given the concentrated set study not around targeted hospitalization on this that distant then We how given know, question so there fairly that wanted I points? approval the at a is much. And is just an Thanks just expect thoughts get potentially was of had unroll separately, could to too that Salesforce, a you future. your MSL’s looking call you

Jim Brown

the And post so, I’ll then we’ll speak Ed. have start little a the off to that. Keith commercialization certainly Okay, let I’ll and speak then and doses, more to WeiQi to

it’s So, at both exciting us allows are these And already we Xa which with two doses, with – the of regard to bit in more gain pretty different the Phase seen doses, a results basically looking doses. we’ve to insights.

And and of of good, in also in looks other some non-clinical. the seen we’ve dose the case experiences, And the doses various the not been bit a low better human than variety higher. tested, if every oftentimes that’s

a it’s as any we what thoughts certainly But from but are to excited this. far additional as will see dosing, – So WeiQi, come there?

WeiQi Lin

Yeah, animals based of two was humans. various obtained top we our on data through based selected relationship Xa were on understanding study. that dose in Phase in studies, in and involving doses and the data those on based of also the NDA mechanistic on the response that, And PK new

should of So, optimum to the is in that’s the be liver-centric how range we determined AH because these disease. liver, exposure two drug dose a doses specifically the

that’s So doses. two these how we selected

milligram in moving the and the is Nevertheless, the XX we XXX milligram Xa Phase that the in that also Phase dose optimal one Xb, know the highest this we range. dose, selected milligram also believe subject. result Although that’s XX use to we study, safe we

Jim Brown

we XXX We’ve – as for – Yeah, safety in a I think a XXX that’s good the NASH a patients, day. month, point from a mil standpoint. as milligrams dosed high

huge amount more we these a than So extended given and period certainly for a more doses, have much of time.

diseases of over products sold has So commercialization for maybe the and who with you he particular, to question then, both commercial those to lethal of I’ll Genentech coming oncology Pharmacyclics hand before a at late tremendous DURECT know, who, of and has he’s in a don’t dealt before. Keith, experience, number

and his So this for Keith we’re team excited take to on.

Keith Lui

your Yeah, thanks, to question hospitalization On Jim. – Salesforce. and potential of

in on Syneos, work doing discharge others. that and and hospitals volumes data and are have working well IQVIA various AH, just hepatology the preliminary their understanding and and some big marketplace like houses known gastroenterology been We the with

there’s gastros population know But US of only XX a year. AH and and rough of around hospital practice providers those X,XXX over discharges had per that X,XXX. about the we X,XXX about have in but heps there’s accounts, of We advanced half to know

pretty still what may So, list we’re funnel on like. look through But starting early down get concentrated to analysis. the we’re that target the in

like through our think XX a hospital-based I I commercial and Salesforce pace on of disease States know, continue would be roughly ample a we’ve calls, we rare cover to like. think You XXX, for what on looks United planning about the between AH, talked to and work previous disease somewhere

at tearing volume like. field tertiary structures KOL be force that good a that may start how construction transplant that sites might we have a Tuesday’s of next But pretty commercial and of talk about a look influence be liver more as well. do think the and little events targets and may sales We’ll to organizations the high understanding where and those bit about where

Ed Arce

appreciate endpoint. and to mortality have days. Jim, transplant. primary I the Do transplants more One Thanks is if look as patients? for AH, for I mortality XX-day rate may, history I mentioned, rate natural about around Obviously, is any of And on you you that. question reduction Keith. it. and know Tuesday. forward just Great, XX details But measures for AH that, XX% we the at additional

Jim Brown

in livers and estimate leverage XXX,XXX some Great AH, in question patients coming bottom States let those bit X,XXX about I’ll to There they’re XXX,XXX again. about hospitalizations, a done. the are the transplant hospitalizations available United and we Norman after little for there aren’t speak country. We there across around. back to represent then enough Unfortunately, the entire know for I’m is that XXXX with line XXX,XXX just go

So, livers XXX,XXX those AH well, fact, in with patients, X,XXX of about aren’t go half don’t alcohol-associated – people they all to estimated that go they transplanted disease. liver transplants, they X,XXX to

to other as Wilson’s and viral to people The who half patients and diseases inherited NASH patients PSC obviously well. remaining and go some, have like

you’ve being about going half around to talking disease, out of to half patients third of alcohol-associated liver XXX,XXX. about and you means, So that patients you’re a got go available them patients, AH – livers a know, which having between X,XXX to and somewhere of X,XXX those, somewhere that about remaining with XXXX

much just it’s And than numbers more can the eloquently there. So this. I regard aren’t with Norman speak I know, can to

Norman Sussman

needed as six were know to popularity. and want sort admit, there they this that because I AH about you sobriety. of was you moving people that feeling is it’s eloquently. gaining didn’t months of fairly Because a sort for recent them, know, people target. development general transplanting is, a don’t But previously, of transplanting And

by universe been growing, a acceptance you Since underreporting tremendous was that’s actually, that was special hepatitis. know alcohol-associated for now created has then, shown general there Brian very Lee. so, paper a in and category nice And there’s

So, get more we’ll going numbers accurate forward.

we But for the to exact speaking to to my a now, that, it’s makes And up volume don’t alcohol that And half think, about that transplant I we colleagues number. half Jim X,XXX said, the transplanted. of that attributed think right people know alcohol. third of as a of approximately patients

to mentioned XX%, all the does obscure is So, to of sort and endpoint, you getting comers. and an XX% the it

transplant to you with you And if shown general been of studies. the you take higher they expect center, a tend So that’s XX%. ranges. when a AH, a in population in multiple just But should see people deal

of XX is MELD so And more a of mortality XX%. like with say, patients the

mortality so, MELD score your And go you up. see up higher admission as you as goes

Jim Brown

Yeah, from I also standpoint. a pharmaco-economic would add

So know if We say take million guesstimate a each. to close Norman rough the us, transplants just close it’s we of number, cost can X,XXX. to gave $X

billion So you’re other And check the the written piece. talking a probably been hospitalization, for as well. component, about that think somewhere about billion maybe $X you of $X range that’s in to then know $X billion we represents

to So a it’s care substantial the sure. cost system, for health

Ed Arce

helpful. That’s very

Jim Brown

Okay, sure.

Operator

Thank you.

is Francois with your question question. Please next from Our Oppenheimer. with Brisebois proceed

Francois Brisebois

All for right, taking thanks the question.

a couple here. Just

severity the from I either the changes in severity Louisville patients and you. know Phase you the of terms on Phase touch the of touch And on remind the DASH, you severity, criteria, can us just difference in terms with of of of patients? MELD and between also inclusion or and also the the implications Thank Xb? the Xa to the score Just the you can severity guess Phase in in cross the Xb those comparisons

Jim Brown

sure. to severe patients. up, we’re Yeah, straight And taking

range patients but XX front trial, the So from Phase in severe in patients trial. with Xa to the these had our exactly MELD Which are match we XX. they in

of got the a got know let’s XX%, XX% a chance to into to next XX% about some dying to XX%. And is that of you in the say, in days. maybe And Norman to of if year in the MELD chance you says, XX of XX next it’s XX%, XX%. XX perspective, as put And to the mid-range XX the dying XX go XX,

And huge problem. so a it’s obviously

you the is, there to to for matched patients we’re know, what would tried objective And is who, patients then pick far comparison. XX-day as was who the And have have a we doing get do goes, as we our That to study. like-and-like. consortium had

XX at days. alive be to had they So

So to died. that we patients the DASH not had count

and were or that there, score day XX And before there ends data earlier counted what because died saw that that function of was a in like patients and a all have in XX-day, survived. versus had on looked who a saw were number eye, to we ours a their And space. still better we our unfortunately improvements liver We they days my survivors at in all. aren’t don’t

you WeiQi or add? Norman got if know don’t to anything I

Norman Sussman

I had DASH look When to that the consortium think survive you stitches. in subjects the the at paper, DASH that a trial, XX-day. remember the the patients in accurately

patients know was So what how out died any better, with prior survival. And you who And much markers even really of bilirubin censored their that you impressive liver better that, scores. MELD their it. to were injury and see biochemistry including of was is

more bilirubin and it’s scores, of While MELD bit significantly were better. complicated. But so, a but survival

Francois Brisebois

Great, you. thank just And ask one last if I one. could

expect And comment answer terms necessarily here? a you the to the Correct? to the response is about of it don’t fair so dose doses previous in used, assume as

Jim Brown

We the might to would say I remains study in Phase don’t determine say information so certainly out doing understand couldn’t two doses, number we were we know that? the think it can of We you that. distinguish order small but And couldn’t what get Xa patients enough the of enough. we’re in doing We the mean, dose. to to between WeiQi this to I seen. I I hope trial be –

WeiQi Lin

think what Jim probably. I absolutely, Well, you answered that’s

see or stood they that to have we well right So not. out

Jim Brown

Yeah, we don’t know. just

WeiQi Lin

Yeah.

Francois Brisebois

All much. right, Understood. thanks very

Jim Brown

happy. one if really being happy I’m either – wins, I’m

So either both. or I’ll one take

WeiQi Lin

Yeah.

Francois Brisebois

thank Fair, you.

Operator

you. Thank

Our next proceed Trading. your Sean with question with Please from Jones question. is Kim

Sean Kim

Thank everyone. Hi, my you for questions. Right. taking

Jim Brown

Sean. Hi,

Sean Kim

Hi. on and on the I a just questions have the clients couple few commercial.

that one. of clinical who if see And to terms you that, into the question tying thoughts your larsucosterol, some any you to outcomes was their Phase in around ultimate curious of dose versus know analysis of characteristics second just patients first of your study, requiring of know, differences the only or my you based further received commercial. Xa there guess kind on patients So demographic those know I is hear these

potentially thoughts potential it’ll about, per per think you product, treatment? the you the If whether be know, you know, or basis commercializing pricing, around your dose

Jim Brown

first certainly it the take to then Keith obviously, ask as and well second. I’ll Well, WeiQi comment and Sure. on

think many just And think a first the note number. have to wouldn’t it some of early works. who dose, keeping the I patients, that, enable kind is the patients second in a didn’t give considering on, they even important I hospitals drug its just because small doses, the the had we in were their the thinking we first of it was physicians second in patients thing to this best severe drug chance, not AH very really testing way

of the to in Outside being modulator oncology is medicine. first developed epigenetic

concept and my the single think reset that what think The a improve medicine. only thinking so And my about organs approaching of is it’s dose I and it. very to might way way about a allow it different for whole epigenome I worth, about

the that get stress, a have can that doesn’t over under great change for aids capacity does liver got stress one liver, attack and circumstance, if drug in that regard. like but you’ve But a it the liver acute heart regenerative

about all the up. organs showing think other up, I it it’s showing

to So second dose? are thoughts the around But WeiQi, repair body itself. the your what can begin

WeiQi Lin

longer the would effects modulation, for typically, DNMTXa long epigenetic know like lasting, theoretically and than as DNMTX even just be inhibition. is Jim we the Yeah, inhibition Xb that relatively mentioned, that effect lasting especially

simply the anti-inflammatory than all regeneration. cell to anti So, or longer aging effect, inhibits just agents, liver relatively death what larsucosterol they our three promoting expect lasting we must,

liver the about regeneration. talking Now

organ or as one very a doses two with is can factor regenerate. that Another unique lever a

selected have doses for reasons that two it episode So once liver we it And recover the the otherwise only to are was acute why acute that overcome then wasn’t particular this these episode, the you or hopefully, the regenerate. we indication. one whatever

Jim Brown

Thank you, around from a or thoughts. general And just away ways two commercialization. But at maybe thoughts this doses we’re pricing. you Keith I point, maybe give some know now, some and WeiQi. the one

Keith Lui

in decision Obviously, say would corroborate was this It’s this early sure. probably although, of point, a access a at strategy topic final Jim too Yeah, It’s saying. meetings, question. to had patients what drugs our and I the good heavily market one is discussion. I’ve I previous say certainly the on would a that similar going drugs, or is results on. of doses. be worked by the cohort run two their pre-launched influenced AHFIRM at haven’t looking analysis But outcomes to that and

I into and as on a pricing run like. say will per various a course opposed on ASP, challenging basis, what per issues pricing you and, government like you for treatment have and it dose best is the basis, discounts

per So kind have have of results determined AHFIRM pricing made not a that effect something while treatment about is you heavy overall like will strongly that, that into on and it versus a we we on take influence we’ll per the I how know, on pricing think any dose course decisions arrangement. said, and

Sean Kim

one that’s Okay, helpful. Thank side. commercial you. And just more question on the

mentioned hepatologists gastros. and you XXXX guess I to about So X,XXX

are regulator needed And of epigenetic doctors much larsucosterol program on those in up-to-date many aware bring to general? these you wondering larsucosterol? Just how and currently how effort of patients

Jim Brown

I let then think great a start followed Norman I’ll let might question. That’s have in perspective. I Keith and because I’d And think finish, I

hear to love one. I’d So this

Norman? So,

Norman Sussman

has actually It data. Right.

that say hepatology going those my sort I of trial. knowledge colleagues, for saying colleagues, So have lived in which practically of world, a among just centers. the transplant academic there term lose so, to I’m And is this among is uniform

happened. thorough done people the pejorative, meaning has a to sound of next sort job Keith to in Not of year. reveal looking much what at more but

would take from And to to so, you Keith, it I like there. like

Keith Lui

various multiple academic unaided what was that transplant centers along typically in in products research or Norman AH some under obviously and corroborate is looking there recall, in larsucosterol in would many in I that at a those that But the have market US Yeah, saying, development. particular specialists conducted are program are furthest development and aren’t too Xb hep centers we’ve and alcohol. gastro the certainly interest hospitals referral with

the you our know knowledge of recall think trial larsucosterol is I high. to and or

only when population AH is not would handful to entire of referred it’s is any hepatologists this earlier, you sites that disease quoted know, the anybody, However, have sites only to a look at the a that training or or they inclusive of X,XXX a AH. handful of X,XXX gastroenterologists, you that’s specialists, to because treat of about I typically have

it And out are and our bit seeing of right to care recall going that when knowledge to a be spread And fairly lower. specialty the AH now. still is patients, those is centers little so, get tertiary sites you out

we’re had therein worked diseases particularly surprising, trying that’s lies the having why now that oncology, of little like standard-of-care fatal there’s baseline have in and approved for no other or that the not what commercial AH given disease understand But nothing opportunity, in and and that hematology. too areas to

a – there may know, endpoint, randomized attention. under until really clinical be doesn’t a to things You development. flag trial controlled, most number paying study of people But hit for a a raise you there’s start lot that

if providers, think whole big the with as hits about, of we’ve talked heps bring and later to AH events, to to community. a have population and that we I of certainly year, will this AHFIRM lot and patients practice flag gastros and raise value a

Sean Kim

very you much. Thank

Operator

to time. hand further are There no at questions you. the floor like Jim for Brown to any over comments. I’d this Thank back closing

Jim Brown

New forward See please always, any you all follow-up. of if even want just next Bye. number for seeing And have you look to to in further hopefully participating care. Tuesday. as And we a you I thank questions, soon. today. Okay. Take you York

Operator

today’s concludes conference. This

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

DURECT (DRRX) 8 May 232023 Q1 Earnings call transcript