Galmed Pharmaceuticals (GLMD) 8 Nov 212021 Q3 Earnings call transcript

Good day and welcome to the Galmed Conference Call to discuss Financial Results for the Third Quarter 2021. Today’s conference is being recorded.

Before we begin, please note that we will be making certain forward-looking statements on today’s call, including those regarding financial results, statements and forecasts regarding anticipated timelines and expectations with respect to our regulatory and clinical development programs as well as other statements that relate to future events. These statements are based on the beliefs and expectations of management as of today and actual results, trends, timelines and projections relating to our financial position and projected development programs and pipeline could differ materially. We urge all investors to read carefully the risks and uncertainties disclosed in our filings with the SEC, including, without limitation, the risks under the heading Risk Factors described in our Annual Report on Form 20-F filed with the SEC and the risks and uncertainties included in the Form 6-K filed with the SEC earlier today. to of forward-looking their obligation which or no as speak respective assumes update statements any information, Galmed dates only. like and now Allen would to conference the I over Baharaff, President Chief Officer. Executive turn to ahead. go please Allen,

us Thank you, Shamali. our be conference Officer, morning our and Chief to Stenzler. Scientific I pleased today Liat Yohai on Hayardeny Chief for am and thank call. here today’s you Good joining with Officer, Dr. Financial

Vlad Ratziu We take Ratziu our our also At Professor of second are XXXX be study our from quarter management. referred ARMOR questions take following also the and guest call, ARMOR Professor of and today’s part with financial third to questions will will addressed dataset ARCON Phase to open cohort. his the results part results Professor the the to Ratziu you today of of will we us from as happy study grateful will have the the Investigator. report we Université the first on X our label to for Sorbonne KOL presentation. Co-Principal happy to present be

highly the effect X to experienced consultation followed robust are and independent rigorous an study you the also in by elevation Biopsies pathology confirm aligned that a as early Professor hypothesis will anticipation treatment of Galmed biomarkers presented direct FDA, the cohorts by early the with higher pathologist weeks. with XX fibrosis and in to anti-fibrotic read larger biomarkers. product designed by dose of profile of study optimal by dose an improved duration including data Phase be support histology Aramchol a and that a Aramchol that fibrosis. on occur pathologists. analysis individually, process, Aramchol Aramchol. designed a consensus may added to As was a effect b.i.d., know, will as by to is corroborated added continue Ratziu label for liver each further three provides reading committee Analysis on open The with XXX% higher year, in this which provide of in size results milligram the show ARMOR effect Aramchol XXX exposure and reading. demonstrated meaningful a It biopsy ARCON efficacy that soon and is treatment

tolerability Importantly, and Aramchol to safety profile. continues excellent show

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Thank can you, always I present am get Allen. positive and I very honored results. when happy to

me you do thank so today. to for So, inviting

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by durations in this day, X-period level optimal what a in will changing with period the a the results drug but for pharmaco effect. delivering So, be the twice than blood placebo, – what strong it results the compared which would try the increases that you reason, as to told, simultaneously. presentation considerably, tested trial. three is was treatment of anti-fibrotic the rather that understand Xb Moreover, Phase histological being study previously of the the effect the in are And length higher of in of if to and understand comparison of published this the interest not were study exposure whether

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the they the reading So, biopsy. do the or are whether know controlled pathologists first not

to exposure will as Disease meeting, been move the will I have meeting results we completed that at late preliminary presentation for the that patients for be Association results present that to Study this here and held the lot week. Liver of am of will the on time all this to on you on breaker assigned – have the a they part that are the So, the results of that very the accepted first of are is explained you a happy slide. now – liver present American later to we here tell going

cohort is late concerns present But XX today available and data breaker patients So, will participate open-label the late-breaker the concerns by was ARCON, also patients in as we open-label and has way patients. this larger accepted is XXX study this which part and labeled then is that that been the called here ARCON of and a ASLD. of the this Aramchol study, the submitted cohort

XXX. patients being that solely of So, are the are XX part this presented

XX this basically can demographics you on subsequent the epidemiology here and the first pretty So, much slide the are the see same and XXX. between the that

patients. is rather high, are around XX% advanced to XX majority of BMI and patients X Caucasians. that have here who others list see then of Mean Most fibrosis there patients XX FX between can years. some is are that You are X. a and females XX% with and are Stage a age then at is bridging at XX and the majority Stage there

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goes beyond that. XX% So, way

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in we very biomarkers, to Now, converging would evidence if all which see moving important, we from the same direction. because are looking at always needles like is

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look at before. Let’s

the are in by the histology. they the in the Here very encouraging again, that sense as observed results same direction results go

the the breaker drop on patients. late it XXX clear is larger look and this you the have the is replicated AASLD cohort at the in cohort, a FIB-X side, left Their XX behavior you patients, of same. If in

that of earlier So, XX to in surmise patients. entire small that, the obtained the this will when be one one from result the from will cohort cohort can be available the quite histological similar

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But consistent. a in reassuring cohort every that So, patients quite everyone trial we yet, reduction the is measures what fact PRO-CX. Nordic down, also as PRO-CX us documented absolute see XXX is by that histological is can for that FIB-X has And here not be biotech fibrosis makes What liver cohort. cohort are strong but you of this trend the think initially change in fibrogenesis in which results is invented that created the late-breaker PRO-CX XX replicated and change, look that the biopsy, has biopsy will of now, whether also this the which in PRO-CX by at for Bioscience, company was larger histological larger and interesting liver a the the patients, regression the where measured relative biomarker of is goes is or XX biomarker. been here that a same

liter. more a However, level, and the assay it, assay Biosciences precisely to measuring methodology for which reproducible that per higher to change and and – results Nordic according more they to here, XX.X the robust a is in did explained also the micrograms baseline

we is can aminotransferases, and you two at are on if again, the from a at Week results being XX%. reminder, markers, that late significance fibrosis at this slide, aminotransferases that documented XX And a are is the you proportion cohort, a it here XX popular I statistical shown high presented and patients and all so of there is just fibrosis true this the reversal significant that biomarkers whether significance of Now, the at of which of you, maintained is the as who level Week baseline, had drop a FIB-X with see looking look the most slide. the breaker have shown on AASLD And of for PRO-CX. was

these So It which what a beyond the Phase go is journal, actually month in the published important? of [indiscernible] less Medicine, of was in and – has Nature why because medical the and in X Xb study trial, is results are which been which very results ago. was confirm they called the prestigious demonstrated than ARREST

results and sort in reinforcing molecule fibrosis in particular, the histological of this the represented to optimism So, that ability are the today improvement were currently reversal. induce of

the results that’s same – from to different the cohort. a So, why good is coming it have always

effect important Aramchol, the of the actually will one be is And study Phase So, that they is X support is to which used the higher study. conduct. this ARMOR why do being of – in a also, dose is this

authorization. these if that, discussions if analysis is of of open-label So the conditional larger they the trial positive, the Phase FDA to allows are the analysis which that with on us practical for trial so the implication will of results, enable conduct marketing the a X that confirmed interim they cohort is

to that the a of thing So it say, is bring weeks, will, allows an market. XX number course, earlier maybe smaller help drug of interim and us performed to – shorter a for negotiate after which this the that instead patients instance, exposure, of be of period analysis XX because important will on

positive very you, session. so And far to it results from open-label this over Allen, for I’ll trial. the initial So question-and-answer pass

for now then Professor open regular So and thank the for will we continue with you Ratziu, we Ratziu, and floor our for Q&A will call. Professor

is of James. Thank [Operator Our Raymond you. the Steve line Seedhouse your that with we with question. proceed Instructions] first from question Please have

therapies Steve Hi, pioglitazone Seedhouse. more, to on consulted Thank E, like any this that? wanted are anything fibrates, also, for any if I eating like of management cohorts is were receiving Ryan patients etcetera? exercising patients other lifestyle these Deschner the on see well, in then you. And vitamin the

Thanks. Yes.

the is all field. time it’s that biopsy period be in before akin to conducted randomization. specified – medication other studies the used have Patients you this ones are are biopsy was other to the the been allowed being that particularly So biopsy the of was if for that on on that for medications, the extended they an initial taken

that because pioglitazone you you – a like with taken active biopsy for the the all not you’re only So shows course, means is – were medication. weeks NASH and selection, of a liver years other have or trials, assumption, particular of was for that have that if few Vitamin before or then, responder a then the he to the If not for months E that number they – fibrosis, started medication allowed that study. in patient the a

vitamin all E. So to patients be as non-responders can or considered pioglitazone these

the some numbers give including what marketed States. United even not is is E on non-responders in is low, these basically is in are that use drugs. to European cannot I vitamin the that are exact pioglitazone Now you medications, to they those actually these but equivalent the of important pretty countries of and

also lifestyle you’re about measurements. Now asking and that

their lifestyle the trial visit, no not aware being does there that. of they of ancillary in So what [indiscernible] they are and like other doing information about trials need are of any systematic diet I’m constantly and pharmacological they in that to they educated is not their doing that given each in lifestyle are all the the exercise reminded program are change study changes. the here and people NASH, or again, and implementation but

active it’s it’s that. reinforcement, no than more So but

changes any effects of one on compounders in visit. Of the any when be in into weight, course, And any taken each alcohol changes histology. at that in consumption the amount on the captured changes of results activity will analyzing be that are will consideration final the this

you Thank it. Got much. very

the proceed Wainwright. H.C. question. Ed Our Please comes next with from your line question with Arce of

data is There on far. Yip questions. a Hello, exciting Congratulations asking the so couple open-label questions are couple of Thomas very Ed. everyone. a This for of

we’ve among cohort? other five in fibrosis the achieved of point next patients was First, approximately we as that reduction at data a expect two-point seen slides, time achieved? when biopsy And from set the who what should in ARCON

exact have So I of the Maybe has don’t thanks, week five Galmed was detail that XX, whether Thomas. these XX. patients. it,

I’m about can think not the sure be the it’s between But with I we small quite numbers, confident equal that. in if groups.

will results given. these So be

Now next so for the study is – the ongoing.

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report that the the XX filings will We it first end-of-treatment instead XX on current time the So next patients hope when cohort, of will continue. biopsy. we the this be will this reach

will is one the – So then so larger presented of number patients on that picture have we higher a than here, picture the a patients. XX

when know that be the hold we by hope we EASL but time that don’t I next So this exactly year. available happen, can will

that I that show So can data we you time. more hope at

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I that And XX for the patients want cohort XXX or Is just analysis part of of year. today. confirm biomarker are separate the of to a cohort patients ASLD presented open-label cohorts? data overall Next they the was ARCON

that are – part in the The They I is there. XX XXX presented. are that patients cohort of

Okay.

overall patients So the XX label open of cohort? the data of AASLD does approximately the contain

have been variable And followed of time. it contains that additional patients for periods

But into exposure of of measurements out account repeated Some weeks built of that data. was takes one each X these individual using been the patients, for the graph methodology period only has X of and the XX them XXX weeks, weeks. used other these

XX% of far are – female the this it. also about Right. potential patients you demographic we last expect any Is about see one one impact? And And design? then patients? point do parsona label in over by so enroll that Got of the study open the

not No, is design. if fact, is in at majority it’s the Actually, majority always it’s look trials see a studies, of women to have at more XX%, published we been far, this so but least you way. is, not happens something be absolutely that of by there most series. most XX%, Maybe that It like that XX%, that in women.

you much Thank understood. taking questions. for our Okay, so

Thank you.

Cantor. the you Kristen of Kluska Our comes from next with question with question. proceed line Please

other Kristen. time how announcements particularly patients? time have believe This is importance discuss ultimately physicians Rick results, you on to you to in space. NASH please the could of Could in in importance you What the at onset the comparison for do look to onset for these and

Thanks, Rick.

So of you’re onset, XX%, time mean to duration saying the you to… trial? XX% in exposure the

Yes, that’s correct. Yes.

So trying happen. drug, understand the to it antifibrotic we’re of the potency because just dynamics the well can of

longer have you for earlier much particular than, drug, that people results. say, one are to which know and response period of – one You you have who that particular time – for other you let’s a that same obtain the a no responds need drug has to drugs use much earlier can

others thing. thing. that’s at act I say, drugs slowly, very let some that’s So, one very one act fast,

– to performed two time these fixed which performed understand X have X fixed all so is been know biopsies other far it’s tested drugs, one don’t were if The to we is so trial that all studies an just – thing did because biopsies, have the was that period. the where the years. period and or year we one other for the Aramchol, But trial, late we in and the Phase trial, one time. Xb response understand where [indiscernible] there The only all a early only of serial including dynamics, trials, they Aramchol,

to at a starting point, maximum you’re don’t effect the you at or you’re know if the of So time see effect. the just we’re whether

acts better injury, of kinetics the order of point have understanding other and response. time one understand in than is liver So aspects more a get how drug fibrosis one it to this of good That’s to on to the thing. the

individual The second there variability. thing is is that

So a and order who to to longer for of in period responders, late time there be responders might response. be need people early have a treated

comparing for different So different the three basis exposure. three that periods of also lengths time is –

enough, reach say, clear at And So to the It the not see, maximum for prolonging that’s that level more reduce it months, we by does are it. instance, And course, doesn’t if the response XX you response. already results if add X all. of any weeks.

of Phase that’s cost, it the adds and but add very an for a X a earlier than the stays does more problems So at of not with you’re reason, the trial point to trial perform good it. Then, wait course, particular months, familiar to and which time interim same, to indication that. rather to lot it without analysis the X a

from it. there the design time would periods drug. to that compares of third is be that it all So interesting thing to this three the understand to different that’s That’s exposure

And practice how of effect will very treating will different long in for to to Now what the outcomes. drug have clinical on such probably, as is a other patients treatment that’s this depend on period clinical everybody it translate considerations, available, time. Most that says once for a you story. have today be a will NASH

is So earlier stop order But something medication once it’s later appropriate patients occurs compliant and you have get the in time. it not response. a that that response with stick the period the will understand for whether or of to be important to you

helpful, That’s thank you. Alright.

Justin proceed from with your of Please Our comes with BTIG. question. next question the Zelin line

question. the taking for thanks Hi,

you if of other you compared as how sets currently? context put the these in curious us into improvement available could Just on view data to the help field fibrosis some results

convincingly shown a Madrigal has a an – very so Nonetheless, GLP-X has intention aren’t drugs receptor treatment see fibrosis. the that effect of as so there very yet Madrigal and of regression, large the academic, can shown compare to on But the your that have has fibrosis – effect population in rend terms is well very of on is So not in you’re shown duration acid weeks, hard but exception careful results that shown period semaglutide, XX defer because in extended not between an clear as on of to trial. for mean, be Phase I and period such the treat I as question only are I over and obeticholic know, as not studies speaking, known, forth. X practically terms the answer it will on you even which trial. moment, time to an out many studies head-to-head, have not of actually there effect way the agonist Phase of so time, yet X an of a in

there So many out drugs fibrosis. were in aren’t there successful that examples of reducing

trial. that even So Xb things of a as level today. has placebo don’t this high I response placebo-controlled with would the and that effect particularly what are way positioned, is historical XX%, with which with in happen. shown And for of show necessary patients – X see be moment, three sense, the is that no that a this you results fact there hopefully, could can consider All been will were a placebo-controlled in than if and not here placebo pathologists, the the doubt trial arm that is trial, have other higher think magnitude direct is Aramchol comparison, not response that especially I is good if have you the Phase the of is today. you to no been position of think, a you rate, considered, I OCA. as this you that I Phase But the is presented in And that sufficient. trial this Obviously, the A be everybody’s But effect. in prove level simply the antifibrotic consider if done, response shown beyond with efforts. there an the ones

difficult positive OCA And other So, the that’s that’s in effect There the clear this and because fibrosis. with here. I But that that – could appears I is just to favor is the sense us comparison other a clear, very in and get – be compare you quite with thing the on of REGENERATE scientific versus the there size drug you think compare difference from because trial. The as this is the trial other only about between only a that to trial design something can as meeting, studies. much the of placebo say given optimistic in one is can’t higher.

Great. Thanks for question. the

And very encouraging disappointment drugs is need effect. that we have fibrosis. far reported very shown in because really lately few that the based the on It’s the clearly work so on Sure. results actually that an drugs antifibrotic –

very good some we that news it’s So, have candidates. strong

again. Thanks Absolutely.

Raymond next of question the Please question. proceed our is Seedhouse James. And from with with your line Steve

Deschner, give of again, for us I to and individual XX more you wanted such loss components the detail you. you cohort to Steve can seeing terms or how are And on ballooning these Thank It’s rest. Seedhouse. Ryan compared ask, in any resolution what also as steatosis equals the NASH and weight across cohorts?

So, effects do and underway, being stress We we not studied We fully them. are the other did histological results. these not the analyze presented these haven’t results for moment.

is So, we keep this particularly that obviously, for the next because, scientific meeting important.

we far. more have you give cannot I detail. everything you so give I So,

here. is there hidden nothing that’s So,

you up have a cleaned all rigorously got all here. analyzed database, has been it that on you information So, got the have

we the fully all other year, XX I meetings two come, far. when it will am of to there details nothing you far. patients, impact we logically, analyzes get one hopefully, information. additional so the get will all shown have that But then that So, each And of of the will the in have is also the stay moment, But we and be else for that’s major can tuned, the the sure histological so drug.

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by terms this specifically there induced no moment, weight weight loss loss for In drug. is of the

change patients, number it’s weight will a moment, we there larger see it’s But effect, whether for a is So, in the there that. of is neutral. clear no

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know can over-interpret how that. much I don’t Yes. we

As you still say, the learning We is it to what all that it worth how so us. lifestyle or confidence were aminotransferase a and than are biomarker intervals It’s are other of regards wider pharmacotherapy changes changes. and on. investigating we in for

moment, after continuous too it much not up good, I a week on it’s the Obviously, for shoot So, would XX. doesn’t elaborate reduction.

in biomarkers So, prudent it’s terms of sort the of interpreting of reassuring. fibrosis. I myself am very

important So effect, rather uncoupled know use simply don’t will variability plus the the to we biomarkers to histological And would and see changes as primarily about not. be how that. individual biomarker today, those we as in indication effect individual the on case, whether those be reflect be, variability histological really to in use biomarkers if then not, an antifibrotic the of because which some itself. sort enough of based that, then this that fibrosis is can first there or them step I is will me, supporting the what might extent, but as from document a particular evidence, response,

holds continues much So, from But it of to there too see are But will a if that is obviously, with this be in ProC-X. number good reduction unknowns drop. true. patients a this sign too it probably larger many extrapolating continuous to we

you. Thank it. Got

the turn to session. will to have first the we now call I of back end over Baharaff Allen continue. reached And the question-and-answer

very continue Ratziu. And let me now. Professor much, thank So, you

treatment liver today energy things for view last at fibrosis. importantly, skepticism for the Galmed. and obviously, both changer moving excitement hear company space over a the results and the company more the fast Giving the NASH are data, the we from So, the Nonetheless, of we presented regarding the in we game the years.

question more One, endpoint result, focus far, of liver targeting and seeing fibrosis reading Aramchol’s specific efforts presenting XX% main three readers minimize the optimal directly production are employed NASH SCDX of translated today. XX%, We mechanism government to magnitude today reinforces over significant dose. that the discrepancies, The results result down-regulation to we open higher of hypothesis in are significant a fibrosis. Two, with study three We primary pathology the data patients has dose we robust to-date. process address a collagen confirmed treatment duration. experienced of clinical As is the fibrosis worsening. improvement designed elevating one one their a the improvement, of optimizing improvement efficacy thus results or in into makes results, action which enormous and only point increased by experienced been effect the a the in its facts. the program. we of fibrosis in is important in endpoint. We by most patient on

doubled approval discussion continuing study three, far we and our fast FDA and up cohorts. small second is on evidence-based and the proceeds. so milestones. an will encouraging Phase the we with look data us to corroborated have with the these smaller With data Aramchol point dialogue our fibrosis based a And designation, as conditional with shorter of to by generating the The this large totality points. data end forward track highly our is allow open X for updates on have our next may at The FDA, the We are on study.

transfer call me our to let CFO, Now Stenzler. the Yohai

XX, be you, third financial our will morning, September quarter This Thank ended Allen. the for I you providing results XXXX. with

more provides For with summary which, Form results. X-K to among our other such please financial filed earlier today information, SEC a refer things, of

the net Research for in and period quarter million third in is $X.X compared the for the for totaled loss XXXX. corresponding XXXX. the quarter million totaled quarter $X.XX third $X.X the share and same XXXX, million quarter General $X.XX the of expenses for in of with $X.X million share million $X.X $X.X administrative net per our for XXXX, XXXX. totaled of corresponding loss with or development corresponding a expenses per or compared the For quarter

cash Our the million compared call. as of said, December balance cash, XX, XXXX. the restricted which September with cash instructions Q&A XX, million $XX equivalents, includes operator, please and With for on provide that of $XX second portion totaled marketable securities XXXX, cash

Operator?

line the your Arce Wainwright. Please [Operator of H.C. Our from Instructions] with would question Ed proceed question. with first be

Ed. This again couple of Thomas questions Hello for asking everyone. is Yip a

for First formulation clinical portion the of trial? the also discuss should new you preparations meglumine when we And question, for begin expect can us can a enrollment? ARMOR Aramchol manufacturing tell you of double-blind to

Thomas. you, Thank

is study to to the previously meet fact, update. are as protocol we in of the need, announced, us part part without the allow the new from So, have There in the protocols next second planning to to of double-blind no reinitiate we existing the open-label XXXX. of because part half protocols double-blind year for shift the a need

this the which the at shorter. believe the we on ARREST designs almost certainly shorter, at design this Clearly, FDA the how it and we XX moment, to double-blind on weeks. we have new sufficient that the effect discuss same are believe is be will FDA We X will stage, study. the the the anticipating, is study, design initial part discuss short do To the that that the will with the size. based and – data we remind you can design going is you, – we will tell that when of I will be was Phase with to be

and doubled on will changed, to number effect have size required significant that FDA the patients Hence, the for has of new effect be the We e-value. discuss we need fibrosis. with

are full in the clinical Aramchol meglumine manufacturing batches. We continuing of with force

current of the for between confirmed, is study BID, double-blind BID preparing and are We beginning we twice daily, done this once bioequivalent Aramchol initiate and the study. bioequivalence meglumine year regulatory can the the Aramchol study. And next

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