Galmed Pharmaceuticals (GLMD) 12 Nov 202020 Q3 Earnings call transcript

Good day, and welcome to the Galmed Conference Call to discuss financial results for the third quarter of 2020. 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 time lines 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 beliefs and expectations of management as of today, and actual results, trends, time lines and projections relating to our financial position and projected development programs and pipeline could differ materially. In particular, there is a significant uncertainty about the duration and severity of the COVID-19 pandemic and its impact on Galmed's business and operations. Risk to filings the without today. XX-F with risks X-K the the investors disclosed and limitations, with filed all our filed included under our in in and in the heading, and with urge the read on earlier the risks carefully uncertainties the annual SEC We report described risks Form uncertainties Factors, SEC SEC, Form including, the as of assumes or speaks Galmed obligations information, any to respective statements forward-looking their no update only. dates which like would to I Officer. the Allen Baharaff, to now turn call President Executive over and Chief Allen, go please ahead.

Thank I'm Good and pleased joining Dr. our for call. here you, be Officer Christine. with today thank on you to Chief conference morning, Hayardeny. today's Scientific us Liat

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ARMOR Phase you X study. update to turn me let the Now, on

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additional We situation information provide mid-December. and by the assessing are to expect continuously

Before Stenzler, now Yohai clinical details Analyst in to Officer, Chief third LifeSci has like Day now ARMOR review the notices call and turn XXXX. of XX financial I by for virtual scheduled contact data over first for to Yohai? conclude, Save date and milo-XMER program. of been allow be to the would the to would from Advisors. results order presentation our our quarter meglumine our Financial I January communicated the clinical our

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

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

$X.XX trial of the per quarter ongoing ARMOR XXXX. from $X.X Research $X.X primarily increase $X.X connection third corresponding third XXXX resulted in the For quarter of share, the loss our an the a Development net with with the our share and million loss quarter expenses trials. XXXX. million or net expenses totaled in $X.X for in is with in third clinical quarter for per compared for XXXX $X.XX totaled million of compared increases The million or

now to G&A. Turning

our compared of DMO expenses cost resulted the premium. in for insurance the primarily million increase administrative policy in The $X and XXXX. totaled quarter period million general for an corresponding Our $X.X with the increase from

from financial or $X.X $X.X unrealized million income a the prior September the million During gains months XX, third to the We've increase periods. primarily in The of ended XXXX. three realization of quarter XXXX. had net of relates

September XX, cash please XXXX, compared equivalents, short With marketable balance said, million term for instructions $XX.X XX, $XX.X of operator, as shares, deposits Our that includes cash, million and Q&A XXXX. restricted cash call. with our in securities which of provide of December the portion

Raymond Our question of comes first Instructions] [Operator question. from with Steve Seedhouse line with Please your proceed James.

TR to could and other that compare and and with betas? deliver stage for you've TR was also very thanks the you that beta potency elaborate the clinical molecule beta hoping it Maybe Great, on just for licensed. the Gannex comment I selectivity contrast selectivity on just that could of just TR if you much.

Thank you, Steve.

is public So you at by will would company, liberty to like I force, disclose guess maybe the information based. and Madrigal but to also a [ph] we Liat differentiation let I are talk any studies specificity little know from what as not is it bit a the Gannex ongoing about from steroid

So Liat please ahead. go

Steve. you, Thank

in-vivo do and these specificity, we ample lower together the we higher the pharmacokinetic clear. and is binding We an compound to Aramchol know scientific study. of they We the fibrosis an for improvement. ASCXX. standalone saw liver much specific. I to The know are effects compare combination of effect good compounds we checking this combination that good rationale, so is and quite be much that rationale [indiscernible] we and talking more actually in know standalone on which It And about MTL-XXXX, the currently in essays the we're talking liver fast, much do about data reduce order the have quite data. with a liver more So, dose given one can dose, should a very have And of know shows that And can to liver be the an fibrosis solution a Madrigal say fat would have data, will fat. massive a steatosis we are natural do very and XX specific.

being said, that solution together, will better natural give So and us that improvement. much fibrosis it

And has very good profile. it a safety

we've seen so As far. far as

good compound, since will combined one safety so it can dose is good I it's, very going Aramchol less well, where we as XX with. to said, have safety and very of has Yeah, places to Madrigal be efficacy it given a issues, as be

early question study. you you that geographically the parts, a And I differently, just America Israel mentioned pandemic. had to the there's still that of and was it's distribution the lot moving the US, But least. sort And originally then if would Okay, other fact, idea I the And of too obviously, a Allen study, out kind all I wondering already out think of at some play sense split think of ARMOR I with moving if Europe, still parts. to lot you into in of enrollment you. had thank or had geographic in if was of play hoping, how enrollment you had the was that tell, will South left heading some given anticipated between I

it a hoping the world, patients rest I Latin etcetera. of coming significantly Australia, then but coming pickup slowed Europe, So, and and the from the June, wave, Europe a we US coming and the unfortunately with it and we've second this again. which main from talking Korea say XX% we Middle July the Unfortunately, and is to -- down study, is from of agents Asia, over the of too rest XX% are the to the reminder, world, is still, it of was between US. early the America the have about seen slowed quarter, rest of coming two the from XX% was the is down kind East, were XX% last

have the why talk big the what our is investigators in internal I've our sit the CRO this team what countries. asked is is together There we Australia, some how down; by clinics, So in those the in is the understand no, one capacity one, to all I need slowing because countries and both the like is doing unfortunately, two hospitals, But with to changed clinical are well need all see and act contained. to COVID quite there compensate. countries we well. they kept. the is engines in doing to so are which are very Korea

people in good Brazil. We They and be weren't in coming news can able so to our to may already news early play we And start regulatory is good game. expecting I come studies, the This Brazil. that. that is tell patients you Brazil I've from in hearing January because have recruit what from been into

as trial. know, Brazil, far in Europe the and recruiting recruit passed getting these the many were study, can U.S. hope the study Tobira mind, we regulatory again, at to that have patients' we've issues, Intercept of XX% Genfit they not because end I only and come day I elegant was in And the of As the all from But of patients the to to contribute bear needs the hurdles.

Thanks question. it. the for Got

head you And And just are to to is data know, are clinical is meglumine. you the we lost, day, because recall, not using this the of this are a why, from as expecting know to not to this using as you as Aramchol guidance, is as we have I up, planning this we advance switch end patients at which mean, time year. we meglumine were early if from to our previous time and

Aramchol on timelines And So also our news. that would study. we impact have own of an hope conductivity meglumine. on we [ph], And that good the bring physicist will pushed certainly I the

of next from proceed with question. Kristen Kluska of line a Our your Please Fitzgerald. question comes Cantor

with and your Hi, questions well. my everyone, doing recently hope MyBiotics. all about ask wanted thanks I you're taking collaboration to announced for

maybe view could on it describe here I the microbiome back take So step you, as of first your relates NASH. the role to ask and to a

market. identify have very ask medicines used the general. in potentially stages. now in biomarker the think wanted potential about successful to lot far for know so I you and might when, if say from evidence precision potential you we've like look seen And the know, XX these the of years from NASH could the to is on I XXXX, this line try then responders that base five as we to some also, this work down weather to be early You a of at tools medicine therapies

take course. you, Liat, Thank please that. yes, of Kristen, Kristen.

Okay.

we Kristen, there So ability say everything treat to to you, thank around its doing multiple in actually patients. this. NASH that to a activities perspective, to Aramchol I kind in for maximize want were just put of order

an So overall Aramchol. to elevated exposure as the we plan,

the better thyroid a and we I agonist, planning meglumine product as combination with that with previously that have Aramchol we with combination the receptor are We MyBiotics. the as discussed use now hormone well

scientific and disease biota to the that to Or that a is XXXX evidence specific I company and end-NASH growing. it [ph], onwards, involvement an that the for etiology science has to to that And, cause. enough this eyes advanced are at called develop of and Now, say say the this is now enhance around is publications different have showing this would microbiome prone and attention this least the and emerging patients around the microbe the [indiscernible] of be more the I it around the profile way back scientific more all may fibrosis. microbiome really ongoing or

actually for We of will collaboration. this are outcomes main looking combination three and

the one the non-responders, efficacy Aramchol. then So going identify to we to of we able see and collaboration for be see is the to example, consideration will by and that how responders first Aramchol, to the enhance to the to enhance be responders of into that from to different efficacy have the and change of to to one take Aramchol microbiome, microbiome induce responses the non-responders that and the the

As a right therapy, a looking this better have standalone change Galmed create and efficacy patients. to of to treatment with therapy. the microbiome combination for standalone course a be together Aramchol can NASH of And flow standalone we potential that

are overall as looking look this patients. at we looking to are at Aramchol for you therapy NASH looking combination So response rate. an enhancements of plan, we're Aramchol, standalone at at if we And

to now three into looking the months, the see micro you as biomarkers the for also can see, can to already also are taking at Aramchol, We consideration we biome change. the that maybe response

can good do to it for three the of is something biomarker months, example, a secrecy So if you compound. this gives the you that in

exert a microbiome eluded. the there work lot MyBiotics, in samples of have we patients, were we and already ongoing we collecting Kristen company with that are of samples, can just collecting is together incorporated volunteers data in is studies, And Liat NASH patients space clinical everything healthy samples, provide Aramchol our now which of to a treated leading of

is I microbiome samples Aramchol well. as way meglumine, already have will of as the meglumine of are on say multiple almost in to Aramchol multiple dose dosing the finalized. multiple The dose going we early as And to the start the is dosing mid-December. implemented

to it's onwards. in be all studies So going our

play Okay, role then, experience combinations where treatment at go as just just look to medicine those to see patients you moving the helping microbiome do can that the and rather of than have as second on we precision and come And is; question and is therapies really that down identify of in might general on patients And to that your NASH if most find Y? which something the you work, can it part doesn't the evidence is in potential great. treatment work X, get line, from emerging. the starting them it think the the

personalized multiple accessorized therapy definitely or in that be medicine time space. I is to biomarker as well. so it's believe and look market we hopefully Yes, Definitely, end accompanied medicine so for for will, also we the for definitely efficacy; have as this will cause in in the NASH also well. going a medicines

much. Great, so thanks

Kristen. you, Thank

[Operator Instructions] Ed from with of Arce question H.C. Wainwright. proceed your next line question. Please Our with comes

thanks for and Hi, questions. my good morning, details Thanks are for the other aspects. more everyone. taking additional And

So I underway. that said a prepared in you your remarks, as new recognize plan recruitment there Alan, is

chance around back sometime of perhaps be that plan? more by there or updated this you perhaps look to the next year. enrollment is, could to you us, globe have Is rates and that, month those. types full revised across on the recruitment for say of at is get when and My details end question and you guidance early As too different the the next various a the but just current that

we for this Ed. right you, call moving your from are conference. away thank Actually So

will all So Israeli you be if be your in minutes or will presenting a listeners, the with XX or I think Liat conference. on fetch, for so

So There's thank bode I us. you mean, this to we too the then where decide. inviting have era, is for in many

we affected and and repeat US ARMOR, I on as to But and less countries are we probably UK, want easier. is for before, which hand, the significantly by in said key one Spain, COVID-XX, European have timelines have which and Europe specifically countries, pushing as and On these as the much that push recruitment are possible places I down or places. tell can I two now Belgium, slowed recruitment France, two countries, for missing randomized not another last we in you the and one like months. patient are

So don't on the I you serious there tell to is very second going what's in And these countries. wave a US. in COVID-XX have

we into switch to very we take So which efficient are want Aramchol meglumine And make more the yes, time, we the more patients. at adding switch. we consideration and But to to have meglumine enjoy end know a better and a we of the to more Aramchol patients be of the for to is period. would able at a drug meglumine our And Aramchol longer like that product more day. same

be happen. Unfortunately, mind, that with is best with new recruitment December clear. order our meglumine we roles conflicting the the the the and much will catalysts. diagnosis, we what a hand, when everything of recruitment, a between have is that guidance and a yet and And of with it's the hope FDA to as push of two try executions on data discuss clear regulator the for we of other two. revealed. way with possible all and plan, So public in patients. to very And come see program have are really, that it's not benefits hand I in European will and as timelines this we the the you crystal kind one decide meeting by make information. to regulators And balance In

phase, this at this in that disclose cannot we So stage.

great my next question. very much And enough. that. Right, that's that's segue, Thank to a for actually, fair you

expected PK next in the data mentioned is meglumine right as you month, you for at your beginning, As mentioned. human first

key wondering, to the to next expecting to your announce the I'm next given plan So month to the you move identifying part salt this equivalent be the of forward the BID you're From meglumine, with what month? salt dose is overall of milligram bioequivalence. to is will that XXX

that. Liat will take So,

the exposure. Difficulty] on go sees by the single the there's just meglumine start the to while to which analyzing dose that single effects December, already, dose, two this know put and month, hopefully end in patient long the Aramchol the it regulators So dosing the just be will dose, half-life, need anything the we we course way let's end for that going next waiting keep side, regulator regulator have [Technical enough. will ask design directly we next for can not the I of will dose by single end definitely then middle the not to will will the of on the the bioequivalence fast in in January I with for have this dosing be Aramchol know only those are go you we then tell present. Because will multiple and present safe we we is to a selecting good has and multiple and that to days mean, we the be on the food we immediately Usually, between have will single the to to will data

to the a it's will will among to we will be those or with Aramchol higher package single will to data, have but dose, to anyway be regulator not? dose be a good good for we daily be reach some enough. the to multiple for daily, to that be able So with know to once meglumine, regards usually already send homogeneity With to the going we us us be so provide we then going going So needed, will long if we for be the to daily. we data patients dosing will to half-life enough regulator with placed back single to is definitely it's we go will able them the that have exposure the and better. multiple are dose lower much actually XXX% If will higher exposure that clue at time the XX% going if Or single it's the need because dose give asking of once is

So much we productivity. better see

results So the the mid-December dose. of single we'll the in publish

actually of we tablets it two first patients Mo, the receiving and results. and doses With our took compared bioequivalence, publish to in the in meglumine to the we we'll that Aramchol milligrams, XXX the human the are

Liat. on for this they've imagine do you if the Great. One that earlier, then me of mentioned with combination would MyBiotics I helpful. non-responders. Thanks, to the Monday, is developed. those regulated specifically question around this That's I you and the that patients one the these efficacy of collaboration objectives announced final that MyBiotics with enhance is that may, you way exactly And biomarker that that

give bit us And a so if you the responders I'm exactly able the wondering detail more is or identify potential company you around could enhance to how help advocacy?

we talking way that the best So about, imagine is are to characterize.

the You improvement. his have well a These characterize that natural and response, all see trials. is that non-responders regulatory which different has from to patients a with the completely are the have, that the Aramchol or solution responds And change to going the one. fibrosis you you what you know pattern, change very patient, is. endpoints microbiome that exactly a company the a non-responders responder's Aramchol you you it are clinical microbiota. off even what you what the do the is Aramchol fit either better of to microbiota kind And to to response is response, by microbiome And to Aramchol push to

Thanks, helpful. That's it. Got again.

Thank you.

no We back time. floor turn Mr. you over would have now like this to closing questions to for further at I Baharaff. the comments.

our you do for today. all that joining our I press And will hope December. you call on thank follow releases during So,

human But that you exciting Aramchol the of I from and products meglumine. pipeline and also, our remind coming first to January, lot releasing also that we hopefully, like early there Amilo-XMER we news I study start is think December that by in QX. would will are that is entering a both

and to the communicate be you as Keep data call. this all able safe hopefully well. some study XXth by thank joining Analyst the the of from of January, we'll for Day So

conclude this gentlemen, and Ladies teleconference. does today's

your have a You day. may your disconnect Thank and for wonderful time. at you lines this participation