Axcella Health (AXLA) 12 Nov 202020 Q3 Earnings call transcript

Good morning, ladies and gentlemen, and welcome to Axcella’s Third Quarter 2020 Conference Call. Please be advised that today's conference is being recorded. All participants will be in listen-only mode until the question-and-answer session. After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] And now for opening remarks, I would now like to hand the call over to Jason Fredette, Vice President of Investor Relations and Corporate Communications at Axcella. sir. ahead, go Please

call those and would everyone, certain no like on include such will Operator, submissions statements planned this not to clinical statements. and forward-looking on studies also remarks tuning prevent morning. as be of to evaluate safety, make ability trials as views call conference update We to statements views today's to thanks note you, our can who's IND that to represent our our forward-looking in or we candidates as our Please relating diseases. data we Thank risks for advise the most stem that upon clinical November undertake designed structures to representing our evaluate for our axcellahealth.com various subsequent to XX, risks other subject were functions. the will All non-IND obligation XX-Q should relied filings, uncertainties. effects These SEC's on any biological to today's or reference studies and forward treat as quarter Form and intended these product not XXXX, be and uncertainties or on are normal designed and looking of and and the from today, are website We tolerability the SEC which that detailed accessed in that date. on website. were recent These

of AXAXXXX clinical trials will aimed this Our AXAXXXX next be at and call.

turn Manu our are Chardonnet, now the Chief Bill Hinshaw; discussion. Chief Laurent our me I'll and over off with Bill kick to today Dr. Financial Officer, call Axcella’s Bill? President call the CEO, and to On Medical Officer, Chakravarthy.

or and you today. clinical three be with key this and brief morning, take of the for upcoming will your will to examples whole, update each NASH on on our and in call. morning validation most stage share on and then our today's trials everyone. as advancement recap recent Axcella, financials. details a period encephalopathy some We follow-up programs, good a Jason, of this we're We’ll you, to happy you and OHE, joining I significant us hepatic excited Laurent appreciate has including been our important overt of XXXX questions. a Thank of and

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review CFO, to Now turn financials quarter. the third our Laurent? for to call let our the me over Laurent Chardonnet,

Bill, morning, everyone. you, good Thank and

position. areas IND. X As morning, expenses. full Bill securities, third overview under with with cash This cash by increase mentioned, thoughtful ended very offering and as million we on May this Phase compared $XX to a of clinical these our stock start can FDAs primarily were in is into and completed we the will $XXX result discussing I marketable past quarter of the that past We management a months productive few XXXX. the of was the trials proceed multiple at end from that net in The million proceeds affirmation

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in pipeline. that With So, very operator, million will well-positioned line with hand, on $XXX are for open please advance to we the to questions? continue our you cash

you. Thank

begin from Please now the session. Sandler. question-and-answer ahead. And instructions] Rahimi Piper first be will with the [Operator will We question go Yasmeen

one continued on questions, related making. of but Congrats XXXX team. XXXX. progress and Hi, Number you're to

get on let's maybe So, started XXXX.

in can So, directed is endpoints. first be color histological question give bit you terms on the you're of little a going us to the for powering what on, you

evolution if you endpoint fibrosis, the and histological be shed NASH You potentially could important. both on in benefits light see would

out of other typical non-invasive pointed interim will the the the be much And the understanding there include? questions. study And very And in would XXXX, will Secondly, would an analysis interested that side that then what MRI-PDFF would you've taking to biomarkers? in that our the Can tell you thank regards would be interim you and be analysis endpoint interim for of us what conducted. be or be. analysis we primary again

Bill. very to Yaz, we've And is yes, excited great Thanks, Great. speak here. This made progress you. with about the we're

specifics plan what and forward What terms are then share pretty into questions, say protocols In specific can first-half you of the we this, of is which detailed on on the communicate and post-IND I'll trials, some expect with to specifics I'll your study. information. detailed tell I carrying both of in we the trials acceptance, and the 'XX, you two

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coming similar IND share for now, is would I finalized that share at position in We to additional the IND. a public share of of where acceptance, the to you know we'll to are of as in we to again going at that run be We information will in is well that and the we're hundreds have accepted. least at in this we'll about be these as then analysis looking trial on They'll the details prior lactulose liver who are going want details guys ourselves dosing advanced a the help IND month likely be looking lactulose XXXX, patients of there And Types patients, all to low more co-medications there. update. analysis. period rifaximin, globally expect terms interim which we're right or be beyond following acceptance plan on in one a trial be details once in the And the they're look the plus of again, six disease. so we'll interim at going near-term. event, to OHE provide the patients

question your those on other include where around to score, PHES elements OHE we'll of and acceptance. expect communicate we finalize terms those In post-IND events and endpoints, outcomes,

the interim, follow-up be that's and/or the on approach expect more number a move for arms, than the plan we're trial. of sites low number examining typical streamlined futility then details be communicate Phase we we're regimens and we submit additionally, on of to have And Here forward both then we we're similarly, because site first-half, to the interim in dose the to all upcoming and on familiar which And selection And four X about a and little the trials. approach here. of in already as you're excited when we and optimal confident very different excited dosed patients to we've then then similar this in patient be this will finalized, again population. IND the And the number an acceptance, globally. with hundreds

for Thanks Bill. you, Thank color. the

And the Morabito come next ahead. Michael with will Chardan Capital Markets. go question Please from

for do think both on plan clinical sites for What studies? trials, bit Can And to us how Hi, when IND, your of your year, officially when what you of anticipate the begin announce for those next you in expect for how have announce us? previously you used accepts of more taking versus those do FDA many color enrollments each the that first-half trial plan you you do team. you please give a when secondly, many each questions. trial? between to enrolling might in versus been the on file And trials? little you you initiating clinical Thanks IND for

interest questions and Thanks, your for here. Michael, your

case a is not fairly typical, IND going approach first of Xb of going you're human will standard IND, announce we're study, not we practice. certainly into the initial an X terms we're and Phase In a announcement, in our is Phase on our into In familiar which study. the as the opening acceptance the

So when will of screening et be normal are opening and process longer I trial, the communicating enrolled appropriately definitely we'll because have setting, initiation that outlined we'll patients all communicate typical the then take And a all. of the we acceptance, IND with will cetera. the because have we than that you

terms of that many that and again, communicate post IND we'll sites, acceptance. how the finalize In with

And of on ability network summit number the in and And with our on with is one that who the of familiar a working Harrison sites with of continue collaborate piece. have on We them, are in execution before. planning to XXXX, collaborated with setting. we're you're confident that very strong continue we Dr. to course, we that a this

to-date, So are we're impact dosing course, not place pediatrics. differentiated this profile. as X NASH, as and on generic leaders, with program And there. our is agent combinations, patient because lipids agent, oral convenient in but potentially with its where as The then the target we as opinion very with in then see safety first there's differentiated well believe lack header mechanisms profile. both itself, of the as be multi a we've the profile of the very profile and need excited, diabetics, profile body be the this demonstrated the on only potential marketplace line opportunity And Type weight and well in and the with terms was well-suited working to unique large of population the they of tolerability as the with population, systems, a a for

you. Thank Great.

your question. for Thanks

Please from Julian BTIG. is question next with ahead. our Harrison go And

on sense now? safe the as your this Or good you're subset Hi, cirrhotic path forward in might for it come say XXXX, I'm have in to stages a the at on for up if discussions taking that to for for explore Is questions. earlier a curious In future morning. all? make NASH is my [ph] focused cohort? you Thank

this Hi the Chakravarthy. Julian, for Manu Thanks question. is

Phase to focused that the course, in first on non-cirrhotic this our Xb going So is, using be has further on guidance NASH of FDA guidance the one.

[ph]. to it'll criteria, FX, Bill earlier, FX, NASH So alluded histological be, as standard XXX

with minds. of spectrum. And a this in more the believe our platform disease Your know, XXXX, all we course, disease patients. We on that's our considering program things, liver advanced already widely as is question about applicable potentially other you across have

on something could then or your be And prior helpful. AASLD, comment sorry, if I expecting Is it. that on new missed any at now? data? should That's you possibly we Thanks. presentations great. data analysis Okay, incremental But of

we the impact So our have Type to as had we've X and both the you on the and on all well overall excited poster diabetic, presentations, focusing population XXX, differential two a of of about talk as consistent subgroup know, markers. as impact from very key

that ones key there. two we'll the are those presenting be So

And you've a gives the specific. so you population in Julian, previously, and little of color seen additional what bit depth versus diabetic

Great. Thank you.

is Fye Jessica with question next from ahead. JPMorgan. the Please And go

Good bit suggestions Hey, for of was Thanks there. that share plan? for pre-IND meeting more morning. you the had, could study What that to I kind my little were you're the a your into FDA if taking question. able incorporate about of the wondering XXXX? some

Hi Jess.

obviously, can share spoke had you we with a that by is we fine Bill go I cannot we as paths into fact we But well phone details So think correspondence, study. biopsy which what that that outlined as written of this. share on straight is the before, the can the all

serial standard that Again, than is population. on XX week greater FX/FX So duration study with the criteria. histological standard not typically in four endpoints, [ph] focused biopsy

proposal all to be XXX we package studies, deficient characterizing that to suggest from helpful. get through streamlined was path. certainly very streamlining non-invasive seems that So generated were which Their of this our have to the that markers, us our and acceptance really XXX far so us

Thanks would XXXX question. the it for morning. for even Good from Bill. is this Jess, back pull And minute. just up I a

we have quite think been you have when Xb which step design and what to how X best is Phase we the FDA tell proceed, remarkable and what's and years, can do. now the And been is, XXXX move path, back interactions had what and inside to rest other about and able a of we Phase I you agencies. inside it. the regulatory of can series consistently there four questions XXXX, we've of just fact can And I about on both want between that, with to so And

non-IND do placebo, Additionally, well-understood that a don't worry to how to gating aspects is related and we the how we of again setting, toxicology confirmed whether programs, number FDA very at in biopsy we are execute case about have don't IND in trial, we we formulate, now we that a have clear to our and work, moving this or the supporting into a safety Phase going is the that Xb us characterized, into forward the level. how

and excited we're terms fact well the efficient about way, in So extremely our approach. our platform also for and in bodes it our future this validates position what highly a to And in of that a for it puts us well-informed this be programs.

your great. then you're And with but opportunity on on sarcopenia advancing cirrhotic know Okay, XXX, just thinking that indices XXXX, I asset? what's

Yes.

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in We population function well. and the advanced will more to be structural measure continuing muscle patient as measures

of core OHE. the is Our prevention focus, existing regulatory of endpoint on recurrent course,

support claims, see and measuring the there whether mechanism then are that the additional potentially additional us addition future to to populations. be differentiated will and in allows these We in

core to focus anything Manu, the approval there? is is now platform. regulatory in there Our the core getting you'd add right like

No, really I covers Bill. that well, it think

Thank Great. you.

you. Thank

Leerink. is Smith question with Thomas ahead. Please go next from SVB The

Hey, taking for the guys. Thanks questions.

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this Tom, is Manu. Yes. Hi,

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all and can -- precise So, is finalize share the more in those once are On your is with question this you But of we Phase do plan again, us. details at the standard doses. we're two the protocol, guidance. IND the X for the But about considerations accepted, breakdown. point, to second we the

IND and So IND again, say, the discussed, you. with recall that, that are, doses, the need we information XXX, also we final up the what wait doses share the enough protocol we grams perspective if that the three for would on suffice on final, and think are it's and do I one and to to get final But doses from being XX we'll day, in to accepted. decision the take based to we think Phase these the do would XXX acceptance details XX you finalize the where the actually two that to trials, have we the tested course, to then per And of wait second dosing XXX in we was believe grams day, per we a until have Xb. be

got Okay, just a it. quick XXXX on cell. And then sickle and follow-up

you're forward? here around to to December, kind this something move not get a more a You're Go/No-Go to to and talk a on of the set you little or the maybe or what little whether on give from first bit open just need you program. see data whether not cohorts subsequent then up decide in to going to the the first from Can color guide decision decision cohort that going initial or results

And was there, coming biologies Tom. as with, excited our beyond lead cohorts. eagerly wait to liver a This optimistic, year, then blood it programs programs major we're at up, vascular then function comorbidities. of Sure, And means looking decision expanding We're into three you're there, this you red readout metabolism, and cohorts the familiar cell see a and forward our for the That's we'll number because number positive. inflammation. additional core tolerability And looking, well safety a of communicate allows at to then subjects, has right directional small is as the that for assuming appropriate decision. you that's as tolerability. population We're safety we're Bayesian a question. into binary of a next biologies, have on and that data. relatively to we'll and and your course, impact answer additional make we're which will which we the be looking design, in What move

Got it.

for question. Okay. taking and the Thanks for color thanks the

you. thank course, Of

next with question is B. Please ahead. Mayank Riley from Instructions] Securities. [Operator The Mamtani go

Good team. morning, on And so for our again, year taking far. questions. congrats productive a Thanks

So, maybe choice next context on of in update the the diabetes I X can may really AASLD Phase if Could for touch on, patients Type you and Xb. your week, this Phase And background pick be What for some be aligned of like I follow-up. cohort? that then are study. that And you in thinking you're therapies GLP-X have included proportion of at about in Xb? if a all,

again. hi, Sure. Manu this Mayank, is

right the don't some now. can an So like I'd partly who to therapies here to tell, many have help somebody patients diabetes very options I'm as because and excited about endocrinologist, really you subgroup, have these

liver NASH with and terms we the certainly XX% the in diabetic. of ends being based more to what share And advanced epidemiology the that diabetes fact So, diabetes typically disease. have people of on that can XX% with you subgroup is cohort up

understood many bidirectional studied well-known been years. a for has is this that pathway So and

Bill cannot And are I say XX% already XX% say epidemiology. the as it's obviously what design, to we think we diabetes. to think outlined the trial proportion, exact people suffice is, the on stratifying based it what So but on I

we this the did is the that thing expect to we do So in same. study, the XXX same

meds, the around question standard certainly, management population, here again, very as very familiar anticipate well. and we therapies to patient had these details we'll again, finalize that of same that similar And we're a we wait you background XXX, until the protocol. have something we of terms from But are the are In recall care the with. similar will fine

findings, without population. on and two really sets XXX, very post benefit would important this a that an in Type then broad and guide also I this replicated that we next Mike, to will Xb this have Phase that for that. both data we degree that the XXX up add our and is diabetes, the X development our understand to opportunity so determined differentiated greater the potential as a And this well X follow-up where Bill. just diabetics, studies next us steps Type population included

That's color. helpful very

OHE follow-up clinical the to study, platform my And about broadly, thinking just have So your earlier drug-drug they in interaction curious of thinking context are kind IND about so -- background is, do. I'm discussion of work, stage what and probably. the I'm also that you also

Phase those had the you earlier stage can are to Type through side quickly Type you moving the in across on What maybe on very So Xb meeting for have walk Xb and some learnings have considerations Phase this another us are study fast different you OHE. X meeting just indication? that to or might Xb you'll talk get effectively

Yes.

here. second of So part I'll the to start for answer hand it Mike Manu the then and

very of gating work we but agency, that something we're is, dossiers. amount of reinforce toxicology excited with just up no I'm consecutive here interactions provide information in I'll not and you or that's to two So that the program the there And our are and have studies our where because data studies, that's able required. submissions now about, modality which the brought

about our platform. for feel So on that basis is go very confident a forward something we

other it's more again models. Additionally, move DMPK-related, we whether whether cetera, traditional can that compositions, efficiently it's have related our faster we to and steps et than

we are there potential the that about interactions prior have quickly feel our is, aspects The studies. and -- interactions some very aspects do. overall we agency there. a new drug-drug mechanism, and significant to gating on some work that's my drug-drug aspects question not no There you sorry, are starting got in these good of have case then are And to I'll you our on to expand DDIs any should in context, based related know is what there requires to that. terms what In so in call necessary

So, Manu?

Yes.

to on just metabolic So modality modulators. endogenous build the is Mayank, so that

the mechanisms xenobiotics. enzymes, So transporter same not clearance general do as biology amino acid share in pathways

So things reflection we've wise, are of things distinguishing We've not feedback usual that unique CMC, from then tox, that the gating got many DMPK-related this is obviously the showcase of is of this the a here. agency factors feature are platform. our like what and

safety So, I think the of modality. that to should the be a testament intrinsic

the very patients meds. beginning, that which from allowed concomitant people many are comorbidities the diseases hyperlipidemia, since CONMEDs, these typical the we've is, studies, have, other XXX diabetes. study, polypharmacy trial the XXX the hypertension, of have The have typically are These all

our And belt these have so already on we under meds. experience clinical

guidelines, quite so we've feel some study, that confident done the where, the again, acceptance we principles, going going to management extent, already essentially same studies to formalized to feel the do because all our have issues. following emphasize again, not in one-on-one wait these the and So, the But be we we've share IND we these that details. same fine confident of would protocols, until order you are with would I have to into and that

was, interactions potential your if think the I question I on XXXX, agency with recall second correctly.

productive the XXXX, interactions, remind actually just ex-U.S. to fairly of able with So, We ex-U.S. course year, had as year, we've last both a I protocol what looks been with the them like. everybody come U.S. as this very of over we've good agencies, including where would agency understanding that meetings along had well the to with and several

we're anticipating further interactions. So, not any

that submit and the question? 'XX. the in of the to anticipate the first-half 'XX We are going also to of X, approval in IND Hope answers your first-half initiate its Phase

And you indication? is reminder my the NASH where with comprehensive quick the one color. appreciate Yes. just are pediatric I a on final

Yes.

is one to because that did NASH a of FDA. health is is unmet again, burden, is Unfortunately, subgroup also the this is. with exciting burden of medical obesity significant So, of a opportunities, raise that happening pediatric We kids. the our this our and the topic like epidemic diabetes just diabetes

reengage their the interactions had we with once lot adult our focused underway. Xb understandably Phase course, have primarily get a of program, agency we in the development since However, development program, We, through. to and them with the plan on us so pediatric to adult

Thank you for taking my question. I appreciate it.

Thank you.

[Operator with Securities. Wedbush instructions] The ahead. next question is go from Argyrides Please Andreas

our morning, our and Good taking questions answered. also for been Most questions Thank you have Liana. actually team. of

score, just gold I encephalopathy. PHES the now. I'll for know two With ones standard the it's brief ask to hepatic regard right minimal So,

use plan how to it population? overt in the you do So,

Thank you for your question.

to PHES of is assessing function various It battery has psychometric different pretty executive spatial actually indeed cognitive from rigorous, to have a to a domains the used So, evaluation, pretty memory MHE from five also prognosticate aspects. but an comprehensive been standpoint, tests, OHE. both visual to coordination,

our impact the in we And that, fact events. OHE. from subgroup course, XXX, of that is, in we sub of but able that to the given believe setting it OHE or future look are used population, how results only So does not at, also MHE

And Manu, population maybe MHE OHE? about that predisposes for speak the

a great point, Bill. Yes, that's Exactly.

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those the to to studies shown best of baseline at a if five you again six higher which episode, people OHE the So, are a far that PHES, going so is future diagnosed event. prior risk MHE have MHE have have fold or with

our assessments for very, very in study. us, of key one and So hence, the pertinent

the know And XXXX, briefly color to much you Okay, proposed discuss at. great. Thank composition, on provide for previous the I key but the on the then things some look you based for question, you could color the the just too on that. mechanism you. Thank maybe of

please? question that repeat you can Sorry,

Yes.

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Yes, great.

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So tackling our of with similar we comprehensive to way, very other believe multifactorial a all our products It's really in them. this consistent here. in of Axcella approach

each to the of measures, those biologies. and of So course, are multifactorial address also

physiology, as those inflammation. So we have as each for well markers specific function, of RBC for vascular

couple see here. biology we of Andreas, And important throughs a read

these approval important important with a also you're disease also biologies where hematological GBT's and there on and familiar endpoint role. an health disease. sickle But course, cell areas are other play Of

So the very our we platform. design we're opportunities and That's through excited that to see this efficient. continued for read see

Great. and update Well, the Thanks we're looking progress. on as the forward all well. to guys, That's me. congrats for

you. Thank

I and to would Ladies back concludes gentlemen, this over conference any to for closing session. our Hinshaw, the question-and-answer turn remarks. like Bill CEO,

in thank today, you all tuning us everyone. for with So,

Axcella. ahead. the made the on you ahead And pleased in XXXX. in of weeks the and for many proud look We company circuit are the about lies what progress excited of we're And that has virtual very to we forward seeing

call, safe. our everyone. Thanks, be this concludes and So operator. well Be

presentation. conference Thank The you concluded. sir. you, has today's Thank now for attending

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