Axcella Health (AXLA) 31 Jul 212021 Q2 Earnings call transcript

Good morning, ladies and gentlemen, and welcome to Axcella’s Second Quarter 2021 Conference Call. Please be advised that today’s conference is being recorded, and then all participants will be in a listen-only mode until the question-and-answer session. [Operator Instructions] And now for opening remarks, I would now like to hand the call over to Mr. Jason Fredette, Vice President of Investor Relations and Corporate Communications at Axcella. Please go ahead.

operator morning much, very you and everyone. good Thank AXAXXXX that we such our will would trials those like are on pipeline remarks to advise to for clinical forward-looking ongoing call We expansion make work well statements certain today’s various to risks our AXAXXXX, uncertainties. include and as relating that as as subject conference and website our be detailed These our most our and uncertainties accessed XX-Q can which are in or SEC’s other and the filings, risks Form SEC on website. axcellahealth.com on recent All July date. forward-looking our not upon of statements represent subsequent our representing views be XX, as today, views as any should XXXX, of as and relied undertake We update statements. forward-looking obligation no to these begin call let turn the the to that to me over President and our With discussion. CEO, Hinshaw, Bill Bill?

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and our and function, People high our HR as our consulting already and Dean, growth multiple cultural Officer development be the from our including Virginia Chief as and insights of most Leadership our from organizations, well for is recent who joins resource’s both leading She We're Pharmaceuticals. initiatives. Virginia benefiting One the us has human as TESARO functions in June. additions led contributions. to ClearSight organizational is ARIAD thrilled firm, joined

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execute strong as pipeline to relates on seek expansion potential to EMMs Our EMMPOWER trials. plan to inbound seeing of we're also our in company And candidates areas. or and the EMMPACT. team multiple in across the of we unlock continues interest as and ready We're ahead it for

the CFO, Laurent? let to a update. turn me our call Now, over financial Laurent provide to Chardonnet

as you, expenses ended and to as manage to continue morning, like in maintain Bill's our I million financial $XXX would marketable well execution compares that we Bill. balance $XX strong to approximately a know XX, December and team which of the with and extend as our securities, about We with And second sheet. everyone. quarter the XXXX. good echoes Thank million cash comment solid

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statement. income the to Turning

Our is expenses of comparable was development XXXX research greater benefit $XX.X is reflecting three non-cash ended stock-based $X.X $X.X June per These $XX.X for This same or June $X.X the six months and three recent the ended of and or net million quarter the XXXX. XXXX. million Axcella’s initiation million G&A the and months and per for for $X.X were increases $X.XX periods million and respectively. our XX, expenses from were compensation the and XXXX. share were the of and for six million months from and and XX, XXXX million and cost. $XX.X up $XX.X ended of XX, $X.XX period clinical related $XX.X million primarily loss EMMPOWER slightly EMMPACT trials. $X.X million for and This the share million the result six up June million

Our expense. non-cash included compensation quarter second approximately stock-based in million net for loss the $X.X

million and three ended or six Our the months $X.XX was formal remarks. net or $X.XX That share, per $XX.X and $XX.X XX, share. June per our for loss million XXXX concludes

will you questions? operator, the line open Now, for please

Yasmeen question go Piper [Operator Instructions] Please First Rahimi, Sandler. comes ahead. from

you Alicia taking [ph] is much Thank for this Yas. questions. our Hey, so on for

we for today. have So, two you

And is study? so the EMMPOWER question rate regarding is what when report this And failure out you the for First, biomarkers. noninvasive current do to in the screen second data study? expect

NGM's in dataset. recently all-time noninvasive discordance and the between So tests endpoints we saw histological

you lose into highlight why mid-XXXX. is in trust interim of one the in could in So, histological predictive head NOA tests of view, in noninvasive [ph] results just we to predictive your as which most were we responses not given these NASH the Thank you, and we value should hoping the us

comments I'll start for I'll supplement to questions. of Alicia, thank turn the or the and to you Margaret one then two there.

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detail real trial providing won't with level that consistent guys we especially of in so you a of And that be at the what time before, stages underway. provided updates we early

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half will And line data to half this of estimate initial in second XXXX. second in of the our puts top so, that stage a us XXXX the position is enrollment. that complete utilize And at

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those Now share can measurement that quite was that to What for the for early NGM the ran et you will always endpoint we refer in company is fibrosis. aspects. cetera, the that timeframe trials, that

data see is impact across that premature that the have on terms an of And one of point so, in to disease a anticipation state. number. may type And been that time it's

there if would markers. context pause she add to I'll any additional So, and like noninvasive ask on the Margaret

This Development. Thanks, VP Bill. of Clinical is Margaret Koziel,

pull done guidance histology have just and as it is understand companies inherently this me that we and are matter. up biopsies endpoint too Let problematic FDA goes liver as early, all back some an on to say, assessing against

of outcomes. that's look There about the that also groups are on predict this. ongoing and are the at We look We non-invasive those very of is number to discussion what really And forward to rich clinical there. forward which heart working results. contributing testing it, missing a

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And Margaret, make to right or answered failure for the more the I EMMPACT. screen that sure, EMMPOWER the Alicia, you, for just make answered was rate, on and it sure to because Just thank EMMPACT? I question

asking originally was EMMPOWER. I Yes, about

Sorry about that.

Okay, Yes. great.

is of year the in me and how around of pleased the response we completing third let terms top-line that. are data looking engagement So upfront in the with that This population We're first at of quarter and clarify timing enrollment and XX-week next of with the the a XXXX. answer. the readout we're quarter same with the trial, proceeding

is and it's this our first recruiting in – experience OHE in Now OHE. we

again, We with our the engagement a unmet medical a for community. have high There's need high medical differentiation here. mechanism. great There's

world of and field. we're And and so, in looking with working very a the leading is community with medical this in series working these interested experts

timeframes that. we So, update you the again of will on

more So, apologies put that you for asked I'll the answers way. for. – it you got than

you. Thank

Thank Okay. you.

Company. The Please from Thank Arce, next question ahead. Wainwright Ed & comes you. H.C. go

with congratulations And I'll so of for this morning. questions start far all OHE. the for EMMPOWER couple progress me, good on A Hi, year.

improvement prior the least walk through a FDA if the two-point could the As remarks, as you us alignment wondering that that primary in PHES. have substantiates of as on I'm biomarker? that you both endpoint amount is mentioned in at well-known that your you data with well

Yes.

the And Alison So Thank address to you. President questions. ask Alison? the thanks of let me Schecter, for those our – R&D comments.

the appreciate question. Yes,

PHES PHES. the to endpoint assumptions these trial level of primary powering that FDA. including is The leveraging, with And FDA, as statistical assess adequately design, change confirmed placebo alluded with benefit our the The previous a most in weeks in Phase and assuming is our are past the terms have X of the did we the group. In experience a trials. and other to that XX you the PHES this study we're data see In in powered consistent regarding we study, statistically change significant in PHES.

So, we're confident assumptions. about our

on questions And Phase helpful. That's few X a EMMPACT then study. Great. the

You mentioned the mid-XXXX. interim analysis in

three So, questions there.

well First, I exactly chosen some two to to the result have as that endpoints of just is you there to this going surrogate the score guidance? to around interim was that primary make data be in given Thanks. the thirdly, a the through expect an improvement adjustments measure. two-point of clear. there's And questions that why us vis-à-vis NAS the given walk that then you report? Is you're you probably especially Second, as that, trial to endpoint collect? capacity what any think also FDA any

Alison?

were stage resolution we endpoints greater of NASH fibrosis powered and used worsening field. define efficient to benchmark us histopathologic And confirmed and enable the in or Phase equal without trial Xb of we believe than greater standard equal trials and to will that in from this of the primary secondary an of proven without two-point or X. worsening well biopsy across to endpoints the a and in fibrosis one NASH that very we So, this about is that's a mindful chose, change NASH

that non-invasive that characterized the such the are about with we'll You looking elastography And and field key to associate case, and that also mentioned at. analysis in at liver serum biomarkers be PDFF, process. pathogenic used other as in asked biomarkers be histology looking as that what well and are validated interim Bill the we'll

Alison. forward you inform you, because Ed, we're will use X go lastly, as we data for of help that And Type programs for? diabetics in know, that it Thank will will population, help. terms on what our It stratifying

It help and we the the help prepare X well Alison for we're for inform dose us us options an as evaluate that looking there, as way. the combination will prepare two dose, anchor dose as related doses As to efficient help because Phase said, active have and can well. in higher us to pediatrics response,

depend to it adjust that'll ability in set for want on and we we of do, up So, really us inform important helps opportunities find this what the to but trial in expanded itself, terms and us what deal.

Thank Great. Appreciate it. you, and Bill Alison.

Ed. you, Thank

Thank next from you. Fye, The ahead. Jessica is Please question JPMorgan. go

for study trials? current in $XX Hey taking my should the COVID trial, the well expenses going context for NASH enroll R&D biopsy paired in of to a of is are how screening you through guys. BXB progress And what situation. like I in we from rate Good morning. using think Xb. specifically trajectory in the last It second, encourage as about the to Phase roughly strategies guess questions. million the run patients couple Thanks these sounds for the you quarters

your you, Jessica then morning. on good and of little and the your bit start, Okay. a to second Thank part comments. ask Laurent question. Thanks comment on for Margaret the I'll NASH

while itself, it. terms So very COVID overall cognizant in of of we're

plus position the of then have working the we're the are the impact We work participate to the last great with a vaccination course, to through rates pandemic. have so fact had the of on this A seeing And combination we're and centers that the limited to sites been in here. fact ongoing. year that far, no over

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that that techniques with and put the had Margaret So, the you combine team in.

that excellent when that an and the been the questions, wise strategies want the it's and science there saying we've mentioned far, always of to sites I are start from of that of anything in have Margaret, encouraging the understanding you them part be is earlier on other had today? so effective of hear one And specific calling flooring engagement. because they the that detail are in trial their you profile. And investigator, principal guys as and

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you. Thank

Thanks.

Please Thank Mamtani comes of from B. the And Securities. go you. next ahead. question Mayank Riley

Congrats Good our and the taking thanks question. morning team. on for progress

quick I and follow-ups EMMPOWER one then on on have two EMMPACT. So,

the on the two on you primary the on care. relatively the on what could have those you just touch assumptions knowledge, of my gather maybe then any, but PHES? So, Could of current standard And if endpoint of to understudied for what comment that? episodes? It’s for a standard for expectation, EMMPOWER are you study, should you care information on will

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just Mayank to component of And your a of on if that, the build standards to question the think, with I care related PHES.

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of test of two our difference stratify top a evaluate and our those for chance make to So, that arms. ability confident we're to on and

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Yes.

So, for I'll Alison it to the the two. first turn with then question start next

XX terms are already areas our in demonstrated of all of activity So, the data. and of weeks these you weeks, Mayank, familiar with program, XX across we've in XX

a looking IND we progressive information So, set XX evaluate to were of with weeks in this setting.

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Now size, Alison aspects the in comment will on biopsy of and that. terms of effect

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terms which [indiscernible]. most the do biopsies. in top diet monitoring as is adhere actively this in which of we're and a better great likely In again, of to question field and a We're is effect, taking studies, on diet variables all and in baseline do biopsies, of to trial discussion of patients variability diet, with these asking enroll the impact. well-known a question when a there intrinsic that is NASH It’s adherence they inherent, diaries is to of patients prescribed discussed and these placebo medications

building we're comprehensive of set, once likely of clinical will perspective, is one pathologist, biomarkers, the variability a the biopsy analysis, ensure who in rereading And biopsies reliability. addition, mentioned, to sample a histologic the and will reader central NASH which representative be full a premier evaluate as histopathologists we've the from future. In in world practice completing the inter guide the

effect the I I the And size, remember if correct. other question was think,

Yes.

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Yes.

Yes.

Yes.

course, pathologist. use to a at said, been terms histologic portion is with plans our all with have of FDA. in be these of changes And with they But reviewed all to aligned the have pathologic and a single-blind re-read. we're going of FDA the of be and I looking essential this well aligned representative as the So, been endpoints are

thoughtful you. you all Thank the for the detail answers. Thank and

Thanks, Mayank.

ahead. go Nakae question Chardan. you. the from Please next comes Thank Keay of And

you. Yes. Thank

Just selection, sites? OHE feed of clinical about the the those patients site EMMPOWER the are treating to us and how diagnosing specialist your captured clinical in patients into terms to talk and study

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that helps equivalent Okay. this? network also And facilitate there that have you is to an NASH with

and right his of this. right well. as large we sites the Dr. have Yes. in to KOL study some exploiting using the Harrison that for for we're make well. the working leaders the And OHE as I with sure fields impact OHE, network been does in And the mean, a we've centers. patients we're one that in have But we've in get

Okay. Thanks.

Thanks, Keay.

high the the differentiated think back reinforcement the here medical I go need to mechanism, again, here. unmet I'll

recruiting of lot system, building on to that a about know meaning Alison's inbound largely [indiscernible]. for larger these patients when had tend interest per globally. XX patients OHE care eligible sites then of that get sites across comments the number studies. these to are diagnosed site are and on in this And are on have And XXX tertiary they have clinical We for you centers, we're they a thing patients is Board,

we’re and of by engagement the the the team. So, initiation here excited

mentioned, something patients that to beyond going the mechanisms think, care lactulose. Bill which then interest standard really about inbound the we're getting removing goes rifaximin and ammonia, multimodality which doing I action. the And of from investigators We're for is of both

mass our mortality. of other our these So on not in muscle secondary terms and And that morbidity with is but are in effects associated and we effects that neurocognitive, frailty, occurs only patients. also expecting of increased endpoints improving also

you Thank Okay.

question from Instructions] ahead. one next Paul comes Choi with please [Operator Goldman Then go Sachs,

the if regarding And This EMMPOWER on Hi initiation the the regarding one echo Congratulations I'm study. on said have what just trials. others for Paul. on We quick have a the one everyone. different. is recruitment looking a of Charlie weeks progress. XX obviously I'll the also backdrop know, you improved question, but it's that to of things lot were COVID-related more has go COVID sorry course we the this year. over back much ago But

considering identifying past you XX XX of the impacts think weeks with around COVID ago very difficulty have And in presenting the lingering there that Thank possibilities a terms weeks, you so, if had OHE that any do are events events within environment patients patients had OHE time? of have much. for we're these who

to you a structured of Charlie, I'll because circumstances it accustomed tertiary of the used very it. was of whether The are change level in previous question. question, that's where care. OHE come answer in these say that's have, events managing sophistication thank as well-documented whether to requires is and a these who a course whether their a having patients alluded centers vehicles, short care therapy, we centers a of are in the these coordinating that for with home are elements. number and And of them The of is as academic are visit, telemedicine, change health, been

not that the have terms manage on how in of you and pandemic the as concern. And well it. very this that's be timing the centers progress seen we for of standpoint, made the from of issue particular worked So, that alluded to has actually us out

progress this it. So, we you we heard course, will of date dynamic to said, what seen but and continued have is in as area. it's And monitor

to so Awesome. much. Thanks it. hear Glad

Thank you, Charlie.

Thank you.

Securities, comes from Argyrides, ahead. question Wedbush Andreas Next go please

as Thank morning you, the and on you operator. to quarter well. congrats Good

you when – Can next discussions Just expect And product NASH? a have Thanks. update us. on tell FDA pediatric also candidate? the the from can you on updates EMM quick what an the with us any regarding then one we

Okay. for the the on progress. Thanks, Thanks and compliment Andreas.

first we've Xb then communicated and objective get for about the right strategy, move the optimal talk the In the adults didn't to at re-engage project with really terms forward. before of pediatric our as NASH, time Phase was the up to agency

development. As that. forward the we profile, one on you us with and updating to in safety time look There's all for high appropriate sets American NASH. including have to is dosing unfortunately believe a very children considered growing We need well already we that. and our at ten our limited know up mechanism this And

be we've team of about The studies R&D in that step the the of that excited We're taken of done. has we'll later year next we've And terms in steps the that the about opportunities. Regarding guys updating company, major we approach, taking the biologies to that next in the additional want the affect. this will we and learnings that the work company. had terms very our number you learnings be from the into

forward at time. Jason, right look we'll out course, to and the reaching of we that schedule to So, be that

Great. Thanks. Congrats again.

you, Thank sir.

back ahead. to go Hinshaw, Bill please question-and-answer to CEO, conference like our turn session. the over I'd concludes This

operator, So, thank of you in the everyone everyone. for enjoy comfort hope and your see then the Thank time soon. the this rest this person fall call. concludes morning. this Until We're certainly please looking circuit forward our And to summer. you of to everyone [ph] the start

you now presentation. today's attending for is Thank concluded. conference The

now disconnect. may You