Axcella Health (AXLA) 10 Aug 202020 Q2 Earnings call transcript

Good day and welcome to Axcella’s Top Line Data Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note, this event is being recorded. I would now at this time, let’s turn the conference over to Jason Fredette, Vice President of Investor Relations and Corporate Communications. Please go ahead.

everyone us thanks morning. and Ian for this joining Thanks, as press we filed quarter About data well study. ago, XXXX-XXX a our financial top release AXA for as second an hour our issued and clinical line containing an results our X-K

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was the session. our President the that Chief on with Hinshaw like Safe first, Slide to But see members On our Medical call would to CEO, our advise are Q&A me management line today please and go to Other obligation clinical Axcella’s represent and evaluate a forward-looking you to Axcella’s of our the or those be of subsequent AXA X, Chakravarthy. will our other the XXXX of XX-Q and Harbor data any make was normal X on filings. trials our see These are we prevent effects remarks model and intention to relied description as Form undertake Those our are take that treat on planned as generated are August function. certain to representing a Officer, The statements these or and today most statements. AXA we part you are forward-looking disease. XXXX product and certain our clinical to All structures be we presentation engagements development We Manu We Dr. safety, not statement. the for views therapeutic. initiating Bill quarter evaluate are under recent uncertainties and including today’s views ability can Subsequent our forward-looking date. a in update detailed Slide biological and be clinical intended IND. develop non-IND as its risks statements the study announced not call our of designed website will the no will upon expected approach. SEC’s designed accessed regulatory on to candidates website. and subject On tolerability to X, study for forward-looking, that and today, should related conference to filings and of as to SEC IR recording are in The or in XXXX-XXX,

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thank Jason and Well, good you, everyone. morning

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Now, back to let me Bill. things turn over

you, Manu. thank So,

Slide tell, you with pleased we as are this good findings from a can summary. As XX study the very serves and

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opening your Axcella’s to also Directors Dr. his Board Vice his Manu call before questions, and to addition on Now, promotion Executive to I and Aradhye on President congratulate the to want Shreeram of CMO.

Chief As to over have you down and activities. stepping Manu be last of the fantastic will May in with done Officer. of Development he a and his joined day-to-day many our this year teams. Manu from accept job role Axcella taking full-time clinical of regulatory At Shree new Shreeram out know, the our as end Together, this of month, position building

we council take continue to are as member we board the opportunity our forward. And to going very am happy from clinical programs. and benefiting our will Shree’s continue well-prepared I a So, steps have next

instructions? would up you please questions. the call So let’s to provide with Ian, that, your open

comes time, of this [Operator our Harrison Julian from instructions] please proceed. question At Julian, first BTIG.

these on data. Hi, good morning. Congrats

me. for two Just

from might the indicated so, program, case that no just the of you if XXXX to to to move trial the this I longer know you able about back is First, decision you and a want that? talk step potentially as for can into be previously next for away registration

Couple a things. good for here. of Julian. So, as this outcome. you your question very We successful Thank see morning,

and you setting. on study our a us that impact was and on proceed. conducted Fischer’s saw that saw science the that findings confidence As neurological our AXA XXX based and in our impact acid in to give metabolism this replicated XXXX cognitive around And you non-IND amino lot for the we time. ratio a we We know, built, important the first of extended

that said, you best what when at will chance an give the what starting trial, efficient in of next you that way. at Now and are look looking do with you the will of course success

believe Phase patient liver And that trial understand looking advanced the to have cost highly prior the is be impact to a the and you next So patients you to there, step impact X effect that we in registration starting and trying is de-risk design. specifically you informed, the would advanced, consider in efficient with are full stage this a disease. size the next and because and at

an have predominantly dysregulated all increased and these in be potentially demonstrated state, an We will patients. that mild we to have able mild-to-moderate believe impacts And we impact. in additional

years we and impact and in this replicate talking have muscle at and allow liver confirm advanced about would a which that and looking AXA in understand design treatment and events is better that smaller metabolism neurocognitive as will remarkable us findings, just the then in later, So, X, are I to our bring would to could again patient pretty remission the to moving will us and designed fact into timeline. new a this MHE and such readout embark that that to OHE X at that specific disease And be trial otherwise for are XXXX function the we And that options shorter back stage allow go hopefully Phase on we population we a a XXXX patients. successful population. to stage patient

case, can informing that there are just updated decision? points in That’s the from data just Okay. walk Thanks, the perhaps a helpful. goes XXXX broader what And that frailty, question, expansion for are not population of you patients and necessarily suffering timeline considering just still patient label my through I if you encephalopathy? an with Bill. briefly the was last is And currently if then cirrhotic opportunity wondering

Yes.

that OHE. patients XXXX offer of the will believe terms targeting it to for working to continue plan in that And part metabolism would as through play in fact we and we So role important additional we be of are OHE. what potential patient an with are to and talk the outside multiple with benefits in you because outcome want At that may more us that point know, to that we advanced the a population may to would frailty at muscle to biologies indeed That’s integrated stage about and in we in. program. of next opportunities premature the time, allow timing, evaluate of continue of And this sarcopenia. are that

update appropriately Of as those plans. course, we will you we go along and develop

Great. Thanks much. very

Thank you, Julian.

question Your Wedbush Lina, next comes from Moussatos Securities. proceed. please of Liana

Liana. for thanks [indiscernible] questions. for And our taking

question the you from you. path idea standpoint? up look would from Phase as a give the to could Following forward, Thank [indiscernible] like on us any X what

from sorry, am couldn’t standpoint, part. that last what I just understand I a

apologies of could But looking clarify with for yes, the going Thanks. I endpoints with kind didn’t FDA, looking the you FDA on clear. in Yes, points I your they sound communications us forward? would forward if be what

also authority. extensive question the had And have not interactions only European FDA, for thanks but we with so Okay, the actually here.

and risk of quality overall for is episodes the can and medical Julian’s the muscle to finalize you function the to tell So, of work very scope positioned there. will potential we design, scale describe that around about the very this are well experts we premature of data of continue I What because feel next again, question, is it to OHE steps recent and with be continued impact life. the endpoint and program, we to it. reduction on forward is And will exact clear our

finalizing the updating those you half the and very interacted factor are plan on into the we initiating agencies that guidances from in a after design in again are So, of with clear have we we that at and to all program design our position point. first have we ‘XX the and

I queue into jump someone questions. and let you. back Alright. ask will the else Thank

Thank you.

proceed. comes next of from Yasmeen Yasmeen, Our please Sandler. Rahimi Piper question

Great you. you. I questions of happy have number a am data. very I for for

off know design Then first be you off considered patients? Can the meaningful? critical So, on tests frequency B follow-up. have the invalidated so And that you to study would one would comment start did was help flicker second why be I other us to studies? Child-Pugh on going helpful clinically those question what not us differences to are cognitive could and that? I include if clinical any the time, then for and magnitude visualize maybe is is been what you those kindly have can Stroop comment another the in include

Yasmeen. Manu I will to the thanks on first the for it ask question start then second one and on Okay. with Thanks, and build your congratulations data. and into the

more could that of the are safety we this outcome. function know, well structure function terms and the you in study setting. that events non-IND of looking And first, In you cloud population, if as to the structure and such a as is tolerability liver as you at nature patient muscle guys advanced and go populations, as that have risk of

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see and and CFF again and answer are ammonia. replicate Stroop. stable population about in to expand will we that Manu to very have metabolism muscle have pleased then question that on amino acid the these Now, and cognitive able effects effects I your be

So Manu?

Yes. Hi, Yasmeen.

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only we this did And looks have the would agents this and approval. that demonstrated achieved is I therapeutics And been how population certainly the that range Yes. review have we versus and the in of there the at indicate is in utilization development. other supplement thing well within range have

that’s that indicator we for are zone. leading in great So the us a right

between on the And you. have phenomenal question do Maybe the what my low dose when given could done follow-up that you and Fischer’s is ammonia look maybe ammonia you on when consistent then comment to just with the assessments have you as at has [Technical high was ratio the handling, we test it could And response dose Difficulty] be measure of the Thank data imminently. seen. to don’t as see and I much we sort dose.

could kind Thank around of if for ammonia comment So us? you data would on be the very it helpful just you.

Sure.

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So, a we more this something again liver be advanced is population will of dysregulated in tracking carefully. disease patients

congrats Great. you. Thank and for taking questions to you my so much

you. Absolutely. Thank

And Choi from proceed. please Paul, our Goldman Sachs. next question of comes Paul

can remind know background Maybe therapy just what maybe Thank I in the to everyone. addition you allowed for but criteria, just can were background on good the exclusion just any clarification regards in new levels medicines XXXX to on data, the trial, remind was the morning, like? there X us us Congrats XXXX? one data. – not you you can with the prior you month were allowed and therapy

Yes, hi, Paul. All background were therapies excluded. HE regarding

their were and were normal to or all not were on the rifaximin that be the those hyperlipidemia, like comorbidities, other doing for people All hypertension lactulose phenyl the So they allowed. etcetera, allowed meds diabetes, doing study.

they domiciled we case, is giving previously. of guidance had right. In this not a setting, as in exercise And in this were terms

Yes.

to well of and population this translate of used as in diagnosing world on I Great. acceptance, neurocognitive Thanks to just PHES for on in real to then comment maybe occasionally which clinical the that just regard terms how compare you specifically And might and utilization just compares that understanding is con and know the and of score, PHES, can with guess practice? how clarification. that endpoints, a degree you

Sure.

So minimal the why that’s detected score and using not hence hepatic definition sort encephalopathy such not are the a of MHE, the only Con typically so at for mostly PHES can minimal grading scoring just be not it’s is right, X overt manifestations is setting test. encephalopathy category as the hepatic cognitive then X ranges decline, encephalopathy. overt are overt It’s same in system hepatic hepatic score. by of and by looking – and the the an designed specifically MHE in and encephalopathy mostly for

ranges What used it So, and probiotics, and of like you we they multiple we for are many LOLA comparisons different are they OHE different at anywhere and that have or same score treatment lactulose for things. the the you an etcetera that their agents improvement PHES, other measure of trials what when scores between is compare X.X. caveats across if can say somewhere will, X.X exactly looked other – not across because all between of

it’s PHES at we the our to zone. look just when essentially change of scores, So, that in score of placebo is around X.X right

caveats we custody to the with sense get therapies. do of comparisons, other of on XXXX of So in where all that PHES a other can types are in relation basically sort way, we the with

MHE us the I is Manu he think and you that looking event the population indicate do significant in warrant the percentage that would a be would be And talking experts known been then, those and to that from that has one with populations intervention. the aspects field and that a of other Paul, of would that progression OHE at

That’s a maybe FDA? to you my would the plans that meeting, your last any your X? questions. Thank discussion taking market on context. And our for to then how Phase plan just Okay, following in date of XXXX, helpful and then the great. for set And communicate pivoting question, you specifics have the terms to you with

you, thank Yes, Paul.

study, a population earlier related you and data exciting we very our profile, we that consistent in had as results about look Phase the all quarter a safe we XXXX, effect biology to, diabetic and forward exciting the the take So to we planned XXX Xb. important the in of alluding data across where shared to saw well-tolerated are is

with I matter, year. other phase What initiate agents. is a the we next for to typically regulatory course, don’t our can of in the on track tell timing our nature or remain time the on FDA in we first interactions half you Now as program comment of specificity and of

trial will the design, which final with and post exchanges shared past. We in the we you have

at finalize are exchange You are can in Xb to a ready the and measures once we be agency expected initiate. will you expect Phase share important that in that with we we that will with looking

that update at time. will you We Everything is on track.

Thank you.

Yes. Thank Paul. you,

next comes Jeffrey. SVB question Porges of Please Geoffrey Our Instructions] [Operator proceed. Leerink from

the This but congrats trial, of X yet is morning. on Geoff planned quarter few a duration Good for And Phase trial and Phase then, the the the describe appreciate X you that you for can I detail data. on on cannot Brad And both space. clinically of been across the regulatory HE? IND there quite comment in typical have NASH and please updates

have So, I thinking for positioning if you XXXX? like to these would hear changed competitive on Thank your you. from

great. Okay,

and I I comment have on will start first second. one So with the the will Manu then

So, Manu?

Yes.

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that So, range. in typically it’s

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play you big and there. NASH interventions space could excited with remains complex next know and the potential benefits question? an for for for to if important we So, take role we XXXX the Ian, of are disease a lots

B.Riley comes proceed. [Operator of Instructions] FBR. question Mayank from Mamtani please And our next Mayank,

been for Congratulations This so far. A good [indiscernible] questions on number data. Hi, the morning. of is on Mayank. team have our answered

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Great. I can start in chime too. and will Bill certainly here

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biomarker. dose that We clear key have response very on a

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on data taking Congratulations our helpful. very for That’s Great. the and thanks questions.

Thank you.

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

very much, you joining for and enthusiasm you data. today us our sharing all Okay, thank Thank our for Ian.

to and platform biologies demonstrate safe have the on a EMM our and tolerated profile multiple and and We another are approach study well to-date. simultaneous to excited impact of continuing have

in you in up. season summer for some and picks everyone. conference stay very hope the you then, rest safe. once enjoy speak everyone. back of your tuning September to thank Until to of soon Thank So, We you the

conference Thank today’s attending presentation. for concluded. The has you now

disconnect. now may You