Axcella Health (AXLA) 30 Mar 222021 Q4 Earnings call transcript

Good morning, ladies and gentlemen and welcome to Axcella’s Fourth Quarter and Year End 2021 Conference Call. Please be advised that today’s call is being recorded and that 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 Jason Fredette, Vice President of Investor Relations and Corporate Communications at Axcella. Please go ahead, sir.

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

and will to as the are be the was what I milestones that strong good a horizon. Today, It’s we again. you Jason and now XXXX. be important with preview of plan everyone. and key to recap will pleasure readouts I execution approach foundation lane morning, you, data briefly we near-term expect speaking then year what other in XXXX on transformative a clinical Thank

Phase remarks, non-alcoholic hepatic details Officer, will Medical our about OHE. opening in or steatohepatitis encephalopathy trials Dr. Koziel our Margaret my Following or Chief NASH, overt ongoing X Long-COVID, share and

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maintain Governance meeting and Committee nominate in our of a number recent couple one May. members a and candidates our strong record. and months track well-rounded with least these candidates of our of expect experience, We’ve also to annual new in committee of Nominating already Our executive fresh identified has at we added at to

Dr. brings right financing Koziel companies. the experience through Chief more addition Bob guide of new ever leader clinical success a experience, is has XXXX development. Bob sciences instrumental to plus our He building in biopharma us of joined us joined since. years Crane. and Chief having Margaret She and and February. our to late-stage and academia wealth Officer, recent in been life group Axcella in is a in XX new both Financial and Officer, Our has Axcella Margaret Medical

in Let have Bob me the financials. trials invite Margaret you to on in the motion, provide a we before of each description of fill Margaret?

Thanks very much, Bill.

little background So share here on let Axcella. further have motion in the at we me that a trials three

was Oxford trial at reading or first, AXAXXXX XX are the out specifically enrolling of key for we’ll Xa Long-COVID Phase with The two Long-COVID. of Oxford is for receiving well in United our study muscle placebo are single Let’s weakness fatigue the start Kingdom. either XX center and in this the University chosen trial reasons. and being subjects be enrolled very one with days. that

of research measurement mitochondrial Long-COVID the centers in First, And the are it function premier the is in working the muscle we’re experts and second, researchers of world-leading with health. one world.

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the functioning. We measure easily well is are muscles in markers how also trial, accessible like looking other blood-based at which are of measures of including range a lactate, common an

our we to and next fatigue monitoring the help inform functional walk like measures Additionally, scores trial. X-minute are

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these later update the and efforts plan to year. this an We’re now success of monitoring enrollment provide

So gear call on that, might very up times ahead. these and our let we here me to over you as surmise, turn readouts busy an at Crane, Bob CFO, With Axcella as are provide the for the new update to the financials. exciting

and everyone. morning, good Thank you, Margaret,

First, ago. pleased X have joined very I the to how about weeks I say to want am company

has in those plans closing was multiple with the platform and and that Axcella in new creation, offering, of that one management board, ideal was XXXX. criteria value by had the I company direct to to experienced for tremendous long-term. that strong, registered the clinic. opportunity, considering both a recent the team As positioned and patient find for to One guided was and all we’re and a of potential with address a our the execute my even our programs needs near-term better fit vision opportunity

the marketable end the million financials, XXXX $XXX ended we of XXXX. with $XX which to and million compares cash approximately to Turning in as of securities,

we closed to sheet. registered proceeds, $XX recently just balance bolster As touched further our which that has I direct offering million on, gross in a yielded helped

XXXX. meet We be expect to into current needs our will operating cash that balance sufficient our

with and development were and and million the to for same of ended Long-COVID, EMMPOWER quarter EMMPACT for the million share million Turning and and to XX, our the $XX.X non-cash-based $XX related the the million per research $XX.X million increase of months $XX.X expenses or initiation XXXX. net was $X.X and XXXX. to share, and X for are the increases X ended administrative months million our and XX, compensation $XX.X $XX.X December were and comparable loss and for $X.X per million benefit-related periods million XXXX, trials. year $XX.X costs. the million General greater or year-over-year clinical ended XX XXXX. of the statement, primarily $XX.X and for expenses This respectively. of primarily December million XX, XXXX Axcella’s These income This the XX compares result compares $X.XX to $X.XX December period and

fourth million quarter $X.XX or year Our $XX.X XX, remarks. share and net million formal a was our ended loss for December the per $X.XX $XX.X and XXXX or share. That concludes

questions. operator, the Now, for open would you line please

[Operator Arce H.C. ahead. Instructions] comes Ed The Please first question & with Company. Wainwright from go

this think Hello, you questions Thanks trial, – on the to is if congrats ask Margaret. you Long-COVID and approaching PCr you as to initial the taking good readout, for progress. question continued about my mentioned this I Wondering as morning. later year. Wanted and are directed could

the And to investigators any sense how of with patients of interaction then evolving you that changes is have regular the follow-up. emerge? variants I would in the for additional a there or as trial And COVID any for sense Just progression imagine going? have I the Oxford.

Thanks, Ed. good and morning,

with We have Oxford. partnership had a fantastic

continued into to the study. have well We enroll

As results had of in they in said, Bill quarter be have presenting periods of seen our the individuals are have symptoms their To-date, those coming that’s these of any this readout features. anticipate subject not trial. most had that or variants terms impact the up. in we releasing of Again, disposition third time, first and why interested prolonged for the we will particularly

only a really it December, you earlier. bit and United at since was States so know, As the has UK, on been in us Omicron least

Omicron. going just to of the are the beginning impact we of see So,

anticipate up will said, large numbers also go the from because Long-COVID had that of numbers here of surge. individuals who Bill winter the past we COVID of this As during

other trends endpoint, Right. the only that, the as And other light of short may go that wondering that in would looking positive you factors a you further could period PCr, stated mentioned, relatively I improvement as inform that then am but follow-up, statistical primary development. of that in had some measures, expectation. if in the Margaret, important discuss is you future are the for measures you treatment and into and significant that perspective help

you. Thank Sure.

an the and to-date, generated And we that mitochondrial believe function. wanted that designing a data of readout other able time. signal within of on early based in the in trial, So, precise our we some be terms period we would that see to of short

in see how to X-minute improvement and So, looking it did long the trends. discuss for why, about walk, that’s an we appropriately take issue as we know, you are might

precise primary signals which directional for move a measure the in endpoint, concordance function. that of looking are is We mitochondrial with

looking trends, and outcome walk that X-minute in which fatigue, the for looking studying. in are we So, symptom in improvement of the trends for patient-reported is

Right.

Okay. for one study. And your OHE is this one. last And

has noted, and easier you little allow could study. I there would of inclusion/exclusion on other perhaps, design amendments us if wondering to exactly that criteria a bit of As some you what the little been bit am enrollment of detail any affect to eased the give if was for there. parts a

that you. Thanks asking Thank question. Sure. for

what one we documentation biggest investigators. OHE. of give was overt the minimize about the burden concrete will really or change you encephalopathy did hepatic So, the prior to the I was and most on

simply they of OHE, required investigators within and individuals to previous in were were the having weeks, XX be clear-cut So, that they with documentation. this that we to obtain the come while unable noting were histories

just other it has been little I and under has difficult been think stress a you system to from get may facilities. know the recently, medical paperwork

that remembering OHE Again, rare kind really we at on this subjects condition. the they a as burden that made. is of change of investigators that’s aimed trial, So, decreasing the into it’s enroll itself

the an are example we changes that’s of made. just those some of – So,

Thank Great. That’s helpful. you, Margaret. very

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

on And program little enrollment questions. some end, we of about expand for I studies the Good morning. a can tackling some that Hi regulatory the scope they University year, Oxford? that trying looking this the activities slowdowns. enrolling think how this just other forward from know talk you then as some the these bit Long-COVID, going the heard there? is taking in to couple on about you of Thanks companies little A biopsy first, of NASH beyond the guys. backgrounds a can the on to about more our seen paired talk data are you study, have Xb Phase have bit you

just steps to enrollment here track are And on what the you wondering taking so half? sure to you complete Thanks. make second are in

Yes.

good morning appreciate So, and the I Tom, here. questions

In terms data. of Long-COVID, closing yes, and excited for enrollment the are we then very

regulatory are had of the an which are of as us And we the set terms X Phase open activities, In the quickly. familiar, interaction we you discussions MHRA allowed the for to with and excellent up with FDA. end MHRA, trial

about discussions We anticipate best that amount then program that need, having will expeditiously we we robust effort. that, a have, of support the high that to that will have the of possible. given we the And to be profile product as in the way that be data there, forward the move engaged medical discussion as unmet us very

comment maybe and the Margaret, So, EMMPACT on enrollment there. study the

morning Tom. Good Yes.

into biopsy progress. is have going always well. good had enrollment to So, challenging, studies yes, liver but Yes, continue Again, it’s very engagements. we we these paired good make

makes clinical over the really to for significant we reported those But the that We that, or in about we we providing screen of pace to investigators last minimize of comes our help the investigators haven’t trials. these how which the terms on. data data efficient everybody of couple challenging months. feedback characteristics, rate, to in move are just always latest providing by to about the the enrollment whether from seen slowdowns continually literature, And in it own do continue is failure information

congrats Great. the Okay. progress. And Yes, color. guys appreciate the on

Looking forward the data. to

JPMorgan. [Operator Instructions] The next Please question Wolle ahead. comes from with Daniel go

site have for commented everyone. remarks, enrolling your Thanks study. question. that morning very In the is our the study Good prepared well you Long-COVID for taking

the for timeline the as patients, a when readout driving number available is data XQ well the what XX-day as of study? considering to So,

Yes.

of good morning for the Daniel, couple pieces thanks here. question. So, A

one Then collection, as actual preparation is the is So, enrollment you there period. is, and noted, this. of dosing the data communication there and period then

does aspects to study, sophisticated measure other would in are PCr of doing we one well, One of machine it’s have we particular access the Now, require say aspects. and precise this MRS, the two MRI very that. is that I which

with The Margaret piece the is and that are about worked Oxford because they team these fatigued, quite baseline. other patients their is

supporting we and is their the that enabling measuring find so study appropriately. through And progress where

So, to doing quarter we are standpoint, we that data and and in it that the we third at share being the well anticipate on from able point. are track, communicate

infection. it as for excited the means disease as well areas program, of results very for post what of are other this We mitochondrial for or viral

PCr then primary regarding time. development? endpoint, within for you X recovery it. specific to a plus difference expected of have XX the significant late-stage consider And time still or into Is patients proportion to minus you there recovery Got seconds advancing the in the product their mentioned normal

Margaret?

we – question Again, mitochondrial to that Yes. we for wanted normalize make No, trial will small we made earlier, question. relatively terms I the this in whether and of back comment I understand function. precise. to Thanks going the

the to And as so powered it endpoint absolute normalization. the in around opposed we change

we want for long didn’t a period all trial I think again, to this continue time. honesty, in of

we we does correlate to And do that what opposed impact with benchmark. here normalization continue to MRS have seeing we we are as to so we that functional is the signal. people treat saw Again, measure want really trying a that function measures do didn’t until and to mitochondrial around

a then baseline statistical out timing well, a to exactly questions is a Ed’s steps. hopefully, them normal. I one with, start of that outlined them say of the this and of where body we will that little impact large The working return bridges this clear we will there a and Then, obviously Margaret opportunity as Long-COVID mechanism Daniel. fashion. a towards and what be terms is the direction then will evidence demonstrate number there move study the to and Yes, on build is of as to of on their of for the in what the and determining they normal growing be in in next the to working in and bit patients

question. you. one cash Okay. Thank take And equity raise? financial last million guidance the Got Does account recent it. into the runway $XX

does. Yes, it

the So, have of year-end direct, with $XX plus the get at into raised registered XXXX. to the that $XX million, cash – we the sufficient funds we million us with

Great. you Thank Okay. very much.

you. Thank

question [Operator with The Robert Capital Markets. Please Noble from LeBoyer ahead. Instructions] go next comes

being Good morning, just on a an that towards question or last can development. year How have use the about the FDA and and approvals emerging approval their on priorities current change priorities since shifting Long-COVID, the be to over this trials anything defining from in are what a such it, based terms Is of of we a COVID would about discuss details and emergency requirements full any or Long-COVID condition? FDA’s they or since recent kind you Long-COVID? is there seen

the question. for morning, thanks good Robert, Yes.

collaboratively dealing the vaccination case a standard I have share with about treatments. don’t So, acute exceptionally interactions associated and to obviously, led of detail we the with health you morbidity in the around quality. the to other of mortality, is prioritization can companies focus, authorities. while the in world the FDA What responsive the speak working and with obviously general, acute infection been with our regulatory the the In authorities high maintaining pandemic, with that

expanding size this heard And include MHRA discussions time. in population you at see we our the with our initial the of energy in point in Long-COVID had and that’s and excellent because have to remarks. interactions of focus the We

translates million estimated the XX U.S. getting are billion million, close infections numbers X.X Long-COVID to We around now, world, talking, in into confirmed XX already. which the

there are And so needs the evolving.

you the clear a As mechanism PCr. measure physiological have we in the outlined have in past,

clearly terms measures, regulatory and will have of those functional of across fatigue a have score, We walk, precedent number approval important X-minute of diseases. which part in be an Long-COVID

you seen to we huge we a and with, post very will deal am looking that And end and have able stories constructive X data FDA have support I other the that excited help regulators. with continued is people So, of are growth Long-COVID. be a sure effort. and to the energy the conversation Phase are around we feel It issue in to

Thank Great. for taking you question. Okay. the

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

operator, thanks in to who you, and everyone thank So, tuned today.

with milestones for expect the substantial We we to opportunity shareholders. address the call, our NASH readouts facing and help are to our to today. that Long-COVID, by upcoming are energized day. help And looking future. other look OHE That people are will the needs forward in we and forward key a Everyone, have our Thanks. We value you operator. soon, great drive in again concludes with the speaking data

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

You may now disconnect.