Axcella Health (AXLA) 1 Nov 222022 Q3 Earnings call transcript

Good morning, ladies and gentlemen, and welcome to Axcella’s third quarter 2022 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] Now, for opening remarks, I would now like to hand the call over to Bob Crane, Chief Financial Officer at Axcella. Please go ahead, sir.

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

speaking period again. extremely we've with been an you, the Axcella, briefly past for has quarter. you It's Thank morning, good be Bob, This exciting and today, during the progress everyone. review I and made will to a pleasure

Bob we my progress will new quarter, with financing. third then remarks, on a clinical Through our the you update development balance and of made sheet Following strengthened opening AXAXXXX, the important our in financials.

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and multifactorial differentiated us the and along in complex and our research with leading extensive trial as an profile, Our position gene us give conditions. company platform, attractive incurring results, EMM treating

with past Chairman two trial these Nissen, This our have our we Crane, And the provide financing, a appointments attractive. also found Board become Rosiello quarter, Mr. to about new members, Board. and round Robert Bob investors new and board become Straight we details completed the very Rosiello, Directors. Torben made simultaneous has results financing, Of will of of which shortly. CFO, Now,

has he continue As years for pleased board, the five company the to towards consultant. additions advances off late-stage trials, and service, to Mr. Mr. the we company And we David support our and have thank board. Nissen, clinical will his contributions, and a the Rosiello, are to after of as many Epstein him stepped of Straight

a on our months, coming of will engaging executing program, with and to pursue focus Now, strategy continue we the clinical in investors.

clinical also leveraging pipeline trials We broadening intent gained on and by have the insights we science. emerging are from our our key

me quarter. a review invite to details Bob? let overall Bob of of for the the and Now the provide financing financials our

good occurred new December million. shares company Thank with of million registered ending company investors, further October financing to cash of We stock amount management. at the This finished cancellation sheet. XXXX. XX, securities, XX, the XX,XXX,XXX XX, and held you, Flagship million included The notes quarter which $XX.X morning, of and sold XXXX, and a balance directors, approximately as compares in million Bill, This financing bolster received approximately the September price $X $XX.X direct of by everyone. current we indebtedness a $XX On of XXXX, and marketable the a common helps to promissory our as financing conversion of Pioneering. to investors, $X.XX, combination upon market announced of

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

quarter the our to quarter the COVID General $X.XX Turning months and September September nine XXXX, loss share, our Axcella’s expenses related and quarter and are $X.X the and ended EMMPACT increase the million compensation million for clinical income $XX expenses per XX, XXXX. nine for million non-cash million decreases for diluted and was same comparable or nine XX, and periods share, net $XX.X compares months expenses. $X.X result ended million XX, ended $XX.X of of September the basic and periods and of with $XX.X million statement, per year-to-year $XX.X compares or and long These initiation the of stock-based million, XXXX. XXXX, the $XX.X administrative primarily the were the $XX.X This for $XX.X were research XXXX. million for to million to $X.XX primarily and This to development respectively. and and months trials. lower

This Our concludes our and third the was per net share. the of XXXX September or quarter loss for and months XX, nine review $X.XX $XX.X or per $X.XX million finances. $XX.X ended million share,

Let Bill. Bill? me the to call turn back

this Right. to we'll attendees. at you, in from Bob. point Operator, move the over Thank questions time, And

question first Please [Operator Securities. Thomas is Instructions] go Smith from of Our SVB ahead.

on on (indiscernible) is the in Congrats progress the Tom morning, Good Smith. recorder. this for

questions. few a We have

more the can additional follow expect (indiscernible) provide interactions and on long up. COVID, a you could First, have XXXX color details on regarding regulatory and regulatory the when in path? And we

Okay, great.

So, thank you.

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we're understand is. government, excellent with long how positioned they to have the well an very issue So, as important and continue interactions COVID

enrollment Xb completion EMMPACT of study the year by end progress what's ‘XX? it. expect in the NASH? And Got enrollment you on Do Phase the

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So, that. we're consistent with

queue. question And back okay, last the on and it. hop I'll Got

alleviate So, what's to financing in your strategy the XXXX? overhang

Bob? So,

Yes. thank you.

development with know, we've the - as in as raised you in engaged direct, discussions the we're recently So, in past, we And business discussions we’ve possible collaborators, are million. as well both stated investors. $XX.X as with register

you company we'll interest forward, can't offer assure although specifics in the this is go can best I and as stakeholders at time. the be what doing that any we what's I forward, Going of

congrats Got so the much and progress. it. on Thank you

Thank you very is H.C. much. Arce question from next Wainwright. of Ed The

questions. This for very questions morning. Thank a much asking Thomas couple Yip of is Good the Ed. Hi. for taking you

COVID question long the whether on study, or First for from Phase specifically six-minute the thoughts includes endpoint X question, primary can discuss it walk registrational or Xa the study test? Phase any you here endpoints current fatigue

CMO, morning, good our Margaret, that We'll Thomas. question. So, have answer

So, Margaret,

question. well measures authorities. health other Good accepted reported - Thanks by is such carrying and is outcome the validated the instrument, that for morning. Yes, this Again, measurement and are a FDA forward of fatigue. anticipate a the we patient

be will a forward addition, precise It with is The have walk to reflective an continue intend tool the would the gotten function. indicates In that agency. discussion we we that the that that physical patient with we of experience. using we're unlikely of it feedback carry assessment is not six-minute as for

discussing. be our we'll what good But in that's endpoints X. in general, move So, Phase forward into to a we're position very

function, walk physical fatigue feel. a these Yes, on a Thomas. but impact The this represents is really six-minute certain patients post-exertional that

more forward to So, at sophisticated scale. impact there going ways XXXX the of are demonstrate

it. Got Phase both you and long opportunity, any to the well? as on size ex-US the US are plans X staying for fund Thank COVID, then what - the of the And your and current additional given study, also details.

Yes.

size to here and long leading as rapidly States. believe to market We potential COVID So, this and the the United the you in for quite time. And for some the the size opportunity the as only have there's significant. we're in fatigue in field blockbuster really that because unfortunately, be need, achieve very is of product note,

the and well execute the to of our support. of capabilities we're approach, in ongoing In next terms positioned terms trial our

know, our look We accelerate will, to alluded global well as the both already to And potential we Phase we either ongoing, we're way you course, patients have UK, in to to how as way NASH. and work in and faster. beyond obviously governments, collaborators, as to optimal reach where the as expand forward reach we a US bring have program strategically, more with this engagements, ability at the of as to, best active Xb can Bob the or as

scale. that we've on So, demonstrated to our ability execute

believe Got did results we What Type see did switching us, NASH, it. as the saw Perhaps thoughts patients better but diabetes in reasons that, the space you on question was data encouraging, and there's main in to still diabetes the we last quite X the for the in in your XX-week are NASH not XXXX? from X subpopulation study. behind opportunity interim a if Type

Yes.

for consistent X the did Type And results diabetics important So, the as It's roughly thank question diabetics historically reaching of with are already. the analysis, difficult an we Thomas, treat. XX XX% X and actually, subjects this of with in to overall and what see is so an patient more weeks. Type XX% patients, And you. NASH that on because far encouraging were or trial, know, us that's interim XX or results is you - the are

position potential profile safety X we the and the differentiation So, know, continue X in we of to we Type two because think as sets pediatrics, this the the overall populations we're you and and us well actually demonstrated believe and have, like studies impact we’ll our encouraged we differentiator, evaluate is an important oral Type like for asset. where line dosing. multi-targeted, up diabetics, if previous for first adolescent offer diabetics tolerated And

to for on it. Thank again you looking questions programs. both and Got forward progress taking

Thank [Operator you much. very instructions].

would further to Hinshaw the closing turn Mr. We back call to for and remarks. have no some like questions,

Okay. today. and tuned Thank thanks you, everyone who operator, in

We to and opportunity address NASH. by substantial the COVID energized long of who are certainly fatigue have help the patients needs

to and and programs, the looking expect drive for forward we'll shareholders. make we our across help upcoming progress value our We’re that to milestones

speaking to you forward look we again. with So,

be operator, well. concludes call. So, everybody, Thank our this and you

Thank gentlemen, you very that much, today's concludes sir. Ladies and conference.

your You participation. at you for time. disconnect your lines all may Thank this