Anavex Life Sciences (AVXL) 9 May 242024 Q2 Earnings call transcript

Good morning, and welcome to the Anavex Life Sciences Fiscal 2024 Second Quarter Conference Call. My name is Clint Tomlinson, and I will be your host for today's call. [Operator Instructions] Please note, this conference is being recorded. The call will be available for replay on Anavex's website at www.anavex.com. With us today is Dr. Chief and and Financial Boenisch, President Officer. Missling, Executive Sandra Officer; Principal Christopher

actual please this These those of that that regulatory which without results company may we number capital information the need note in obtain Before turn company's or events begin, limitation, inherent commercialization rights. And involve approvals, to and differ filings intellectual risks during property Forms predictions limitation, in on without products, encourage forward-looking some the a to and ability materially and expectations Missling. and only Dr. will that, to of projections in factors from or may identify conference the the forward-looking These are statements. with XX-K I like review potential statements future based uncertainties. current with and make the development to call We XX-Q, of the the factors specific and/or SEC. described of clinical cause statements. and and would to risks you the these company's This includes, include, maintenance trials uncertainty over call, results

and review and quarterly being you everyone. morning, us today financial with update. business to Clint, Thank to you, our Thank reported good recently our most for results provide

is placebo-controlled underway. Full to sufficient as Agency, RNA is trial application blarcamesine is will pathway published journal presentation and of open-label that parallel Rett to share forward by at new participated Phase with opens another the for syndrome for positive to of the use expected ATTENTION-AD are sequencing endpoint an Rett from for this Phase states in participating alone, the in second feedback blarcamesine to the Rett real-world believe in underway, well early in extension for half the be proceed be process cognitive Syndrome EXCELLENCE syndrome, of this ongoing caregivers one to for the trial encourages study our We already the analysis open-label initiated June be interim primary ongoing, to us Concurrently, efficacy move community XX, which we encouraged XXXX. evidence Alzheimer's disease. compassionate patients taking the IIb/III disease, in data trial measures for III a peer-review us continued a continue syndrome partnership of patients disease, IRSF EMA, Alzheimer's is trial disease, by expect We ADAS-Cog, able authorization upcoming Meeting very and the to European clinical treatment XXXX. In interim to XXXX provided XX with trial will the and recently and be and guidance this An mid-XXXX. Medicine issued educational data possible Rett which program extension data and XX-week early in market Alzheimer's who study. of FDA guidance appreciate the like year, the place Alzheimer's Scientific from could

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the morning you, results our year. I'm Thank quarter Christopher, with good second and pleased to to financial share everyone. you today fiscal for XXXX

position March $XXX.X Our was at million. cash XX

into we account capital During runway approximately At cash equivalents rate, of utilization noncash in working X after activities $XX.X and cash cash the accounts. changes our believe have utilized years. quarter, current million operating cash in we we taking

recent were the in quarter, quarter. as compared most first expenses to our and our $X.X immediately preceding million million administrative general During $X.X

compared research or $X.XX per and share. And immediately as to Our the the we $X.X quarter. are And a for of for million net preceding $X.X quarter million $XX.X you. loss quarter for the first reporting were million development lastly, expenses thank

Now back Christopher. to you,

are we back entering Thank to medicine turn for Q&A. the history This the be our Clint for to an of time to phase new would very you, with biomarker-driven Sandra. precision is call a the programs. I company, company's like excited and now exciting

Thank you, call our Research. Soumit Instructions] Jones first [Operator coming Christopher. from from like And is it looks

to And you're larger and Congratulations trial? see amyloid or ask FDA you you to the compare for really the the through because the cognition error data and biomarker they about Yes. when do outcome a your support many with would I are all How on on few bit a is bars looking little strong size just when the the on to And when FDA the understand cohort guidance. oftentimes thoughts. company the you strong progress. was How qualitative these considered line, It's of trying clinical curious was statistical interpret that front. just ratio, a is larger. a be strong questions saying at read XX/XX patients there? do

easy of that our once available active to but removing mechanism they background that an the drug to changes features, warning, Abeta arm, of has been antibody administer the we have are drug, scalable with they drug placebo and it's having the and reminded challenges not a biomarker for fact box key which be to in don't an is lot So orally the the which that in have for antibodies is Abeta the of versus given. have black that daily, convenience addition

challenge there's and So a are measures from repeated safety also safety on MRI required.

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] the of with biomarker to FDA filing the open-label you I'm You do European extension X FDA few trying out trial before then totality with publication for have the FDA, quite you along probably would extension the up when go trial next and the the before of the catalysts with be approach to data completion would long Or in the to meet the you data? wait and for data coming long-term the with months. understand term? come what to arm that, would and a [ strategy

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measures to profile regard, [ to principal For X-XX, efficacy demonstrate existing you expect get sense in safety such you a, with atypical from wanted or respect for and of certain of to as the to as you And is to, to to how extent tolerability schizophrenia, candidate this example, efficacy the be as Great. which example, differentiated X-XX efficacy the what than to Or as front, PANSS so safety the efficacy? of well differentiation expect the appropriate compound as versus well ] just and be on the you for domains profile do anti-schizophrenic this antipsychotic monitor most it the you of example, be? if a areas currently differentiated both expect drug medications marketed, medication? the expect

better think as want Yes, could I approvals, drug And be there at is if what market. to it's it you out the than stated, the exactly of always really look you be both. you on landscape

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point this are of want study, we a out on considered also biomarker focusing to in surrogate as schizophrenia. We EEG/ERP

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And question query. financial then a sort combination and of is a the of strategic last

into you to at disease in an that Union. launch undertake that whether be of for get EMA do Or related elect strategically, will assuming that you activity would identify strategy approvable the you Europe the to that of look self-commercialization Let's related partner? or for expect a any MAA that say you point hypothetically to your look partner in you take Alzheimer's Europe? identify cash And does blarcamesine burn the Alzheimer's in runway to disease juncture, you in blarcamesine of that years whether not activities or treatment terms drug agrees independent preferred pre-launch is guidance what which account expenses your in of next a for At the to to four if are approval treatment with Europe? European

for the you Thank question.

what try to point decide So it that comes what most for when shareholders. to value creates we is

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congrats again all Thank on you all the for clarity, and progress. the

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Yes.

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of cohorts So several and parts. several consists it

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in there parts. So two are two cohorts

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Yes.

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presentation reasons So up. coming these excited we're this very are X the why about

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Yes.

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that's Dr. today, the like all questions Looks Missling.

programs And neurodegenerative, neuropsychiatric which and committed closing, in Thank our medicine our of could access and we therapies, you. further disorders. neurodevelopmental the disorders, expand within our to to precision remain of treatment transformative development deliver options scalable platform differentiated brain for investigational portfolio utilizing easy

to focus as continue and you very living Thank we readiness commercial on potentially We execution devastating advance patient improve conditions. much. our these therapeutic to lives pipeline with

Thank conference concludes We Great. gentlemen. you, your That appreciate and ladies today's call. participation.

You're now welcome disconnect. to