AVXL Anavex Life Sciences

Clint Tomlinson Investor Relations
Christopher Missling President & Chief Executive Officer
Sandra Boenisch Principal Financial Officer & Treasurer
Tom Bishop BI Research
Call transcript
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Good afternoon. My name is Adrian and I'll be your conference call operator today. Welcome to the Anavex Life Sciences Fiscal 2021 Third Quarter Conference Call.

As a reminder, this conference call is being recorded. And I'd like to call over your host for today's conference, Clint Tomlinson, please go ahead.

Clint Tomlinson

you. Thank everyone. afternoon, good And appreciate you third and Anavex Sciences today the joining conference call us quarter results business for to company's Life updates. We review discuss financial of after replay The be call available tape the this call. will call Anavex's at on for website also available The will replay be With us today is Dr. Principal President and Boenisch, Officer; and Executive Missling, Officer. Christopher Sandra Chief Financial

management's there will session. remarks, be answer Following a question and

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

Christopher Missling

strategy. on everyone us describe appreciate And today's call whole you, Thank results we our joining and to conference Clint. the company's review financial

using in we line placebo to background we controlled ANAVEX blind of Phase neural blind function X trial or X of cell homeostasis, correlation two doses placebo. and daily efficacy, of biomarker, is ones sigma and X sigma all within activator pre-specified restoring clinical measuring only exceeded blind trial The balance of enrollment molecule and study of in daily second benefit, sigma our debt. with and patients receptor. of with in clinical measures gene medicine disease by in the on is with XXXX. pivotal ANAVEX disease X-XX ABL restoration the patient double Alzheimer disease. Let over X that previous North cash a suggests half is ADCS body results patients expect those stage available remainder X-XX, tolerability ANAVEX activities Starting target data X-XX no sites different America, Parent expression, Data sheet [indiscernible] housekeeping that with activities Alzheimer's [indiscernible] at the confirmatory in The activation the X-XX is neuroplasticity. function the candidate stating with into Phase precision strong X confirmed safety multicenter, stage top endpoints. previous XX direct proceed complete double living of and late Sigma a includes small cognition lead start stage ANAVEX X-XX. and of daily which Xb/X XXX demonstrated dependent announce from and me Xb/X $XXX and placebo million across primary can a XXXX of double others This beyond Australia ANAVEX and controlled XXX of results of promote Alzheimer's late engagement living to Europe

Alzheimer's may disease treatments. of drug in expression data gene disease, and and ANAVEX reminder data of in is companies is phenotypic success relevance Syndrome chances clinical a approach predict expression and particular, trials gene Parkinson's to sequencing variants the in exome genotypic and studies analysis leverage the big to other of strategy clinical whole development. As and patients medicine our potential biopharma the that of of identify from precision differentiated of in And the pioneer clearly changes clinical to continuing Rett CNS in increased

in results at like can we trials Life the to are Syndrome. medicine study Financial summary Sciences half of in currently that corporate Anavex I milestones reported targets with patients the ANAVEX AVATAR XXXX. call Boenisch, presentation, recently would Officer Anavex topline second now, available for expected latest And clinical X/X announce this direct Rett exceeded Sandra clinical the And to the enrollment provided X-XX of brief for of financial we Further from Principal Phase the quarter. precision are Additionally, in

Sandra Boenisch

in Christopher good We afternoon a cash and you, increase everyone. Thank report can to significant runway.

XXXX. on is cash was XXXX $XXX.X June fund we clinical which runway XX sufficient [Technical beyond million, Our position believe cash Difficulty] and programs to operations

Christopher Missling

injection lose they maze the get the from better in They seven measures in you the cognitive that this who sick, had given but as the path, day been never those pretreatment any noticed their impairment developed we the see these so pretreatment, that Animals [ph] which forth. impairment. usually cognitive after ignition. a of developed stood expected And And water with in and animal adults better prevention you cognitively a the without symptoms they type and behavior wild they behaved as model. given were arm

which observation better rejection. led activation caused able we which prevent by X-XX, and potential by So upstream as is interjection the the ANAVEX is know to to which is possibly now with this one via the cellular that extremely the stress

Also, Alzheimer's [ph] credibility The also noticed has which the could we is to capacities. intelligence seems status to since used a data in that giving not of gradual ability improve the in be study future, of be completion, the this earlier to stage be challenges prevention. a have we a direction, productive that confirmed. as pathology, if awfully so limited in entire And the to it

those and cognition treat better or lower the MMSE impairment, cognitive were more impairment So the XX before mentioned score lower when earlier that the means than you off cognitive more I them.

the cellular continue cognitive patients, able before impaired, we the be the ability problems. And breakfast. able might this as activation. they we give be trajectory prevent into even take present, either many impairment you in this to any And out mildly do point cardiovascular place. which we of avoiding So take that aspirin, people just even stress way some or drug impairment prevent morning cognitive cognitive every for of to to compare the which for When a to by are to is symptoms to always to

is saying will I'm human. able So one in that But that. in a eventually not day we confirmed this is tackle be plan the that study. And to

Unidentified Analyst

anticipate to ask give could experience us initiative enrollment. Great initiate thanks. X to clinical syndrome wanted to Fragile And with potential a their program also the development the you Fragile your sense syndrome X of I rest compound lessons patient takeaways [indiscernible] regarding also if your from about you. applicability you with and in And syndrome. the Thank thoughts when

Christopher Missling

in was improvement and enough in called in We a with have that the Adam a our of secondary that score general included Fragile and very is study, improvement, global. trial, extremely behavior interesting measure Red syndrome positive broad Red which but [ph], in is score score behavior X a studies anxiety, mood it often syndrome very as is clinical used of compulsive were and significant and primary endpoint which Adams

family progressing and which forthcoming, we ANAVEX out Fragile soon that reviewed preclinical the this also could of syndrome basis into the ideas choice of largest an also with peer for as part in need be data a this of forward, that of to population X autism spectrum we for possible So come unmet readout X which Fragile nature of as given is X-XX to of paper ANAVEX we good submitted a indication of a Fragile paper, which disorder. a data X-XX, the the this is move to rationalizing, of that very autism as expect X disorder. spectrum the of the And the believe

originated places symptoms the but are with they have causality, symptoms these in causation, So each in diseases, similar they correlated although overlapping other. in different are

reviewed the So we are a trial the paper. able in showcase to once initiated, to we data expect peer be

Unidentified Analyst

Thank much. you very


Tom Bishop And our question BI comes next Research. from from

Tom Bishop

we that? you the said I expect Christopher, prevention that prevention and soon how were could know, phase for X expected was, Hi, what study, the initiate of wondering indication, to was and include to that a of you status one or you

Christopher Missling

something right. So this awfully because which important an we study. like, And agency, discuss the a very want that get we is with it's to

reason with, before case. I But like that given but potential just let indications, more body's degenerative causes I'd the therapeutic, be drug effect, as a to like diseases effect the but point is why the which broad prevent that we cognitive and So beneficial first, remind upstream stress, in developmental not own also And for and that other that. the also is came mechanism well effect hope defense providing which everybody, and cellular new sigma the to and this the vacations, which that the the us a probably broad gives it's we endogenous avoid see activation, this Parkinson to will we details Alzheimer, to the strong as impairment, up indications. on out great really of it's something want different with happen also X to

agency something be is that long making providing the So this this a not prize, treatment. only treatment with But used day, like diseases, one prevention first, the of as the to and as details. all before discuss And could this is more we shot. probably for degenerative big for

Tom Bishop

lot it you've to possibility. just of or lose three I'm exciting you with seems between presented the the final Have And very scheduled or? to FDA wondering a meeting I Sometimes on know of the Parkinson's? is we proceed status here. the phase That's is a the trials. one What add time and timeline like meeting what data.

Christopher Missling

good very question. There's a

for has exome but Your RNA. of endpoints what Parkinson work that the DNA the to including done key itself that we RNA right genome. have gene, dementia reported. unique the analysis we of have they know included genomics X finished and have RNA this is which which intelligence in also background we Sigma trials, And we ANAVEX analysis, our the the PDD work whole differentiates the the the trial, all you is both more on limited is are changes the And There yet ongoing now. up is know companies reported trial but the other disease or that to whole other not not the trial, also genes, the

of put more this dialogue this dementia, that are pivotal the right with now the the we ability putting much So, more much all design three we which requires study this forward hand. have from that, we entire before will study, but have first will to in have we and intelligence at Parkinson, together determine as the robust agency as will then but that, because have Parkinson's data in a also a phase well to there PDD so once be

Tom Bishop

they're but Well, J. you. I Fox drug, study. I independently Is Michael that doing the Fox you're mean, imaging. imaging okay, and dollar the of million status going? how's that the Michael supplying mean, J. of doing the

Christopher Missling

it's that process allows drug a Nope, this profile will And us grant and same have of capture to and imaging, in a of starting with year. ANAVEX we study. the pet three the already study brain do in of [ph] humans the done the basically the the are animals. which the in the we which in like It's this

So by this funded fully brains. is Foundation, a will And in are that was we be a the of with that and funded effect that which human Michael they basically study Fox confirmatory, executing study grant. which

Tom Bishop

Oh, see. I

this know. two, is a ongoing? on you same? mystery don't earlier a And X And Okay. XXX year. trial, comment where a I phase there's those they also, you indication Could not there indicated

Christopher Missling

to only because the the is make were this ANAVEX a before now. it's ultra a indications, effect and been sure, have want with indication, we which we yet, to the rare achieving animal that very we pick positive, are models nature, several have well, has have Right, on disease choice have we forward one of confirmatory we doing X-XX clinical not not move we And in mystery indication, a do, rare the we trial, said, nature. we several right right disclosed

of IP, and we of data an has well. So have And basically start on X-XX dementia, And has progressing drug half unmet platform And mechanism portfolio and will expect regarding once in molecule to away. disclose because trial received of is Frontotemporal without that focus it we that in that and ANAVEX which also action X. phase the this an X its our is also is second completed modulation, a now are need. right that another we indication we that sigma excited, the own orphan designation also confirms, year, it for is validates the assessment,

the well of an with So could an the indication unmet impairment. now we after next cognitive phase dementia will very studied in that be the are indication stage preparing with Frontotemporal one, it cognitive impairment, need another of which for

Tom Bishop

it's one done? But are is, saying you the study phase

Christopher Missling

It is year. able the data to will second of be correct. to this And we report wrap about this in That's up. half

Tom Bishop

data trial Will safety just it the or any efficacy include literally?

Christopher Missling

But what in is It's share that it. that predominantly allow on a visibility one on beyond the safety data once us I we And basically better trial. to gives included data. measures have outcome will safety in phase that us data

Tom Bishop

very you're a many does see which indications. on I've And the getting really encouraged that it's different know, readouts positive idea do little brain, something by support have just the the doubt I variety of, breadth so positive think too, been you. in X-XX you of coming. of and readouts, well, I but Okay, to a think helps that the I you good Thank

Christopher Missling

the clear which important all trials X-XX efficacious indication only so doses, always of biomarker also or the response, in by a very of of biomarker by borne but thirdly, expression is it I at our of right dose trials was is it very of so was our the fact highlight the the have have response If ANAVEX we performed, add, we a that far, performed itself. the effect. level to response noticed to not notice. a had strong far data, clinical And which all that And predictive curve, target was might the demonstrated drug mRNA all really

the these primary a showing biomarker endpoints correlated really confirming have of which all of we there's performed. and drug secondary no So with with drugs efficacy way and better outcomes, efficacy of the strong

Tom Bishop

Alright, thank I said, encouraging. it's you. very Like


you, ladies this call. conference Thank today's gentlemen, and concludes

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