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AVXL Anavex Life Sciences

Participants
Clint Tomlinson IR
Christopher Missling President & CEO
Sandra Boenisch Principal Financial Officer & Treasurer
Raghuram Selvaraju H.C. Wainwright
Soumit Roy Jones Trading
Call transcript
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Operator

Welcome to the Anavex Life Sciences Fiscal 2021 Fourth Quarter Conference Call. My name is Vage [ph] and I'll your operator for today's call. At this time, all participants are in a listen-only mode. [Operator instructions] Please note this conference call is being recorded. I'll now turn the call over to your host Clint Tomlinson. begin. may you Sir,

Clint Tomlinson

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

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

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

Christopher Missling

while took approximately place precision treatment the placebo based dose phase week two controlled for Rett a X/X than United in precision conference ANAVEX patients phase higher XX financial study using study slash study placebo [indiscernible] medicine We X/X Rett joining study review are line to of everyone around enrolled of biomarkers. our obvious This in drug well Phase Australia end ANAVEX the in patients five results of X-XX Top AVATAR call X-XX expected patients second Syndrome ANAVEX XXXX safety and to with with XX exceptional and and the treatment to medicine the continuing the excellence half from period, treatment reported Syndrome, update. lead expected expect most including Thank X-XX the results you, X/X our the XX Rett efficacy our a momentum Phase the Phase Clint. US This two of with X-XX. clinical Rett patients specific XXXX. week treatment three by We over study appreciate Syndrome, candidate be [indiscernible] efficient controlled an Starting X-XX, year highlighted clinical for business as us execution provide AVATAR Rett fiscal and year first with line biomarkers. XXXX. trials evaluate recent Kingdom concluded which patriotic as seven in syndrome calendar on really to will the over including announced [ph] are period, XX X-XX top from Syndrome, patriotic outpatients specific we with today's results the

preliminary are ANAVEX two south last number from our patient [indiscernible] is living The completed double pretend of efficacy, clinical of all controlled Alzheimer the the Xb/X XX of the [ph] phase and blind study its half are trial targeted patients late daily board double of across enrollment the XXX Europe second of study independent X-XX Alzheimer blind XXXX. treatment month, safety in primary Alzheimer placebo recent program and Australia activities patients. in of America, most others on for North exceeded ABL line disease disease using Phase free is tolerability endpoints. with top [ph] of disease measuring ones results stage the expected study Alzheimer in the Regarding multicenter, and ADCS for and placebo Xb/X the controlled and XB company's XB/X doses pre safety review function This daily different study data placebo. the or Phase for face data monitoring asthma confirmed

safety As X-XX attention the humans received safety BS placebo to XB/X recommended the excited data, are clinical Frontotemporal time to control reviewed continue evaluating the study. the compound also the by its extension study specified XXXX. X in Upon protocol, expected modification. for X-XX is in We're a label review in interim open top Phase disease [indiscernible] XXX designation the data and study of drug another X-XX interim very to report FDA study calendar that line around Phase data often of for a from the ANAVEX ANAVEX the dementia,,

I financial another also closer also the of the gene rare Financial further precision genetic for Officer pivotal plant call [indiscernible]. In During to [indiscernible]. XXX moving to expanding a this imaging of most initiation of new a treatment biomarkers heart study. of neurological [ph], lead, direct planned would end. including for unmet XXXX, with plant the frequent indication Boenisch, disease initiation disease a a initiation new recently August and like summary cell applying the Phase a of the brief X reported Phase cause trials X of disorder lastly, A [indiscernible] Federal specialty we were most medical clinical to data medicine for pipeline focus, a Sandra of respond, [ph] a year of initiat year announced of XXX for using clinical three Principal

Sandra Boenisch

afternoon everybody. Thank good and you, to Christopher

sheet strong responsibility. balance and We maintain a to fiscal continue

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

the increase reported $XX.X operations in as utilization for year the the which development of cash $X.XX Most Research $XX a compared increase XXXX prior you. over Christopher. full and call year. million to increase XB/X is the XXXX. continued million $XX.X General charges. We $XX.X Phase ongoing million mostly personnel and year. or trial back of disease net per related for And share Syndrome administrative label our significantly expenses notably comparable studies $X.XX fiscal the and the with compared fiscal is During our fiscal full the return $X and in comparable Rett internationally. to for to per of loss $XX.X non-cash and million. advancement the continued The of enrollment trials compared enrollment and for and advancement associated open The the Alzheimer's stock the was attributable associated year, an million to share million as extension international expansion were option $X.X and you, clinical expenses Thank primarily the compensation in were million I'll the year trials. now is year these of to

Christopher Missling

XXXX I'm Thank programs. to you, we very company's the excited into medicine and of Samra. advance continue XXXX, And remainder about potential expand we the and look to to as as position our

driving we disorders will to platform, growth transformational ahead, CMA on neurological focus As both broad patients and the one across meaningful we developmental portfolio look degenerative with around our continue world. deliver treatments for to

to to forward also and like open continue updates ahead. we the So like this providing for and I now would point, at Operator, look I happy of please call to Thanksgiving. questions. wish advanced everyone a go further

Operator

from Cantor Fitzgerald. question our first Duncan And instructions] from Charles comes [Operator

open. Your line is

UnidentifiedAnalyst

efficacy from Charles. congratulations for that effect in the out can I And to a or that subjects team do [ph] the you feel which Syndrome. excellence of scene that Pete is if all we the and progress size When the us excellence on the couple questions afternoon about size appreciate planned have XX role Good also sample Christopher decision, made samples the the the regarding in and how you think were you for and AVATAR on measures and adult the some of that. study, size upsized about updates. Rett US color you This give efficacy saw XX study.

Christopher Missling

Appreciate it you. thank and

study, calculation, regulatory additional was on number XX X.X which to show have higher from to which in for dose, and using or number So power very a sure as XX ended X.X, size, effect the based on of patients first different was from request thought in since additional effect we you enough are the might a And study. effect inclined five The to of based also five doses, considered from prudent to an an efficacy to range total AVATAR a it of with response have the the to X.X significant in the as of excellent -- dose sub expect really this in we patients was higher from also study, originally was was those second the study compared example, for the US is and low AVATAR extension to XX, size we to we age remember, groups additional a higher the analysis patient the add other make communicated. XX analysis then number in size to of of additional large. basically we using up have to the request similar not study patient order XX XX we XX if the to that US just given a that study XX number believe to in

UnidentifiedAnalyst

Very helpful. you. Thank

us study. FDA and second give what on understand the Can other few the drove advice the decisions, saw a agency, made help primary also you any in that was a We result or changes with a interactions to excellent or endpoint of regulatory you those us very

Christopher Missling

Right.

a noticed in RSQ that of dedicated can has a questions of rigorous RSPQ, still, There's very this most have look we reliability, make presentation that ability we the would a XX, ability score. noticed was sub of through score that the So and is published precisely. It to say that I doing we that of entire when assessment more and have to also we question, but a include rigorous, also sub-analysis is going we and really it's which demonstrated because it's very seen, we the but very be have weak it scores answered detailed really want didn't basically the there that the the endpoint. our global really at and we weaker known however, overemphasize which

the was on focus for the the RSPQ. background that So

UnidentifiedAnalyst

program, have And you. do or you future? you the question updates Thank Parkinson's to near you the met discuss disease on agency in any regards that right. All and program, it anytime dementia can with plan last the to provide to my

Christopher Missling

do informed we foundations fully the Parkinson Yeah, We much. get you the that. to go discussing now design pivotal Yes. that, you then our the And valuable feedback Right. on for to a are dementia. respective more pivotal in we about Parkinson to with educated also data study and of we very with actually expecting communications. are the the if agency in like, the input We and proper a and Thank of for do studies plan plan, pivotal feel with to study the for discussion robustly package, in process

UnidentifiedAnalyst

think, will going you the some it'll imaging occur the beforehand. Do or results by to wait you're for chance study meeting

Christopher Missling

study, still not before definitely gene but analysis we the the imaging reported will This the study. are total we yet which have PD be including of

intelligence a an of we've which at So chances that mRNA, the in the of down believe arm, road. additional that placebo study, be as looked in the the to of can only expression not changes make the but Sigma the pivotal participants and as the a out gene expression well of means that study drawn also further that is all increases one active design informed arm gene

UnidentifiedAnalyst

Thank much for the Thanksgiving, very taking you. my happy questions Thank on congratulations and you and again right. All progress

Christopher Missling

Thank you.

Operator

comes Wainwright. H.C. Raghuram from question from Next Selvaraju

open. is line Your

Raghuram Selvaraju

for and the progress our thanks questions. for Congrats taking

do trials? XXXX, envisage providing [indiscernible] for NDA an the you in positive early how firstly, Syndrome, you three in filing from Rett So readouts

Christopher Missling

obviously let soon we as really, and can as possible. come but about pending It's that, I data would out first the talk data then

Raghuram Selvaraju

share fragile the Excellent are mechanisms? with are Syndrome what cellular analyzing that syndrome X-XX the development? as trials, overlapping into X to over data Fragile For regards transitioning the syndrome and two X underlying as of you Rett then planning well symptoms sort from and you syndromes given learnings cross example, your on

Christopher Missling

right. exactly That

be X to in pockets here these the see which to and decision used the the two Fragile there with primary one And for clinical the a potential very the prior are pocket, preclinical also leading example, the then could is yet had Rett the Fragile but that endpoint. this overlapping of endpoint, of see and model has that of included a very pathology. [ph] our also So and measure we some atoms about X at Syndrome, for made we for be could use one strong believe also study reversal how and well as is look at used as the this between the that drug key X even been the not And Syndrome in we animal them end Syndrome Rett been study and since exactly responding are that The in Fragile to look study, even we one phenotypes two indications. venue. points, Rett are study a of is

Raghuram Selvaraju

plan two, with helpful. Very so. Okay. paper do disease. interest wondering number targets one, number these and test a therapeutic were Alzheimer's hand you company opinion targets to if in drugs we We And together you in not, benchmark you've XXX nation described recent on for read your where expert published do and as hand XXX pre-clinically, if

Christopher Missling

angles now but and a the so more go. only the able the into world really labs of engagement. not same and we which from we preclinical in receptor, affinities is call, And very as indication And we So see really could we different early moving of to of to than be same the we different the believe assay far Sigma muscarinic learn But run what there differences find indication important. to X also compounds parable assay we ultimately are the the will both in and are two they other the drug we difference came try also trial. difference two if target receptor

advance, Frontotemporal, will and each eventually its drug at really it good own very in could that good think at right very XXX could be we now find well merits has more more is that out, also so XXX but and we [indiscernible] be focusing we So have

Raghuram Selvaraju

recent protein Appreciate younger planning a a cohorts, brain help or in using genetic in the saw describes XX. test age of working then finally manner. And which article, younger a talked kind mean science kind in of on cohort about protein a to a or advances Are of color. administration just prophylactic XXX unique XXX We future? you signature currently your in the you've

Christopher Missling

intervention into and is age, the look with while most incubate clear very most showing really we is point up a that it's disease efficient correlating because good early Yeah, likely this way it's to that that the developed before was a And the that Alzheimer done injected successfully our And who in never with drug got got load. preclinical which the symptoms very indicates toxic, better animals data disease. of potential, they a they disease.

to committed that So likelihood we there's proceed. really high that and time, we should sat in And eventually do the road. with appropriate encouragement also appropriate down to or the we the

committed early look So into you described are what we that on. to

Raghuram Selvaraju

everyone Congrats and happy again, That's Excellent. us? it on and to call. the Okay. from you Thanksgiving Thanks.

Operator

Jones Trading. comes question Next Soumit from from Roy

Your line is open.

Soumit Roy

as color you for you dose I So upcoming Could Hello the a around us thank understand, And cohorts. will Rett study? different be everyone. taking question. little give there the

and be intra dose there size idea the you of going is could expect? What should cohort we escalation? an us is, So give to

Christopher Missling

Yeah.

is explain dose. not So higher a than is there a just target study. different that It's US dose let the me

a one will So placebo and dose there's dose. only arm, one that target one dose and be

that is than So study. US higher the just

there doses, technically just be higher will So multiple one dose. not it's

Soumit Roy

Okay. Got it.

So, be XX, and going XX, you to disclosing not XX if are it's or

Christopher Missling

Right.

data out that. disclose the be to find when able learn will about We and then we we'll

Soumit Roy

on out planning are maintenance Alzheimer's going Is, of the there? or color you any Got they into And week? patients plan to what are are as go the coming it. is trial, XX trial what the

Christopher Missling

Right.

a patients finished which label the phase label after because drug. called up Attention week, XX study have some following study has to on these this And requested an after year which have started, open we study an they the them two is actually, weeks. as two of ID, So first open XX of the extension, to finished continue had patient stay extension the

years extension to so and from now did, successful open this label two AB initiated in we And we what we're years. study expanding three attention

that who continue the the enter two of are into because request finish study, years physician. is conversion is patient, finish into to now control year. the add extension study the is the from And open add and currently, by So study, the to go caretakers third placebo above patients it's will the the the I also high that study label placebo I a like good to to the which It the controlled part of also, like XX% very the sign. that the

Soumit Roy

conversation Great. Rec program, It's turning to really the are good last one to going data you hear. [ph] the these whether question be on the back on the to And where

Christopher Missling

potential data said itself. the also It's a we data pill it's study. of speak for to has a now and the And really question

in, So how looked the determine this will really and weighs really this the data at. will word be

have And not into the harder disease point because trial no is there out trial. the to they're more available. available a patient patient They they're to early because We are many at that find treatment to also adults, large. in the is on, bring passing population for also of

the is reason, for So X but the study an all that syndrome. on patients there's for still unmet really for need focus ages of

expect, say rolling first promise the even be it we filed. submission with I cannot approved trial, start if before pediatric could could it that I be gets a you either. could be but cannot really and, excluded So the would adult need

US from two said I is with why independent study beyond ANAVEX in the usually. [ph] which and diseases rare we that's So have placebo would study for request the usually disease, control

package. will very this So powerful be successful, a

Soumit Roy

happy Got on again Thanksgiving. all Congratulate progress for the and it.

Christopher Missling

you, Thank Thanksgiving. Happy

Operator

BTIG. Next question from [ph] comes from

is open. line Your

Unidentified Analyst

Hi. Thanks very much for question. taking the

are pediatric responder patient clinicians is definition and a patient, Rett be the as definition of also is going as with the consistent viewing that and a how meaningful improvement? of that adult endpoint, clinic that efficacy two, each the an in is one Syndrome first so the responder, on is So to same on

Christopher Missling

study first assessment. then consistent with consistent and It's correct. That's the That's correct.

Unidentified Analyst

I upcoming Then I in an didn't sorry, program of think XXXX on XXXX update XXX terms Okay. see the milestone. in

to temporal for is frontal do still first that dementia you expect if the just going I wanted a to So check study potentially start. indication program. And to be when

Christopher Missling

Right.

prototype we indication. And to ahead with definitely forward dementia related So before data have we we would but that one phase or have dementia, we in with hand will FTD solid like this. move mentioned move say other commit we we the to any but really

Unidentified Analyst

just like to target and the but Of be Okay. which And very you I going Rett for? you it's partnerships? prioritize going but to think encouraged think then would do course, on pipeline, the be you indication well, the indications, which suited think multiple indications for able to to might be is wonder do lead Syndrome indication,

Christopher Missling

the So Syndrome disease into others not Rett the first that commercial company diseases. been we has it's believe red FX that built this disease franchise, a have and with which a rare the entity with we is and ability, time targeting the

to much the that will the at retain be to partner seems our prematurely Parkinson holders, disease the market it right require and right that these physicians. but additional at time for of not to very also So upside, to for to make the a that this give is comes more upside large be up sure detailing time which doable. the the of no indications involvement support. might doubt with to be and of like Alzheimer of most large we done Anavex powerful requires and penetrate indication it general pharma to a support and It physicians the disease, Then practitioners,

Unidentified Analyst

And you very Thanksgiving. Thank happy much. great. Okay,

Operator

And your [indiscernible]. from comes question next

And you Your answer call. line And portion. concludes Thank also is the concludes the participating. conference question likewise. for that and it

now may disconnect. You