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AVXL Anavex Life Sciences

Participants
Christopher Missling President and Chief Executive Officer
Sandra Boenisch Principal Financial Officer & Treasurer
Charles Duncan Cantor Fitzgerald
Jeffrey Cohen Ladenburg Thalmann
Raghuram Selvaraju H.C. Wainwright
Tom Bishop BI Research
[Abrupt Start]
… recommendation for each of the three studies. The DSMB recommendation is to continue the studies without modifications. This is very good news and indicates we are on the right path with all these studies.
As a reminder of our clinical strategy is to clearly differentiate from other biopharma companies and clinical studies in CNS Anavex is continuing to pioneer the approach of big data - including all mix [ph] in clinical trials to leverage the relevance of phenotypic and genotypic precision medicine analysis of whole genome sequencing and gene expression data in drug development. And in particular - the potential to identify patients' genetic variants and gene expression changes that may predict increased chances of success of Rett syndrome - Parkinson's disease - and Alzheimer's disease treatments.
And now I would like to direct the call to Sandra Boenisch principal financial officer of Anavex - for a brief financial summary of the recent reported quarter.
Call transcript
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Sandra Boenisch

Thank you, Christopher and good afternoon, everyone.

We continue to apply fiscally responsible management of cash utilization with moderate increases within budget. We reported a net loss of $8.2 million for the quarter or $0.12 per share as compared to $7.2 million also $0.12 per share in the comparable quarter of last year. Research and development expenses were $6.7 million for the quarter compared to $6.1 million for the comparable quarter of fiscal 2020. The increase is primarily attributable to the continued advancement of our ongoing clinical trials. were million for period. for expenses compared quarter administrative $X.X to the and $X.X the million as General prior year increase the with is our The team. growth of associated

on runway for to to million, division Our will was And Thank Dr. up XXst, call now is cash believe Missling turn three $XX.X the cash sufficient which March you. we I years. XXXX over back

Christopher Missling

Sandra. you, Thank

go the current look clinical for summary, in we also of So, would trials to the with multiple ahead. as readouts from Anavex. providing now very be rich expect to open I updates data call quarter, data year and continue. please a forward remainder XXXX rich questions. And for advancements like further a catalyst to We Operator,

Operator

we question-and-answer analysts. a time, this Cantor session question from conducting be Instructions] [Operator Please Charles will equity Fitzgerald. comes Duncan, first Our ahead. for go At

Charles Duncan

the on Hey. congratulations Chris appreciate on team program. Alzheimer's Certainly the update Good and in progress. the afternoon, enrollment

quick -- a I assume or had and/or an was modification. to dispersions change decision at they end only did any look continue not data, safety, it trial sizing efficacy opportunity without question look to call there at DSMB done. So, the noise points did study that upsize they this regarding the not was the but say to recently I'll that and

tracking would anticipated basis? have is on you data as blinded that So, a

Christopher Missling

The question? Alzheimer DSMB study related

Charles Duncan

Yes.

Christopher Missling

Right.

review understand without that data. all though We safety. we changes on know review. to that their to focus made to do access has the on And DSMB the the according the DSMB So decision continue was also

Charles Duncan

Okay.

opportunity any events, efficacy? have based they futility adverse kind of data the safety but were analyses, upsizing recommend at did there considering looking dispersion? or on to trial they Were they're also So, the

Christopher Missling

recommendations, of itself The safety the assessment. on the ability DSMB has usually very -- priority independent is but the DSMB

Charles Duncan

Okay.

in sounds weren't this really point. this case, at efficacy it at they like So looking

Christopher Missling

I way the question. data, can all so to best access that the their answer Again, is this

to futility. not into there was something request a like specific So, look

Charles Duncan

for Okay. Can you into you or provide the say some dosing give rates Label the not Can on patients beyond color Open the perspective period? whether us that study rollover are going plan on Extension?

Christopher Missling

Yeah.

physicians, to us and a this in placebo into extension study rollover from participants the the five-year So, happened -- ATTENTION-AD produce requests study a to the because and we of study, of this Phase the a you drug extension ended rate we as as procedure. terror five-year, extension – reach this extension which And of the to study up a for two-year is caregivers also end on the was And human close XX-week part a period. end was extension because extended control on allowed have high multiple Label very patients continuation exception study, will happen received know, have open then Xa, it the Open label. a to and long that that. study. early study a times extension Extension to in of And what Phase originally extension we the of from participants being of after Xa the which reminds the likely seek total. we been of And of limited up And very investigators, request a

the so, Alzheimer larger feedback Phase this the And from study is Xb/X. we received

Charles Duncan

XX% assume that's the relative issues. benefit something like the to is like tolerability that mentioned or And high lack rollover, rate patient could perceived within seems on what the me the well assumptions secondarily thus staying trial help -- like placebo the of controlled I when dropout the rate positive portion, rollover in that. did you It But far getting -- do and within patients excuse of failure your terms were rate or that? then how

Christopher Missling

Yeah. Right.

percentage the the in what So, retention. of of range indicated you is

dropout open understand, we study. and the from into the field have modeled to we label a disease. extension other what similar at drugs rates long Alzheimer So, It's study in this

there a diseases, with in patients with like only features. cardiovascular Alzheimer, impairment, also multiple - Alzheimer is So, not

this So, entire there that the is patients finish often phenomenon not do study. an

So, as worse assumed passion are comparable than form rates I numbers. in similar these any length. not than think studies other in we or And have the of in we different

Charles Duncan

the Parkinson's when helpful. And if end that say Phase an dementia you you some That's the color program, regarding be? can question to on might thinking about so, of disease X Last were agency meeting? Okay. going with provide

Christopher Missling

that the up. said completed, we're we once about Yeah. that. would data wrap is And do We to

understand be in the this UPRS, to included. and been then most system, all importantly, PDD paradigms, the pivotal sleep able there a CDR for consuming the were the and get what have in measures the will one, study, be have The analysis the PDD. the gene that with most report respected of You the the study together will time FDA, and the and put be to in actigraphy, together shared recommendation we will lot

Charles Duncan

in that Could or quarter …? this be

Christopher Missling

do as will it as We soon we can.

it We as we soon can. as will do

Charles Duncan

you and the added Okay. questions color. my taking Appreciate

Christopher Missling

Thank you very much.

Operator

you. Thank

Our next H.C. is your Perhaps question Wainwright. phone comes on go from Please Selvaraju, Ram ahead. mute.

ahead. go may You

Please Cohen question. Thalmann. the Jeffrey to go comes will next from ahead. It go Ladenburg We from

Jeffrey Cohen

you? are Hi, Christopher and Sandra. How

Christopher Missling

you? Hello? How are

Jeffrey Cohen

Doing fine.

a Just few questions.

you can for as purposes? year, the modeling on income Sandra, far as out what incentive and of savings. look first quarter the help on the the for our like income that balance us So, might

Sandra Boenisch

What is question exactly? the

Jeffrey Cohen

the year? R&D and the Wanted of Sandra, how quarter for about that X.XX for like to may look the know balance development, the

Sandra Boenisch

the for the the of throughout expected I remainder think it consistent we year. XXX,XXX that remain quarter, and will was

Jeffrey Cohen

Okay.

X-XX accelerated you with sure, specifically discussion some trial as can more as far give fast-track any Okay. And insight as for agency, far it. approval? into us as Got the the or

Christopher Missling

Meaning for Rett syndrome?

Jeffrey Cohen

Yes.

Christopher Missling

Yeah.

were for have One data group stage And first be with that with RS-XXX also high now study. study ongoing line could we to U.S. with younger age the top that given studies. we year. that population population. the we is And study in data RS-XXX in recently And we higher like patient finished, entire the We'll we study potentially doses the RS-XXX. will study. the which syndrome, we the the and the presented younger patient discuss data, explore where FDA the very the path the And to was the to pivotal which syndrome, with we a positive U.S. will believe last outcome share and go So, of -- had discussion them RS-XXX the a is study. very forward, And the the have two RS-XXX, with together be approval with doses that have we Rett first Rett is agency. first then seen the with able

Jeffrey Cohen

PDD and Got Are the Phase it. AVATAR those in still track? on RTT? update And X/X the Phase Okay. any timelines X on

Christopher Missling

Exactly.

PDD this So this of and line quarter of release in will mid RS-XXX the year. RS-XXX the data be this be the the is full the study quarter of data will top by expected

Jeffrey Cohen

that's Okay. And population, adult in correct?

Christopher Missling

population higher right. That's dose. the That's adult

Jeffrey Cohen

Okay. me. Thanks taking the Perfect. all That’s for questions. for

Christopher Missling

you. Thank

Operator

Thank you. Please And line. we have Mr. Ram back go on ahead.

Raghuram Selvaraju

signal problem have very apologize. a much I for must had Thank Sorry. my questions. before. the taking with I you

looking of as at to And differently commercialization or are self you actual to terms them degree going First the of in looking strategic may I of Are you at PDD. have what comment regarding terms could is syndrome involved to implications you if commercialize of entirely, versus Anavex's was the on of blarcamesine that overall in the which potential be of all, in in Rett wondering positioning? each opportunities drug? those directly the indications Anavex thoughts sale

Christopher Missling

That's a very good question.

to a I plan for think is if -- not not approved. rare the right market the disease Rett now ourselves, company are we would And first syndrome. that be going

in prepare for place order that. So, have in we put to steps

because be a anyway, study, have the concept proof X which to we to not aware, PDD, have is have which pivotal another we we first the study was a of planned didn't we Phase study. For -- -- do study

have going partnership, so, second forward. or marketing, in indication we of more would a think like to And the terms time structure license if we PDD at to how if it all needed some to about

don't the be But syndrome, ourselves decide something it So, right to this would we have to U.S. would market to we in content be able Rett now. this

Raghuram Selvaraju

that, the or other words, in you would fugitive of eligible definitive you that review PRV for won own to would monetize if a be the you you pursuant voucher made pipeline, it? be approval definitive else disposal something you, priority And syndrome, your of apply the decision regarding blarcamesine Rett to that would would have and in it

Christopher Missling

symptoms is that we but well opportunities also the very and we as flexibility to to have is another able the Fragile to drug are or given -- superior open good is retain of also are current within study to shortly rare Right? treatments family have after spectrum also another planning treatments we disorder, have the And current -- the autism like syndrome not where also X, X, Fragile expected disclosed. we study Rett disease, in disease which to or rare we the This where data. Rett be drug pre-clinical in same is

to we address don't yet the regarding to different are So to voucher. how about have think there ways that. make decision But the

Raghuram Selvaraju

with the one clinical And last you what milestones the respect to X, indication? be just through question. development to walk X us in expect clinical development The Great. term timeline Fragile Okay. near you can Fragile

Christopher Missling

mean? you approval, for So

Raghuram Selvaraju

when it clinical development with start that likely to is clinical report milestones, Well, next study the near when -- the data. likely is term

Christopher Missling

Right.

data full the between year. the therapeutic approval discussion So in will will patients top half in the order drug how for with mid RS-XXX this quarter. RS-XXX year. the for utilized agency, of of no get be have be be second this And which syndrome. Rett the will can And the data the be RS-XXX in available which The determine line to for will

Raghuram Selvaraju

Thank much. you very

Christopher Missling

you. Thank

Operator

you. Thank

from Our from comes Tom BI next Research. question Bishop

Tom Bishop

a that gets Hey, Extension that questions. assumed little Is Label Christopher. correct study Open assumption? I always means drug. got couple the that I have But of everyone

Christopher Missling

for in involved being are drug, not to the not study. who previously, that drug, Extension study, participated Everybody is active the study an or association Open those get either Label had who finished in any without placebo the they the able everybody in had or

Tom Bishop

And get still? for they the Right. Right. drug free

Christopher Missling

That's to anything. pay right. Yeah. Nobody for has

Tom Bishop

just of quarter, Sandra, now, average the but you could number tell Okay. now? me for shares not the outstanding

Sandra Boenisch

Q. we the about in should It million. think be disclosed I XX

Tom Bishop

It should what? be

Sandra Boenisch

XX million.

Tom Bishop

dose the and of or XX like original were a the patients XX decline if A those XX was study, shows dose very medium cetera. -- on drug. I patients million? still two, that that the just X-XX sort number MMSE still total which from in the patients XX And many and went. recall, little like decline. famous patients. Okay. and of are on sharp graphic I the was a the And wondering where showing of there's was the on the that And showed Alzheimer's how But the high I And et that as others wondering I'm low

Christopher Missling

Yeah.

that three-year in was interim the analysis. So

We in -- clinical eligibility because than That the when device patients officially possibly the switched anymore But will a it have exemption. future. the but study, less over has a they exception means understand share in have they be trial the run timeframe trial continue able drug. remainder completed who to now take the I been they're -- And extension, been it's not humanitarian to XX. the in the that about, to of

think mistaken. There's that taking years number if after XX encouraging not still and there's I XX very people it's I'm between drug. five patients, a

Tom Bishop

one's Alzheimer's they regards of me. true. funding, are some rather I'd than but I NIH said Yeah. has with course, think and partner good one there's to read neither. has guy from indication, Anavex for But I've Yeah. reason and of got -- -- you hear the one a them a companies Also where the articles working it both, other on That's other that

Christopher Missling

then quickly. the who published get it look long grant. get grants, think have time you a takes NIH moving money. if And until a I those to the and time very have When get you takes that we're you the to at get grant, a you long data

too with the way moving of kept the been the asset. very the advantage We've a that happening moving upside. and So are you early, in of that's preferred quick forward for assets not

biotech a there's So company.

upside You for retained not is for upside just by of the pushing this out, having Anavex. real shareholder. advantage have the shareholders And that of

Tom Bishop

to people you've And was shut you wondering just XXX%. or because other I down had if want partnering, some you just from Right. if interest the them in keep ever

Christopher Missling

And this. always at knocked have called We we the discuss upon bio like and on been regularly. to the regularly participate door conferences

our very it we we upside projects in to pipeline. are with structure big So, And pharma excited retain discussions a but And something. that be mutually are the for we'd companies, striking the has our again, and about beneficial for reason. to like

and as at right mean does time, do we mind. have now. partnership right flexibility are this maximize eventually value but proceeding aiming not it speak -- we that we It to not requires that of for to are will We the shareholder and

Tom Bishop

Okay. XXX trial, ANAVEX or And is last question, the XXX? the XXX Rett trial, that

Christopher Missling

XXX.

Tom Bishop

I due is -- on coming that Is was wondering the that remind how if you the and enrollment's size, us? could what

Christopher Missling

we've from XX. Yeah. said set than We increased size XX, -- the more

more it going will have and So, well. half and to enrollment that than it's XX the this be be we in is year stated second then going

Tom Bishop

All Fair right. Thank enough. you, Chris.

Christopher Missling

you. Thank

Operator

Thank you.

follow-up Charles go Please Fitzgerald. ahead. a from Cantor We Duncan, question have

Charles Duncan

Hey, back the PDD follow-up. on the one Christopher, is of the questions, thanks Had taking for couple Rett. on a and other

answer -- PDD, the trying your out. to before figure I'm just back to Going it

will, [ph] with that the in intend the or but to the lab or agency? genomic which X the function near with be or or you in do little analysis, you able the move more bit anticipate, I meeting it if forward regard would you perhaps from end study year, has quarters a you'd with Phase then, findings last to COVID-fied of days present know weeks to First of been that data months call And term? in all,

Christopher Missling

Right.

of recognition, a like have have of and because memory, capture and we'll data, accuracy, time, word been measures. a multiple We're system, time, very the the about PDD picture CDR memory recognition, the reaction of long-term memory different no -- captured short-term and CDR is has the entire score granularly memory, accuracy, total a of all domains, word total there So picture the domains and time. lot system lot cognitive talking a short in it's cognitive they data reaction levels action system

So, and X, were we called more participating X, that, agency, And battery have actigraphy, we have sigma-X paradigms. measures, X, is are tests, cognitive and paradigms, not entire sleep of there of and are already disease, a what then of that it, X the analysis measures how Parkinsonian up, and then for there, lot we UPRS, different the of so this we we the will to we sleep presented of up are discussion present levels which genomic comes different the which then the have UPRS two now with patients have And regarding we it we'll rapidly be this follow and finish expect there as does despite the status. data top what moves very on to speak. announced, we sigma-X this the once the quarter, that. of But

when additional the Just basically And understand audited Business report, done. to And and also will be be report all the some the request has completed, to all and agency that's this reviewed a time. be submit requires now signed. done we to has agency.

it. expected we to but describe would not question so, be way part to of I days, And the we months, of -- not need many say That's months. too best more

Charles Duncan

helpful. program. then Rett my That's And the Okay. follow-up on

given the range groups Just studying. terms safety required disorders. that said of agency What It age in terms sizing, to in has for of going what's be on safety to rare database? its the is database you the that of you're quickly

So owners. it's I imagine two not

Christopher Missling

Yeah.

we included Rett our all extension studies So, in clinical study. and

the before. was RS-XXX, in XX Extension extended Open weeks study originally XX -- that So, already months Label of it's

X history, is patients also and to also the EU same that's we that, for the is in Anavex started are year with one to safety what to what given operation, from RS-XXX, we're the study committing side have we extension on on here timelines patients drug feedback that from the of these those extension safety, X. We sufficient chance and have the a that's will and study a a who very happen ANAVEX will a European Anavex and always for extension and what believe also for likely, stay continue one RS-XXX. And year the believe a but and or

it's anticipated. period extend beyond So these we'll also likely time extensions the very

Charles Duncan

Thanks Very follow-up. for taking good. Okay. my

Christopher Missling

Thank welcome. You're you.

Operator

to to And this back moment, Christopher at would you. Thank Missling. call hand I like the

Christopher Missling

and tuned. trials very you XXXX And as remainder good reiterate, I have address really you. platform for clinical also a we very to data providing of unmet a very current needs. allows continue excited look and multiple to afternoon. the And and believe expect multiple have In catalyst summary, we with pipeline much you be our Thank from year about program. which forward bridge stay we're With to a that, and want We to quarter, updates a data thank rich advancements very -- good strong a week thank we So, much. us Anavex. readouts further

Operator

gentlemen, call and today. Ladies concludes this our

disconnect. now may You