Anavex Life Sciences (AVXL) 10 May 222022 Q2 Earnings call transcript

Welcome to the Anavex Life Sciences Fiscal 2022 Second Quarter Conference Call. My name is Clint Tomlinson, and I will be your host for today's call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session. [Operator instructions] Please note that this conference is being recorded. available on be www.anavex.com. website will call for Anavex's replay at The us is With Dr. today and President Principal Missling, Executive Financial Christopher Chief Officer. Boenisch, Officer; and Sandra

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

Thank today's reported review our a joining financial provide you, most results us We everyone conference Clint. update. business recently appreciate on call to and to

of study Alzheimer’s X-XX-AD-XXX the patients readouts, X/X with syndrome. the XXXX, drag we advancement overall including placebo-controlled second the as of and continued for we ANAVEX of excellent X-XXin lead the and randomized and clinical each line product disease our Rett the top placebo-controlled line top execution pivotal programs In treatment with of for results business results regarding pleased are We are X-XX-RS-XXX two the our syndrome, our attention study across randomized pediatric half ANAVEX ultimate Phase from treatment operations. maintain from on candidate, ANAVEX Xb/X expecting

investors with leadership for development June R&D R&D will the include company's clinical on month, XXXX. This focus ANAVEX will our and day team XX, Tuesday, a analysts the Next Day host pipeline. company's on from presentations

Michael using And and closer Parkinson’s X-XX imaging-focused potentially ANAVEXX-XX the a of fragile for indication. July, reported a is Sandra to the of recently ANAVEX Conference, Phase trials dementia, Principal receptor of indications. summary Frontotemporal to rare-disease including XX, murine event. Additional for quarter. Alzheimer’s oral XXXX, Officer Boenisch, planned in in X a the of taking model details blarcamesine, Financial Diego, neurological schizophrenias direct the the gene brief call discuss treatment International of I the initiation presented meeting presentation of now new of to XXXX, like And a Anavex, syndrome, of California. FX financial by of X/X initiation ANAVEXX-XX would clinical disease Effects of clinical place applying trial clinical for Planned Fox study. medicine a study X Parkinson’s disorders Phase X, pivotal response, Phase occupancy’ expected the planned initiation Fragile receptor pipeline Foundation X planned platform Sigma-X most Neurobehavioral agonist And phenotypes in cause XX Fragile at a of the with FDA Phase ANAVEXX-XX disease will need frequent J. and pivotal follow the Further a NFXF a medical genetic X/X disorder. unmet of San be program X spectrum autism in sponsored of initiation study a to XXth expansion for to July precision ANAVEX biomarkers with and International including In to disease the

everyone. to Christopher, and you, Thank afternoon good

fiscally we continue and expand advance we ended XX, responsible the March cash our pipeline. as XXXX, quarter to During maintain utilization

to million, and fund which position the XX, cash our March programs next cash X clinical was $XXX.X runway our years. at believe operations sufficient XXXX, Our we beyond is

staff $X.X the compared the which quarter, in is Our and to of and for charges development the first the administrative to for compared the second per we increase development. were our $X.X is XXXX $X.X clinical fiscal and studies a quarter support share. addition compared turn year comparable in XXXX. $X.XX Christopher. of million driven to call expenses compensation XXXX. you, expenses to to Thank for which increase as loss were you. the same quarter $X.X back of over to is by period non-cash the now $XX.X million General period-over-period, net previous an quarter million related of overall in - the The fiscal reported research million primarily for of Overall, And million I'll manage

you, Thank Sandra.

at looking we we deliver are the readouts Q&A. us to well next and meetings and within where call medicine back to SIGMARX which presentations the R&D clinical rest present month's remain the day throughout the I forward planned. turn Glenn - precision our like medical are to would biomarker-driven present broad we space. to on And now platform data So to as track as we disease studies further neurodegenerative will of event allows as the initiating expand rare year portfolio, for

coming is Thank Our [Operator ahead, you. Yun Instructions] Go first Zhong from Yun. BTIG. call at

see on very patient and enrollment. completed I not the for that pediatric study taking you question. thank has Yeah, Rett Hi. syndrome the study, much the

So I still assume ongoing. it's

you're guidance readout or assume So is the you completion on to the to enrollment I endpoint, were guidance was believe that syndrome FDA. be on put the have AUC business second primary Rett from release you to going talked it's the to patient talk to the the still to And data wanted I to reasonable and confirm going press the after [ph] the it that last FDA out last going if -

has So happened yet, that please?

NDA that heterodox with [ph] small we fact Indeed, the study, its approval. discuss study, move Phase finished the that the a an study, successful small to so study, planning we the and a study call. the for in filing to communication for is in last you completed EXCELLENCE it's meet despite to ongoing was since study which Rett FDA II which And is Thank is the which program largest the in and procedure are study. also a the AVATAR adults, forward

we It taken take the with indeed, has meeting not are to will And So still for patients study but place. and and we is rolling, place how have learn yet waiting we EXCELLENCE then release a will it place, move completed. enrollment pediatric press this And forward. might is take the when ongoing Rett soon. to

regard is So endpoint the the to [indiscernible] to going primary still well, be with instead... -

That's right.

AVATAR, Phase RSBQ the first includes AUC analysis. II study linked we responder So the when from the we that that presented CGI-I learned

also CGI-I propose the analysis That analysis. So the RSBQ the we That It's response AUC respond correct. includes is consistent which study. the EXCELLENCE endpoint, for linked AVATAR with the is study. will

Okay.

would disease imaging that So what do And Parkinson's before to remind you the study? you to with the second the the you on can to study? imaging And initiate FDA program. is us like achieve question you need talk

question. a It's good

That's and engaging also So Phase will the Fox the were what have able among for we receptor full successful III, with is show likely Sigma-X to totality, forward very we to the discuss an target the meet program patient. the additional to in in given Phase humans receive Parkinson's Michael brain. this in support that its in the are confirmation to the the is clearly with funding probably as goal II the And dose-dependent And why them opportunity we also a that Parkinson's including we completely already non-dilutive Sigma-X we move Foundation presently is said study. the to use seen that study. FDA with the from which [ph] happy PDD grant

look the Day Thank June. Great. in Okay. forward very And you much. R&D to we

much. very you Thank

The from Pete. Pete think Go Cantor. Thank you're call next muted. is you. from Stavropoulos I Pete, ahead,

Hi, Christopher you? are how

How you? Good. are

Good. Thank you.

the adult previous don't you for spoken know you not previous So need know recently. but whether discussions, you have the question, of you that to the it data to the a are if going haven't for sense pediatric missed from file indication? or to I to I But I wait agency do in

the the FDA program. would the meet in until probably But totality to But filing how what prudent for the pediatric we for a X-XX Rett a as is for different study stated, that move include guidance we And yet age you a is its for forward data approval it's ANAVEX file on for So to theory, need is of because adults, pediatric study. believe we group. not we syndrome. in if know regulatory assumption don't you larger would Rett of terms it in

the for clarification. Thanks Thanks.

in say, initiate of wanted development could to X. to also patient anticipate from the XXX and regarding give I when initiatives takeaways lessons of your and you fragile applicability a sort thoughts about sense with syndrome clinical if potentially And program experience X the us the Rett enrollment. with the compound, their ask So you to fragile

right. All

So the two we are fragile very excited X program about reasons. for

this of key it's strong, be have phenotype we're solid which was the anxiety, is known it patients and autism in that which ADAM Phase we limitation X, out And which conference like endpoint and both artisan in in last spectrum with largest Rett successful spectrum of of biomarker as published year. the a we at both and disorder. data second new of model it the And side the in is is data will to point is all, the they the is largest clear the autism. very among pointed of on out we successful measured First these And of drug the autism data, the reasons for pathology, in which score. disease, well problem syndrome evident under a biomarker making and will for Rett coming really measure of the this exciting additional a the July, disorder. And of very clear we in Phase very as because And the are were pathology, improves that also with excited, studies [ph] which of is inflammation feature fragile animal score, them, disorder drug clinical be a very improvement this there why preclinical why from and III can from view. II the is very ADAM spectrum AVATAR presented

the very challenge doing, we it's what fragile the So sure are patient of X robust that a very because want profile. diverse protocol we to is now make

So are the will we the key pits in trial not we make agency population, as homogeneous this then And are a a a the - as that and want all. disease, because that they you failure not make in similar. And meet this apply to and the which of pivotal as and is very work, the population, sure a but a we because using trial also doesn't order of patients different which don't these is so with drug to study. avoid we the now is different approach run patients to confirm are are we endpoints figuring so sure process selected for what out can possible

in So we expect of this to this half place the take year. second

same consulting time, at in that - will at the EMA? the Okay. the then later same Or point? be with you time And a also will be

patients, we a right. That's that most starts. be is discussion with because have to discussion pediatric also also we will include important Since include which EMA, they will want the before likely trial also

question type Phase IIb/III provide rollover expansion? open-label last from into program. the any color Can the And on on rate just you the one the Alzheimer's of

Yeah.

the XX% was finished rollover So label study heard from in placebo-controlled patients the the last over who I open there extension. was

excited as So then locking releasing we're then study we're positive the process very can well and this. data. that's of finishing last getting subsequent really start very close the about database then cleanup, And we And and the to out, because patient as of data very we're excited sign. a the the

very Excellent. our Thank for much you questions. taking

you, Thank Pete.

Jones guessing I'm The at is next Roy Research. question from Soumit

Its here here. Soumit Iad for Hi.

Okay, great, sorry.

all on - come detail it still fourth the Alzheimer is quarter? little the A a the Comebacks to it or give on out? could on think quarter And... third progress. question Is final data you when us front, we should

a It's good question.

be that just long feed takes. half, QX. like it second the into in will QX. to - said if quicker the how we longer, exactly since than performed data because stick than it's we And So if it don't to slipping might know I'd it then it takes be And takes up

question? when it's So But clarity, really Was XXXX. provide we half update. second only to we'll closer the more have best a it call that

Thank you.

Thank you.

I have are with H.C. pivotal points with from And one said, question for your disease from study. Wainright. the key of what [indiscernible] the the Parkinson's upcoming agenda the program he meeting FDA

our to a in priority pushed with endpoint example, biomarker up success with Phase expression owing recent mRNA in For data being Sigma-X II?

since timely Parkinson's now data all make also sharing are And And just referred all this will And the we to sure a want discussed. extension very on able to bigger have This is will able study. picture since program to include now. and are have that, this Parkinson's we data items we you the the be completed. of And agenda. we we to of the once will be the be

can Okay. A indication you'll your Day event? second Moose give space new near about that R&D a and from of us you disease you're upcoming degenerative is the question excited at that rare preview in be showcasing the

Right.

data we we really preclinical and And kept we to that's shows different why indications, ability that. value the backed work rare the platform So it's lease the choose the and on by will have several it And indications. between have. have like of

sure want we really with the are so to to make are rare And design prioritizing - disease And the if on. comfortable working show or that's what doing right we're we we efficacy. clinical the

that's in mention it's So didn't the models. disease will the is. we And we respective release starts. by the what because there X-XX great showcase could demonstrated which only why indications, have are independent ANAVEX chemical which indication opine indications, to once indications, different the positively we But become separate drug it trial animal impacted being indications several indication

see I the Amos, in chat now. you're

ahead own and go can your You ask questions.

Chris Hi, our taking thanks you. for Thank questions.

II wondering trial. study, terms did, imaging if if we image from your your to from And used this Phase could in we XXX data? methodology data you of the focused So current combine study collected the you upcoming were Parkinson's

may with ask If I what combining exactly... the data

trial not collect you imaging? From have II - imaging or if collected you in Phase may any did data the

that's Yeah, of there the And separately care dementia yes, were this imaging study we is collected. taking II no that. did not. disease imaging In study study, Phase now Parkinson why

Okay.

this of Okay. differentiate subpopulations be characteristics? some Or Understood. do And from in potentially in think terms same patients? AB, cohort and will AD you XXX you efficacious for XXX use the could drug of more

excellent That's question. an

further could So availability XXX homogenousity make going and best, this AD, its without for guidance will in give as us we're clinically consistency But the which are to be enrollment. now, fine-tune and the - best any expecting knowledge that right additional choice would - there on on possible trial as also on indication. it data be to per some this, patients the the cohort to into have and robust I also with say, to as quick

the more So what early similar Alzheimer's likely this will the the be disease patients, ANAVEX II of right Phase is X-XXstudy to now.

been Okay, understood. for you appears that's the FTD one. three front you receptor this briefly on on in for action forward program? run associated How strategy in here. Could to the finally this off-target indications are be looking XXX. psychosis? And the effects clearly, So to given We're indication confident a just schizophrenia expound with Sigma-X

Yeah.

to all than at more has a speak, trials by Sigma-X MX who agonist. but is always of he also looked not reminder agonist. X-XX MX saw target was at to XXX a and agonism now, actually we that this a MX drugs we profile ANAVEXX-XX ANAVEXX-XX are been being in what the looked as MX as but not previous we at so everyone successful the were And very Sigma-X potent told us found developed a only of accident, there an molecule the have agonist he out MX of agonist, agonist. that And indication also activity. as inventor other if from with heard look because the And there schizophrenia pure you we which excited So now we shown very only

successful schizophrenia that because of be So even the he Sigma-X. and more ANAVEXX-XX in would posted proactive possibly

And as so that's the why well. schizophrenia we're excited about into XXX

for Good Thanks year. taking my Brilliant. questions. luck this

much. very Thank you

to You a follow-up question or... you maybe look like had

Yes. follow-up Thank a very question. you much

this looks a like it year. So planned of milestones half have of second the you for lot

do think I'm to the the - capacity for all of since think But the milestones so that be if pipeline not have be And to the which development? you could about wonder activities. to one important you lot one questioning you most I priority, a the talk complete able

you really today. I with consistent seen points it's have think the bullet

finishing which really Alzheimer's an it's the So is autopilot. study,

to the then like, of So a unmet with a And is a times seven in study. of relatively if and would also fronto do work, fronto the we syndrome But that. XXX, to huge into also do short schizophrenia, terms is say Parkinson size important following rule study rare red forget the for But Fragile be because I to study. Rett following it with pivotal not study, finish have it's XXX have I yet hopefully and But you indication given of when and pivotal and in the schizophrenia a cleanup priority, to same And we also, be want just go disease and out number given up which study. short think to potentially patients. a that mean I can don't also, then schizophreniafor study, indication name mention need X I for relatively that I and the the dementia the pivotal the dementia, especially not that's disease, would indication. would

points consistent have with you really the bullet So seen.

you Thank for great. the Okay, confirmation.

have a from maybe Thank follow-up as well. No you. Looks may like we question Pete not.

further that that, think I so questions have this I at can you Christopher, no time, - So continue.

Thank very much. you

are are of as We're company's on precision biomarker-driven into looking very looking medicine studies, excited completion we especially its build about excited the potential forward reiterate, need, Alzheimer which pivotal successful studies, and and XXXX. we about move disease also, forward really important of with to forward in pediatric initiate to because we're we two very want the again, very in remainder So this. we readouts to platform, unmet planned we're to excited of clinical this pivotal the But syndrome.

look for to forward and So questions. out to reach updates you

Christopher. Thanks,

today. the for Ladies concludes you now you that disconnect. and Thank may call gentlemen, participating, and