AVXL - Earnings call transcript Q3 2022 | Anavex Life Sciences Corp.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Clint Tomlinson

Good afternoon. Welcome to the Anavex Life Sciences’ Fiscal 2022 Third Quarter Conference Call. My name is Clint Tomlinson, and I’ll 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. that is note recorded. Please Instructions] this being conference [Operator replay be website The also for on call will available Anavex’s at www.anavex.com. With Dr. is us today Missling, Executive Financial Christopher Chief Sandra and Principal Boenisch, Officer; Officer. and President

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

Dr. Christopher Missling

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

X-XX in and pleased are continued disease our lead the Alzheimer’s with We ANAVEX syndrome. candidate, advancement product Rett regarding

end of overall across milestone the very operations. a of As We important our we our clinical the maintain business programs and on each attention execution at June. achieved

for treatment study in visit of of the early patient, ANAVEX last Phase the disease. With Xb/X randomized Alzheimer last the X-XX placebo-controlled

Xb/X on end provide early of activities disease. completion of Alzheimer’s study focused order Phase ANAVEX of results of now to trial the for X-XX treatment associated placebo-controlled are the We top line in of

of an which ANAVEX on are unmet coming to of disease, Alzheimer’s placebo-controlled X-XX order condition study which focused This a provide of associated in end-of-trial expected completion the indication, now is Phase is are burden. results significant top-line economic Xb/X early We of this activities and in need fall.

only For which limited treatment there options. approved pharmacological are

including Alzheimer reminder, and is hospice nursing disease associated of disease XX at are direct of $X the healthcare home for trillion for total Alzheimer’s common adults and ages. $XXX healthcare cause estimated are fifth likely Most care, in care of death years. as the care. costs care to to dementia increase than cause life the the than leading treatment burden. to of with older The attributed a costs the is As most Indirect negative in societal of disease and estimated the population billion, and skilled personal cost Alzheimer’s expected cost underestimated and are more care, informal significant giving XXXX of with of quality

important strong blood Fragile ANAVEX placebo-controlled pediatric X EXCELLENCE We the In the the of X-XX our year-end open-label Fragile clinical identifying dementia XX-week in in publication Data disease which treatment from planned study quarter. presented is Phase study data. by also recorded last completion Phase X-XX Rett patients assessing scientific X Rett extension End the in of trial XXXX. Genetics, American syndrome. the expected study program, the patient, XXXX. ANAVEX for peer-reviewed biomarker Anavex of of by this a announced of X visit syndrome randomized very expected support effect Medical of June, of end syndrome July, with treatment a Anavex In syndrome Journal the this provided in for occurred is last of for X/X Parkinson

not I Sandra California. Financial rat International a FDA Phase Alzheimer’s but decline Precision Anavex a planned in prevention X-XX, of to of disease direct ANAVEX dementia initiation study ANAVEX disease of X-XX-PDD-XXX ANAVEX Anavex, preclinical Also San the transgenic indications. the of financial of Fox discuss precision reported the Parkinson’s and of in Boenisch, disorders clinical frontotemporal of like Disease Alzheimer’s with at cognitive pathway human J. autism Foundation by clinical the ANAVEX Association disease of now disorder, of rare initiation Diego, unmet clinical for syndrome, AAIC indication, genetic previously of recently initiation and Phase would and a is call X initiation is August, schizophrenia, SIGMARX ANAVEX clinical potential with disease expected with imaging-focused treatment gene need applying planned spectrum Parkinson’s induced X-XX a most gene medical in cognitive meeting least, applicability using for planned at and of Officer brief strengthens a the frequent significant Anavex ANAVEX summary entire program, presented Further effect model with Phase the Alzheimer XXXX, Dementia X long-lasting X/X AAIC, therapeutic sponsored data in pivotal Medicine pipeline platform for including and from consistent a disease. Michael correlated and Parkinson’s first the disease platform trials preventing the to And biomarker a new cause X-XX Parkinson’s of for Alzheimer’s The Anavex Phase study importance disease expansion data trial new X-XX reported last pivotal response X Principal early and the in Fragile the quarter. Conference, study, This X-XX. of to of medicine dose-dependent including impairment X/X neurological the planned and better biomarkers study

Sandra Boenisch

Christopher, good everyone. and afternoon you, to Thank

we quarter, to clinical continue responsible on maintained fiscal as third execute we cash our programs. our fiscally utilization During

in our XX, on have position sufficient we June operations runway the cash range, Our believe rate clinical was to utilization and and cash years. $XXX.X put cash programs this To beyond XXXX, current four million. context, at fund next we

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

Dr. Christopher Missling

Thank you, Sandra.

readouts well precision medicine data now Q&A. back as clinical as the initiating would as We’re call looking to planned. forward -- we to biomarker-driven studies, delivering I like for turn as Clint to

Clint Tomlinson

question-and-answer the session. Thank you, We’ll Christopher. now begin

a please in or If question, enter you Q&A raise hand box. the your have

first Go question will coming Soumit The today be ahead. Jones at from Research. Roy

Soumit Roy

trial. all progress. getting when of pediatric the is on we year-end the ‘XX? XXXX, you is Rett Could on the at mentioning Congratulations question you’re still push expect its back completion into data of ‘XX? So, EXCELLENCE end or One everyone. Hi, clarify the trial expected the data

Dr. Christopher Missling

be that the a the Right. the will study ago, of while December. in completion clinicaltrial.gov We updated

Also completed our data be readout, by the to completion after can point a we time, this EXCELLENCE out syndrome. to that I the best this of and that sufficient release the line once So, for entry confirm in the manufacturing the want we top the try year-end data have soon definitely, we will will have the that -- looks point Rett study. at like we point study the or so, rollout time study also obviously If But it study. market data at study provided in products potential positive. is for

Soumit Roy

it. Got

So, to syndrome understand seems Or in enrollment in like why is just taking for trying enrollment you any see there the to the do -- -- pediatric -- it’s longer the Rett complete? the trial? headwind it

Dr. Christopher Missling

the the vaccines for the quarter And three constant that pediatric three approved or trigger duration. a requires reminded a medication, were population. had vaccine trial months We since is we of this for last months that a consistent situation

we taken, join be last in will that has So, willing a are and or slower three-month period part the that. that’s And noticed the before would can to patient trial. participant to just will process. dose of when study enrollment, And a be participant study aware or some or that this a somebody the we the made of vaccine triggering join a vaccine lead

want there’s else, we but follow So, that of the to that sure three-month make guidance not requires which period. this really the we anything protocol,

Soumit Roy

I totally understand. And question. last

from is available So, you currently entire want and where curious on adults file until BLA, whether thoughts Any are separately pediatric then BLA you or to to filling the data still together? that? pediatric are wait the on you

Dr. Christopher Missling

It predominantly. they remind an affects The when are so get close at is years And Rett -- we XX%. an is readout in onwards is syndrome study. study point, many from should and pediatrics EXCELLENCE this expectancy indication of early a die indication XX life patients At the only everyone that age a which girls older. it’s we to

is also submit study. to sure And important and for voucher, size study focused a And eligibility, voucher focused in the is the study as we want clear why order we a so, entire point study we to adult you we pediatric to that the in valuable, that are successful we group. that quite the want this at this make pediatric know. is sure the able have make age time, predominantly. which the to approval indication that it first study And since on receive makes That’s on to also patriotic get

a is the addition finish entire So, predominantly into Phase three which the in this and Phase then it that we of and Phase EXCELLENCE AVATAR again program, key just EXCELLENCE the studies, study. fact the the so X far but file study the more and X, preferred that patriotic that it’s -- EXCELLENCE prudent the are indication to thing is X consists placebo-controlled to study

Soumit Roy

for congratulations the on you again the all all And issues. Thank clarifying development.

Clint Tomlinson

will question BTIG. at Go next come Yun ahead. Zhong The from

Yun Zhong

PD your study Parkinson’s with clinical information provide given And not case, question from follow-up your have on population done first was that’s you patients do PDD, the the the FDA of FDA the on study a So, additional for disease. Phase if question. for X you discussion you pathway ask Parkinson’s think with the the will What’s I of might And the in information? patient? disease or data imaging possibility really that the sufficient is

Dr. Christopher Missling

Yes.

good question. a that’s So,

first only. the Parkinson’s this is proof-of-concept soon patients study animals initiating model. the animal good for our received reminder, So, which PET one, covered I the And study disease, disease-modifying their support we’re a thank And for this, after imaging second Fox Michael study Foundation as again, in for the in would to for funded. Michael in Fox disease want support a Parkinson’s which indication a a brand be in Parkinson’s which

very measuring is standard this believe to though because gold study to score, which see we robust Parkinson’s disease, the have dementia we a measured that We improvement the in was parkinsonism outcome. -- Parkinson’s and standard dose-dependent the in strong of is in noticed Parkinson’s demonstrate that features, for patients and robust its dementia parkinsonism study MDS-UPDRS we very very

we forward placebo-controlled moving study, a that have in pivotal because patients of disease, Phase believe of Parkinson’s study the Parkinson’s evidence in dementia from enough a disease study XXX So, study. a we X in in data

Yun Zhong

Okay. that My have lot data. you of question interesting quite reported is a biomarker second

be incorporate wonder, patient the that better a to have plan to future in, information patient identify you to specific allow will And to that you so information you also, population studies data? biomarker study? enrollment do clinical you in I show Alzheimer’s for maybe So, incorporated maybe example, able in that

Dr. Christopher Missling

takeaway analysis a was again pathology to counter we volunteers only to as dementia also really that ability down-regulated the in Alzheimer’s X-XX of ability of broad autophagy pathways, Parkinson’s are better evidence the is X-XX the disease various that down-regulated this the I compared important that imbalance these to as respective Parkinson’s pathways down-regulated on are capable most Parkinson’s features indications compared Alzheimer’s confirmed getting reduction about unilateral the noticed and pathology placebo of one very again, and X-XX to the not the that whole and ability diseases, genome in that the are resuscitate reduction in gene biomarker complex gene and complex learned to disease. pathways homeostasis which we’ve or counter The broader disease, ANAVEX of with pathways gene And respective different of have that but features from address fact those really drug patients outcome the able remind we which disease in of not papers, down-regulated mitochondria, or were to genetic these study really shows ANAVEX of up-regulated in And tau pathways in and restoration. that studies clusters the whole of in important pathway well All been and and -- pathologies. which but and arm to that that And like includes already want SIGMARX of pre-clinical gene them ANAVEX that. restoration, were is healthy and the in a clusters animal degeneration on analysis. genes this demonstrate patients pathways various these what extremely published in clear really addressed of counter talking And is shows range the in correlation doing genome is top data is with benefit. is to

a perfect highest us why strong the which shows genome readout the only and does correlation as very again that with since indications. makes sense SIGMARX studies. impaired of I’m again, in are but these also most future should analysis fundamental that’s not in in activate So That but outcome benefit this patients and And the whole the excited broader also one pathways, biomarker had gene, come also SIGMARX. activation surprise, not give confidence we the who

Clint Tomlinson

Next from Ram question Wainwright. from Selvaraju H.C. is

Ram Selvaraju

could my respect of Thank the regardless disease aspects. exploring imaging you are partnerships questions. in all the what to to utility just versus if I is those of wanted how thinking use the through ex-U.S. And blarcamesine at in be context. congrats this level? you and really potentially provide might both extent ask for neurodegenerative once its taking to demonstrate comment the commentary again. other One China. And you a molecule so commercial much about you those particular, the optimizing fronts, evolving commercial with if ultimately the you of territories. be? was progress its what regarding that strategic envision value use of and some protection therapeutic in is to in context, two on on on significant of in could the X-XX of territories, Should timing how blarcamesine, that like also IP the wondering I you particular, And expect

Dr. Christopher Missling

you on for clarification the May Very please? to referring effects ask question. of good imaging question, I a drug? were first the What

Ram Selvaraju

is yes. That correct,

Dr. Christopher Missling

No, you ask do what may I by mean you that?

Ram Selvaraju

treatment, drug a the purpose the above call beyond So it, diagnostic if, of value of compound for is imaging some, were sort the there utility optimize way in the example, of let’s there and for the diagnostic to of context? optimizing both, and therapeutic

Dr. Christopher Missling

understand. I Thank you. Now

So, pick me let that first.

want out. might So, as re -- and point I and you remember, to that

We being in which when a body, amino XX% all on So, the which variant call noticed as dementia equal, which the allow gene, clinical different expedited One the we need because seems slightly talk better or we minority difference ANAVEX in wild-type, is everything and diagnostic, developing relatively this two are we noticed shows prevalent that genetic Parkinson’s, that acid, with in confirmation a might up committed if real we enough, the in noticed then patient. in parallel to WT. in change patients patients, did far, would the no diagnostic that those But its notice to studies, XX% Alzheimer’s, so forms. syndrome. with to We that gene. more Rett therapeutic a high patients test, one as activity hence to are then world in two doing its still XX% predominant. those is than job all to forms would it not we there SIGMARX test, genetic for We with diagnostic use the other. said be those this a call but and then response three studies between most become the X-XX. about would for studies, that participants the of And having -- XX% SIGMARX and things companion needed we have wild-type wild-type that SIGMARX of had -- that, focus in dose It’s

X-XX. the precision that to able the that would X-XX. ability that -- the from patients need out And again, cohort XX% pediatric diagnostic this the ANAVEX sure companion will But case, the Rett the diagnostic genetic then wild-type into far, benefit we having study over we from might even most have which therapeutic we don’t only see again population. with of identify of additional that And study respective So, patients it making gene, if like approach. will go SIGMARX we to of market not these patients Alzheimer’s ANAVEX does move that is companion to kind be benefit find so with selection. then, and into medicine, all if that But just background be will

we the and we’re for move planning and also the Rett marketing forward commercialization regarding stated We in marketing rest syndrome are And World, U.S. and ANAVEX with and or would globally, partnerships Rett then X. Chinese to Fragile happy of in of we in South including Asia dialogue and regional to outside the outside drug and companies Japan of the possibly or in partnerships, a U.S. America. Secondly, X-XX to Asia the be and syndrome, European, able actively Rest ourselves are in planning separate Europe discussions in planning and for Asian of example, of There’s ex-U.S. also for potential the expand

the So, question? miss discussions the I order that worldwide. additional are any of on Did in in rollout already maximize also we to drug

Ram Selvaraju

IP about China. for Just blarcamesine in as an adjunct to currently that, asking I protection was the

Dr. Christopher Missling

Thank reminding. you for

to we the patent protection, IP the so X So, back well. China sure years. company’s application far, going to that with aggressively when X strategy all portfolio included always China started make so as specifically We filed that the we we in X patents last the in have is very did include years, to

also So, IP China group we we the have of largest always market, sure into make protection only specifically protection. in but this that not added

Ram Selvaraju

then, which to identity you release still the do of you expect And with when the rare Okay. question for just identity from as to was blarcamesine indication year? that disclose ultra X/X guidance press disclose new respect this the one the of initiate development per you the indication? expect last to Phase clinical for When

Dr. Christopher Missling

disclose really, which we will are indications. But excited we don’t Right. we we that And to diseases. we then, progressing impression ultra-rare a rare the convinced only the which if predominant existing reason not as the as indications, disclose FDA want first The with have reason about not of those succeeding in sure pick just make and in make trial we the why that sure to on speak. of bit And clinical in That’s we that indications this to sure we be our message progressing reason we it. the don’t we ANAVEX the convey several have We trial the give the are to the mentioned data would background make are very this chance to we I has existing get like market. would focused we want We not about It’s to clinical are to very success. the to or focusing make one want disclosure. is be just and like we discuss that this. form don’t that highest is happy the don’t about to it. indications where we want the with pre-clinical X-XX we robust shape distract in diseases and that

Ram Selvaraju

effectively One you as I have length actual drug assumptions commercial may I can along expenses the Based commercial-related whether not the if for includes very minor may. say, Just example, with with with you the clarify is to expenses likelihood to financial actually commercialization those to other on respect the operating the well. And expenses runway the whether blarcamesine? guidance your in guidance your syndrome, whatever possibly regarding wanted includes of highest of Rett associated might but confirm or make budget deployment that one runway, cash another of financial indication. also just clarification,

Dr. Christopher Missling

question. excellent an is This

break it me way. this let down So,

already product you sufficient capital rollout The capital for is commercial I we market. So, have, marketing cost commercialization, just before, your equity you entire as drug, for briefly as know broader in X-XX the have Rett when access mentioned for syndrome. that ability an the than ANAVEX rollout approved and to the drug resources of

access You use are not other which debt basically and of make financing to we dilutive. vehicles will have certainly And financial that.

available, can shareholders. expand right ability -- hopefully this change which equity, where So, limited we’re revenue. use financial very focus stage very on yet the vehicles the does the and now basically is a company have quickly which is in to not resources, to But the to cash not soon non-dilutive that able are to is and

Clint Tomlinson

you. Okay. Thank

Duncan next Our to from going is question Cantor. come at Charles

Unidentified Analyst

for on Hi. It’s And you our progress. [ph] on Thank Avian questions. the taking for congratulations Charles.

So Alzheimer’s I guess a the open-label I was wondering program. the quick to enrollment extension. question regarding speak could into rates if you

Dr. Christopher Missling

Say please? the what’s question, it again,

Unidentified Analyst

Could Phase Alzheimer’s you extension study? please from X/X rates open-label discuss enrollment the in the

Dr. Christopher Missling

Yes.

the of -- study, the finished enrollment high two very after have years we you last as is know just June. extension, which placebo-controlled So, which you

I XX%, And last was number range XX%. think, I received -- in the of so, XX% the

Unidentified Analyst

Okay, great. Yes. Awesome.

program. the good. of regarding I a Sounds then, couple have Rett And questions syndrome

last last press or first, release a when we potential I patient could visit an update So, expect guess, reached? is

Dr. Christopher Missling

the From study? EXCELLENCE

Unidentified Analyst

Yes, exactly.

Dr. Christopher Missling

Right.

that. provide will We

Unidentified Analyst

thinking you’re an had you. that what to I take Thank you that, hey, in between guess, Okay, is distinguishing be it feedback to should signal then, or sort there’s with versus I But, wondering, of the you to related has call the an And to And with sort you. you how mentioned you forward positive, try enough I are about we my question positive was an NDA the would FDA further. what continue could -- approval? submission. explore a if Thank NDA And get wondering earlier that should move results of you wonderful. would was last distinction? move positive how forward positive regarding to

Dr. Christopher Missling

Right.

now the in stated clinical we clear existing to order getting the last study that study. studies, to with also make strong and X chance and order FDA of the ongoing Phase these have feedback the EXCELLENCE potentially sure in studies two -- AVATAR the And also and make placebo-controlled design time, the have the studies, of -- have submitted study with is with we now data we very from these we So, our maximize that to get moving approval. we -- the our submission agency comfortable sure the design, to a forward NDA the our

feedback, this also and expect accordingly. we will communicated that be So,

So, this is basically the data best way to make or sure we’re not when whatever running out. into a the roadblock is

want before approval. finishes, So, to sure the path make have study a we that we the EXCELLENCE to study, clear

Unidentified Analyst

Okay. Wonderful. the Yes. our And on Thank you taking questions. for congrats quarter.

Dr. Christopher Missling

Thank you.

Clint Tomlinson

comes question Berenberg. next Caroline from from The Palomeque

Caroline Palomeque

Do FDD just as like an a work. or well? on such genomic any expression analysis, you on mechanism work as some I on follow-up doing plan gene have the indication X-XX that

Dr. Christopher Missling

correct. That’s

include of So, analysis, have in as done, now time, we Alzheimer's as first the study applicability in we genome where of that more way now our disease, about will we because the since we well first can believe program learn the Xa, ANAVEX for effect the the used the the broad Phase X-XX we, drug. and

also So, X-XX in we the will clearly program. ANAVEX that include

Clint Tomlinson

Dr. that believe was question, Missling. the I last

Dr. Christopher Missling

disease much. medical needs looking and Thank Rett potential and syndrome. unmet forward we’re looking we about significant medicine in pediatric forward very and Alzheimer’s burden, studies. Thank build as With are Again, are we excited you. biomarker-driven to very on the clinical trial you and economic we very precision readouts much Company’s

Clint Tomlinson

thank Missling. disconnect. for Ladies may today’s We this gentlemen, Thank conference. you participating, concludes and now and Dr. you, you

Anavex Life Sciences (AVXL) 9 Aug 222022 Q3 Earnings call transcript