Anavex Life Sciences (AVXL) 28 Dec 202020 Q4 Earnings call transcript

Good afternoon. My name is Vanessa and I'll be your conference call operator today. Welcome to the Anavex Life Sciences Fiscal 2020 Year-end and Fourth Quarter Conference Call.

As a reminder, this conference call is being recorded. I would now like to introduce your host of today’s conference Clint Tomlinson. ahead. go Please

good today and webcast. We you appreciate Thank Anavex morning, Life us for and Sciences joining you, everyone. conference call

Our today hours provide for website also call the fiscal agenda this remain call A Boenisch, review Christopher available results equity is then be from Missling analysts. available questions us of call's for will www.anavex.com. is its available approximately and Executive Principal will conclusion Sandra prepared be will Boenisch make for will Dr. Dr. Anavex's X taped President company's replay and at Chief on The Officer. XXXX and the and clinical Missling, Ms. one a financial take and month. will we remarks, With study after replay update. Officer; year to and Financial

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

call our everyone Clint. today's for results clinical to We and you us joining updates. Thank review financial appreciate conference

medical in plasma we discuss CGI-I using X-XX these December X X/X the to gene spectrum glutamate. Rett a in XXXX, autism the global safety, study consistent X-XX trial In and data results top-line with RSBQ, frequent Phase efficacy X scores results, meet neurological plan improvement, and into precision with a applying advance for the planned very First, key secondary X/X syndrome study scores. improvement pivotal we with disorder like the of updates need. Primary Phase impression syndrome Rett syndrome. are We convincing response which to meaningful U.S. improvement for medicine provide new of to clinical Improvements with patients a and adult preclinical Syndrome, encouraging met pathway. a in study. Rett approval planning female RSBQ Rett correlated data. disorders AVATAR are U.S. clinical to in Based given biomarkers Anavex for clinical have accelerated trial. initiation genetic announced cause expansion I of Phase most decreased pharmacokinetics, would on Fragile a questionnaire ANAVEX behavior unmet This of clinically significant total were the and we Further, with pipeline includes planning from were controlled FDA statistically in an adult syndrome pivotal of endpoints

trial in to of also We sigma-X targeting a and small the muscarinic clinical Phase initiate in with line rare-disease currently that are anticipated new, and is for track Phase X/X top receptors ANAVEX half a administered molecule X an to neurodegenerative on a is the trial planning first data orally beneficial X-XX, XXXX. treatment indication, designed for diseases of be clinical

the in last to to The results precision genetic patients XXXX. dementia plan Since placebo-controlled disease primary SIGMARX trial the assessment biomarker approach submitting clinical dose-dependent, we X-XX, to of and significant we study Data the cognition study in our of tolerability, study FDA CTAD line ANAVEX dementia we another meaningful, a analysis. ANAVEX of the to imaging-focused as regulatory safety, were and confirmed of show trial proof-of-concept in November results from and placebo. X-XX initiate trial top-line in to obtain compared system reporting X-XX the program. Conference, the data efficacy targeting response reported clinically medicine ANAVEX Cognitive in of X-XX met. presented planning with call, The Parkinson’s conference objectives in a ANAVEX are of study Parkinson’s of disease Research, Drug the guidance. top objectives statistically XXXX Parkinson’s improvements Phase results CDR, pivot clinical after Both computerized at this in X primary disease Lastly, was with

methods expected among United treatment November as other syndrome, of including a application disorders Rett drug until a indications. in sclerosis least and lead well Office, as and XX/XXX,XXX coverage disorder, at X-XX for its of force candidate patent syndrome, Angelman X-XX using Trademark number palsy, expanding cerebral candidate, received for to XXXX, XXXX neurodevelopmental States Notice remain Lastly, range the Anavex Allowance multiple drug treating USPTO, in Patent spectrum its autism from

call activities place, slowed marked I trials of in was ongoing XXXX in reached the enrollment And reported direct enrollment has our COVID-XX, of outbreak While now, Alzheimer’s recently XX% which clinical Phase by brief expected currently enrollment of of to policies, and financial including Officer the Sandra disease were Principal over complete to study, like with which able in Anavex would our regulations X-XX in countries the quarter. down Financial largely many to early trials which uninterrupted a summary for local Boenisch, the Xb/X continue the temporarily compliance are XXXX. taking with ANAVEX

fiscal afternoon, expenses Thank fiscally or XXXX compared reduction per $X.XX XX.X and $X.XX as General of you, a million million result fiscal year charges. as of We activities by an a with as trial which or XX.X XX.X clinical of existing connection the non-cash clinical year. to other million development of everyone. trial for our per fiscal relating share net compensation We million advancement fiscal Australian continued XXXX with fiscal increased research increase were in our the over X.X X.X in year, million XXXX comparable responsible and Research for expenses development to a increased share increase XXXX to $X an activities approximately result million of XXXX, income a and comparable in and the fell trial. loss and the activity. for clinical reported reported continued good in incentive Christopher, income administrative

at XX.X Our compared was cash XX, position XXXX. million million XXXX at XX.X September XX, to September

months. position to Christopher. cash also I increased reporting sufficient of back our which as for will XX to turn are you. And gives over cash We today, today, now, next call million XX.X Thank the the approximately us has

now of momentum studies Sandra. all XXXX was to Thank an across key summary, programs, providing program made the of X-XX with this call look new questions. We the please on further need; who like for Operator, stage patient, despite on from late-stage would ongoing X-XX this like modifying advancing and into Rett testing the progress progress Anavex additional all portfolio. challenges into to and Phase late rare continue. late would stage year this extraordinary to building trial; thank expanding I milestones completing high team updates disease. forward to open with forward Alzheimer’s disease multiple In Xb/X our We in go the including unmet expected clinical At doctors, as look the for biomarker-driven you, the I and medical disease syndrome trials, the X-XX entire data AVATAR the Parkinson’s advancements with point, Anavex possible. significant ahead. clinical EXCELLENCE; disease

Fitzgerald. [Operator from Instructions] Duncan Our Canton first question comes from Charles

will Rett of all have included consider AVATAR And I for moving great then then, change Hi. mentioned recently study, that with regarding study? Christopher the forward? what the in follow pivotal, changed, questions. going different the kind I the is my taking wondering the any and the of Holidays. you congratulations. when a with recently, versus was Yeah. are And I'm Happy a Thanks recent of and read-out that up that couple the adult has program you as sample And forward how characteristics AVATAR cohort way move I have quick AVATAR in what guess, questions study, the, to adult in question. you that progress

Right.

Phase So, now the endpoint. a primary safety designed a as as is X AVATAR right the study with

we endpoint, efficacy to and is So CGI-I primary which measure RSBQ the doing, are secondary endpoint. what switching to we a of are

which U.S. study, change the do difference in AVATAR the is a doses the the you that's can studies So ongoing average to the And higher without than are on U.S. blinded. profile study where being study[indiscernible]. higher exposure drug

important can So, response. we element, which looking think is also this is very FDA the for dose a capture which way, we

effect or in size Okay, going study, the in hope were size efficacy enroll size of how measures to Is U.S. about efficacy AVATAR? to the the for or sample a plan the when that planned in change sample study? you feel do the and effect that you about be made size adult the and then seen think there out that you

that of basically not Yeah, you this just don't regions we out before it might want change excellent an of increase question. discussion, that not still adjustment to of part on before, let require any enrollment change in But number discussion not study, change have – know, well making Right discussion now, numbers. any will the to need the but the increase but with to we it’s of completed at point. could we FDA in patients this make AVATAR the the but that be size, come to then a maybe that additional level regard,

Okay.

you're the and AVATAR? and you sizing here to conduct outcome do request meet with meeting impact you perhaps FDA, the possibly to have design then soon will So, done that going plan or of so, meeting a and of

good Right. that to we even we of knowing a the size stronger was size. very effect expect dose U.S. dose, high the low effect I strong even mean, it study, have

design ultimately, now, right study endpoints, the switching make secondary an need is immediate and the that. FDA want discuss we and certainly as the And with to if what change this want we point the final out because other to recommends, but we will to primary changes additional agency FDA to study. are the of also be have that pivotal don't the than So want the there to we open I

Yeah, you the able prudent. alluded form? reviewed dementia the on is studies but study Last regarding that or would data Parkinson's this cognition you makes present study out two that those recently, to It disease, peer in also a when sense. question seems being anticipate from to, Rett that read the

Yeah.

want transparent, and we very to we So, be will.

and that efficacy endpoint and of endpoints looking will time studies, be studies the submit both appreciate over we will patient, we publication, and we to the background we of to study. basically more to this as publication outcome patient’s the about XXXX go of the before can That's submit the more a well why requires genetic we that that early as also but will genetic of a through details bit [PDD] at a probably a have to course present usual analysis than of the studies. study secondary, this the Rett to co-primary mentioned You the have the PDD

regarding mentioned taking up last for the if you mentioned in Angelman disorder that Okay, example, for a neuropsych in then indication beyond pipeline, of all hop pipeline, rare actually inclusive regarding it this to, question, or discussion back IP indication disorder? sorry be wondering alluded rare had or could the another the the an you and Huntington-type and that say, you I'll But and I'm queue, time.

drug – it Yeah. is don't infantile syndrome which in and to want you know, not we because shown just Angelman to Excellent we diseases? landscape want didn't addition the but the mention prevent rare We to, before in data meantime, clinical be study which the yet nature, that have pre-clinical now the into with slides engage addition also far. we of because clinical, those our mentioning so in syndrome, have of perform first we on diseases, Rett mentioned. so as mentioned just in these quicker to infantile spasm well it we and is it are like as basically look knowledge, to to since clinical of I the And is confirmation which homework models versus but trial, it be of new have in in preclinical would have which past. we what yet others? We now don't and as which one Angelman competitive spasm developmental indication rare repertory are – presented the is, I want for design, well top How's to in get the already additional data, In presented were efficacy will strategic as do able this just with discussion not but question.

color More you XXXX, suspect? in

again, And ultra XXXX. colors a is come more disease. definitely Exactly, a it it's even rare in disease, maybe rare

or has regulate is features it and engaging to an this stopped need in basically we opportunity of quite on drug which for of based to a never finding approach homeostasis of and imbalance So rare unmet quite in have. that's the and the the thing the communities, be additional downstream and that diseases about that we intriguing biological upstream want indications, system, among lot not to benefits patients why this pass-on really them

for Happy Thanks my questions. taking all it. Got Holidays.

and New Happy Likewise. your to Year you team.

Our next question LeBoyer from Robert Ladenburg Thalmann. from comes

the afternoon do and that of in complete you cut congratulations wondering see with was question first data? all expect the XXXX, on had My and Good and you I recent to progress. mentioned the when study, the enrollment Alzheimer's might to has we early

So the a is study study. XX-week

XX Because patient Once add. also study. the determine And patient to had basically last last So the patient will been weeks. that's – study arithmetic the it's enrolled, simple to then finishing do. add simple the the very in enrolled last

XXXX. So be will that early

Okay, where money also that [Technical cash extra addition was of and Difficulty] from? great. to And as came the wondering September I today as at XX, there the of balance XX XX.X in and was September

Yeah.

also of the were and always in have stock we purchase able be two say, when features one moves make higher we level, ATM of basically would sure order to, utilize we and to able to to those have utilize agreement. to basically And the always two possible up cash. years So, programs basically I a place, dilutive in price as to strategically, two least

it frequency. have we to and have high as will always use our we shareholders going to that in cash of to we a to message send that enough we basically use to obviously also not today, make cash anymore we that's need forward Now resources. And sure want the want

problems executing have activities. So, we any don't our

Okay, good hear. to

much. you thank very Okay,

You're welcome.

Research. from next question Our BI Tom Bishop comes from

Hi, Christopher.

Hello.

you Hi. Can Yeah. hear me?

Yes.

it comment and on Parkinson's the disease dementia focused this little bit noticed clinical a planned didn't of initiation more I Okay. you understand Could I didn't either. the focused study, about imaging X-XX ANAVEX say imaging put that?

Right.

we we successful. Fox we'd disorder. like a this So, not for Parkinson And Michael very drug is also next make is a disease, sure better we in that dementia, want preclinical how modification been was the study in as not that funding step, for movement understand fortunate And received for have disease been which And that to works. previously have Parkinson's we explore now year. patients this something Parkinson dementia, to just

about the the mean, a there would to to U.S. I getting and that had Okay, company to Australia what trial, XXX? [Technical patients Difficulty] more? say thought that size Can of I just your goal little it would enough is why go Australia you market explain what reach have sites, be does Australia? the in to in bit

Australian the In mean? study, Alzheimer you

Yes.

study So is the Alzheimer international Australian now an study.

to the and in in now UK, addition we the Australia. Phase actually Netherlands, it Canada, Xb/X Germany, and started in enrolling Australia So, is

Australia so overall. expanded, been know, you continents has what And now we in studied three in

to we were to Australia, not has limited an make study sides there places. was many proportion just in running advantage in that sure that an this want we And up advantages, have international different it's but so, and always

Okay, and the also, XXXX? Or to interim got study, thought given wait there any to analysis? being unusual? Alzheimer’s is that's we till some not So,

analysis, interim different it allows analysis is seen analysis. an that as is company. in there the it misleading interim for option have could another be because that useful can be shown in mentioned protocol we The explicitly And

this to So, point are use in chances the we that but want we don't know time, at there. if

for study. that possibility data before there Alzheimer’s there's XXXX the is So

the Phase way a you with syndrome your through prong study, going thought and advance adult? that I X/X, Rett market, going and the all which know, you adolescent of the test on you to are that moving initially to kind so but was the to adult was that to study I just – market, primary Avatar regards Okay, into thought could you're

sorry Right, interrupting. for

strong brain population the very is expectation a favorable for just ultimately, doesn't is intervention. has [indiscernible] often capture patient, to often advanced Rett you received in which So response more and market, but age very which go attention. much is right? group, higher brain is to data already respond population younger patient's not in Mostly patriotic and seen – it's syndrome, But makes in an the to go the age, entire that a a older excited to the a as one interpreted, stronger signal the because patients. bit to patient, that potential the to than has be So population, see if adult even anymore, We've younger we the more much response not limited therefore, the it's want us is trials because little when a younger patients.

aiming capture are adults with So below old, above excellent study the year to the the age we exactly what groups, of group AVATAR we and and the both age. capture XX age XX years and

excellent study now the enrolling? Is

very the Yes, nicely. it's case. enrolling That’s

you. thank Okay,

you. Thank welcome. You're

Thank are concludes now time. gentlemen, today's questions you may call. you at you. disconnect. no and There further This this ladies Thank