Earnings call transcript Q2 2023

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Clint Tomlinson

Good morning. Welcome to the Anavex Life Sciences Fiscal 2023 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'll conduct a question-and-answer session. if the like your Q&A session, question, ask hand. this use please box during you to would a And or raise Please is conference note, being this recorded. www.anavex.com. replay will Anavex's available call for The website be at on

Officer; With us today, Boenisch, Christopher Missling, Financial and Chief Officer. President Principal Sandra and Dr. Executive

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

And Dr. with call would turn over to Missling. the that, I like to

Christopher Missling

Thank us provide to our you, you today Thank recently Clint, with financial and results and quarterly good for to most being morning, everyone. update. reported review our business

Accelerated through this community, positive against caregivers Pathway Recent fight especially and and families the positive disease. Approval patients, who for devastating results approvals FDA Alzheimer's for clinical are the disease study everyday

agencies trial ANAVEXX-XX, oral for the initiating complete promoting neuroplasticity, in treatments. a Alzheimer's Xb/X blarcamesine, our including initiation a regulatory we and Accelerated of be of available journal to restoring disease parallel, the of might results for homeostasis dataset ANAVEXX-XX. Alzheimer's upstream confirmatory small-molecule cell patient-centric, we forefront forward receptor, biomarkers, consider medicine the of activator available, precision at Phase once-daily to Pathway biomarker-guided discussions sigma-X involved Alzheimer's With neural In surrogate once look presenting, the disease newly which plan next-generation with We with efficacy preliminary proceed convenient of the Approval of in study. disease scientific

to We neurodegenerative neurodevelopmental portfolio making our and year. forward advances other look this precision meaningful in medicine also

In with RS-XXX in of Rett we the February, announced enrollment EXCELLENCE the X/X completion pediatric of Phase patients syndrome. study, treatment for

announce XXXX. We results of from clinical potentially in expect top-line this pivotal trial the second to half

patients' that Difficulty]. under study extension preliminary the the secondary has data that The the the on [Technical open At symptoms trial. ANAVEXX-XX disease, during end the the March, reverse longitudinal life-altering consistently as objectives, suggests endpoints. It dementia beneficial prespecified effect active ANAVEXX-XX clinical label of clinical reported is open symptoms the time slow we demonstrated phase the of label XX-week data key and unmet need. as over of and global potential Parkinson's well the an urgent the disease to longitudinally, of improved, extension potentially encouraging Parkinson's primary This secondary primary planned on and

same the use in disease. study ANAVEXX-XX Parkinson's to of endpoints in intend we results, forthcoming promising these a on Following pivotal

X/X study, a Further, for Foundation; ANAVEXX-XX disorders Fox Phase a potentially neurological J. pipeline platform the using expansion of publications clinical Burden gene ANAVEXX-XX Rett involving Michael and planned expected, Phase syndrome; a including: Phase X/X initiation response, potentially planned ANAVEXX-XX, trial initiation trial several in Parkinson's trial initiation biomarkers pivotal a clinical initiation treatment the applying ANAVEXX-XX, Illness precision X schizophrenia; Fragile indication; X of a clinical and pivotal is imaging-focused of Anavex study. ANAVEXX-XX disease planned by medicine the of rare syndrome is of for sponsored planned a new of ANAVEXX-XX in disease of of which clinical

strengthen industry to as and to expand as to Team other support adding continue well of former objectives, studies. Head we including our Leader as developments, planned our professionals a Statistical Biostatistics, these and team manage with conjunction FDA our In support

Finally, for into pressure hypertension. high adults of States, the affects indication commitment portfolio new we our nearly half ANAVEXX-XX with recent product range aging will a further society. of Hypertension especially This our or the patent the our commercial the our patent robust patent expansion relating are strong full of portfolio. and of to within demonstrates in to of United add blood portfolio pleased already opportunities ANAVEXX-XX protecting overall to

And recently the Sandra the brief call to a of financial quarter. Principal for now, I summary direct to like reported Anavex, of would Boenisch, Financial Officer

Sandra Boenisch

morning our today to Thank am to Good you, I pleased second results. quarter financial you everyone. Christopher. share with

$X.X During recent at our most year-over-year administrative million. consistent expenses and remained quarter, general

reported for Our we research as research clinical future to of quarter net inclusive well fiscal supply. were million, share, of primarily potential development as quarter XXXX. million items. the $X.X in compared a $XX.X for million and $X.X is in per for as development team non-cash drug increase the and Overall, in our and $XX.X market was and manufacturing result an expenses $X.XX a comparable of of which loss million increase development activities expanding The

cash on XX Our position March million. $XXX.X was

operations. beyond to and At quarter, programs cash years, sufficient and consistent current have four fund rates, with next we guidance equivalents previous quarters. we we the runway operations fund cash clinical the During utilized of we provided $X.X in these million believe that cash cash to utilization our

you, now you, Thank to back Christopher. and

Christopher Missling

Sandra. you, Thank

planned. readout we on trials and initiation medicine clinical This company, precision is the completing for time remain for of trials additional biomarker-driven and track and of ongoing exciting clinical as

Clint the call now would for Q&A. I turn back to to like

Clint Tomlinson

Thank Q&A you, session. the now We begin can Christopher.

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

Soumit coming at Jones Research. first from Our Roy is question

You ahead, go Soumit. can

Soumit Roy

congrats all and on progress. morning, Good everyone. Hi, the

idea details the Alzheimer's or you If much of this us how maturity datasets itself? of the on like front the quarter, biomarker can a little that's give data on coming on kind the the up what details

Christopher Missling

Yeah.

they've receive to at of been and put all collected, finalizing analyzed the which the into all the be So, they will once process black trial. we were paper. measured And biomarkers are in the

pathology, We field, surrogate into a to biomarker been to has that new approval biomarker, a of that. case which the is that the accelerated thought since now, possibility also approvals is previous faster in the also because for encouraging to Alzheimer's we us the data the program have advance than a and see two of on for very

Soumit Roy

Got you.

So, six you're going versus amyloid's time months' to status baseline or point? show the months XX

Christopher Missling

right. that's Yes,

the of a have of inflammation beta, very making pathway (ph). [drug instrumental is with in intervention, then this do -- have We we not pathology. they the neurodegeneration, with the significant if these the other of are are and And and different pathology only information biomarkers describing all tau itself] of drug outcomes

Soumit Roy

Got it. Thank you so much.

Clint Tomlinson

time, questions. other At see I don't analyst this any

Christopher Missling

address. Yeah. other ADCS-ADL Will break We meaningful see ADAS-Cog we're and happy Anavex questions of individually? here to out clinically scores a couple

I think per that clear group, detail. done would be doses in per very

is is, AD confirmatory before submitted trial completed? will the question be the NDA next The

answer for to with the approval other is company The approvals. path after accelerated Accelerated discussion was this also Pathway, Approval given agency the would the which be

be begin accelerated this need So with. the well. as it case to not could Otherwise, would study you approval a if be

drug a goal the So that confirmatory getting is the second approved completing trial. before of

status the see I what what The are partnering is here other of for discussion is, -- the questions blarcamesine?

possible assessment shareholder market the shareholder is is into maximize with we we to the said, for value among And drug U.S. try disease which a value. always the potentially ourselves, space if forward can of We rare the move

levels For for reaching challenging, Parkinson, other like a to that be indications cash way, regions, large Alzheimer's partner. could with be higher more needs it put that faster assessed. this And flow be and could or it

higher So that's why would always partner more flow, our to value create shareholders said reach of likely very larger we shareholder cash indications we the for company. enhance, these

are more think any I there -- questions?

Clint Tomlinson

Caroline from see I there in one from Berenberg.

Christopher Missling

Yeah.

is mention did a confirmatory was, question needed? the study So, you

study after accelerated is confirmatory a needed Again, approval.

regarding drug approval And approval is the study, so but required it's study. for that for not the the for of additional accelerated Alzheimer's

Clint Tomlinson

then, see don't any this at questions I further time Okay. Christopher.

Christopher Missling

Yeah.

thank the much. studies we're you medical about we're biomarker-driven medicine significant And Alzheimer's build looking on in very forward, readout very the study. again, and pediatric addressing disease Rett the forward as looking as precision upcoming excited and undertreated with study the and potential And syndrome economic need burden. we're the to to well company's unmet data So

much. you Thank very

Looking forward.

Clint Tomlinson

today's participating. gentlemen. and and ladies concludes you conference, you, Thank we appreciate This

disconnect. now may You

Anavex Life Sciences (AVXL) 9 May 232023 Q2 Earnings call transcript