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AVXL Anavex Life Sciences

Participants
Clint Tomlinson Investor Relations
Christopher Missling President and Chief Executive Officer
Sandra Boenisch Principal Financial Officer
Charles Duncan Cantor
Ram Selvaraju H.C. Wainwright
Robert LeBoyer Ladenburg Thalmann
Tom Bishop BI Research
Call transcript
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Operator

Good afternoon. My name is Aaron, and I will be your conference call operator today. Welcome to the Anavex Life Sciences Fiscal 2021 First Quarter Conference Call.

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

Clint Tomlinson

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

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

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

Christopher Missling

conference I pipeline like recent everyone joining and Clint. call clinical our updates. financial first updates. our We today's you, results to would share Thank you and business to with on us review appreciate

positive extension At for good same which approved an And ANAVEX ongoing ANAVEX That ANAVEX progress clinical safety clinical commercial excellent to XX chemical strategy based Rett Alzheimer's is completing for needs substance adult to Australia, with Let X-XX had Australia. data clinical syndrome available the with AVATAR open-label recent has stability to Phase ongoing news U.S. accelerated II/III support syndrome II treatment Phase and Phase the approval cases. years data, on start clinical is Syndrome extension This Access extension trial XX first ANAVEX Special time, adult is And use of and trials the the with and drug from Anavex has substance a data, planned stability in drug me as oral potential Phase upon Based disease Syndrome study showed Anavex syndrome after compassionate very planning in II Rett Rett for Rett activity and launch syndrome as patients U.S. weeks. X-XX program. both year all important. solution Special Rett EXCELLENCE weeks II/III Rett Rett pediatric for studies. syndrome. underway, compassionate X-XX received syndrome Scheme Access In continue of approval and exhibit X very X-XX, the previously approval Rett study. patients. Scheme we the AVATAR use received sufficient FDA reminder,

treatment disease. Michael Parkinson's of explore imaging for on potential Parkinson's of Anavex from Parkinson's utilization been the has J. me that a Foundation Fox Research nearly Let to ANAVEX develop continued to for for the We recently million switch a which disease now demonstrates the PET to biomarkers $X briefly Parkinson's announced treatment focus disease-modifying grant awarded X-XX disease. of research

to trials approach clearly is to of system. leverage to studies biopharma Anavex in relevance is gene genetic and analysis in central nervous success in and reminder, Exome clinical from drug expression changes the of and continuing development phenotypic clinical potential disease the Parkinson's and companies particular, our Whole and chances predict disease Alzheimer's genotypic Sequencing medicine other Rett variants in precision patient syndrome, strategy the a pioneering that and treatments. of may identify As data increased of differentiated gene big of expression clinical data

and receptor, experience, important and over target enhanced Regarding prevention Phase relevant in XX% the X-XX, Alzheimer's, the demonstrated induction differentiated trial, have ANAVEX a gets cell and criteria, is a X-XX cellular Europe. X-XX to cause to the changes activated clearance which in emerged discovered which published responsible. with in through enrolled In University at of chromatin diseases the very linked Alzheimer's San the structure ANAVEX study scientific chromatin recently. in finding are California, They disease underlying identified that the Diego IIb/III also the diseases. autophagy been Researchers Sigma-X in direct ANAVEX these clinical restore protein utilizing disease structures. presently treatment of of of Alzheimer's of is age-associated selection and process patient has currently recycling randomized. is

And Sandra outcome. recommended of to Officer The call for DSMB of the to Boenisch, without the reported small let the Phase Lastly, Financial our is DSMB, investigational I has switch clinical and completed a ANAVEX of Board, Anavex, for company's direct preliminary Phase its the the is in Phase X-XX, now activating track. recent compound to receptor, brief study ANAVEX a Safety And sigma-X currently briefly like financial compound, is pre which a modification. of summary safety quarter. new would study its I Monitoring also I very also review data. on Principal that molecule new me to X-XX, pipeline Independent planned the continue I positive recent a Data

Sandra Boenisch

share, unchanged for and administrative the Research quarter $X.X a the of compared reported net to general you, Thank afternoon, expenses remained over the per quarter the and for period. while year. quarter million We also $X.XX expenses $X.X compared in $X.X in of were period, loss the last development comparable comparable million comparable and Christopher, million as $X.X good $X.XX or share per million, everyone. to

Our to the for clinical internationally. the as increase development activity. expenditures in quarter to to clinical Australian period. increase continue research as reported related gradually trial compared and million in We other our increase the with and income $X.X incentive comparable enrollment an $X.X trials is in This million progresses trial connection expand to income

Lastly, to today, our $XX balance as expected providing is to cash years. of is runway for approximately up sufficient be million, of which a three

call was Missling. Our Thank cash to December I XXXX, and you, Dr. million. at XX, the over turn will position now back $XX.X

Christopher Missling

breadth which from converging in www.anavex.com. providing, meet basis giving us receptor, clinical multiple interventions management milestones we of Thank our announcements, of data thrilled new programs. fiscal the for allow In to clinical business new with disease. to you, to efforts and on readouts clinical added available data these a clinical using the disease The we've latest of strong goal in clinical continued ANAVEX look data presentation, therapeutic across XXXX, reported bringing resources. Rett in potentially precision and Sandra. Alzheimer's medicine to available adds responsible of near-term sigma-X are for further the year pipeline dementia summary, strong target, forward this data begin molecular We Parkinson's This understanding our corporate biomarker-driven outlook, to will confidence is our X-XX provided timely on our syndrome, biological patients. multiple Further, our are with orally combined once-daily

and throughout new this We we look about open please are year updates to data continue go I like for would us, forward before very the to questions. with ahead. XXXX. call Operator, excited now

Operator

[Operator Cantor. Instructions] first Charles comes Your from question Duncan with

CharlesDuncan

couple a of questions. had I

a details to with program US the bit continued extend able provide regard that additional that you X-XX, extension of the percentage Rett on congratulations extension that being kind wondering to when XX enrolled study, of And with But help the extension I'm us on First, into patients weeks. on that XX the anticipate study the from And of for open-label little from what the have study? study to phase? would of or you able is understand to weeks can that study? in the being rationale Rett

ChristopherMissling

with start last the me Let first.

continued interest to syndrome ability the And with term the from XXX%, the the Rett months the patients of controlled the the the in patients from extension extension for study. of extension reason patients finished participating another So part as study, all families continue the for who well US the and data safety by compound. long as six patients our add to learn was placebo and

study precise question, the first in what we we the in the prespecified data will precise yet actually have patients. the the in have situation sigma-X baseline of previously the this it and and relatively we the near-term, near and be fully the Regarding which can outcome, feature be Phase the together RSBQ changes, released the as protocol clinical the syndrome as IIa not term, the identified well the Rett SAP, other biomarker effect of with measures done genetic of variance, Alzheimer's on in

that relatively be this near-term So details provide study the can answer to of exactly outcomes measured. on the measures the is more

CharlesDuncan

from forward Or look specifically meeting? anticipate one or I Christopher, that's upcoming conjunction you to advocacy And We'll Rett with -- psychiatric neurological it would community? the that. with an driven, in guess,

ChristopherMissling

it we is conference, soon. for and as it is in So community find to this which but data until a informed ready genetic and and timely press allow We this because learning as with which only not in the order data. get this interested can be or it, have everybody we be do provide will release soon it to variant to we to we webinar will either will data that can together, in the about requires available are happy now, a suitable about we in provide analysis, more

CharlesDuncan

trial, going? the being last provide studies? Can you And One the those two is to would And out you read how anticipate when color AVATAR? pediatric trial, question adult then Rett. able on any on EXCELLENCE,

ChristopherMissling

the the of So year, studies. on EXCELLENCE the the trials expectation We are of this update stated half half right year. these latest well. our is and will we that readout second and these within study in AVATAR first be That now time proceeding think a study this

CharlesDuncan

would had the X-XX, disease wondering And I on believe spoke it guess that companies move dementia. question program? disease I into about see guidance Parkinson's I'm later recently, is a And study And then in side that? for be that that Could this year? your seeking steps Parkinson's year, the last last agency you was what not of provocative with we lot my CTAD for on next data have are stage success you a at

ChristopherMissling

patients noticed which participating their which to the correlation then at the we are to data pointed that had it that present guidance background companies failed that other Parkinson's studies order in X a out So study disease of study with now the an least the that shows that dementia And that outcome, we gathering difficult fortunate pivotal are detailed we agency, CTAD, And on it and study at now execute. with is FDA, when patients we are we entire recently, came design, understanding out disease and the to to then we with and and Parkinson's based was positive. would undertake our extremely what on dementia for were have there doing Parkinson's with the information, the to dementia. agree data seek data

CharlesDuncan

that back us then it Is any the hop can different series? it anything pharmacology? different on X-XX, new how differ? that tell But on about Final you it does -- brain I'll have X-XX, question penetration, chemical helpful. What candidate regarding that moving color be the different Does congrats relative candidate, to a one platform, would forward. queue. from in

ChristopherMissling

in X-XX, bring to know it's ANAVEX know, affinity affinity is we was do toxicology, also a necessary point. Weizmann ANAVEX that licensed which preclinical what more muscarinic MX different data, differences a manufacturing, in about in It more X-XX all strong where receptor the Institute completely a X-XX now. pronounced we it molecule. from in and much we is developed to And X-XX and the stronger has what has a Israel, the it sigma-X to CMC to So twofold. other muscarinic are has weaker affinity ANAVEX but receptors, and

out. towards received comparison, X-XX one X-XX also we how we which for yet the for really that What valuable and not can So are ANAVEX not frontotemporal and see dementia, compound out by But the noticed FDA ANAVEX turns excited playing bring drug need which another of we are they competing designation to direct we this we covered biologically first, indications will activation, orphan we have for target that with the so important that very be X-XX. we X-XX to with directly. same sigma-X indications, we use are have might have

Operator

queue from in H.C. with question Selvaraju next our And Ram comes Wainwright.

RamSelvaraju

to program. wanted I few progress. questions recent the syndrome off with first of just, all of on Chris, Congratulations, the start a regarding all, Rett

upcoming any was data elaborate positive. Firstly, from could the you assuming items, is that upon if the wondering additional gating I studies

market to a through regulatory competitive blarcamesine a had at I United nature on then little better landscape bit comment And the or You if gain the that also be of an Where treatment the expect give mentioned gating time of are serve what a submission it a to launch steps could the to be could wanted stands. would it there that potentially still in the required of a of could into as to into us the a maybe to Secondly, potential be population? you blarcamesine receipt the the program, just Rett what as go voucher? introduced syndrome? thirdly, the as for an for that be as currently need this items when approval, basis of if you preparation wanted you previously potentially for priority understanding review this might qualify additional you syndrome like but drug And subject ultimate Rett if syndrome States, be clarify Rett whether to the NDA? sense regulatory might of may were you there in

ChristopherMissling

question gating items. So the first was about

eligibility will is also EXCELLENCE is is also we which doing data a and if study clinical which designation, are supportive. Parkinson's designation study, is The and voucher I the I additional the share prepare positive for from voucher to supportive, expect the to dementia, it FDA. positive. meet of same, that get given to AVATAR and a faster we orphan entire that data The be we so package want the analysis, we genome/exome be So FDA and is pedriatric with and mentioned have ability answer and the have what part the that and the the

dropped the is is Regarding in in fourth is trial competitors syndrome, Rett heard the us, have their which has and marketing. for situation, landscape, And of and entirely regarding the learned we question initiated the of They believe. syndrome Pharma. program Rett because positive GW and retired a we that stopped, the one entirely, which out COVID

And the also We have Rett US, this very marketing classical which the move And syndrome. in an really hands we Rett the U.S., the around Rett the have not Center and extremely setting with rare a well. Syndrome the a community, physician understand is the shown size example where in like in with only disease good Excellence especially a launched relationship comparable, physician's case had other a with the but Rett has the syndrome, but Foundation, for Alexion can in company into world. of background, and the drug we at company successfully and ourselves, drug center like

RamSelvaraju

future syndrome team element overall yield comment usable Rett clinical is program, special Also, support that, if or I the many whether And access that use size sense could now? maybe on the a Australia to status are regulatory significant the wondering was could part of receiving that How data if of and could give the you think as applications? of you of in you drug patients you us of FAF? current what in is program of the that likely right

ChristopherMissling

the on finishing much advantage allows this that study, And the it who extension continue our extension is in clinical patients Australia study. automatically So finishing will use overly up market it's for the any them program to after and will has the for on the drug with clinical once drug are becoming left study to be be without treatment. once that patients then allows now, study they which existing the get would approved, the prescribed the drug authorization. physician after right the we and the And supervision to the pretty eligible entered of the benefit that further basically compassionate study, and limit a approved be

RamSelvaraju

disease. thoughts a recent more on aducanumab, space clinical seems And comment your may further regulatory great proof-of-concept the actually there. point easier, the that of to been which what has have I if for apart, juncture the out that in that reflection, a in program? that need approved, can are Just results attributed look situation? I for little was construed and from could in in a activity me. the the approval what enthusiasm regulatory with this goalpost But implications Alzheimer's in moved post-aducanumab fact, perhaps part like your think at and more fact anticipation favorable process fact, of severe conceivably by environment be drugs deal, a to potential could the wondering what get be unmet Alzheimer's on regarding be Alzheimer's getting And a the you Alzheimer's couple as of decision might there

ChristopherMissling

IIb/III I supportive Phase study. then it as Xth be way that that our time, there's in a If of not because with more X is us Obviously, positive FDA IIb/III could the scenario the would to if will we impaired be FDA will I ability with or well, clinical the and predict study running approve since are also for about by adu. what now will out you Phase say it that in and that would we drug the that study, regard. would would basically, this to cannot data June study a turns negative it the referred from sufficient June for positive, I when robust mean IIa take believe decision a robust happen would Alzheimer's Phase in decide advanced in But on is still shape on outcome, a our disease. place are the from to, actually that one agree And meeting

move other down mid I think will be be year. there put study approved But the resonance approved would just be positive that of that it's and ahead. the we the would would our So possible study heads -- if

RamSelvaraju

And ones. then just three other quick very

something have have you potentially with Firstly, the blarcamesine is data future reiterating could And that. indication this in I about touched compounds it to then positive be diseases? wondering co-formulation, co-administration, that commercial lastly, synergistic you in the with blarcamesine pipeline? And if of be this that might other oral is a probably the choices portfolio future that neurological you be if syndrome? likely to types Rett with what And the that's Secondly, what other other can I case, may particular, wind your in think development? was possibility point to might from CNS in exploring Anavex the Rett standpoint in at regard have from likely the comment we other priority future, or in assuming but this elaborate think syndrome, combination solution, of for of orphan compounds significance development most you of be the highest juncture, would as if worthwhile compounds which is Anavex implications something you to earlier what blarcamesine? which orphan this the synergistic be pertains stage past, up might of upon at

ChristopherMissling

girls, hard of the question swallowing. regarding the second a -- very question time advantage because or they have many I So a solution, think these it's regarding strong or kids first the

very substance way Some liquid patients the other even drug overly and eat. a cumbersome. actually formulation provide They by is a feeding pouch, injection, an to the which cannot only inconvenient even is than tube, artificial have to and

is a administration. therapeutic strategic very that of advantage So the

strong spasm affect the treatment been what ANAVEX rare in Rett which first than spectrum seen have a and But syndrome syndrome, as trigger is spectrum we pathology of three Angelman The these is of all but largest multiple patients. question syndrome, disorder autism Fragile Rett that X, also this diseases. well patient studies, extremely the disease, infantile of to X-XX autism with could disorders and disease the of another has rare Fragile X as regarding approval the

preclinically preclinical syndrome spectrum clinical in data, Rett strong autism of since in we syndrome. basically data and a have given be the very very have strong data, now we happens Rett So disorder, part to supportive

for to supportive that's developed X-XX. we're and a to data preclinical the be believe and as We We in the X. have And we clinical now very increased already Fragile in that why planning, ANAVEX the have chances X X. have successful into move a study in design study Fragile next Fragile also strong in study

be adu if questions Regarding know with will best we also, the prevent because we the like synergy believe targeting agonist get preclinically ANAVEX pathway. have compounds to it another pathways, be think last X-XX But has approved, different ANAVEX if with might synergies, choice. would is a rather be the it a seen that will don't shown about X-XX to disease. sigma-X been that could we I other other the synergy synergistic

treatment, a the which disease, ANAVEX -- is a and X-XX coming strategically as in So ahead disease. potentially avoid one daily now such it's that affected where III disease we're but to horrible study could with near in a not only Alzheimer's day out by ongoing to you finding being also goal, used that's like the be be mini-aspirin Alzheimer's Phase our get what thinking situation of in

Operator

And your with question Robert comes from in Thalmann. Ladenburg queue next LeBoyer

RobertLeBoyer

question the quick that on had a DSMB recommended had continuing trial. and you the X-XX mentioned I

you When saw And be some the also, positive, wondering Parkinson's secondary that if included how forward? might it's Parkinson's Is any anything continue where from or the presenting trial? data results? the November to going move on I program, we study for? plan And full when endpoints. So long data see I in might was the might that there

ChristopherMissling

to move have in female/male food as panels into was of going First got as of panels effect, their as the the well that effect single a several dose. panels ascending treatment we light recurring forward drug. differences Phase question, as I, was this the And that now we X very in green first impressive well the and X-XX,

was information hurdle just the we of well about nunances dose That ascending, important So tolerated most, most And that We comes I dose, I said Phase was a data the within is planned of would the the the dose I. to highest study. Phase basically, the a that positive. of would XXXX. Phase half like the I first now crucial have say, is

I we it than until much the are earlier but be than looks June with not think it given that, study. the earlier -- like will waiting time where

question, Regarding the the second question, please? remind me again

RobertLeBoyer

to of that the the do had with full… presentation -- Just

ChristopherMissling

all of also to than ones have at other and system, include data presented was of factor that CTAD on the at And a of really webinar What a So in also of the minutes, measures the will focused short the was very time CTAD, the up, fashion, we are or portion XX and presentation only CDR form fashion, that will will of Dementia proper the data which entire so or study. study, in. now more we the disease. a is either PDD peer-reviewed we a the frame -- provide which present that a Parkinson's come portion related of data actigraphy Dementia conference or will many the it in in to the other

this be something to will short a So relatively which are also notice. on planning present we

that picture FDA to in and this PDD, order of same data seek so pivotal design PDD. front guidance will this the in in and to have of order be put to And applies data, study aggregated the a here, in full

RobertLeBoyer

Fragile move mention plans or you did clinical to [Angelman] into any trials year? this And X

ChristopherMissling

expect entire mention with soon. hopefully, X preclinical preclinical data that have initiate I'd to clinical Also, and we from be paper the Fragile Fragile published we a FDA. to guidance do of like with of a which we one submitted paper that X milestones call the and the the study, the ANAVEX we provided and anticipated X-XX, eventually for So that was will package, at last to have

data Fragile the moving X Fragile of So ANAVEX X-XX with will preclinical into X should ANAVEX X-XX, of case, this make is will and strong which be the the that the a warranted. clinic package entire case,

Operator

in comes BI Research. Bishop next And with question queue Tom from

TomBishop

puzzled Christopher, saying the back you're XX% November, you XX% a now enrolled. in said enrolled, little were you and over at --

I math, about XXX, had X% of which what you the little of XX it's the quick last about If up? this only here complexity is am X in a signing -- patients months, missing

ChristopherMissling

time that So and in the the of stop full literally it you in we now December, things. last have such appreciate the holidays, and was enrollment And a was before during it's to spoke activities holidays.

We also added an more on. and be I sites, out want to point from think we that acceleration will now there

too So much to that about. I is worry don't think

-- hand, the we're study. the sure to solid that of and requirements screening study, getting pin a fulfilling of inclusion into sure want make have to On make out are right to we point that want very other the we clinical they I process the patients the

I have other good there's patients And too literally wrong really, very so the companies. holidays, to [indiscernible]. it patients. much the a That's think But we comfortable into rather not want that too But really are right to is very enrolling and then actually relatively. quickly this, we led compared enrollment have would basically the I the read which to this,

TomBishop

now? sites So are right enrolling many how

ChristopherMissling

But I to I'm count we think have to XX. in between Germany, if XX again U.K., it's Canada adding I Netherlands. XX all and sites. around up, -- in all almost sites in added the

TomBishop

end XXXX early for enrollment? hoping of still we're So the

ChristopherMissling

Yes.

the will the for in data also actually add changed enrolled. first for have have which time data lock of after set unchanged then the time but and half data will be data, that. and still of be patient And the not matters, we line the gets to clean, it, you announcement is last We a XXXX. what It year

TomBishop

spending a been that the that [indiscernible], that price, of in take I to in the was of $XX today, given the you've regarding ATM? that of was maybe as jump, quarter in big $XX also bank it advantage million. you've stock indicate Or a the does recent increase And able had the million think last with your

to So hoping have ATM at well… as that use higher the I and able somehow myself that to have these dilute not been you've prices been shares

ChristopherMissling

that least that to in good in And unexpected we positive really as way dilution this last able to right. in we're to that capital, you this work that possible and tool least there possible advance was meant fortunate use move to, we it know. the that basically to share dilutive asked was point, for you progress shareholders of excellent because question, continue our when Really an assets, do Tom. and reason, without order That's this price to have with That's that. exactly the make is tool cannot place, an weeks to, and in

TomBishop

many shares are now? how outstanding So

ChristopherMissling

to filing week show a will fortunate likely. next Tuesday, provided of in be week, next which it I but We holiday, is be will up latest because this move, the stock details were next think obviously Monday our early because most on the Monday will very take so advantage the will be -- Q,

TomBishop

you'll have the on the share the XX-Q? So cover count of

ChristopherMissling

you dilutive figure out, least as possible. But can

will it be So not much. by

TomBishop

or may company continuing, III the IIb on Phase a news So IIIa that as Phase is has data if Cassava is still to trial trial, correct. SFVA or a start of well interim allow my proven perception

is on thoughts ahead. there wrong this? an any So So more I'm readout? interim Or maybe of go

ChristopherMissling

think study. I the referring trial an is you're to open-label

by to make program disease you the just is like, soon to dementia other also that mentioned point of are in you for still addition could generate to which Anavex. revenue point have different that start. have the we tried Phase III pretty in unique we, Parkinson's so the syndrome, is Rett And I data, which that other itself to randomization out a here. I company almost you completing our So want if is obviously, But situation has the study,

I just we're and as go. in we a progress we think So making are position, good

TomBishop

Phase analysis But an trial regard Alzheimer's? the interim to IIb/III of as for

ChristopherMissling

Yes.

it's that, that. that. it's I we there possible, guidance theory, the let a think a the And know don't So yet. that. the It's possibility. chance and on protocol, If with do allowed will In do discussion do to is to I we FDA in

So there. is the possibility certainly

TomBishop

that understanding enable that the correct could my Phase readout is full possible the interim study, from already the is and Phase But data ongoing? III IIb/III study even is going this it while enrollment on get to the of study just you

ChristopherMissling

that a our Phase study, IIb/III III Well, pivotal is the Phase think we so is study.

TomBishop

and still of I in that right? my that, I fading understood if out data, we're question, was somebody Parkinson's else's line awaiting he And physical was think

ChristopherMissling

actigraphy the will presented… Parkinson's, is and the The that be data you're forth, genome so data what referring? and That

TomBishop

itself and the there's Parkinson's then effect think is… data, the I on Well, which dementia

ChristopherMissling

the on that's mentioned. I Right This correct. what is movement,

and for order conference or will short We present at will a the in the patients. drug of see either everybody in together, that we it once to exactly release in have all be data effect something webinar will a we these the

Operator

Ladies for participating. you. you this today's Thank and Thank gentlemen, questions today's and conference. concludes

now may disconnect. You