VYGR - Earnings call 4 2023 | Voyager Therapeutics, Inc.

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Operator

Good day. Thank you for standing by. Welcome to the Q4 2023 Voyager Therapeutics Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. Instructions]. [Operator that being advised conference today's be recorded. is Please hand over Pfreundschuh, to would Financial now first conference to like Peter I your the speaker Officer. Chief today, Please go ahead.

Peter Pfreundschuh

and afternoon. you, Thank good

the turn on our Chief and The will Officer. Sandrock, moment, on call Joining XXXX Dr. and our press our XX-K Scientific to Al. a today release financial I Dr. Carter, and release results We Al press me website. over Todd In our call the QX CEO; available year-end issued are is afternoon. this

Before uncertainties forward-looking are during results are prospects. I actual future on These uncertain those and may statements do everyone to this, deck. I differ want include All noted plans this make materially expectations, to by statements remind may as Slide statements. that these from that today's forward-looking statements cause risks inherently and representatives indicated X of call, and Voyager forward-looking subject to forward-looking

uncertainties material to encouraged recent review are SEC and with company's Form the described annual on You the the the report, most afternoon. available company's XX-K the and various company filings this All in filed website. as risks based SEC understand are on

pleasure is to call it Al. the my Now to over turn

Alfred Sandrock

Slide and everyone. Pete, neurogenetic an as good by Thank you, defining position I'd Please X. turn afternoon, like to I Voyager's start in to emerging medicine. leader

XXXX the in of least owned data partnered and XXXX. end in the generate at clinic wholly anticipate four our having by We and First, pipeline. CNS programs potential XXXX the clinical with to

more for ALS. disease therapy programs minutes. in antibody Alzheimer's our and SODX I about amyotrophic our a programs sclerosis, program anti-tau few lateral advanced most both or are will talk Our gene for

challenges CNS to our Voyager solve therapies Second, platform. discovery the working with our inherent is to delivery TRACER capsid gene platform.

ganglion areas brain doses We and root de dorsal the relatively multiple low demonstrated high transduction multiple with across species. targeting in of at liver have

is receptor have expressed and penetrants We multiple animal in barrier a have also across identified species, that we shown blood-brain humans.

box and January to a Third, gene million longer-term payments. This this to not spinal it for received is to Neurocrine total program. programs development upon runway selection Novartis therapies In Whereas lead equity our triggered a of cash atrophy. is note billion candidate partnered of number, investment becoming for into milestone I million our week, a XXXX, of we and $XXX real. that ataxia this from is in bio a with $X.X potential will Earlier payment unquote generate it factored develop milestone Friedreich's the guidance. muscular disease our brings in $X partnerships. some upfront we of of combination partnered payment XX Huntington's

generate given potentially runway this provide All us to has into overhang we sheet, and data value-creating which financial XXXX in us enabling clinical -- of and XXXX. us expect XXXX, strong balance all our removing to a

potential. Finally,

our We modalities have now already from potentially capsid medicine, as expand broadening demonstrated neurogenetic other in into of strength gene We technology. aim and our antibodies a therapy impact. CNS leader to

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$XXX the the million to we offering us brings the Novartis of collaboration, in million Novartis the of approximately When approximately and million XXXX. XX, XXXX cash. Following from We pro $XXX forma $XXX $XXX closed with cash from million as million December $XXX public add offering. a number closed a you that

ALS programs, remain the program. an selections on development are Alzheimer's achieved ataxia gene of SODX progressing antibody, IND and with two Friedreich's gene on for We one candidate toxicology partnered for our in work filing with We owned our this and therapy Neurocrine also GLP VY-TAUXX half therapy our anti-tau first with year. our disease wholly track

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therapy. do into gene particularly antibody, I our I anti-tau wholly detail and some all our While gene ALS these into won't dig our of of owned therapy SODX go on our want programs, today, to knockdown tile

Moving by the the target approval antibodies. I'm to exciting as to Alzheimer's I next in the known this of anti-amyloid X progression particularly We've of at Why? spread When pathological Tau I Slide Alzheimer's encouraged space, long disease. field. the look of that correlate the to X. the progress, view

is by progression the disease Alzheimer's based Braak staging, spread characterized fact, tau. In which of pathological is on

in other located pathological is C-terminal than based been epitope N-terminal the has from inhibit of to mid-domain approaches which antibody, spread targets, anti-tau the by XX% more is than the Our on study. differentiated the and or shown tile rather VY-TAUXX which preclinical

ascending and and dose year Alzheimer's spread it initiate volunteers, We this in next Imaging approach turn hope about to of track an dose Todd half the to I'll another XXXX. with early studies first talk through in to pathological IND progressing via ascending data of remain study generate We to study PET over to Tau. in to plan developing initiate disease. proof-of-concept a now we in we are this slowing stages are of tau patients to for file target plan healthy on a year.We the year currently IND-enabling multiple single

Todd Carter

to Please Al. Thank X. turn Slide you,

how immune our are therapy. on BDD we also addition In tau Vectorized This siRNA. approach, to deliver AAV targeted working to side interact tau entity to refer [indiscernible] the capsid antibody penetrate

across some XX% have reduction This bring tau up of As a cytokine model we and our multiple observed to in administration And RNA and therapy RNA. tau a was mouse reductions in to shown, caused gene tau seen health humanized intravenous single regions. robust human protein. regions,

This quarter at presented AD/PD will Conference. the XXXX be

in promising anticipate We we an important incredibly these an advanced tau data, IND Alzheimer's prioritized research, just see this is here. a target and program what to disease. filing XXXX. said Given echo for Voyager I'll Al has and it

multiple antibody So are much therapy. pursuing and gene both so that in modalities, we

We are data by the encouraged early share for forward these of look to both continuing to and programs [indiscernible].

for little the XXXX. In I a in announced to addition, program development share program. December this want We ALS gene of SODX from therapy data candidate selection the our

data some Slide on this shown X. decision of And the are behind

in disease. spinal cord respectively. in in our some affected As the quite of These you can significant motor and candidate see, none reductions resulted and key SODX in cervical development are lumbar neurons, mRNA by single dose of XX% IV primates types the XX% a in cell reduction

an to progress motor addressing will system the down ALS. along not across we often This But continues of medicine benefit deliver injecting off not you because see and effect vascular Additionally, spinal grades eternally, to also toward we blood be cord added the which see is we barrier, once bring look the brainstem to important believe only is the away our lowering but steep cortex, the in and limited the filing cord. you injection When that leverages mid-XXXX. effects think approaches IV spinal program of ID at approach move you dropping site. strong the from map

Al. turn to the call I'll Now back

Alfred Sandrock

Thank Todd. you,

X. to Turning Slide

$XXX into the to started muscular through on with this we second a has Voyager million see began milestones. disease the year our advance raised execute Novartis time spinal off our XXXX. therapies We for We then runway can January strong, of atrophy. collaboration, Huntington's providing to offering continue in and year public XXXX, You gene and

Just we by progress this the acknowledging which to the week, $X of of all team, work selection we ataxia our a have. milestone. a I million has Friedreich's much therapy of program, the close as Voyager us which Neurocrine development candidate allowed announced for to partnered want gene as hard triggered

that, to advance forward, removed, four happy generating wholly questions is least Looking have. look With XXXX. programs Operator? we're CNS any to and we in forward well XXXX data year to partnered financial next. clinic our with owned and may and overhang take value-creating into capitalized the And this potentially Voyager you clinical at

Operator

Yes. Thank you.

As Allen line question from session. mentioned, conduct time, comes [Operator Instructions] at Jack the question-and-answer Baird. we'll a this of with Our first

Jack Allen

How and all about the fairly throughout made you're anticipate should ataxia it question the forward towards moving all Congratulations studies to think program high it three ALS Friedreich's you relates pipeline the across clinical team move assets? the well. towards internal using are progress is level, can of the as these clinical translate prioritizing? that then guess, as data selection all to be externally Do the across we vector? these you that forward results clinical quarter. vectors? My that program the move programs Alzheimer's here, what going results but clinic, I vector latest the on to are same assets the an assets three preclinical and they degree to program, the you And each from of feature novel you early they Or to

Alfred Sandrock

over and his is comments. turn Todd I'll it this to I'll Jack, Al. start, for then

disclosed capsid. So with respect which capsid, the to we haven't

these use because And well jumping issues will TRACER by are the capsids -- programs. other safety platform. that the discovered vg/kg those be be where will AAV We They through delivered doses of programs doses every below we one use we BBB. will will anticipate of -- one that's novel our EXX have with

we that target for capsids that and of array diseases that we profiles. can targeting select we That in single to also have create from leads single sure and parts luckily, every different are capsids from. our on can disease a nervous we be of de while profile reside every the may capsid fact want system the cells these based and that an we based -- we So partners target to the choose And and choose cause cells case necessary that us these these Todd? on toxicities. the

Todd Carter

to a Al, the lot points. have don't I major to your add comments,

each for identified As that disease specifically that to going a Al we the are after. we're oriented capsids profile mentioned,

a Of payload in there's case. each course, different

a effectively the that each risks mentioned to success those capsid tolerability that us reduce zero that best and that to the we any Al envelope issues. payload. is components opportunity the delivers to You're of of And give try talking really potential for hit of about type

Jack Allen

genetics trials. think about we chose that or human And so-called Jack because us be of of the -- had doing nonhuman size targets, choose validated the just the models types, think, of with think don't part the you and preclinical human as including are to do similar based in And of think do the to I clear capsid disease. models. more do question animals. from primates, predictability, don't studies or the pharmacology what And informative for is pharmacological aim different we informative to a I anything? we on perhaps Jack, and then question. be that animals humans. Todd, are of clinical we other controlled add to of studies availability where We the obviously helps to may more that characteristics hope have I want mice help delivery may you right that us,

Operator

Citi. Yes, with next the line excuse The from question Hong of me. David comes

Unknown Analyst

David. Sam This Congrats back progress. is the on for on

Just partners lumpiness that could should provide there about if revenues could Is on any revenues? near-term any how significant lead XXXX. to think quarterly we for color for in potential you collaboration milestones

Alfred Sandrock

do take want you Steve, to that?

Unknown Executive

Al. Sure,

So collaboration revenue, specific collaborations guidance to with provide per especially regards we don't se. new

that around been the with what program collaborations out already moving advancing place, have collaboration and week validation forward. that and the was is we in further today's have that specifically announcement Neurocrine very came as in this part FA fortunate earlier We of

overall that an final the and organization with subsequent as as have do not additional today's SMA the had kind financials of validate That's year, the the at significant largely XXXX, to we around program. of year. with program we for you cash our and and we part agreement this revenues second in conference runway. or the Neurocrine of through I that also collaboration call. discussed bring as 'XX, that company additional think so first revenues previously cash driven And continues projected to earlier we look license then, $X Novartis our well as Novartis with the pretty million that And option science do the at collaboration of HD to close the course, the did originally of flow the deal beginning the as was the in

So banner us. year 'XX a was for

for discussions and perspective, I -- going very to to associated you think programs. flow we're XX be conversations. further to cash obviously, and as from open think making with revenue milestones revenue development open generation a our could XXXX definitely there be our existing capsid forward about business platform generation and always And

we generation that in mindful that we be there move just to revenue 'XX. we do provide important don't as it's guidance think I So forward be but believe could here, further

Operator

line Olson question. with moment This comes our Oppenheimer. of the question from One for next Jay

Jay Olson

thank Congrats and for on the all progress, update. the you providing

the about program and for about Phase OGA readouts question a including and UCB there's since from have TAUXX II mid-domain targeted to anti-tau tower We an I follow-on, inhibitor Lilly. maybe your then please. Roche targeting readouts talk some Can TAUXX therapies, just from the program near-term to antibody the across could, potential competing from a you and to have more if broadly And own I strategy? read

Alfred Sandrock

multiple the were would yes, in work that That's in be as read-through. antibodies and blocking chose C-terminal of did chose and some And the great antibody effective. regions. it antibodies out, where the pathological experiments tau. mean, into we case other there's the of the animal, and robust the a that we turned human number Mid-terminal a tau, of against certainly lot, We are various in C all that actually on amyloid question. could and look the antibodies against not tile antibodies aware had a was terminal spread. because on the C-terminal epitopes terminal matters at the believe epitopes because I for case amyloid blockade ones that of In pathological brain molecule. we I -- the other the And are specific terminal to we spread highly most animal where we that inject we there based tau say epitope

one we had -- to that about those. we decision on them, to we we half our dozen decided animals assay, make which bioassay this choose of to We a had of epitope. use had and So would spreading in

negative a a underscores, long is positive just I it's maybe towers So the I think wrong go say was to to a because a target after, that answer it result the result that great think but epitope.

then there. even antibodies C-terminal antibody, some Now we have same notice within if to others. than take region, better spread it's a the But again, block

either. So do seriously Todd, to you even that, we can't want too anything? take add

Todd Carter

I And one and point targeted there we think the that did captured on protein. very we our made cross at that it. can studies to through the tile you was Al the antibodies another identify end epitopes close

some upon have not. And assays, reiterate failed particular clinic work well. that epitope. antibodies And N-terminal and well our others And would quite those PET failed it really in dependent in just our of the would screening that to the a assay in I'll as antibodies in date that assay

targets taking we're quite something pathological robust So and tau specifically. forward that was

Jay Olson

in Great. therapies? could the broadly comment biomarkers And accelerated question follow-up just their FDA. on of Can the to gene about I you for with use more if squeeze a recent plans discussions approval

Alfred Sandrock

confirmatory and And get with applaud valid And the was then think markers, right will. to patients. if we that the the that patients -- drugs approval approach. surrogate surrogate that the biomarker the for the Yes, I use are And accelerated trial, exactly to great of personally read I use with this can patients. and if it's we interest. you get in confirm diseases marker, terrible These is surrogate a a for approach consequences access right think I earlier. And I right the for disease think such

Jay Olson

regulators Great. takeaways opinion And CHMP U.S., maybe looking any outside from positive the for at Tofersen? the just

Alfred Sandrock

Europe their which but that efficacy. outcome use was as mean, -- that pre-specified the was surrogate based essentially of predict clinical positive other functional great we biomarker strong I assume, as a on measure the have the suit to week support the ALS another a surrogate followed did exactly statistically biomarker. wait scale, effect EPAR as again, measure, the primary know lot approved be person outcome -- measure but all that's strong note not approved The clinical saw example. NFL outcome I have yes, the was that effect, thinking but measures, to Tofersen meet the did measure Well, now the specifically the it last was allowed NFL. And the of endpoint, main we rating of clear well, know, likely reasonably that that just regulatory for what and on cut neurofilament. to U.S. a outcome was for to the with one was, on based only that important the to neurofilament significant it's from We'll outcome a was -- clinical

the maybe point. thinking you're So guess, is lines, the same I along

Jay Olson

all helpful. progress. Super on the Great. Congrats again

Operator

line the question Forset Ray Guggenheim with comes Securities. next from Our of

Ray Forset

tau This And question the is targeting as your your you to would relative the questions as our clinical informative Lecanemab highlight that historical Ib what Albeta to ongoing or advantages of a Phase would second One, you Debjt's and program us. of for design to Ray is Forset Guggenheim. tau-targeting team competitive specifically plan clinical Two features could from most from point VY-TAUXX from clinical other point program? efforts? you lessons therapies and VY-TAUXX at

Alfred Sandrock

Yes.

get that VY-TAUXX hope tau imaging. the proof concept of Phase based PET the II program to So we on

know and to very tau a that Our current about other spread from probably Braak patients, toll do great to the brain Alzheimer's that to. as cortical get or X, plan, FDA, But obviously. The the X of more other the early spreading enroll Braak plan it's and staging but we and input to stage is in work stage that still regions for well stereotypical Alzheimer's spread actually is a disease look the thing by to we investigators early-stage perhaps current have pattern. regions

recapitulate talked human to about that the the robustly at can to animals look we the we whether reducing we we where some in just use pathological the spread. not and quite spread at earlier we're regions brain saw data. interest and the of see want in or look ways, So in We

advantage competitive a mean for program because very We we the whether a proof X-year that efficiently. like on think concept the the can of of on spread we -- proof-of-principle it's so spread. or it do or patients with XX that's duration in whether order on we tau I the get fact group -- can So chose of and the we

So current that's plan. our

said, still away. years I couple kind still of of we're a -- As it's

but So that's plan. that change, may current our

go. to need it of where a lot matters And I Lecanemab, a patients mentioned then terms are early-stage need you -- epitope that way probably in lessons In from have to well, the the earlier that you a you Aducanumab effect X distinguishing PET and feature and that a Donanemab had Lecanemab, robust robust of effect. is I mean very in other Imaging amyloid on year.

so not we we're if a fact that will. but hypothesis, not And to don't robust on see hope Tau And see going forward. got you effect We pharmacodynamics we clear-cut PET target engagement, to move on tile we've a clear the effect to that, need only see if the Imaging. spreading

move If forward we But you takes that, that we we're important program. a to silencing about that still the have approach don't with to very earlier, target. going different which see top as not behind talked a program

Operator

line This question Cowen. Nadeau the TD Phil comes from of with

Philip Nadeau

us. A from couple

the guided the that first Any SODX next the In starting IND to towards in lines an you filing? the time past, you're program. XXXX. GLP-X towards on see We the the of First schedule? the GLP-X ahead tox changes year. guiding on Is program tox of IND half for

Alfred Sandrock

time from that planned timing. Phil. very change we This is in the our Actually, been -- exactly had the line no, the there's in no beginning

Philip Nadeau

the follow-up VY-TAUXX, a the And prior second, then question. Perfect. to on

the data pharmacokinetics? any Ia of generated able data track. Ib Phase the proof-of-concept the PD Will to PET on to On good that to ensure you're advance target concept biomarkers make on to look have the be producing -- markers towards the data? you'll and Will engagement that by you sure or PD that Ia be at on proof scan other sure from look able that to appreciating in be track the at and make PET right or it right simply will will Ib, of getting scans. Phase What PET you're be

Alfred Sandrock

good a That's Yes. Phil. question,

volunteers. on dose So be a going single to in that's normal Ia, healthy the study Phase ascending

going get pharmacodynamics not we're engagement to target any or data. So

earlier, Phase may and on at. of data there into the We will PK. on in primary the Imaging advantage a doses one biomarkers tau-related I attention And trial, to of that have get we're because or The based safety point take X addition you the the But going in regions looking be of if the test additional the PK and and try look pay will. stereotypical are will to biomarkers for to Phase will identify spreading to there trial is in where to then Tau the to we of safety we -- pathway said and be we a are number move brain a biomarkers tau. Phase look Ib be PET tau will I as to CSF interest spread optimal hypothesis, we getting at at of whole called Ib could we

tau. We forms pursuing. will also forms of have -- blood have to as trials, seen phosphorylated Biogen we're some as we that in the biomarkers tau of bit that at, tau those, a well, XXtASO of covalently the of on VYTAU trials of example, people some modified can efficacy amyloid also but certainly lucky is for various such And look

earlier. our Phil based be primarily the decision-making, we'll Imaging look all stated going them, PET but think for reasons of on to I I is at So that Tau the

Operator

This Moment for Truist Securities. our Lee the line So Joon from question of next comes with question.

Unknown Analyst

our quarter is questions. maybe for -- on on This congrats taking thanks the and June for and

choice And elaborate candidate you over please shRNA a I [indiscernible] artificial microRNAs could So have or yours? Vectorized follow-up. on for the of siRNA of

Alfred Sandrock

want that? Todd, do you to take

Todd Carter

Sure.

are the a are Vectorized our pharma technically microRNA. course, Vectorized prior the siRNA Of artificial payloads

at Voyager years Vectorized how a things. lot many, this experience. been on We We've these doing for have of to many

We a a expression. approach cytoplasm. where exported it deliver, siRNA, processing in involved is lean and we You single to the be attention the as cell the our the and lack to the mechanisms catalytic the processing, Vectorizing that know are the expressed, these is of selecting the of into careful level cassette. it specific within quite dose of When of sits in by It think type siRNA. mRNA. of of get and siRNA of And down can, a these nucleus mRNA identify processed of get will process the call, to knock like we sort particular targeting can things We the thing. targets the with used continues digit process whole

So take. we're comfortable and the your approach answer actually siRNA we about very Did that enthusiastic question?

Unknown Analyst

backbone a to Is promoters of quick addition So the or [indiscernible] backbone question. from of this shRNA different type it that use?

Todd Carter

I heard shRNA, -- what was you're?

Alfred Sandrock

Artificial micron.

Todd Carter

an entirely It expression, it it involved that microRNA, artificial in in in that not RNA. a shRNA, -- of processing resulted do is that the effectively reductions in but choose It other different is we is artificial microRNA. those those which but hairpins artificial in are types exist is endogenous from an

is distinct. So it

Unknown Analyst

several how like there provide insight you you targeting. multiple tau terminal only please targeting one Can balance? domain. of C-terminal antibodies it have the binding been for been the with some And lastly, and has are less on And selection end microtubule for per seems that C-terminal the

Alfred Sandrock

Well, thank you. Yes.

I various And pathological do Again, forms tau. two tower. we pathological right we're So specific it And of How antibody. a well. that with at you're we of, of for And antibodies had there of are binding those? the targeting I all C-terminal you as aware -- could targeting regions turns that is select a for are couple least microtubule are two Lundbeck think be the other of example, other forms us, which of Merck, Phase targeting are out maybe also many one in is -- a that three other these there C-terminal number region. antibody. more. there But in Phase companies They're pick that I companies monoclonal for also C-terminal they against selective with that the

that assays brain I spreading that And We until biological where the look the so use? Vivo inject be like it's assay some the assay spreading assays these to predictive." it's the right know have a to with human pathological mean to choose take the In we chosen, toxicity happen the of that's one of mice the for Vivo see say, human a knows human was at one we pathological or data tau hard Who In which you assays. it's fact spread. and example, is cellular cellular But able we one most tau. "Oh, to that that starts to into

not seems. why the we chose C-terminals chose only Go to ones that's terminal directed we're ahead so Todd. see that to but And antibody,

Todd Carter

couple points. Just a of other

in-terminal the those work mentioned I that those have in earlier, without I clinic. And and Vivo Al antibodies, in the that not think, You do described, have, antibodies not almost this fail, then model the in they succeeded mentioned model. in

target antibodies those date epitopes also our that so say And epitope these are C-terminal we the C-terminal the and from We've in other different the chosen region, antibodies region. they clinic. that to have C-terminal, failed when target distinct in the

distinct might region, another are C-terminal we well. from likely one what in be as call to antibodies different even the So

Alfred Sandrock

you that look you point terminal. at the we But the But has weather make the value. were when the know value. it that's also negative the on antibody, far, has positive So predictive predictive to enthermal think trying seems animal don't I

Unknown Analyst

Very helpful. it. Appreciate

Operator

comes next line the Kulkarni our Sumant from for Canaccord. with This question last question. of One

Sumant Kulkarni

It's relates I it to question a quarterly talks to GLP that anti-TAM on asked follow-up actually a update the antibody. and on last the

You had expect quarter. studies first to you nuances mentioned running in that and there the today studies these say were some complete to slides your those still

half could specifics share an first the submission year? needs this so for on you you IND time more done any be So in line can your hit of to what

Alfred Sandrock

wild-type animals. on-target be human it's animal no -- look binds in animal that and toxicity. that -- nuances stock the done evaluate typical to are to is to at And tau used are antibody on-target so specifically the Well, toxicity, an studies pathological wild-type typical that there can tox

sick, the that nuance the do pathological carry studies is tile, problem you have tau. expressing those otherwise, because no human there's they are target. pathological that are that And animals So animals to human in is

you'll hard very a to meeting been have chose the lot look, in did animals confidence we've package we it's year. a sick. -- of So But but recall in have -- last -- pre-IND that we do toxicology have studies we long-lasting that are we

March almost to A think year, of I was of ago, based it think we look, goal the that a of of this filing where interaction. with was on is actually work And I first it on is achieve year of all year. the our interaction our half lot -- in FDA. our we're last IND an track had work

next months we shortly the the start in so in-human and or study hope sometime So couple to thereafter. first of

Operator

Thank you.

turn I closing the time, no questions. this at remarks. further So now to Sandrock like for back Dr. would I'm showing call to

Alfred Sandrock

say today, want thank you. just free questions. and with follow I please Thank you us for directly up to feel joining any Well, to everyone to

Operator

you, and your This Thank disconnect. conclude in thank you you the does now and program, Goodbye. conference. today's for may Yes. participation

Voyager Therapeutics (VYGR) 28 Feb 242023 Q4 Earnings call transcript