ADVM - Earnings call transcript Q4 2019 | Adverum Biotechnologies, Inc.

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Operator

Adverum Biotechnologies and Year End 2019 Corporate Update Conference Call. At this time, all participants are in a listen only mode. Later we will conduct a question and answer session after the prepared.

As a reminder, this call is being recorded. I would now like to hand the call over to Myesha Lacy, Vice President of Investor Relations and Corporate Communications at Adverum. ahead. go Please

Myesha Lacy

on of and release Relations operator quarter Today, Web issued is of www.adverum.com. and replay corporate we Web XXXX. call page Thank our welcome Presentations the financial site. Events also will section of Please section press available release site that this our note reporting copy fourth press the results a our releases Investor A you, on of of a everyone. the today's for of at be the available

for Joining call Then me call. the Dr. President Executive of our will for the the Officer. prepared available Officer, and Aaron Leone, remarks and Q&A today portion the Financial portion Aaron Officer Medical Leung, Chief Patterson, of is Chief and Osborne, Leone Thomas Chief be

we may actual will found well operations, and making description are subject in and be research afternoon. forecasted. can those regarding which filed to outlook. statements our of forward-looking this differ as plan, development A these our was be These cause a risks risks As results that reminder, to product materially activities from as XX-K, financial our statements uncertainties

like call our and over Leone turn would President to Patterson. to I CEO, now the

Leone Patterson

everyone, afternoon, Thank you, for today. joining us thank Myesha. Good and you

Like situation Before and community. to closely. continue employees situation many to business and our companies, as necessary the we dive are to and progress, business, fluid support broader into we like acknowledge we it coronavirus monitor the our I'd just the relates precautions our to will taking

clinical with for or and data corporate DR. review retinopathy, ADVM-XXX including AMD, we'll therapy in ADVM-XXX and provide diabetic second During targeting update. advancing advancing presentations a progress review significant with this indication, our candidate, momentum then plans significant will the Aaron our a gene call, also the recent lead

in gene We consider working questions. part be gene a what exciting open be many of call serious the to to diseases. to treating in This and will therapy for an time is therapy be then

with and what injection transformative are diseases. has intravitreal ocular This therapy believe serious therapy to study. We believe progress gained Adverum the of ranging lead we with XXX be a ADVM patients have year, can delivering momentum gene significant in focused AMD. indications be past on rare program At offset clinical potential the lead we we baseline living with therapies for our the gene approach our onetime development for in dose our

the a dose As XX^XX we in OPTIC a x two lower reminder, been at three-fold have XX^XX. x X and exploring X doses trial of

I'm from completing two on to patients ADVM-XXX data clinical announce and presented can We recently dosing in completed and a enrollment that very screening first of of third robust where our excited presentations begun. cohorts, OPTIC response. in dose focus have we have now nine We our on cohort. has demonstrated data X, patients promising evidence X been and X Cohort and efficacy Cohorts all The

forward data news look year. OPTIC this May in We presenting from to clinical

second plan all in to data half the cohorts year. of from we Additionally, four this present

an with second year. to in Phase half retinopathy a XXXX DR of the in in and develop also beginning plan a second submission IND diabetic We or XXX the of the in half indication first X/X

a to positioning be company leader are gene We in our therapy.

novel a are we focused on of ADVM-XXX, Beyond developing pipeline gene therapies.

to Our this course expansion, talking for with other strides Also, leading the we of areas we making great of this compelling us and industry business. platform options during AAV in of our number year. progress a provides are about forward look

and expand including moved the plans to of manufacturing. year, process our capabilities, enables headquarters Redwood This we beginning at a City. development new in and growth move to supports First, the our us core

manufacturing stage manufacturing commercialization. in [Technical culture for advance Difficulty] leading strategy, as Thedinga process. manufacturing and will which Angela experience as toward manufacturing the early we early relevant focus our process deep on Technology prepare [indiscernible] in to trials commercial she strategy potential brings and in we gene as to scalable later therapy AAV a stage them clinical Chief Next, enabled Angela transition made to Angela developing appointed Officer. efforts

finally, we position $XXX is public cash. in operations $XXX And cash into our financial approximately offering a are month, with a net follow-on over which together completing proceeds with XXXX. of fund to expected After end strong million in million last million, raising of $XXX

with how to patients are DR. cutting share time turning the company to one be and I this AMD Before a for to over the am at leading want where potential treatment call Aaron, edge excited we wet just I developing of

to are diseases. our rare serious our therapies to for gene novel of We pipeline with mission ocular and in committed advance programs these patients

like now provide to Aaron to clinical turn who I'd ADVM-XXX. over Aaron? call for the further progress the details on will

Aaron Osborne

Thanks, Leone.

OPTIC as primary of to-date, impacts the regard, trial. any In this not Our we of focus patient a population. always the is specific coronavirus on company needs our aware on are

we’re We with the communication trial and our sites involved evolving our situation clinical making are our the monitoring coronavirus trials. and in continuously vendors with clinical

has thoughts by wishes are with COVID-XX. everyone impacted Our been and who

progress This been as well. in AMD for retinopathy. OPTIC clinical exciting develop Now second wet very OPTIC. truly advance to and diabetic a has for indication plans we turning ADVM-XXX OPTIC continues time a for to

Cohort four patient us investigators enroll this X. this all quickly from clinical and a mentioned, of There dosing from screening to completed XX share Leone and cohorts Cohort later to the X to patients in open sites year. As total data support is we cohort strong recently for in allow

in David this from Wykoff, OPTIC, in including presented Cohort X, a summarize of from data demonstrated us dose patients. measured presented Cohorts a Dr. Dr. received and who ADVM-XXX Charles update January further from ADVM-XXX. see, follows. threefold evidence patients the To and data X, from data efficacy and detailed X Boyer safety Then, X In as signal of Cohort dose briefly we robust which a efficacy lower response, of February,

patients at eye, X with remains using rescue XX [XX] weeks of per injection X threefold to X Cohort or beyond. three a out using of follow those injection cohorts weeks. injection a x us patients weeks efficacy median four six a rescue response. free genomes lower evidence In free In XX% X XX^XX Cohort rescue patients XX^XX remained dose In patients to sick a provides at combined, robust both XX dose or of free. up addition of in of dose free, vector x This were of XX^XX, further

and as baseline, mean For patients, baseline. maintained demonstrated to] was to these central as were generally acuity by sub-field maintained, vision [compared thickness best corrected anatomy mean by visual demonstrated achieved retinal improvements compared stable

to of events, no frequent we patients profile procedure adverse ADVM-XXX are It's to ADVM-XXX the to responsive the anti-VEGF important systemic related the to and Low related for toxicity. remember an drug of The is injections early inflammation And commonly dose treatment anti-VEGF pleased maintain vision. In meeting Cohorts adverse over nine been in in report received serious eyedrop to that grade that limiting with months criteria OPTIC drug in reported. favorable OPTIC. clinical prior previously events importance no average events a and or to safety related continues safety no has demonstrate adverse steroids required X, paramount XX injections phase their in trials. of is had patients X assessment receiving

Importantly, ADVM-XXX we choroiditis following seen administration. of retinitis intravitreal have vasculitis, no or evidence

that used of and steroid decrease steroid as X. X exposure Cohorts we're of and in of We allow of X of X after will believe use and reported later steroid oral administering to X the eyedrops potentially this forward and the occurrence sharing inflammatory oral period in cessation mild OPTIC, Cohorts X X Cohorts coverage, instead steroids the and prophylactic for eyedrops that steroids longer Cohorts reducing In year. to of the were a look X. from events systemic generally prophylactic the steroids have data been We

potential underserved presented from represents with on market anti-VEGF long-lasting onetime, our U. million receive concerns and anti-VEGF their ADVM-XXX diabetic duration a data in of to excited retinopathy to million only patients S., subsequent to-date, therapies promising and progression X therapy therapy. with people Diabetic that to X sight plans the excited million a large forward retinopathy. specialists second that the may not benefit of another anti-VEGF retinopathy Of diabetic most estimated offer. and intravitreal intravitreal risk around retinopathy very one-time could are loss. do short diabetic are with Retina diagnosed by Currently, indication effect only the treated. we're are a due gene Given retinopathy the explore diabetic move and X

Diabetic and retinopathy is impairment blindness of vision amongst the cause adults. leading age working

over to prevalence to that of the increase. outcomes There important an point of retinopathy the particularly continues improved believe currently ADVM-XXX more rapidly the effective for allowing unmet complications anti-VEGF therapies maintaining progressing and expected and is significant and disease, more levels with therapies intervention. sight-threatening be We improving suppression earlier is of of incidents can potentially treatment outcomes. needs VEGF prevalence As for reduce this available time durable of diabetic for grow, consistent diabetes could

I will the over to call Leone. now turn back

Leone Patterson

Thanks, Aaron.

We to open Operator? the will questions. now call

Operator

you Instructions]. Thank [Operator

with comes Young Our first from question Cantor. Alethia

You may your proceed to question.

Alethia Young

from and for the on progress Hey angiogenesis. guys. Thanks my taking questions, congrats

figured demand just bit of about there X. good potential two I probably in maybe little I state I maybe kind me, was know, So a from to X. you want of Cohort don't enrollment talk Cohort and

like people was And seen able let's you of efficacy or question kind So that be how when on which and dosing think perspective like this on perhaps touch than staked kind like remains might the start be we've second we about still talk potential there? of potentially something about any to Eylea do upon give kind maybe data can retinopathy. thinking the enroll an is that there Thanks. from versus pretty Can my just And any comparative start potential a population. you standard see monthly could of or of we drug, the just could to impactful more then have that like fast how making care, of therapy in prevalent wanted that read-throughs AMD you diabetic if say you you that out? might kind already

Leone Patterson

four in which enrollments, So done. getting week much recall, in heavily anything of soon XX had and focused same state patients that may add. part longest dose still start as enrollment very efficacy we're XX^XX, if with time as it's enrolled really x to the cohort as X possible and has you those But out durability as is get to And patients. is showing are of cohort, medium. point to on see we're Obviously, the screening we're the on the the efficacy, Aaron of robust we terms primarily first really I'll focused is now currently what we

believe to XX^XX. investigators of interest continue patients that there we So enroll hear X a we that to x cohort from in and is lot that

add you we know don't points well. if I and anything go two Aaron, to have So, other can to on the as that

Aaron Osborne

contact daily know and in the of sort we're investigators. actively these in really X got we're investigators with add, about to U. Cohort the in excited patients. truly screening We We've S. just So sites and well they're

up enroll lined X. many Cohort to have We rapidly

Leone Patterson

DR potential perspective, first study. And Phase obviously then read-through, and X Phase It's in I of safety terms OPTIC. X safety for the of on a think all

the is manage we're and therefore and safety earlier may that's you X. think foremost Cohorts important, so and are first inflammation have on been using will Cohorts hopefully prophylactic --the I in X and steroid seen thing X because And to the why steroids X that due profile which eyedrops,

the and what is steroid along using some it read-through measure. the in do X prophylactic apparent be we with X with as that from So presented there we'll Cohorts safety eyedrops on even see that to we and will comes believe data

of can through between difference wet differences AMD relates Aaron and some some speak the as the obviously to efficacy, in do I'll what to DR we profile. compared would the to in talk And would and in use and is there with I in VEGFs wet would be to DR, doses be have the disease, the that the think yes, levels about the patient would we it two AMD be same there and diseases as because read useful

Aaron Osborne

and AMD generally are are macular the them approved well use doses most in been as approved at moment, So the in of patients anti-VEGF diabetic most as for edema, the same. have wet that

there’s anti-VEGF AMD So evidence be wet is exist lot macular in in of treating in that dose effective edema generally and already. and of that effective diabetic drugs, the around retinopathy also improving will diabetic

macular efficacy possible diabetic of is the OPTIC to in retinopathy we're applicability seeing terms and exciting So in really diabetic its edema. that

and And second part which which on currently between of the currently question, extent. but any XXX diabetic the for are used are I the just not to retinopathy think was anti-VEGFs, available difference great approved

can of that available action improve and to not their they I really with is happen several years. then clinic. can But the patient short think a to last back for superficially retinopathy actually can back And disease come is of the because complications that and the what are this the if do the experience duration comes that appearance durability therapies diabetic to they disease. the give anti-VEGF

this And and could those I sight a is for something that in threatening lasting for you promise retinopathy risk that complications. something approach importantly, than period rather hopefully And of which the anti-VEGF, lasts retinopathy diabetic assessed sustained last of can the or through diabetic can a think active reduce that sustained several the just provide delivery months years tie that few weeks. it's most long patient

patient complication. is the make wear be it this wear threatening that's the So would gene therapy all of off further happen in difference big less starts that when about a And much that's think the potential start excited sight does likely it the retina and experience really to much down I why to to retinopathy. would line diabetic community the intravitreal to off.

Operator

you. Thank

Our next question with comes from Sandler. Piper Tara Bancroft

You may with proceed question. your

Tara Bancroft

great that’s great. guys be to so experiencing progress also any to and hear so Its far, really OPTIC promising with that your due hear COVID, to you delays to

So lasting read have how the think be? data in the there's towards could may just therapy it thoughts that. if think you to therapy wondering, about to Do get may Thanks. and like and you I intravitreal [Bayview] affect on view sentiment led was I XXX maybe that what any seeing safety we're longer this could general that signals was product your the with recent through

Leone Patterson

start I what other think topical with that has been his and is the low some But say I'll we're ophthalmologist will [Technical as could and very a So very grade as experience more worked anti-VEGF, different, I on he contentious think steroids then I and [indiscernible]. off that number to of which Aaron obviously specifically. an as having is of of so is, with the types type information Difficulty] it's can the experiencing, manageable information a

turn important are I'll of we occurring. will the I and over also of to that, where it what's some be Aaron the the with information think to of But type this, hearing we on information So emphasize but it to talk difference hypothesis happening. have about with really is the

over it Aaron. you, to So I’ll hand

Aaron Osborne

has been to ADVM-XXX, of so those the reported inflammation, with reports be vasculitis. back in associated information a most Yes, concerned obviously hear we’re to an and inflammation posterior with the for which the has loss sight been part vitreous body

which called blood that certain get So potentially vessels, resulted able and retina in and being that's affecting means the an vision patients losing vasculitis. the that not be retinal and could inflammation to permanent has to

Ophthalmology about think this community lot retina So, is recent was really the and what discussion of I there a that at Meeting. concerns,

[indiscernible] So, those single therapy, the which the fragment, remember is potential that class chain in were that used of that a could is something a is cause we around terms of -- different some antibody what But be, for on things and are route come not up, widely. potentially XXX. that this focused novel

and that maybe an deeper issue single could be there it related there conceivable fragment, it some penetrate be or that into retina contaminant in related causing which production the it's another thought that to the could certain there, to problems a So may being is with be it could some specifically chain be patients. could and

times that it's or the of an fact the of it's high Eylea ranibizumab times third XX the intravitreal theory dose is injection. think of around I anti-VEGF, the dose And very people dose a that discussed XX

what's are to of explain potentially sort here. areas that are at those happening people looking three So,

of seen with low not any we've that longer is is this evidence evidence any something inflammation importantly the we XXX, of and vasculitis, expect intravitreal retinal retinal a sorts of see expected, we with lasts think front response, eye time any of seen topical but affects it's do commonly grade. period over steroids. have some eye XXX affects of the and viral injecting the of which injection it's predominantly We that and we're inflammation, material of inflammation. following a grade not the part I It front immune manageable very degree of part no and

have of ADVM-XXX. inflammation we inflammation type seen and any different very of with that evidence type not So of

Operator

Thank you.

Nadeau Cowen question comes next Co. Our from with & Phil

question. You may proceed with your

Phil Nadeau

from Maybe for? that Have or a on seen. this regimen DR you've information that use that third to cohorts couple planned going in you're decided data you the await now does on that you trial

Leone Patterson

for you I up. that think, basically, thank So bringing

a one of using completed protocols weeks, steroid six I our steroid So, couple X into six over eyedrops the drive tapering. an things, it's study. open-label Obviously, have mentioned earlier, week Cohort eyedrops dosing. we we've X, grown And over same as Cohort

So of level in with X, comfort x that sense a forward which Cohort is of that gives confidence that our approach move you X that to and XX^XX.

of would haven't for have forward The submitting we a Obviously, done year going second first design. part then terms share get process what that we would which said of using in submitted, IND protocol we the in this still in we're the in the bit we'd of little about DR, be more DME. and half we

that. would patient wait from to given till see way managing need in willing that we safe is that as that potential that be and that will of would protocol at But we’ll design benefit any using our it's as topical opposed share But clearly to get looking that actually we the a inflammation say oral, to we study. this to steroids population to

Phil Nadeau

prophylactic you are seeing I nature comments on in about follow open detail of what the bit in of talk long-term you just the the about paradigm? patients dosing week particular to I there, cohort, Cohort end regimen you Could maybe X. steroid mean, week what your can guess the label six just the today? are six efficacy And more passed week up So how of a the many and six see

Leone Patterson

can that that obviously remind is to say we'll data, just Phil. patients at were some that first in point, what is I say But you we think that enrolled the can patient We real nine I were I think there release November. enrolled. what our

x we say patients presented to six thing steroids of and dosing a our proceed out haven't data we've was to we can steroid think felt only regimen weeks. six over seen number the So that topical same we X what I since of on with safe say I using with to those say back it’s to that that that weeks, to have XX^XX

Phil Nadeau

remind you topical can four And possible necessary? be would to if dose that for of the steroids, of the was us dose cohort increase it the

Leone Patterson

Aaron ahead, answer question. I'll that have Aaron. Go

Aaron Osborne

X for times we're day twice a weeks day X a for So stop. a times week, then giving once a day three a day drops week, a and for then a for and week,

potentially frequency that. given So, X the and be a can frequently is maximum eyedrops more today times than

that cohorts So, increase we've with the has we and But be manageable topical of two, based one inflammation seen certainly that those needed in the steroids would if option to the given. on been steroids. one experience amount being

we're now experiment quickly that data doing as as and So the to obviously, and look in getting Cohorts forward X X possible.

Operator

[Operator you Instructions]. Thank

with question comes LifeSci Patrick from next Our Dolezal Capital.

with proceed question. may your You

Patrick Dolezal

ARVO you data of could I guide just was the hoping update? expectations

Leone Patterson

has that ARVO So heard may was as you today. the is especially in person meeting today canceled probably

on in trial we that see in still to press the wrote also May. present OPTIC release that today we our and will our what we do see you remarks in data However, plan

it’s when present different OPTIC present kind ARVO and virtually as without May would will In and we that and clear under whatever the to it are it'll be webcast way happens, that of to we still allow they or that, we of hear the but and/or offering said. as data previously we've present whatever from And in on form do ARVO. of to as do some just plan we that saying it'll done to ARVO, part we’ve have still still umbrella They data, support to ways waiting data. of be, obviously, done presentation, way would be a terms that presentations we’re so data, back that we we're or of ways plan will

Patrick Dolezal

of playing then and guess of used could Cohorts possible, tapering on Phil's And X? of X of kind I additional steroids question. the color off provide If the you status any in

Leone Patterson

can major at there level time with at present of I about I'll what we'd point. what protocol think providing talk think X some we terms I we what think give as X later we does [NGL], that in updates, to say is a any of that inflammation forward we tapering. think on steroid anything with do where But Cohort the what do be see that do, and as has it's I I to safe the continue in might And period comfortable be if there you’re useful beyond investigators to managing Aaron we the any insight prophylactic add that more well. as using are see. eyedrops But I a of the had tapering can reminder the

Aaron Osborne

different remember amongst had inflammation, we detachment and optic that which unrelated and last would had time was Cohort steroids, with and was you the steroid, we’ve we the if learning was who patient adverse that Xst, serious after was event that oral point kind surgery. some that December oral of detachment an variable one any we some But had was that one actually that and some data, retinal cellular types inflammation we potentially patient cellular through in post follow-up So the old on only steroids got of that patients has the timing a had given was more who even a prophylactic treated in and topical analyze patient degree. of postsurgical which remains really patients retinal expect surgery we process X, there post of the

any longer we steroids, a any two of time none a point. of patients at of inflammation that steroids. on had those amounts the and patients each were tapering day was And two no other which two others, five were drops topical on three five cellular The had those other

have of [indiscernible] surgical, those patients was was outside taking one remaining -- post who patients the and two steroids. had we we the two certainly cellular topical So inflammation

So that's one. cohort

other And short out we at dose, another inflammation. maximum lower six not it have data we zero and who of we or and that and point eyedrops other Cohort up, had but the have zero steroids next patients XX had had two lower X, is initial have the the course patients absolutely threefold had, any required dose, which patients that their was had weeks tapering And inflammation topical steroid that two of inflammation and who’ve follow to the after eyedrops. through there minimal they had, have a a and the resolved plus, patients then courses of had or oral was of we two those and were half resolved improving more significant inflammation we

had So Cohort week who XX. we patients at X two drops are on in

vast that for seems on it better having The to there predictable six a of been the have weeks course. be eye, can or back a steroids the low and of asymptomatic, eyedrops of inflammation any spikes the and patient the of it in the who this the the we're inflammation is all of so it's of hoping Cohort to been on nothing with and very has hopefully affecting comes grade, approach. getting patients topical inflammation occurrence adverse the we reduce important manageable events next those remember has topical X eyedrops, can six obviously topical majority are But early that weeks

Operator

the CEO, back turn Patterson. to call now Leone Adverum's, Thank and you. President will I

Leone Patterson

again for call All right. today. our joining Thank you

year. real past We progress a this mentioned have

of half OPTIC program diabetic trial second execution cohorts year, beyond treatment finally look our We clinical to and and novel key presenting catalyst clinical serious IND of sharing year presenting data all ahead, initiating half the ocular data this an our half. first the continued for this four in therapy May, submitting of are in of the diseases. progress the from retinopathy forward X/X advance gene second in the of our development Phase new the we in Looking ADVM-XXX for OPTIC as year,

to and Adverum who the And patients, efforts. retina I the specialists for trial. I'd thank their not but employees givers are certainly In like the in tireless want to participating closing, care last least, OPTIC thank

possible Thank are weren't the time call. our concludes you team. for that if wouldn't for achievements Our your of it there this be and dedication this

Operator

and Thank Thank you. Ladies for conference you participating. [indiscernible] call. gentlemen

now disconnect. You may

Adverum Biotechnologies (ADVM) 12 Mar 202019 Q4 Earnings call transcript