Earnings call transcript Q2 2023

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Operator

Welcome to the Invivyd Second Quarter 2023 Business and Financial Results Update Call. I will now turn the call over to Gabriella Linville-Engler, Director of External Communications.

Gabriella Linville-Engler

Thank you for joining us today.

Before we get started, I want to tend to a few housekeeping items. I invite you to review our press release discussing our second quarter 2023 financial results and business updates, which can be found on the Investors section of the Invivyd website.

remind several during forward-looking to will discussion, like making be statements. would you today’s that we I

Forward-looking statements and not that include our our future including of expected statements timing historical regulatory concerning, among COVID-XX the and strategies our facts. other and landscape, cash commercialization ongoing and these runway are research of clinical plans, plans, the development plans, things, opportunities, the statements other

to cause differ a number from of and our Forward-looking actual implied are Commission, may results under the or statements, subject to expressed in heading statements forward-looking XX-K. Risk the with including and including materially U.S. made described uncertainties those Exchange risks most the our Factors Form that in filings Securities our those recent

to team Dr. and my Invivyd joined the am I now Officer. to call. Schmidt, Dave is Hering, of management by Chief Medical It pleasure CEO the Pete Invivyd; introduce

over turn now Dave. to will the I call

Dave Hering

In quarterly near-term towards people the of viral thank our significant serious us progress VYDXXX call. our joining and you protect to mission weeks, advancing made threats. from recent the in update everyone Gabriella, commercializing Thanks, to we’ve on QX, and goal today vulnerable our in

call, initiate pivotal COVID-XX as people, Pete trial robust provide initial provide clinical from X we and the and CANOPY to Phase to positive referred for Since our results our very that to immunocompromised, X tighter are VYDXXX We data our results the for protection vulnerable as and symptomatic encouraging COVID-XX. a the speak trial. clinical announced the last of believe color safety additional serum clinical with robust ongoing XXX-participant the initial on trial. VYDXXX have potential X to VYDXXX data symptomatic neutralizing rapidly such will of prevention Phase initial Phase from trial Shortly, plans

in our clinical authorization, the initiating endpoint enable primary used we Phase the the CANOPY initial swiftly that trial near-term neutralizing XXXX. the serum trial, submission. we necessary expect size day With at XX, use generate a the to and by to clinical CANOPY same the based trial believe titers compact efficacy on can forward and of the biomarker data We of of analysis enroll endpoint in approximately potential have a to emergency the end primary data EUA and or X look

with In also on a alignment COVID-XX. QX, EUA we to designed VYDXXX symptomatic prevent general pathway candidates a the we reached anticipated and that announced for follow-on potential to FDA

leverage the that developing accelerate believe development encouraged companies of rapid few pathway provides pathway. it We this to previous the meet potentially by very outlined opportunity FDA FDA the are criteria the our adintrevimab development work of are one and for VYDXXX. very by to to we streamlined We outlined the positioned development the

needed a see from to pathway, we symptomatic to bring Importantly, with much people. COVID-XX immunocompromised this protection opportunity near-term

Before I to the plans about transformational hand the points. period want important for call over our I underscore three to Pete briefly to ahead, talk

And the cause ever. Roughly where to a more deadly more to continues months, protect to underlying of more be XXXX, winter the people COVID-XX higher risk deaths outcomes. that severe COVID-XX be before the contributing and on even fall estimates from are have was vulnerable halfway U.S. year. death COVID-XX than listed deaths XX,XXX XX,XXX remains CDC death for at than or certificate. in the the need broadly, cause Immunocompromised as a is attributable That the this urgent as First, as entered through continue we threat. related COVID-XX populations COVID-XX to

the in morbidity point, of that the as adds consider at risk driver the that some XX,XXX remains deaths for XX,XXX have COVID-XX have context, that COVID to year of adults roughly flu-related U.S. fluctuated X National for to well. in cause long Statistics in substantial for estimated RSV among Center which unacceptable and X experienced The levels disease. States. highest estimates between groups RSV the per per roughly For is deaths in Health a and deaths and this year pre-COVID XX,XXX burden unique at the U.S. United

While quo are COVID, to many particularly trying with not that we to have live accepted continue vulnerable status the population. argue well, are all and living

million a people from who not U.S. may an that X believe there we to are immunocompromised alone, opportunity. Second, need ongoing protecting In million large immunocompromised COVID-XX the is XX estimated and generate vaccines. of for population. monoclonal is COVID-XX candidate very development To a clinic the this few with in in prevention Invivyd of from robust one our antibody in now protection companies knowledge, the people

Evusheld conducted immunocompromised. different were the to In we physicians patients for they respondents of said conducted patients immunocompromised immunocompromised to a available forward U.S. immunocompromised XXX who In may extremely or nearly chronically types market types of recent treat or sharing insights captured alone prior against periods, further clinicians different refine look the be for likely care our concern. the circulating more in who activity billion views strain. different from total to survey the likely somewhat the of lost market from its with we’ve Evusheld to temporarily XX% the with emerging research population understanding patients, and that in use growth who of removal the of it of be variance when COVID-XX SARS-CoV-X it and XXXX revenue to still relevant we Consider if $X.X strong coming would the

that to and with therapies evolution pace Third, uniquely vulnerable. we is mAb Invivyd that rapidly deliver and protect the positioned perpetually viral can keep believe

required the innovation to the response protect against with therapies continuous that vaccines and approach that is premise access similar company serial will are a serious populations to strategy viral threats, built Our to periodically evolution. mAb to our discovery vulnerable modify on be viral to provide used platform in that

to be state-of-the-art Invivyd could due deployed quickly starting that generate viral future. engineering and in and our be a also products predictive optimized to which viral be point discovery influenza, the an with applied pathway. we such mAb vulnerable designed market early we to the stage program. area see can surveillance, protect using the other for could To brought EUA to techniques the we as evolution, antibody have platform threats leveraging the respond modeling of believe optimal people advanced We anticipate as are an from viral candidates to From there, pipeline speed COVID-XX where that

Officer, data, I regulatory the Schmidt, initial X and call pass clinical now will our plans to Medical our Chief pathway. Pete more Phase discuss trial detail in pivotal to

Pete Schmidt

Excuse Dave. you, me. Thank

clinical We have X:X to are different three healthy data were shared from initial X events VYDXXX placebo. X that a with volunteers VYDXXX single at enrolled initial trial generally cohorts. data Participants dose serious ongoing Phase adverse randomized which tolerated across Phase was three showed positive XX of administration pleased no our of reported. clinical tested trial The all levels recently VYDXXX or to dosing well

against the As day neutralizing neutralizing mean lowest milligrams, X,XXX dose XBB.X.X. XBB.X.X rise from were expected, X, mean we titers serum At XX-fold a in saw tested, the X,XXX a titers Omicron serum at geometric baseline. dose-dependent increase geometric Omicron against

X,XXX-milligram dose, the titers were At the were the At X,XXX. XX,XXX. dose, the X,XXX-milligram titers

meeting administered XBB.X.X titers that higher reference, at tested who recent treatment. neutralizing shared of are resulted even adults to in serum point a vaccines lowest Advisory VYDXXX were the the from immunosuppressive than titer not Committee Omicron Vaccines the against dose XBB-targeted on investigational As

because levels. titer reported meaningful that vaccine vaccine VYDXXX correlation targets were COVID-XX. correlated levels mAb of well X/X mAb neutralizing This adintrevimab above Higher protein the Serum doses for titers that serum-neutralizing receptor COVID-XX those in expected, titer has SARS-CoV-X also individuals our trial data EVADE VYDXXX. immune-compromised spike including a in higher the trials, are resulted, have as prevention binding and with receiving are referred of to COVID-XX like of the prevention demonstrated past domain been titer observed as that Phase clinical clinical Evusheld,

Based solidified geared submission. enroll VYDXXX symptomatic prevention we for the serum potential our to on titers that cohorts We initial our Phase of XXX are for of support from support X to which symptomatic VYDXXX With in trial meaningful a EUA the the clinically protection this CANOPY encouraging in have across correlation, trial seen provide now pleased we two neutralizing COVID-XX. potential approximately total are plan to is Phase X in parallel. the design positive participants highly and data hand, clinical believe of COVID-XX, to

of other serum systems via day a a medical have weakened as Cohort All neutralizing and immunosuppressive result A, condition who significantly are will immune VYDXXX tolerability XX. administered for regardless be This at A enroll acute will safety and/or participants people tumors, people endpoints the solid Cohort hematological to of may as people leukemia myeloma participants we cohort as example, for approximately who with expect being as treatment co-primary and such receive IV well treated include, in treatment. malignancies, groups XXX infusion of compromised. and In titers actively who multiple status or are immune

historical immunobridging analysis clinical efficacy. the In approach, titers from in for comparing data to in an clinical this efficacy obtained cohort, adintrevimab observed certain our correlated trial CANOPY data neutralizing which of serum primary with previous use will VYDXXX

VYDXXX exposure the Cohort Participants we tolerability. is be are administered and primary placebo essentially randomized Cohort receive with endpoint approximately SARS-CoV-X, IV In interaction or In in for safety unmasked via XXX plan to regular B, be risk who participants B B, to at which to who anyone enroll X:X Cohort has will infusion. will others.

include efficacy. neutralizing Secondary and endpoints titers and will clinical serum exploratory

X,XXX-milligram We trial with plan dose to the initiate the CANOPY VYDXXX. of

titer This to potential in protection the decision to clinically neutralization highest titers has Phase three significant over this was trial duration clinical all the the protection time. serum-neutralizing X,XXX-milligram Omicron provide COVID-XX, a informed have serum have neutralizing also as loss against that protection providing against believe potential while meaningful benchmark the with we dose. by XBB.X.X. a the the believe of initiate for provided we of decided conservative against tested provide activity and preference X While that symptomatic the FDA’s We evolves dose doses potential CANOPY the to SARS-CoV-X dose the trial

may and XXX. at symptomatic on believe For to relatively low data mAbs against that we own context, the antibody-mediated clinical our from COVID-XX of there XX serum of studies EVADE strong be protection other even neutralizing order achieved vaccines, evidence clinical COVID-XX on is and titers based

other we parallel While leverage of in program rapidly clinically to likely X,XXX-milligram to dose advancing well to of doses the continue in the provide we to meaningful VYDXXX time, provide above opportunities for is titers level future. excited are VYDXXX exploring minimum observed believe significant possible while a the period protection the

from designed, relevant modify a dose. the combination all As observed appropriate. against as pharmacokinetic We data redosing circulating CANOPY use potency trial months VYDXXX X variants to of with the strategy to second SARS-CoV-X the participants in plan currently neutralization VYDXXX receive dose will of our trial after the the initial in

we seen strong interest immunocompromised and sites the the given we size the have that design believe and CANOPY, we trial, trial With of enroll quickly can from people.

many of registry immunocompromised to trial site potential the enrollment. than unmet drug initiate completed, and to a facilitate enrollment eligible strong pleased the the potentially study X,XXX individuals speaks are believe established recruitment-ready in need. A, in To clinical have Cohort selected, already we we activities other more be our CANOPY we on have individuals We now With track to near-term. for available in which database,

regulatory Shifting pathway. to the

As criteria approach trial to a FDA of are or use that candidates request indicated reasonable mAb surrogate an support Dave correlative in a new has mentioned, when clinical pivotal the for a certain clinical be protection immunobridging a briefly efficacy may approach the met. to EUA of an

leverages prototype efficacy it candidate a similar is and one, new has from to manufacturing a structural functional mAb the platform when mAb provided clinical and the data is consistent prototype such differences. mAb available, that, that limited Specifically,

mAb the the meet VYDXXX the data, as potentially the leverage currently such to immunobridging has of previous data that utilize circulating are favorable mAb candidates U.S. with variants. development our supportive pathway criteria all development companies proprietary in We vitro future adintrevimab serving believe against one and two, the of this clinical very new or and in of the prevention candidate mAb. this neutralization prototype accelerated plan anticipated accelerate few at mAb we COVID-XX. follow-on as We for And non-clinical pathway to can mAb SARS-CoV-X

enabled and adintrevimab of for use potential of is our trial had Invivyd of event symptomatic the mAb the points. prototype from The the end clinical clinical proprietary previous data by prevention Phase COVID-XX, X/X which as adintrevimab to

from data plan we from addition XX a potential data, VYDXXX. along CANOPY safety submission neutralizing to serum data CANOPY, immunocompromised both of with use clinical cohort titers the for enable In to cohorts generated day utilizing for EUA package previously adintrevimab the to

meaningful have engage difference we people that in the of which the to most program. opportunity optimistic continue authorities people miss from a cause Looking and outside make ones out regulatory immunocompetent In development U.S., activities. the the and I’m regarding we compromised, clinical in can of their our with illness to and have to many individuals leads closing, the Viruses self-isolate progress minor team pleased these very about has with global some the our made, VYDXXX immune I’m moments consequences important all in many of for the loved vulnerable devastating communities. typically on lives

compromise, and immune mAbs to threats deserve. the protection from they require that the the For robust potential provide have viral

I that, over to With Dave we provide the overview will call our an the to for Q&A. turn before call financials open of up

Dave Hering

enable excluding will Thank in earlier on any us won’t the of the fourth securities. today, ended The fund and revenue equivalents marketable the plans, second the quarter quarter all our details into our so with second expenses of cash with you, operating financials Based Pete. reiterate to Invivyd quarter associated included expect of our we $XXX.X VYDXXX, I our operating issued in press potential million details cash, current release XXXX of cash, are XXXX. that here.

As CANOPY believe past trial. now the We to we of have on the are our that strategy we and you guided may we our that for to our our size create finalized half execute refined on recall, stakeholders. capitalized but well of second guidance have value quarters, runway, in XXXX

With the please for operator, call that, questions. open

Operator

comes Morgan first Instructions] question Stanley. Our from with Skor Maxwell [Operator

open. is line Your

Maxwell Skor

for questions the you on Thank Hi. and taking updates. congrats my

guidance fulfill evaluate Cohort Just boosted? to the long the to be requirements? profile plan did to you. can patients bit patients you Will you clinical safety these elaborate Thank more how FDA efficacy? how unvaccinated, the provide follow on related these do you a Also, have of to And vaccinated, B?

Dave Hering

good Max, Hey question.

In concerned terms all-comers points cohort status. that symptomatic this gets of aren’t who COVID. is be EVADE, call disease, will what with vaccination in or were symptomatic Cohort B, the really they an we clinical so so as exposure cohort, their And for we anyone end

we In stated. terms of follow-up, haven’t really

we We will the initiate details put those trial. up clinicaltrials.gov on when

Maxwell Skor

Thanks. Great.

Operator

question. next One moment for our

Our next question Guggenheim. comes from Evan Wang with

is Your line open.

Evan Wang

guys. the Great to design. SUPERNOVA seem It to some trial progress I follow-ups from see had Hey the all the compared smaller Phase the on does X. trial. significantly

data I focus garnering and know on a is there FDA. – from So FC

you third, more seems cohorts the just by you platform? commercial So, I trial enrollment it seeing. the to been the on you on color the about talk like some there you AstraZeneca data? of for thoughts smaller down positions is to data well in remaining by confidence file this especially can versus it enrollment get has both of really generating focus if year-end, this you driven opportunity your pretty what’s approval immunocompromised, all-comers. immunocompromised with trial FC Second, just share year-end? are need on And the and And whether of and could terms by started, then and know

So, updated have all-comers just some on the wondered if you of opportunity. thoughts Thanks. commercial

Dave Hering

of part the you So, this, Pete, take and on. I tag can first will then,

our I we Phase about are mean certainly, I from not prototype study we – December the their the is X specific relates to being put mAb utilize that that. started SUPERNOVA, detail, key And in had is, think and have able then bringing talking size as joint versus this against that’s And got how trial concept into and a a immunobridging we as where press accelerate they that this I is further started knowing adintrevimab. data specifically concept. to in the up we on COVID-XX. why conversations first meeting talking session study, about release which development forward had So, FDA specifically can’t But these since where FDA/EMA it to of they it what’s size comment

pull put you for a through design, clinical has I of SUPERNOVA quickly a trial together And get variety to need which potential have data a and that specifically, a really Cohort the don’t allows trial. may iterations overall safety together to the Cohort of know. But think this EUA. level to A this, package you in end that. subset at gone necessary when titer impacted gets look – small then you I we B

bit, enrollment, asked about of starting other that a the You Pete, can little Evan and about. pieces talk some

Pete Schmidt

can clarify in an exactly opportunity necessarily I really Dave just there it’s it’s said. Cohort And this B, about was think – specifically as intent the there. provide created. database terms Yes. to goes enroll That’s it’s you is imagine, as what easier what all-comers we to commercial than registry to I of what the pursue in recruitment it to don’t And and immunecompromised. supportive expect, saying a I think to safety we

interest compromise So, in immune every trial. an and expressed in as has registry has identified individual that interventional

pleased very X,XXX think over will of individuals, large a and are we interested that very be enrolling So, them database ready that of have quickly. to we proportion

Dave Hering

relates our variants. just the where that on The are would the who at state etcetera, immunocompromised been it could as and vaccines, I we are thing COVID-XX. have against initial vulnerable current of has mean severe given from the all commercial focus contraindicated we who always this be be protection are opportunity, which with about outcomes is, Evan add, folks Yes. said, risk I only those on highest to us of With argued to focused been for group, population,

Pete Schmidt

before box initiate that activities necessary a it’s of you you the start just to CANOPY, largely terms to checking in And trial. stuff do have

think we have all I hurdles. passed the major

going specific the efficacy release provided end the we on of we can to when but by around XXXX. some data start, say – endpoints that see preliminary did guidance will primary by are of you haven’t We we end

Operator

you. our question. moment for next Thank One

Our Yee with Michael comes from Jefferies. next question

is line Your open.

Unidentified Analyst

on Jenna for our Hi. for questions. Good Mike. is Thanks This evening. taking

have we We may. two if questions,

looking Phase Are replicate data, looking is And upcoming this of to the readout at already the or results, which X what you titer initial you point is to market? what are soon show? question you show from you was even is, could pivotal second year-end expect to great, are the levels? you. milestones First key And afterwards? looking forward, And what then Thank higher how that on the are be bar? question to

Dave Hering

Yes.

that it talking That So, yes, based analysis about Phase are titer be we what it be so data XX. saw X, would the for on day we from preliminary an said, the to values. the in year-end, similar will around

are So, of the data from that it’s on looking values. Phase titer to based X, X similar be getting some in high to slightly have we the and but X, day equivalent provided we A repeating seven Cohort we for there, Phase different preliminary everything but data. than that They don’t it’s Phase terms in that this of saw

Phase an so in what you would EUA expecting the for that confirm what need data. have CANOPY. are we after, see milestones in clinical seen right, X And we and Key to submission,

preclinical more CMC, etcetera. need And to certainly, activity, we even it’s cases, can of to believe hospitalizations, we set an all provide something that starting that information as we are fall this uptick as information, in possible increase clinical etcetera, the guidance rapidly. You a We we an certainly, of we prior are and see will and But to etcetera. closer get to in as season. as COVID quite do quickly assemble especially looking winter

as and can. where are are that it’s no lost we time essence one we And mAbs there so situation on looking quickly the market, on certainly, not to of rectify as the us in a is that

Unidentified Analyst

so you much. Thank Great.

Operator

next question. for The from H.C. with moment next One Trucchio question Wainwright. comes our Patrick

open. is line Your

Patrick Trucchio

the and afternoon, I congrats couple follow-up of good progress. a on have and Thanks questions.

if different with talk VYDXXX just this is variant? we can seen you to first I so The variant, XBB.X.X? would similar have these What is activity of the EG.X. expect new variant to retain against How cases COVID-XX? or COVID far And you am this about wondering

Dave Hering

Yes.

innovation I piece, one see is I to That’s continuing critical which of the continue first we guess expect the answer, the we to right, continue why On update viral mean to the as which the most etcetera. strategy, antibodies, we is to evolve, components virus see of right, serial evolution. Invivyd

it looking seen activity are pull on belief EG.X, vitro it in we cause what reduction As a our to it. have so based VYDXXX. to wouldn’t relates and far, on we significant data But in to that is get

etcetera. from will have a so it’s have the a not said, do And additional that at which think progression take we now, do we now confirmatory the some look that variant summer predominant I unexpected. test, is, I into and like seen

of at look specifically, surveillance specifically even and our before We so continue predictive to do designated become side on variants. and modeling a mutation they variety

ones And different so would do start start that’s to we like and we against how we against, to which eventualities. continue look at to prepare bring those what to assays test in how see for coming, we

emerge. really, Invivyd and like assess how have embedded I as the then that’s to to is structured and So, our variants they different strategy into said, in respond looking

Patrick Trucchio

these And compared schedule you Thank what about of to some advantages Cohorts methods? Great. and can of And very the perhaps primary from you you some antibodies of And to endpoint point through for development the channels or the are contracts then the to primarily of And relative just can at to other for just and for then those talk be would that of about XXXX? VYDXXX, the be to approaches? a dosing clarification expectation of traditional advantages lastly, you A or commercialized question. end can COVID-XX? us sort Is potential B much. talk others have both in VYDXXX data government this

Dave Hering

take government contracts. can I

expecting the we of You the to the year? at want data endpoint from the first around primary preliminary take end are

Pete Schmidt

Yes, good a that’s question.

neutralizing titer exposure the data from just to Cohort So, we for our that an that increase There, safety need the understanding and don’t needed serum the B. is EUA. group plan actually serves database,

the just the compromised A. see cohort, be you Cohort will immune will So, from which is preliminary data

Dave Hering

and environment not government our the we related about related Yes. for really on readiness contracts. putting contracts anticipating in contracts, commercial government to of primary source are much as based current terms question And to then transition, your government the

in a your to reimbursement activities preparing are for We related market etcetera. and traditional market, payers access,

pandemic in launch for different the That a of that said, of we and traditional Congress acts Medicare, variety of team preparing for being coverage now took during for really And the etcetera. that a a different focus so the potential that’s as do market. the and provide reimbursements things ready are

And all those. so we of continue to look at

as So, for products. we during put COVID-related been government there support that of is even contracts, a pandemic, still in saw place variety without the has

one is a relates affinity quite a it for of looking reengineered is antibody while process this of the things we have the XXX advantages through version our that to and BAX, As at saying backbone it Omicron. maturation of BAX of we VYDXXX, ADGXX. And did an been did original

set slight where And changes, able to came a so with binding a of a, from amino acids, reestablish lost. survivor. we has SARS-CoV-X ADGXX were ADGXX

And has that setting. neutralizing natural so that in to to-date, that, not see an as we and activity really we continue XXX a occurred has broad is one antibody see

feel And us of so activity. of higher duration probability we it a provides that

And look critical and advantage, XXX. able hypothesis we that’s to test, which but have so to we the think for most at continue activity is that’s being as what probably prolonged our

ADGXX the Beyond the that allows advantage. well adintrevimab, quite that utilizing as platform significant this to that, continue see by to data, a we be

said, full to that clinical that’s companies Invivyd an than as patients. in we As could studies, who fashion few and much a faster utilize running to And previously. is quite current data pursuing a advantage was endpoint existing we the recruit especially relates see done looking it given that EUAs environment one of

Patrick Trucchio

much. so Thank Okay. you

Operator

remarks. closing showing not time. further over to the am I And I questions turn to would for at any like call this any Dave back

Dave Hering

our support as thank that be call to much. look for would We milestones the your coming interest shareholders. and for closer organization very for get all will with a in you to believe we you and we up we days. you forward exciting individually Thank and Invivyd, It’s you over quite any joining so impactful time the today. catching for Thank of Invivyd continued patients,

Operator

Ladies conclude does this presentation. today’s and gentlemen,

may You wonderful now have disconnect day. and a

Invivyd (IVVD) 10 Aug 232023 Q2 Earnings call transcript