Invivyd (IVVD) 10 Nov 222022 Q3 Earnings call transcript

Welcome to the Invivyd Third Quarter 2022 Update Call. I will now turn the call over to Kyra Faircloth, Vice President of Government Affairs, Advocacy and Corporate Communication.

Thank you for joining us today.

Before we get started, I wanted to attend to a few housekeeping items. I invite you to review our press release and the Q3 financials included with them both of which can be found on the investor section of our website.

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

Forward looking expectation statements variants. the and future include of statements concerning, the emergence landscape among COVID-XX including variances the new of evolution of continued of other things,

file ongoing implied for plans the call. from Exchange Other other and our It cash such clinical those infectious timing and develop made therapeutic other pleasure my development expressed the resources are cause our the the is or differ may our to the risk with in runway, Commission, are that fact. heading technology diseases, including under factors management now factors and to and not statements or filings research of Our today. in team welcome described results including to report plans, preventative to the our Securities historical that statements options expected actual Invivyd most U.S. forward-looking quarterly recent materially

David and Fred I'm joined Chief Officer, Chief Interim Hering, Walker, Laura by Officer. Financial Driscoll, Scientific Invivyd, of CEO

call like that, the to Dave. With turn to I'd over

first Officer, Good a our be to company as call first earnings different be third thanks as joining just so Executive than call our my little call. agenda be forward. It a quarterly and Chief for afternoon, quarter may going and happens public Invivyd will it

opportunities. , will start back about my Walker activities. for term future. enthusiasm CSO come will ongoing to our Invivyd pipeline then a sharing and like by our I'd bit our Laura I unique and near Specifically, Then talk describe capabilities, in

open line we through our are for will any interim our happy results financial walk Finally, after Fred questions. Driscoll which the to CFO

will up one or glad be one call. with As on analysts follow we always, following this investors to

role and was urgency which products allocation was worldwide the COVID situation of I vaccine development. sale broadly portfolio. the and you responsibility Pfizer of the an involved may the global make joining vaccine mRNA which the Being for COVID-XX mRNA head included mRNA production vaccine, future to have U.S. market prior of effort the vaccine at prevention the is in Essentially, franchise the Invivyd my and ability operational recall, to now that privilege, As for important leading the medical available. a great the and given for the in the

At the other humans vulnerable populations, to vaccination. to always neutralizing vulnerable antibody After to be made the quickly, would to that infection. titers of vaccine two time, same may immunocompromised the SARS-COVX it weighing was people practical all, well SARS-COVX as respond rendering there limits benefits provide or repeat in especially response relatively all not who clear for such infection to natural

scientific Over and thoughtfully the broader antibodies. the therapeutic year, learned challenge have past discovered the community can most we, even evolution viral that alongside prophylactic

rise been variant to past diverse now and The system distinct new this immune adapt of human human and moving to human dominant years have a presenting of then three evolving pathogen, naive areas, system swarm. a first the immune experience through series

to all available of set the prior prior the These public swarm human infection. convergent mutations are is challenged exerted this As evasive or scrabble antibiotic increasingly lineage pressure called somewhat Omicron and mutations in vaccination convergent titers predictable immune coined immune in by therapeutic. commentary commercially induced of increasingly and viruses, so acquiring antibody and relative face vaccine currently

and candidates current in that to-date retained our late all of discovery concern. activity shown pleased have stage against emerging are variants We and vitro

COVID-XX a pre-Omicron largely challenge company to with molecule. meet the single attempted Previously, the

proprietary evolution through platform. use ongoing by the our So has this we design mission company, and of been created channel In with meet contrast a to innovation final

occur we aim at offers pharmaceutical that very and viral way, antibodies that viral properties beneficial possibility meaningful zero And engineered responses. natural the escape, potency, make drives us it this antibodies resistance Our to makes or the such human integrated outside low high pressure frequency as in discovery quality platform immune for to escape.

position Further, our able going believe a ourselves what the of developed antibodies for single to we, of and use rather company about efficiency development overall forward. to is discovery is and any the potential our as expected our obsolescence of platform that anticipate Invivyd most platform being important one productivity particulars and antibody the than

We allow license be molecular in our technology speed from and to utilized proprietary [indiscernible] will new corporate underlying diversity engineering. for believe discovery in our unparalleled laboratory

Our pace the our requires with and is plan, and over evolution to years viral get to of continue COVID-XX. deploying speaking, indeed broadly keep with intent as innovate to technology the ahead coming

I Laura development our review recent to will and and progress activities. discovery ask ongoing

for our ability our to are indeed Adintrevimab the concern, few SARS-COVX. founding broad monoclonal on target now time with describing as Invivyd. an our divergent hypothesis, emerging that one or SARS-COVX can number This one exert binding Adintrevimab XXX. such variants, in acid version clinical of development. relatively former clinical of we've forward backwards We its subtlety, in the we more SARS-COVX reengineered receptor and antibodies as a indeed anti against combination combination, that is and properties even RBM Steve. our It's amino lead studies we with rescue towards molecule. variants proprietary of neutralization or changes, monoclonal well Recently, as to nominated for which domain that evolve announced its as these sites through of is reengineering exciting look But Thanks, that of lineages beta prior activity important are NVD development, we further, calling as sub viruses before an advanced Omicron to and multiple a RBD supports there to SARS-COVX

our discovery variants. in David candidate antibodies platform to potential of viral novel develop as mentioned, SARS-COVX a engineering, is against well utilize integrated with and suite plan best our threat ongoing anticipate discovery antibody to of the early As class ongoing evolution, that as emerging stage

track a engaging viable of for health antibody with of candidates variation. global of months, weeks late stage to that in end, to authorities discovery forward To preclinical announce steady XXXX. on half is stream have viral coming we look therapies in today the the are we face for patients first which vision, in on multiple Our that activities anticipated plans the in pleased we that or

on target SARS-COVX two molecules the our MBD as other been of lead within recessive shown unique amino this well therapy. have components Each represent to that combination, to site as binding in our vitro candidates on distinct,

different, subtle, In or varying see, neutralizing those differences may important strains. potency addition, sub variants differences all is simply, be embrace out and that to shown ways interact Put with lineages, in sometimes have unpredictable our view different to the of in to across perhaps RBD currently forward. that they SARS-COVX important and appear going in inaccessible turn and the be swarm we vitro ways

In along will was evolve into toolkit continue rapid a be a for demands. addressing hope potential with these unique backbone continuous, map, for candidates, will rather broadly, what both additional academic studies to each be and [indiscernible] development is growing represent to anticipated like evolution which antibodies, re-engineered we engineering of treasure our hidden and

conclusion, a rely single experience not uniquely In may to epitope from integrated targeting single is discovery platform our escape. which that molecule on a follows our strategy,

antibodies access rapid viral engineer face such in instead, discover even that strategy continuous, and have breadth in high Our evolution. patients to to of sufficient protection and with need continuously is initialization quality potency, the

competitive a potential platform by believe advantage in discovery caregivers, for our offers provide need, to and durable benefit in health to COVID-XX. unique this a We and ongoing effort authorities the solutions imposed to distinct global the searching integrated patients burden

Laura. Thanks,

a potential in believers all As in that have platform heard the development value protection we need. are for high providing firm you to to probability high of generate our antibody candidates populations integrated

polyclonal protection, describes very a the and by for out protection varying very currently levels of colleagues symptomatic disease antibody neutralizing and monoclonal levels vaccine titers that of by antibody is recently and a both tight archive, relationship titers. Regarding paper other antibody from COVID-XX in that varying mediated Laura neutralizing review between induced

This potency, included corresponding setting clinical outcomes fortuitous patients of pre-Omicron sampling has have in outcomes. participants virus vaccine of both post-Omicron the study with prep neutralization in and a different paper trial, in and timing across draws a recent Bebtelovimab clinical scientifically across on XXXX. controlled pivotal Bebtelovimab from studying which The study evade our and recipients

vaccine experiment work That assay mediated the titers, embed vaccination and by provide with protection assessing natural monoclonal companion mediated from study a all for consistent a in disease unique from elicited performed on by data, relationship disease along between protection antibody.

monoclonal found broadly replicable target results. about titers The out Obviously, and antibody protection a correlation a vaccine monoclonal post underline to the is our the hoc mechanically intuitive unusual whereas within antibody immune an by engages turns that neutralizing antibody analysis be they specific system observations biology. titers. highly neutralizing of is What is vaccine its

by that that a potential from suggest It monoclonal antibody protection these combined falls the neutralization symptomatic for is on surrogate data is neutralizing afforded within the protection belief nicely antibody also pharmacokinetic associated paper curve by found the of disease. and one marker afforded the with from dosing analysis fascinating any that information symptomatic degree by shows vaccination. of degree protection our described of a monoclonal disease The potency,

the reverse data under clinical you potential monoclonal many that on COVID-XX titers against be have prospective FDA neutralizing of evade data, clinical as which [eway] a Further, has correlative first changing provides variants, protection. pathway controlled with potency the of neutralization antibody based or viral dealt corresponding against -- without a data represent trial stopped distribution routinely of from antibodies has a consideration to a using the

produced consistent clinical The is Invivyd IgG, biophysical consistent at was generated a least company, high implying case ours RBD, observations a in antibodies with as by in protection the such of from of that leading that directed work against finding is other correlate. consistent principle

to that COVID-XX. and is and look antibody more perspectives forward and all sharing these data regulatory and belief efficient broadly. approaches are seeking to more patients, Our authorities rapid our we development global And caregivers

goal protective serve the We potential future. we and viral anticipated current on evolution that to planned benefits industrial to big and the our our not so and create our demonstrate In rapidly platform program, clinical patients continuous able through forward to doing specifics molecules allows therapeutic in and look process share the is innovation a and are future to picture near yet requires. to of but us

the perpetual health wellbeing. and While represents human SARS-COVX toll unacceptable some have an feel on declared over, we that pandemic

XXX,XXX From and moment. our being to are move reducing the that will an Invivyd we committed world to business fate. the How lose COVID-XX mothers nearly According important we this for opportunities approximately CDC, disease those year from imperative something. XXX value from people beloved can are vulnerable. dying and a for U.S. we we grandparents, is It of state now, we this COVID-XX is our a members, continuous virus about fathers, deaths to we other a is is unless family solution right that forward create in as that shareholders, each future. most differently spouses in of our do the nation for if think innovate day part the to each as a and toll reduce managing approach the perspective, tremendous see the we accepting of

represents billion prevention billion $XX COVID-XX to Annually an treatment $XXX and of market.

portion in COVID-XX class antibody ongoing Our to is on which goal approach platform with to iterative in a solutions of basis for an beyond. those best we our and strive revenues capture develop

that, With discuss the results. Fred the call over turn will to I financial to

good and everyone. Dave, Thanks, afternoon,

For million for XXXX comparable the of RV million operating quarter $XX.X to the compared to XXXX. quarter third $XX.X respect was of with period for expenses, the

partially related wind materials XXX trials. attributable in studies and activities. clinical of expenses manufacturing for by and non-clinical is increased the use offset down decrease contract production clinical to to was of The adding the This manufacturing the NVD decrease [indiscernible] related planned trials

million of million quarter for million for the $XX.X services, XXXX. were Our period The third in was third is loss to third $XX.X costs, Basic professional the related the loss comparable $XX.X expenses. quarter increase XXXX personnel quarter the higher net period in attributable period of XXXX. was for compared net to for $X.XX the to comparable XXXX. and for of for million $XX.X XXXX to diluted per $X.XX the share of XXXX compared comparable company SG&A expenses and This compared public

will position equivalents cash marketable cash cash, our expenses on quarter We of strong company current second fund in of securities enable into exited operating the Based balance third our with to XXXX. sheet the plans, quarter operating the a we $XXX its and million. expect

we are on we working cost our complete approach and plan a zero once update runway close budget for looking said, budget, cash that and opportunities year to fiscal our efficiency based guidance XXXX. XXXX With our currently

operator, call questions. that open With please the for

question [Operator line Instructions] of Yee Jefferies. from Our first comes with Michael a

Your line is open. now

Mike. This afternoon. [indiscernible] good Hey, is for

find forward moving infections when design to be that be NVD going may of or for of with they're One, clinical clinical new the are quick COVID about planning kind two challenging questions. thinking Just to XXX path you patients vaccinated. what trial given highly kind

question your bit a And in of how about XXXX is talk guidance clinical you. you So terms up, my forward moving ramp second trial are that. then to thinking etc. about Thank

question. thanks for the great, Yes,

know, even didn't done, that it's looking global And here partnered a you exist very have seeing how As space. three they've is past what we've a doing really recent sponsors one fits all. with ago. Invivyd programs what in that years how forward, they bring dynamic One size regulators and been not knowing it's at

we studies is next data while NVDXXX, we be the specific be clinical we which year. provided calendar will year have where in is yet ongoing phase this rapidly. what guided, seen one So done we to are, And we've haven't And throughout it on relates we of QX anticipate designs, guidance do as XXXX. can entering clinic these

And that unmet given the apply our years urgent from as to companies well learnings the had in space over need. possible last is and we've to do this goal we've other quickly learnings as few as this as the seen

you. Thank

of comes with Our Stephen Stifel. a next from question line Willey

now is line open. Your

can you me? hear Guys, Hi,

Yes.

Thank this quarters. you for is [indiscernible] Stifel. the Stephen Hi, on congrats and taking question at my Willey on for

have just NVDXXX. quick regarding a I So question very

are know, there given newly name we as So all you [indiscernible] that etc, so variants, emerging like, them.

newly neutral variants, you that at But manner? activity XXX can guys NVD with just emerging guys know just comment exclusive qualitatively against I of these in qualitative you on So least a you details. comment cannot can, neutralization

Yes.

Of course. that. question And for thanks the

becoming and market treatment it's that incredibly the reduced antibodies seen, showing. the we've need, again, seeing for an are As that of both left pressing once [indiscernible] activity on prevention are

as you've And our that we're you it and mentioned and in we late so, retained validates ones our for that shown NVDXXX about as approach NVDXXX, and in as so mentioned have well asked stage we this upfront are that have candidates, beyond as specifically us, current as really on pleased vitro focus that there. I these all against testing, platform, discovery far, commentary, variances our have in activity the emerging that

singular because what we to really of from was And fascinating to previously, it's a space, saw gamma. beta this change virus alpha sort

of scrabble been this Now, variants. we're in it's as what seeing put the is press swarm

new so focused just not we that that our And and underlying we for us, areas of really antibodies new for even for today. and so mining critical where and it's is more one antibodies, utilize feel differentiated technology the we why engineering, in searching are excited for we're that is critically

thank Okay, the you. receptivity related second more would And to the question of platform. be my

been mean, evolution you like, like know current been like, I it's the guys I of observing So have variants and changing. just

So of, rapidly. kind like

new emerges? is come candidates you potent guys say any capability like three time? So can novice like, have like more with quickly you, current like, maybe like on next if with let's guys variant if your months, there how like, actually you idea up Like, more, like, can how –

listen, successful of game, definitely what company I is Yes, And name the on is that I has the speed focused key been to-date, the say right. would incredibly determinant. mean,

them the even slated results, curveball that than So We less candidates, the candidates, to with created half a clinical again new have of company's from to meaningful and and year years change. have data our demonstrated the already into clinical put in two not Omicron, forward go old. manage clinic generate a ability

right. is on And the observed the instability is that so from built and company whole now that been focused virus,

we've mean, changes. fast this seen the how and virus I evolution

for eventually but obsolescence as have it other the with will this And virus that not them. as that move past probability will so just is what antibodies NVDXXX, the planning well platform we're targeting

rapidly that's to do so we're to focused And this continue where as as possible.

the is to certainly ahead more we that up variant. we of to stay that sure And how showcase with come, move as set in and that Invivyd we get can speed will mind ahead forward. was But make that

All much. for you Thank right, very great. question. you my Thank

question the next from Guggenheim. Our line [indiscernible] Instructions] comes of [Operator with

is line now Your open.

FDA surrogate the with with discussed other gone recently? Just Have marker the Hi, has question. wondering by how guys regulatory the for you Laura. guys. the regulators Thanks and taking conversation work Interesting agencies?

Yes.

had think have but a as in talking we our do get covers website. We well, looking in But comment community. which something really is, And this this for And that published, how posting regulators. for critical hearing be we don't broader is eventually it all noted about, lot on, specifically these scientific the it global we're it approach we're say it we've is to what preprint. increased we available of and components with the to have. the etc, is need are speed. we virus We're being products have So data, that situation continue that certainly the conversations speed populations in knowing of is that that left we can immunocompromised now this that We'll can underserved generating that paper are on these with archives. on available the in particular meet current we huge that seeing

come about really and forward we've and come done are we conversations, to having excited months with weeks work the that up, scientific to paper, we community. weeks regulators scientific the and this well and to So broader that as both as months look with this recent global

versus have thinking treatment one should up. Thanks. side? prevention I the about prioritization follow patients How we on particularly for certain just available opportunities, lack of And of Great. be given prevention options

their to immune group the they meaningful in really certainly working as lack of would they immunocompromised. particular the mentioned, left still which able see We is responses. were opportunity like This and prevention their be perfectly, populations underserved, is create that not, if immune a vaccines are Yes. I critical for most systems being given even

[indiscernible] seen continued certainly there that us, numbers, continues the uptake, area. key continues which then It's this grow. with necessity their announcement even the just And grow one that is with today, that so QX and to and for we've to

time antibodies a our in anticipate priority. being utilized and for treatment that highest and continuing prevention we've what And we so certainly shift it's seen is over into

guys. thanks, Great,

I'd question That concludes back David the like Hering answer to call and today's closing to session. remarks. for turn

so us you earnings all today. our It Thank joining concludes quarterly much. you call. meeting first thank for for our for And

As the up one-on-one one analysts thank follow but with way, you joining. always, to after tomorrow, we're for all or call and tonight investors happy

Thank This conference. concludes you today's participating. for

disconnect. now may You