Invivyd (IVVD) 11 May 232023 Q1 Earnings call transcript

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

Thank you for joining us today.

Before we get started, I want to attend to a few housekeeping items. I invite you to review our press release discussing our first quarter 2023 financial results, 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 fact. other and landscape, cash commercialization ongoing and these runway are research of clinical plans, plans, the development plans, things, opportunities, the statements other

introduce to cause differ a joined to number call. Chief from that, of Schmidt, Driscoll, and our to the turn Forward-looking Invivyd actual most implied are Financial Dave XX-K. It by Commission, Chief Fred may the With call results under the or recent statements, subject to Invivyd; expressed Form in heading management I statements forward-looking Medical Risk the the to with is including and Dr. including materially am Interim U.S. CEO Officer. made pleasure described now uncertainties those of Exchange risks the Hering, and our Factors Pete that Dave. in filings will Securities Officer; team our I over those my

of therapies perpetually update thank on Welcome. devastating threats. joining antibody-based pipeline capabilities the and update discovery Since circulating and deliver viral and on continued of us to our our vulnerable as you development early to VYDXXX our well mission rapidly advancing of the call, last Invivyd. as support and for strides great protect consequences our Thank overall from designed the call, our we've made your progress quarterly today for you significant candidate, lead

the development the of conducted as people. At neutralizing in of being I swift monoclonal prevention of announced making first progress end a vulnerable are with participants in populations antibody Phase candidate trial VYD-XXX we the our dosing Australia. broadly clinical in in for the We such March, immunocompromised COVID-XX VYDXXX

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program we and Before I call hand to brief and field regulatory cover overview on need Pete the I provide for therapeutics to overview strategy, are developments provide VYD-XXX focused of recent in COVID-XX. new speak population for to patient the over strong an a the will our our of unmet the that

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perpetual X innovation has Our pillars. key to approach

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advanced adintrevimab, IND engine first from XX candidate in data trial we from our The pivotal clinical to months.

now. trials development package. of robust previous to is is leverage with Our data unique aim candidate, from which safety has will clinical a adintrevimab, published meaningful the monoclonal from second in discuss candidate, clinical protection to III is results development faster VYD-XXX, VYD-XXX. Phase including antibody much with engineered research because global Pete And recently and move our demonstrated shortly, it VYD-XXX insights in of correlates experience landmark clinically adintrevimab, on our our we

recent proud tremendous to on progress VYDXXX the and our and have discover engineer keep characterization. I become discovery drive program. This of provide to our we I the new Chief monoclonal have to further forward respond now can Schmidt, in antibodies reflects viral who robust these candidates Pete will continuing and the am antibody anti-SARS-CoV-X continuously antibody multiple of pipeline for our speed be urgency update months, call pace preclinical populations predict look with to VYDXXX, that pass evolution. we to with nominated in Medical and they vulnerable made the before advance an deserve. I variance Beyond will monoclonal concern candidate additional to our leveraged clinical an that and discovery variant forward and Officer, recently work to strategy mission

Dave. hanks,

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optimistic address the immunocompromised our of ability COVID-XX, turn will and need I novel financials. individuals. With are Chief Driscoll, the Invivyd's our to discuss that, approaches from about forward for call Interim for to Financial path over our who Fred particularly Officer, will significant therapeutic We here prevention for the

good wind-down R&D manufacturing and attributable XXXX costs to trials. the commercial compared respect to XXXX Pete, lower quarter costs first trial lower contract by and clinical clinical adintrevimab period manufacturing were $XX manufacturing costs is for adintrevimab commercial due million with decrease afternoon, in-process comparable no XXXX. driven expenses, in R&D, to of in including for of the operating the This XXXX million Thanks, comparable everyone. of expenses, $XX to With

XXXX call expense was consulting period for partially net of and share fund operator, expect we and of in period cash, of $XXX.X $X.XX offset the comparable costs, SG&A the company million XXXX. With the compensation first questions. the of plans, professional to to compared million in loss were to comparable our please comparable for reduced $X.X operating open first increase the $XX.X compared loss million XXXX. in for in $XX XXXX This million by Our fees first public quarter is the diluted attributable Based the The quarter net cash XXXX. marketable equivalents for was quarter for lower expenses of XXXX, our per for operating stock-based XXXX. Basic costs into excluding associated current VYDXXX enable any expenses, will second cash the revenue that, company potential $X.XX and with its $XXX the of the for to half on quarter compared million. well-capitalized period We exited with XXXX first XXXX. to securities

question first Evan Our Instructions] [Operator with Securities. the from line Guggenheim Wang of comes

progress the on Congrats and completing enrollment.

is in terms a highlighted approach you progressing? how design III how is Phase I of proposed you And but into that once ongoing, how you a And them guess, know recent move wondering III I interactions regulatory I design? quickly III you of potential data? agencies, with with finalized? some Phase that's can currently Just can aspects quickly Phase Phase Have preparation

you. all Thanks, the news little have from the that design about I we the quarter we're for pivotal So right? participants. the cohort a excited more, finished part and really A we Phase Yes. our Evan. hear dosing bit Great study. the III IND, Yes, Phase submitted as of to

So and we're that. waiting that certainly excited for about

ready previously, clinical As that done amount I've trial. and of we've a work be to prepared for mentioned considerable

ground this individuals to potential got in we're that from that rapidly able the Pete to time. waiting then call, that be utilize instead at for looking of in and sort even database and point zero enroll we've As mentioned of of to immunocompromised starting trial

elements of the underlying vulnerable cetera, our lined is seeing quickly possible, that the pathway in all to plus all and is the as approach, that that, open. as up, CROs, do this place, in be part populations continues So trial material the a made, still which to different need et being of clinical EUA remains

and ready so Pete, anything everything more that's from can different these eyes cross, to teaser the all smart the the this desire start. of all completed to so at that once possible about supportive is as our clinical we be and your and dotted preparations And and really preparation? on quickly are do side as be

Yes.

milestone the well course, have some but data dosing quickly that about III, a here completing of concerns the we provide will as big Phase Dave think Phase I as have we from to I because, no happening is initiate said. to

how confidence And how I thinking had able III? and one in pivotal follow-up. dose guess, I you to this a quickly XQ in dosing be go-forward decide give the for on will Will read about initial you're dose? a Phase

a it's question. Yes, great

The read to able having that of decision the X dose concept answer be see early But from have quarter. time to is We on Phase you'll we'll submission. on decide of first yes, there's at the I this the part later dosing. points dose from flexibility also the

why the studied the the because changes antibodies evolving, as know, time. that's So against range this we dose we virus over is the potency virus of

And so able we the decide time in then of pivotal to be we go trial. with the lower submission, at dose a may

So we're kind for door multiple open of leaving the there. discussions

I I and be. exciting gives we of what data, know, really this curve, the that the these us SD&A a initial read that's the levels would thing paper which, fall you that to where view tighter an talking on we're think would readout to other related about us I that as based they this Phase would get predicted early we give correlative on published the would there which is add only about for protection efficacy

some which appropriate make new most at the model time, us dose. of apply that the of throughout determinations of and can those circulating concern will back so looking also influence this as is are we period greatly And into and variants assessment well as whatever

line H.C. from the Trucchio next Wainright. of Patrick comes Our with question

Or virus the would a VYDXXX. earlier you're earlier -- serum And of the new readout? data would for data from that looking be programs activity for good be this that there Phase is data to initial a neutralizing variance follow-up look Just data to? antibodies? those sort for relevant new on given and us is in less I What's first this question, comparable

Yes, concern. contemporary it's of a anticipate great variance against data We the question. will be

So valuable. not programs or at probably previous variants as looking previous is back

the the just if I'm us for Phase of progresses the kind assuming would authorization. as that use wondering And expect. program you clarify can emergency of you use III

like to to look continued needed be from that submission if when Specifically, or submission And ensure BLA what process the potential would a of time authorization? would access. a

continue that part, We fall under have information from clock, the specific any first is So done in but have lines, EUAs, unlike part very we've dates certainly, companies on that the doesn't right? FDA So we time the emergency course, PDUFA set and it filed the EUAs have a timelines. past BLA the see that, to It's an review when don't news, that period exactly that news good but other quite seen being is of exist. the a bad which quickly. doesn't use peso clock, of

months And along data continued authorities past. certainly, and the be is in with way. them conversations in idea regulatory And the providing so in seen the we've to it

like And But on and I pieces so I from insights. they would what's is know, need no or certainly for any them. with have fast no it hard package. this. market, an them antibodies certainly not understanding there's other that the on products lost in Pete, the coming others, of don't mean

of is certainly a indicative review. be quick And to would why us that there so

designed. the the towards Yes. And I intend EUA criteria trials sponsor currently written, a BLA. continue as are to need BLA, And our to Dave. develop terms you of completely to are in as agree with

we safety you have follow-up. As a know, long-term

support designed as are a potentially BLA to trials well. Our

what ask I approach want approach confidence last in what to of if openness antibodies additional helpful. the Or already But What comments this endpoint FDA approving see Yes. the for about trials the just might further data data surrogate regulators for That's in one, are may would give -- that I maybe new to might earlier the appreciate for? additional with endpoints. may. on And ask they COVID-XX surrogate the one setting? they the from then running

question. good another That's Yes.

markers. studies. a our endpoint, And the it's that always endpoint will not that clinical the this anymore. endpoint difference will to generate data do there But is we continue to all be secondary endpoint of primary supportive confirm clinical anticipate here portion of surrogate So I and our primary others

Our Michael comes next question with Jefferies. from Yee

on different What what biomarker. your Jenna the We for And would talk This level want a SCNA the doses? on about could to is Mike. biomarker? expectations wanted see you to on follow you are of up reduction for

Yes.

really protection. profile is what in about of X talked a least at from provide goal is past we've months to So and product target our the right

are infusions care. highly inpatient receiving groups are vulnerable these and and are of Now a variety currently who in outpatient

in symptomatic earlier limited functioning with emerging populations that's who as the can prevention properties disease, so populations, fully In what the bivalent systems. terms vulnerable and vaccines for frequently. I well, that said showing data immune patient And they're mean have with I of anything these with we really in against folks are looking and speak protective them help

would be between And of what where look see in and trade-offs duration of we or so terms at getting here can make you some protection. lower is and really dose providing predicted a higher we

titers And shown between and clinical of And curve. SBNA at. are correlate linked the efficacy again, publication, these we're studies looking so things that that has made previous is then from specifically we've those this the and in that types what

have curve, to where on none. and And looking you those to usable we're so again, are what and people provide, that's see who comparing really you currently can products against that very

no questions the for closing like Dave There at remarks. further to queue back this time. to call I'd are in turn Hering

for Thank today. the you all joining call

technology. strategy any thank look up catching you over are believe forward support and days. coming potential establish and realizing of and continued in interest that near-term Invivyd, has you individually transformational by success creation period for to your the the you we We Thank of the much. We and value our with and potential to so long-term entering a we

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

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