OCX - Earnings call transcript Q2 2024

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Operator

Thank you for standing by. My name is Rochelle, and I will be your conference operator today. At this time, I would like to welcome everyone to the OncoCyte Second Quarter 2024 Earnings Conference Call. [Operator Instructions] I would now like to turn the call over to Jeff Ramson from PCG Advisory. Please go ahead.

Jeff Ramson

highlights. thank call everyone quarter to results recent and for joining XXXX Rochelle, and conference today's discuss operating you, you for to us financial Thank OncoCyte's second

please If visit prepared you've build information letter. this the shared upon today's not shareholder remarks investors.oncocyte.com read it. seen to Today's in robust already letter,

future the and Private The I'd go of over company's required actual regarding or our including turning materially. Securities over law. OncoCyte Any provision update expressly Litigation which to forward-looking to Before events. Act XX-Q, make of results President and XXXX. be and harbor differ the made OncoCyte Reform may harbor the applicable are like facts any otherwise statement. as company to that review the SEC disclaims Forms or call company's the CEO, of will cause XX-K projections meaning We may under Josh risks These to and within identify these except intent safe that filings, not to forward-looking future Riggs, forward-looking are statements statements, safe pursuant statements to statements events the historical you obligation are statements. encourage

now I'd Josh turn over Riggs. call to to like the

Joshua Riggs

Thanks, thank Jeff. you Welcome, and for in. tuning

on Officer, James. Andrea the our Chief as Financial Chief Science us have call We today Schütz; with as Officer, Dr. well Ekke

initial with feedback until is in you be out to customers. but we're your and our GraftAssure great able had It's our beta field, expectations. the is of confidence successful to the product the know exceeding into getting launch We announce really never launch, that going commercial

we've low, we research Bio-Rad. meet this product the to X cash launch pillars to things: up commitment Those GraftAssure keep are and were to with set And and say channel our done year we we happy that going burn our product we all which from X X, are us As earlier met. made we said thrilled a the a and partner. to pivot welcome year, partnership in investment strategic our QX, started last beautifully to produce we do

expect IVD and maintain the on the to up focus model, in market. in an us exceptional Germany, deliver transplant U.S. deliver X Success Going a disrupt capital-light to product margins. and site to market sets testing forward, we business the and adoption all

like Commercial I the amount the and Our the biomarker don't explosive has care in that and believe model, questions central opening field nearly exploring research And been next and up, want an keeps the to double the more that done ask. which with of lab our we in been responding. support we is this market, we that accepted customers standard research. clinically yet see more This product Head We just believe years, to DNA. over they all talking or the of out using and a have more not research been community it's partnerships. will cell-free you the triple fully disrupt, with flower It's of has the engage and able is research reflective to growth donor-derived of the aim how few

to research a centers a today. there of out are institutions unanswered lot giving our meets field pediatric of paucity these research is questions really the first going early our patients. of and the it are in need. a studying this feels space, sadly, and in around transplant seeing adopters We that that Putting market there good. And there's one research one jump access in a real of know tool world And

but the for research OncoCyte, opportunities including in market serves it not research use. also pharmaceutical new Empowering more only broadly, creates

which HI-Bio, that in the with of trial published of results for by see kidney were to responses which innings to New assay can the Journal the anti-CDXX VitaGraft You of their Phase clinical therapy, used England early our the monitor Medicine. II

second then, this for Since study, a were anti-CDXX blood case for antibody-mediated therapy able a Kidney working the ability to was drug identify monitor given that series antibody-mediated test. a In to rejection. and second publication shown to to patients treat response daratumumab was has off-label VitaGraft simple the rejection, with

dd-cfDNA speaks publications, partner signed letter shareholder In in to second an biotechnology you the we agreement European provider addition the a to choice. of leadership seen II to market growing with a Phase trial our quarter, company. in research and think that in the of these this may testing that for be AMR have We

recipients real the by go that they into human the I lot not when consider with here back as companies that Many to organ the potential to world options Before go And experience to organ the on, condition. manageable happens, and transplant a humbled pharma. eventually antibody-mediated and pharmaceutical lose a for on it's kidney are even And there a study or there's element may historically, turn patient. problem. important support rejection. dialysis we're of regarding doctors die, They partnership a sentence problem death solve and opportunity serious from an or rejection ways an

technology available can antibody-mediated very be once problem the important that this will has are can to drugs detecting disease. course, treat that early, Of do, which rejection solving shown data very our

transplant, field. company small in science in largely the pre-revenue a and than an of of research are more years we we XX are sit upon we body still and though Even established

investment time XX, clinical our the long OncoCyte generating. research began lightly. been technology, of on the bring using in that data the time for because It's a are it's outside you don't with what have And of excited, are workflow. like building. believe commercial that We major We're take we as front up this the GraftAssure. significant researchers a for they they labs in letter, They July saw to out first shareholder up resources, signing and and effort are we in it

IVD send-out an quickly routine want so model, us, IVD the only in site, tests. with by of [indiscernible] technology. exhausted be and that to technology. access easily they are like test building believe They work and on to power test alongside can labs these rejection detect transplant that that believe want in We they they democratized an the They, to able and run want to us

with sample product. program, our get using switching product they to revenue-producing In the some start to comfortable launch assay before over

of our than key expected As have launch much shareholder would we in roughly into nearly of U.S. letter, weeks GraftAssure, that the markets. commercial represent we transplant Germany, percentage and have volume This RUO is and with are the an pointed out in launch X about X our XX% we product. faster funnel transplant in we and the the centers exceptional same

support in test well saw our to year enthusiasm support compliance relatively confidence to the submission submission consumables has and back QX up. in commercial an FDA some incremental include necessary bring generate for aim FDA and to to the engineering to market IVD line as investments launch cash result, inventory given GraftAssure The FDA software hold for build the of the QX. product. in investments us the in a with sites half you QX process burn as the We customer These what to make

process. could on in the late to And development decision is submissions product FDA data a QX. that depending in approval invited of positive IVD is how processing is I time, team to by quickly expect coverage package call. expects details help Our next at why which on summer might We Ekke the strength questions earliest you the FDA address the completed support the here a FDA us to deliver the we to process, enjoy year. He is bench to today any the have have

be the of It's lot next to going fun of a in years. couple

to testing, outcomes and along We improving execute, the creating have a we are novel diagnostic molecular substantial but shareholder patient lot to way. democratizing to dedicated access value

I'd she to running. earnings newcomer to a Now James has ground the Andrea June, welcomed to OncoCyte We like hit and in introduce call. our

may from growth. analytical Some Andrea, Tesla comes particularly it preparing or and from I'm Andrea explosive I'm our the Axon. to work thrilled building and and insights, leadership already for to so when She partnership. thinking to with team, know decisive is delivering are of much heterodox by and benefiting delighted our we you

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Andrea James

you, be Thank to here. Hi, everyone. great Josh. It's

Tesla And some the of side that. you from know sell Axon me before may or or

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strategy to a to selling of to strategy at that timing, In disruptive attractive I margins highly the is very gross found model addition compelling. diagnostic business much I'm industry. to the the tests be via software-like

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this shareholder telling story, can report, far As earnings letter. are that as that with we you see introducing a

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projected these get excited revenue XXXX sending we customer are build and to presented a tests about is FDA that the to that In the so that bringing understand out patient up speak. In for transplant graphic are product materials, online their in-house. sell late eventually clinical populations center an assumes customers intended switches managing we to approval we a show assumes in IVD we from we why their we that as our beta graphic, you

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Okay.

So any your we now ahead, we questions. Go welcome Do Jeff. have queue? questions in the

Jeff Ramson

can the Rochelle, verbal do. you allow We questions?

Operator

from Your Certainly. [Operator Matson with question is Needham. Instructions] first Mike

Joseph Conway

Joseph Mike. This at talked out. increasing press the the it I in just a quick start that is for throughput saw about lab. you VitaGraft, on But question release on CLIA

obviously, you Maybe this is volume review liver at to an up. of are that test get want then CMS. what I set aiming could kind of you Maybe under And hasn't understanding volume kind where assume little of dissect a bit. Just for this test? for prep stands. for, work, this still

helpful. would there, you if give that update could be an So

Joshua Riggs

the Yes. Thanks question. for

expanded what our think in Nashville. lab in is I done the capacity we've

investment to So the work that the into we're FDA talking that about at we're lab us support primarily an for extra infrastructure. that's coming making It's program.

just that's generate amount to samples that about the support So submission. and FDA of amount the we to need of the data

support more of that's really so capital to effort. that a spend And

that for commercial more our our placements of back efforts to into RUO product. activating kind on needed service an towards the all on towards We've product most where of you largely energy overwhelming LDT and the commercial put and we pulled sites team site response of pivot had just the working

Joseph Conway

sense. Okay. Yes, makes that

maybe another that. to guess on question I ask So just

the you terms provided in next material for driver Kidney? just at start the should path, our beta point, that point chart, look we VitaGraft that before IVD revenue of there estimated inflection I baking is anything for the Or is estimates? guess, XXXX, inflection really I into around half guess, we As second material

Joshua Riggs

Yes.

to to the material for be product I RUO revenue had it's a us it's of dollar is to this this. because every haven't burn, gauge And industry. low the that hard anything modest going revenue. But new With with the like feels They mean, us. product, for

the now think much expectations to modest could going So orders, surprised I that be those going by until we it's pleasantly to we're for get we but above. be confidence keep

IVD highlighting do graphic kicks job we out a of of an it up there's a have think And burn I pointed we good you kind for that out, that as the relatively there. in really slow RUO once per site product. product revenue then

Joseph Conway

these then And just look years. Okay. couple to maybe of just we question, final as forward next

burn, that. how of terms setting wondering level kind you're and site of In adoption cash just

If strategic there, time? it's slow planting or looking buildup the finding a to over relationships if there be and you're going customers more at just centers of

Joshua Riggs

say would X I at concentration that Thanks. top. is the have in an exceptional transplant advantage we

surgery, to higher-end that's is both the and Europe and the transplant a world. So around so here relatively U.S. tends it complicated aggregate at in academic and the centers

And meaningful here so top do better. X of XXX are United in because of volume to XX% the us top the centers transplant XXX feels any these States the

And so about. of we what I I'm to we're to very think going meaningful sites, local get we question, to will picked when XX that think market answer a I excited if to up I that's XX and opportunity, your percentage have guess, XX

of the of us. strategic all So our we U.S. these is represented today, I mean, funnel when to at feel look guys transplant I XX% there. mean volume

Operator

comes BTIG. question line of from next with Massaro the Your Mark

Vidyun Bais

Vivian Mark. on is for This

any sort but of 'XX the that? bull late the give could as to Q-Sub the to FDA and us you publications release, there? represents of think expecting I interim FDA case, So was just studies I of to get press timing in can leverage you believe approval, us remind you're it what relates then range milestones, just of mentioned. clearance a in And your

Joshua Riggs

have I'll of some to get -- may 'XX the really he guess FDA Ekke Sure. about front I ourselves that how But we're and him. the going things through of that will best and -- We time. think processing I at of quickly we we to has to talk we're into depending ask just is on the that question, then the part don't process. take we're that milestones chance in the That hopeful I'll give control early timing drift the FDA move by end 'XX. of quickly, very

just talk key you Ekke, and a about into development the what in doing could hope But and little have next from of guys year. product us, Q-Sub front then that where if you to a milestones the view bit point you of you be going kind of are

Ekkehard Schütz

right. you. All Thank

planned is from to now. like Q-Sub weeks in our So X X

We are say material right together. the we there. now XX% putting would all are I

going would process say, are We to start, week. next revision the I

So into it divide and all needs. the all we going are by that

Is the submission what had for? did according good are clinical cooperative. BPD with validation year. looking validation to the And ask you pretty method fine it's your last you're analytical what for? And use, process, FDA the where are validation, FDA hope the our a pretty you're And you get planning. when that? good are or are very you question, with presenting we presenting kinds presenting a Is you We are of experience to studies like assay, They made validation our just what our formalized are intended analytical you actually looking according then and you we then to clinical answers.

against which And appreciated. really you, really trying with and I so they are you not work to

want that where IVD So bottom is which have to end at of this time all for might of planning this us. endeavor. our This some helps okay, and are is the there day to okay, for modification, we be tell -- us something a the detail the line, design us,

is IVD very, this together. also X, way starts a putting documents said, data It and and of formalized route very with inputs. selling which is Phase That a design

to So What all we finalized okay, completely like. And from put get there X target? achieve? want your are by together are that's our like, And weeks how in is actually, should in, you now. what to input something we going design look the

into in X development the have So phase and you second which from to design weeks. we there, that phase, done And are want is getting output.

that study everything there, means developing into can from then to design want so do packages, you you forth. output achieved. work So document are want And be what are that, to like put how you what really you and controlling do, which your have you design the

the that's phase gate. so-called So second

phase where we locked do this, third is to validation. That's are final particular planned the and we then And point, and QX to product. an 'XX. 'XX/QX And the, by with accomplished going analytical get validation that have verification validation at in

of FDA you be the a entire that's everything documents have and that and about that idea you along you lot the [indiscernible] randomly writing just not Everything that to about chance. you just and that So needed be It's put from very are have plan. needs beginning, thought the -- just show data set thought getting design some what entire together behind by control. then working The are to is so-called planned. are

Joshua Riggs

quick I apologize. pleasantly Can with comment make just Ekke. been But thing reception Yes. comment. the IVD -- the from want you, on to community. the kind is of we X surprised we've Thank felt warm just program that to X One I

the in you moving the kind interested IVD the been up we're is, are of positive. questions hey, in it's of overwhelmingly sites them just bringing we're funnel them participating program? these as we're through One asking And and

to these think us with I to the the samples studies. want They reproducibility get help together. want us help centers

IVD process along. And effort so community to it's really here the push like feeling a

we're think community. there's just it getting they're technology we're to overwhelmed to access positive a I from they the have I help support general to that think happen. And we're get and this So going make excitement that by the --

Operator

time. at line webcast. if questions the from the we ask I'd to further Jeff this There see are any no have to like questions from

Jeff Ramson

opportunity? do plan opportunity? calculate actually. Yes, Andrea, you how transplant testing the Josh, billion few, market OncoCyte does we $X do have how billion capture $X market And to a its

Joshua Riggs

opportunities estimate stay our million expect Europe million a Rest got And our about IVD of investor by to it's according that a that good out, X.X year. We think, where the We've IVD RUO at then in and product to our and question. in globally. we probably estimates, RUO X obviously, That growing, a somewhere World. mix be multiplying current market X% testing to an is this deck. product, mean of U.S. and of put least number, I around I

So we relatively and to opportunity that going is the hard chance the see move up price have do you're discovery. market the to billion until We're this out estimate $X actually conservative a of more there And reimbursed. IVD have not going is. what get that's know to we a do product you that what to is just something until

So the side we're being conservative erring there. on of

point good this for market think now, about of at and is, I right? works a it have them view, today. demand a From but where it's meeting it's It's the we that access right the don't people democratization, talked which and the giving bit, demand technology to access is capture a center, local they

Andrea James

add market just about based little to the bit billion indications? current want addressable you on $X DO is total a that clinical

Joshua Riggs

creation kind recurrence a value we're the enormous meeting that pharma of opens that's here happening just seeing transplant. that the significant of an in up so just now, is a an I monitoring that's view. oncology point there's amount X And emerge therapeutic monitoring. efficacy in in X monitoring, that and need efficacy also the oncology Yes. exciting drug done they're of monitoring. these unmet the mean, And of I like from of past really like this out space therapeutic starting and thing or where most just that's lot just kind on clinical come like we're see the opportunities, to anti-CDXX us and recurrence drugs, months for on being the is right working, think And of work then

because to got fingers for front that tailwind incredible trials we're there. that crossed patients an And in their losing option an creates that's organ. out will so us just I -- of continue so that have be successful these think And -- we've we're our instead

so that opportunity market would And of say I front the that's expands easily in us.

Ekkehard Schütz

to was I add to really [ may, perhaps is. ago, Board recall I situation a population. X where were If the want are have any a We new much would you dramatically test Why like should it "Why we has how I? do created we changed. that use I clear. to know?" ] high-risk make most Josh the saying, And this And just What what therapy. the talking have in would months people sustained of meeting don't I

Now have we test rejection, It's for monitoring. patients and active only be we now suffering. and something therapeutic there we have our ultimately working relief lost, huge, first who huge chronic a organ option earlier no that, the is also therapy for and show antibody-mediated it's perfect can was where a not are Because would the than therapeutic option.

standard than this is do contribution our into And... disease And going we with care. really can to of show are it people that earlier

Jeff Ramson

recurring question, X have performed are when other How currently envision most revenue OncoCyte Josh. I diagnostics does building streams episodically?

Joshua Riggs

rate XX, living say their I these a patients rejection. XX, of or high is better. transplant for organs, unfortunately, there's the Yes. recurring inherently with because revenue are And would a opportunity years XX though, hopefully,

so of number over a touch points just patient. of the inherently the life there's And

We're -- invasive the minimally that check physician way to or organ. other kind players noninvasive a the just of are needs way We, need. space, on a in along the that meeting with

product And the it's inherent that so just we're and the in. industry to I think

Jeff Ramson

Got it.

Okay. more questions. Great. There's Rochelle? no

Operator

questions have any the line. we Currently, [Operator don't Instructions] from

Andrea James

will this for out. pause, And we'll Josh Rochelle. maybe like then Jeff, close maybe give a it here X seconds and I Thanks, guess

Joshua Riggs

research out joining support. to feeling the thanks with engaging a be everybody Guys, about in for field where a obviously community mean today. It with the Okay. feels excited I we're us great we're company. and of product, just a at groundswell as

forward So you United States across sites our look capturing we on the updating and across and product Europe. these to guys

and exciting things for announce thanks future, playing along. the some very here I to think have we'll in

Operator

Ladies and call. all today's gentlemen, you Thank that concludes for joining.

disconnect. You now may

OncoCyte (OCX) 8 Aug 242024 Q2 Earnings call transcript