Sera Prognostics (SERA) 8 Nov 232023 Q3 Earnings call transcript

Good afternoon, and welcome to the Sera Prognostics Conference Call to Review Third Quarter Fiscal Year 2023 results. [Operator Instructions] As a reminder, this call is being recorded for replay purposes.

I would now like to turn the call over to Peter DeNardo of CapComm Partners for a few introductory comments.

Thank you, operator. Good afternoon, everyone. Third Year Prognostics Call. Earnings Sera to Quarter XXXX Fiscal Conference Welcome XXXX. the today, the results XX, market of quarter Prognostics September At the financial Sera close released its ended for Zhenya Presenting Lindgardt, Aerts, for CFO. today the will our President CEO; and company and Austin be

the the results today, will we a question-and-answer review will which we host we session. call, released During financial after

via website section If webcast in be can be it quarterly earnings you've release, can a and not had seraprognostics.com, website. the call on at a at our recording chance heard archived This to live of review our be seraprognostics.com. found will our Investors

projections Please other These expectations trends differ our financial of results information forward-looking a or statements based note presented market business, that the events or actual and these about on and projections circumstances may and contain reasons. occurred, expectations, for that and statements yet and of from management's have for future the adversely today some are current results not events variety may materially plans including and opportunities.

We statements. risk reports on These Form the forward-looking and on results its from current XX-K, with quarterly to time annual reports XX-Q could documents Form Exchange company Securities factors the identify Form documents cause differ refer from X-K. projections those other our and and to important materially that to time actual the contained in the report Commission, its files specifically you on the company's

website. on As Investors a reminder, a our this be replay webcast the will of section of call available

over and turn Prognostics Zhenya? I President call the Sera Zhenya, now will to CEO.

to value free near-term over for vigilant shareholder success, we and debt, last and means cash the is comprise Since pursue of while preserving coming the which position to the controlling of quarterly and Peter, our generate sufficient in years. much, evaluate balance believe and sheet, solid costs being good revenue you Thank everyone. afternoon, all to our call, best continued the company long-term we've so

balance the to the health strength accelerate expenses focusing operating the on take expect us future. in leading market We pregnancy women's a while in to means will sheet best position managing the and revenue and

develop to PreTRM Test, focused market. the assessing a rule-in products many the As to unmet we're One support provide evidence adoption in needs rule-out in clinical results single address continue new complications, developing example a high-risk pregnancy multiple we for to test. to on test pregnancy assessment risk is and low-risk both also a tool of

in more to to a estimate Another arrive is a of leave, travel provide and important other work help a our planning on mother accurate will product maternity a baby when milestones.

all are Sera. is data that towards establishing to critical results technology publication showcases of These pathways study our our further with revenue supporting of for adoption benefits of technology. compelling additional the Key

with detailed TRIAL. mind, in XXXX, from Wilmington, update a after elevated our September start This for in results in and using been conducted assessment AVERT, preventive those after that intervention PreTRM was journal. submitted a which with guided Detailed Delaware Test study risk risk to peer-reviewed our designed have June to me PRETERM determine AVERT outcomes neonatal using let of With on targeting at was ChristianaCare XXXX for treatment. publication

care progesterone be milligrams the test of roughly or Pregnancies to management. identified high XXX at women were the roughly COVID-XX in results ineligible XX% with screening. the accepting were to patients XXX manuscript. after for and due daily, were tested risk Of provided total were summarize or preterm the deemed these ceased study screened birth was the and X,XXX of as daily subsequently these, research aspirin preprint of risk A me elevated milligrams XXX by of before women vaginal of pandemic, offered Let X and deemed interventions. XX XX%

risk low Our and high in pregnancies. goal was risk either a historical or who screened XX,XXX arm accepting to study compare outcomes of with for those treatment women

Our were earlier analysis and and found neonatal The morbidity ordinal had stay lower prospective that index hospital primary neonatal neonates discharged score. index morbidity neonatal arm hospital were scores. the co-primary from outcome in the

impact in XX-day for gestational XX% at XX% of showed length age stay hospital improvement born in risk unit XX Test neonatal mortality, X.X-week of PreTRM infants most in intensive and and of driving for neonatal length severe reduction delivery. an infants, stay, in before reduction care weeks. neonatal early impressive morbidity reduction

note was to test to which neonatal test at blood pleased preterm really cohort treatment proteomic are those when racially our outcomes risk. diverse for improved birth validated in coupled to a that with risk, We compared the AVERT control

With shows impact at of these those negative cases, strategy mitigating premature results, some the for promise hopefully, risk. we believe treatment among significant eliminating our and birth test in and

insights, Moving the the we will those if PRIME PRIME study, updated believe stronger number test-and-treat to and study on project update up we study. patients to our more a Having of observed to add anticipated results impact AVERT high-risk the on have the have compliance our to now patient we model from be Armed patients. treated and expected with read X,XXX sufficient the an strategy. of physician

will we enrolling only to have additional results so impact PRIME our in these At patients study, expect the add we do believe to to not months this final overall rates, a current few XXXX. change plan

the interim give the to difficult in delaying decided success the look. look interim power opportunity readout individuals to without study an the additional us enroll to final readout to favor and the shift final We from also to

concludes study Monitoring the As look full readout. enrollment expect in to that a and Board, One, X be December. proceed are to we outcomes final possible that Data completed in may result, the there the DSMB, interim the Safety

study indications instructed study given very in unlikely are use the for the should community. tolerated DSMB risk for although the that highly safety interventions low the common the and stop as reasons, viewed Second, in are well obstetrical by other

final. We is enrollment, and full the which and reported due in deliverable would to result statistically interim which the to available be XXXX. look, with and known, anticipate interim we #X, also would their the and will all very from Three, the babies power pleased analyzed highly of in at the outcomes benefit be recorded, shift demonstrated scenario likely

the PRIME expect the as expected before end be to completed of and by We look this communicated year. interim

the and look of a babies of mothers this final of results, interim all requires discharge the which study to PRIME progressing hospital and of the timing and As analysis cleanup event delivery are reminder, prior the of as planned. data

to adding for customers with On roster a coordination to large We're that. women institutional our high-risk commercial quarter have update. this rolled progress alongside and out excited offering be care as provide to identified new

in us preterm identify that coordinating birth. customers risk facing expected of institutional new and help for evaluate the expect mothers We to are care works what best

We our such by by patients offering adoption believe care. service their physicians overall that to test can better providing improve

customers, expect become to scale these gradually medium source better we revenue rather the adoption. testing institutional over Given to as the for short separately, catalyst size of institutions but volume though serve time. Sera service Sera provided we of for a within term, built expect of a and is don't to care these patient for coordination the major in care

you important our We're QX for looking forward briefing. to next analyst providing XXXX commercial in traction updates X to

of product X their new are logistics development First, experience. to of progress stages in moved collection we've next making we the products enhance on improvements on as our blood to the to development. our And second, customer new

our call Austin? a review third over quarter now turn Austin I'll that, for financial results. to of the With

good afternoon, Thanks, everyone. Zhenya, and

to results approach cash our align review of for better me our bit steps runway then the to to we quarter, provide detail Let moves reduce and commercial extend our the serve. a and our our financial on I'll burn following market

the for of as for for adjustments of our of to regular result quarter Gross the revenue Revenue XXXX. were XXXX old accounts were third review the $XX,XXX $XX,XXX our revenues quarter but offset third by compared of quarter a estimates. was $XX,XXX on

on $XXX,XXX. revenues be call, expectation our we noted reminder, a that our As than last less will XXXX

$X.X efficiencies $XX.X for compared to development quarter million Total lab million third the as the down $X.X clinical a we and our same streamline and costs. of for Research lower to for were XXXX operating improved the were our from significantly expenses operations. third to study ago primarily in expenses due the million $X.X of operations million year period continue quarter

million, for for quarter steps million commercial were to due past taken to a level strategy Selling, to costs our streamlining streamline ago, while year the current our operations. the also better general primarily $X.X $X.X we've from significantly over period administrative expenses of same year and third focus commercial administrative to down the XXXX of operations match

third was of quarter Net million, loss the second XXXX. quarter $XX.X for million of the for from down XXXX $X.X

the $XX million. As company of securities XX, equivalents approximately XXXX, of had available-for-sale and cash September cash,

focus commercial near- the organization, we development structure to revenue part of further improve we've believe addition and while early in additional cost the long-term cost the taken reductions, operating best to fourth the on across activities quarter aligning are opportunities. the carefully steps our our year-over-year In what aforementioned and

$XX be $X or XXXX Our year the XXXX, gross approximately an XX% compared to approximate million in for to approximately $XX expenses decrease. year million million for cash are expected the

$XX This the expected efforts plan expenses we've of fully expenses recognize strong for approximately cash streamlining our less believe XXXX as be into We than enable in Our of us million decrease $X position. gross cash XXXX. impact XXXX for or operating future the annual in given we operate XX%. managing to our million very are additional the to represents made an should

for questions. please Operator, open we now call can the

question The Instructions] is [Operator Patrick Citi. Donnelly at first from

who for on Patrick. Congrats sound about start the want like the in if data. some some wanted talked And either off you was place you to? data updates people -- lot and possibly quarter. a ] the any wondering Brendan to or possibly licensing in-house guys so on [ is of your may by partnerships to quarter, last This guys I I asking there? ideal of establishing had you partnerships

see the so would in jump anything. off much for add then and question. like you and Austin if start I'll to Thank

lot still and opportunity our on companies incredibly actually We are of about not products able partner the share both excited I'm on a our discussions We with to have data. underway. to specifics. live other

lab for commercializing have et overlap cetera. relevant product capabilities our However, in looking commercial collaborations, companies footprint for products that space, our in we're in presence,

data, definition the product, On the and developing target the our audience of model. continue commercial we

in So partnerships. be the that we up shaping share very calls and us how the we to with more with is on unique seeking we're optimal asset. potential of the where about for to place driven alongside will are excited those be products analyst partners coming what land type them will this But contribute by

then Great. follow-up. one And

those the be line For know publication, later the documents may that I it 'XX, 'XX? line submitted Any time year of whether published, next AVERT year. kind or be this into for when you time of

submitted. cannot under review Great time estimate guarantees, there where are but XXXX, question. not but at the is hoping it's currently The the review. publication I'm publication we under no know I line. we

moving. is process the So

it. Got

question Blair. Andrew William next from is Brackmann The at

This is institutional how of today. Maggie feedback shaping far, thus Boeye talk your conversations kind just with and add on from AVERT customers start wanted the I maybe to gotten Andrew them. on about KOL for to continue you've you as maybe that's

early couple is creating of The excited noted. have data course, opportunities more conversations that for the us we really question. of opinion customers. to our important really to a is Great additional add goal, And key which, powerful. leaders were brings achieving the that been course, produce data The takeaways of

unlike with the the So of shared portion because is everybody with had patients the and study significant AVERT previous of the backgrounds, delighted PreTRM strategy seeing was populations what of high-risk are that by patient test-and-treat before. diverse treated impact Number studies one those? we've diversity is a the population of varying

Number babies are that impact born on the earliest. is the X the incredible

as As XX of becoming the matter and some go morbidities the babies that of severe could health of death life that it weeks, born before you over impacts time. be know, for well probably some can away as the are

powerful. some in improvement exists gestation, a not significant of by their X.X earliest matters what weeks to gestational because be weeks these are, XX breakthrough if been let's for age incredibly say, the X.X noted for earliest improvement has after births weeks, who babies, of really So versus powerful, gestational for born in extending is as age today babies

as carry doesn't of babies as weeks -- it significant it age. XX under does significant outcomes However, for

more been have X customers. those with the engage from insights more most share and and as we're really So excited the highlighted as striking to data, more we

to customers. arm, I will the clinical study endpoint add shown impact economic that the if to historical nature the of out explore are the significant that could due we looking the of we've on results pull with we also

So all providers valuable will in of with these important will be with discussions they be with as very payers. as

helpful. That there. And Great. was just then a super maybe follow-up

moat the as Just you care on long How your service term? expanding are down viewing offerings. the those

great a It's question.

Majority with providers. replicated many for another customer. that by OB/GYN can exist offerings to standardized from one They're not the management of protocols care time, know, you As customer be are generic. specifically nor they're they

engage they how we have in last about offering. our even we especially and So trials management full we the large the the months, clinical their interested get own in our when customers, where clinical X we've with excited and intrigued the outcomes in scale focus of institutional their players studies, began new and achieving protocols demonstrated found patient randomized we've seeing if they they are population institution, will tested care general impact that

impact we catalyst in time, drive would it strategy our will be institutions found great product. having to show of So engage Over the our to of however, care as themselves. the a offerings offering management say that standardization I to that

that really and conversations and again, across payers achieve to drive ability So results need are do time for Sera coverage that for adoption. doesn't the standardization present that the payer outcomes these replicable broader with institutions, to to and

next Instructions] Tom at The from Stevens [Operator is Cowen. question TD

extension on interim PRIME questions a of Congrats and around I on readout. of comments burn. the couple had of the your cash of follow-up some kind

guess then bit And let's PRIME? to color give guess the we to guess, from why I start I and you Yes, follow waiting seen there? I more up readout that, can afterwards. a my for any as with you're first is, full So results have give data one you could

a Yes, going to was great. anticipating question. was I somebody ask follow-up

show in outcome So and of strategy. thank for study patients to benefit with that teeing need a we do treated has fundamentally up. of test-and-treat the the It the the number that you high-risk to

ChristianaCare. in both When we for population, had patient national population from we interim that see initially our from, this how the final, estimate of initial set the and high-risk many over for PRIME we we've study seen for the site an example, patients single data will

the the And the compliance outcomes for to Second the is patients are how by we we show we be treatment with order estimated will overall in is estimate physicians seeking. what model to of the needed power for a third offering. had we're number

levers and in last outcome. need update many allowed order X we new these we that of our significant X saw us see all in full to with X how to So the patients months, to data model achieve

Again, and we're reporting really on study we increasing study basis, in that we've recruiting about it far doesn't and the even lot, patient along the estimates. extend the not not a population XX% we're And only need of significantly. by quarterly many, may as along our been by patients, original even a

in what that national, with So when patients, we of updated PRIME our model high-risk rate for a what was of the the the saw is different in study from homogeneous population which site the studies, single is terms population than the is. with we needed, single-site number high-risk is

shared what of but my that with study. in Second treatment, see was impact now is just high-risk different of treated to we with a compliance in I population, last we had And the achieved higher. not have benefit rate as AVERT least, the data the remarks,

given armed better population, we X and fully then interim the complete the interim the are more so line of that go those new if by it into miss at of time -- look far final felt we're the for full patient is the study. the and just with we recruiting ahead along So readout data, enrolling study, pieces powered

made why that's we call. that So

very to benefit answer That see see is study. no. to very, when now -- now we're any because going we're completed that of will specific. AVERT is said, not with the are results going Unfortunately, model we we updated Now your the data. PRIME strong confident was question Are seeing data? the very The we see the

so with going the is sites, And far everything we course, are well. communication of in

we delighted study results, DSMB, help? counting hopefully, the reviewing the and feedback all showing back that we we're and be will in hear a enrollment the interim Does So by us give data from without the is great with which when you on us to to full study time will continuing coming of concludes. and December,

expect widening information could incremental color helpful of population? really, follow-up another color PRIME just population there. have that patient maybe any potentially If kind narrowing you on be would Any really study there. or there's I that in Should helpful. the That's patient ask really the the around we

Another and the underway we're recent discussions of excellent publications question from submitted the having questions papers with a payers the getting with lot for from learnings we we're and providers.

now have are reviewing right We or how on can extension come we a but for the you for rich we exploring set back know promise now. I answer data don't make target to more. and right population, narrowing I to that you of the when PRIME specific

that you same and they're the PRIME. or similar the are will AVERT tell endpoints between I very exactly

best for continue come bit and from reported our data date from investments to to sure, PRIME, believe, significant of adoption as made we make I analysis most given expect the we So we time questions are this help customers do drive answering AVERT the many what a very shaping into our with done, data by same to significant -- really PRIME today have we as to Sera will actually has can. to

for thank So raising you that.

I'm would going you lines the wonderful in as more and for to because [ kind time alpha lines our us to updates any development? potential on guess one That maybe coming just data readouts test squeeze calendars. on other when do I offerings of in time give pipe, be that could you part of your have just in ] own

absolutely. Yes,

this I and of we that clinical the lot with market a one our a which quarter, each say bring them stage research of into as deck, to work on described for big products development completing to them corporate validation. underway the focusing as moved will are for up of possible. have are milestone, teeing that We quickly our we've is next

I in launch QX as in are much call early that on you don't -- my call year. update we analyst date, I new hoping next analyst give to exact you a time stage have While product remarks, mentioned QX deeper line happen will for

[Operator to any to Instructions] over questions. No for the Zhenya further Lindgardt turn I'd conference back closing remarks. like

thank much, Thank everyone, today. our you, you so and operator, for attending call

futures, We continue we word the and our form and for insurance that studies outcomes with technology better health and shared physicians study care companies patients, test-and-strategy. the mothers These to that improved that and utilizing today results along show, our the expectant indicated cost babies, of that be benefits in costs. afford health reduced health really excited care the reductions support PreTRM the can for care about in results including data better

see We key of in help pregnancy change really grateful and of premature support and paradigm our for company investors reduce birth Sera's pursuit overall, as a role all to a of is the enabling overdue endeavor. impact and going to on families their that that our we're society forward

call. Thank you to you, are so it Operator? much, and turning over operator, to the we conclude now

conference Thank attending has today's now The concluded. for presentation. you

You may now disconnect.