PROG - Earnings call transcript Q4 2021 | Biora Therapeutics, Inc.

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Operator

Greetings, and welcome to the Progenity Fourth Quarter and Full-Year 2021 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Chuck Padala, Managing Director with LifeSci Advisors. Chuck. you, Thank

begin. You may

Chuck Padala

operator. quarter Good call. to you, and afternoon, corporate update fourth XXXX conference Progenity's and Thank welcome financial results

Joining d'Esparbes, are of me call Chief on Officer Executive Adi Progenity; Financial Chief Mohanty, Eric Officer. and the

forward-looking limited to statements the Before Mohanty, of in reports like XX-K could including, federal any statements beyond substantial today's our will be including securities I the section. the that available this identified are within filed statements not call Mr. include the risks I will actual laws, that our many you results call represent Investors file forward-looking that from report forward-looking remind which projected These to, statements. in the materially the subsequent annual with would of on and the we call forward-looking and turn our that as as the later our uncertainties, over types date to control. and meaning and today our but periodic SEC, of in of involve Form note those website statements differ Please only views will

description and could actual those business, SEC. over that, please uncertainties call to to reports with the a periodic cause filed well from of I forward-looking the of the Progenity. expressed With differ related that materially statements Adi the to turn our For results in will as further risks risks Mohanty, as CEO see now Progenity's

Adi Mohanty

I at here the to of absorb, about My the days plans products, the a various plans. of lot had and have thank company an even and I greater of to our before saw in the we because refine and our continued company, journey us am I focus the team you to understand to I details a came process first that call. for the very levels the now commitment with products and of significant of transformation at will made the forward. here time. earnings the see happy everyone, for the commitment potential all of big work on started potential a I I and I a assets, I Progenity's today. transformation. for some going I Hello, joining saw learning thought as last couple decision people than I see time was

to game-changing As last stop I'll company of the forecasted a the over our on lab transitions that us within with later. most from months, talk years. further focus to month in assets In the process pipeline. business progressing about on it been and last company which the few call, developing have the diagnostics we the our oral Avero completed we our diagnostics expect for organization more next potentially last away resources oral business, our allows by platforms executed reset all importantly, as have aligned the few other the be that our sale we to therapeutics

of burn have actions to us these significantly cash company. the the of All allowed reduce

pill bioavailability. make that our two need of On the systemic our GI the in localized a on and initially to and main for of drugs will available other diseases side them to site of form delivery or focus we a transformation, drugs achieve platforms, take for targeted platform platform IV injectable a resources can

needles. therapeutic without profile, the similar but So

discuss first me our Let company transformation.

of the affiliate we our As December. promised, in completed Avero lab sale

we to remaining our open beneficial with diagnostic continue therapeutics commercialization. capital by focus conferences programs our good the data at our as towards working to to can pipeline. time, We allocation made oral allow presented ways us while shown stop those to these assets take scientific allowing eventual This remain We finding progress KOLs. but we developing, reach towards further spending on will with options

We this more for a that come long-term of expected We patent issuances further the in success. to believe portfolio be company. recently and execution continue company positioned with This year to months, year. we will announced our for have the the strengthen IP last few

clinical investment We and is are now clinical one impact entering have the We readouts we data main a serve patients priorities. phase our data data and where generation understand generation of subsequent on the community.

will and working clinical is for patience as diligently our studies The smoothly anticipated company. to clinical news ensure progress of efficiently. We biotech typical development any flow and plans require our timing are some

product quicker validation Although be platforms the expect other value biotech development. should inflection than we of our potential and the

cover the guidance additional I in months, I XXXX. we over will the have made on milestones anticipated provide few last As progress also

First, our targeted therapeutics platform.

or with Our $XX billion estimated globally. UC. colitis drugs bowel IBD $X global is Annual billion are or and platform the about focus UC space for this be inflammatory ulcerative to globally an is disease about sales initial

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need. Materials tissue XXth patients supporting and the Crohn's GI the severe patients data options so of remission a at in approved for of tissue This cannot and identified presented were However, tissue be tofacitinib. any In work included theory evidence and moderate higher benefit enough edition could patients believe collaborators, get at recently drug scientific do in from significantly to significantly our therapies. current UC UC that Congress that the achieved to need tract and lower be theory many current with of improved we more drugs safely One conjunction remains was biopsies correlation formulations the systemic Week European concentrations levels in of more none the and the disease with Belgian leaves significant in tissue Organization of platform reducing long-term is side We all not by main outcomes. of of the commercial of of a entire reasons from from without while drug than compelling February. options. the Colitis GI receiving exposure. increase half clear between the XXth and need. in unmet we drug our the why Gastroenterology and There these presented obtained proprietary patients the the many can disease patients long-term

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drug. technology issued already covering capability that patents of the We precise our delivery several allows of location for the have auto

patient outcomes, limitations, safety drug deliver of the to of reduce potential which superior events be platform ultimately clinical rapid site offers remission the therapies more Also, diseases lead of right for use The systemic of enable for further systemic patients the expanded could need in the and outcomes. same to amount tract. UC. reduction Our potential induction with combination platform to of can improve GI other could toxicity at the toxicity without

continue with studies demonstrated we & study was identify ability in continues by in payload our to We are fund device and Foundation. share product year. device to better, healthy its colon release funded with foundation portion other for commitment the The and to options development. their we and Crohn's GI therapeutic a patients While year accurately of This diseases. preparing provide completed volunteers. execute to to longer-lasting program this development manufacturing, further the and We Colitis last part this a study first UC clinical liquid the several the

colon successful the of have similar then patients a conducting the phase in next Following be used confirm UC of enrollment. patients of results enable the further beyond. to Positive first now quarter. fourth trial and the UC a PGN-XXX are can which the announced patient in our in initiating in will us This and in with deliver platform, the also robustness completion will to of development therapeutics healthy a study by we Phase I to range volunteers, move of start to this recently study study clinical

part a test of stages bit drugs particularly for serious of you in requires the patients early of can developing many and several a of be As know, development. methodical conditions

have development efficacy Our are we advantages approving success next should drugs molecules because And add profiles. desired, may the functions to early in of well-known steps are and compared device development. have likelihood path using proving many combination safety finish we once higher the some a that other the that

have believe start with to Because regulatory depends generated we line our time combination. we agencies begin date, our approaching current have the device on in trials we sufficient data and for drug to to are clinical Our data be patients risks. UC could the current some that a the trials plan

studies before able drug earlier with to need it We we for provide But projected planning year. all trial, updated another the additional QX. device process. as pushing and toward a request these FDA. for to so quickly to rationale will file be if complete of We after it I are need Phase product to provide we begin and good guidance could possible These that data the the we to committed as animal trial, add However, quarter we progressing We in start have required the than stages begin rather meet we while there months. trial planned are next later, the for development before plan the coming or approval for will the understand patient's to initiating the and Phase is the are trials. chance this our for to I early into studies them required animal we feel

Our blood Phase trial colonic tissue and I both tofacitinib. will clinical evaluate PGN-XXX of with levels

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at will DDW San this We Disease Diego in Week, data present additional Digestive May.

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systemic to require injection platform drugs our would or goal IV. is oral of otherwise I'll administration biotherapeutics that cover this platform. Next, of The facilitate

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platform. We a and wide this of to range the pathologies potential target have with treat

progress During implementing make with design will increase and manufacturing manufacturability. that the fourth quarter, and we device continued reliability improvements and device performance, to

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assumptions. collaborators who validated have We multiple this for technology have our

of eager the We our other names and have these mentioned is share collaborators. that one Ionis of we collaborators are to

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partners to advance we and or will either these As be programs, to significant pipeline, execute organically programs we with our able new add to summarize.

platform targeted and plan drug begin Phase year. this the device study. early next of study UC, And Phase Phase planned in We will I year. therapeutics our QX We to study in if animal the begin For a Ib/IIa we year-end conducting hope feedback a QX our are in patients complete device a and safety by approved, study intervention study UC to combination we I larger QX. disease FDA by in function have on for early

with We updates the FDA. as will provide discussions complete we

into pharma For the and our platform helping therapeutics best is towards broadest the delivery we the year. our with company will systemic believe the transformation biotherapeutics. continue preclinical this generating to end platform, of and data with drugs trials toward those having move partners build oral the of of goal for clinical We our

that, market, markets needs programs will that I'll and on IBD that Eric $XX the a discussion substantially well on market We our needles. of results billion With for focused GLP-X market be lead unmet now our as dependent capital call over highly is serious disrupt billion to address the for financial as activities. large turn larger currently progressing the and biologics patients the market $XX like

Eric d'Esparbes

afternoon, Thanks, Adi, good and everyone.

of original we support in programs. sale more our cash target mentioned have great and the Along earlier, cash After our progress clinical towards allocation we available company the December, profile. our burn goal capital leading Adi million the by to our the a cash made annualized decisions now than transforming and frontier a company have As into burn runway our achieved development made solutions. reduced changes extending therapeutics $XXX of our of with therapeutic orally significantly focused way, Avero reducing affiliate we of

Operating compensation and in pipeline data clinical biotherapeutics to picture. representing goal as variance look our stock-based of milestones a from the XXXX, generating away optimizing the development-stage in we our we fourth key expenses we spend million achievement transformation, excluding fourth favorable quarter were operations data-driven during a million to allocation complete at and from elimination with the the are expenses changes on in shifting capital maintain development generation. compared the expense, focus $X.X the million representing which near-term we $X.X variance expect capital of that R&D cash $X.X with expenses previous we from revenue to associated also favorable guidance, generation way financial $XX.X in a of guidance. quarter quarter on fourth Consequently, our As fourth company, $X operations million, our favorable use to through company's a of our QX. concentrate stock-based last G&A commitments. focus demonstrating value discontinued in stage-gated million, reduction including our were $X.X our including compared million million operations our approach million our guidance, QX $X.X the the variance we to to were lab achieved the stock-based expense, compensation compensation in $XX.X a new quarter expenses and

Our expected R&D are largely testing assets end the first the expenses by associated with remaining XXXX. to molecular be quarter of eliminated

approximately with regards the are completely and million slightly of after XXXX spend million molecular XXXX, in incurred following stock-based to expenses, compensation be lower quarters excluding invest range level approximately the a the programs spend in in So Of enrollment patient and clinical therapeutics with of amount, during profile year, therapeutics timing programs first expect and targeted invest stock-based we subject regulatory to compensation expect our the excluding achieve final million eliminated. $XX that for approximately $X testing spend quarter. $XX million approximately expect million of we quarter G&A expenses, R&D to million by $X to a systemic during processes. which to expenses, work, to activities first a $X we $XX this With is driven activities to

in average previously achieving be guidance line is total a is of an burn operating between $X with and million cash burn monthly in million. expected stated result, XXXX, approximately which our million of to cash $X $XX As our

million the in back With the $X gross million of our The $XX warrants ATM turn raised call as in During second gross a us quarter, XXXX capital exercises, XXXX. into in over the registered proceeds cash direct a program to completion strong Adi. a company's proceeds through allows of have XXXX. fourth burn, position with cash we leading transformation half through a of combined substantial in $XX reduced now million puts will XX, proceeds balance XXXX, in well offering. to through I of our million December $XX and in to and runway had gross that, liquidity the us raised

Adi Mohanty

Thanks, Eric.

We We transform are transformation discuss that that, about operator, a enhance value ready our and company. have the vast addresses to excited biotherapeutics for patient With care. are into can questions. we potential today the we believe markets milestones our materially pipeline now

Operator

you. Thank

be a [Operator Instructions] We conducting will now you. question-and-answer Thank session.

question proceed with with Joe first Wainwright. is your H.C. Our question. Please from Pantginis

Joseph Pantginis

go guys. describing backward for get maybe, sense, Hey, what taking Eric the Good afternoon. question. in to let's regard first, the to OpEx, thanks you And Wanted with Thanks a for were guidance. curious, testing, FTEs regard need going your to company, repurposing et away rightsize? do to currently just you molecular at efforts you strategic Do cetera? from with the are new any for the

Adi Mohanty

This close Joe. Hi, pretty rightsize. Adi. Yes, we're is to

a that. we've lot So of done

the talked in in about company. aligning – the we think I call, our

to skill now tweaks sets, close So we pretty on need just we're some rightsize. but

Joseph Pantginis

of clinical studies for of then UC just need specific you're the to animal on specific or That's that. the of the looking great. answers to program. color any Maybe kind conducted? so information And And that more still ahead the the what get curious, questions hopefully then, program? be little start a FDA provide more And on thanks

Adi Mohanty

Okay.

have data. I QX, tox to references that animal Phase file we that, a FDA referring the filing. request includes are discuss you're to studies. In So And tofacitinib looking with data includes a existing us trial. in It package we to upcoming our to

that As you tofacitinib. form Xeljanz is of know, a

a there's think, data. lot together, quite So package package. put existing of a is All that we compelling

the leaders, we had They who with all that some sense. space. of meeting significant In GI GI this morning, who’s plan are fact, a big KOLs thought made our thought

animal more a wants extra few conservative say, because this FDA what, a the approach might days know tox sometimes package. studies of do for you they However,

might possible stuff it. fact a we small we're strong we're about, talked and We wanted with be. So talking the people that's about to going the kind be flag to the think But just require that the little package meet might could that's we when the it why is more. forward. difference FDA, go enough, of We've they

more a we and to when will That have so are then let as talking happen, little And planned. know quarter, time about. you tweak lines, but by mentioned, we'll our I a finish those forecasted maybe we'll

Joseph Pantginis

and to the color. some eyes Sure. hand-in-hand you'll just like dotting Always agency, be helps there. sounds the work it just I with appreciate

Operator

you. Thank

Our next question. question comes your with Baird. Catherine from Schulte with proceed Please

Catherine Schulte

today. from Hey Any steps guys, And are the you've those those? thanks next more comments on hearing updates how around partners? are OBDS I guess, the any for first, the progressing? partnerships for details then gotten what three feedback

Adi Mohanty

Hi, Catherine. question. for Thanks the

So I call them collaborations.

mentioned we're molecules, people I pretty there's to think make early been happy how I were them, potential that I But able really more. us some on think to continuing progress. we here. had. their We're us. work progress. what with to being say, able they should where work made was, share to were they've they with that We've restrictive – able that what we're shows collaborations It in These interested are

will this by not can can year, decide continue to we year, with We're what and where us. a with in we enough some next for we later at stage sides that We've and they've these them on all share with over where they more a partnerships to with the the That's we'll progressing that all at So point for us. details. working happy have work stayed everybody. announce give cases been whether stages be we are both or mean information what

good lot this year, be to we that this there. together. a year, We not We're So be making says just yet. we'll later we're And will there share progress that more. hope able

Catherine Schulte

has of should about a thus for finding a those Okay. of process that potential how far? asset? think Great. And been feedback And we partner conversations the What outcome timing then any potential for kind from for on garnered Preecludia? details

Adi Mohanty

Yes.

assets. of couple a have we So

been I that right, external looking of figure test, think a process has so predict. of our for the best These been data are to good have couple I case kind trying the diagnostics difficult more advisers path the mentioned, managed far. to forward these and In a the on we working Preecludia assets out of some assets. with

However, some more on take commercial clinical order have needs us can PE done. work a study, year. more to be we the would run we to to sense for a In than spend And to test, for since to utility a, that diagnostics, example, which it continue make commercialize from effort. moved away didn't

at been it result ways we will take we've And could does, back. could so in something. as has anything That But And we'll detection as yet process not resulted this looking it or share. that could test. somebody we ways forward. hopefully, And out that molecule in partner single have also report work soon a that we

as can. hasn't fronts. come have a we're place to multiple share we as where we soon on anything progressing, It's to yet So working

Catherine Schulte

All you. right. Thank

Operator

you. Instructions] Mamtani Mayank [Operator Please with Riley comes Securities. question. from Thank your with proceed B. Our next question

Unidentified Analyst

Mayank. Good This Hi. is [indiscernible] on for team. afternoon,

the sort around we've Just any bit that's And on more a kind you study both looking And also single in I/II of you're proposed some and could remission color program how work push seen? of multiple Phase that provide thoughts well. of what dose dose-ranging delivery efficacy? on of segments that generate? the the couple sort you the give durable and thinking of then associated sort of some questions of JAK applicable how design? liabilities to can you're And UC around biomarkers a targeted safety from information us Could as about some on the

Adi Mohanty

questions of Well, Mike, a there lot question. one was in

to my what you do I'll cover best asked. Okay.

So have tell we the of that's is. proposals. for some can because get that be and things for know you publications tissue. of don't until it tell FDA, to answered that to we there. you yet that we pieces I And the it validate certain have would do We internal fully asked don't lot the with premature that what referenced different everybody of me we show enough we a sort tell drug you that that

the twice disease where is. XX in XX And enough GI, start and what's get not tofacitinib is in just the GI So tract, lower serum. but they the even is XX, to in the about dose People its have day. tried drug a tissue mg in in about typical that which current at to go the worrying mg, but not what's XX does

So in what's going the blood, the a higher and increases that's in and issue. blood, toxicity doses

concerns So that's where safety the come.

it's You you with look get to mg get and significant you'll it tried physicians safety but cannot that then GI far that have current push better it that label. where XX the because see if tract, in up, might up issues outside to a way response of substantial ends approved

then the good, be or part the done more accurately in without far, system. tract GI So shown the get getting our the platform, drug that could is so show more a we drug needed. the that I'm do half detects in in current all, we lower know that drug more to as need as that allows entire the by able us in have drug substantially the and being that less releases This right the of location endoscopic We've certain from and at and own, calculations colon be And on careful entire the combination its get than exact less we we formulation the the the say good. could of multiple but of ways body. That lot to that where XXx the location such site about maybe dose, part drug colon. numbers. the lower the in more at It's is that giving well entire you our serum that of be more drugs studies data is could first coats to

a them at more or lot better about. being lower dose until else We went your location, than talking coat I entire the be careful. a that's the get a worked have make a hope which colon is lower be right that to idea question. I we've But faster and it want is conversation to off and in the to general, a drug, have the we out. to currently I But things publication, explained I the nobody can what that's been get prescribed, of then outcomes, induction, leads bunch covered able do

Unidentified Analyst

was and Maybe of kind here. very about higher meeting. sense then level you No, absolutely. a of thinking as helpful FDA more one lot get at makes that a towards it more, That

by recently As you and Pfizer over thoughts treatment you current do the might any And and time? where fit how fitting on sort think treatment today. of paradigm about in in targeted see have the paradigm you Arena data some the released the a approach treatment of

Adi Mohanty

Yes.

ours is targeted and topical. So

we is That are potentially a able about, And talked so At first-line is just as which not move of to body. safety. a rest therapy. safer tofacitinib, show a or up even faster of could is the of or biologics. tofacitinib think some line topical because a of it's doses, better point, rate induction is I which the going Xeljanz, it lower what version your – the this second sort about If to in number of third-line that

line, about $X the line. the So it billion first will But always be line. anti-TNF into $X all that using the talked that, currently, second – you've billion, which is right I fall close line, biologics, to first after got third

So we up all we the way believe first line. can get to

it's point, these even XX patients had But the At However, probably in on a though a substantial anything start which option significantly, it data. We multibillion-dollar years more that approved data. real to not need who showing drugs. is depends have all opportunity. that there's for

Unidentified Analyst

and Great. lot our helpful. Thanks for a on the quarter. congratulations taking questions Very

Operator

time. floor no management over closing comments. I'd to are to further the any There you. Thank like turn for this at back questions

Adi Mohanty

thank forward technologies. best We us coming pipeline progress to everyone platform for the using with to eager want oral I make We're today. back to and joining Thank therapeutics talking our look you. to everyone.

Operator

concludes This conference. today's

may disconnect for participation. you your You this lines time. your at Thank

Biora Therapeutics (BIOR) 29 Mar 222021 Q4 Earnings call transcript