BIOR - Earnings call transcript Q4 2023 | Biora Therapeutics, Inc.

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Operator

Welcome to the Biora Therapeutics Fourth Quarter 2023 Financial Results Call. [Operator Instructions] As a reminder, this conference is being recorded.

I will now turn the call over to Chuck Padala, Managing Director with LifeSci Advisors, Biora's Investor Relations firm.

Charles Padala

Thank you, operator. Good afternoon, and welcome to the Biora Therapeutics Fourth Quarter 2023 Corporate Update and Financial Results Conference Call.

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

I'd our but that turn to meaning forward-looking statements of I our we the securities over next to, in the Mr. Before forward-looking in laws, the federal on including, quarterly reports of and plan few call file as statements Form available that within remind report limited call today's the Mohanty, identified you XX-K the the with the will to in days not are SEC, subsequent filed include on to like types Investors which section. website our

this that the involve including could call and uncertainties, statements actual beyond that those are risks expressed and in forward-looking as forward-looking These our of views substantial many represent control. materially from results only the statements. Please our differ note date of the

cause uncertainties description further forward-looking well a For to expressed as reports in see company's filed risks SEC. from our statements periodic could of to the with the as the related risks and differ materially please those business, that actual the results

now of I turn over that, Mohanty, call CEO will With Adi Biora to Adi? Therapeutics. the

Aditya Mohanty

platform technologies thank platform Thanks, to as for capped hit a we Biora. us. our everyone, transformational continues you, Chuck, our The continued and execution. year with its progress We joining for fourth NaviCap The both quarter milestones. made strong excellent

an combination. trial in BT-XXX As the clinical to trial, U.S. believe forecasted, FDA, for which be by the and we we clearance clinical ingestible initiated our IND achieved of device our first drug the we

will first, BioJet later. progress BioJet We'll share I'm Ariella? an platform. also our clinical who on Medical by trial. talk But more today our a BT-XXX about with joined Ariella, Chief our to update Officer, the pleased bit I'm see

Ariella Kelman

significant unmet colon drug to inability a high colitis, be that shows UC, needs, to current have the and here levels efficacy. with with treatments ulcerative and speak to better Adi, in or of all. continue tissue you Thank is Patients research to and to you, achieve happy with barrier enough

to in increased efficacy with the NaviCap tissue, drug to drug systemic potentially our concentration lower achieving drug bloodstream. device, due less Our by in precisely improve colon thereby colon levels to goals are delivering the with toxicity

conducted that deliver As to precisely NaviCap confirming we bypass you detect studies upper tract, know, humans previously colon. the gastrointestinal device separate into is X able in colon the the function and payload

in study Our the first platform trial with active ongoing device clinical I drug. our Phase combination is NaviCap of

clinical placebo-controlled tissue colon pharmacodynamics, and is in BT-XXX trial safety ascending are randomized, of administered to objectives volunteers. the in when pharmacokinetics BT-XXX It healthy our January. a multiple adult evaluate orally double-blind, including effects dose and initiated study. We single clinical and Its on

X of parts. consists study The

The first comprised in a happy liquid you intend of future ascending is receiving present tofacitinib portion the publications has the XX been participants or NaviCap a doses formulation with to BT-XXX, I'm This of SAD, dose, data which combination results is at with scientific proprietary share completed, or or single We and XX-milligram X-milligram placebo. full of today. now to forums. and those trial in

was as intended what It's the functioned terms designed. BT-XXX The expected pharmacokinetics with data. that We're well show we safety. and excited data single-dose about of in pharmacokinetic BT-XXX and consistent tolerated.

in studies. and animal function colon released human at we and Specifically, drug devices opened predicted device times that in the

X observed maximal study blood drug in hours was systemic administered released every hours and ingestion. X drug All participant. corresponding NaviCap concentration targeted devices indicates with evidence tofacitinib showed active This approximately of post every anatomically approximately at Measurable is There the in delivered that first colon. delivery containing device at in absorption.

delivery where than occur maximum what occurred dose dose-proportional intended as an drug than pharmacokinetics dose. what's tract. opposed NaviCap, at is minutes the colon XX-milligram lower were upper hour X-milligram Further, to oral observed, after XX concentrations it's different that gastrointestinal This tofacitinib, blood the in plasma the ingestion. drug with seen the suggests concentrations and with conventional and absorption This with is to with consistently

in Tofacitinib plasma X pattern BT-XXX. over see levels with levels. seen animal amount to more to and colonic Xx with approximately what circulation, at through colon of These tofacitinib that lower are than blood. time the were in reduced plasma are drug might previous confirming passage studies systemic the tissue tissue see data we we the a results levels the into with indicating drug conventional same elevated doses, hope the suggests expect colon to The oral from delivered of being

findings the also data, the pleased study. device portion with functioning of growing all performance confirming on to device single-dose with devices are of the these what and we forward of be to data multiple-dose adding and the as to NaviCap with performance. is expanding the expected appears body and This look on We

ascending cohort dosing the with multiple or which tofacitinib, is conventional daily. of participants MAD, The days. comprised is once-daily This of dose, and receiving X-milligram for is X daily at twice tofacitinib doses BT-XXX or XX for placebo, dose XX-milligram normally of dosed half

anticipate MAD at the Dosing regular I progressing the confirm including colon currently is we obtaining toward SAD the in with pleased execution addition blood of the the will both final which effects of we're of are In data, for can the study data end study MAD and end well, the to also study. quarter. colon samples, includes of tissue so portion biopsies and having study things on portions, second far. and We the be underway, tissue the

time, turn over to it back you. Adi, at I'll this

Aditya Mohanty

data platform's very we're a new but isn't gratifying prove IBD. to are seeing we paradigm far the outstanding, which surprise The us, so treatment to it's potential Ariella. a truly create Thanks, work as to for NaviCap

for the As from current believe ulcerative while of reducing can lead outcomes conclusion trial. we're concentration this increase patients demonstrate systemic Ariella mentioned, suffering at is potentially exposure, what NaviCap colitis. We will technology the our tissue to better to aiming which

clinical colon, for potential So has outcomes. delivery. that in the of far, our by precisely data the conventional has drug this will methods. compared greater tissue platform device believe the colon We to demonstrated beyond functioned, payload the the intended, NaviCap to as concentration illustrating patient The trial in current with suggests potential tofacitinib delivering drug our achieve the improved lead

door We reduce of also substantially open conventional combination tofacitinib was treatment. patients concentration than and blood toxicity in This through saw that UC. the the colon the absorbed therapy could lower to for

a the the trial, we're of in using clinical also actively ahead In conclusion second during addition to and anticipated of XXXX. planning study patients our looking half

confirm this to of and in pharmacodynamics for purpose is our future plans tissue UC and and patients pharmacokinetics plasma to The inform study trials.

in have blood of data proceed UC the Although healthy confirmed accelerated representative that new patients, patients quickly UC on fairly we pace development. to tissue are and to an want KOLs trial to volunteer maintain that and

the X portfolio XXX believe focused applications for NaviCap and platforms. for also IP delivery program, patents platforms. granted to most intellectual both devices ingestible clinical XXX and with on our strength using we team While we drug portfolio execution hold pending continues our the over over We are the across comprehensive BT-XXX increase our our property of for

of program, JAK inhibitor. delivery tofacitinib, This supports Recent anatomically proprietary patent included involves targeted BT-XXX the formulation delivery wins directly which patent a inhibitors a GI JAK our addressing a to of tract. of

BioJet jet parameters received which platform, We notice for GI patent of liquid the for key of to a new important also our covers tract. broadly jet delivery an drug

track. the Between for liquid GI IP that Biojet jet this I portfolio say to own platform, existing we we and delivery we our and the can think invented

platform. We designed make where liquid that, once of into It's delivery the delivery continue of to excellent small of to jet can foundation with oral stream achieve drug wall BioJet the swallowed, the a using large small molecules this circulation. platform. progress into Liquid be delivers systemic a absorbed intestine it is the of capsule

delivery platform those also We alternative liver, provide molecules efficiently believe which methods. with to BioJet delivery difficult needle-based the complex other It of an oral could the can enable reach molecules. more is to

few the as as both past strong made our device. molecules quarters, assessing in we've the with Biogen progress own well collaborative Over

our rapid bioavailability and enable achieved our to excess studies, device. our XX% IV in have made studies compared with with infusion with iteration and efficient and has enabling animal in animal which We performed antibodies We first-generation faster systems formulations, us of development. more of assessment benchtop optimized oligonucleotides molecules peptides, that successfully

As pharma research their study animal coming new company. our a and data In IV. we reminder, is the collaborators and receive molecule, the us weeks. a by a in performance is that with XX% large recently considered We target commercially viable expect around completed to we studies announced compared from that collaboration to December, pharmaceutical with

execute on core our continue also we collaborative enhance molecules, BioJet platform. we to While

for our at that upcoming in our candidate, studies We'll more We over adalimumab, candidate. have as be the the in even demonstrate of bioavailability range an animal months XX% as better with semaglutide, to data June. the completed details few XX% further past peptide sharing conference antibody well

We we're delivery potential its and to an to enable the ability liver-targeted its in a existing technology, category-leading formulation competitive the deliver to excellent position large payloads without complex BioJet advantages: which molecules, range ability its large with of of has of reformulation, bioavailability deliver to number complex multi-milligram its believe achieve in liquid ability molecules.

technology, pharma broad potential continue to we the this see applicability from With of partners. interest

to good current goal get progress enhanced either We're that partnership others. this near and a collaborators interest continue year to more partner potential see even in from companies. more our the term remains making with front on Our or

To summarize our anticipated milestones.

completed For final clinical we our from to the as in be data the conclusion and data study the execution possible. We line anticipate SAD/MAD MAD the share during trial as during top our receiving U.S., await quickly BT-XXX platform, QX, to we QX. of and NaviCap expect plan of the portion we

the study XXXX. plan of patients in a second UC initiate also to during We half clinical

For an pharma an our on animal share some QX, to recent studies collaborator conference. with BioJet large during X the recent animal anticipate data upcoming study and our of we from update at our expect platform, we

partnership progress continue XXXX. to enhanced in our toward of an We goal

results With that, market now our call over to capital I'll of turn review financial and for Eric a activities. the

Eric d'Esparbes

our good a first then financial of positive activities results cover of We evolution and balance afternoon, everyone. sheet. and our had call. on Adi, I'll a capital the number provide more market Thanks, important since background last our

charge Operating restricted normal related expenses run stock-based prior compensation rate expected more our $XX.X million, onetime aligned fourth a noncash during had of to compared was quarter stock we to when with employees' were units. vesting the which the quarter

were stock-based quarter, preclinical million activities. Excluding expenses operating and during in device investment compensation with development, fourth the $XX.X clinical expenses, continued

fourth down further, the this million, compensation quarter G&A R&D $X.X while were the expenses also break stock-based stock-based quarter were fourth in To excluding million, excluding expenses. $X.X expenses expenses, in compensation

our with our BioJet programs, on preclinical spend core clinical remains work development with focused our pharma Our OpEx R&D execution on NaviCap collaborators. and of

our with we was run loss expected included in to Net line $XX.X which the XXXX, for noncash note charges ended months expense December more X also for charges the implemented quarter, convertible September attributable large third XXXX. noncash stock-based million rate XX, exchange compensation compared and in to the

during progress million spend substantial with our in of made represented to the Those fourth the G&A more also associated investment our which recently nondilutive spend QX. our quarter and XX% We in matters, with efforts legacy cash of activities in Enumera culminated Molecular, ongoing in $X than still eliminate capital. monetization efforts generating

remaining reached impact an forward. litigation of having the resolve agreement minimal of securities any the going to Biora also on we company's legacy are in and confident matters, We one about legacy principle potential issues

to on structure. our capital Moving

through note the balance reminder, convertible a reducing forward note step by substantial exchange a during by agreement. a we made third As on million had $XX quarter

in during happy reducing to announce remaining well I guidance have executed making notes and this We call to alone. in company's in by front, million progress capital that also further provided new in December which last outstanding we're $XX we XXXX were reduced debt balance. notes our our convertible XXXX, $XX very a a reduction brought total, net than of note Biora. million exchange, XX% in we In more the on

interest and file the XXXX, the went we actual when the GAAP, investors items In we end Notes liabilities to X balance to $XX accordance payables, reduced we XX-K read to future notes actual that invite notes, will during of and including balance other reflecting X approximately with and million at sheet warrant the financials derivative so from $XXX to principal outstanding balance in highlight our our period. our be beyond million down of which

new our and from for support in investment large investors reduction substantial notes demonstrates institutional The continued programs. outstanding capital

total In in March into exchange, with the investment, a new new note $XX.X months. bringing exchanges third these Biora last million fact, earlier announced over X to we combined investment institutional capital through

on these important sets the component We believe potential up transactions, the of the of clinical nicely data which of acute and stock. truly want success from We this for our partnerships and us equity shows appreciate their ahead with transactions potential this of development series investors, focus we to pharma. our value commitment future highlight significant of

will the I now over call back that, turn With to Adi.

Aditya Mohanty

to excited We and achieve start the early clinical our to execution look with are BioJet as a We're continuing this on Eric. data focused we're partnerships year great complete we forward from further progressing platform, BT-XXX updates Thanks, year. focused strong on continue From providing this to trial. the our milestones. to towards our trial

Operator, we're now for questions. ready

Operator

[Operator Our Vandermosten Instructions] is John first with question from Zacks.

John Vandermosten

reduction just to question say to the steps next change. in Great. first huge pose I debt. great That's about for And -- wanted for a BT-XXX. for wanted first congratulations the the the

you already do and approved, expect front second in of approval the numbers see good patients? study kind UC shown that PK the to half in tofacitinib, -- this following FDA the you've get PD to of underlying and understanding what that what is the Now for drug,

Aditya Mohanty

for the Thanks question, John.

to get very, second in what this should front we the say near want coming talked future coming we we very put what's to we that excited of what in up about we're Before about really FDA, quarter. is

to a Ariella of portion about back So MAD little the what's to our data, we'll then Ariella. I'll talk let ahead, and next. you Go bit come

Ariella Kelman

much, very Thanks Okay. Adi.

data to So a the expect Phase results early portion time same receive week. so from we again, are well of over data that but the is, designed also QX. including the concentration confirm multi-dose I for as this which expect those similar as data tissue. colon we colon forward And of course, there so is or study, colon NaviCap pharmacokinetic expecting what end the daily X biopsies, the we the pharmacodynamic and looking see to and in on data, delivering hope histology pharmacokinetic safety a colon. And summer, to profile, And confirms tissue dosing functioning we're tissue, as and we to MAD have by to from for the from

So we're looking forward that. to

Aditya Mohanty

Ariella. Thanks,

we lot a So think know more. will once John, I we get this,

been many get patients. keen Of right? getting tofacitinib what fantastic really that. course, do the data as get mean been drug and to People we is the in less it's So used in we've we're looking have this the I possible. move colon to as know has works. we're for. this you fast more But now, blood? great it's Can so It

look we yes, to at data we're now. at, So going look coming approaches this up but that's let's have

John Vandermosten

the GLP-X getting Sounds think We've about on just billion $XXX orally. look course, good. there And revenues I there's large biologics I also delivered Goldman showing wanted about our number $XXX to billion then, from for in or to drugs at the of that some research the larger billion put done side, agonist. environment of out potential molecule biologics. And $XXX

sponsors really they benefits I used So it? with is What and lot of behind about. back as we moving see lot of before be it a there's that, on from fast as a jumping something could and possible? What that forward products keeping know do has want all which to money this guess, executing, potentially that this board there's to way,

Aditya Mohanty

talking about which our deliver So able BioJet to is you're these designed platform, be absolutely biologics. to

in can't So engaged say with I details. I've -- talked they in. a discussions the certain resulting I difficulty we until they end where about want willing several companies. -- quiet this share to lot because wouldn't to pharma been what a large you stay up of it's spot already to are they're tell has get our past

fully absolutely engaged several So conversations. we in are

the could timing, do good likely partnerships are gone feel of predict something year. about conversations we but engagements we have in these way to that this and pretty hard I think terms

We're of to. and fairly doing year, yes, not to publish a a share and that, to I we don't saying, is be keep allowed to say we're hard fully partnership involved. with more for, So lot of kind somebody. progressing. is going And we to get able we're soon. what the this But the know they're looking And hopefully, say what that's It's great, can work. relationship we'll we because engagement

Operator

next Harrison BTIG. from Our is Instructions] question Julian [Operator with

Rei Tan

This is in on on on We for Rei far. a had Congrats the BT-XXX. so data progress couple Julian.

is where The studying open SAD/MAD XQ, for PK confirmed final be to in the in you developing first payloads is, data to or if optimized adequate could lead any other expected the would efficacy? PK in IBD, gut more

Aditya Mohanty

Fantastic question.

know, to we turn with with, we work you We've are and do it. that don't, we or our other that. keep could this So certain done could maybe adalimumab. we use that you own version there Certainly, about approach know quickly we of some talking molecules have

to want get molecule to ourselves do to the know-how, jump expand with fairly not going internal either we're and have those all of data going We to we We're ability don't quickly, ability have somebody. ahead. and jump. but by Now things, do availability this to or

So quickly yes, as data. this we few very grow get really opportunities will start next in months to the

Rei Tan

We therapies use. know use a BT-XXX's elaborate UC you potential safety given Phase profile for touched current could earlier, how another might Great. the I on enrollment in influence population future one target combination but the potential preliminary in on and on had potential you in Ib? landscape this positioning

Aditya Mohanty

Okay.

this to population, XX% about already XX% trials landscape. are starting as the tougher for happening, don't know, where here's up like it's or anything. multiple the combination almost end core remainder, all and are, you these drugs a right, people So patient the try to like some issue, population. There molecules the therapy in of have Because of little talk X/X, working

compound it biggest people then these people and with combinations. The drug each with toxicity, multiple is issue you so toxicity often trying holding drugs. back are when And and individual

to level with things potentially So toxicity -- lower BT-XXX. along or clearly, try provides multiple a opportunity low toxic the having

telling kind currently could early third-line what terms it's see exactly second, but to preliminary So combinations sooner is potential in much we therapy. the in start have had of do to to of BT-XXX where some where you move use. We bit a conversations, tofacitinib than we for use

And much we so the be going go opportunity larger as forward. is to

a that. more. will tell little know We early It's you to

patients being will acting kind bit we the current selection potentially more about little learn patients, with MAD. of But terms let you thinking the Ib. thinking In a that I'll about of as our what of of evolve tell Phase Ariella our from we're

Go ahead, Ariella.

Ariella Kelman

Yes. Thanks, very Thanks Rei. Okay. Adi. much,

half UC trial. coming second to But the first of in in higher tissue planning the and should are pathway our of which to targeting across from And able population know goals ulcerative are with severe can treatments studied the inhibition during the We that's disease months. colon with be moderate more we we patients be site study details efficacy are for provide a So patients we data to of think JAK-STAT a better should considering at concentrations, XXXX. which are UC lead BT-XXX, with that in associated colitis, what patients the greater UC. for we're and multiple that

Operator

time. are to There call the back for hand I'd at Adi questions over comments. closing no to Mohanty like any this further

Aditya Mohanty

with joining excited for progress We're back and all updated. you us. our Thank and to keeping really Thank look you. forward coming everybody

Operator

once joining fourth for quarter results all XXXX financial you for again call. Thank the us

completes have everyone. our about a progress good are We excited call. This the -- evening,

Biora Therapeutics (BIOR) 26 Mar 242023 Q4 Earnings call transcript