BIOR - Earnings call transcript Q1 2024 | Biora Therapeutics, Inc.

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Operator

Greetings, and welcome to Biora Therapeutics First Quarter 2024 Financial Results Call.

As a remainder, 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. Please go ahead.

Charles Padala

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

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

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

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

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

Aditya Mohanty

clinical update, study Chuck, thank had of our progress for we plans corporate weeks excellent for clinical of you, our joining everyone, since us. the the Thanks, dosing BT-XXX. last and successfully of development completing few In the NaviCap short in our platform, execution

pharma. development continued both and with to development For advance the our platform have BioJet for platform, business we goals

and to ulcerative of BT-XXX in better of in with shown across the clinical in clinical colon higher the our likelihood battle is a The with inhibitors update of including exposure UC, drug colonic on JAK an associated tissue. tissue in Research our First, or colitis, basis platform the mucosa. and exposure drug that targeted classes [indiscernible] colonic higher therapeutics achieving colitis. and ulcerative importance is higher activity our program, UC tissue The lead in drug NaviCap activity outcomes approach anti-TNF.

designed in tissue as increasing to Since provide toxicity colon. delivery to our advanced the directly UC complete simple have of Achieving therapeutics Studies are shown the risks. is been colon of not in due achieving colon, dose-limited NaviCap therapeutics anatomically for drug the that length of That's systemic increased levels has with many NaviCap targeted platform delivered why is the to dose. colonic of payload the coverage. disease as entire the along site

be month. Week In sharing data at fact, D.C. we will the more later Washington, in this Disease of that conference Digestive

show present We of in the studies the well performance data device data active clinical as will UC including and successful the patients. different device NaviCap These participants the colonic across platform. healthy of the as humans, by full function achieved NaviCap on X coverage

tofacitinib what were observed, GI During as interim in is ] from with our X in is consistent at that No minutes were an observed at NaviCap, safety last the devices first is approximately measurable intended That found portion trial. was our tofacitinib occur recap, and drug to concentrations well approximately the single-dose tract. hours injection signals hour [ with NaviCap at all we update, with maximum in and upper absorption after intended absorption is clinical colon. delivery contrast we BT-XXX positive of with maximal where is it double seen which ingestion, results consistent performed in what and To old blood tolerated. hours post in to conventional concentration the X blood shared

reduce see participants and remainder GI portion for Everything tract, colon compared patients. conventional days. in and seen was we doses to UC for delivery data of the and achieve could methods. as placebo These tofacitinib. the the indicate toxicity and tofacitinib of tissue the from to with they drug announced potential suggest data lower BT-XXX or of Xx at that absorption the cohort with keen the and once-daily with dosing to We're of BT-XXX X XX approach a upper of share trial XX-milligram X colon the to we've in levels of trial, in our recently completion delivery far Colonic efficacy greater of improved the of drug milligrams end, that remaining so associated the lead healthy opposed which to systemic or concentration to received indicates X

also In results, opinion addition those data the and study in study. those Advisory Clinical leaders, samples, June. These will full sharing we data We're discussed Board. key our late and the of part blood in this awaiting be with we analysis anticipate also including of biopsies to GI obtained tissue colon experts on now

trial study learnings Phase to clinical an for a we maintaining towards the our healthy for our with in the development this continue UC from of later In begin Getting to patients in and addition eye prepare platform. help would us trials year. volunteers, plan future of to add our accelerated to NaviCap X data clinical cadence conclusion patients for

need UC we in and remission, optimize unmet systemic UC. need in therapy remain share therapies potentially believe and exposure results the experience from with tremendous to UC, excellent quarter. serious this in advanced high and to focused more data in can clinical tofacitinib far, for so without gratified sustaining efficacious later We remaining drug continue patients we're our achieving to We're the we higher, see trial patients difficulties exposure. the all by on the Despite for tissue the excited achieving

optimized believe potential UC a the to BT-XXX, Beyond NaviCap therapies. has create we of portfolio the platform

jet the platform swallowed, It Liquid delivery outstanding capsule delivery. performance promise We the platform molecules, a foundation platform. that Moving BioJet of called jet on systemic of liquid of drug to our also old platform. delivery efficiently delivery the the shows can the uses the its small exceed challenges is large with other of which The alternative solve has molecules. BioJet is grail small to provide into BioJet therapeutics targets and to those the continues of holy oral been drug an intestine, to through delivery the it [indiscernible] difficult of is more methods. believe the reach complex where once to systemic enables liver, It needle-based absorbed in which delivers molecules circulation. BioJet

bioavailability We've candidate semaglutide, few over peptide our animal completed advances in that collaborator months candidate, past studies and further and molecules. our for consistency in antibody adalimumab, demonstrate to for addition the

payloads that have the preclinical is We bioavailability the complex ability of BioJet to to believe now data multi-milligram considered an the in is compared achieve position liver-targeted reminder, range without IV. molecules complex a and by platform's and viable we're advantages, delivery to performance large demonstrating excellent commercially With molecules. competitive enable formulations deliver potential with reformulation, pharma BioJet us collaborators its in target existing these large deliver we all As XX% category-leading of the to to platform. our of

is Our and preclinical data an well, to work collaborators in we upcoming sharing forward look at update June. conference progressing with an on our

bio into liquid to successfully proof creating inject was an and large the We focus device molecules with smaller that assess first-generation concept of vivo BioJet our injection that design. used jet Our on technology experiments, performance in XX% deliver initial [indiscernible] Through achieve blood. as able molecules an we and animals average of adalimumab an drug for to availability variant with well with were as from semaglutide over those in our collaborators.

This concept to clinical we're that stage as device serve to have further proof BioJet prepare evolved platform. studies continued are of well successfully assembly development, which for of BioJet able We BioJet. manufacturing platform. development from including improvements We this make with R&D, to NaviCap our later the leverage under we will and process, to stages acquired our with for future for clinical us expertise

process interested mass shown BioJet the have We partners The parties on by partnering are the are this also the partner work our by ways potential this a card with and and to some mid-year. the critical stated by technology We're interest of and We're from see for may companies. clinic. have currently of who to process flexible running collaborators to engagement seeing platform bring strong a we're together. eager the encouraged data interest new we like-minded for and to parties is interested are evaluating goal confirmed

our milestones. to anticipated Now summarize

MAD from the data platform, second NaviCap quarter. toward execution our have our we share We study the the SAD MAD completed the of clinical portion and trial of For completed to for plan of end BT-XXX.

participants We active and device later different Washington, will patients this human at in of Conference present use the function the in in clinical data the Disease studies healthy Digestive across D.C. month. NaviCap on X

the anticipate UC with second a in BT-XXX We clinical half initiating with patients during of XXXX. study

summit Delivery studies animal at update Formulation data shared For our in and Peptide recent BioJet an the on June. platform, will Next-gen be from

BioJet We With continue a turn goal results our market for of I'll activities. that, review to and for platform financial enhanced XXXX. Eric toward progress partnership call capital in the an now of our over to the

Eric d'Esparbes

associated Thanks, market leaving which Adi, with preclinical We spend-based our further, our positive quarter, $XX.X activity first continued expenses excluding device first XX% results in financial and during expenses remain with year. background almost were and first by very actively quarter, during the down the on this working activities. clinical active afternoon, million, provide capital evolution compensation stock-based expenses, compensation legacy matters, and then cover development, activities of core of which with G&A are balance the the To were excluding of to everyone. million, XX% good end quarter. in the expenses I'll investment the first spend eliminate costs break G&A of sheet. $X.X continued more . Operating we was

programs, expenses core million. result, was R&D including allocated R&D OpEx expenses, the and million preclinical on work our The QX $XX.X to majority spend execution development concession BioJet NaviCap with the excluding of of in with spend pharma collaborators. stock-based were clinical our with Biora's our $X.X

I'd include million is our ended refer for better that X was for the noncash why months $XX.X Net as XX, those elements just and expenses, for like the $X.X expense gain which loss in many for million change stock-based liabilities. actual results included remind cash operating investors was which our I noted. around compensation to also XXXX, operating warrant financial we to quarter, burn, excluding noncash items, which March guidance

structure. capital our to on Moving

made by quarters. bringing XXXX progress quarter As to Biora the new we last in XXXX, through a net We total XX% further by note exchange, notes in these during than investments, $XX first more with outstanding reduction X third in new combined in completing alone. the investment debt institutional million exchanges in company's reduced the capital a to reminder, a million $XX.X

value potential we We as investors institutional truly their to our approximately demonstrates in the end equity As our reduced of debt first by a the to from appreciate agreement materially of continued note for confidence our million commitment the $XX result, convertible stock. quarter. balance this trade

we quarter, months closed million million capital a the than last capital noteholders of registered funding During from a direct placement, through million which equity our assets the X strong securing from $XX in of $X.X $X monetization million proceeds to the legacy total raise over by $X access complemented this brings more markets. demonstrating This or April. early and to raised

for are call of and efforts with with we making and Adi. turn We clinical quarter of of that, the good important now have to expect to the eventual I later up optimize With will believe set structure, over progress our capital data development our company further transactions pharma. soon. success readout this We ahead our back partnerships to this updates the series additional

Aditya Mohanty

clinical to excited platform present BT-XXX the trial We're Eric. the data weeks. in for from our coming Thanks, NaviCap

BioJet towards this ready our further partnerships achieve Operator, focused to updates year, for we on we're we look providing the milestones. platform, now forward to . continue For progressing questions. we're as

Operator

we that comes H.C. of Pantginis Joe have question first The Instructions] Wainright. from [Operator

Joseph Pantginis

a So you could first, I'm curious just if give little perspective.

to NaviCap it's levels it you program that as talk your with X seeing Xx obviously are that the -- tofacitinib, appears encouraging about. -- you're lower With plasma

the even Would I'm you within wondering like little were of is see perspective Or about expectation could And looking physician give towards if just the where levels? does lower to on So you physicians' play continuum? that for? that? it sort target views a you range

Aditya Mohanty

Joe. Yes,

which dose on expectations, to is is So X I it's That much lower. is tissue say to the can but we higher a other What physicians right, we from probably you side less. Xx you're which doing, the what with the physicians, X that lot. know plasma than are were have slightly Xx better so to conversations matters also side, to [indiscernible] seeing we're lower with because side, X Xx combine is a

than dose dose we ascending for there have. multiples the we talk On believe Xeljanz. about publications goal tissue so being can the a we current in lower how a tissue, behaves which much the with were side, for XX to higher, mg tofacitinib the the that with actually do like dose And dose get more label single

get likely so tissue we in the we the see more And look delay. can that because X-hour we

yes, interested in our clinical And conversations is a couple members the quite and They with were Advisory seem this well, good. quite initial -- of Board encouraging. data,

So wanted. far, what we so really good,

Joseph Pantginis

That's helpful. maybe strokes second then to of can I little more brush guess, a study? half, design And bit forward some UC with the give the to the looking you regard

Aditya Mohanty

we'll get excited few the We study to hardly June. the like in later in about So part What in a of weeks. weeks, really is, few UC well, said a right? we're in

it on already look things, to some about after data. and study, we've on MAD that will that opinion UC the from -- a data the time. as get in key have to GI we'll is will everybody, the we but determinations And we having help So actions patient share after information looks make some leaders, from started experts, have protocols some got ready data, to we in. at few work MAD final weeks, us the MAD starting we've data what roll like we're getting with We're going

more. And be to so lot able we'll a share

past get in Let's coming the weeks. MAD the

Joseph Pantginis

or Absolutely mind, statement, little of is more this maybe Are about don't you -- what to like partnerships? in be last then are and partnerships we would clinical some of sort models XXXX, guess fair. if looking forward-looking be potential what continuum my I more do Or would maybe a if what sort looking at? even collaborations When for? you early essentially will. you talk And question, these

Aditya Mohanty

Fair question, Joe.

process, when have soon, excited So very with short answer pretty actually everybody. about I fact can a a and to will with we the few lot tell are that we'll months trying We're prepared running process. that we in a share you, a more to in get are running our remarks talked we we a that specifics conclusive

into for to Clearly, but past is more want prepare clinic. of getting what We'll collaboration into molecule, really the we're then want of do say we we're want others to take not who be the What -- focus. specifics disease willing it this can with feasibility this to we somebody And who our is to have stage. we their combine clinic. the it, get do might kind that's on their take and to work we the indication, happy to to

of of to it would So mean be doesn't collaboration, that kind commercial looking not we've sense a though, collaboration we no kind and would that -- somebody Ideally, right seen that are for makes interest. that's anything now. say we

but looking the work we're partnership. together can something wants and who on somebody serious a take so beyond into we And that to a collaboration, for clearly clinic

Operator

comes have BTIG. of we Julian question next The from Harrison .

Rei Tan

Congrats on is on This Rei Julian. for the progress.

within that have framing follow-up -- framing Are then is top a success? you guiding data question. BT-XXX a expected weeks? line Are you for bar previous a to And how certain the next for the we a follow-up. expectations you Just on are few

Aditya Mohanty

Yes.

how a time. it to the even delay data of clearly be confirmation because success colonic look supported uptake the of -- data -- showed that the kind if washed at in us, shared all that saw we colon, that the body that through would data So X-hour supported and we -- uptake out in more the you over supported SAD

would to several confirm to time. that And we SAD all getting similar be being multiple would be would awesome. have same body so the want no at with to over the in and data days devices potentially something issues have these multiple dosing and That

kind it. right, But know we're plasma we the some to tissue that already be of colonic we're to data have will multiple that data with -- that needs to us that's over what because doses success and multiple getting looking uptake would be over support days, We confirmed for.

Rei Tan

Great.

factors program, are what the to forward your that turning to the adalimumab influence data. biosimilar go/no-go might decision some Looking And there? then

Aditya Mohanty

to a little making only go, go. a be no It's

I extremely we're encouraged with what's think happening [indiscernible]. we're -- by so the

this little some even our think data ADA that. we that to to for expecting what We much eventually you all, currently get do with That us what of remember maybe could because can remission want and saying a almost than is we drugs tofacitinib, the some with potentially keep and program actually guide with what are a better beyond have have rate latest that ADA. further, in better that in take various remission than it gap early data patient to XX% initial be shorter the a in would TOFA molecules. -- we currently We development the that rate that, the if think beginning, we are XX% approved approved is available we're significant

program point better taking BT-XXX we can to important. a So is outcomes show where our

However, with little from but shorter bit, the ADA, look a also slightly development a much the we faster and that plan. could learnings for could be outcome take different the BT-XXX a

Rei Tan

guess, looking payloads thinking days. Are a I with others? in understand Great. you pipeline? And than the helpful. your more there it's you how I opportunity that little forward are Very forward obesity more certain early are about interested

Aditya Mohanty

Yes.

in into as us much the current clinic. the right to, a faster really you molecule So about now the but partner's us clinic we taking this a investors. allow this of talking indication we not with the platform that more potentially in and allow for take would molecule would to preferred the with something even that efficiently partner's progress partnership resources, want have necessarily we're get done know, with the amount -- fair to that's short We work, semaglutide, decided run, that the

a be year. own for And maybe our that . past get sometime that we'll next would so program clinical BioJet back to

Rei Tan

to the looking on data. all Congrats forward the BT-XXX Great. progress and

Operator

from have from next Vandermosten The comes John Instructions] Zacks. question [Operator we

John Vandermosten

question start I you're conference the the me out Phase Let from PK. trial? might trial. share with the you at I safety at What know and June a BT-XXX looking on else

Aditya Mohanty

is So at clearly, animals, the drug over a being for first it lower what been we more talking the about which that our indication plasma can dose we out. and currently in with in comes tissue, have in back want used. to that next yes, goes the single from got confirm to time got we dose, colon then we than is deliver beginning said, what indication what less We

sure we way make to of want the approach. those a We do Getting truly is confirmation data our multiple sustained doses. in over can that

As right? than works. The tofacitinib of label. has knows it order in to work, there already been kind prescribe that dose make what's the on been proven, even higher a tofacitinib has Everybody having doctors to keep issue

really able To that's plasma So toxic. home tissue be low with the is get run. really concentration a to concentration

kind get. what that's looking we're to So of

John Vandermosten

seems looking some like BioJet. device And of is commentary call, it the the and Okay. the may -- more design inquiries Is press based earnings release. last what have moving it to there at release the the around? Or financial related since evolving it are your I'm And conversations on in aspects on forward? been new something wondering else? or

Aditya Mohanty

John. Yes,

interest. So yes, got we more

Part and people process. running to also we a You driving been this has making process are aware that, correct up. and look, that picking of that us are

collaborating along who with forward clinic. into Of learning the to we some with work course, getting we'd going on we you. But love to need make more choices continue

of I great, the this want entities some to they have point to, we're with process, idea that. want for some drove take at to them, the fairly we fairly talking molecule and line for when various clear still forward think, have . We're drove is for time to we're decision soon. some this that a talk us, investors ways, open through around so are that conversations which that the going a And in for

Some they yes, idea have molecules on, a is take broader in might clinic. of the to want to here Agreeing number forward. the take

conversations, do going indication, need That's the that people optimize we clinic. to certain that things we something ability be that specific approximately because just molecule, time to And all we'll decisions. point a really line have where specific in Now within that's that, us to we then conversation. clinic, for going if got we gets platform, to there's to certain based to on the agreeing can get with to and multiple make but our a that

John Vandermosten

as that as keep multiple with the there pharma, came license? be it is can Okay. as Or a specific And they to negotiate block to look what how guess you big to or do it that? biologics? you to license at get probably some able I other down you possible. that they perhaps from others. thought is Are kind -- on you -- you another parties mind how way negotiating when will But narrow broad of you to want is have specific we want as they narrow

Aditya Mohanty

I the months. a So short question is news few to very close we The share The being appreciate get we're able to could long a to time specifics. your getting good that specifics have we get to in through. take breadth of

trying We have focused are but very absolutely on we good. answers We're -- optionality. maintain the value and maximize to that

trying away clearly us. So our of optionality, is bunch we're priority that to a give for not

John Vandermosten

Right.

several You've capital on over There's months, the got last that? question terms see X. movement guess, that what we in and And off the path, for of next a then between do dramatically. seen What capital structure structure. we've last next I of lot is been the narrow improve

Eric d'Esparbes

Yes.

So thanks, here. is Jonathan. This Eric

lot So having we've coming milestones very about up, of talked here a catalysts. important

we pretty next. the think take how key I capital the will be those to establish much structure

I and have in of think see the the results, an the capitalization our and improvement company. structures expected milestones further expect of achieve could we market to the [indiscernible] potentially we can we simplification if

how we that. see I is, wait So generate the way let's answer would and

I answer those of lot a questions. think it will

Operator

moment will see questions. have if We a Instructions] we further pause any to [Operator

no So questions. further are at this stage, there

Please question-and-answer go the back have we sir. turn call I the Ladies closing and remarks. like And would to end reached ahead, session. our of to Adi gentlemen, for Mohanty

Aditya Mohanty

I thank really I for everyone joining want appreciate your us time. today. to

very to forward coming back Thank you. and looking and updates eager are soon. sharing We

Operator

then concludes today's and you us. Thank Ladies you. conference. joining gentlemen, for that Thank

your disconnect lines. You now may

Biora Therapeutics (BIOR) 15 May 242024 Q1 Earnings call transcript