BIOR - Earnings call transcript Q2 2024 | Biora Therapeutics, Inc.

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Operator

Welcome to the Biora Therapeutics Second Quarter 2024 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. Please go ahead.

Charles Padala

Thank you, operator. Good afternoon, and welcome to the Biora Therapeutics Second Quarter 2024 Corporate Update and Financial Results Conference Call.

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

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

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

Aditya Mohanty

have University partners Western been and of And NaviCap us the the patients over treatment Biora in platform disease everyone, for knowing joining Chuck, Despite these exposure see BT-XXX Mount major and of colon a Feagan, by are them the an colon. Research tissue. and UC our our tissue, help physicians joined pleased see using the XX was in platform. Sinai therapeutic have to therapies, names colitis, the Ontario. in colon treated Dr. contextualize I over drug treatment significant over, both of trials many investigators. look appear These now platform. I'll affects layers our for the the an reach Sands principal if to the quarter on responses including being program the number UC that in you'll recent submucosal of colon. We receiving results of ulcerative disease It's successful that large of X the in at KOL patients largely cohosted who therapy. Brian IBD. even for the the higher and BioJet our the years of better as to powerful is present of which Thanks, developed drugs trial NaviCap great inflammatory is clinical busy levels local and UC clinical and mucosal Dr. BT-XXX. BT-XXX with very of you and is for which Phase people Bruce colon with disease by was of a systemically us. legends It clinical tissue are attempt you, event, and our It's productive that begin announcement with progress were shows the thank for the with to trial significantly of work for

been not site and drug a way tissue colon in With tissue we activity delivery achieve therapeutics. attempts targeted reliable delivering of to been to has exposure approach, disease. drug have achieve several aim there directly higher by to the Although made, colon our of

achieve was incredibly and the this demonstrating Our this objectives to platform's colon, have study. step our all we're forward direct Phase NaviCap trial in to big with topical I pleased very delivery clinical met a to ability

XX hours and circulation, oral circulation wanted toxicity risks, we approach, drug in reduce JAK delivery issue consistent believe profile lower systemic for levels the were we systemic help did. with at drugs, than colon. could we with the inhibitors. blood many including minutes timing which the when delivery colon. Looking known PK achieved indicator is We oral to X With this conventional compared this see entering delivery. via the at Systemic of a drug of the The are to Xx X an in levels conventional data, tofacitinib with lower shows UC in therapy pharmacokinetic to up about

We also wanted to on to exposure get tofacitinib. tissue some data colon

travels payload several recall, to of to you device has proximal wanted may far function As previous side distal saw studies. confirm NaviCap at the to that colon the We as programmed to we the the delivery been entry deliver in or colon. with the drug colon from

we both trial, conventional concentrations also and X/X strong correlation a showed able of The in the predicts through XX% to plasma after between accuracy than dosing. Across greater that performance. which tofacitinib. correlation, X Our study XX this biopsy above the ICXX tissue to which at level no timing doses excellent we tofacitinib at the the release the we extensive studied were hours points, of before distal the after dose that performing those X/X should to colon. colon before tissue ICXX indeed procedure. Despite which And with Phase could release mg at model This across locations. notable saw half design concentrations a the levels of tissue observed least biopsy final of approved biopsies I entry, especially early quite in this data along the this because X of exceed confirm with did daily with be we trial is mg or lives colon prep colon XX that of because and sites XX are these sites levels X results arms, anticipated tissue levels. all of hours We detected drug all since low X doses biopsy, for time earlier in late tissue is X for required

lot presentation. included also We safety saw data the KOL were details trial. A excellent in in our of the

presents to remission. difficulties And this where achieving remain data. Patients need. viewed haven't Medical Chief tremendous job event trial, the Officer, and replay, above this you exists UC to yet, advanced has the is Ariella did the focused sustaining A clinical unmet to you approved continue we We so invite who a on a watch amazing because important that If in serious Kelman, for of many. platform potential that Despite XX% for through it an Dr. with I ceiling our to leading this believe many good placebo. delta approaches. XX% suffering isn't induction therapies, therapeutic NaviCap XX% the simply about several tremendous the enough therapeutic condition causes efficacy at break ceiling experience

inhibitor we safety First, achieving JAK therapy therapeutic better reducing outcomes can platform risks. this by while think optimize

a Phase demonstrate Our proof of I for Data this. mechanism

We platform molecules, could and delivery for of UC and optimized ultimately outcomes could envision Second, deliver the improve research a drug as therapies. integrin classes believe we colon NaviCap those inhibitors. shows other such also targeted TNF that portfolio inhibitors

UC Third, into combination near of believe our in UC to leading Phase inflammatory to therapies. In physicians pathways. support moves combination We development a I term, therapy plan very order a clinical enabling importance patients. NaviCap talk study for target multiple in results clinical the positioned platform clearly facilitate would the about the us well be that

we seen objective for our to that trial. and to to have the forward that patients, and I College PK in improved efficacy our that Annual should development community. will prove is UC presenting to a clinical Our we Gastroenterology's Everything selection medical looking trial we're reduced response also with Phase study confirm October, lead from inform eager the for be profile toxicity with out. We're Meeting of the to to induction dose American continue and indicates where subsequent data clinical to in approach UC patients

to been outstanding its which on promise of holy to targets has grail continues to our BioJet exceed The the therapeutics performance and called platform. Moving of challenge of systemic solve molecules, delivery. shows oral drug delivery BioJet platform the large

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

interested we As partnering with steps that. a quarter, parties, during shared established past significant the with quarter, we've you made with pharma and I forward defined last process

and for of his stepping shared Formulation as such up goal we on are forward Novo multi these of position molecules, agonist. we competitive platform, a formulations clinical to least on these on near shareholders, to also I'm more encouraged has our about by enable will session payloads to but update to pharma Lilly, Sharat Our are our our achieve Nordisk BioJet to across support completion progress oligonucleotides. We currently ability as bringing to panel speak conclude, demonstrating pharma partner-stated partners. To milligram we platform, one results a June, continue Next meeting, With Research, [ This Delivery peptides with platform's an peptides progress XXXX. an recognized on successful GLP-X we're and Peptide partnership been operations excellent & we its in where ] critical from who our discussion to our for large active continued antisense by confirmed NaviCap anticipate and BioJet bioavailability conclude goal a liquid Gen a of share our antibodies, plans at met large I solely data where to interest Summit, in delivery who Head our industry than while that potential the alongside using in unable multiple of Dr. including one trial large anticipated remain by presented category-leading process. our several the Eric delivery through platform, remain interest bring with until molecules. we complex shortly. In Phase he look in little We partnership also an Singh, that receptor of we liver-targeted the our the at we our midyear. We shared track to peers for I company. of advantages, mass all that And was of discussions existing focused deliver say goal. Dr. to provide and BT-XXX. presented partnership we're summarize from more evolving details milestones, and in term. achieve Merck, BioJet have Singh the pursuing all can oral

American data We the will patients in College in presenting of We the Gastroenterology the Meeting end anticipate year. study trial October. towards of initiating with clinical BT-XXX Annual be next UC at a

over BioJet our review goal company our We call we're track Eric capital of active than results turn on partnership activities. platform, one a of for in partnership I'll large of the and pharma more with For market platform remain now to our BioJet part that, for for defined the XXXX. With our discussions financial in process. as

Eric d'Esparbes

development, today, Biora. I'll second with provides afternoon, towards the crucial company. million, funding the this $XX.X spend, clinical associated quarter, break to Thanks, device continued that we nearly then were provide legacy expenses quarter, Adi, the excluding stock-based of transaction. important progress our the cover capital investors leaving announced and during see we approximately on with which compensation which the by costs million. support in we excluding eliminate end milestones to and year. R&D for from expenses preclinical expenses, activities. We're happy a compensation further, as matters, raise excluding are $X investment G&A in core good second first million, To stock-based expenses, working Operating results XX% were of G&A background compensation more expenses, for down activity financial XX% the and $X.X were stock-based the expenses, everyone. of was Earlier continued

As core QX. OpEx million spend was result, a in Biora's $XX.X

allocated clinical preclinical the collaborators. with NaviCap -- development to BT-XXX the majority R&D of BioJet our spend pharma including our and with and the With execution programs, our of work with

to is operating that why financial many to for which cash expenses items, like excluding burn. on operating our those our guidance remind I'd refer actual results investors we elements also include better noncash

other have warrant including statement, income changes and derivative items our also We liabilities. in noncash in

a position XXXX. net we As million income a $X.X of for the result, quarter posting second are

announced to transactions outstanding in million a in afternoon. raise our note brought new from our but early importantly, we group core institutions. large more of XXXX, and reduced of this year We a on last Moving where capital investments series substantially balance we in $XX.X made

of an additional is happy We an $XX our these institutions see contribution commitment tranches to from the capital sources structured transaction complementary same are by $X noteholders million This this to facility The to $XX million capital adding additional to as from as increments raise Biora. to the as to needed their allows funding required. us existing available and million in provided be company. preserve if other

a a and equity addition, allocation, partnership, this of capital stock. and our a features an the highlighting there's as we're anticipated view for value bridge on this In our investors focus and and excited large warrants We to convertible from what future to raise structure transaction ahead lies about strong Biora. component pharma

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

Aditya Mohanty

of look we we pharma the stage preparing the first ceiling the for platform, Thanks, to our completing development break for for and as Eric. We're the work and platform, BioJet to sharing UC. next towards BT-XXX therapeutic forward actively And partnership clinical working NaviCap in we're more.

now Operator, we're for questions. ready

Operator

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

John Vandermosten

with out talks around the I areas technical market too with start topics are it revolving execution? main about I'll much just know a you partnership. -- of your can't negotiation going? assumption, wondering are Or is question the the it I'm penetration, just of what pricing, how focus? of say And on kind but

Aditya Mohanty

discussions are the yes, John, narrowing.

So how they narrow, partner figure did and with would talking way with very are to they starting and about. you're broad out than best one the things the potentially all to to work we're work. more start trying that But

the end to tell more it. but there. of We're it's to really difficult. kind you we're close of So love getting We'd

soon. hopefully, And fairly able we'll share so to be

John Vandermosten

other for about the times the anything from one way uptake to needs it's trial. to it's through -- in any oral there's if we direct look the that. contact it you about the a the BT-XXX all of the the tissue given and results And then the wondering have tissue. technical And way, drug to that go? I'm gets couple of at say vasculature, pill, versus the with the through at difference if when and where of way, through to the looked it's questions in at Exciting When from Great. it kind getting the

Aditya Mohanty

to have drug which we is for because been matters. why able a that more believe they question what it is where of do mean Interesting do, where lot I not the get tissue us, core we -- can

a oral into blood including gets the certainly, medications of everywhere, And small or of goes stomach So absorbed entire absorbed, where the basically lot vasculature. in GI the the get tofacitinib oral Xeljanz circulates after just It colon. which blood these lots that tract, system. is

quantities get blood the the to. shows colon, through published in into and they comes the a data it quantity. what So all certain you to And get

and able are a in get do that enough we they've And day, had you is much do tissue. there's the you to you the tried. want it do difficulty publications had to if how if compare there dose you hey, mg because So that, if increase a and you show, twice how XX that,

and these that, events the So on people drug however, XX our who look, worse. were think was also got I response, it who with also event, adverse toxicity, KOL trials mentioned Dr. tried Feagan did mg the better outcomes

And mg so so label twice approved is XX the day, a XX and not XX.

colon, telling colon, drop enough, you, the the get in one through All enough. get small of the look, cannot these along blood, the colon. you the when get the into past are how event, just intestine goes pictures. to of some to tissue? high the And nice we works, it We we again, actually order but Dr. dose there have was, really Sands concerns done the uptake as as would it tissue, in when that presentation So through in KOL you well actually the by some drug there's

look through it tissue the the some into goes it out of and if blood. up, comes it So you

what And so dose first that the we in you blood, X drug it start and hours time peaks is around to then seeing our -- X about XX noticed hours. the into

So the it's is not Being tissue the more in the absorbed blood. in and great. over getting and more in blood systemically time, coming

the not a high really amounts. You small amount, need just

without So it. tissue lot into to the the we And that can a into of to get beauty that that having need large reach we quantities was blood. get

higher higher, trials have more adverse outcomes. the they So other stop. better compare information you at and it's is keep great. is give would already dosing look inhibitors with in if to some says It's can response also And reactions there that where they JAK it, clinical you -- you

And we very deck. So through the that systemic fact in KOL, high did small with in got that partly partly exposure can extremely deal. information the is get exposure tissue walk how big a we the we

It's look hoped what really people we to with we We encourage thrilled up. for. exactly were saw, So I it what exciting.

John Vandermosten

the a not all same you're already the to Great. the processed that's you mechanical product the description body. the pill, amount of oral kind take the line, And processed. of really it all entire of drug then is on when But when good is And that's there. approved, take of using

measure? you passes passes work the at of touch it kind something through. drug is estimate difficult of to through how Have Some not, any body of and very doesn't done the much and Or to all? that's upon that

Aditya Mohanty

Interesting question.

have information. do that we So some of

we'll things, be in information. these all Majority different collected of more we the and it sharing get does colon. So absorbed

the load end that And entry colon. sometimes the it because entire other collect the the time, we of over information. but Some know the to did come We getting we it took without beginning And biopsies. absorbed colon. out does remember, at we crosses dropped

we to colon. small it way out. more mentioned. the quantities of the end So that we'll of coming get all majority went The data some conference absorbed, we the the know And the does in it of share as that come and

we have more drug of much end. the up other to So this the and to that in of and goes that, tissue how if what, do any, we'll collect continue see information comes

Operator

question Joe is next Wainwright. with H.C. from The Pantginis

Joseph Pantginis

So questions. X

perspective logistics question, second First, question. is is a a and

discuss manufacturing. the for device of whether clinical your was current on in in logistics advanced and hands partner's relative your front, or a So capacity hoping availability more hands, intermediate studies, anticipation I you in and could needs

Aditya Mohanty

Yes.

So about you're NaviCap? talking

Joseph Pantginis

Yes.

Aditya Mohanty

Yes.

which trial, we that being our some used BT-XXX work NaviCap, UC already we is manufacturers the with. in have So contract for

planned to that a build even of that that these. and we be ready several could team contract we've able be manufacturers to in able the we're meantime, we'll make internal the has we to need period our have But some of on them, with We so we But work of to We're short do several in expertise already that plenty handful further working these. the automation time. hundred, like when make make thousand. to

So period motion XX is those all of for thousand pills next time, the and in have to XX short exists. a vendors these of to months. The set ability of go. manufacturers few that would make to be we And contract which up

that see the need a to a to more though, we be that huge thing. to as started we need the So we road. have work to build to the Down building don't able hundreds of required do do thousands as would automation road, we the down make little

Joseph Pantginis

helpful. some hoping information I perspective one with And asset. is obviously, provide because, the the key was you very the question then of can of is, That's the BioJet, bioavailability attributes

Now the bioavailability. lot data the and your of put some about of press range of that a in you a reminder, out XX% in or release also as data the seeing talked you're there, you

was I So some compares to up could formulations perspective really to hoping as how that offer of IV you drugs.

Aditya Mohanty

Oh, it's Yes, wow. interesting. really

those have there's of are single get end hard to There they that shown or that Sharat, even I on to consistently all higher up presenting. really to to have has was numbers. And They all our So coating, back that permeability just that commonly reach But claimed most enhancers, entire large Head were look could the these mid-single were the methods make panel. some through being Research, ability from used digits. to technologies a of lot it's were about There through of They digits. available when nothing double of companies. trying sort of others digits talking pharma beyond.

could the XX%. essentially delivery that system for currently be have get formulation and XX% we is a things So you what comparing which able needle-based us technology, your be use BioJet that close take to done where and it's for your basically can to in platform reliably potentially is under to to

being So XX% injection XX% sort when standard, IV, of of gold ranges IV. subcu the compare you to IV to in

which of to as such getting that time, can phenomenal, We so IV, with term. And is coming places. that's X so step big injection. do good over up another in collaborators. this of get it's so that X, a many see almost XX% applicable got have being and whatever do think to we formulation subcu you as minimal fact to our We the this near advantage. And really is manipulation the just and we as to step

them. double So different to thanks for looking keep We see. that others all these do digits, a that for show We places question. Perspective-wise, to even could platform broadly thrilled. don't applicable hard and at it's we're see

Operator

Thank you.

the are hand would further questions, there to over closing Adi to no comments. I like now for As conference

Aditya Mohanty

want to to thank everyone Good look Well, programs. joining I you advance forward continue to updated our keeping afternoon. We for we us. as

Operator

concludes Thank today's you. This teleconference.

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

Biora Therapeutics (BIOR) 12 Aug 242024 Q2 Earnings call transcript