Earnings call transcript Q3 2022

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Operator

Welcome to the Biora Therapeutics Third Quarter 2022 Earnings Call.

As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions [Operator Instructions].

I will now turn the call over to Alexandra Schuman, Associate Director with LifeSci Advisors of Biora’s Investor Relations Firm.

Alexandra Schuman

Thank you, operator. afternoon. Good Biora call. XXXX to financial update third conference results Therapeutics welcome corporate quarter and And

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

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

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

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

Adi Mohanty

joining thank us. for you And everyone Thanks, Alex.

program. new systemic for our During on to at studies device we PGN-XXX. We conferences presented optimize data more multiple conferences. program, important function our data scientific progress targeted presented our the and for device quarter, scientific filing continued therapeutics IND towards we to focus and continue from our important at execution our In key therapeutics made detailed

from to now sell transaction some firm Roche spin We energy or earlier by and to completed company a our an of a And we through legacy of to remain we committed the our further therapeutics to biopsy with capturing experienced recently all capital licensing our other program. completed on this is our year, funded legacy agreements. IP. pipeline, our a assets focus develop value out liquid venture assets, almost While sale,

those moved stake our towards in inflection As to assets in return value eventually key result financial forward programs meaningful points, could the Biora.

opportunities assets. We legacy further to continue our remaining pursue to other with create value

opportunistically extend our also runway key capital We in details will Eric the call. the incremental to next readouts data cover towards raised year. later

investment only the programs believe, from is but largest stock We're additional their continued Biora illustrates very our Their to happy support not the commitment our that we share, with also in investor, undervalued. therapeutics which their Athyrium. current currently developing, we’re

based administration, with the let limited are Moreover, work Currently to available overall IV and is be about UC me taken are cover or the $XX to lead most billion program burden. sales in therapeutics which disease up a our IBD estimated being patient's our First, or adds global drugs Annual area therapeutics given bowel therapeutics needle in inflammatory tissue throughout body for targeted colitis. reaching amount billion with the the colon. $X systemically disease via the approximately by or ulcerative platform globally. space

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development At Gastroenterology ongoing Annual the the active PM-XXX and targeted our with College pleased device patients. shared from delivery the of study. study American device. assess of recent drug Meeting, results of the extremely performance the UC This safety We're our we in

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other We're technology that the potential delivery seen three environment have oral now and bleeding drugs. with the platform completed our patients who detect device, colon localized any have delivery motility of accurately for an in We demonstrates of studies with drug highly of can inflammation, entry, UC. variable especially aware successful human of which not

are As tolerability, previously pharmacodynamics multiple and safety, PGM-XXX. pharmacokinetics study planning shared, dose ascending of and Phase a single I to we evaluate

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a have We of our included corporate on clinical design study in diagram the Web site. our presentation

the reduced. known in therapies. our preclinical in compared we of high can a outcomes. important tofacitinib oral patient to have and co-relation tufecitinib with data shown the on as studies, just rates safely seen X tissue UC the we believe believe of remission between there current improving improved have standard concentrations formulations, achieve for are phase profile well of PGN-XXX data tissue generated therapeutic in clinical likelihood that development If our risks PGN-XXX confirms high we we in Because is concentration We trial patients of

our We're plan will clarify study active trial We majority earlier Soon have to to file incorporate move UC few agency after suggestions treatment patients. been with still X vast over year engagement is we we that months weeks next where with disease of continuing patients We've and we clinical eight year. our in next remission are with this our that we early into a as completed, the the helped with from a active interventional plans. able know suffering unmet received FDA constructive a to evaluate need. PGN-XXX generally large feedback UC phase after the development the IND steps, next aligned prepare

Our can drug current gaps main the options, one the the solve inability which therapeutic is solution get potentially tissue. to all of diseased enough to of the

necessary that forward steps. and we keen follow while the to So program move we’re clinical this ensuring regulatory expeditiously,

Next, I'll platform. cover our systemic therapeutics

During the development we systemic of quarter, third device. delivery continued our

in seen data platform mentioned very before, earlier year. we have As encouraging the this from

the we been grade the to to grade Over a several device. have clinical development last evolve research device device a moving from of with forward months,

that Our evolution of and meet use. human ongoing the suppliers device medical regulatory late for improvements improvement complete can stringent the requirements expected from this summer. will to sourcing of in had parts ensure We

and towards through of to data partnership complete progress are worked supplier could few these our timelines and studies successful, Having issues, forward collaborations we If be months. with hope in now affected pharma by these our the goal our expanding program weeks. sourcing However, coming supply these to our discussions. some challenges our sufficient a moving

drugs As require a platform administration aims or injection reminder, that facilitate otherwise systemic our oral would to infusion. therapeutics of

and molecules of acids intestine device, proteins, range is an without deliver solution We molecule management of help use patient reformulation. believe a market more help competitive platform and costs, reduce Our large the and broad uptake. of monoclonal, systemic infusion to with delivery which the intravenous range associated across indications disease nucleic complex liquid become oral small the peptides such such small to help can large to this as chronic platform provides potential has drugs The improve a for outcomes, maximize substitutes. biotherapeutics, molecules, jet as expand

other on Parenteral both key model Controlled and development, at our Society Universe scientific the quarter, College Meeting, conferences, Annual well third Devices data Injection and During Release American data Annual Pre-Filled Drug conference. the Association of of as as Syringes we including preclinical Scientific Meeting, Gastroenterology presented the

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coming expect generate in to the device months. data to and evolve the continue We

platform support continuing be to commercially very and feedback platform. to that to intend collaborations to protocols interim We with having X the these delivery our systemic platforms: summarize and PGN-XXX on that next from would after phase from X phase bioavailability our be our potential to XXXX; trial additional sufficient the with later milestones on expect this expand believe data QX XXXX based to work additional 'XX; this study study; finally, XX% in To the we're our mid data molecules, the of FDA on completion of results data remainder Our initiate preclinical by tox file collaborators plan a we both through anticipated into IND to obtain continue range the enable upcoming believe for year XX% initiation next partnerships new PGM-XXX broad be complete of to study to the our our QX collaborations and on could some to large based final of our for we we achieving generation supportive QX start support a stages. next oral progress studies viable optimize data, initiate next year, expect we to phase of nd device around study to during our of year. we an and to expect 'XX; by therapeutics we X after generation our

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

Eric d'Esparbes

good Thanks, Adi and afternoon, everyone.

firmly is milestones is we We Our support which $X.X announced while to the have focus recently million for take our existing in programs. to Biora We towards reflect face stock convertible performing optimizing well, earlier, challenging direct generate their well, company's been work progress commitment continued allocated gross Biora’s up are programs. progressing XXXX, our encouraging. notes time near The many extending raised investor, our key funds on capital the clinical our the their programs markets, runway. We coming but will therapeutics companies, to believe are allocation our in or an pipeline, Adi to in in reinvested just by term priority programs million the from company irrespective with $X Adi Separately, financing. and activities, it price value from may our remains Those a in investors and as million funds development smaller help clinical described Athyrium total in interest no registered in $X.X properly very biotech, from our proceeds exception. the public ensure the to of highlighted. stock of especially of not important cash

look enhance a statement preliminary our As split nature, milestones. investment this in procedural generate approval a with value Management this we in to NASDAQ at week on generate our profile. last and last change result, doesn't conditions. is stockholders opportunity forward capital compliance and we to a data raise, affect seek the filed to path unprecedented to as and shareholders the way achieve face our their of proxy board important following a our return difficult should We investors’ stock ensure company from believe market and and exercise reverse capital is the believe necessary public requirements preserve

to our the financial third Moving now quarter. for performance

a a we to million $XX.X profile. expenses, are of organization continue Operating to much company million organization in of stock third excluding focused expenses, We quarter needs. to were XXXX, a reduced with as reduction burn our compensation based the QX $X.X cash more focused align the compared

result, expense, a in QX. based original As having million. cash slight the including were are $X.X burn expenses compared compensation operating we or below quarter in stock More goal monthly third $X.X meeting to at our million, of reduction million specifically, $X a G&A

compensation based third in expenses $X.X were the stock R&D million, While $X.X in including quarter expense. million

mainly a clinical and expectation of we million as with cash our next million combined of balance of call, a our in with ending year less operating key runway monthly had will G&A track data capital the mentioned cash $X.X And than with our we burn. We combined QX we of our towards cost to raise in further have our expenses savings, cash expect just workflow, R&D reduced XX, million. thanks we extended studies additional $X maintain readouts recently, $XX.X year, September As the XXXX. burn previous

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

Adi Mohanty

our Thanks therapeutics progress in continues systemic Eric. to therapeutics good Biora and make both programs. targeted

generate forward more milestones. about updates to our We we data. to a We of as excited continue near are further providing number look term

operator, now we're questions. ready that, for With

Operator

[Operator comes Joe Pantginis Instructions] Wainwright. first The from H.C. question with

Joe Pantginis

couple questions, are of few a them A logistical.

might So anything you step rate tox point considered IND. Obviously, the that be Is besides limiting with else first study. a to at regard mentioned tox? the outstanding this there that's or

Adi Mohanty

No.

Joe Pantginis

the I look dose then part FDA observations? answer. phase that of when between love study SAD simple requiring ascending is time you any is it, the even simple safety X or for patients the great. Great, multiple No, towards X/X, the delays And or phase

Adi Mohanty

No SAD actually, SAD, pretty is, like really a smooth, we're and patients. great. interaction typical. between to was faeces, few small waiting. We're we're so and taking previous days be waiting which this the is again, serum that between why the going It's getting the But not no wait, the MAD,

Joe Pantginis

samples. just process, talked little bit And to of that's if you then getting can you colon great. I talk procedure, Great, the MAD will? guess, you when about look give of you the commonality towards a little listeners tissue sort the bit the and teaser, about a of a

Adi Mohanty

our get So intention some also get mentioned, in like faeces, of couple and just MAD, the biopsies. a is to serum you points but not at

pretty patients. a settings drug other that just that bit normally a want itself little But procedure like it concentration do about actually common not is any tissue we so routinely special is nothing get So unique and in not for common, to it it many so medical we different tissue, in what sampling. That do that can they tissue. check it's other than of procedure done really it's really it's is sample of uncommon, UC -- that

that here's so think getting tissue And are in we concentration shown we a that like UC be what papers the what some value patients the we which with provide, of where published. will have big in is matters

that everybody simple data. in drug And drug really we are not. the we extremely but a important, straightforward well in where have separate into others tissue can because also shooting could known is of or the procedure, right, us flags for from that's valuable tissue, target else, what terms concentration that So get we

Joe Pantginis

track established the gears monetize sort obviously, you company. last to of then my And guess, a being in just the to legacy already able switching record have path. I question,

assets? to I So guess, what's you describe, the with legacy regard remaining, to with level guess I discussions can maturity of regard the of the

Adi Mohanty

me Let just verify.

regard of maturity the of conversations? So level

Joe Pantginis

Yes, of conversation…

Adi Mohanty

some bit Yes, fine, the a fairly no, more a of there some lot it's over because little that's IP, is needing mature. all work, place,

of hope way fairly a some -- take conversations, it have while could in thinking, weeks, it a not long know of well. going are near we is are these We these where that have couple and several you we'll it's of happen have couple a term the we progressed conversations, quite things. But some in in have had But never could really term for on kinds months. been

Operator

comes next The with question from Julian BTIG. Harrison

Julian Harrison

Thank you any questions. for call got missed of few to my taking And late. if apologies this. I minutes I the a

does a from across beyond Wondering much this at clinical all delivery reasonable year platform. if First, enter point? antibodies, on seem characterized you testing, varies have benchmark the you next can at also payloads at PK systemic point? your soon this different And standpoint sometime how wondering how

Adi Mohanty

that's question, Julian. Yes, an interesting

are and for it So regimen correct also to on depending that how some is commercially viable the vary of bioavailability could be you is but of it bioavailability will some dosing much necessary change. molecules, is it the

So our are available have profile with XX% dose. XX% familiar for and a for kind would daily their injected, they molecules, a of with requirements that get example, of very that currently what can we drugs to we're to commercially similar couple pretty

in all general, be could For higher et some then those, of XX% And possible Each makes are to would different, some it of others viable. less in amount different of molecules or we in these bioavailability five dosing like same at monoclonals frequent worth XX% sufficient a have data. to there's consistency bioavailability. less frequent the molecules that, with four What's XX% least commercially at be of a cetera, dosing. XX%

regimen. you same even the change could with bioavailability, dosing For some, the

it's on So the things, depending of combination molecule. different a

inflection. move our way, targeted our the sure trial. a as far that company as into focus, forward we efficient that our on program is progress, As get making clinic significant towards means right, And said, in we capital

generation on systemic that creation. in we that collaborations, that new the data we're start side, that we this of value conversations, lead would focusing to So think on progress our could the allow have. And us expand significant coming collaborations months to maybe the

so with where the a FDA, do And data would that had but not We we focus. our could the have some conversation be term critical ready that's near priority.

let's our Our is the the turn device grade data would get and that priority to to way with would get device, conversations we program. the data and that the clinical a that's sure make the preclinical now we similar in expand can focus ready, this us allow be, systemic

Operator

next with B. Mayank question Mamtani from Riley The Securities. comes

Mayank Mamtani

Mamtani. Wood got on quarter. here. success the questions past William on Mayank with for is Congratulations the This I've two

The centered bit first little know IND, I around touched that already. a one you've on

plan. I full think a the in just you with next little want stated get over I to on I'm be a of have left occurring you alignment the appreciated? development of what and couple color to FDA? in order you we would maybe -- alignment, any bit clarification aligned what were curious additional the just with to months if generally come maybe know that

Adi Mohanty

Yes, FDA, not I with say to the approval you they mean, the better give there's IND. the XXX% to it's until always

feel So we're We good. pretty good. pretty

have to just them, be a maintain safe, conversation. with safe, extra filed tox We protocol our

So them. we well. want to full feel it's do with this completely going conversation open that interaction, with We

as tox soon the sometime soon, as So that study. we we'll run back have actual

the piece get the that a have tox will So study, you filing. once to an run IND final and go into report you that's

getting of executed. to reason in about other to these coming this than things do No able So to year. the expect all of worry we QX really be just still anything

Mayank Mamtani

extra you're my expanded second or for a liraglutide. or current GLP-X that GLP-X specific is dual centered question or great. sort? this agonist actually then [CAG] And formulation agonist to the with patent. your then or to know GLP/GIP, in be only even glucagon, the is of a [Semma] something I triple for expanded curious has If platform. glucagon therapeutic potentially is say this to out regards color single I via actually systemic would I'm currently or delivery, that curious of working was potential if this sort. your study, be Any if around your like And GLP GLP-X [Semma] delivery

Adi Mohanty

we're patent, broad GLP-X it's excited, patent. the pretty a pretty first, So

what orally. of broad we you which GLP-Xs it specific not So mentioned, the through it tissue coverage covers a that delivered is to one is molecule is a of it have, lot all

dual So ends. cover it does

is So all things the of those. covers that, of it all

it, very yes, broad, file, I our can and covers covers So site. through on it's we even dual, mean, Web it have patent it -- the you read

the details of little We'll quite a asked, dual the is possible all valid, questions us try focused But and and So there, very stay exciting aspects. that opportunities a those are to to focus molecule. broad you all with it for and to trips covers data that be expand. generate it different will bit all it's all those initially

Operator

question-and-answer the like back turn any session. Adi concludes conference I to the remarks. Mohanty This to would for over closing

Adi Mohanty

for joining us. Thank you all once again

excited our really on progress, updated our progress. keeping are you. to forward all Thank and of We about you look

Operator

conference This call. concludes today's

and pleasant You day. may Thank participating, a your disconnect lines. you have for

Biora Therapeutics (BIOR) 14 Nov 222022 Q3 Earnings call transcript