BIOR - Earnings call transcript Q2 2022 | Biora Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings and welcome to the Biora Therapeutics Second Quarter 2022 Earnings Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host Alexandra Schuman [ph]. ahead. go Please

Unidentified Company Representative

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

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

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

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

Adi Mohanty

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

not large our Biora data impacted efficient safety much demonstrating a is on changing data of recently Therapeutics, transition with that the second top-line delivered diagnostics quarter, and into making continued performance a changing molecules biotherapeutics and is Biora rapid outcomes. to our be that's generate the program, therapeutics we in We've with shared game completed ingestible a patients company performance where human from resource our targeted working potentially its human can more by from to During device we food. development. progress the way study company

active We results Additionally, trial design these proposed the our FDA feedback colon. where our in their intend will already functions study we robust recently received device plan, concluded to UC patients QX and of intended clinical another the plan disease have constructive we as IND us generally appreciate demonstrating will the in this We from on much they with provided and the recommendations, agreed development their very comments patients that suggestions in UC despite outstanding a for which implement studies, allow more filing. the including year. FDA tox on expect feedback to with

QX expect in our to to allow can us We activities of X file these study. IND XXXX, so begin Phase we an

data and plan animal continues therapeutics on models. additional generating systemic program bioavailability Our in currently is

We expect current us believe to and generated that the with is and We data plans allow of in year and conferences, will progress these systemic our and received be this partners. October. were to third at conference what potential collaborators in that covering targeted programs recently announced abstracts at well very gave several ACG DDW CRS quarter accepted our upcoming presentations the the and

I'll expand very awarded of moment. in to two were patents, a which cover in the and platforms continued detail protection important our we more beyond. Finally, these

platform. therapeutics targeted our First,

overall an to is $XX Annual estimated ulcerative globally. for inflammatory global reminder, colitis UC IBD bowel about space disease billion our are be or and with sales drugs UC. this first the approximately or billion $X a As program is platform

administered size treatment technology, PGN-XXX like of device version commercially Our orally are our pill, a the available Tofacitinib approved other of liquid approximately of oil using formulation proprietary the fish delivery mostly is a is tofacitinib is which the orally drugs for lead tofacitinib a program, a the is in delivered disease and is also colon stomach delivered is a needed, the that of targeted the tract. upper potential UC to We're PGN-XXX efficacy the lower has whereas drug pleased the systemic it the delivery our in improve tract, improve is GI drug absorbed or By device. limit exposure GI and of where with at to delivering development site of extremely of disease topically safety. UC.

completed our three We device. have now human with studies

study was XX naturally. The data capsules indicated the by entry and devices, during recovered ingested a completed measured colitis. was all ideal announced completed XX patients, study food. were safely retrieving dosing protocol. were different with four QX devices devices included knowledge, is ingestible total food observed fasted participants specifically not performance capsules the study for damaged the in of with data greatly recently failure modes This a convenience diseases administration of state. following feeding we what enhancing To chronic recovered showed from analyzed retrieval. occurring from restriction demonstrated required the is or diseases. device device ingest study administration fed use, to capsules or successfully were norm per to schedules. Data with be exited per analysis could patients body chronic patient was in XX delivery results other regardless devices. not first for with deployment We therapeutic required for which Healthy The of particularly the previous may or and devices and is that four frequent our that helpful excretion events All requiring that study fasted for and device's multiple ulcerative a for with retrieved for like device and devices. the is year require no in of in activation fasting especially for subject ingestible our but this as the included Fasting each performance administration colon, dosing, the last fasting schedule first top-line

in the patients. ulcerative another of results safety We also recently colitis announced device from active top-line the that assessed performance study and

game confirmed delivery delivery demonstrates successful the method. imaging is released study, to management indicate also and solution and critical of included platform entry disease a in entry further it entry, In intended studies performance release key it entry, as with and orally identify tolerated Given any humans these platform enrollment other a variable the of isotopes. in these can the study with study motility in patients. the identified of that colon advancing colon therapeutics that completed that saline the identification program; performs safety used accurately entire detect as ulcerative device by potential was targeted colon, and the patients demonstrated not This makes the ingested achieved changer blood, support payload and of device oral the an seen liquid drug seven the distribution and ulcerative highly the and planned. tract. the device We're that all being payload across colitis. PGN-XXX potential was payload physiology independently localized especially our device was and gastrointestinal device scintigraphic in release and colon delivery colitis. the These in activate different the the for triggered drugs. diseases other payload of clinical to can of the location like activity active of colon, device well the technology of a independent imaging radio lower Scintigraphic into patients inflammation, GI accurately aware The no The are UC towards lower is the with in steps into After and environment patients, in by patients. a

our our for lead our was and The agreed our in is The device proposed need animal program the filing with and asking the response proposed platform PGN-XXX to know, helpful. submitted trial FDA combination constructive In on plan. Type you we data. the a our had As tofacitinib. targeted and our generally formulation QX, also on extremely FDA and provided supporting a FDA data package proprietary of for is feedback clinical protocols. of helpful and confirmed our toxicology C development design feedback therapeutics They reviewed

year. mentioned, the study tox will in previously IND had QX this of completed functional file XXXX to We initiation we final Phase the had animal tox support studies recently a of planned with year, to that an we reports our an believe human X the be in for animal As planned and position the later already this study we study.

of clarity single Following and FDA we certainty design pharmacodynamics and PGN-XXX. to feedback, studies tolerability, able and share multiple safety, evaluate and for with X our proposed are dose Phase will more ahead move study. pharmacokinetics The ascending the

of in include our These doses twice study We're repeat and expect concentrations updated studies: study also approved seven PGN-XXX feces. and serum multiple evaluate drug the daily. planned the design daily dose are measure in in healthy ascending presentation XX study for is days. volunteers serum drug concentrations drug are below including for and of concentration ascending XX the tofacitinib and And XX doses in dose website. colon we volunteers single our to addition commercially healthy dose tissue. of diagram well milligrams a will both planned Two clinical include We feces, that daily. tofacitinib in The of with will dosing milligrams induction different of X corporate to XX on

formulations we trial achieve presented tissue the tofacitinib Given in or of generated high to well-known confirms can believe reduced. standard of believe oral Because seen we with the in as correlation these we of clinical concentrations are improving improved there if on data and patient ability PGN-XXX remission data between reference preclinical have safely to risks in already and tofacitinib X existing concentration of from outcomes, Phase the patients utilize generated high studies, current compared just therapeutic and tissue our PGN-XXX that data, development UC the we profile therapies. is our likelihood the and rates

Soon is eight to treatment where after with into remission completed, patients. plan interventional move after to disease trial active UC evaluate we the X we PGN-XXX study, a weeks in clinical Phase plan

confirming unmet by development important phase levels opportunity improvement and in titled Disease Dr. presentation the In May. others. Week are colitis address concentrations “Tofacitinib tofacitinib. program need author Vermeire supporting with colitis the excited a Bram presentation, help drug endoscopic We’re Vermeire for moderate now data in Data high in who to significant gave with with patient at entering presented with tissue patients presented relationship substantial for Vermeire and lead and correlates between and UC co-authored in outcome,” to Digestive to was very ulcerative Séverine opinion Dr. their were Verstockt which Key this severe endoscopic leader, of the ulcerative remission needs. tissue patients achieve an tissue Dr. a treated exposure Dr.

than correlated the indicates data commercially Preclinical available achieved Specifically, that a or is doses with of the be concentration even directly at of to tissue patient doses ICXX these significant tissue exceeding can outcomes. tofacitinib. oral study in that with tofacitinib supports hypothesis PGN-XXX, improvement lower concentrations

addition, pathways UC. combination data therapy suggests for a current multiple to In patients target with need some inflammatory in

therapeutics However, systemic therapies limits must approaches. toxicity targeted to in overcome doses combination due current higher toxicity the platform achieve designed is tissue of to while systemic significantly reducing uptake. Biora’s

therapeutic granting patent, U.S. accurate colon of localization to consistent announced improved patents of Our patients our many approach the the achieve This and detection essential with is could pathways inflammatory enables unable allowance facilitate additional outcomes IP of multiple two patent today this to targeted therapy and respect the at delivery for recently simultaneously U.S. are our colon. of to an European the combination technology to we to for a device, remission claims symptoms. the that technology entry. of leading including directed issuance the target With in who area, UC

in be addition to potential to localization device, delivery used technology broadly standalone is our technology has that In for use unique devices. the ingestible the drug a

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

substitutes. to therapeutics intravenous patient in range Our help improve for intestine liquid is more associated of competitive monoclonals jet and chronic to uptake. reduce We systemic disease order across management device, molecules of costs, and the large help such believe use this indications infusion molecule market maximize as platform small drugs a which with outcomes, biotherapeutics, oral expand the become systemic an solution provides help delivery can small delivery

without Our platform complex deliver a as other has the broad proteins, such range potential nucleic acid of reformulation. peptides, or large molecules, to approved and

quarter, During to continued progress with second design and make the we’ve manufacturing. device,

early agonist. on this and a is as formulation of several Meeting and At to be including a enable Although that antibodies, results data receptor of Society achieving initial commercially the pharmacokinetics. further bioavailability We our oral molecules of monoclonal preclinical therapeutics XX% Controlled we platform, of with the to range evaluation of such concentration peptide models focus on Annual that through presented Release platform, with device preclinical large have performance on our anti-TNF-alpha development a believe high research viable in systemic broad liraglutide, delivery enable would GLP-X molecules. July, platform the we XX% the

results the oral to use of These demonstrated in bioavailability with animals protein study, XX% results support where presented average detected an also monoclonal with an than preclinical we drug the or antibody methods magnitude are of and We current order XX% platform. of broad blood. delivery the potential in a of the peptide greater of up

QX. for for potential via collaborations recently the of partnerships believe liquid studies method small We property liraglutide Pre-Filled GLP-X liraglutide We To share bioavailable. Biora for over our results currently we trials these the molecules. bioavailability summarize receptor in next ACG a to proteins. Conference, the jet to any patent allowed milestones than delivery other into be This our It new of including has We and with significantly formulation position is for X with consists have Drug Parenteral forecasted patent and better receptor is readouts small jet Injection clinical The us oral be systemic October. sufficient data liquid next therapeutics footprint candidate, expect portfolio Data well combined for using existing $XX our of Universe multiple with application both to market, billion IP important agonist conferences, the stages novel notice that the platform. We and animal Devices pre-clinical future treatment of of currently ready as Syringes over averaging shown strong PGN-OBX GLP-X delivery are which application intestine some GLP-X only year. diabetes. We liquid USPTO in from any strengthens intestine. the can intellectual of do progress and the oral allowed X% have our that other of in and covers that as XXXX. The about be could been of allow upcoming Type a formulation provide delivered human of our platforms. of at to Annual the ongoing an the Association studies we marketed already rest well the XX% Biora which application by liquid in expected Meeting as upcoming received believe by

later XXX be We initiate to study. initiation studies to results. finalizing on reports with a Phase QX XXXX tox facilitate of and the recently based for XXX of that were file support future completed in and will the year, the results, PGN-XXX IND publication X to We this the our plan study we’ll

QX. therapeutics running systemic data multiple currently with and We’re program with our through generation animal liraglutide expecting studies

molecules We of expect to studies this execute for by a collaborators animal former QX year.

at presenting systemic upcoming be several programs will the and our Conference We abstracts targeted ACG in October. both covering

with one With for systemic our the we to initiate a of next therapeutics our Eric now study call that, program expect to activities. with the of Phase turn our over PGN-XXX next year. FDA And a results market expect financial X for year. discussion and our pre-IND for capital We I’ll filing molecules

Eric d’Esparbes

Adi, and Thanks, everyone. afternoon, good

achievement generation. Our remains value systemic the the targeted allocation capital near-term generating goal data through with milestones to focus pipeline development optimizing and and key therapeutic our of pipeline therapeutic of

of $X.X million organization compared expenses, a our stock-based a cash expenses, to of by expect organization profile including in XXXX, to $X.X cash a a needs. we the the platform. we’ve transfer now QX. $XX.X compared million stock-based our with eliminating million the on we molecular excluding focused And continue a second as burn of as more testing We’re second reduction end created generate year, quarter a of further quarter reductions assets. G&A expense, detection a in expenses a million, specifically, completed $X.X in while opportunity were More our the G&A We’ve spin were to a compensation QX, burn. in reduction with the align to investment our out now XX% compensation of Operating past much to molecule associated return reduced single

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

monthly mainly As year G&A expect combined clinical ending will expectation with R&D XXXX, reduced we’ve mentioned expenses savings. our our operating in thanks We cash studies with of our $X cost a burn of million. less cash previous in $XX.X the burn. XXXX, cash than track of runway well and We had million balance maintain as a we further us call, of XX, workflow giving to June our

and active important plan community. story investors. our We sure our the are a visibility IR to programs adequate engage make investor very with Tell maintaining of with

an now investors We from our following you to contact will in seeing strategy. that, and invite call With increasing to have I and over biotech the development if turn back interest are analysts programs us Adi.

Adi Mohanty

Thanks, Eric.

good moving about excited for making updates more ready programs we’re progress So operator, With and providing continue further now generate data. are ahead. we as look to forward with our to We that, how pipeline our questions. we're are

Operator

Thank will [Operator session. Our BTIG. first question question-and-answer we Julian from you. time, Harrison go is Please be At a ahead. conducting this Instructions] of

Julian Harrison

for to for thank you updated you on progress. taking characterized recent wants there. congrats the the questions want FDA is if my before to contributing better could any detail what slightly share to better I'm have timeline PGN-XXX. more curious what understand you the Generally file and all your in just IND Hi,

Adi Mohanty

these of of them even in with Hi, you time. said planned approaching book already year data out internally the animal and by study, they ahead had aggressive on past we package a like know though approach we the the a Julian. tox you tox remember studies animal slightly Yes, we some were supporting way, if the

already coming for had sometime in months. booked it we the So

it study, existing of any the one tox referencing own, was but our not using main animal things. So

we're XXX that to so, didn't have and And like of time. any the studies and XXX current planning we do at completed the

that of that we and information reports, get coming think these it's of this filing. Now we study planned all have tox best. kind of and that anyway, that, we requirement have the We include meet up all

And so input. filing that takes quite fact to us QX they that us that detailed the with gave along

both so we Phase design. our We So why sharing part was the and good we're proposed X, X that's much more. proposed and Phase

of more If our shared those they design we feel itself, the not a gave we us, tighter, that before, things because actual of at gave that little you that comfort and most help and will the make look think idea. some us were generally input sharing protocol comfortable had just good is good but that they all plan of a that us a this

So the it's combo. that not drug, it's – a just know good just feel about we because the getting it's device, not pretty input you as it's

worried it. any So about we're not of

look We about all up dose. the really expect that execute of and looking the of at to a current quarter of this XX, makes is maybe study, which interesting. That packages the And dose fact it filed. people somewhere in the buttoned to commercial we're hopefully at range a what get X

Julian Harrison

that. then a X for what Okay, to can interested for be remind in great. safety? you most early And win healthy you Thanks study year? parameters Phase clarifying next the this curious the are your Generally would start us mind beyond for just early volunteer you're study in plan what PK

Adi Mohanty

Yes.

leveled levels ICXX early that plasma just and referenced think tissue range a get a the for able low somewhere us the And be on call, so level. in and tissue we very to to so I

we tissue issues. plasma systemic have so the problem animal in factor, a uptake. in show higher we right, can safety showed our our far what models, So levels models lower If that's and toxicity the animal multiple uptake are and much shown with the we the

like. out if is. card that So the what interesting. reference anything looks we range what commercial And – We in And Dalvance would the X. comes very we that range we tissue places less know Phase in be are data than systemic of the that uptake, existing can know can those get now and that the anything this much all from in of that ICXX number in

Julian Harrison

Excellent. Thanks very much.

Operator

of Mamtani Next question B. is Mayank Please ahead. go Riley. from

Yuan Zhi

Yuan Mayank. taking from Hi, you Thank this questions. our on is for

few a have them. We of

first is you related And clarify JAK off So to can whether has the device IND specifically on commented the the feedback, it inhibitor itself? FDA tox what's or study? required the

Adi Mohanty

couldn't understand that we we tell inhibitor expressed JAK concern with fact There uptake, or lower the was a own, if we inhibitors liked you a no that the I data we the concern the that that And were to of a the there. than question that much meant about about what drug I the systemic go our of It much to combination the JAK know studies kind device if shows there we're can previous is the and your generate concern that's device. that So dose. had was some to commercially FDA in the lower. explained and given reference worried correctly, idea. we the is And want quite have us. approved you we what They no was which to them had was was generally trying proposed There no to they and to that animal our were safety, levels tox which especially doing. about agreement

do, through All requirement proposed which Those about other animal are around JAK just tox have that need is study came. combination, safety not going no something to that design. the so to those worry that we comments complete. real combination not of inhibitor there are or we the the concern comments, the the main the So was a is any

Yuan Zhi

it. there. Got That's helpful color

if asking the confirm different same be more for device study FDA target carrying you use a the or will easier? will IND to drug, filing want Just

Adi Mohanty

ready to first the we have that. program one. we easier once absolutely not that me gets a speculation. require do run do that would believe little That every to I I'm done

would’ve gone our combination good own in we time the molecules But preclinical by through predict were even would or through gone combination like. data device get look to there next because conscious could leverage the drug what generation enabling IND now package more would’ve though right cannot molecule. studies, different the package – that the I I’m next we quite So sure

Yuan Zhi

question Got you UC have when those it. could open GI with And is them active when about our wounds in some as GI the you disorders diarrhea patients be of associated next such tract. show and –

effects hear as impact the your to thoughts want the tract? drug have Just your absorption diarrhea studies on in such that trial from those, will GI

Adi Mohanty

I clear? clarify, want understood sure Are to if work formulation make asking I or wasn’t completely. – you device that are you as may question – our our would

Yuan Zhi

Yes.

we just the effect So the such PK a that trying of see are those to device as ingested diarrhea have by profile you patients? impact have when on drug

Adi Mohanty

Okay.

question. I So through you goes point studies, this one be patient. happens would the of right? our So of fair to UC when device an can what recently completed worries actual one

So disease. gave very actually the we I with active can’t we to study all severe published, we this patients that XXX just had quite share where UC pretty the yet. data

in were it, that high active study. scores them, can completing they completing We’re the publish but we very that reports so

terms And like there independently the was patients still in the And that bleeding, so variable of locate disease, deliver imaging, day, several of colon. accurately was varying there was drug. said, entire show times able inflammation, to right, was the capsule right coated location, with with or drug device could our we a motions, you the there rates motility in variable many

the be that is So the entire would have would happen. we coat where the colon, able the which to that expectation uptake is formulation

about, that quite that us talk work inflammation, believe it you bleeding, that all multiple variations would this motions, we those confidence of well. all motility, with of even gives So

Yuan Zhi

is Got designs? candidate That just our performance or designs it clinical it. drug device What or want to for question future language. And about sense. track your does plain last hear elections mean in trial it study, your

Adi Mohanty

to Yes, we studies actually This just – we’re thrilled, the so reported extremely on. at two look right?

We healthy have patients people, and them many all through different worked. many now devices of done volunteers, UC

in went So in transition, dropped drug It them detected that right accurately it spot the right of into intestine. the the location. that the all

on of We’re fact also restriction things works. before requirements to fasting that worked well. that is our now quite after it the are all label the multiple great the is shown These excited not give potentially feeding trials that working or it the by through with pill. have that different It us regimes, really device different confidence

also more that We to make continue looking molecule data. the clinic. take molecule that We at the At need drug delivered over same say on want our sharing that’s to the are months sure in uptake saw progress other now If think few well. so not that of when a the us device right to is more quite we the animals, like to systemic the work we in able all put functions do it the into that the that necessary right next is find we’re our we the to next next to molecule. we on But now. out We now continues first this the progress can we well. device to confidence the gives to that and time, location. lot And look drug forward going

So where quite development about our stands. happy currently device

Yuan Zhi

comment. from That’s for all us. Thanks additional it. Got the

Operator

the like remarks. Adi to reached call [Operator I would for And Instructions] Ladies Mohanty session. turn back the closing any and gentlemen, end we question-and-answer to the have of

Adi Mohanty

We as everyone data we look you. with through Thank go joining Thanks. to forward Thanks for us. more coming interesting our back programs.

Operator

This conference. concludes us. today’s you Thank for joining

You may now disconnect your lines.

Biora Therapeutics (BIOR) 15 Aug 222022 Q2 Earnings call transcript