BRTX - Earnings call transcript Q3 2024 | BioRestorative Therapies, Inc.

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Operator

Greetings. Welcome to the BioRestorative Third Quarter 2024 Results and New additional Preliminary BRTX-100 Phase II Study Data Review Conference Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Stephen Kilmer, Investor Relations.

You may begin.

Stephen Kilmer

Thank you. everyone. afternoon, Good

are by include start Private guaranteed. and that conference forward-looking this involve Litigation beliefs, by Therapies' materially Let and be be assumptions unknown statements pointing statement within will statements All XXXX. forward-looking Act the different those on implied the call BioRestorative known expectations statements. Reform current risks, me of out based meaning Securities factors No other can to and such or cause may achievements statements such forward-looking that actual and uncertainties results, performance from of

X, to statements, this as reliance among XX, For are as ended XA details or year on Commission. Listeners XXXX, report quarterly undue of than on on statements, September expectations, that XX-Q of place revise Exchange factors, annual BioRestorative any Securities XX-K XA Form others, December Item call. law. XX, events conference the Part the by our of forward-looking report these Item our to of a period future Form otherwise, no see forward-looking ended Part on filed X, XXXX, the affect for the as for with could or undertakes and cautioned publicly and new result as required obligation other update only speak date not whether which information, of amended,

Development; of Officer. With turn and Lance. BioRestorative's Chief Financial Executive and I'll Research now Lance Robert Officer; company's Chairman call its over the the Alstodt, company Silva, Vice the to said, On President are representing Kristal, that Francisco call Chief and the

Lance Alstodt

your here you company. you your for the behalf to Welcome like interest in appreciate shareholders, to Thanks, of support. management thank afternoon, the for Steve, everyone. I'd good team those are obviously everyone and BioRestorative, On we of at who And our call. and

to the very see of quarter. can business press today, across in our the earlier third execute all well you we issued that from release we continue areas As

really and financial exciting data and we encouraging are we're data II very XX about patients XX a at our tradition progress Spine [ we're ] break slides as that X results, little in excited at Francisco operating preliminary than most right our Research financial to the PSRS making And announced into going that the data was going quarter and rather delivering BRTX-XXX BRTX-XXX performance Symposium. As our weeks patients is with year. Accordingly, same at to review we the it Phase this morning program, this for that with the to Xth that here. a I'm jump International preliminary gave he ORS today ask ThermoStem

if you course, or as to answer have results, over well. I'll now. it third Of business, program our them call's the about bio-cosmeceuticals fat Q&A our we'll financial be commercial any Francisco turn ThermoStem to the brown session happy quarter during questions

Francisco Silva

Lance, Great. and everyone. Thank good afternoon, you,

is the or lysate that's clinical lead platelet or enrolled placebo using X:X your and from sites oxygen included to disc from or novel that to XX therapeutic will We therapeutic in that to is product II ongoing our up own treating CLDD, in trial bone safety lumbosacral of United product A randomized, target collected complementary intend across an double-blinded as is lumbar at formulated sham-controlled study. BRTX therapy Phase and being of receive the treatment the eligible XX for subjects sham-controlled. mesenchymal of marrow The areas body content. flow engineered So cell cell-based the little blood procedure. The autologous up the candidate BRTX-XXX. chronic have to a It's a BRTX-XXX in to randomized will total will which States subjects data efficacy prospective evaluated and cultured or of a disorders used as stem patient's surgical collected cells and is the be be patient's non-surgical disease well painful disc the blood. either be

same discussed pleased I review ORS As I'm to mentioned, the the meeting. earlier slides podium today Lance Spine that presentation at at a

the quickly the slides. Obviously, quickly go deck, on jump I'm through just And [indiscernible] of want X, statements. the so really the some to going of in product just is important through our forward-looking microenvironment, disc Slide I slide we to the review And to have understanding It the has because which It's levels are glucose. is very pH, harsh extremely it's and to oxygen low high really the osmolarity. also the within way found been targeting designed that's low cells. It a X%; of and low engineered has it's microenvironment detrimental which lactate very tension about disc. impact

important within the is to remodel not to especially there you're put you a and disc, harsh biologic that this because to nucleus environment, developing are the acclimated when work going could in trying cause to have death of So if this treatment lot alive not cells that you're a worsening the patient the be pulposus, perform at anti-inflammatory potentially to need the because for activities. of all the cell cells might to their treatment or them actually experience you're symptoms

critical really have last years in of the and product. developing So couple our developing is product, over microenvironment when a done the understanding BRTX-XXX we that's what

a in So microenvironment, -- let disc me the as go degenerates sorry. healthy back,

is -- bit -- this little degenerates disc guys, healthy a different. a something moving sorry, As but

the... As

Lance Alstodt

Francisco, I'm Lance. sorry, it's

better punchline Slide on profile of based kind may it on data. get right and the call, of be XX go to to investor the to I this think the

candidate. the as as I the lot understand environment people think well of a product

part the talk the exciting results. it. really about Let's most That's of

Francisco Silva

Sure.

No Lance. Yes. Okay. Yes. problem,

to that group this you treated, particular using So of VAS pain go an BRTX-XXX. function ODI. blinded, this that is product, in at And let's correlation in measured And the -- patients by direct have XX patients a as very, encouraging, is both see of as had the XX% been XX the weeks, patients again, well that patients XX% treated improvement in of and but very Slide the #XX could of the #XX. Slide the are total

benchmark which is of improvement, So did hit XX dictated X of and the FDA the XX% by improved being efficacious. X the not as of the patients

So the that the is again, patients point randomization of that within continue or the a the that falling treated to seeing trend move that is from patients use other terms which treated the the in is true showing the treated. patient-reported grow of that in the we expect on with the line been very to that's endpoint. treatment in scale outcomes, is or the as XX-week And view XX-week which have you group another this And is we some of as will for from also clinical to the the encouraging used RMDQ is of this in is the sham being endpoint as another data review which as -- efficacy. patients in decrease time protocol either of FRI, determine one scales well

are see the trial. You similar very in in decreasing profile trends patients enrolled of once the terms the patient

that to very found is very we're we safety what early, strong So signals. summarize, seeing

So experienced toxicity, to adverse of dose-limiting our intradiscally. we dose million have not injected date cells event current any XX severe or

So of this primary is this encouraging, and very terms very, is our safety. endpoint in

throughout trial. that So this we feel very is going the to strong continue

about rate the compared a starting the met VAS showing now strong is and that XX of is both the to the emerge to improving efficacy, that the efficacy by significance in we're very responder additional beginning function. endpoints XX% of importantly and with also ODI, that form to preliminary seeing data we're in see And More is pain patients which baseline. trends there's X the

endpoint preliminary we're item contemplating efficacy we're is emerge about Another a this we're XX-week because lot that very of see a encouraged interim that to starting data positive analysis.

So that's the for on something us. that's horizon

and profile In include to that, the cervical of to addition we're to product Thank indication you. expand indications. looking BRTX-XXX

Lance Alstodt

Thank you, Francisco.

function as ongoing safety Phase the efficacy see blinded preliminary treatment clear II the and positive from chronic disc outcomes demonstrating very trend. with pain a the patient-reported are from So reviewed, you just very clinical what trial can data endpoints of lumbar clinical of encouraging disease and Francisco for and

So at function than pain. patients XX% decrease reported in mentioned, XX Francisco like the study more than a in first increase a to in of and greater XX% XX summarize, the weeks, XX%

we increase and those and have I hurdles far in than of be function in to those the XX%. that by pain decrease to efficacy, demonstrated have Now somewhat the as low, do highlight set been we for greater find want ability XX% the forth endpoints FDA preliminary to while

look XX%, some at the these better patients, as function as if and going that each you of those So individually, to than far responded XX% that around others close sort they pain geography. high and responded, of circling in improvement

of we that in in the these know It hit to data results. trial. this a We're we're population us our puts for to with that weeks months. endpoints position weeks. we and this really and we're we trial complete will January II next patient with larger trend, and intend more data very continues of before efficacy XX the continue the enrollment, So the to from an year, with both to with And to our be a we end the group, expect which progress continue optimistic Phase to February XX even confident well, present very expect XXXX. We out somewhere larger early I if about pleased. coming will

provides by held financial us our be outstanding $XX.X additional with with with a cash, puts That, with no in financial Finally, in profitability. and I'd quarter equivalents securities, combined we and to mentioning strong remiss improving marketable a a the very financial us investments not third perspective, cash path that position performance steadily from flexibility million ended on debt.

prepared in. any very remarks take much to our as That happy is our script, it that you So are those listening and we're may pertains thank have. concluding to for questions you --

Operator

Jonathan question First Capital. Instructions] [Operator with Aschoff comes from ROTH

Jonathan Aschoff

enrolled north and you for only XX? many are thanks saying are it that comfortable How some data. far? thus number -- sharing Is Congrats of patients

Lance Alstodt

more considerably it's Yes, XX. than

We about publicly. that talked have not

to to Track RMAT, FDA Fast et as of continue until approach and we that we'll So on continue we navigate -- strategies cetera. take the

Jonathan Aschoff

Okay.

when cut, old that just X show X than of think weeks, weeks? XX it's data. the that you kind there's it So Because that X-week because when was not more many someone makes data

was So that when cut?

Francisco Silva

the is of X-week some point. X-week in months old several terms hit This the point the where data time of patients

yes, XX cumulative of Most So than data lot February. more more will the where presented data. patient be patient will a have ORS at it in be we

Jonathan Aschoff

Okay.

with Do next still additional see out 'XX. see Or will year-end XX time? will by why it basis? the intend we you're now the to blinded with can XX-week sticking So still see data? on When XX- I data first and a unblinded come unblinded you we

Francisco Silva

we're will Again, where academic still is an blinded. this it No, conference be presenting.

have present as we We to well be careful the blind. to very maintain how the data

think even are is But from by the encouraged this results something the is the with we're so positive point results and responder we are view I appropriate emerging of of that's And impressive an -- looking at of of the versus very So rate. encouraging XX where unblinded we where have the where BRTX. weeks interim to for patients. would data possibility be have group at that an the treatment analysis the sham the time

Jonathan Aschoff

can't you interim that XX-week look might -- look when occur, postulate can unblinded you? And

Francisco Silva

I in lot of would be compromise a to of early But mean, again, -- make next we it interim we it's need I mean, of to the the do sure integrity were analysis, we There's don't trial. if all logistics terms releasing. an year.

Lance Alstodt

sometime of and to the I to that's 'XX, subject but would updates. commit in further half weigh first in

Jonathan Aschoff

That's definitely helpful.

X and this do the like and that versus were the February. saline the February that's fourth about. patient, you split that line work, of weeks to X, think versus and XX just X they was fourth the behaved it X patient think X eventually was have year, last the back you Do other that why you So talking clear you got in between X that started

Francisco Silva

group. a if a I clinical comment. see think Yes. one And and is beauty begin to And that's that designed emerge. trial is subject that the of it's great part that of that's product mean is you And I trends well the efficacious,

it's We have and very known that are does saline they effects the trial. do have impact -- that that was well saline maintained, therapeutic but not long-term treated

a have So we're group. very happy now that protocol to our to sham we amend were able

XX are recorded. this weeks, the where at so the patients sham is And being

delta of patients, particular you'll terms what's that in and So a data view happening. better presenting we have XX-week these a expect better of

Jonathan Aschoff

be they of X X the the extra we can or XX, get get represented No, did confident placebos shams to as perhaps well? patients that that did be turned both X into sales they X

Lance Alstodt

data else sham. saline patient -- XX%, injection, it have while the you further there's the only as XX%, one to the X significant and all injection BRTX-XXX, got patients, appears received the sham achieved XXX% as And results, know at results with in X a considerable don't we then the of far them that but look one versus XX%. answer others just that achieved which more well, to while separation than achieved XX-week Only the the the everyone received -- now

we hydrated the hold and there, that its separation of disc take So the very and effect possible still and and environment. pH lowered healthier maintained did a a see placebo it's kind was further

to between So of that we bit we those not, and can to those time that from the X:X. are injection, randomization of have a the Francisco's expect sham it where that, point, more with bifurcated time. But XX-week did I little kind data, those and responded matches the up guess,

Jonathan Aschoff

That's long very helpful. do $XX Rob, million how think you lasts?

Lance Alstodt

He's do I'll having we a anytime Well, financing Rob timing, don't in commit the here. to to anticipate while speak But we background. soon. for don't

trial. to goals we achieve our get we an strategic this answer to So have that within the and all need cash

Operator

Okunewitch with Group. from comes question next The Maxim Michael

Michael Okunewitch

idea of to up before you talking patients you and I little guess, magnitude about prior data XX-week off look of an the through had and just on on bit interim you kick responding all versus X X give X. than how on at Could guess things X, X response patients saw because X a the I that's the down really Congrats significantly patient more blinded believe point for, broke interesting follow where you the patients just the it respond. just data. X X where patient I were

Francisco Silva

is which trend based careful don't XX% Again, with some randomization, of in the improvement but baseline. effect the the lower, patients range, but have significantly we We on X having again, are that numbers is data. And Yes. patient to one is, to this present other unblind, greater continuing. but how trend terms want be the they're to compared we continuing than

Michael Okunewitch

Mesoblast, more space, in just, therapy right, what that others function a in this be And possible that would Capricor, are could broadly, achieve seeming like more to that accelerated you cell it of seen bit with from be the right. then for All we seen guess, study, to able if approval? something you file given I supportive could FDA pain the we've and both have be

Francisco Silva

I I considering clinical so. very data again, the other out patients, that something it's space mean, with disc been is believe We XX in is trials or -- what's but mean, encouraging this there investigator-initiated it's studies. the either

use accelerate these really especially help data effects very encouraged that disorders, for to really needed this continues in which data, product, we're we of So these could that in potentially terms you're of pivotal, the in if I are looking commercialization it would overall getting which musculoskeletal market think, U.S. show and the the is, tremendous. this us the when cell-based which therapies at approved,

for we're with there's product. So and our market a huge confident very it,

Michael Okunewitch

hop then I'll And right. one me, last back one the in and All for queue.

Lance Alstodt

what [ appropriate. as as therapy we've temperature this you FDA of and consider at and accelerate also the I'll study cell in of our Michael, data data view, pivotal trying that mention that changed of strategy to its just to terms because pro at ] some perhaps mentioned looking the more

do that we the FDA view and believe the comment, in a of appreciate has positive taken much that So more do sector we general.

Michael Okunewitch

the into does at question. data. particular, percent that somewhat just to bit secondaries will the of I looking baseline in Actually, whether looking that a groups. next wanted from you how some Yes. ask in between unblinded would be final you little at you be varies lead And the about my change

Francisco Silva

sorry, I'm didn't I question? the repeat you Can it. understand

Michael Okunewitch

something responder groups on scales actual pain looking you'll analysis? Just addition to the terms the in at and secondary unblinded both be the function for endpoints for in percent the baseline final change different the from of data is that

Francisco Silva

Right.

that points on has we that into We are they've protocol. guided put that out. change, is exceed data the can a trending XX% their that based our the feel So MCID it's FDA coming that

of in think if the that that's we we and whole a to feel disc, demonstrate MCID powerful that we're general other host that. We're of the a that not radiographic demonstrate have of for to data. terms will very subjective radiographic strongly to to we efficacy, a be but would looking going set that hit be able endpoints measures but just it's So people only we can just there's in also exceed improvement very not good issue, at information

Lance Alstodt

And mind released we that, Yes. here MRI really add images of is keep disclosed have to just to any patients. that important in that's not of these or that any

So that's of something that's happening the terms additional the remodeling something to look forward to evidence in disc. of that's within

Michael Okunewitch

compelling the And again, here. data congrats once on

Operator

Piros The with Elemer next Rodman. question from comes

Elemer Piros

it ask, Lance, these And it group you both you called have could demonstrate Thank if them remind demonstrate the that and you at would for ODI at would to functional the on would or have XX% us improvement on be they level within least that to for to whether I'd the What the responder? same have are to verifying endpoints? least the XX% improve like patient at to the is if VAS pain co-primary improvement you the so, that. and

Francisco Silva

well both to VAS labeled responder. have as ODI the both to a they respond in as Yes, the be

Elemer Piros

So in the X the XX the responded pain in Francisco current study, that is out that you of improvement... X see

Lance Alstodt

And Elemer, for thank you your question.

and I think there has you're just looking where well. bit function in at us been as thought a open pain going to as I the a are of strategically know as opposed It change we perhaps of for people now leaves amending go about now. within agency this because as as protocols think factor one there just out we success really do to that by increase there's such we that believe precedent through limiting it our to probability because pain

the of is XX% a responder of what we the is minimal think But is pain for disciplines. both good we bar for And that function. in both discussing. as clear group are that and something protocol us it's written So news now, the does

Elemer Piros

that the the successful for both, would... product a make were day, you the I would end Yes. stronger of argument if in mean for at

Lance Alstodt

of compelling, to be we very also showing and the intend disc While be radiographically changes some which in improvement do. and also the physics interesting would

Operator

no turn any have like the remarks. We queue. further I'd management to questions for closing floor back in to

Lance Alstodt

you really this on your interest quarterly certainly Lance. behalf and just in clarity I our we spending clinical time On appreciate data. following would our the team, accomplishments our is further get say, and of to us

our continue February on have intend developments everyone to in within will the available frame. more we and new January, appropriate to We update as company data time

excited really working So to stay what we're share with We're tuned. on.

So have again interest. for a night, and great your thanks

Operator

conference, at this disconnect Thank you Thank you. This participation. time. may your you lines today's your and concludes for

BioRestorative Therapies (BRTX) 13 Nov 242024 Q3 Earnings call transcript