BioCardia (BCDA) 29 Mar 232022 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia 2022 Yearend Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions]

I would now like to turn the conference over to [indiscernible] of BioCardia Investor Relations. [indiscernible]. ahead, go Please

thank participating and call. today's you afternoon, in for conference Good

Company's me are Officer; Chief the team BioCardia's and Financial Altman, McClung, Joining leadership and Peter from PhD, President David Chief Officer. Executive

address technologies management's the will Such management products, factors current developing obtaining and forward-looking statements future call, this inherent projections, approvals. with BioCardia's references outlook, new be for to During expectations results, expectations. others, uncertainties beliefs, regulatory statements associated include, making and including among that intentions, operational or performance analogies

statements risks actual from Forward-looking involve that and may results those other cause factors materially to differ statements.

information described refer to in more this filed the statements on these reports SEC cautionary XX-K Form and For risks, BioCardia's with about risk please the factors morning.

contains as after that accurate that any Except or call time-sensitive information disclaims XX, the XXXX. update reflect The information of circumstances required March obligation events content only occur by law, any revise this to as call. company this is today, publicly of to time or

is ahead. It President please to Peter, over call CEO. and PhD, the go Peter turn Altman, to BioCardia's my now pleasure

Thank a you, I in take fiscal doing and few and it. Moranda but, doing everyone the XXXX, great into we moments before get year review always call. We like afternoon what we're on details, to the [ph], to to had a good why we're

chronic ischemic failure, cell to syndrome. significant treat heart and ischemia, respiratory platforms diseases, advancing therapy efforts are focused specifically two on BioCardia's unmet cardiovascular and pulmonary distress myocardial acute

locally. the where intend heart lungs, cell-based our we therapeutic delivery therapies act to to of involve the of All local them or

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working pharmaceutical cell XXXX. therapy to second failure. had second July, formal with in of device approval previously ischemic we expects Japan's Japanese shared submission have for complete heart leaders, we quarter with consultation distinguished After CardiAMP BioCardia our for in medical and of agency As physician the its registration regarding

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of Our There therapy offering biotherapeutic were been navigate developed initially and these products help steerable product similar Avance procedure assets we billion. cardiac have sheath our recent in $XX today. acquisitions to $X.X established use product to our delivery cell between million every offerings for to systems

FDA-approved that indication for our offering this compelling provide Our first is transseptal benefits. patented may incorporates Avance technology and

we week announce these to expect new to Next patents of steerable related issuance two additional the sheath assets.

to an looking Receptor related platform. be forward mesenchymal and to Helix a we to been patent soon delivery are announcing Biotherapeutic Positive We has our related our to that Neurokinin-X patent allowed stem issuance that allowed additional expect cells also

now will review financial XXXX to CFO our will call pass David? David results. the our McClung, I

partners the I'll Today Bluerock revenue fiscal year fiscal review relationship from $X.X to the for Thanks increased our increased financial million mentioned. due everyone. primarily Peter ended new to from for $X.X December including XXXX Revenues and results the year XX, in million and XXXX, year afternoon, the collaborative XXXX. just Peter existing good

to be revenues to the therapies rate and royalty the effective commercialized. underlying and revenues, meaningful reducing today in Our if to contribute and our have they burn the develop licensing potential prove

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to cell XXXX, million reduced Selling, device we general decrease and even was versus expenses fees XXXX due decreased and The million $X.X new as in our manufacturing licensed and in compensation administrative $X.X stock and facility. service established expense. lower therapy to professional primarily

the $XX.X a $XX.X operations loss million comparable totalled $XX.X compared XXXX, net XXXX million Our $XX.X in in used million of was million and cash net XXXX, to in in to in loss XXXX.

and million, additional While the the quarter provides or development year activities. third equivalence into from $X.X runway ended cash business with funding capital without CardiAMP cash totalling which

we're and questions. take remarks management's concludes This to happy

[Operator Please from comes instructions] Wainwright. And ahead. here H.C. first go our Pantginis Joe question with

good afternoon. question. hopefully getting one guys, Have I Hey some, the will Thanks be which of based questions, perspective. for believe three on taking important

I'll one. maybe start that with So

we the for to history? when perspective the XX% maybe criteria look Peter, roll at compare, and the So, blinded in inclusion give relate overall improvement LVF, the that would of ACC, you to how can data at how their that would the echo patient population in natural of

failure is question reduced these heart the Joe, New it we're our trial looking thank always fraction difficult patients. that's Association Heart and also to you at look that another, of as great XX% patients. makes but to etiology in sets, XX% for compare -- Class data and ischemic fraction no, something Joe, ejection Ejection we II to at population York with it one III

So this X% XX% done per what up I trials, the X% some with mortality in in of shared to caused mortality of other well patients. in year all lines been mortality larger of cardiac data these has -- of whereas and the

that up wind that Now patients who excluding actually there could are are sicker. we're things doing

have that population. us tilt to cardiac and So a conceivably for towards example, treating healthier the patients eligible we're be for could catheterization

population we're population is impact have a should compelling cell or superior that have seen addition, analysis and long-term have that own XXX% population who a patient time, improvements at year, In patient's per group deteriorates. survival really therapy the we our patient it's and XX% an same mortality in autologous having potential in a their typically seeing patients But, could selects autologous cells that on for a the potential prognosis. there

So many Phase with it's set, data across on we metrics. II recognize what we were line approved completely saw and it's in in Phase a but patients I small

controlled that what placebo-controlled find trial. true that's population so you or this And does population this how the is, to we're going question in a pose a to compare and out

regard right guess, regard talk studies helpful. with do that's now, your on immediate serve have want then, I No, you, to studies initiatives to or your needs, with manufacturing about especially and Great. to when have multiple to Thank and ability versus, manufacturing term larger management you expense ongoing now have you right and any focus additional I And you. capacity? term your nearer cost what management you

BCDA-XX our So and manufacturing BCDA-XX current will all allogeneic I BCDA-XX, capabilities right trials fine and for now, think for that BCDA-XX. clinical be actually four and both the the autologous

the We have taken own to it. -- it and control made decision

So in as here manufacturing as for the drugs with -- are delivery for medical David our we drug new for facility those device our of those certified systems. mentioned, that manufacturing well delivery

are not result most could and we're but as So, greater advanced clinic. partnering our as folks need, others with we with of partnering are in the in far as the

in XXX So, working they're trial, a BCDA-XX. we're XX-patient trial patient aspiring to a while towards do

enrollment also only and cell facility. our handle we in incubators we manufacturing one of do note the things expand our accelerates, the one example, add can and We're as I So for on rooms, currently capabilities. to we both We our can manufacturing. shift out that here at running have as can capabilities BCDA-XX

and comments it. on right to in helpful. my of study obviously And lot been discussing now, based question the while, obviously parts. failure, what your last Got XX a then heart for regard No, with moving very we've

with coming FDA. depends lot what's from So, upcoming your on up discussions the

futility, place, analysis already be I to be the safety, at ask essentially everything is now it look upcoming right what would know would design? changes what So analysis I'd could of or the analysis interim it we statistical guess in efficacy, impact there, around that ahead adaptive or plan alpha an going spend or -- any current from plan is how the is

and a of that's great statistical Yeah, challenges the these -- question -- it's adaptive of one the a analysis. that's great

statistical a that going like of PhD the for what you going alpha p-value don't is in is significance. folks level to call are Joe to lose have spend to does, the order think I alpha be and very have low the on the spend

as one device study. achieve for large agency less alpha as adaptive is only the regulated now, than therapy, look P-value a of to We to analysis well-controlled of So right this have in we're expecting the autologous plan reviewed won't a we're system what get until Again, will at statistical the know data. the totality we blessed by the spend and X.XX agency.

As imminent. I've that shared, is

you amount do want we the with alpha as We and that forth. the minimize the appreciate But Friday. a spend, amount can I'm for Joe power to lose. others, agency and call of we're going that We have of sure it's a scheduled to typically this our back

a And a of a There's wind all much alpha, X.XXX going working adaptive X.XX to statistical than good brought they think high spent pretty in this. so and the in design, the to agency profile P-value because to lot up some rather place. I'd of with appreciate be we experienced we're help regulatory analysis were I folks of that consultants facing we've plan, but on one the the

this get sure is key the you a I you're of to that's have to why in the the for trial, breakthrough trial. is this want the breakthrough going designation other some results us to lead we program, collect here in safety in that presenting trial. after experienced designation endpoint that on approval, now success also job our thing think I when we've And for, can enable primary in data an -- the make meet and folks, note very additional side this brought and not

Our to approved available therapy and cardiac get here cell is job patients. for

process success, of on this be term commercial maximizing want technical we very also near so in but our thoughtful success. And to probability

for lot color. Understand. the Thanks a

questions, them. Joe, really appreciate great No,

ahead. Capital. Raja our from question Roth go with And Please Kumaraguru come next will

one regard two ejection and Again you what and know point? time my with baseline range the Thanks range also was questions. year the for left to the fraction, taking the at ventricular at do year

actually I the all the presented appreciate poster that's website. and think in question. So, of on available data Kumar, the I our is

criteria the is to think I the XX%. XX% inclusion is patient that

addition, follow the XX% In up be of the would that. is top on

like my data call. it's XX% before follow and I'm can in probably high you but have probably up at mind, after don't up, being me. I poster XX% the So, shoot if you here high wound would estimating this right baseline I that at

like the to also expected with And is treatments kind I Okay. range of guess. the that heart seen XX% other range, fits XX% with of in it for failure,

the most So you the think so that patients therapies the in heart LV excluding bundle your failure don't function with transplantation, of heart and native where I'm fraction. pacing a therapies and branch the in in most general, I but failure truth, really one left can assists have heart therapy ventricular But in block. some part, heart is enhance of significantly devices still ejection left improve biventricular

running a have than they're Typically most that these that that they're deteriorating better control in therapy doesn't group that so other group. showing comparing comparison, are this and it slowly patients and they're therapies a against space, in

cohort, rolling heart actually not show ago. in we been themselves That's this that years were in Here than failure. the two they patients are better done

the it's time and was set blinded was core lab the of these it, to I data a these don't Now Yale Echo are small it over that results they patients I at very as this to out set, being came but know treated is want and blinded and with. data a worth the that looking interpret

And under the plan, under and you context have you to patients patients and patients that statistical mentioned in active also would eight pre-consent. that XXX XX to Okay. patients about require it XX with consent analysis regard

next number be regard DSMB, timing patients would would the what that with So the of be analysed? the to of

the there, that's great So I have question. a answer Kumar, don't exact but

So way that would think about here's folks it. the I suggest

follow-up DSMB a of we additional but time, again, failure same have success this a this going. patients the -- trial all is the in data early So heart if is, the be with to number very it's exciting, That's set and the have a keep success. would at

last trial or patients already a DSMB if there's have stop primary efficacy. early review, said Yes, XXX recommended ring they brass for the they we that the stop At past at looked a endpoint. our

letter we And so in released the we also at a more December, color. which I had and light end provided of shareholder the that of fact,

things measures different very address to a up though interesting fashion. trial controlled many is it the of being variability even meant doing slightly follow more was approaches, the trial in lost with or centers because the One to in the a all issues in larger it do design associated measurements they're in of trying greater patients different,

that, larger endpoints was baseline arguably and a improving data saw follow And pass there only XXX of the did patients, a greater in actually actually we the was what patients some not we variation of reduced number, clinically meaningful endpoint many expected. and the we primary that than in saw a have weren't levels, would've than but in measures a lost up there aggregate

are and So, This here, analysis we And there's to and will we is, things we -- don't oversell the pivot approval are be commercial. [ph] trial after we already the not, the but implementation there, to and completing statistical trial. and if continuing then going the we're will of if trial if adaptive leaves the tea plan, wanna reading this. rightsize a some interesting will degree, I

it. up The share, plan, thing you enrolment we've And analysis it's I taking all the going guess into clean adaptive I'd statistical not like this it's but the data nicely, done. gotten is about it's looks think done as last till of

have on if this going halted don't even clean very, we So trial early to very review done for data. efficacy, DSMB the is next be

even on its So own. it'll be more meaningful

much. so Thanks helpful. very That's

you. Appreciate call. on the Thank you being

Alliance Please [Operator instructions] ahead. Molloy from next Partners. Our will question come James go with Global

detail? Friday's I wouldn't through expectations the bit, or game questions. advance for in you call do you of any something sort a I the was little can that my to know thanks we but of -- it you talked more is guys, Hey want for call, taking out

the -- trial And the what's OX the you patients expect still said XXX OX, in XX XXXX? steps then first and we for anticipating What's next the you that consented potentially on in. are in get on roll you

and We're all around be being So well. James, what thank questions. call on as walking we're Friday's doing you going the for to wondering on great call here

we clarity design have the us. on have before So, we that

bit will little color. I more provide a

expecting agency. us. And to are we not written comments today those So comments come the from have yet

after we series with whole review -- high the folks expect a of will for series what scheduled you a for a agency whole the was feedback those well really of and to meetings has as have adaptive to digest an We the prepare profile Implementing address with to no safety calls issue. to and call statistical ramifications. any conversation is as trial might outstanding here. -- issues plan analysis the comments design It's

will with And also to to And reasons like fully conversation that level the They comfortable coming certain one smaller with patient safety. But, of why not see they're that it's the the trial nice that's data a of have us. a agency for we expect we a into folks respect say feature. with that approval. the

that breakthrough us the this Just conduct additional the completion trial. remind have us that we after designation data of lets safety

that's now. it sort color on right of So, the

it spending on amount best the could all enormous plan dialled get us of call. share other we'll may time in and it's more and of and We statistical analysis change, implement think recite it on I in But, adaptive have the probably side. let as things been I verbatim details on an the likely the it,

in and have be it I'm get that my scheduling it dated, is QX, in place. we don't get may for and it have the next a but place, still expectation in we if will much very DSMB QX DSMB, we of getting that I expect this place DSMB in in meeting, expect will we'll do in the place I

the BCDA-XX for with to patients on myocardial with the regard As ischemia. chronic second your status question

rolling the based expectation so experience the what for the this we been things Baxter much no the is the exclusion, our logistics respect doing in XX therapy are on on advanced patients, issues. that to by So inclusion folks There initially therapy, we've to is cohort of really up call, very and failure Healthcare. a trial. It's had is there's the with was have patient heart some far, and cardiac

a data a III approach, excellent, much Phase for business of they an but for chronic reasons approach trial stopped XXX different it different with was and but renew a And myocardial patients. was they therapy after initiated delivery They intramyocardial their cell the enrolled ischemia. trial CDXX

for now the borrowed we so through design their of and elements in because we of to in are looking was go some help downstream much the issues of much are we effort The working some are the answer but why it modifying the successful. this potentially we the is also that patients, of faster. significant know kind goal, is which the the trial so from of enrolment make elements we at trial terms go efficacy smoother But and

receptor positive we're stem the mesenchymal, excuse me, Also as neurokinin-X an neurokinin-X mesenchymal heart we're program pushing program of cells that we enhance enrolment as are all in these elements on the the think well. advancing, lead CardiAMP failure actually trial, those third the the selected

ischemia because qualify who is trial. poor together. so based mesenchymal for marrow dovetail things Patients too their myocardial on trial. therapy Patients CardiAMP for these And qualify can the of can they high are data, have nicely a lot bone excluded the who chronic ejection from allogeneic for culture-expanded fraction stem the cell

So this shots gives three all really it we're a goal. us way needs really trying the patient's on meets that in to do and of

you for dovetail Thank That that actually. nicely answer.

far second OX. guide and then how OX is on behind OX off, behind? to saying for 'XX guidance kicking You getting you're Any trial guys the quarter

was manufactured humbler, but already. of last we've because had need after it the the I to time, long some -- the have in patients term it cell cells prioritize that be point We the year, datasets this actual manufacturing, At to decided the timeline. the want manufacturing, the delayed those lot that we we cardiac wasn't release we testing, the

it. in for centers. being that cell failure might And that roughly of like that therapy you BCDA-XX a would patients the have have we the analysis, and it with ischemic as mean expect downstream odd a So heart patients population at XX% can't cell already presented would That patients. XX-plus have XXX-plus excludes the

So patients into bring potentially that could immediately. trial we that we have

and we're program so enhances the And to with something be that lead going that's well. that as starting we think

for Great. questions. the Thank taking you

Appreciate day. you have great a James,

this remarks. session. any And over for I Dr. like back to turn question-and-answer our Peter concludes the would to now closure Altman call

I participating all interest BioCardia. have be call sharing Stay of on healthy, you We in Thank progress. you, to and Joe. Thanks. your to look a continued thank for wonderful forward for kind, our want and day. today's

today's Thank now you concluded. conference The attending very presentation. much for has

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