BioCardia (BCDA) 13 Nov 222022 Q3 Earnings call transcript

Good day, and welcome to the BioCardia 2022 Third Quarter Conference Call. [Operator Instructions]. I would now like to turn the conference over to Jules Abraham of CORE IR, the Company's Investor Relations firm. Please go ahead, sir.

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

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

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

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

November Altman, the as information of revise about only the -- X-K Form more filed of the most statements filed X-K refer to and recently contains SEC content XXXX. the obligation reflect The filed cautionary President risk over this and to factors information publicly It's turn information update my occur this ahead. now CEO. periodic required disclaims go company's the Peter BioCardia reports the call. For events X, call please XX-K, and time-sensitive Form risks, in any is to after within. Form particularly BioCardia's accurate these to with described by any on circumstances or law, PhD, pleasure that the with please to as today, or XX-Q and call Except Peter, that Form

Jules, Thanks, to afternoon on and good call. everyone the

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we product. David? call to began protein delivery as McClung, And the is the now cell, Avance fourth sheath Third CFO, introducer financial relationship the our will perspective. biotherapeutic transseptal some pass therapy for David quarter. in our Bluerock I catheter-based monetizing will gene licensing last such provide heart, systems candidates is our and to who

now $X.X Peter. revenues. programs reiterate dollars primarily first BioCardia of value, in we of million when the into a revenues to quarters provide working I'd partner To on collaboration to like we development $X.X totaling X on Operator? million. ready period reported with XXXX. months of XX, help XXXX compares favorably that is which you, same loss is can are second net second the million, net in due for than the $X.X should be programs. We're SG&A of of we loss X net ending with Thank meaningful And greater million, the development into them. on revenues far and quarters successful, business runway increased increased provides the XXXX. for upside XX, if questions. million collaboration compared XXXX, financing. loss $X.X in The X million a a This X-month increase which $X.X of from modestly shareholders. ended we September participate cash additional the Research the to value months expenses of of them we Partnering company decreased September expenses enter we of the quarter be the to development to with million revenues the receive XXXX. million in focus in had potential XXXX, approximately the nondilutive the revenues to decrease ended first in with our $X.X $X.X In quarter period $X.X the activities for runway, $X.X where of pathways and extend million had X take from

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

guess my you're housekeeping it's it working related, is -- multipronged. adaptive plan goes I into the first currently question the a design regarding really And but it's Peter, bit weeds on. I mean that

some provide can information. you hopefully, more So

what would finish if topics, the it's there regard topics consider what Is we regard the in here, excuse are adaptive especially FDA, -- lower to the outstanding FDA it's around the components else spend the guess outstanding you there -- wish that really line the the related on that's now any is of over how the of the #X. with really have So this guess, with -- enrollment me, your alpha discussions I and with I getting with FDA. stage the with list, to

process. with can are we I So the you in that share

you to are with the straight question. the the still off, FDA to So for Joe, thank discussions early. But the answer, first jump

a We have had not Q-sub yet with them. meeting

the number process submission situation, about this to understand this a for smaller it will them of Safety raise in And in really appropriate But by enrolled the Monitoring Board. is undoubtedly their the wrap with patients needed agency detail preparing are the it. We heads recommended that's of sense is the being and Data the in around concerns my trial.

of data advantages we significant the that scenario. us have if safety to FDA in does understand, that the is I ability, such indication, from X need to the So a breakthrough a capture designation potentially give we for post-marketing additional

prestigious another. group And a regulatory is world-class directors. two of have working statistical plans. are One cross consulting former analysis X recommended We high-profile groups that other with developing very adapter senior FDA number includes in is a who very actually the group a

the expectation it our the the at results equation cost. going this do I significant the the having understand plan how design And first be. not enormous trial. not going the But to large guess because in and from an the a question of it's not of pulling statistical a of there's trial we're is be that should may that meetings. team is asking to here, and the cost together dialing alpha alpha looks what regular be, But so makes And we're analysis what is cost sense to changes my are in order alpha so thing adaptive

to data have we This where effort they're that's we note next and can Board the to is they of Safety input parallel effort the I Monitoring a Data the today. in all of meeting, we're regulatory that a at. provide so on clean rely significant And work, active at side very have very data that so upon So ongoing other the statistics at looking cleaned this. the that the

said, exciting. continue. enrollment shared trial. pretty that I no as in diligently we the comments, guarantees But experience as to here. participating in are working of the the there's may in it's as enhance physicians So And just in the all Fundamentally, this our trial well enhance ways trial

it are about those David's sort list ask your this And it. Got goals, comments. it. way, ask moving I I would bad you appreciate and of of never guess BDs? of list you different always of I No, predict to would all components comments the those ongoing level even maturities would describe and I the But development then a business fair how That's thing. to timing. of X

would significant that discussions delivery and say they would is others. I biotherapeutic quarter, Therapeutics. first Bluerock and the CardiAMP may arrangement on partnering I of time-limited them. had We, that into in the some of progress see now that say year we've That right option really a all with the an our is enter focus ahead. third we is on the OUS And that last in X on on the did with them. that have, the

done delivery those the propositions partners we've you're value sort a of And that efforts, our remember, value the is of could data are this to ahead. value system. partnerships, historically. have grow And other sets into we have nuances when of with we propositions with developing So quickly comments, significant what previous David's these of -- number

just use the sticking maybe and last broad And the then changing. consensus. look, broader the question, of end if ARDS, the still to It the is of platform on my around dramatically XX cells in skip Got in landscape be guess, concept allogeneic our I will pipeline based COVID for it. the I it. Got of

study also you So will, why this I of this doing finances the just status standpoint this at of and while important. at rationale if are guess COVID,

patients so we're therapies from indication respirator. right recovering off the There no question, is a there's come So COVID. really Joe. great there. And going indication when now actually they significant The targeted after gap -- essentially patients for very are

chronic ARDS. after, the A of And there's ARDS, tail on are note there's inflammation. that at of but And long a respiratory it so all we've COVID-induced to se sustained refer of I happens respirator. not inflammatory being in indication out about etiologies to COVID. something per folks there of other that's will with there lot that also patient what in impact distress going the or we're as gap acute also that a heard end

what a And they there's space anything. doing routine a so is where therapy. have don't relatively And we're

economic side, Joe, great On the question.

escalation So typically these with to start cohort trials, dose start as patient. Phase I, care great Phase they the protect II, with with a

so centers to number not to of added a trials. be And of these that's either there's significant going

that's as at manufacturing issues and safety a these X of cleaning the we're tolerated all expectation optimizing for think basically, ourselves significant out of BCDA-XX and burn. therapies, the So BioCardia. the going it with to BCDA-XX, maximum the We're cells dose not be here

trials has a For the been out based short for of effort, it very ARDS have efficacy, lot point end on that other a the there.

So think we're feeling it's about I we're the I for substantially pretty to going burn portion. going, the direction and don't impact good Phase rate the

later stage increase significantly into to II portion, would on that's we yes, burn something decided But in be there. future. the the rate move As Phase

next question Maxim. Michael come The Okunewitch from with will

I you we data? how And more could analyses that. just be Peter. provide see on blinded the the should a then a walk how interpreting of more bit me color and bit if on you give through to could conducted you if kind us wanted

Yes.

an So a the session all receive for was all so blinded the on patients. data, you normal at package data is the that -- open monitoring review, a safety will process that looks it data of Michael, of board

aggregate data. it's So

looked that of data. improved, deteriorated us the And the And treated from you X which expect. are heart data. would different the over don't patients in is but the know the control just we're what data out after is trial, sort condition. jumped which another it And time, a we chronic II it as are was at is group our patients out at we Phase patients -- when improved. going whether look blinded what group. But failure, So the to at stands is we We

the Now better out animation, patients that trial the of I trial. even call cardiamp.com. animation mentioned clinical fact if And at a you in we in the -- that typically do

may just on we that the is in trial. literature seeing the And we the field. So the compare would in which the I a better we're which group. in together than significantly all But less it related the again, doing we of way mortality patients based don't because rate blinded as be clinical note expect have are to to patients, also

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with we a -- and coupled And have designation. that, also so breakthrough

there full would significant of you safety. great enrollment want our a the my completed on treated designation say the approval. a indication everybody did of that in pathway the heart that before even comfort other so such a future And we trial, to reached that we've to respect to collect if the so concerns, But breakthrough additional sure data with in efficacy side that has one have patients gives you've us enough make be divisions we wonderful is to already ability in

at addressed it high Michael? Have I level. your question that's appropriately, So a

X comparing to aggregate on I'd compared you're greater saw rate the to Yes, other a you're large pivotal you bit trials? -- that data data like aggregate saying you little point just particular. down survival When other to in similar did. pivotal -- drill that trials, deeper on Is from idea? that's the a

arm fair, actually, as dangerous mortality be about that reduction Heart because out considered is you're the in still there assessment, one the talk been Failure But trials problem and this have we're the Michael, the come there. we trials. comparison, think positive the mortality. be really such to trial England great of that to out the really when not our exact it press out the this But would I'll is And They're trial They're discussion in when release. always is a successful order out trials apples I same showing of I trials in conferences aren't there, in, of topics exact a referenced because patients. a what other are Society not fair the therapies. New out, a they're that's it comparing to that have just actually is that that Journal That the oranges, not of same in same at America, Medicine. call SGLTX the to comparing I previous And

is So are we're the and population reduction is comparison, oranges in apples this an this to not different. across an an that again, apples-to-apples us. doing things aggregate it's very mortality But a striking for

know. X that it's is than don't the so And We all interesting. group other? more in But That's I'm sharing.

delivery therapy from attracted could platform? particular your indications benefit see kind And And how them All or sort to right. just cell Bluerock's candidate. therapeutics if of what like then touch could biotherapeutic benefits just on X other platform of I'd to the device? more follow-up. then you What the

Yes.

respect our a has with delivery couple anything that advantages. you tell on to comment system transendocardial I can't of I can Bluerock. Helix biotherapeutic So But

in that it clinical intramyocardial I'm also is -- delivery It Helix in the Boston who Johnson it's its safety that is of retention and believe only in over delivery, been literature, competitors also in approved I enhances to which tissue companies profile, of Europe, delivery after such myocardium the the First, And has have its left in previous the we although Johnson that the is small the only control that in arena, stability aware partner be heart note delivery. it and is of superior today. it. we & which is stability yielding system published would as efficiency of since Europe, Scientific. in really and our the the far don't due to its use sell we

with So therapies our multiple have delivery retention dosing simple different data others have straight of the had on needle with threefold the that have classes intramyocardial a sets system or we multiple approach. shown, roughly threefold

helpful. And so also that's

of use of system. the ease the is lastly, So

we with to We this equipment And their have wanted capital larger cycle, us their with own a world. no number sales would ability and in that past, of capital entities around equipment of the that of physicians or product. primarily because work in involved slow had absence work to the train the

last key those indications. say folks myocardial heart would And So I is really the ischemia. are on after thing today is guess, and the BioCardia I going are chronic failure focused advantages.

partner There are very and/or successful or after in myocardial indication ejection fraction And failure we're a X which great myocardial acute that's there's failure need. in a sophisticated it's preserved heart ejection those potential clear after heart disruption, heart Europe with that fraction heart to great in eyeing with we're myocardial is have fourth ischemia, well. view out is today, also really infarction as We that soon sub-acute, in preserved because is And have failure our made preserved as And chronic a X with folks of to failure due that microvascular indications [indiscernible] go indications number the fraction. infarction. ejection interest today. because ischemic direction that if folks big going maybe there, X

and for. And cause X for & a up indications quote I the And their with are be Johnson in And agree Western they heart who And couldn't efforts of that in the disease That's So it indications, can amongst the he leading failure. bought opportunity we're doing. are we billion. wind the those X $XX those world. heart for frankly, helping greatest in just said recover. of where that it's used more. exactly recently them CEO really death Johnson, we what hearts biomed all the forms would has see of

Global Molloy from Partners. question Alliance next with will James The come

I patients? Or Is first on And when here, OX had XXX 'XX. XXX-patient be of quarter a the that look, interim cohort anticipating XXX subset enrolled? that enrolling question we're the the the [indiscernible] XXX is of a will out patients?

So enrollment next complete we to that are working year. in

-- it's the in And are first the a good off, James, thank currently you We question. so for eye. process

so QX cohort, the that -- got our cohort XXX probably that But pushing is We by patients full year. rolling that The rolling to get be to treated. from year. patients have available next in until already phenomenal are the results are rather enrolled. that patients expectation going been next we're actually are still the have hard not results for to we've And

So again...

In the cohort. rolling

sorry. I'm

How on are year many you're in the reporting first You patients cohort? said 'XX just rolling

patients. cohort rolling is protocol The XX Right.

you remaining anticipate the the from -- And in XXXrd data anticipating potentially in 'XX you patient data the having final when XXX with and were Okay. enrolling the trial? then this first XXX potentially

Right.

an a long statistical attentive this So you're analysis plan be very so The which -- -- approved. Jim. focused that's said conversations we've having talked The so about the X-month -- that plan BCDA-XX. we're very the And -- have has for follow-up endpoint, with of on expecting is here, that we've part the adaptive the -- there again, agency. agency being

the in are process. We

centers actually have we things cohort you now of successful a also online and easier We're one in where the coming perform heart program. trained for across is you roll the a are situation before United do you and that the and be trial it So rolling way States potentially across in up all to to make failure learn Canada every more can you try the to out. likely

So of it's study that the same same both the training. documents reference same logistics. of these much programs. support many It's very It's the

at actually, the I doing now, that that idea back. is And take we're right so are not this centers --

then but in centers yet. that all of probably that will are that additional the We're are not well patients... trial. active the have we program, point heart it the to that centers the centers not some adding in we're We these the are at in failure at just failure trial. And doing active point, are expand heart And

data? follow-up for XXX X-month first for the and you'd be mid-'XX a so in it's So means looking it's 'XX XXX you that's

I would but it say going and clean it's to that data data than to will for stuff. take time take the that go through efficacy. and to some prep correct, is X-month follow-up longer get

add the So on completion a the you of should probably side year other enrollment. of

in and between hopefully XX approved XX I/II in of the third That's now BCDA-XX? XX first the for here on was X-quarter The the expectation expect approved Should quarter IND start we 'XX. December. the Then a with approval Phase IND would April trial on IND the the similar delay for the trial filing quarter 'XX. BCDA-XX,

no. don't delay. Actually, expect We nearly the

there's sure lead of make items. clinical of time for cells, a substantially So still manufacturing we're -- for were patients. elements And those of cells safe with involved but today that to long there's time long manufacturing in clinical are cells and the awaiting have the cells -- even on couple ice the lead steps long X in BCDA-XX, QX, process the the manufactured that

we've identified cells the on work program. BCDXX BCDXX. note, have that benefit of manufactured the BCDXX of BCDXX we've all the all Jim, will I patients the today already So in advantage also from will

the we weren't excluded and So to take a BioCardia patients going very at have on trajectory the could decision interesting, that idea the other here BCDA-XX to large focus in BCDA-XX because is concerned from to treat of items. we process is number that BCDXX. patients The be if about been

we're our pretty because we're II study, that Phase once it. launch to study into now, to the at will commitment before but phase responsibility probably need of the right a the that you portion So quickly, a a complete sponsor, more of have on And going going rolling to a make to do is expensive. where focus as be you cohort we're BCDA-XX assess to we

We have Medicare and with that the nicely with reimbursement. BCDA-XX X

For reimbursement. won't that BCDA-XX, it from benefit

sense BCDA-XX trial, have James, we a system BCDA-XX them consume treating stage. I'm the that's now I into of need don't we your with the we company, complicated from value since And physicians can -- have I but be synergy BCDA-XX the know of of same complicated we're it's we prioritizing different manage a right all does a programs programs, these distract over by patients, Even X think of so in lot as interaction they're though And II we having thoughtful program. before a the working patient lab. to in want to Also, move the the it's Phase cath time physicians, through significantly. this at but patients it's because far. these small

real with data having for What's Last quick. release? question quarter numbers for the and X the the the not reporting in press months David the

Can Jim? say again, you

into put of the your instead reporting? It's Why quarter X-month sort press don't the atypical. just for release you your guys putting third of numbers

now put more are we presented pretty versus the months the -- and X whereas They're numbers fluctuation quarter-to-quarter. in think both the towards Well, they're flat. the the X of shown I trending year tables. we're We end the of meaningful could have

the partnerships. -- data with in Yes, lumpy is tables. And are our the all revenues it's

ever year this far. have So we've greatest we the had so -- where do revenues

session. turn like to any go Please Mr. over conference question-and-answer for to the I This concludes sir. our would back closing remarks. Altman Peter ahead,

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

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

may now disconnect. You