BioCardia (BCDA) 14 May 242024 Q1 Earnings call transcript

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia First Quarter 2024 Financial Results and Business Update Conference Call. [Operator Instructions] Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately 1 hour after the end of the call.

I would now like to turn the call over to Miranda Peto of BioCardia Investor Relations. Miranda. ahead, go Please

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

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

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

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

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

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

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

clinical big Thank the call. a the everyone you, to this BioCardia results quarter in each autologous presented have on we for X candidates and as been has Miranda, will ongoing trials positive therapy This failure update clinical good to In our these from investigators our clinical afternoon of myocardial and product ischemia. call, cell and share allogeneic treat development. ischemic chronic heart on an active

therapeutic of with cells reduced ] ischemic of [ unmet these of X for an having heart therapy and is have clinical and failure CACHFT targeted trials: Our cells efficacy ejection that the treat clinical CardiAMP results lead heart now reduced enormous to cell fraction, safety both CardiAMP fraction. HF CardiAMP failure from ischemic patients support the ejection CABMI, need. We autologous

patients all in of reduced the these mortality seen Failure events adverse most active recent CardiAMP a treated the risk and failure, elevated focused signals Heart first relative in heart major of is where shared reduction well-established death cardiac patients Results NT-proBNP, have XX% positive quarter are benefits treated cardiac late XX% the reduced with in we trial, in and nonfatal in Although a show heart relative remarkable remarkable risk biomarker and equivalents patients today. events. in adverse a major cerebrovascular reduction we in

death do that equivalents on at is heart of Our to patients unfortunately, approximately not all-cause ventricular for today these these replace a years. X This include assist patients. is are still a implantation function. available have significant and mortalities therapies XX% And as exciting cardiac device death, for impact transplantation left particularly mortality

in in parameters patients measured of improved improved Further, death fraction, ventricular Heart the Living the show as the ventricular with therapy, greater life Both outcomes walk recent therapy patients Minnesota these significance, statistical quality interim life echocardiography outcomes left ventricular and all demonstrated heart test of volume elevated X-minute cell end-systolic of quality improved reduced the left volume. left including equivalents distance CardiAMP Questionnaire, Failure reduction of favor favoring with NT-proBNP. results levels, clinical and end-diastolic using and NT-proBNP ejection

in BioCardia submission team enormous ongoing to enrolled both presentation an by is available monitor is of to final scientific and fourth this patients regulatory goal have results quarter Our There study. for for the XXXX. activity in the

results don't than expect have final patient the analysis, that XX% more to in we we follow-up will As already data significantly. change have ultimately the we the of

element of approval. a results Device The to a expected final provided Medical for to be as Agency Japan's are Pharmaceutical and submission key

consider post-marketing final Medical and approval analysis, it based be remains that currently willing this appears the good as as consultations consultations already agency. Japan's trial Agency Agency the leaders to and without Subsequent to requiring and with world-class if in last with Medical an clinical A with expected. attended supported additional are Pharmaceutical Japan. Device interventional cardiology our consultation on interactions previous at Japan in Pharmaceutical Our is who Device they data data heart active the cardiology are failure study Japan's and in discussion with

for We their are thankful involvement.

our The trial estimate as this reduces in back to Heart cost approved confirmatory more and for the are expense by reimbursement February as research focused for payments reduction the paid Medicare the cover as than that reimbursement Failure in in R&D CardiAMP was these FDA the by doing dollars patients centers costs million NT-proBNP. patient activated a centers elevated in in study December, is by March. Medicare of on trial then We record II from follow-up. United $X States we approved with to The

trial based primary endpoint has the power confirmatory XX% than success greater the This on probability Heart statistical of to a or Failure trial results. meet interim CardiAMP

cardiologists support Board distinguished to Safety our continuing Steering Monitoring program. on Executive world-class this Our Data are and the Committee

clinicians world-class We expect additional to failure our Executive Committee Steering join soon. heart

enable when this data cardiology actively enrolled, the be working first are this experience we that leaders the network failure heart will We have fully patient with but goal, we feel with being to is results enrolled achieved. aggressive years. to enable to in study in and and X an available that be our in This X years

ahead. sites, and the in onboarding this effort We months will accelerate actively are

average XX% refractory in therapy primary is X-month in at CardiAMP sites. to XXX angina, The up the double-blinded presented Our to episodes intended trial receiving include at the to in an study a roll-in cell myocardial study a company ischemia angina reduction second to follow-up controlled tolerance before endpoint chronic cohort were compared III Phase XX exercise patients XXX up randomized treatment. increase an and call for showing last BCDA-XX month, with results multi-center patients demonstrating or

this the treatment on therapeutic randomized Part based the costs. control for investigational of place results. this to the these includes of arms utilizing offset in Planning Medicare the both positive planning phase continues study reimbursement for and clinical

is was reported ischemic BCDA-XX that clinical program and or for Meeting I/II Technology low-dose XX been in trial cell it March, and allogeneic Therapeutics a events failure enrolled. Failure At the heart there encompassing patients. follow-up have Heart in no patient CardiALLO adverse cohort first the Phase company's The therapy

failure C-reactive for the responsiveness to failure cells precision correlated of of this has high-sensitivity ischemic in on to is build a X we elevated previous have stem a with marker study as immunomodulatory that NT-proBNP have The co-sponsored are medicine that mesenchymal a trials cells intended elevated therapy study. been significant first heart in BioCardia. CardiALLO patients who is time and inflammation protein, stem study mesenchymal on focusing heart previous at we This

the X study it be in to both has in of the CardiALLO approval portion receive United States We the to performed based Phase and this trial. potential II conditional on intend Japan, where

StemCardia's delivery I/II with biotherapeutic product biotherapeutic on advance participates initially StemCardia business long-term to announced clinical of delivery Our value candidate pluripotent the created. where failure, we stem partnerships, in partnering BioCardia XXXX, study. cell partnership meaningfully through for In a a focuses Phase investigational the March heart treatment

positive from In delighted I/II in they Heart this have in CellProthera, results European they Failure announced post-myocardial May delivery just Phase therapy to partner, announced. biotherapeutic Cardiology results XXXX, of I infarction. Lisbon study Meeting the that clinical week am of the would Today, CellProthera their Society on cell congratulate at have

on In partnering, business a delivery to returns pathways X we succeed and have and our significant as multiple biotherapeutic summary, biotherapeutic with shareholder cardiovascular provide programs investment. our clinical

aiming first on program as are which as We in U.S.A. lead could our of in approval for early followed the based thereafter. the XXXX, Japan be therapy soon

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

ended months decreased and X Thank decreased $X.X trial during to the quarter the you, XXXX, $X.X to of quarter clinical expenses primarily XXXX, the of coupled CardiAMP months due the good with to for in afternoon, reductions of Heart quarter XX%. Research XXXX, first in XXXX. expenses. Peter, million million everyone. and completion X first fourth of the $XX,XXX $XX,XXX March XXXX related Failure and Expenses March quarter-over-quarter Revenue supporting compared comparable ended in development enrollment for the the function to for by

March the expenses million from months March X administrative months and ended X general $X.X to the million ended decreased XXXX. $X.X modestly for XXXX Selling, for

for quarter, prior for $X.X BioCardia's noted. expenses the the in reduction net first million previously decreased quarter first to the to $X.X due million loss year's primarily XXXX from

of XXXX. million operations for the $X.X cash used of to in compares quarter That $X.X quarter in XXXX. first We the first in million

is cash of ability to capital-efficient use as very we trials, our accomplish to fashion. the increase a our advance demonstrates record expected and goals in While moderately operate BioCardia's track efficiently

to questions take management's attendees. prepared from We're concludes happy comments. This

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

Lander is for on Joe. This

follow-up. Or is about patient roll-in not not to proceed program. So you CardiAMP patients the data that wrong, has think ask roll-in additional the to the X be X to patients I X to expect completed enough the phase? months we randomized Should to with that CMI cohort? I'm If added there's the do wanted

appreciate I question. Lander. you, the really Thank

enrolling So for is enrollment been refractory CardiAMP the randomized patient have who been other moving with is through in ahead. is consented in patient not ischemia has that very cohort and pipeline. we patients one feel the angina, we've you're has treated, correct for chronic that comfortable that myocardial We with yet What done there additional stopped patients.

The trial results excellent. the been have first in enrolled patients

XXX to pivotal will we is the patients been have -- phase follow-up. adaptive endpoint trial. shared historically, randomized. X-month steps this follow-up randomized ahead. readout the to taking as I've an be have shorter trial so is a after a And It's is endpoint. trial intended And initiate of The this a This

data, our we in program ischemic to because support indication that that note precedes failure. I And actually clinical have heart the also essentially in the will presented heart this we've same failure and therapy program buttress another have which safety

or yes, are to the will don't trial, to they've but to not move the they answer that as are moving cohort, your we of randomized been is, a roll-in through enrolled, know long trial the whether more the question very we part patient. process one is We that and there ahead. these controlled comfortable be ultimately honor patients going So

besides HF Okay. are the think original going the that Perfect. that HF Japan, results on are with PMDA? the important program, still other CardiAMP CardiAMP that final is discussion any points from And for you in there

that it completed, because so at submission. in they in November, the and the yet And the seeing they would what data so yes were last for PMDA any that although of trial we foreign XX% patients, we met quality end support need have these from changes. us follow-up So But the them, have entered States the follow-up we the is with They of we and approval. is them United that to in year. for very my interested been accept expect status clear on as it's And November. to data data of assessment will not -- made data with this don't noted as data said, of still in significant I've is that the we the complete comments, the prepare in

optimistic with be normal PMDA the So we there pretty will And course. feel respect to dialogue with the following submission. other ahead

approximately One therapy treated. There's heart patients nuance to of provide those Japan apply Both approved folks trigger have have those based enrolled. a to approval I'll for therapies that is they expected have. based require failure XX of arrhythmias cell therapies. in are therapy X None for that on we for potential intervention on share another and which patients that's therapies to surgical

a head-to-head than result any approve of therapies much Japan. that therapies potential in to those there so for have studies in ultimately them is of more and data other this We good

we're about honored with these excited luminaries pretty we're be Japan on this in taking we're conversations of and great some having. forward, yes, to the that So working

next investor. Brent [ Pearson a private question from comes The ],

front congratulations partnership your wish wanted I your to and both front. you trial on

around around new know I/IIb EMA apply ability a the was results was announced It But that this this conditional based conditional expectation study. of marketing And there early is today. for CellProthera's guys announcement on their The first wondering had approval? advancement an today any approval trial. potentially information. positive And seem question color. if the appears to pretty you an some I that they've it's was to I that Phase had I from around that I recall results with and

the you the of stories. Brent, And their for question. partnering let thank partners is we of need So nuances our one to biotherapeutic our tell

for to on will efforts Europe something in potential looking CellProthera their have trial own. is there business and clinical That's that access. at their assess ahead early their So

efficiency of therapy And published but are sense. we by results. makes that what don't that, with in we own comment their we've shown the have you on types think the development very cells our intramyocardially. So these of strategy on, We have they XXx we've of delivery their encouraged when can data done and approximately that enormous delivered

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your I and on towards there. simply, was we that of some appreciate then I potential and response end understand front Great. potentially there QX of And expected completely follow-up partner the XXXX. had end my developments were towards heard question the the

Just there was for it that on that be wondered if update and front, any me. will

are No, questions, great these Brent.

So in partnering.

very every senior we knowledge we experience and to for them term, help are procedure as we clinical typically have, successful. really So long transfer and single our for the partner's involved much staff. X a We with be attend partners trials of

needs developing different of them for data you see are with in earlier excellent in as already BioCardia, these clinical their have so our right development folks deck. unmet now approaches And are significant efforts. few a slide Many corporate that quite can there

of And take much depends go on so and their next it forward. steps initiative the to

folks but partnering we're who with with folks data many slide on aren't also nontrivial. that us have deck, that is There's

future long the partner we if in the And the the and in for you have demonstrated of our view technologies. value we are shareholders we at current is are for heart. we've -- our here, we're look technology a seeking intervention delivery And and biotherapeutic we estate, We intellectual significant capabilities feel so what property fundamental whole our of coming term.

delighted folks, but we're have with to we shareholders. respectful our work of be so to And

solution, talked business So have I delivery models experience in few a nobody has clinical else the updates other of delivery on we are and who any quite there out that's discussions than are today. and solution nobody have going the today, of development clinic we've don't has all need clinical there a in groups to the about preclinical level and for else indications a

often move will do believe they our good in that's in it's we're that hopeful for to same believe delivery folks valuable hard we to company a we're So and programs, forward. the their assets but We space. do tie another partner,

Each we'll So day new a brings discussion. see.

to been are at take Brent, late-stage lots nature final a there there's lot And have where agreement -- that and And experience of so these. for getting the some just conversations, are discussion but term the and does I'm there's time. exchanged a it's of sheets of answer, been it's together, sorry long-winded

my Completely I positive And lot looks like again, understand. I it a there's to -- just of developments out wish and wanted congratulations. there,

I appreciate Thank so much. you it, Brent.

Will in Next [ queue investor. the is private George ], a

stay-tuned be there? partner that's that a it strategy Is strategy What you treatment forward? I if you the guess, let's receive to item? commentary firm? commercializing BioCardia could say, are the on what some share BioCardia larger be move do If Japan, approval Would you would you forward -- in if can a moves provide little, would for And CardiAMP the there Peter, zone? there? anything that look a or you with

a think share things. I'll we about and great question, George, how it's

enormous Japanese luminaries market So we've with an the some in learned amount been fabulous and right delighted have with now, Japan. about physician interacting

so a And relationships. of we've number large built

reason Japan Our for first CardiAMP the choice that partner future. that myocardial with also in experience chronic of failure the we we relationship not ischemia do And they to confronted. where the have yet nuances that the a indication have for is the heart indication distributes but a have that is in for all

conversations of in know Even interested the for But haven't part Japan. involved they're number study. the on they approval had the forward. on stepped And entities at in with very a working commenting, very of time, as same a number is And proposition. have and the we we've reason a significant this that they in the active is we're a value process, that is yet advisers significant of This distinguished getting deal.

our order carrying partner So game have to we in to CardiAMP some be forward. they are requesting significant the skin in and commit that

remarkable cell roughly CardiAMP X from therapy. patients That as could heart quite far who said, in benefit therapy. is failure a new Japan as actually There's potentially CardiAMP with million

United could enormous and I that therapy treatment. but around a is choice what reimbursement is of have. CardiAMP lead which not United step This Our the Japanese other involved in it's up, that's USD subsidiary the skin profitable game some in margins. said, significant for in Japan CardiAMP price is XXX,XXX very on on in tag for that's be have we first as a we that advancing cell touch the we're our there X therapy a of the in partner reimbursement, know has order. of for pursuing put to in don't in it to States, I reimbursement, point potential type really the States Japan short approved on have clinical build have we is of That each the indications even level expect, but and the both

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

kindly, you Thank Debbie.

returns significant to to with Our therapeutic has now biotherapeutic cardiac technologies heart programs candidates X these potential potential the and programs of have biotherapeutic Each partnering. of in development, our meaningful delivery We millions for investors. including provide have patients disease. help our

in develop support interest for Have I your heart in and a and for to call, today's treat mission thank you of all afternoon. BioCardia you to for enhance our provide great disease. participating therapies primary

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

now may You disconnect.