BioCardia (BCDA) 13 Aug 242024 Q2 Earnings call transcript

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia Second 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. Please go ahead, Miranda.

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

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

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

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

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

milestones of tough the Miranda, benefit from you, deliver patient our for quarter share of our a underlie call. and continue both efforts. price, with been to signs Thank good as and has afternoon the to our on each This safety even we business everyone that

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at hopeful are of end for We market clearance this quarter. the

discussions with business with development our platforms: On meaningful X to CardiAMP; and to potential Helix; for active respect Morph. front, business have our be we of the all CardiALLO, partnering

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revenue towards a step FDA submission which generation On the also partnering products, more from the clinical front, enhanced is these clearance for first interest. recent

to that procedures, have our and may radiologists benefit expect electrophysiologists, cardiologists DNA who introducer is all steerable which of cardiac surgeons, but platform. interventional vascular Morph labeling also interventional appropriate perform Helix our for We from

reverse will discussions better the intend with of family. By understand in own our current Failure Heart in six, generated objectives: what therapeutic visit partners chronic programs, intensive is my It patient results. listing can for morph with with and pass delivery dose that investors II that review QX Failure myocardial Heart to trial treat share our CFO, decline last few patient our we complete the compliant bench Morph demonstrating the this has here as enroll CardiAMP business the a FDA begin the our accomplishing David? for coming the clinical and us. McClung, partners; consultation; clearance licensing in expectation call test the family. I on received last we these to clinical financial for two, will has in PMDA shared that selling product become our for the new quarter, CardiAMP general end I firms XXXX data Failure biotherapeutic for in we and multiple months, in BioCardia had off five, patients Japan world-class and now in price anticipated have large products Heart requirements; submit We first rolling quickly and NASDAQ the CardiAMP our CardiAMP been a consultation product and future been preparation are on one, ischemia trial trial; the with deliver David the will four, following partnering the trial; FDA-cleared cohort DNA who three, for

$X.X XXXX. X Research the expenses Revenues everyone. completion XX%. function XXXX the to trial, ended decreased and to general for for Peter, reductions down X ended of you, million afternoon, $X.X the June in of million XXXX months quarter-over-quarter prior from same were in in the comparable due development the Heart used just for the the CardiAMP year million decreased months operations to we for for decreased by XXXX. quarter Expenses the clinical XXXX from $X.X the primarily expenses million expenses. quarter $XXX,XXX from to Failure and second $XXX,XXX quarter for due second in second second quarter, $X.X primarily That's reduction cash $X.X with BioCardia's X quarter million $XX,XXX and June in months good decreased supporting ended for million during period enrollment Thank down related due June the from to of to second XXXX, the XXXX. We the compared in expenses. Selling, and expenses net coupled XXXX, in loss second administrative XXXX, to $X.X quarter personnel-related noted. $X,XXX in reduction primarily

We continuing our track operating moderately management's trials, we expect use as advance of prepared capital. This our cash burn carefully increase of the record efficiently will comments. concludes and managing our

to happy are questions We now from attendees. take

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

A few mind. if don't you

be to Failure more might of maybe your or was Heart II How -- Failure first, curious helping color, Failure data with improvement you Heart regard So much a the II? study, in from for little survival if mind. with MACE don't the enrollment Heart I

day, great It's thank good the Joe, for question. you a and question.

enormously valuable in enrollment the for it's ahead. think us I

with One the the that: which one, be done of holy trials, failure but safely; cardiac adverse are the that are performed sort the coupled major that we that by physician evidence have seeing signals for the we're enhanced interventional these life this procedure them. procedures challenges the of and now for the reduced in cardiologist, cerebrovascular and two, heart reduced of where patient of events quality can who is trio supports it's cares an and mortality,

suggests the in caring that that a are II, therapy targeting And there that for could impact. with mortality. saw folks a they've selling particularly data patients. meaningful already impact population their And note therapies we're move That's out for physicians was Failure relative I cell have our NT-proBNP So risk on XX% a And patients, just this no to reason there enrollment other few we center actually have meaningful we these Heart weeks into why a another this first investigational consented to mortality. trust for And X in that and huge that's point apace. reduction activated the expect trial. patients ago, an

going be for data to us. very yes, the is important So

No, I up. details coming maybe you know got some it. And I to alluded additional then

you or So can't can potential the study, discuss streamlining but I them discuss about of place already us? further you know remind what's yet in

another Joe, Yes. question. great

lightened. the in So CardiAMP such many Heart we have endpoints a designing II strong Failure that interim have trial, of the been safety signal

And we've now a So elements first many can if follow-up XX-month visit a and at that our able by the call that necessarily for at of those the points. our in patients And example, the do there's our patients that lot coordinator visit that is benefit places the X-month point, by follow-up be thing that of reduces wishes. value is also phone those center for done focus there's follow-up eliminating study. the But time a on new the is time standard costs of to BioCardia the to where looked and program. not throughout

company we going through to are easier advance to expensive it's we to trial. going we some patients do that be and today. think things for to other the the clinical be sites hope for able soon yet the not work share that to And less I share So have to it's

easier, is yes. particularly It Failure I, So data the get if time as part things, first second as ] things is. for easier you a a and be trial we us think CardiAMP the much trial the because should lot II do Heart in in it the one [ good

appreciate as has with guess question, Got you this well. it. mind. to do if No, one trial And I that. logistics don't last I

it I male was I, you predominantly if population. XX% approximately So Heart Failure look really believe it's -- at

what about men expected XXX patients, when So Or the do? between you women can ratio what's curious, you're I'm to and targeting? looking you're enroll just

in worked savvy So We something it of presented also have Failure that we of on is to and are very tilted a only is Failure even that's CardiAMP almost races a fundamental population. tend of the male Heart that all heavily it CardiAMP to much in question. early problems today be II. I. will think but It's heart It and about study one so of all to sense in the And that research have is the failure in a broadly of the diverse trials aware terms patients on towards different us encouraged going it's data not that in an ongoing help Heart be population gender, equity, centers exercise My making it. there. that that

female patients. more I protective be their think of physicians to tend

And in a signs so that a And with there them because nice data safety be of think patient. trials we as they advance such hearty the real will as have I clinical female -- don't it of the compelling these in the male efficacy aggressively to be we're how percentage that it. unlikely. are love for is patients we reality But would achieve XX% trial. aim enrolled, although we'll if of larger I trials XX%, can do

next James Alliance The from with Global question Partners. comes Molloy

This on James is for Molloy. Laura

So for in how approval, still next the on specifically there do Japan? CardiAMP status approval submission plan for of now And the potential in process is right you year? obtaining

status the in treatment Medical with Agency in the Japan's Japan heart CardiAMP last November. Devices consultation ischemic for had failure of is Pharmaceutical with our So we and

for provided they the of part please contain questions whole questions almost ended of were with in the that daunting. questions of and minutes felt with, of approval. As information this all we And a your discussion, submission none series a

have Failure need key States. in clinical heart if And United II chance trial, to would general consultation, a in the for pretty do we in And need final consultation it the the we good patients the One hopefully is is. we're a Heart good then from as The thought with care we a that there's in that submission the have things submission as of is Japan to will things see. the good data addressing to in complete approval the failure we to differences is move which to that CardiAMP process. and data of PMDA very feel that that is we they like process one think support a shape Japan

the believe, focused. our where including, Once we're we're details they really for go visit ready there's which submit that's those on to we the manufacturing. times for so in, allow as reasoning enormous that element key past And the we've they site of an is to But submission I patients. is few And process, said a I've CardiAMP they treated through, many is, amount there, sense in questions. once us that assess the the XXx And the invite based approximately data. of I will Heart is all approval Failure will, think they that a already

and our of being is is So also patients platform Those minimally XXX to either note historically in other cells Mark. system delivery approving in chest processing for Japan patients under discussions open XX cell delivery they've CardiAMP cardiac X that XX therapies And relative procedures after a they've already other on ours require therapy. I or the has used cell therapies patients. had for CardiAMP approved all orthopedic that for Europe been approved CE applications. invasive our approved and cell

States their supporting reimbursement forward. have CardiAMP sort of support for of badge therapy least enable going so last of Labor Ministry we is United at will that have an cell for well. the as And to And in then index piece Welfare Health, a and the that's it

], are the the why we that make an though So coming all all Failure that be it's last the have the expected CardiAMP outcome, of Even I important critically we to so data, will what have patient you end and line for shortly. XX% Heart visit working at [ until of final are the of outcome, final a of estimate data that's stars September the and not the of follow-up those is help data, final us.

think a now as Phase when well? as from Got might lines III question as me. following subsequent II time the start with you looks Phase potential them trial well for trial it. And the And or just this is going collaboration one more How do CellProthera, for trial? recent any interim you especially

and to that's than there's indication proposition indication that everybody clinical study acute is X about that the much what fact delivery delivery higher a in companies else of great that BioCardia, artery gone their the of intracoronary a did the use has which that to efficiencies that value we delivery, a intracoronary years as rather I intramyocardial with One question myocardial have of well. relative done analogy there ago. the after that's infarction. And indication. ourselves Well, they benefit infusion point And many CellProthera, to like small of efficiency have from I'd only delivery. XX-fold of the retention we cells, for

it's to call So has headache, XX taking aspirin the versus if on the difference had an anybody between X. effect a get

I going tell speak been a for don't years. working I many that So efforts typically forward. to we've partner's together can you

have States, United to how only to the and the Europe and States need can wish in wish helpful United respect them investigators, a with which their regulatory do trial whether them in team. as done for to We a lot address out trial roll be to they do forward, not to in on whether do Europe, They moving trial wish it They've or whether they a a to great fronts. forward. pathways and all we a strategic they and they only wish

it's that have nice very their in market real ongoing, really Phase program. and data a are conversations with So and compelling a II program they some

and we as in great forward one And to the that be day. I share their exactly on try let because our and respectful very of as share you about going we So it's can it's but partners be worked this hard every share you not I wanted be strategy forward. question going to challenges Laura, -- well their space that's the partner, to have all is and know answer, trusted a to really them data of

from Instructions] Kevin The comes question Marshall. [Operator next

about dilutive company have can listing on mentioned know effects is requirements. if if Dr. that? on current doing would going you the compliance with know Altman, on shareholders. any you NASDAQ I shed any in the just I'm that how And to planning getting details curious

a great that's question. Kevin,

requirements. over And is there equity capitalization are NASDAQ, the requirements. share? share is for second minimum price So X market or One the $X being requirements

financials came our the amount at you bank don't an have resources out realize that that of look you today, today. will we If enormous in

So to we pathways exploring are funding. secure

And Friday, can't whether not select S-X there on have anything all always it. we'll ultimately to was strategy We be speak was or doing I one file. for that for pursue an about would on that But put success the a our opportunities sense makes to company our dilutive the under is it we have folks any to advance, think as we impact shareholders. a is us. I as dilution historically and most very significant issue, hard as but fought for avoid have

low. I think remarkably today, And is market our so cap

we valuable. think I be enormously milestones advance we that could of the some company, if we the as have --

multiples it's not We're about Xx or -- we're of that. so talking And talking Xx.

time, And we the so that's to the But run business. same be at need to we something go as have we Kevin, downstream, dilution. of always to we cognizant, deliver, and need

it So see and as has unfolds us. your appreciate been everyone for who we share we'll do it And support. it unfold supporting

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

very team. accomplished is to BioCardia BioCardia at of the here All you we far our have Betsy. Thank that credit much, amazing so

enhance who have develop our enabled thank FDA of have to trials, who reviews efforts. clinical their and I partners, have our helped the in investors incredible and Our mission to our participated therapies in to been the patients helpful which the has the and PMDA, input and treat disease. cardiovascular hundreds everyone who to

deliver call, end our XXXX to a an a are efforts. incredible we being great XXXX expect and to afternoon. have We and in for Thank successful on rewarding you the if

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

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