BioCardia (BCDA) 11 Aug 222022 Q2 Earnings call transcript

Ladies and gentlemen, thank you for standing by. Good day and welcome to the BioCardia 2022 Second Quarter 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 one hour after the end of the call through August 24, 2022. I would now like to turn the conference over to Jules Abraham of CORE IR, the company's Investor Relations firm. sir. ahead go Please

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

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

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

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

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

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take are ready now We to Operator? questions.

first go of Instructions] [Operator Raja Markets. The Please Capital from Kumar is ahead. Brookline question

in site my first taking also When patient on when onboard you do questions. first other for sites treated onboard? Thanks the expect Canada. do the be three the in And expect getting and congratulations to to Canada come you

are the patients today. is for Kumar Canada, you question Thank first in and the activated, site currently screening there

and inclusion when the exclusion delays patients identifying other enrollment than - hurdles clears for them randomized, standby through know, you on process. for this no be and the a there's were the we So, moving patient at point there'll

sites, we're as far the targeting. As other currently

you the we have onboard approval. which three we're We well. coming biologics Health in branch involved sites, the this know submission those Health expectation the three are as process the began and secure device to Canada, the in both late branches, very sites on other our was is branch But parallel to other Canada to and soon

in any efforts screening the being increase terms U.S. encourage in of Are seeing enrollment, you what are And results in terms of are there? screened? seeing you to patient patients in seeing you Okay. of kind

the staff So, is during our they of that folks last difficult call in we things a of has sites shared that the many had, this have don't for is pandemic. changed so - I really that appreciate. that one the lot

up. a lot sites so back staffing And are of

yes, are working enrolling. And through we throughout we've with failure to patients previously. the control this release are And heart to patients patients we are sites that who that, process more ease have concerns trial. sites I But sites note in the solve for issues the actively the enhance detailed who think, of So them. been want process the also are discussed fully don't things staffed we our we are CardiAMP know, of we that I today, the press is enrolling in you the one have or have things group. bigger be in to working

publicly the that's own. best available, they have I information meaningful themselves this study, its the all to that we're materials would now call are the in make going identified the think for give in diligently I them working show enrollment that help to to of think like a and on impact in I choices

can cover concerns staffing, designation, sites from think reimbursement breakthrough don't by the CMS are, validation these the on. this won't where the trying launched that for working sites to easy very either lastly, CMS. any that all patients are CMS insurer associated support just research the investigational centers that's follow where coverage are an that or make provide therapy understand well as in with costs working patients then as paid participate identified I that the as external We've if to decision identify data is with to really have to well we're A then it have And make those their insurers, that with - potentially about changing are, the help study. So trial. things you're to for are to still things trial hard getting the they to solid as they some the really

about talk to related there? have finally, bit to you. questions And also they clinical PMDA, great. the a little like with maybe not some looks steps Okay, regard next which you can is it. data, the And the Thank

into. question. that you should there's, don't dive so I I PMDA, that thank we guess nuances think Kumar, of lots for Yes, with

key the trial. treated in solid few as the think have quite is as that a that on three is, thing published I we've as patients shows, And designation and well breakthrough has data mind in we there United of the a approved ongoing the our Cell randomized based and them trials keep one is processing Furthermore, on and seven are patients approved approved in Therapy been the delivery Japan, actually our approved our States. of CardiAMP in in in systems all already Europe, cell here Japan, only treated. platform is clinical

So of had pretty review amount already regulatory the is we've solid.

guidance goes. initiative clinical see you on today won't required. that is are data they potential, and on, for we'll efforts it approve get But protocol risk their know, it, approval we'll secure that's with a comfort the is based enhance have to our that to where we it our There So dataset that today.

Great, so thanks much.

The next of Michael Please question Okunewitch go Group. is Maxim from ahead.

taking Hi, thank the my you progress. for much on and question congratulations very

you getting So to like or plans, for a up patients about and on I follow-up I'd it a this Japan end approved strategy first your to get about guess bit if there? over and the to off, discussion commercialization bit the do

for Well, call. first, question. being Michael for second thank the And the on you,

in distribution with even there conversations deal. which we wonderful PMDA, not principal in efforts conversations with enter having involve potential is that And in partners identified That's well. the Japan, we're Japan. a with distribution approval, already to support Japan, dovetail So other have we investigators, before would development yet we're we Currently two as who work that have co-national the into pursuing.

therapy, outfits, that working Our from potential data even in be honor with lot additional collect world-class expectation them distribution successful are of supporting we post Japan an we and work is having had and with to interact approval them. approved? the be groups it interest in will We've should a it's to

We And Japan as with ahead. we're on PMDA in really Japan spent on initiative approval, in but looking Ministry - this on also Health time have is efforts derisking the issues forward, past the summer. of reimbursement

that the understanding one transplantation they price reasonable heart level there's, found the And I that $XX,XXX helpful to And in population closer not I level failure. also patients I though reimbursement note organ that well. be roughly that therapy And I Japan, quite has a can't less with make ageing in for has could achieved think level advanced, the by part and do a with allogeneic an note million where we United is culture Japan, not and that cell that that for point nature attractive. of us that per today. note level than ahead. is even Japan there's in our USDXXX,XXX. money my because the at therapy is that is patient I is level that States us procedure treated significantly therapy think, will other for in control reimbursement which approved both at Medicare reimbursement also

quite areas. However, other done in autologous therapies attractive well have and are cell-based

is So that is your pathway answer for approval, the question there fully, our high come for potential if a in degree data already short-term the a with have. this a And that based is real sense Does Michael? - reasonable of to on approval fit. this that together we not

comprehensive also thank like IND. you given program you answer. I'd very quickly Yes, an that's to see allogeneic approaching that, the know,

to a heart stem that particularly You cell how failure? about other compared is program discuss in approaches, differentiated more bit mesenchymal

so be what about find to, delighted pretty ourselves. I'll exciting we

according cell that we them our taught are we to cells marrow marrow the cryo sites BioCardia. from these canisters, in we our wish And the others marrow the - strategy aspiration expand at attractive. have protocols to patients, take it then to perform So who find aspiration they to from have Physicians and don't them sort be in program and off bone of bone facility administered, for will our autologous then ship they're who wish - will don't bone where here quite here patients will talked are young clinical shelf about. manufacturing

our substance the a human that NK, what neuropeptide, or advancing we of mediators So the that body. being P of And all responses. positive that distress P, we're one cells - one primary receptor X for call fight It's receptor of the positive. in substance are Neurokinin primary involved is in our is

of to off it your process feel substance P, causes stem home and in. mesenchymal landmine, that marrow if reparative from as if stub cells gets foot blown well the you know, you is that's by and P toe bone normal part the your the If substance a pain,

receptor is formulation. think compelling with of have very positive mesenchymal studies in stem ourselves. that just that do Neurokinin with a are a not mesenchymal cells stem So aspect We having we X trial head-to-head clinical the other cells

our fared programs. favorably positive do on MSCs studies cells, have allogeneic indication, than both of Although, program lead X they're lead actually just relative head-to-head program, so Neurokinin the more our in the to far and that, to in And I cardiac taken and MSE we've focus compelling. steps the because autologous note we receptor

that, up respond to have that having remarkable exciting. the signaling on As actually on It's the cells that a and a you surface it's receptor is you read their as to neuropeptide up-regulated peptide P. it substance

any we that groups, said, data mesenchymal stem better program. other Now is cell than that have any may not

hallmarks substantial doing and key it's lot Our MSCs receptor, testing. surface differentiator and of have that is the the is the MSCs in in how that both markers differentiator another things. we're we phenotype assess But - Neurokinin other release all X

we from enhance And cells our sets program. NK-X the But excluded that is than So, going also you in population lead phenomenal we'll the will are know, then program the everything cells. that cardiac on program. safety of stage we've build our modest potentially the after program potential a it where patients it our lead upon. other And have the will lead actual the

completing orphan And including and we're of respirator. a with an enrollment, trial, indication that so, there's where work mesenchymal phenomenal acute our patients been potential has but that's not completed cells, distress, very are indication there note or some for there's just large I following ahead. also stem efforts respiratory targeting the we're in enrollment, NIH is and others, who those that the on done

over who sickest noise heart from those a know, we a in have as view it's it clinical staying the me heard the signal our years development, because, you to away failure, primarily issue. For we're talk patient on efforts

they've development the Second activity begun an And so, and we're more we're company just Syndrome, patients humbly the the treating and is to off they we're know, those anything And, there no that today. there where those clarify Phase referring and patients data what that's to that realized have Annual groups favorable they with, they're we for treating we're speaking the more where patients. we our cleared And area today. no cleared acute with they've yet becoming symposium. III on after the actually said drug even do no II, follow-up, an development you indication in Acute once quite is activity we distress patients well, And Phase and recovery at in And ventilator respirator. who I it's you We we're fact, not because respiratory and even presented And excellent and And companies don't are today, do And taken important. been indication. yet, that on significant had going a respirator, response, ventilator. clinical in indication treating and patients have has Distress Respiratory that, the they've datasets.

that's very to future. focusing COVID peers we not can that done MSCs know, worth without expand I Michael that But a the confirmed other COVID from in on that's right against learn X to distant we've planning this signals it's the is the we're ARCHE been pursuing. you in potential pretty work post, on know, the specific a you indication there and So doing be Neurokinin from But other in the indication degree community potentially secondary, We're are is in think future. future And now, us at on gotten for the mesenchymal some positive programs. done, head-to-head studies, our something a point. could that, one approval that's that any

or on you in that can All you the, given COVID-XX specifically, the and just mind, how ours, development of difficult follow-up to more, like could be much. quite your be on right, enroll, know, thank unpredictable? thoughts don't easy especially you the very trajectory if And one on to

was the topic symposium. the Second for development you Art's hot thank So Michael. question, That Drug Annual at a

And I have the we're the for experienced, rate. recent we a But hospitalizations we've society. your is you on trials.gov our great is hope same correlated. can design, not all see great question, design. also the As you clinical had news time, to for heart That's - know, Ischemia. spikes infection or lead know, in that's news three-by-three and trial But our programs as failure Myocardial the at Chronic in

of and cohorts. have So a rope review dose the between data escalation - we'll DSMB the the

therapy large also don't patients whole respirator patients. that once gamut at there. number the a been hit as the probably these off there's time, I detailed, they've whole they're really And out no in today. Currently, are So of of been therapies point with they've brought we need for that

you slowly you know, today, wish it's sort be think going know, patients. of And that had of, armamentarium to so, with we're and in a we're advancing, few their I they physicians something addressing that, number

our So know, shorter follow-up also, rather in delivery. trials is the reiterate is actually this you intravenous in just as is - it this than indications. these to And cardiac

So their that to straightforward The trial administration. before. an cryopreservation, in of difficulties this perform. But it their a their is shipping, thawing, relatively is, cells, be mesenchymal logistics stem the we've are all really trial been should around their preparation that the from involved in

we significant ahead. don't see So issues any

Thank you very very additional the color. much for Yes, interesting.

Thanks for the questions, Michael.

comes James The of ahead. next Partners. question Instructions] from Alliance [Operator Molloy Global Please go

Hi, for that guys you Japan? my when the other opportunities guys, you I be steps there couple thank on timing. just next when particular at you will what a exactly questions. through, had Japan walk are taking look for quick next you And steps potentially And about what at? speak are opportunities non-dilutive there funding mean, you in this out looking you questions

PMDA at guides process involves consultations. of the process this each And us So in know, in a Japan next steps really, the number you are, stage.

likely stage translated that much that to And and is shared me, information a sections in we've in to do into other Japanese, we last we that, we providing includes had with includes, them our of related their in we've resubmit excuse the And, will on once So consultation. And full have a steps. new next also protocols. the it conversations submitted format. details essentially already next certain feedback

that's So today. where stand we

this tend respectful as our documents investigators. of including conational our because here, I the Q don't everybody's already, that we follows we'll staff, juncture, know, you next well consultation, the input don't in I or out whether As diligently do of very know, world. expect the long, on that's as in approvals to and have be principal have our our that we're preparation to this get us alignment. working take report a consultants Q at this regards and review data that staff, it next these not, lot we around folks and timing it, of And as we

ourselves. So the don't But to for non-dilutive a as the activities of there, it potential of regards potential funding, get on potential to development Japan, number related is want there's business there ahead for to levels. I provide yes,

right we need now, think, proceed de-risking I this. with to

a, in while clarity the I think we about have of in so program, is and at a And know, most to proposition behind valued clinical have a we United they're dollars, see even we're have, even doing time this you first have reimbursement value States confidence though degree billions where various which is heart from matter Japan know, the programs just put when. know, we a it's a stage people That floor in high the you think the are are, of is significant embarrassing. this, coming you preclinical the designation it's and late pieces If - that's failure markets done. of you ever breakthrough this the we are of said, our is kind that studies, been potentially together the FDA, they

able provide our because as any profile of of where so, shared in in in is I interest how significantly. resonate originated the lower therapy the of our And keeping autologous burden other is, And in cost with therapy significantly their very Japan fits therapies that well this whole, cultural being body and therapies as heart advanced as there call well fundamentally significant it. failure autologous Japan, than sense there's, the we've the is therapy firms and to this disease that of

expect that confidential we We'll with conversations keep forgive of and in think wait as we partners clarity who PMDA some on and in privy be I answer submission. our from those So will were you feedback status feedback point after clarity but… and, both me will from We'll the under submission. the know, the on agreements, And we time, in disclosure longer waiting for the do Japan. at

you port things indicated should on enrollment follow-up, of Is that first on I that the still track the and could call, line? XXXX? heart XXXX. BCDA yes failure Peter trial include won complete And of just

Yes, wouldn't James, I I would it's on so say say we towards. are I working it's what track,

for team. great them deliver of into team, time you're are But are you where so, it. to And that. the of that to on clinicians, everything dominoes full bore we are through, as working we take supportive I'm, with some it's And And at doing does know, And today. interactions going things deliver to we've we've we to we it a diligently are pursue practice. clinical I having on seeing on fall, that can got non-trivial yes, that a and that. But help roll as based been the also support

So that's lot Can the work deliver a it thing. we ahead. of it's and key

questions. the taking for Thanks

Appreciate James.

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

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

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

now may You disconnect.