BioCardia (BCDA) 13 Nov 242024 Q3 Earnings call transcript

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the BioCardia Third Quarter 2024 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. for call is that the being is being this this audio Internet of also call conference broadcast recorded Instructions] Participants are the advised of and [Operator purposes. playback live over after the of Relations. replay BioCardia would be one the call A to the to Miranda webcast of turn the end like Investor over available will approximately hour floor now of call. I Peto Miranda. ahead, go Please

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

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

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

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

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

call. disease. our cellular good and precision afternoon medicines the BioCardia to continues advance cardiovascular Miranda, targeted you, for to everyone Thank on

we patients most cell the CardiAMP of may These disease are and our state, candidates with benefit, in patient’s mononuclear medicine precision biomarkers stage targeted for therapies, our are of target providing specific own the the biomarkers. a a that are clinical therapeutic Our patient’s the benefits. perspective and case needed cells identified by tissues where they therapies potential delivering cell-based to autologous for locally characterize therapeutic and

I their mononuclear invasive a concentrations critical CardiAMP patients on trial for randomized will cells. I procedure-controlled additional therapy of heart Failure the procedure. procedure cells minimally the avoids The CardiAMP the role required in the our subjects. and selection the with The own own have single failure. treatment on is delivered autologous aspirated cell designation no Center Our of been breakthrough CardiAMP is reimbursed treatment cell heart by cell by and Administration granted of repair therapy one-time in where failure, which therapy Medicare cell has therapy mechanism is is promoting and being have of Food tissue capillary based studies. CardiAMP the and the in as Medicaid fibrosis on Drug action two the preclinical lead clinical which is who microvascular today delivered, for of studied active two study cells heart of surgery in and Services, high been immunosuppression now rejection trials. The a CardiAMP are treatment the in a the cells density patients of increased in patient’s reduced for both which need detail heart XX viewed trials to prevent these demonstrated qualify cardiac for in to criteria deliver XXX and is catheter-based Heart status provide to a placebo

this a lost patients year will of follow-up been of XX% data two-year patients a have a study. We with outcome the one having Only and the follow-up two-year follow-up not minimum have will follow-up have of of measures where patients soon a results. final approximately maximum of lost in X%

improved I interim Japan. in therapy. Final data source Heart therapy additional those expected results to interim results an survival, trends on Failure last year support randomized similar seen patients intended adverse approvals in year. I reduced received anticipated that QX the This of commercialization future major XX will conservatively CardiAMP include events completed in States cell additional trial the provide outcome are of CardiAMP Heart United has this review life based and and trial XXXX improved are of results and in the quality data patients be verification enormously and that be an of QX CardiAMP We for from who measures. These will had in optimistic data data release important will to cardiac showed review XXXX results as for with the Failure product and follow-up is

heart cells previously of analysis, CardiAMP number requirements dosage considerably due the a fall the increase short the population nature protocol results to CardiAMP the put, trial. Simply expected receive of amendment we Failure the the higher Heart patients protocol remarkable for the clinical to of enables to I who and up Multiple sites of to advancing the CardiAMP of at on seen with trial. The biomarker active enrolled patients to Heart their a on screening because to queue It XX cells. Failure data therapeutic we expected II be in therapy benefits cell centers. failure. The are elevated trial, eligible CardiAMP would XXX from significantly being is this approved from CardiAMP in important is and II recently study advances well-established confirmatory personalize in XXX-patient treatment amendment patients the Failure FDA in in are based Failure trial today study patients the and positive As Heart deliver trial. these trial the a patients II I study pivotal plans focuses the an of work enhanced actively the same treatment CardiAMP Heart the approach Failure consented experience a Heart are NTproBNP, in to treated second onboarded. Enrollment

study, be broader their team enrollment. Additionally, CardiAMP enables that to the based the taken implement efforts patients are leverage streamline enormous all experience the enhance in clinical the to cells on planning we nature clinical trial treatment the have more to eligible approach of and expected

therapy detailed, heart I’ve quarter just in programs. autologous this which failure, our have cell program Beyond made also we progress in other lead

and cell in myocardial follow-up or means patient for therapy This was will last study QX the in endpoint all reached six-month in trial this which patients chronic quarter, cohort the primary the enrolled, XXXX. rolling ischemia CardiAMP be cohort BCDA-XX,

approval CardiAMP them FDA also to patients our in failure secured have and or trial. from excluded mesenchymal the have Heart in We heart IRB enroll ischemic requiring been therapy CardiALLO cell BCDA-XX, allogeneic without Failure stem to

to patient We enrolled last I/II single cohort dose the this the escalation study. expect low-dose center in quarter Phase be

at updates the On Helix delivery share to this on current and biotherapeutic we have partners. no time front, partnering future

received where provide focused introduced website the partners XX of DNA or devices of or contributions vasculature our array guide medical will and family to our vasculature broader product wires Helix the heart. The instruments as be of centimeters our for French currently Marketing introducer into available to well catheters, release the has a configuration. We performed product balloon and is family dilation this XX of partnerships, CardiALLO preparation with this for company’s delivery platform. such materials approval coronary the DNA enhance other our product products. Morph product product centimeters, chambers in is procedures through has sheet in initial X of centimeters peripheral products shareholders. One and may other intended XX be commercial Morph potential covers are We Steerable therapeutic XX CardiAMP and XX continue The lengths to past which This success clearance Introducer proprietary family a equivalent the a reward on to an for on element procedures pathway in design X, as clinical the FDA long-term system many centimeters, X, diameters. of commercial and X, quarter.

to own teams don’t procedures be products. inviting interventional reaching management senior to their their to other We products these of support companies aware are Morph out sales who the and DNA at have

cardiology, we reaching We do ahead leaders to radiology expect electrophysiology, surgery the obtain will out applications We significant elegant progress. the interventional platform. this on near-term and expect interventional have enabling as procedures any many revenues do soon to commercial to also here make not news first-in-man in vascular cardiac many but be of in

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

cell for many heart therapies interest from CardiAMP partners expect Heart we enhance receiving distribution business that development, are guideline-directed data patients noteworthy on Failure by I therapy medical and will symptomatic interventional the there is failure remain For more are final and therapy. because CardiAMP even more state-of-the-art strategics. It attention who

heart currently in therapy cell clinic experience for we clinical allogeneic the trials. our from have development, three extensive failure, business CardiALLO For

partnering likely allogeneic had User company with peer anticipated a X, date clinical around in clinical cardiac We cells around FDA discussions for indication that Fee beyond stage the and indications pulmonary our will note set similar of disease. I other a current in our Drug for Prescription whose platform. our discussions Act therapy these success has another have plans January XXXX very cells enhance cell partnering

not For Helix biotherapeutic wish support it invasive operational enrollment, products reducing enabling means much minimally remain capabilities active their therapeutic partners for partners our significantly development, also biotherapeutic access thus realize have but to only discussions. faster clinical as is platform, enhances delivery costs development. delivery in shortening their and future by delivery our commercialization, that seen for timelines who potential delivery experience, to critical a Current

pharmacokinetic heart so in data We supported and control encourage we benefit efficiency perform to the have pharmacokinetics enormously the therapeutics believe pathway surgical seen. delivery our the threefold with of what and system many studies, all stability will advantage have the Lastly, are by tissue. beating the partners data including a to their due to from expected helical is own partner Helix delivery into supporting from We groups. our they this Helix the enhanced of self-sealing

recent we competitive we the in in The trial market. this clinical has begin but last an had quickly patients impact in in delivered patients step had conference We goal front, Heart will can real summary, and Failure are Morph queue this a in the Florida partnership. In realized quarter hurricanes us or call. this first world-class detailed first that usage commercial the approval this with our the trial in the II of for is have our six to enroll treat the towards milestones and soon. goal. on CardiAMP On any distribution demonstrating business be Physician five partners. Two expected FDA have open

our the the this a have trial end following I to Three, CardiAMP working with cell review CardiAMP Four, three of Heart the trial. begin procedures. I financial first centers data perform before David first will quarter in an the lock Failure DNA quarter, Heart trial. II are the activate to enroll and the Two, third consultation And Morph complete pass shelf low-dose now McClung, CardiALLO who XXXX. One, QX Japan Heart commercial five, call data CardiAMP and the therapy. put products our in CFO, and Failure set. David? We PMDA Failure last will additional XXXX results. treatments complete patient on on the

$XXX,XXX I to to the $X.X Thank clinical public CardiAMP for Heart trial decreased everyone. you, This XX% Failure XXXX, results reductions expenses $X.X we Peter, primarily third In quarter in afternoon, pivotal CardiAMP extends XXXX, million compared QX million to XXXX, million us in enrollment compared quarter bringing the supporting in good our Heart QX and to requirements. functional offering, coupled into the related XXXX. Research NASDAQ’s our $X.X quarter-over-quarter past September, due the listing expenses. completion in third of in QX of with million development compliance closed runway XXXX. Total to with decreased expected of our Failure in expenses and and trial the during $X.X

We XXXX. increase of quarter Failure Heart CardiAMP to beginning ramps II expect the the in R&D as up modestly fourth expenses trial

of system, in reduces general coverage, from XXXX, Medicare the in treatment the heart control same million at Peter $XX,XXX primarily of failure CardiAMP accelerating the screening, reductions including due Heart expense expenses. arms. II qualifies to expenses for costs September $X.X the investigational XXXX, the decreased the As both the procedure down CardiAMP the and three patient This with in for the to clinical cell cell period for therapy the and treatment substantially months from therapy personnel $XXX,XXX mentioned, CardiAMP ended trial. Selling, covered follow-up administrative and the enrollment Failure the for

loss reductions net offering quarter expect We the million and SG&A year’s million third run cash to the primarily XXXX, for to third expenses prior remain those from to $X.X to R&D due in $X.X quarter, rate. BioCardia’s SG&A close used in expense. Net the totaled current in of of to down the decreased XXXX the closing liabilities operation million public in to million for of compared third third of and quarter $X.X quarter the September. XXXX. $X.X the $X.X our of increase The following trade is million, settling payables in accrued due

than flows in That’s $X.X the less XXXX. September were the nine-month For perspective, million. for $X.X million cash months ended same nine period XXXX

carefully increase moderately use we’re cash We from the record expect to operating the track questions of of concludes our burn coming comments, year, our but management’s will take over now and prepared managing attendees. happy efficiently continuing capital. This

Joe [Operator with ahead Instructions] comes today And Pantginis question. your our from H.C. from Please first go question Wainwright.

Hey, afternoon. the for Good Thanks questions. everybody. taking

prepared of Peter, So, I at mind. start the comments, to your don’t you back want end if

the lot what Morph are and at? a details partnerships than, or around partnerships your guess, What program? you’re of great gave options individual are that entire or You your DNA, potential or partnerships I even monetizing other company options broader looking

It good you the Well, is for thank question. Dr. Pantginis, a question.

I’m with market procedures single and on platform. The type for realize partners in we Helix, we fibrillation units cardiac access recognize one So it durable XXX,XXX States per of hospital product quite year indication introducer a hospital, aware and the for clinical here that is therapy performing our an all it’s procedures. provides of using atrial large. cell of United advantages the Morph actually transeptal for uses is one side of elegant, actually this the sheath DNA because a that

market down position very that’s So with in heart earlier electrophysiology advantage In whip another using vasculature. across a in that Board. does we in the heart this it we our when saw $X.X eliminates We the catheter, that compelling crossing it’s be so position based length the what you systems commercial DNA goes buy Scientific a for and quite or to opportunity for the catheter last in it in a on is the whip that company wall here, a space. electrophysiology but buy the million. has brochure on other the Boston our to technology company year a available primarily for patient’s tendon those stable but assets stable competitive Medtronic saw product their very It’s large that a Morph steerable which of for the $XXX roughly see introducer one have space, pathway the other these assets. We’re in catheter the in device tendency in rotating can And the to element is jumps website. And unstable the position. billion

to one of technical things the we’re be proving that so out. is that going And advantage

website, the naked the clinic anatomical you If at different what an this places all that there’s the the on we look brochure be approvals model our on have in we can man, call have. and the of configurations used the today based we

your will compelling to We from in unit the more ahead. And for physicians who be for will use this with outright. provides our There distribution. are going perception to be a selling is world-leading that populating there physicians a if will months it, that image There benefit options, Joe, this business be the be answer options question, case numerous. for options reports far

agreement. we are is we pathways sell far more can to open And at we this into enter say, unit that’s reached reasons why we today product a present hey, as to perspective is companies into these our would distribution out at that company we’ve than think the are to available. groups a where to of today where I executives sell physician one pathways our

a company a you ahead. a for product that, of recommend product resonates could a for right You potential potentially it recommending of and acquisition your be could are you, competitors now you if tuck-in

commercial analyses we we for significant So which a physician right efforts, support be expanding in main to capital to our our procedures length have. And in pathways we use our non-dilutive platform product in a over we for that in And product this for can to the is other our divestment to manufacturing utility exploring you on that either would do business that is divest parallel where centimeters we’ll brings in available plan side. XXX advantage significant website, rights note also platform focus. I trying now our demonstrate is barrier our and our products, footprint, retains is yet existing we’re use of would note because and commercially this that anyone consider developing fashion wishes technology there little therapy the intervention, what of exclusive cell BioCardia and we in only at today that that offer that we any into that have commercial guarantee puts this a sort look to it biotherapeutic centimeters that all length. for if that to the I our XX

it’s long-winded So a answer, Joe.

but had on good underway. we’ve thoughts it’s me, Forgive it and some

helpful you all No. Yeah. that appreciate options and the very, There have. I Absolutely. were very details

for So if and then efforts because process and you of in your believe curious, in looking therapies. regarding designation switch a status. you don’t the seen I’ve therapy sort that to since similar as the in you ex-U.S. CardiAMP curious regarding get were to And or Japan Japan. the mean, to cellular for Sakigake if designation wanting concept like I’m mind, examples And just other called I just I’d gears is well. have breakthrough U.S., general timing I

yeah, after question first Sakigake who satellites. you Japan Sakigake and of was great named what I status. think thinking on So, know their of, one And is you’re

next in tie are Device our and So that approval PMDA, we of And your Pharmaceutical present. the the in CardiAMP have is that the the the in clinical last November is scheduled we’d for on your raised the written sense And Failure into for talking United FDA a with Japan, detailed provide of, of supportive they’re in December in States like to. statement with minutes this consultation and about they of data. Quite last year. consultation we’ve to in Japan. year or that of Heart based our many what submission United consultation, please really data desire my a foreign i.e. in this end them clinical trials Japan. And approval. our we’re few to where in of that’s in questions our the here questions process trials, PMDA pretty interactions for States. In those answering and questions that we application had of to month number Japan and We’re address get with Agency ahead have And great Medical our with at

So it’s really couple step here. a process

it data, would up And in the is yes, step is tee come they you consultation the to to like last is clinical this we formal to for to submit and yes, first a step review your The say, you can consultation. if hurdle next really a clinical significant approval consultation big was which that hurdle. a they second before is for really say, so

answer and So significant data allow the have CardiAMP submit them that extensively. there they’ve few Japan, that we questions in in some quite fits we’ve already failure care with have hurdle they us a data pretty and Heart next from They’re submit of I so how given they us on positive all heart consultation? is, will detail engage clinical to into the So very will a far. and Failure oriented, but which signals on standard addressed

so Japan And means failure. And as distant should too are often on in I a would for our cell That’s that’s the And significant roughly in approval all system. regulated the cardiac the cell-based in the biologic we’re expected and hope we note is biologic. Sakigake. hope which therapy you clinical in get device or be as They our regulated system. heart deal. it elements, of in to is if submission the regulated is clinical manufactured the really to States. after device that the for big to a that Japan, bedside, consultation. that about hurdle. in in to In the And But therapy approval, apply in going that That a to us get QX that asked pathway the first full United Sakigake invite to clinical at as QX, cells tied future consultation, patient’s effectively a they a our will means are device-based the be not get patient a approval. in be a way into consultation approval, selection it’s it into Japan, more therapies. Similar is a a

of timeline that’s ahead. So the sort

that all us all the data consultation our and So clinical we for with Japan that answering of with, the the that of from they this clinical will the and year very had early next from the heretofore, three are looking PMDA. provide questions that end of please that have application clinical address we’ll all consultation, in hopeful, consultation, ask trials, after your And at they’ve they hopeful, in minutes approval. questions

Really helpful, again, and clarification on appreciate I the Sakigake.

look a medicine good, different me, investment last goes If in or lot Basket at or many space, therapy regenerative approaches question. what approaches. of there’s are When you or one the you you. all therapeutic thinking, would cellular for always that, alike technology or and all indulge this have ugly, and cells bad indications, different

So date, comments for is an your for prepared upcoming you course, in GvHD. PDUFA Mesoblast and and referenced of this

know I for say, like can on your just have approach? what can it’s positive point you similarities curious, about, in have they difficult positive competitor you products or to a differences or a help, that any but basket cells to I’m if calls outcome, talk this, So

Yeah.

surprised a the in that graft to earnings gosh, time at I a not question indication think the back a year over was probably, an versus pediatric you what it did or of go their agency for panel ago, I I asked supporter. was panel as approve disease. And Mesoblast’s call big chance I we had was did two host if that So of the years didn’t. ago,

ago. to years out Osiris said, ways Osiris program cells we indication years panel That many many the of think are by supported, with most very begun that significant, are is, die there. That initially the I similar cells to in host didn’t, ago. their advancing. graft because one was disease the has Therapeutics versus agency that BioCardia worst worked

derived, are mesenchymal we’re So with. These culture-expanded, very allogenetic, stem cells. bone marrow familiar

delivering the can by process fundamentally, cells because cells. we’re process, stem be characterized similar very slightly each Now, different. But are manufacturing mesenchymal

is so clinical-grade programs around but of indications, likely PDUFA ahead in many indications. interest their significantly meeting their those, other their enhance to for And in same both cells and success those partners also our

So think opportunity we ready. real a that I it’s this have

delivery FDA-approved delivery, for cardiac inner-tissue INDs an have but for for PulmALLO We our both also project. an intravenous

my our interest So as boats, enhance allogeneic well. in will all lifts success, platform sense tide rising is their

Excellent. Peter, upcoming the much for to thank the you I very and details all looking data. CardiAMP forward

Our next Markets. comes your Brookline go ahead Raja question Kumar from Capital from Please question. with

questions. and afternoon taking thanks Good for my

in with would regard in CardiAMP had, like, similar were who protocol to this patients First, nature fit cells, the the amendment II treated trial, they profile CardiAMP similar what patients of percentage of how were I how the trial? and

Great question, Kumar.

call because patient patients to criteria, $XX BioCardia how didn’t enroll the that trial. here pre-specified the Previously, it going it’s how a population they to I it in million from amendment approval, is excluded cell I change, meet call significantly were at trial. the So easy the of if amendment analysis

that the who who in the our patients Failure trial, of of make really threshold, Now, there the trial make portion XX% saw within, say, population just we analysis the patients for CardiAMP Heart threshold. was both throughout cell were of the under and the large it and the the trial, patients didn’t that did the analysis a data measures we took into it into

instead excluding more of going presented we ensure give that we to have are patients, them, to XX% target went the dosage, a deliveries. potential help those for they whereby and so them to reach plan agency And to the we

around patients damage and infarct dosages sites. we with treat XX currently, So

to that dosing. For dosages dosages, target the cell are that the with than additional score, XX doesn’t those an fall them those will that be in to patients population are targeted full greater analysis but class plus optimal XX% below five a meet get the then

pretty the our have numbers target team, up cells data to changes about the get that not I excited It expectation don’t say dosage of our about exclude detailing we’re my we details the because, XX should based trial. is deliveries patients yet a the we on still appropriate so having will is this. the them in exact pass will But final and number wind that, -- XX% having not the will again, we’re versus expectation all to and of that yet XX. And the has and expectation, therapy. But threshold patients of and for

truly then tissue, where has is I’m qualify looking we’re a own you for this arm developing is, medicine, arms. at it don’t now its sorry, which One and a your three assessing for treatment personalized So patient’s cells autologous treatment. composition plan,

other five arm for provide The nature an the is, arm yes, your qualify to is, cells, treatment. the but you cells cells your of treatment, going we’re of qualify for your third you dosages. because And additional

what now the that’s So we’re out BioCardia. rolling implemented here and at all paperwork’s been

II IRB full approval. The that incorporate Heart Failure CardiAMP Failure have We trial, will Heart element. trial,

or with And Are the there? what to That’s plan very helpful. great. be That’s what Japan, regard would partners there your commercialization strategy? you is for looking

Absolutely.

is when partner depend that upon And partner in and how we expectation ahead. progress we the So Japan, Japan. will my will in

a involved. group We have have physicians world-class we and world-class of folks

additional enhance study data. The be a really to first is step post-approval awareness, develop post-marketing to expected to

of into little types is here as manages Each some So we of interaction have hospital in than with distributor slow other States. it that first year, that on commercial takes the distribution’s sell essentially proposition a these think Japan, XX% therapy then efforts and sort and for every In the the and rollout. there are value it this might players their conversations what these to those fit have active larger into distributors. in distributors are continue we’re and doing where has a a Japan of conversations. different how hospital. There And of products who within it the transitionary we

had Dr. was a enrollment I that one difficult. Pantginis is trial without long to I just enrollment believe I’ll Sakigake, notoriously clinical approved time. to clinical cross-question referring Japan, clinical and because in because think it very but Japan valuable the do are comment complete quite in couldn’t a being here. very, a program be take able that that was as is viewed trial quite expensive Japan trials in

us enables to approval And without think forward. so by move that getting I it requirement,

heart there So, that treated with of in have who for two other in surgically-based in access, today, on compelling chronic minimally that approval requires going patients share requiring publicly for addition, i.e., as for a to immunosuppression. And those XX companies well we Japan failure, the you patients. therapy be cell asserted total in table a advantage for a applying I’ll they’re are based physicians, no is which as really not bring the invasive advantages things, immunosuppression, to

interest And side be on is of will other the there so approval, lot in my sense a this of therapy.

conversations TBD, PMDA So determining is a exactly for turn saying, you that it can of of lots yes, there’s ongoing. distribute apply green lights. but And on will how to lot approval, the

So it there. we’ll take from

And time, gentlemen, turn would today’s remarks. this floor Altman for and the ladies at over back any Peter to end closing question-and-answer to like I and session

Jamie. great win and everyone we ways potential and mission I disease. many have with today thank to and that on things our enormous to to a that develop their a opportunity company has treat enhance that you, to is therapies helped to achieve our who modest cardiovascular Investors Thank able investment capitalization remarkable support know with success do should capital. presents market

for great we if efforts. to afternoon of a an XXXX are successful support continued deliver and XXXX end you to your Have interest expect We rewarding and thank BioCardia. incredible in a our and

that, we’ll with call do Ladies gentlemen, you and thank conference and We joining. today’s for conclude presentation.

disconnect lines. may your now You