BioCardia (BCDA) 9 Aug 232023 Q2 Earnings call transcript

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia 2023 Second Quarter 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. [Operator Instructions] Participants of today’s 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. the end be November of of hour approximately X, replay the after the webcast call available will one XXXX. A call through

conference of time, to go this I like turn At would ahead, Miranda. Miranda Investor BioCardia the Peto Relations. Please to over

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

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

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

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

these on XX-Q For on BioCardia’s in please and the filed more statements the company March XXXX, refer reports cautionary and risk XX, Form about subsequently risks, reports information factors described Form filed, XX-K to quarterly

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

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

distress cell and and heart allogeneic and the current cardiovascular respiratory syndrome. efforts BioCardia’s specifically its ischemic everyone platforms are significant call. Thank advancing myocardial Miranda, failure, on afternoon on its good ischemia, diseases, you, autologous to and to acute pulmonary focused chronic unmet therapy treat

we mission them heart delivery changed programs therapies all has or of still to of act All lungs, the therapeutic involve This cell-based to viable. local of are these and not locally. the intend where our

and XXXX, on We milestones team of delivered a solid second the promised. quarter our had

in Japan Heart We patients For enrollment, increase with towards we in plan finally number and significant implemented submission BCDA-XX, existing including on FDA completed the adaptive review. complete from our based Therapy Autologous we a or data, Cell statistical our CardiAMP are Failure a Canada. and the analysis seeing approval of

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on on modest in a BioCardia three delivery which publication of a had therapeutic development discussions. of and closed million business scientific had invited also CellProthera, insiders advanced $X.X the financing with our participated, importance partner, presentations

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will appropriate. material New shared as information be publicly

system or with approval on existing first of efficacy fraction Japan's our submission ischemic the Cell heart for and Device to towards of indication a ejection -- June failure June CardiAMP Therapy and the On for Agency, was formal consultation reduced Pharmaceutical Medical safety PMDA, data. based

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other we program for we decide gathering important information for PMDA, clinical to our consult programs. through BCDA-XX and more As the expect of with the next milestones steps work process

patients the Phase rolling multicenter BCDA-XX micron company is sites. cohort XXXX believe CardiAMP of at of the double-blinded to of the compelling the to the this expects begin to or principal five in The and a to randomized indication controlled Therapy trial. most fourth this The number randomized clinical trial in including Cell ischemia up X for to enrollment complete investigators, intended this patients include study chronic trial, quarter both XX of be A therapy. for phase XXX in up leading investigators

patients Planning cell randomization population to strategies to experience promising set exclusion analysis rapid on criteria are using dosing opposed based enrollment. on baseline under means include modifying the to excluding the the phase based patients patients as underway a enable for treated of consideration patient as is already and more to date, to in means more

have cell Six being BCDXX been company's a manufactured additional cells allogeneic heart or are The I/II patients. for Clinical-grade the for at failure manufactured use encompassing actively clinical ischemic company's also is system, trial delivery program are at Phase ready with therapy proprietary XX BioCardia centers CardiALLO onboarded. BioCardia.

center its the for third runs this activation begin at agreement in and month. clinical site scheduled IRB clinical expected Patient enrollment Cellular the conditional has quarter. site clinical preparation study the finalized are test first vision approval. to received and The is

events. This study company's cells the builds mesenchymal stem showed Previous of Helix benefit. proprietary XX adverse three patients previous on encompassing failure heart no trials results compelling signals for trial serious in treatment-emergent using System, treated with Delivery early ischemic

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the Helix System and for delivery cell- genes safest, muscle. therapeutics efficient It delivers into to enables Delivery with heart to remains heart the Helix and BioCardia's local and Biotherapeutic the from penetrating most therapies, cell needle therapies. the It cells, gene-based a BioCardia's the helical of proteins heart. within own including easiest or use muscle delivery means of

deals steerable our in approved areas, includes investigational potential to have end we close the avoid platform Business is enable working Biotherapeutic to and around development year. systems, imaging deals the to catheters Delivery navigation. other delivery guide The financing. These System delivery approved of and proprietary are and Helix us meaningful by active

in deliver heart biotherapeutic to allowed patent company XXXX. Japan target titled with future endocardial in and Underlying chamber. a granted patent our property. delivery In programs needle covered will June, products The within BioCardia’s claims expire term existing tip delivery describes a platform products with specific that in features. enhanced technology is Patent the catheters Radial catheter in by interventional helical announced that and Office The the extensive biologics development intellectual sites patent catheter, active the to

with procedure our remote navigate patent Also and to further Office and uses grant high-resolution, images preclinical catheterization MRI the in intention compelling merge titled this during approach image entry such cardiac image for been June, describes procedures magnetic techniques to previously Site the bring has image in update the enhance procedures. issued or collection to expected patients' application ease X-ray heart, to studies automatic Selection current X-dimensional the images The data a is of the as resonance obtained to procedure. of to physician European with patent a targeting and suite into an that annotation. compared and This from Patent

our but DSMB data In compelling there and there's value. does We is reflect active We around great this. strategic market built the disappointment have recognize that on programs platforms are of and products from the and that programs price of significant data and response, generating clinical wealth share confusion not we summary, assets four a three recognize more data.

from each programs, as ahead catalysts business our near-term as of our development significant activities. three have We cardiac well

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

the were agreement Thank revenues. you, Peter, March the for June afternoon, approximately collaboration to and for timing the due Revenues comparable approximately good ended first ended primarily XXXX, months of three months $XXX three XXXX, everyone. to million XX, $XX,XXX

similar. the $X.X comparable general XXXX. months and the at same second Expenses quarter-over-quarter to expenses administrative expenses months remained were $X.X of the remarkably for June XXXX. and three Research development million ended in for quarter of XXXX approximately selling, approximately ended the three quarter second June in XXXX amount million the and were And

Net $X.X approximately XXXX, during revenues. XXXX, quarter in $X.X cash primarily was $X.X compared operations in approximately approximately to second million, compared million of to was loss to quarter the fluctuation net as in $X.X XXXX. the QX the in in used QX due million collaboration as Our million

and funding ended or cash without earlier. in with In $X.X equivalents, development Peter mentioned the approximately November activities additional from cash provides million and BioCardia into other that capital runway the which business quarter

This we're comments, now concludes take to happy management's questions prepared and

call this to open Instructions] you. we will At Thank the up [Operator time, questions.

comes question proceed. Pantginis H.C. Please Joe from first Wainwright. with Today's

everybody. Hi, taking for and afternoon the Good thanks question.

the obviously, guess unique answers focus Peter, yet I little I something a this really review, to and the don't you situation. you forward then So, of like want even bit. look want I though to said, DSMB somewhat a on have reconcile And mean, because I

down out it's DSMB and data now unblinded wind if essentially would says trial comes and right done. meet you the unique study that's activities very the be the primary be not But the aspect. endpoint, So are likely not, that and usually, to would in

seen how you I comment the ongoing guess, standpoint, that do from you've with the that still in reconcile So patients? study and improvements that -- blinded

one-year question the then is, that benchmark. And blinded that important of is then be second followed to for the which think I aspect fashion for listeners in is a will patients

should investors be that know You for the we looking are with effects? deltas benchmarks to treatment what and and regard

review I question only Well, don't DSM some thank on I you, Joe great the so have first for and of part, hypothesize. I the the clarity can guess nuances. and the on

comments, little we solid a also As assembled I it's prepared noted and we a are DSMB in our confused, group. the very but

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walk. six-minute is element third The

distance in there's that with this something hypothesize as the walk measure six-minute can I so And wrong endpoint. primary maybe

the so trial respect And likely larger impact it's levels low with of the a as events, may -- have mortality Finkelstein-Schoenfeld nuance the expected. We we may in implications walk to well. in this the have endpoint are six-minute how MACE has because have and than incorporated

is And group already that been that we're DSMB a actually data, data data that was the analysis. has conclusions by substantially It and drawing a separate so as from confirming being correct analyzed. provided mentioned, they're is that I are analyzed to the

appropriate that whether to follow-on are is clinical with at a to and thing a that potentially a other conversation of The all we company DSMB to we're adviser, assess have as recommendation. altering the not have materials the clarify doing look the or external going we

restart right now, that make the not think months, is detailed, sense I does of lot XX sense today to as in our I've a management.

the to maximize stay And advised potential so ourselves data blinded -- to but been forward. we've going to

Our these next expectation is that will evolve steps. after

just we are. that's so where And

down on and question, wind Now your I second trial think, was

No, more of – sorry. benchmarking

one that yeah. year, Forgive me margin

Yes.

receive information So as this the we the far impact as data from trial we wind that down, will have.

today. data we're this past still efficacious, randomizing patients the So that And on because and the is we all supports see of going. all we is that are still safe supports bullish we're that data direction the this

eight be data And them is so so the readout those weeks follow expectation be get the randomized, a patients then outstanding of to weeks. in next a six for year all randomized the patients will And to before have true they will trial. we looking period that many we'll may data been is have, and of have that viewed, yet readout interim we'll will we this endpoints not if from at be The challenges the monitored, that. the

if I I I for is a that What that is the that, mortality reason be would be look primary we're data the look look to will this would I explain, that to expect be can't if interesting thing And on I also at. The mean, endpoint. losing mean, for here important. that on surprise. to data some to follow next going losing be will we're at. MACE

are interesting two treated Again, I low of either signals. data. population; those any feature expect to don't not to primary those already But the privy the since have I so this I'm think in

be I'm our some if at So we we the And something, guess work the from look endpoints, laboratory extensive other all here Yale, may the there my interesting our all. is best my comfort problematic. there's that pre-specified there providing that When in data it's echo core quality expectation six-minute have of life, observations of walk you enhance is level. at

the LV functional all those important of the where really life, look look quality at and also we'll would, And there. from at haven't to walk, also objective, data the And such all at important. survival end data, the I quite how but MACE dimensions, the data going of looked -- And diastolic fraction, and we two doing of actually six-minute echocardiography data end these I two-year understanding endpoints are again, the go then as ejection see and are endpoints LV really patients I I long-term are then look really and we dimensions. years, at follow-up, systolic is be

don't mean, I successful, their If this six-minute walk, think than we're all trial know. restarted guys pause hit clarity It's we why endpoint, guesswork. other these interesting. right with they'll another variable the primary be would this I going and perception it. they now, it's they and I is maybe on think pause maybe have stopped don't don't to

But we're being prudent as we're forward. moving

and to answers right folks, We are it value stewards taking for rather take that sooner that our we're in for we're the and shareholders doing the than of we'll order it that with we trial later. steps world-class this get have all to taking, has so the hopefully and so we're of and patients, the

I lot. this and for a speculation pretty to forward unique a thanks color lot. Peter, Thanks the and looking outcomes. the appreciate situation the

the Yeah, question, appreciate Joe.

At turn any does session. and this we now over this I in time, the showing remarks. questioners for to further back no closing conclude the our queue, would question-and-answer Altman are Peter to like conference

thank want call our of and you. BioCardia our heart We and I progress, wonderful always sharing interest and mission stay for be I to in disease. day. participating to a kind have today's to and primary as forward in your say, for you all Thank continued treat healthy, look

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