Pulse Biosciences (PLSE) 11 May 232023 Q1 Earnings call transcript

Good afternoon, ladies and gentlemen and thank you for standing by. Welcome to the Pulse Biosciences First Quarter 2023 Earnings Conference Call. At this time all participants lines are in a listen-only mode [Operator Instructions] Please note this conference is being recorded.

I will now turn the conference over to your host, Trip Taylor, Investor Relations. Thank you.

begin. may You

operator. Thank you,

only begin, and more comments our Actual I may call inform we predictions, differ XX, like management's These and forward-looking implied, opinion statements release would of responses result a and to today results that including XXXX, our May and materially today, today's plans, uncertainties. as you or will and in Commission. your include information. filings Securities views certain statements and risks fully expectations Before issued earlier estimates, of to and are other with questions reflect uncertainties as press and from those described risks in expressed during Exchange the

website are forward-looking update website. or on Our filings obligation disclaim forward-looking SEC the statements. cautioned reliance on to our Investors place statements. undue We revise these to any can be or on not SEC's found

non-GAAP including call on the our & also Please pulsebiosciences.com these available will found at in that regarding press discuss the certain audio replay section measures for News be be website on financial our GAAP conference this with Events comparable Investor reconciliations page. Relations note the measures. Disclosures can We measures will release. financial on non-GAAP most

would and like With Chief that I call President the now Executive to Danahy. over to turn Officer Kevin

call then to and of a how initiatives. advance regarding addition a Officer, objectives. all us. review question-and-answer results, discuss will Darrin On first Finance, our quarter I joining plans open Mike Chief Koffler, session. significant call to thank executive the today's product to well Uecker, for Trip. excited our you, and Technology the President you and turn share Thank conclude I'm to will to before afternoon, financial corporate for team our Vice our, updates everyone highlight regulatory development over and Good team, I the call, achieve as our as

team. highlighting open our call to leadership this want I by

to to technology. proud assembled the and structure team designed our are innovative We organizational broaden and of have accelerate world-class a application

announced Medical leader Officer focused of Just a renowned Gan lives of surgeon, He procedures. technologies is that is pioneering month, applications. less-invasive appointment minimally-invasive a Dunnington, novel we cardiothoracic Dr. with complex this in the specializing on cardiothoracic patients Dunnington atrial in improve Dr. our the as Chief fibrillation.

leadership Chief look portfolio complements will guidance, our forward We a as Dunnington work Strategy and Dr. advance clinical Darrin for Chief technology. our Officer, Dr. devices. Mitch the team our cardiac to Officer, Levinson. Dunnington and Technology point his closely Uecker at programs we regulatory critical for of alongside,

device a new Mitch call and industry of track record is to a medical will of Q&A. veteran variety market products and across is He on bringing specialties. with in medical a the participate technologies successfully

that the to Pulse our enables to within have achieved pulsed effects first-in-kind on The be multiple is field a therapeutic current possibilities. beneficial, Biosciences nature ablation of technology clinical market. deliver path yet platform

share shareholders to We and our timely and If something opportunities cardiac. of with important outside continue listen you basis. a manifest, will we on evaluate look, it when

and clinicians. catheter physicians that cardiac this nsPFA than ablation remains is can and further that believe will surgical we emerging RF treatment more cryo a and the a that or and Our top advanced both faster of creating clear fibrillation benefit safer is we utilizing take by and PFA treating step There from ablation treatment focus patients a developing consensus a for atrial clamp AF.

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corporate focus: goals regulatory complete two, FDA develop to several two cardiac that last to develop regulatory our call, and appropriate advance to cardiac milestones initial success nsPFA deliver tissue. working On and model. patients. milestones groundwork to one, we space products our treat heightened and We path; the support XXXX. unveiled the the devices are a catheter plan half cardiology in all We accomplish clamp the will viable required aligned a clinical goals our to and that through these for study long-term of with should Achieving lay business first these to during

they're achievements We quarter. finalizing process regulatory of FDA are pre-submission first our ablation the completed clamp proud the with of meeting our the throughout pathway. and We recently in cardiac our for the

our Rhythm the first-in-human three at related We preclinical Meeting. with have Annual device we studies to support are continuing Heart Society XXth and accepted abstracts trials our catheter

turn the discuss I product it the and map. to will now technology over road to Darrin

priorities Thank call, current to nsPFA preclinical we clamp advance last you, our and our with Kevin. catheter. our work overviewed surgical On

into techniques As catheter or AF standard clamp a will using blood these vessels EP heart are devices intended both be The electrophysiologists during by the with open minimally-invasive to but minimally-invasive the by approaches. through used heart navigated of reminder, treat in will cardiac catheter surgeons. different be large The lab. surgery

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Turning cardiac to clamp. our first ablation

surgical continue to procedure ablation faster, believe can more current a AF perform We than and to for significantly nsPFA safer a easier precise, offer technologies. way

of will believe nsPFA physical with clamps to We physicians today, clamp replace and nsPFA able the ablation using and nsPFA, ablations transition including speed immediately improvements appreciate the all because our times in frequency used up should clamp with XX precision in experience radiofrequency as be benefits procedure to design, ablation increased as of ablation to easily well of our being is of being ease radio use. overall claims similar clamp faster

ongoing FDA for the the FDA clamp. process. Administration FDA's of with will Drug as Food and We FDA, the a a to of the with Q-submission clearance clearance nsPFA initial part discussion productive requirements was and finalizing potential recently goal with now or for XXX(k) discuss This standard met communication near-term for regulatory US requirements our further be the

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the by preclinical We be to encouraged testing are continue doing. we

our a the cardiac of safety leader, preclinical of precision testing join differentiated our team potential involved validation our clamp this year, to nsPFA highly goals we experiencing and our will when consulting since a delivering our device treating major is surgery for a decision patient cardiac tissue. key that and a the of speed, as of team achieve application Dunnington of the and cardiac to both nsPFA Dr. has beginning using His in first-hand ensure been boost physician-friendly opinion to and help surgeons.

our our second times in modalities. safety and device full following mechanism of to a of design We well circumferential design the efficacy, compared development, our single in for resulting study, suited catheter believe in to treatment ablation will enable first-in-human studies. product and action device. ablation Turning clinical a completion cardiac treatment, current is several unique believe a better ongoing the traditional preclinical shorter We

an distribute PMA. catheter updates the and market our several and FDA effectively This device anticipate the we take will to or progress approval along process we pre-market years forward way. US, sharing To the look likely will in require on the

we have the further increase of be throughout of our year. the nsPFA awareness our team this To be key Orleans, team Rhythm technology, upcoming in design the Notably, unique Louisiana. devices. to will Society data our our abstracts month continues preclinical The at will validate conferences three participating Meeting produced New in several presenting Heart

team speaks meetings and is top on three Meeting of very the encouraging one scientific States our premier work United AF to from the attended The excellent by by and in abstracts Rhythm is done our Having and world. is around the for the Annual physician work physicians collaborators. preclinical Society Heart

for giving and in our Society Dunnington audience cardiothoracic to the Surgery Invasive surgeons. Minimally nsPFA of oral on the will Meeting information Cardiothoracic Dr. presentation at Additionally minimally-invasive June, an be clamp be will providing International

Now, our I'll Mike Koffler for results. an call on turn financial update to the

Thank you, Darrin.

quarter prior total results. to Moving commercial expenses the discontinuation detailed down we reconciliation and and the to review year $XX.X and a GAAP prior XXXX, to $X.X our was compared operating The restructuring. encourage by cost statement, in $X.X non-GAAP focus release decrease first reduction reduced I driven of comments headcount my million activity non-GAAP million by measures in earning expenses on the In income the for to of non-GAAP period. you million the comparable today's measures. I'll the of most virtual dermatology

in March and -- March investments million for quarter the March $XX.X and as and in in quarter XX, of excludes the same net the quarter compared from ended to $X both the of used million was December million the XX, $XX.X period proceeds the cash XXXX. XXXX XXXX compared totaled in first million of compared used XX, fourth for the million Cash $XX.X in million $XXX,XXX the year Non-GAAP in million warrants. of XXXX $X.X used XXXX. ended XXXX. reduced Cash, as the used Cash quarter to net prior of to equivalents first of exercise $X.X $XX.X year quarter XX, totaled loss was

issuance closing share, price corporate As purchase a result the quarterly Pulse company's million. to a a strategic we into the we million agreement stock Biosciences' private of of need we XXXX with to price the capital million. accrued oversee slight placement Executive should transaction $X burn to of for premium in runway successfully entered the shares closed expect this the month placement all indebtedness transaction owed company and of focus, previous week which resulted Duggan approximately stock the this XX Mr. first-in-human day. of earlier the principal average million per the approximately interest trials. This us including Robert common the $XX of private Chairman unpaid business in cash and our of tightened approximately the This $X.XX the Duggan, of the balance over $X.XX by shares clinical We a of cancelation at purchase provide

XXXX other balance Rights Offering late of raised in opportunity efforts share June on outstanding the a our chosen Friday, company approximately the decided in price as million be warrants warrant. announced June to represents performance capital. have the up $X.XX redeem redemption take recently at XXXX we sheet, The to the final strengthen The As an $XX raise redemption additional the company's from per of presented to of will warrants strong has to by any based which $XX at to unexercised the opportunity XX which million. warrants time XXXX date of an redeemed company

exercise per $X.XX meaningfully of a warrants have share cash exercise warrants the all runway. The of our outstanding price. would the reminder, extend a still As

turn I over now Kevin. to the back will call

you, Mike. Thank

provide we preclinical place, team our in path strengthened and veteran even Now on accomplished balance forward. a and progress, closing the are remarks. more now a will some confident are we I leadership regulatory With sheet right

nsPFA technology cardiac space. differentiates others Our in from PFA novel the us

for ultimately treatment call. to to updates We and it are forward look devices on our advance excited AF patients. and the next catheter providing We progress clamp advance the

Officer, are Uecker; me question-and-answer for the Duggan; Mitch Chief Darrin Chief and today Joining Officer, Strategy Chairman of Robert Executive Levinson. session Technology the Board,

questions. open the call please for Operator,

Kevin to Thank you. time, turn polling back this will I are [Operator while the for we Danahy questions. Instructions] At call

we questions few in a Thank Conducting session e-mail. question-and-answer came you, via had the operator. that

that first Darrin. surgery? towards The the With device nsPFA in cardiac envision cardiac clamp, you only question for directed to regards your is is the this

Yes. Thanks, Kevin.

RF into surgery in key area that believe definitely to are treatment for not -- this clamps. does because they and really the we growing is current we with a clamps into adopted the for would tools use nsPFA it device. of opportunity significant the a nsPFA clamp We And with AF. end cardiac be clamp today there So over it chose introduce more of and a would easily procedure expect one

many open combination a significantly minimally of and procedures However, surgical to and treatment expanded over a hybrid what today to or cardiothoracic procedures from from procedure AF referred has an of surgeon videoscopic from as procedures is which minimally-invasive a a the catheter electrophysiologist. procedure last years is the invasive

a So to going help we procedures hybrid and believe enabled by significant novel opportunities that devices platform be strongly growth opportunity. for to opportunity represent there that are these CellFX and our nsPFA expand

led to is bring Dr. work And procedures. CMO, involved what over and us this to as he's also him with on X,XXX been Dunnington, our in hybrid

in technology So procedures can insights has as surgeon, like types these into he a hybrid how evolved, experiences a these and procedures nsPFA. of has one the of biggest with unique be cardiothoracic great

this nsPFA and in opportunity. team we this So, take play evolution role but time, how will about a our can excited think we're

Darrin. came nsPFA And areas into these to value? are looking is Awesome. you The that in Mitch. What opportunities? question have other directed you, Thank next can

Levinson A - E. - Strategy Officer Director Pulse Chief Mitchell Inc. Biosciences &

disciplines. Yes. all is of important the to outside about we'll out. cardiac. for heart over as as, years intangible report Chief we've across now about mentioned, the in other progress focused sure to of cardiac Thanks, large future of information we've applications, And When field and that it's a areas, virtually we be incoming analyze Well, Officer, as also medical my have number Part we we a interest on Kevin. resources the to about have our here our role pulsing potential utility extra talked Strategy will platform. our And nanosecond technology, opportunities.

open up Perfect. the Thank please Mitch. question. to Operator, you, next

Robert [Operator is from question Instructions] Our Investor. Private first Levande [ph],

for compared to ablation procedures. guys. give potential, Hi, an the Kevin, us you of market can catheter-based clamps idea the

Kevin, Yes. question. to then thanks the I'll come on top. Bob and your just it's, Darrin. and jump Great in for hear voice can

how that larger the for now, procedures And of landscape. excited response surgically, the is, up what of electrophysiologists. in I those many market, AF. the So, in the treatment I hybrids, cardiothoracic is that versus catheter of clamp what that of that those mentioned, was like done clear are right is think, really substantially So is ablation just as a think to more how isn't changing terms I about yet? much procedures the we're catheter with than are surgeons just and -- of market probably number again, But done more question teaming actually a are

been cardiothoracic thought turning a and one traditionally as of only would what electrophysiologist. procedure, the catheter-based by so, And surgeon, another maybe is into now step the step by then

one And that sides on the so, only we're the companies that. or probably both maybe is using of of PFA only company,

sets to. problem. there's that So, Kevin, if a physicians don't work with I to of opportunity we unique want both you to help solve really know think

then the with electrophysiologist any team, as but reason, a is it nsPFA will be we And been with to opportunity that work on treatment in for have by Gan programmatic right after is And treating Yes. Robert, to is that's you're there question. we think allow that you our I about. Dr. touching and the believe that procedure technology thank afib. believe we market then thing in think heart to a cardiothoracic Darrin of Dunnington, that the that for we provide that, we we new mean hybrid don't for working you us exciting the side, know technology, realized, talked what I exploring the map if should the a a And solution can them is wave cardiac yet. And that use now, is and that collaboration for what talking has saying afib. in platform to

that provide opportunity about the we're being So, be able we only that company in and believe, that excited will platform. one to nsPFA one

a update. Okay. the lot Thanks for

a lot. you. Thank Thanks

Medical Our Home next question is from with Robert Lovgren Productions.

just I Bob person [indiscernible] but you. was don't it he's this a in living started just the this or I'm that this just in there of was was Duggan who -- And And said a the a room. the that a whole Bob on comment beginning. -- just to possible. platform this with if the the afternoon company. there -- if laser meeting unusual public gone laser the Duggan, meeting have had attended like Thank guy or just I I'd was was basically, -- -- procedure. very this that, was morning a -- the know reminded discussion make it --

an market Bob What We're me it. that polarity can unbelievable attend resident guy. change did thereby cell the with not well Hi, Yes. meeting. there essential out using to determine we mine have nsPFA that and significant mentor is a been the And of nucleus -- that function. change energy is, the to core say the is and I tells a [indiscernible] front we've here every runway on of its cell of the in ability function. in energy core of an I

it Fortunately, does operates. a it way with the consistent natural and body amazingly, the form in

is apoptosis wind death, opposed that. benefits poration a So, good are of a cell natural lot something there death to up you called, And which to with cellular as [ph].

the to technology through going don't going drug to be who's end be clear how going work? they way open very of I'm I of exciting is is well to something, would very, -- FDA going plain, you you're unlike announced that the early most [indiscernible] think where it does is to this here, mostly it. listen, win days technology mind business, a we're very or business, It's make label, things not in basically, These on in the the days So, was clearances. we're to early if -- and Award. this but say, our do We're the Academy will of is in he terms performing. until appropriate, know

Dr. cardiac of And to into numerous onboard, have other to really are for just that us them. that Dunnington and we can our anxious and come has where perform a cardiac place working like this move at technology currently with validate luminaries outside side, it

So, to something be exciting. that or yes, onto without I places say, and would there's reservation a going that we're is just doubt

Tobi I That's CABG for run. can that they said [ph] all on the we're So that this Fred you Clinic real Cleveland your question. the mentors earlier hope But where it dollar can't something home the is [ph] that inappropriate. on I and evolved do would headed. Loop the be answers procedure day, put of a in afib. That's back always Cosgo

something afib. for is this So,

So, yes, excited. appreciate question. I the I'm you asking

Thank you.

My pleasure.

Our from is next Kruger, investor. question private Kurt

Kurt Hi Bob, right? hear all here. Can you me

Yes.

you. can We hear

Good. -- fully this are in of of lots and somewhat Good. realized that. reasons catheter, way very markets It technology promising I addresses doesn't for pivoted it's never much the those interesting potential, that some reasons afib has company been now There It It's feel of time. you procedure very disappointing why your but like impediments huge indication. takes a has too lots that well. your work fussy. Do had? the your towards

we're Sure. biology and the human eye because renders cells, as about [indiscernible] a life, the chemistry human in a the there of the This the significant body XXX% Bob damage. bull's is heat talks Duggan. inside body,

the sentence. the -- So, a volume heat energy is where times, But the is it's damage that's of really word occurs. the

X,XXX before explained human it's otherwise I count of with volumes XX vital be billion. dead zone deliverable The of today you if patient by puts incredible rate -- ask body. we've products the as to me speeds, XX other nanopulses to safety got in which can one not area a lightning deal to years energy, us to there, blistering as we we it, times the speed Darrin of I'd count faster at So, of a at deliver

come and RF patient if is to places it's do -- collateral that the is So otherwise a We of collateral relative damage they in work the places work, it's that Cryo them at out risk. order ahead. doesn't -- to that's available not handful our that really where it's percentage we points what damage

by get it. of that those that about that pretty be be we the apply demonstrated and a meaningful get a understood pleased first-in-human. preclinically. peer-reviewed this as demonstrated can substantive, the So is hold It's those that it will then But been We're journals. difference

basis this -- the excitement So our that's is here. of

Okay.

I'll to Good hope that accurately. your communicates hear voice.

because big maybe it a looking but be Yeah. I this Bob. you and Thank is have do missed have And from or know, but, man, obvious year when a require exciting. from could do straight sales going make I'm may think difference PMA X.X to now which I now? XXX(k)? a are may a you somewhat it being like to you this of it And is you you said to years -- all then, could see you, may

but be Yeah. would said of we track, Well, said, we're in assume this we is down a will second. couple it efficacy may be our likely the quickly, trials safety, ahead it don't are Those area and The time know. the close as we -- truth markers. take of -- it slightly go but will could I first PMA it a enroll years. is, safety and may because two

path. it's an be untoward I don't going think to

robotics challenge we something to major to it. It's did are to We I've of that my personnel a device in we're that's such view introduced Our the novel new. accurately first life without explain make how course. not time going And trepidation. is this about the go able sure FDA

therapy easier by should and all long a those of in oncology was leap And be which two. patient-friendly brought an then, we work. if those in oxymoron either interesting quite This

and So that will size to get know. appreciation think accordingly. results good continue news there available we I of be we're to really it The the will it going the of market will to get probability don't And we will as that do favor -- the we're there. adjust reality is, people's going

isn't to very, get until get are until tough be double-blinded up And where whether It's case you FDA, standard very line the and care. not. the trial of placebo-controlled open want drug here. they're a the to a through that like -- going with you going they double-blinded drugs these This be with not it's it clear. again, or So it's

the have we And clamp.

the let The be I say clamp, well, cautious. it gets that I believe, more hesitate have we than FDA? But and determine in circumferential advice. less don't we'll mind. me be through that lot difficult will catheter to their How the a follow – FDA the So would

the human as hope going but And very just are we as again, will active I to get story. immediate that here So soon first-in-human quarter addresses, be and then possible. the but tell to the over that

Yeah. again, checking Thank you with much. Nice you very Bob. to

Yeah. Yeah, too you well. as

Yeah.

and for out Ladies gentlemen, end and have today's question-and-answer time thanks the reached the of of Pulse we Biosciences, call. session are participation. you for your

your disconnect this lines may You at time.