Pulse Biosciences (PLSE) 10 Aug 232023 Q2 Earnings call transcript

Greetings, and welcome to Pulse Biosciences' Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question and answer and session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Philip Taylor. you. Thank

begin. may You

operator. you, Thank

only we and begin, comments call inform that predictions, XX, like management's and forward-looking opinion statements, similar I responses to information. would including XXXX, August and today, today's plans, as to will your include views statements expectations you estimates, of Before and other questions reflect during

press risks and Actual release the described certain risks of as a results may result and fully today differ earlier U.S. more materially uncertainties. issued from and These in those in with are our expressed Exchange or implied filings uncertainties and our Commission. Securities

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

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

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

are The us. call, and Mike the and Koffler, everyone, you today Thank we Good breadth to Levinson, robust Officer; on team display Strategy Uecker, Mitch our full you, Finance. making. will Chief of experienced by Trip. leadership highlight afternoon, Chief the I'm be Darrin President all On for joined thank expert to joining be today's fitted Technology progress of and Officer; Vice

current ablation, the we of efficacy technologies, appropriately nsPFA, emphasizing potential and CellFX focused to science meaningful continue pulse clearly from nanosecond quarter, for the to we pulsed the on In all safety on ablation, were continued field nsPFA. the nanosecond improved technology with PFA differentiate behind build validation and field second

call news hand over Then will Mitch discuss to Levinson to top and discuss specific core second describe benign company's First, opportunity exciting conclude open on development Darrin results cardiac Then the progress question-and-answer to will our for business first I Koffler review quarter would provide achievements. a and the first-in-human I nodules, and call experience I nsPFA. device Uecker our financial thyroid Then priorities. our surgical will and session. before for like our performance our Mike application noteworthy development with

during invasive our the lab. faster is fibrillation that of blood and we by utilizing on a RF cryo. clamp treatment There and patients, and for EP reminder, a heart potential cardiac by And catheter treating the further nsPFA the Clamps nsPFA standard benefits large in minimally creating vessels safer electrophysiologists advanced clear with from more clinicians. PFA this that the primary is will surgeons physicians As ablation or by has for focus to consensus atrial techniques is and cardiac intend treatment invasive catheter take using a surgery emerging minimally in step a than heart surgical through a open for or navigated be used surgeons AF. catheter developing will into ablation be the

procedures. amazing an and in This engineering development. new history. visionary safety years demonstrated in being and of nsPFA period is in first-in-human in preclinical standard establishing is efficacy Bioscience our a now surgical follow exciting Pulse studies results These

in designing and cardiac understanding As since and XXXX. a since for Biosciences Pulse reminder, nsPFA investing nsPFA applications engineers XXXX been have

space, We pulse are ablation assets. unique of field in because development our the partially

appropriate tissue nsPFA, to engineers Energy factors electrode that up. the to ground then the CellFX of Pulse the built multiple generate endo designed the We of created at areas. then have nsPFA the System harness built response energy Biosciences from nsPFA science deliver level, understood console a across knowledge basic purposely first therapeutic the took electrophysiology to and and create CellFX

of dozen in what results academic at accelerated engineering, a surgical cases of see. and command to and tenants, science in studies allowing rooted we date advanced in the followed preclinical half nsPFA cardiology thyroid by an research move wanted Our years pace at first-in-human of years Pulse XX is to Biosciences to are

I Darrin let the details. and fill in will Mitch

the track to ablation to file cardiac cardiac technology vision for we period. submission remain plan a of begin feasibility been same and cardiac cardiology As programs. first We half preclinical an the accelerate XXXX in company the surgical strategic time of on our surgical on device in the development, validation and the the catheter FDA for focus catheter clamp study has the the that during for

tissue cardiac our a was As have important validation studies tissue of the advance action available response our of efficacy response human safety the We and as tissue. ablation. we in potential of nodules, otherwise unique product on performed using study an proprietary organs thesis incremental engineering tissue the benign to work an internal first-in-human towards internal feasibility to demonstrate and as study conducted our and safety in first capabilities from deliver of our the demonstrated nsPFA nodule and we of efficacy organs, nsPFA action demonstration thyroid supplemental not engineering and human This of and of data view initiated and is and point of treatment the further of thyroid SPF mechanism validation validate factors. mechanism novel to

results, our see these develop platform external cardiology. Based technology interest in opportunities on further beyond we to

inquiries that evaluating goals. licensing align and our are with entertaining partnerships We corporate or agreements through inbound

preclinical the their hand the progress performance. to development now off discuss Darrin we to our on will I made in have device call initial cardiology

you, Thank Kevin.

as several evolved well very study those last cardiac the as studies potential capabilities physicians results performance for of our preclinical the the we pleased on step have in been human the our the clinical are each use work as confidence of and these to of of clamp to The has am devices. our active both in data conducting foundation with. process. over we catheter the path that report the we lab devices build towards have with surgical I months expectations preclinical in are honored We the

and our device each treatment prospective exploit of market-leading we indicate proprietary custom in durability that By potential and tissue atrial energy, the fibrillation. safety our application, for that nsPFA results capabilities effector pairing uniquely efficacy and are ablation nsPFA of achieving novel with designs and the

The to transmural Specifically, or continuous in ablation our frequency, recent cardiac ablations cardiac as generating nsPFA of ablation studies is and preclinical the results are using muscle including to cryosurgery in in possible. to we consistently use, modalities clamp, as full also referred quickly cardiac relative our currently radio exceptional as thickness ablation. produce goal RF, energy

are RF limited of independent ablations thickness, in XX which XX X.XX when up millimeters. to transmural thickness, which is seconds approximately XX treating This to several Endocryoablation, require even which ablation XX tissue on clamp, can thicknesses cardiac nsPFA approximately consistently is minutes our seconds per we per requires to ablation, to achieving millimeters. generally the compared tissue With tissue depending ablation.

of thickness novel the clamp proprietary transmural which of ideal enabled and challenges seconds the outcomes. for tissue, the ability through multitude predictability thickness. to in as our Thermal surgical Lack such tissue predictability automatically nsPFA consistently through physicians. supports rely and vessels. delivery produce of tissue thickness varying on of inherently treating Optimum collateral is X.XX clamp action, the modalities tissue adjusts pulse The cardiac that of on mechanism parameters ablation our design depending vary effects algorithms nsPFA by nsPFA will presents conduction thermal based on a

especially surgery. world around impressed the Officer outcome Dr. group treatment enabled cardiac thought-leading cardiopulmonary the cardiac cryoablation speed anaesthesia for counts, been cardiac while Dunnington, These the of have In our surgery, very cardiac second patient cardiac Gan under is any bring Chief from every significant extremely surgery type cardiac innovative ablation Medical and clamp and of group of bringing have at by of surgeons potentially us of AF currently and available surgeons surgery, Surgery, we is with experience RF the busy of system. on to treatment our bypass. general Cardiac as together nsPFA technologies. This consistency but using to surgeons a nsPFA in work

multiple required translate time significantly perform in the procedure reducing a the risk reduced to patient. So to for the ablations can

pulse minimal to damage surrounding require nonthermal, longer damage. electric thermal is generally addition, repeated spread, field controlled collateral is and the is which jaws the which of structures. modalities, cause Thermal can tissue clamp unintended In treatments collateral there risk cause because in between can turn,

with For these development provide nsPFA to reasons believe our we thermal to progress. faster, with a safer available more, cardiac we preclinical and and the has what continue our and continue be encouraged modalities, currently cardiac is potential effective ablation than more to clamp

in believe requirements On the regarding we for the the on regulatory FDA track be We we half with continue the a in nsPFA XXXX. communication to file of to submission the XXX(k) clearance are first for front, clamp.

nsPFA to Shifting our date studies, our our a catheter pulmonary orientations circumferentially novel other design consistently catheter, collateral the seconds. RF tissue electrophysiologists ablation using cardiac of able to systems veins the X approximately device, without studies pivotal damage indicate need traditional which perform our in shot that ablations achieving the with is in and do at to device PFA In ablate positions to ablations preclinical to underway. fast effective catheter when targeted or and single to without often focus multiple or preclinical different the studies need is

use and we enabled catheter. concluded nsPFA novel by wide generated. in the hospital catheter can was cardiac create Across Similar Annual of circumventional highlight device our phrenic a novel clamp, specifically physician benefits to were platform. our for by Rhythm our minimal that these One which York, abstracts our with with three presented Meeting, outside safety nsPFA circumferential data our relevant Society studies, are clinically performance performance designed New study the we stimulation. At the Heart muscular lesions believe X the and from combination our favorable of collaborators

study did nerve associated demonstrate ventricle our thermal and clinically lesions of observed tissue, injury. was by Delivery can only nsPFA mild The stimulation. evidence and which muscle and next any catheter with create wide delivered not

at Finally, will our safety trials. electron the manuscripts microscopy. data efficacy observed All in Each that newer of The first-in-human at also points thermal X abstract for these design potentially the belief effects between of our PFA nsPFA and these trade-off catheter and time suitable available be technologies. that support modalities nsPFA belief our third can website. the substantial are of demonstrated cells heart confirmed acute traditional our have cardiomyocytes, on muscle eliminate abstracts of using the ablation,

started regulatory nsPFA have for first our feasibility for system. catheter clinical ablation the in-human study the We process

in expect study previously, reported the the As begin first we to XXXX. of half feasibility

PMA. also We on the We premarket are U.S. approval, forward progress require way. FDA the making determining the an updates regulatory look along line catheter. or will our cardiac anticipate catheter pathway to for our We progress in product sharing

to providing are improved X In and cardiac thrilled summary, devices, we patients we performance forward with surgeons preclinical our of with look options. ablation and treatment the

I'll platform reaping how feasibility the benefits the to over to now nsPFA Mitch? some Mitch call nsPFA recent we exciting describe broad the strategy that an of potential are our to demonstrates turn surgery. work and first-in-human our validate in and team's expertise clinical of

in your work to from application. Thank clinical I'm the preclinical about you, a first cardiac in recent Darren. echo ablation, our and surgical excitement results I the early excited study share

making energy nature being founded, types to nsPFA impact we're our platform company the medical programs the our of pursuing System was and the with progress nsPFA's with top The our Since how cardiac is The specialties and of cardiac tissue across deliver today. applications to research testament multiple ablation to CellFX with various best was CellFX different continued the to developed on tissue. System. we've priority nsPFA vision a

of R&D that Today, the effectors end we throughout entire experience gained expertise body. nsPFA leverage and the of the team in to how have novel an nsPFA benefits through therapeutic develop with use

determine explained. Part and range great have of cardiac impact Officer of been as areas Pulse One the are prioritize care. Chief technology my clinical just significant evaluation was role to where patient now decision of platform resources across on as effort lead of a can Darrin to ablation, effects, largest and achieving the this result efforts on Biosciences our those our exploration has applications for Strategy to wide

medical we with have from shared on partners urology, specialty and physicians stakeholders, ears, Over cardiovascular, focused couple throat. applications, including and oncology of the high-level pulmonology, strategic gynaecology, the past work in gastroenterology, the our feasibility nos otolaryngology, years, results and potential

applications propositions external in in opportunities have exploring Our the nsPFA multiple value clinical attracted interest. feasibility mutual expressed of who've demonstrations and interest organizations of

our on While we'll are value-enhancing evaluating cardiac to focused we opportunities, continue stakeholder acutely applications. remain

safety was As feasibility broad a of using study The energy. the surgical understand of further proprietary patient the potential the deliver thyroid a recently initiated to nsPFA to tissue ablation endefactor clinical this body, nsPFA human custom inside the means effects goal of tolerance, to and measure an we procedure and in nsPFA study. response nodules benign

located in nodules hoarseness resulting treated near neck remove common benign and open requiring are pain. entire tumors to box thyroid replacement. the These lifelong voice swallowing, thyroid most difficulties can commonly the breathing surgical neck in resection in They're cause the and half scarring by hormone and trachea or and

Percutaneous ablation offers other surgery and damage other RF alternative the create scar critical and and mechanism risk and effective thermal the after has structures microwave the thyroid to more significant unique with of a of carries trachea the potential they inside action of vessels, ablation to thermal or resolved. collateral a modalities nerves, can nsPFA's injury modalities. safer

treatment. local We them following under our under All then the resorbed, with XXX which days, for days procedure with These patients patients at days XXX, novel effects. imaging had reported benign nsPFA subjects the or be can very already other XX, that evaluated and post nodules mostly showed guidance, pain serious tolerated compared ablation ultrasound additional at follow-up the XX no is while the modalities. been post well portions conscious XX side of procedure, and treated XX with fast very treated the immediately with electrode completely are Ultrasound tumors procedure, anesthesia. plans accessed or

vasculature while and lymphatic or cell no clearing benefits another own which of scarring unique fibrosis, of infrastructure of was the the and scarring our natural preserving facilitate unwanted ablation of demonstrates regulated to There modalities. the side the inducing sign technology's This effect tissue. also treated mechanism body's other of unusual death rapid action, avoiding is

initial these the results, to positive the treatment in to and on an quarter. protocol fourth thyroid next focused on Based we're and amendment enrollment study is preparing optimizing to the phase occur parameters expand anticipated

in the without dominates that this Our experience inside an is a well human organ skill human suggests nsPFA to and serious internal or human body study effects. side first in energy application surgical tolerated also our in delivering pain

While it safe developing well may remain treating other that treatment AEF, and conditions on focused well. nsPFA we for as devices of the clear is effective in many be

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

you, Thank Mitch.

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

Non-GAAP was million compared reduced to loss $X.X million the same the June the cash XX, million the June equivalents of March nonrecurring in in and XXXX. in of totaled compared used ended XXXX, and payments, the million XXXX, used the to XXXX. increased and as used XX, million maintain XXXX XX, of approximately was million quarterly of million first our from XX, period June million throughout $X second quarter burn cash recognized year We quarter and $XX.X resulting for totaled our to $X.X in of increase average expectation largely $XX.X timing investments certain Cash, quarter ended for $XX to as cash in to Cash but quarter compared compared the $XX.X XXXX. net $XX.X XXXX. usage, prior

$X.XX In with effectively the price Duggan, Chairman preceding shares common closed April, entered sale reported trading purchase Duggan, these successfully stock and a placement day. private and stock approximately interest premium including $XX prior a price Mr. indebtedness May, of of we balance XX, the than company's the stock In over per share, sale common agreement of shareholder of to all April XX,XXX,XXX unpaid XXXX, million securities, this and canceling and we Robert greater by company immediately a into the on purchase principal at of the owned last the $XXX,XXX. accrued of the company's for Executive of majority X% our

company less for of cost At transaction to loan Mr. trading Duggan's September $X.XX share. financing company Total this in under the per time stock XXXX, the $X,XXX. original than is the

from in of warrants with the connection stock redemption May, second issued offering. approximately rights a approximately the Prior in shares redeem XXXX from purchase $X.XX This warrants common of shares to the of gross million proceeds outstanding of proceeds XXXX all to warrants in brings with million rights X.XX the million, company's of including in total notice at delivered common outstanding Also the our date, stock million in $XX.X redemption $XX.X June exercise generating still to to $XX in per purchase approximately share, offering, million we $XX.X X, our were to the coming exercised XX% quarter. total. received approximately

additional from cash In at addition, shares exercised adding XXXX, company's stock in of company's $X.XX sheet. common the of Duggan an the $X.XX, to purchase an Robert options to July ranging $XXX,XXX balance additional XXX,XXX prices to

are from We shareholders. the our existing see continued support to pleased

back over will to I the turn call Kevin. now

Thank you, Mike.

will I Now closing provide some remarks.

encouraged preclinical We in by our are our we cardiology have results devices. achieved

devices, of our action novel unique the with demonstrating mechanism engineers expected are potential combined anticipated. Our our

leadership technology in can are multibillion-dollar on of depth We a to atrial our progress breadth providing team confident market. and forward We achieve fibrillation propel in the the look nsPFA position to next this call. a update leadership

Finance, session question-and-answer Executive Officer, Technology Strategy today Chief Mike Vice of Koffler. the Board, and Uecker; a Mitch Levinson, Robert of Officer, for me Joining Darrin Chief is Chairman Duggan; President

please open Operator, for call the questions.

Instructions] [Operator

Kevin. is this Rob,

in of a online. couple came have questions that We

together can questions So online. I will read these questions you first, the and put

the Considering if you continue success lines, says and great have cardiac the focus the in your congrats, study time thyroid news new the expansion you needed? you why on validation the results. and the catheter cases and So clamp question first in in would both the first-in-human progress and

Yes, one. that the color yes, is that right. is Thanks Mitch. this take I'll question. for Yes, And

the will application it interest expanding tissue first parameters. the so treatment the of our energy The outside the us subjects, allow we optimize to body. the inside to the decided of and and look was human our Because that validate has others, to safety, tolerance, helped in promising worthwhile nsPFA study there's this and results preliminary patient number demonstrate response us these because ability

in the The next to question with that regards is clamp catheter. and came

these You can spaces? compete you like feel

can absolutely, And the I Thank will take kick you one spaces. and we off. it this in question. think we these for compete

talked harness stated, that and years science shows in nsPFA then understood electro the our in knowledge of Anything These energy and designed response. Darrin? investigating Darrin's and section to this generate and we and of space. like to that end tissue application we academic of the and the we centers we have XXXX XX really first of nsPFA our since understood took is As cardiac that then that have and to XXXX. add We research, we've purposely nsPFA nsPFA rooted basic said. to And created can we level, nsPFA results the command been built engineers energy in designed factors that, and we lead and electropology how of console appropriate have our command today believe since

of a Yes. And that how and I how Dr. think patients. devices and to much, liked certainly, he But I he talked lot real terms who other proof getting the of the in with think of then I I to is feedback. time Kevin decided for physician become process our come And and Donnington, CMO devices. I speed spend devices. a of talking would said so physicians did we and the the development cardiac from We differentiated attributes are lot our mean, what wanted it accurate. just will our physicians their say, numbers of Nanosecond in competitive different about

I customers and proof physicians is really end So patients. in the and end the the think like stakeholders

in And of that very going I them think and both that far, the be spaces. we're is feedback differentiated, these gotten so to highly competitive we've from we're

Operator, online? you, Dan. questions Thank

have do audio we Yes, an question.

with Our first comes from question HC Stephen Hammer

the to firm Pulse of I'm projects I to abandoned. people and how supporters relates curious, teach was great working. market to from of that obviously, Was the them to is a on the physicians question start. the industry technology the that been we've the use the And leave equipment? it that, cycle My decision took Yes. basis in think to the would dermatological education the other long

then you come I'll jump do in Bob, want support. and to in and

first Kevin. that And not ultimate a really device to Sure, expectations typically, and The outcomes, experienced all pennies dozen very electronic in We the patient I a clinic. were while exceeded nature use. And frequent the can with and difficult and we half digital X appreciate And we or a that. terms was for robotics. are in device fraction of on The product Any it question. use that challenge take was was it's benefit. the effect revisits that which clinic, in the affected your case, can this Steve, modern pleased of excellent to times. the is in with and challenge dozen profitable competing requires really multiple compete dollar. hours the didn't

And but needed use tissue think we get the it very in done be as ago. had the the FDA to as first -- we've had looked soft was human a body the only years electricity very, would We we opportunistic demonstrated obvious. them. safe spectacular we inside ability an by face. in safety felt became and we the that for body to clearance challenging approval We more that job. on at considered go do So that stares tissue FDA a We side,

an forward. with have We're proactive We now going the excellent very FDA. relationship

in cardiac into at with the look been we have and in outstanding. And preclinical the repair. in we run Then So and thyroid similar results studies who's analyst looked the to tissues frankly, in who the profession side forward

excited that. when about is better surgery one-off. and we than this that think not response been somewhat something surgeons did surgeon The with they as match has robotics, I'm the prostate acclimated get if

the not we I personally -- So with more be excited could opportunity. personally

as and done business in the training applied in prior this communications It's and physicians all has and of work our -- company prior to the experience years with I has is we've real in robotics robotics, Kevin field defectors surgeons. also a us. half dozen very think everything people. spent that patients and

personally I and I I've been be better this in probably significant don't most consider to hands. look fortunate could be So with, forward we to to the difference of that years as a areas next and builder body. in the substantial half the the I dozen going we're something to work human that think betterment in And the opportunity for make opportunity think other cardiac Because a broad it's for time, companies opportunity, occur. relationships, and that have the of different we'll results and this through next way to we back got as our don't you interest, a business and we're is to over the such talking diligently made work stakeholders our certainly and report fund large period us real progress through potential then and showing we'll lack to

that to question, So XX hope addresses following and Steve. your years. the X, then an I it's going months be X, exciting X,

Bob, years, does, career the Santa followed your time back the a Motion you Computer Barbara in I and of sure first It quite Day. and number in have for met

the we're this for and you very company, thank So for excited. support all

a very with going this, positive all thanks been on it patience. and well very, I'm for It's ends where well. we're is but your that journey,

just I'll Steve, add. And

how the we're people and console going went console through we forward. designed unique cardiac dermatology, I learnings this we look at us that what's where see today. proud we're One from those evolution but really to work, really and have of it is And dermatology when developed us impressed the polished as goes the and things the milestones will talked we how that that doing had console clamp that history of And this we know we it's the our those about of is and is space. space is that well and how cases is. gotten or how with for I'm back astonishing And to it we've are

There are no at questions time. this further audio

you, Okay. this you Operator, so thank call. for much. everyone, joining Thank

about We are future. the excited

and coming Pulse the going. up keep we're more and continued informed. in to you will the we much Bioscience in have all months, We in for direction support And report your you thank and interest

This concludes today's conference.

and lines your this your we time, for at disconnect you may participation. You thank