Pulse Biosciences Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 13, 2023

There are 10 speakers on the call.

Operator

Greetings, and welcome to the Pulse Biosciences Third Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce Philip Taylor, Investor Relations.

Operator

Thank you. You may begin.

Speaker 1

Thank you, operator. Before we begin, I would like to inform you that comments and responses to your questions During today's call reflect management's views as of today, November 13, 2023 only and will include forward looking statements and opinion statements, including predictions, estimates, plans, expectations and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. The risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the U. S.

Speaker 1

Securities and Exchange Commission. Our SEC filings can be found on our website or on the SEC's website. Investors are cautioned not to place undue reliance on forward looking statements. We disclaim any obligation to update or revise these forward looking statements. We will also discuss certain non GAAP financial measures.

Speaker 1

Disclosures regarding these non GAAP financial measures, including reconciliations With the most comparable GAAP measures can be found in the press release. Please note that this conference call will be available for audio replay on our website atpulsebiosciences.com in the News and Events section on our Investor Relations page. With that, I would now like to turn the call over to President and Chief Executive Officer, Kevin Danahee.

Speaker 2

Thank you, Tripp. Good afternoon, everyone, and thank you all for joining us. On today's call, I will be joined by Darren Uecker, Chief Technology Officer and Director Mitch Levinson, Chief Strategy Officer and Mike Koffler, Vice President of Finance. Today, I will start by discussing our progress advancing our Top corporate priority. Then I will hand the call over to Darren Uecker to detail our cardiac device development achievements.

Speaker 2

Mitch Levinson will then describe our Extra Cardiac business development progress and then Mike Koffler will review the Q3 financial results Before I conclude and open the call for a question and answer session, it was a highly productive Q3 for Pulse Biosciences. In the lab, our CellFX NSPFA technology continues to demonstrate the potential to revolutionize the treatment of atrial fibrillation. In the clinic, CellFX NSPFA is demonstrating the ability to safely and effectively treat benign thyroid nodules. And at the podium, we are pleased to be seeing increased external validation of our technology and presentations from KOLs at various scientific meetings. On the business front, we are excited to have appointed renowned cardiac surgeon, Doctor.

Speaker 2

Nivad as our Chief Science Officer, Cardiac Surgery. Altogether, we've done the work in the lab and it has confirmed our value propositions for CellFX and SPFA. As we share these preclinical results, awareness of the benefit of CellFX NSPFA is growing and attracting industry leaders from across the globe who see the positive impact of their engagement and want to be involved with advancing the technology as quick as possible to deliver improved clinical outcomes to their patients as well as many others. Our primary focus is on developing a cardiac ablation catheter and a surgical ablation clamp, Both utilizing CellFX NSPFA for the treatment of atrial fibrillation or AF. The clamp will be used during open or minimally invasive heart surgery cardiac surgeon and the catheter will be navigated into the heart using standard minimally invasive catheter techniques through large blood vessels by electrophysiologist Importantly, we remain on track with the development of both the clamp and the catheter.

Speaker 2

While we previously guided that our milestones would occur in the first half of twenty twenty four, with the excellent progress to date, we now believe that they will occur by the end of the first Quarter 2024. Our preclinical testing results have validated our confidence in our cardiac surgical plan As we prepare to file a 510 submission to the FDA by the end of the Q1 2024 and to begin the clinical feasibility study For our cardiac ablation catheter also by the end of the Q1 in 2024. As a reminder, Globally, over 1,200,000 catheter and surgical ablations are performed annually, and this is expected to grow by more than 10% year over year. Still, there is a significant runway of adoption for both surgical and catheter techniques because of the safety and efficacy limitations of the current technology. ALKS biosciences has now demonstrated preclinically with validation by doctors in the lab, the technological advancements needed to accelerate adoption of both the CLAMP and the catheter ablation procedures with our novel proprietary CellFX NSPFA technology.

Speaker 2

This past quarter, we saw a significant extra validation of our novel CellFX proprietary NSPFA technology from predominant cardiac physicians, including Doctor. Usen Siddiqui and Doctor. Nivad, along with leading thyroid surgeons, Doctor. Stefanos Fiatsa and Doctor. Ralph Trefano.

Speaker 2

We are thrilled that at the Global EP Summit in September, Doctor. Siddiqui shows our CellFX NSPFA circumferential catheter system to highlight Pulse Biosciences' highly differentiated and advanced solution for electrophysiologists. In addition to our cardiac ablation catheter validation, I am pleased that Doctor. Spiata and Doctor. Trefano presented 2 posters at the American Thyroid Association Annual meeting detailing the early results of our clinical study for the treatment of benign thyroid nodules.

Speaker 2

Specifically, Doctor. Spiata Highlighted his participation in our 1st in human surgical procedures and observations of complete ablations of the cellular tissue Without evidence of thermal necrosis or damage to non cellular structures, Doctor. Ralph Trefano found the results benign thyroid nodules. This further validates our belief that CellFX and SPFA is a platform technology that will make a significant impact On patient care, as an additional point of external validation we received in the quarter, we have had multiple surgeons volunteering to join our studies With the purpose of advancing CellFX NSPFA and our novel endofractors in the areas where they are well respected, We view this positive reception from the medical leaders as confirmation that our CellFX NSPFA technology can have a significant clinical impact in cardiology. We are also encouraged by recent comments and earnings conference calls from companies in the cardiac surgery market and industry analysts As to the size and growth of the cardiac ablation market, and we believe our highly differentiated solution can capture a large portion of this expanding opportunity.

Speaker 2

Doctor. Add's quote says what we all believe that CellFX NSPFA has the potential to not only replace all other energy modalities In cardiac ablation, including radiofrequency and cryo, but due to the speed, safety and ablation performance of the system, it has the Potential to significantly expand the number of patients we treat in cardiac surgery. As awareness of our novel technology spreads throughout the industry, We are also incredibly excited to have Doctor. Niv Ad joining our team as Chief Science Officer, Cardiac Surgery. Doctor.

Speaker 2

Ad is extremely well respected cardiothoracic surgeon and will aid us in bringing CellFX NSPFA from the lab To the clinic with his years of clinical and leadership roles in cardiothoracic surgery. Doctor. Add brings unparalleled academic experience Helping to launch new medical technologies, which we believe complement very well the clinical experience of our Chief Medical Officer for Cardiac Surgery, Doctor. Gann Dunnington. Doctor.

Speaker 2

Ad's experience paired with Doctor. Dunnington's industry leading minimally invasive approach Further validates our CellFX NSPFA technology and overall mission to further improve the life of patients and physicians. Overall, awareness of our preclinical and clinical achievements is leading to external interest in the opportunity to further develop and eventually commercialize our CellFX These opportunities are only being considered if they align with our business goals To create value by accelerating our timelines to market and facilitating health innovation that has the potential to significantly improve the quality of life for patients. I will now hand the call over to Darren to provide updates for our cardiac device development and preclinical performance.

Speaker 3

Thank you, Kevin. We are making significant progress advancing our feasibility and preclinical studies for cardiac ablation clamp and catheter programs. Our progress is garnering the attention of KOLs who are actively reaching out to participate in our CellFX and SPFA studies. We are excited to leverage this shared interest to continue our momentum into the clinic and view this external interest as a testament to the immense potential of CellFX NSPFA and future cardiac ablation market adoption. As a reminder, our core technology nanosecond pulse field ablation Integrated into our CellFX platform is fundamentally different from standard PFA.

Speaker 3

We believe CellFX and PFA can deliver safer and more effective ablation of cardiac tissue. CellFX controls the delivery of nanosecond duration pulses of electrical energy, That's pulse durations under a millionth of a second to non thermally cause cells to go through a natural regulated cell death process. The CellFX NSPF A energy pulses are uniquely able to penetrate the cell membrane and alter the function of cell organelles, Leading to regulated cell death rather than immediately destroying cells, like other energy modalities such as standard PFA, Brio, which uses extreme cold or radiofrequency ablation, which uses extreme heat. The penetration alters does not destroy Internal cellular function while sparing non cellular tissue and leading to a more elegant, precise regulated cell death. This differs from current Microsecond ablation technologies, where physicians may use suboptimal parameters to protect surrounding cellular tissues, And as a result, sacrifice efficacy for safety.

Speaker 3

Our early data shows that the CellFX NSPFA non thermal mechanism of action As opposed to thermal can lead to beneficial outcomes in the clinical setting where physicians do not need to trade safety for efficacy. An additional benefit of the CellFX NSPFA mechanism of action is that it requires significantly less energy per unit volume Because CellFX NSPF A generally needs less energy per pulse to ablate tissue, we deliver our treatments through electrodes that have a larger footprint, Due to the patient value for time sensitivity in surgery, Particularly in cases where the patient is under general anesthesia, reducing even seconds of treatment time can greatly reduce the risk for a patient During and post procedure, in present time, we believe our preclinical studies and accelerating first in human surgical procedures Indicate Pulse Biosciences CellFX NSPFA devices provide a new and higher standard of safety and efficacy. Our competitive advantage is protected by 148 issued patents globally and 103 pending patent applications worldwide, With more on the way each quarter. In the lab, we consistently see the clear advantages in our CellFX NSPF In 1.25 seconds, independent of tissue type or thickness, which is roughly a 20th of the time it takes for radiofrequency ablation.

Speaker 3

The results from our preclinical work support our hypothesis that CellFX NSPSA ablation can produce highly differentiated And market leading safety and efficacy compared to traditional thermal modalities, including cryosurgery and radiofrequency ablation. In addition to the speed and consistency of the ablations created by our CellFX NSPF A cardiac clamp, The preclinical data to date supports our intention that CellFX NSPFA has safety benefits over the extreme heat or cold of thermal modalities. Due to its non thermal mechanism of action and the lack of any concern regarding thermal spread that could lead to damage of collateral tissue, which is a concern and has been reported with thermal modalities. With the preclinical data we've generated to date, we retain our belief that the CellFX NSPF A Cardiac Clamp provides a significant improvement over current thermal modalities and tracks with our expectations to file a 510 submission To the FDA by the end of the Q1 of 2024. Doctor.

Speaker 3

Niv Ad, who joined our team in late October, is bolstering our development and clinical programs by bringing many years of in the surgical treatment of atrial fibrillation and minimally invasive heart surgery to the Pulse Biosciences team. To date, he has published over 200 peer reviewed research articles, all while being responsible We're in excess of 3,000 minuteimally invasive cardiac surgical procedures and we are grateful he has agreed to join our team and to apply his experience and expertise As we move towards the clinic and look to drive adoption of CellFX and SPFA technology in cardiac surgery clinics. Specifically, his academic expertise will play a large role in our future trials focused on optimizing study design and parameters. Doctor. Nivad's background is extremely complementary to that of Doctor.

Speaker 3

Gan Dunnington, our Chief Medical Officer of Cardiac Surgery And is innovative approach in the clinical setting. We are very fortunate to have 2 of the preeminent surgeons in the field on our team as we advance our product development and clinical studies. Now onto the progress we have made on our CellFX NSPFA cardiac ablation catheter. This past quarter, we achieved and accelerated key internal milestones on the path to first in human studies, Completing important preclinical safety and performance studies as well as the required testing of the CellFX System and circumferential catheter. As a reminder, we designed our catheter to create a precisely focused Circumferential ablation targeted for pulmonary vein isolation in a single five second application with CellFX and SPFA Without the need for repeated repositioning and treating, which can be required with other technologies.

Speaker 3

We believe this capability will lead to a procedure that Easier to perform with significantly reduced procedure times. In September, Doctor. Usman Siddiqui detailed the benefits Our CellFX NSPFA circumferential catheter at the Global EP Summit 2023 in Cleveland, Ohio. The presentation outlined the differentiated nature of our circumferential catheter, including performing consistent circumferential ablation

Speaker 4

of

Speaker 3

targeted pulmonary veins in a single application in approximately 5 seconds with CellFX and SPFA. We look forward to our 1st in human feasibility study with our novel CellFX NSPFA circumferential catheter Integrated with a navigation and mapping visualization system. With the preclinical studies and other testing close to completion And the required regulatory approvals in process, we remain confident that this important milestone will occur by the end of the Q1 2024. As a final point, it's important to note that while our cardiac clamp and cardiac Cathar both represent significant product opportunities in surgery and electrophysiology respectively. They also represent a validation of CellFX NSPFA in cardiac ablation.

Speaker 3

And we believe will be the first of a portfolio of CellFX NSPFA devices In cardiac ablation, as we deliver on our goals to provide comprehensive solutions for the treatment of AF and significantly improve the lives of patients. I'll now turn to Mitch to outline the additional validation we received recently regarding our work to understand the applications of CellFX NSPFA across the human body. Mitch?

Speaker 4

Thanks, Darren. The Pulse team continues to explore and develop new clinical areas where our novel technology can have a large Positive impact on human health. We continue to explore potential new opportunities while prioritizing cardiac ablation and we're allocating a large majority of our resources to advancing the treatment of AF. As we reported in August, We started our clinical feasibility study for treating benign thyroid tumors or nodules in the Q2 of this year. This study represents the first time our CellFX NSPF A energy was used inside the human body.

Speaker 4

We intended to assess patient tolerance, safety and tissue response. In the fibroid study, Benign tumors were treated with our novel cell effects NSPF A percutaneous electrode using ultrasound visualization. Patients were kept conscious under local anesthesia and with the intent to assess tissue response at 90, 180 and 360 day increments following the procedure. The 90 day evaluation has now been completed One of the problems with thermal ablation modalities like RF or microwave is that the treated volume shrinks down into a ball of fibrotic tissue that can persist Early results from our study were presented At the American Thyroid Association Annual Meeting in Washington, D. C.

Speaker 4

In late September, our principal investigator, Doctor. Stefanos Pietia, presented 2 posters alongside Doctor. Ralph DeFano to their colleagues about histological and ultrasound observations immediately post treatment. The histological assessment findings exemplify some of the key advantages of CellFX NSPFA technology, including cellular tissue cell activity, well defined ablation zone margins and the absence of thermally induced necrosis. Both presenting physicians felt that findings provide an early indication that CellFX NSPFA may be safe And effective for the treatment of benign thyroid nodules.

Speaker 4

The reception among the clinical community is uniformly positive. It's creating enthusiasm for what many are now expecting to be the next breakthrough in the treatment of the 9th thyroid disease. Based on these very encouraging early findings, we've decided to expand this study to enroll additional subjects. Treatment of benign thyroid nodules is a large and underserved market both in the U. S.

Speaker 4

And abroad. Almost 3,000,000 patients worldwide develop a palpable thyroid nodule each year without being treated. There are about 800,000 thyroidectomies each year worldwide and the vast majority of these because of their inherent risks and scarring. We believe the benefits of CellFX technology will improve Clinical outcomes for many thyroid disease patients can be much more readily adopted by physicians, increasing the number of patients who can be treated. With an optimal clinical solution, we believe the treatment of benign thyroid nodules represents a potential market of well over $1,000,000,000 per year.

Speaker 4

It also will serve as the first foray of CellFX technology into the treatment of solid tumors, potentially opening other critical markets. An FDA cleared product will allow us to validate our value proposition in the important U. S. Market. So we're preparing to file a 510 submission with the FDA for our proprietary CellFX NSPFAA percutaneous electrode by the end of the Q1 2024.

Speaker 4

We look forward to sharing updates of our continued progress over the coming months. Now, I'll pass the call over to Mike Koffler for an update on our financial results. Thank you, Mitch.

Speaker 5

Moving down the income statement, I'll focus my comments on our non GAAP results. I encourage you to review today's earnings release for a detailed reconciliation of non GAAP measures to the most comparable GAAP measures. In the Q3 of 2023, we reduced non GAAP total costs and expenses by $7,600,000 The $9,200,000 compared to $16,800,000 in the prior year period. The decrease in total cost and expenses is driven by the prior headcount reduction in restructuring And the $7,200,000 inventory reserve related to the dermatology business in the Q3 of 2022, partially offset by an increase of $2,300,000 in Research and development expenses to support advancement of our CellFX NSPF A Cardiology Devices. Non GAAP net loss for the quarter ended September 30, 2023 was $8,500,000 compared to $16,800,000 for the quarter ended September 30, Cash, cash equivalents and investments totaled $50,400,000 as of September 30, 2023, compared to $58,700,000 as of June 30, 2023.

Speaker 5

Cash used in the Q3 of 2023 totaled $8,700,000 It was reduced compared to $10,600,000 used in the same period in the prior year and $10,000,000 used in the Q2 of 2023. We expect cash usage of approximately $8,000,000 in the Q4 of 2023. I will now turn the call back over to Kevin.

Speaker 2

Thank you, Mike. Now I will provide some closing remarks. Host Biosciences is receiving significant support from Highly esteemed physicians in the field of cardiology who have been impressed with our CellFX NSPFA preclinical study results. We are excited to further build out our medical network as we deliver our novel cardiac ablation devices to market. 2 of the top cardiothoracic surgeons in the world, Doctor.

Speaker 2

Nivad and Doctor. Dan Dunnington committed to joining our leadership team after firsthand experience We look forward to providing additional updates on the next call. Joining me today for a question and answer session Our Executive Chairman of the Board, Robert Duggan Chief Technology Officer and Director, Darren Uecker Chief Strategy Officer, Mitch Levinson And Vice President of Finance, Mike Koffler. Operator, please open the call for questions.

Operator

Thank you. Ladies and gentlemen, at this time, we will be conducting a question and answer I'd like to pass it to Philip Taylor for some pre submitted questions first.

Speaker 1

Thank you, operator. In your press release, you noted the cardiac milestones between December and end of Q1, twenty twenty four. Previously, you stated in the first half of twenty twenty four, which I assume is Q1 or Q2. Does this imply that these developments have gone better than planned and are expected to happen soon.

Speaker 6

Yes. Thanks, Trip. This is Darren. I'll answer that question. So that's an excellent question.

Speaker 6

For both the cardiac clamp 510 and the 1st in human feasibility study for the catheter, there are a number of tasks that have to be completed, including all the preclinical testing, device verification testing and regulatory safety testing, just to name a few. And for the catheter, there's an step, which is a regulatory step to have this study approved. And all of these tasks carry some schedule risk associated with them. So as we stated in the prepared remarks, we're encouraged by our progress. And while there are still a number of these items that are outstanding and need to be finished Prior to either of these milestones being completed, as of today, we believe they will occur sometime between the beginning of December and the end of Q1 1, 2024.

Speaker 6

And I'd further add that we have site approval. The site clinical

Speaker 1

All right. Thank you, Darren. Here's the next one. I understand from your remarks why NSPFA PFA is potentially superior to PFA. Are you aware of any other companies using NSPFA in cardiac ablation besides Pulse Biosciences?

Speaker 1

And if not, why do you think that is?

Speaker 6

Yes. Thanks, Tripp. I'll take that one again. This is Darren. Thanks for I'm not aware of any other companies utilizing NSPFA or specifically pulse fields with pulse duration is less than a microsecond in cardiac ablation.

Speaker 6

Of course, there are several companies that are using pulses in the tens to So there are 2 important things that I think one should consider when thinking about Why we're not aware of other companies using NSPFA? So the first is, Pulse Biosciences was founded on a large intellectual property and patent portfolio that was acquired from universities that were at the forefront of research and development of NSPFA. These patents include core nanosecond pulse field technology as well as the application of NSPF A to cardiac ablation. So we believe strongly that this IP is very strong. It's likely something that One would consider if they were going to get into the use of NSPFA in cardiac surgery or in any other field.

Speaker 6

And I think it's also fair to say that, pulsing in the micro as other companies are doing has been around for a very long time. And so that technology is readily available and it's likely That there's less concern about any competitive intellectual property for pulsing in that domain. 2nd, We also know having developed this technology over many years that it requires unique engineering capabilities with regard to the pulse technology and end effector Development and I'm not aware of any other company that has developed these kinds of capabilities. So I think those are just a couple of reasons why we think it's Likely that there are no other companies in cardiac that are using NSPFA.

Speaker 7

Yes. If you might, if you could add to that, the very tight knit Pulse Bioscience team As roughly a decade of experience in CellFX controlled nanosecond pulse field ablation. If you call it a juggernaut, that would be an appropriate description. On top of that, we have our intellectual property, patent base and A very dynamic present time IP activities going pellet to the metal. So we're pretty excited about the position we're in.

Speaker 7

We respect the time it's taken to arrive at this capacity and the opportunity now looks brighter than it ever has in the past.

Speaker 1

Thank you both. Here's one for Kevin. Why is Pulse pursuing surgical cardiac ablation when the market is relatively small compared to catheter based cardiac ablation?

Speaker 8

Thanks, Chip. This is really a great question. We see this as a huge opportunity in cardiac surgical ablation. There are over a 1000000 Open Heart procedures done every year worldwide. And then NIH says it's up to 2,000,000.

Speaker 8

So it's probably somewhere between those two numbers. And what we see is our world class physicians, Doctor. Gann, Donington, Doctor. Nivad, They joined our team because they recognize the quality of our lesions and what we could create with our NSPFA energy in this game changing locations in cardiac surgery and they look at this as an opportunity to really impact that larger number And that's a possibility for us in the future. And that's why we're so excited about it.

Speaker 8

And we believe that the CellFX NSPFA can accelerate surgeon adoption and Finally bridge that gap between safety and efficacy and reduce the OR time significantly. So we see bright opportunity for us in the future in this space and we think this market is ever evolving.

Speaker 6

Darren? Yes. I'll just add a little bit to that. Thanks, Kevin. So today, it's estimated just to give you a couple more numbers.

Speaker 6

It's estimated that Of the patients undergoing open heart surgery globally on an annual basis, over 300,000 are potential candidates for surgical ablation. So that's a market opportunity of north of $1,000,000,000 The interesting number is really that there's only about 20% of those patients are being treated for their AF today. So according to our Chief Medical Officer for Cardiac Surgery, Doctor. Dunnington, this relatively low penetration rate has everything to do with The current technologies that are being used and as we've noted before these are thermal modalities like radiofrequency ablation and cryoablation. These devices have been available for decades, but still have relatively low adoption and penetration.

Speaker 6

So clearly, there are challenges with their use. And it's Doctor. Dunnington's belief and our belief that the speed, lesion quality and inherent safety of CellFX NSPF A powered cardiac ablation devices, Starting with our CellFX NSPF A cardiac clamp that will enable a simpler, faster, safer and more efficacious procedure It has the potential to both expand adoption and increase procedure growth in this market. It's also true that The catheter market is substantially larger than the surgical market today, but we view this as a single very large opportunity for the treatment of AF Where patients will be treated by the EPs, the cardiac surgeons or both. And as the technology and devices evolve, we think it will shift more and more to a hybrid approach, which is why we're focused on providing our technology, the CellFX NSPFA devices to both of these groups.

Speaker 6

And it's our belief that we'll be able to do this and leverage not only leverage those channels, but look for opportunities to create unique Synergistic treatment opportunities.

Speaker 1

But for the thyroid market, Mitch, do you want to take this one?

Speaker 9

Yes, sure, Tripp. We've now treated 21 subjects with our benign thyroid nodules with our percutaneous electrode And the early results are just they're just super encouraging. And like we said earlier, these clinical results, the safety, the prospect of Clearing the entire nodule without leaving that fibrotic ball, all of that in our opinion makes our solution just It's just a lot better than surgery or any of the current ablation options. And the thyroid market itself, it's Peer reviewed articles estimate about 1 in a 1000 people worldwide, that's millions of people each year suffer from Symptomatic thyroid nodules and most of these go untreated. We welcome all of them to the world of patient and physician friendly treatment And that's what we're shooting for with CellFX NSPF8.

Speaker 9

About 800,000 thyroidectomies done each year. That's where they're getting half or their entire thyroid removed. But most of these patients choose To just live with their condition instead of having surgery. For some people the cure might be worse than the disease. We think that Not only are we going to be able to address a lot of these thyroidectomy patients, but because of our better Safety, the efficacy and the healing profile, we think we can reach a good number of those 8,000,000 watchful waiting patients.

Speaker 9

And we also think our procedure is going to be just really teachable and reproducible. That's going to allow us to enter the market and grow this new market quickly. And not only do we have There's a large opportunity for thyroid nodules, but this is also going to open the opportunity for a bunch of other applications, including Treating other types of tumors.

Speaker 1

All right. That's it for our submitted questions. Operator, we can open up the line.

Operator

Our first question comes from the line of Robert Loveren with Medical Hope Productions. Please proceed with your question.

Speaker 2

Yes. It's a very interesting that you all the stuff that you talked about here. We've got a couple of questions here. First of all, Safer and faster. And I guess it's what I'm told is easier To do basically for initial electrophysiologists to do it, they're just starting out.

Speaker 2

In addition, have you sort of thought about an advisory board, Scientific Advisory Board? And then this papers business, this, the those papers up on your website, so we can read some of those papers. And then what about the company that you're in Business with, they're developing, is that part of the process? I forgot the name of the company, but Hello?

Speaker 6

Yes. Hey, Bob, this is Darren. I'll tackle some of these. There looks I think you have kind of 4 questions here. So let me see if I can go in order.

Speaker 6

Yes. So the first one you mentioned is Safety and speed. And so I think this is a general capability of NSPFA, Both on the catheter side and on the clamp side. And by safety, generally what we mean by that is, Our system or this technology is completely non thermal. So a lot of the safety issues that you see In ablation, in cardiac ablation in particular have to do with the fact that thermal modalities are used.

Speaker 6

When you're using a thermal model

Speaker 2

Reversible, irreversible, reversible, this is reversible. Nanopulse is the only one that's reversible.

Speaker 6

Yes. So there is a reversible component to it, but the safety really has to do largely with The fact that we don't have any kind of thermal spread, and that thermal spread is something that can when you're doing cardiac ablations, can reach the esophagus And nerves and other critical structures. And of course, we're non thermal. So we don't have that aspect. And on the speed side, Speed has been demonstrated by us and others.

Speaker 6

It's a very fast technology In terms of the speed required to do the ablation and substantially faster, many times faster than what you see With radiofrequency ablation or cryosurgery and really speed isn't just a convenience, it's also a safety component. So The faster that you can perform these procedures, the sooner the patient gets out of anesthesia and back on their feet. So I think there's A safety component that is also has to do with the speed. You mentioned or a question about would we have an advisory board? We're starting to build that team.

Speaker 6

So you've heard about Doctor. Dunnington and Doctor. Nivad and some of the other EPs that we're doing work with. And so we'll certainly over time build what we believe will be a top notch Advisory Board, likely both on the catheter side and on the cardiac surgery side. And that will come in time As these things evolve, you asked about papers and getting the papers posted on our website, which We very often do sometimes we have to make sure that whatever the society or scientific meeting that That publication exists and is okay with us publishing it on our website.

Speaker 6

But when they are, and

Operator

And we try to make that happen every time.

Speaker 6

We certainly will do that. And lastly, I think you're referring to a partnership that we have ongoing with our catheter To deliver mapping and navigation technology and we view mapping and navigation as kind of Part of the overall system that needs to be delivered into the EP to do these ablations with catheters. And so our first in human activity, we will have a mapping and navigation partner along with us. We've integrated our technologies together to provide a together to provide a really physician friendly and what ends up being a patient friendly solution. So I think I got through the

Operator

Our next question comes from the line of Jason Smith, a private investor. Please proceed with your question.

Speaker 4

Hey, guys. Congratulations on making fantastic progress on bringing NSPF8 to patients. It's just been awesome to watch the evolution of the progress taking place. My question is whether the patents that were originally held by Feripulse or other standard PFA patent holders is broad enough to potentially cause Patent infringements by Pulse Biosciences.

Speaker 6

Yes. Thanks, Jason. I wouldn't want to Comments at all on patents by any other patent holders Specifically, we spend a lot of our time and energy and we invest a lot in our patent portfolio. We invest a lot in our product design and we invest a lot in doing everything we can to ensure that any of these markets Are open to our products. And so I think that's the best way for me to handle that.

Speaker 4

Okay. Fair enough. Jason, this

Speaker 7

is Bob Bergin. Just the process of vetting the patents is inclusive of validation Of its appropriateness, that doesn't mean after the fact one can't bring that into question, but it's no small task To get through the patent filter, so with 188, 148 in hand, 103 pending And a very rapid set of developments that are application specific to CellFX And the nanosecond pulse, we're in a pretty good we think we're in a pretty good position. Time will tell, but we do not consider our business to have a significant or serious patent risk at all. We think we're very strong in that area.

Speaker 4

Perfect. Well, thanks for putting my mind at ease, Bob. I appreciate it. Yes.

Speaker 7

The biggest factor is when you touch the patient, is it safe? Patients are really reluctant to Go from a current condition to a surgical procedure, if it's not safe, then it becomes, is it friendly? But If that if those two questions are answered positively for the patient, then equally important, if not more important, is it physician friendly. And that's why you see 8,000 procedures today done robotically when we used to celebrate back in the day when we started our company in Goleta, we have one procedure done every other week. The times change, but safety, friendliness both the family is a true ally to the patient And to the physician and therefore is it scalable.

Speaker 7

So when you have coming into the business, They are. The judgments that they're making, it's not to be underestimated how positive that is. So In this case, we've treated over 7,000 lesions. Now we're treating some very specific areas of the heart. And once that's done, you'll see acceleration of our activities.

Speaker 7

And now we await those opportunities and The timing is coming close. I can say that to when that will happen.

Speaker 2

Fantastic. Well, keep up the

Speaker 4

good work you guys. Very much appreciated.

Operator

There are no other questions in the queue. I'd like to hand the call back to management for closing remarks.

Speaker 8

Yes. Thank One of the things I just want to close is to say, the past quarter has been outstanding for us and we've done the work in the lab, We've done the work in the clinic and we've done the work on the engineering side and we're extremely excited about where we're going with NSPFA, CellFX And we're really excited to bring these results to you. So stay tuned, keep watching us. We are really passionate about what we're doing. We think we're highly differentiated.

Speaker 8

We have a robust IP portfolio strategy. It starts with our energy. It goes from the energy to the console, from the console to the end of factors, from the end of factors to the patient. And we think that we've done an amazing job there. So Continue to ask questions, stay engaged and we will continue to communicate.

Speaker 8

And we thank you for all of you for joining the call.

Operator

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.

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Key Takeaways

  • Pulse Biosciences remains on track to achieve its two key cardiac milestones by the end of Q1 2024: filing a 510(k) for its surgical ablation clamp and initiating the first-in-human feasibility study of its circumferential ablation catheter.
  • Its proprietary CellFX NSPFA non-thermal mechanism delivers rapid (~1.25 s) and precise regulated cell death while sparing non-cellular tissue, positioning it as a safer and more effective alternative to radiofrequency and cryoablation.
  • Early clinical data in benign thyroid nodule treatment demonstrated complete ablation without thermal necrosis, prompting an expansion of the study into a global market projected to exceed $1 billion annually.
  • Pulse has secured strong external validation from leading KOLs—Drs. Usman Siddiqui, Nivad Ad, Stefanos Spiata and Ralph Trefano—and appointed Dr. Nivad Ad as Chief Science Officer, Cardiac Surgery, underscoring broad physician support.
  • In Q3, non-GAAP net loss narrowed to $8.5 million (from $16.8 million a year ago), with cash, equivalents and investments at $50.4 million and an anticipated Q4 cash burn of approximately $8 million.
A.I. generated. May contain errors.
Earnings Conference Call
Pulse Biosciences Q3 2023
00:00 / 00:00