Thank you for standing by. Hello, and welcome to the Pulse Biosciences Second Quarter 2025 Earnings Conference Call. Please note that this call is being recorded. I would now like to hand the call over to Trip Taylor. Sir, please go ahead.

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, August 12, 2025, 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. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the U.S. Securities and Exchange Commission. Our SEC filings can be found on our website or 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. 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 at pulsebiosciences.com in the News and Events section on our Investor Relations page. With that, I would now like to turn the call over to Co-Chair of the Board and Chief Executive Officer, Paul LaViolette.

President, CEO, Principal Executive Officer, Principal Financial Officer & Co-Chairman of the Board Good afternoon, and thank you for joining. Today, I'm excited to share updates on the progress Pulse Biosciences has made in each of our 3 market development programs. I will then turn the call over to our CFO, Jon Skinner, who will review the second quarter 2025 financial results, and we will then be joined by Bob Duggan, Co-Chair of the Board for a question-and-answer session. Pulse Biosciences has developed a next-generation energy modality, Nanosecond Pulsed-Field Ablation technology or Nano or nsPFA technology that delivers therapeutic ablations applicable to numerous clinical targets by generating much shorter pulse durations measured in the billions of seconds. nsPFA produces a fundamentally differentiated mechanism of action that delivers deep ablations in short delivery times, all while delivering low energy levels to tissue, which reduces the risk of thermal damage and other complicating factors reported in conventional or microsecond PFA as well as with Thermal energies. We are progressing as expected on the priorities we established at the beginning of the year. We have expanded pilot utilization of the percutaneous electrodes for soft tissue ablation initially in benign thyroid disease. We have also submitted our nsPFA 360 catheter IDE to treat atrial fibrillation. So in addition to our previously submitted IDE for the pivotal trial of our cardiac surgical clamp, we are advancing toward our regulatory goals with 2 IDEs under review. In parallel, we continue to treat additional patients with our cardiac devices in their respective feasibility studies in Europe, which continue to generate outstanding clinical results. These achievements further reinforce the advantages we've seen of nsPFA and by continuing to generate these early clinical results, we are increasing awareness of the technology among clinicians who may choose to support Pulse…

Thank you, Paul. Now I will highlight our GAAP and non-GAAP financial results before providing commentary on future cash use and revenue recognition. I encourage listeners to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the second quarter of 2025, total GAAP costs and expenses increased by $8.5 million to $20.3 million compared to $11.7 million in the prior year period. The increase in GAAP cost and expenses was primarily driven by an increase in administrative expenses related to the expanding organization to support advancement of our nsPFA device clinical trials and commercialization, along with other compensation and noncash stock-based compensation, which was $5.2 million in the second quarter of 2025 compared to $2.1 million in the prior year period. To remind everyone, non-GAAP costs and expenses exclude stock-based compensation and depreciation and amortization. Total non- GAAP costs and expenses in the second quarter of 2025 increased by $5.4 million to $14.8 million compared to $9.4 million in the prior year period. GAAP net loss in the second quarter of 2025 was $19.2 million compared to $11.4 million in the prior year period. Non-GAAP net loss in the second quarter of 2025 was $13.7 million compared to $9 million in the prior year period. As of June 30, 2025, cash and cash equivalents totaled $106.3 million compared to $26.2 million as of June 30, 2024. Cash used in operating activities during the second quarter of 2025 was $12.8 million compared to $8.4 million used in the prior year period and $13.5 million in Q1 of 2025. We ended the quarter with $106.3 million in cash, which was a decrease of $12.9 million versus Q1 of 2025. Cash used this quarter was a result of disciplined expense management and aligned with…

[Operator Instructions] Our first question comes from the line of Suraj Kalia from Oppenheimer.

Gentleman, congrats on all the progress. Paul, on thyroid ablation, and maybe I'm jumping the gun here. Could you share some patient baseline characteristics in the field that are driving or causing a pull-through for nsPFA?

President, CEO, Principal Executive Officer, Principal Financial Officer & Co-Chairman of the Board Sure. Thanks, Suraj. So first thing to think about is these patients are symptomatic. So the -- if you think about the base case for thyroid disease and the growth of benign nodules, actually, the prevalence of nodules across the population is probably 50% or greater. That increases with age. But a lot of patients have very small nodule growth. And so for those patients for whom nodules become problematic, these are growing, and that growth can be stimulated by changes in hormonal levels post-pregnancy or immune disease. And those patients undergo a growth that become symptomatic. And so it is driving pressure in the neck area that could affect and literally encroach upon the trachea, the esophagus and alter thyroid function. And it also just becomes unsightly as a growth on the neck and it can become uncomfortable with compressive symptoms, if you will, pressuring inward and disruption of sleep as an example, based on the fact that a patient would have a growth on their neck. So patients seek therapy. And today, if you think about the, I'd say, the expensive real estate of the thyroid gland, it is surrounded by critical structures. It is difficult to operate on. It is surrounded by nerves such as the recurrent laryngeal nerve that controls the vocal cord. So it's a very delicate space within which to try to manage growth. And despite the fact that this growth is benign, the most common outcome for these patients is to have their thyroid removed. This is not a late-stage disease for aged population. This is commonly a younger patient, 60% female. And so the option of having thyroid removal losing the gland that produces vital hormones that control blood…

Fair enough. Paul, just I'll quickly have my other questions, and I'll let others hop in queue. Paul, catheter ablation is expectation still for a single-arm study and in the surgical AF ablation IDE, would the label sot be cardiac ablation or soft tissue ablation?

President, CEO, Principal Executive Officer, Principal Financial Officer & Co-Chairman of the Board Thank you, Suraj. It would be a single arm study in EP. And yes, in the clamp because we are endeavoring to not only perform an IDE, but also submit that IDE with a Class III designation for PMA, we would end up with a cardiac indication, not soft tissue. So that's the goal. To take soft tissue as a base case, which in many cases, let's say, for an interventional radiologists could provide them an opportunity to deploy, let's say, the percutaneous electrode in multiple organ targets. But in the case of the cardiac surgical indication, we are pursuing a direct cardiac indication with the PMA.

Our next question comes from the line of Josh Jennings from TD Cowen.

Congratulations on the continued progress. I was hoping Paul to just follow up, make sure I heard you correctly that your -- Pulse is collaborating with the market leader in cardiac ablation and you report on some partnership progress later in the year. I want to make sure I heard that correctly and maybe see if there's any other details you can share today.

President, CEO, Principal Executive Officer, Principal Financial Officer & Co-Chairman of the Board Thank you, Josh. No additional details to share today other than reinforcing our strategy with a number of clinical indications and markets to pursue, we're being very selective about those with which we can pursue with capital efficiency, a direct business model and those where the market dynamics may be competitive enough and costly enough that it makes more sense for us to pursue with the partnership. We have determined as it relates to catheter-based EP that a partnership is most appropriate. We're in partnership discussions. We believe we'll have a partnership available for our -- certainly for our commercial time line and possibly in advance of that during our clinical stage.

And I know we've talked about this earlier in 2Q, but just about the compatibility with mapping systems, Abbott's [indiscernible] and Biosense Webster's CARTO 3, there is compatibility with the nsPFA platform. But how does that evolve from here? And are you -- any details you can share on the collaborations with both Abbott and Johnson & Johnson.

President, CEO, Principal Executive Officer, Principal Financial Officer & Co-Chairman of the Board Yes, Josh. And as you know, we have done cases and shown live cases in fact, throughout the course earlier this year starting at the Boston AFib conference and more recently at HRS in which we demonstrated that full compatibility in live cases with each of those 2 market-leading systems. I think it's safe to say that each of those systems has different levels of integration and the more one works with each of those partners, the tighter the integration can become, and so there are, I'll call it, simply off the shelf or out-of-the-box software integration capabilities. And then there are -- those that are more elaborate, more customized based on the specific rendering of an individual device on the mapping system. So they are both compatible and they're both suitable and over time they could -- each one could become more tightly integrated depending on the interest of each party in a potential collaboration.

Appreciate that. And maybe just lastly, we've talked historically about nsPFA and cardiac ablation potentially being a great solution if AFib ablation moved into ASCs and it looks like the potential could be sooner than later. Maybe just talk about the ASC opportunity and how your platform is positioned today and better positioned after the IDE trial under your belt?

President, CEO, Principal Executive Officer, Principal Financial Officer & Co-Chairman of the Board Yes, it's a great question, and we agree with that premise. So a couple of things. Number one, ASCs. If you just think about the benefit of being there, but also the limitations, you may have less desire or capability of using general anesthesia. And so a therapy that can both enable very rapid procedures and low neuromuscular stimulation from the Pulse electric field. Both of those factors would create a lot of benefit in the ASC. That would be, I think, a critical factor. When you think about overall procedure speed, if you will, patient throughput the ability to ablate effectively, quickly and have high patient turnover, lab turnover. We are seeing in our most recent cases in Europe as low as 45-minute skin-to-skin times, ablation times consistently below 10 minutes with operators that have just a little bit of case experience. So we think our system both on procedure workflow based on ablation effectiveness and based on anesthesia requirements could be very well suited for the ASC.

Our next question comes from the line of Anthony Petrone from Mizuho.

Begin with one on cardiac clamp and then follow-up with 360 cardiac catheter. And this is really about data that's being collected overseas for both product initiatives. And so you have the multi-site study for the first-in-human clinical trial for cardiac clamp, it's out of the Netherlands. But you're enrolling here the pivotal starting mid-25. So I'm just wondering, will the Netherlands data be published? And how will that kind of play in the PMA application for the clamp? And a similar question would be on cardiac catheter. You have a multisite study, I believe, in Prague, and half of the patients have been remapped and the data based on the filings is promising. So how will that data play into the IDE pivotal trial? And then I'll have a couple of P&L follow-up questions.

President, CEO, Principal Executive Officer, Principal Financial Officer & Co-Chairman of the Board Anthony, yes, thank you. Good question, and great to hear from you. Yes, we -- in both cases, having human data -- and clamp, as you know, patients end of about 40, obviously with the catheter over 100 now. So the more volume of human data, I think the more helpful that is with FDA. And so that is -- both those data sets are included in the respective IDE submissions. And of course, when you think about the threshold for IDE approval, you're really getting FDA to a point of determining that this device is safe to enter a clinical trial in the U.S. And so having dozens and dozens of well-tolerated, safe properly documented and in some cases, durably followed patients. That really does provide FDA, I think, with a very important checked box for the IDE. Of course, you can get an IDE without human data. And of course, you need other layers of data, benchtop testing and preclinical histology, things like that, that you cannot extract from human data. But the human data is collected, it is submitted in each of those 2. And I think it will be incrementally just positive for FDA as they move us toward IDE approval on both of those. In the case of clamp, for data publication, there is a meeting in October in Copenhagen, which is called the EACTS meeting. It is actually the European Society of Cardio-Thoracic Surgery (sic) [ European Association for Cardio-Thoracic Surgery ]. And we do expect to have additional data publications and case demonstrations at that meeting for the cardiac surgery clamp. So we are flowing data, if you will, in that direction, and we're continuing to advance our catheter data. Similarly, I don't have any near-term conferences to announce for data issue, but we are working on publishing our European feasibility data and that will, I think, look very good. So more to follow exactly on timing of publication, but we're certainly advancing the feasibility data to transparency, if you will, for both studies.

No, very helpful. And then just looking ahead, both PMA devices. On the clamp side, obviously, you have breakthrough designation and you're now enrolled in this TAP program. So just high level on both studies, will they be modular PMA submissions? That would be the first question. And being that you have breakthrough designation and now enrolled in TAP, how much quicker can clamp kind of get to market ahead of PFA? And then just quickly on P&L, just in the second half with both studies launching here, just directionally, the uptick in R&D. How should we be thinking about that?

President, CEO, Principal Executive Officer, Principal Financial Officer & Co-Chairman of the Board Yes. Thanks, Anthony. So yes, breakthrough designation, I think, is very helpful in a number of ways. And the TAP program, I would say, has been an excellent experience between our company and FDA, a lot of transparency, a lot of interactivity. There's no wasted time in sending questions and answers back and forth without clarity of intent. And I don't think there's any doubt if you just look at the data that the TAP program, in particular, is helpful on regulatory timing. So that's been very helpful. And then I'll just spill over into the modular question. Modularity in your submission really is independent of breakthrough designation. It's really the sponsor's choice, the company's choice as to how you submit. I personally having been associated with a couple of dozen PMA approvals. I would say modular makes sense basically every time. It allows the FDA to review components and spread them out over time. And I just think it's a much more workflow friendly process. And I'll just comment in particular because as an example, our console is basically shared between the clamp and the catheter. And so if you think about a manufacturing submission and both reviews taking place within the cardiovascular group of FDA, there will be real synergies in not only taking advantage of the basic benefits of modularity in submission but then having [ FDA ] module, the manufacturing module is an example for [indiscernible] submission. And then also to the other, you can imagine that the overall review time would be lower and questions that we might have received on the first review of a module, of course, would be answered prospectively on the second submission. So I think there are a lot of benefits to that. And with that, I'll maybe turn the call over to Jon to answer the P&L question.

Thanks for the question, Anthony, to highlight and address your point for R&D demand. We do expect that to increase throughout the back half of the year, as you highlighted, with the 2 clinical trials commencing for the IDEs of the cardiac catheter that will cause an uptick in our spend along with the associated headcount that will go along and support those trials. And so we don't expect an uptick in the back half of the year, and this goes hand in hand with the operating cash burn commentary that we provided, where we're at $13.5 million operating cash flow burn in Q1 and $12.8 million in Q2. We do expect that to tick up in the back half of the year as we again hire more heads to support those 2 IDEs and also the initial commercialization activities that will be working towards on the percutaneous electrode in the second half of the year as well.

Thank you. There are no further questions. I will now turn the call back over to Paul LaViolette for closing remarks.

President, CEO, Principal Executive Officer, Principal Financial Officer & Co-Chairman of the Board Thank you, operator. I just want to thank everyone for your attention today. I appreciate the commentary about the progress that the Pulse Biosciences team has made over the second quarter. We're very pleased with that progress. We're very focused on a lot of activity for Q3, including expansion of our pilot activity with the perc electrode and our 2 IDEs, and we look forward to keeping you apprised of our progress including at the Q3 call that will gather together for in October. So thank you very much all. We appreciate it. Have a great day.

The meeting is now concluded. Thank you all for joining. You may now disconnect.