Pulse Biosciences, Inc. (PLSE) Q2 2026 Earnings Report, Transcript and Summary

Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Pulse Biosciences Q2 2026 earnings call. [Operator Instructions] It is now my pleasure to turn the call over to Philip Taylor, Investor Relations. Please go ahead.

Thank you, operator. Before we begin, I'd like to inform you that comments and responses to your questions during today's call reflect management's views as of today, August 6, 2026, 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 today and in our filings with the U.S. 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, 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.

Thank you, Trip, and good afternoon, and thank you everyone for joining us today to discuss the results of our very active second quarter of 2026. I would like to begin with a discussion of the amazing and novel technology that sits at the core of everything we do at Pulse Biosciences, our proprietary nanosecond pulsed field ablation, or nsPFA technology. By delivering electric pulses in only billionths of a second durations paired with high energy, we are able to treat tissue non-thermally and with exceptional effectiveness. This translates into tangible and measurable advantages across a range of different diseases and tissues in the human body. nsPFA produces targeted energy, non-thermal ablations, durable lesions, quicker ablation times, and faster procedure times, all complementing the natural body function of regulated cell death. This mechanism is uniquely stimulated by nsPFA and is unmatched by existing ablation energies, including all prior art and the broad category of microsecond PFA alternatives. Underpinning the platform are a uniquely experienced technology development team, which has produced the highly novel nsPFA system and a deep patent estate of more than 250 issued patents worldwide. Together, this team, a number of whom have worked together for over a decade, and patent moat, are fundamental to protecting and amplifying our long-term leadership in this field. Last quarter, we announced a strategic alignment to prioritize, accelerate, and broaden the development of our nPulse Cardiac Catheter Ablation System. Our focus remains concentrated on the treatment of atrial fibrillation and the development of our nPulse Cardiac Catheter Systems while we continue to advance our surgical clamp and thyroid programs with discipline and optimism. As part of our strategic alignment, we focused on two key pillars in our program, generating compelling clinical data and executing rapid trial enrollment across a growing base of studies. During the second quarter, with this shift in focus, we have delivered positive and important achievements in our Cardiac Catheter Program. We enrolled the first patient in our pivotal catheter IDE study, including 7 cases on day 1. We activated multiple sites, presented outstanding feasibility data at the Heart Rhythm Society meeting in April, and further strengthened our leadership team with the additions of Liane Teplitsky as Chief Operating Officer and Dr. David Kenigsberg as full-time Chief Medical Officer. These two leaders have strengthened our ability to execute a successful pivotal IDE study and advance toward regulatory approvals. We also meaningfully bolstered our balance sheet now with over $100 million on hand, expanding our runway to fund development and clinical milestones ahead. Our financing progress was an important marker of external confidence in Pulse Biosciences. Through our at-the-market, or ATM, program, we raised a total of $57.5 million in net proceeds to date, initiated with continued insider support of approximately $13 million, and the remaining portion coming from outside institutional investors. This strengthened our balance sheet during the quarter and reflects growing and expanding conviction in the nsPFA platform and the growth opportunities in front of us. This is a complex environment for raising capital, and we are proud that investors who took a close look at our technical and clinical progress were able to appreciate the value creation story we are building at Pulse Biosciences. Additionally, we recently announced that we have surpassed the halfway point of enrollment in our U.S. pivotal catheter study ahead of our original schedule, and on the strength of that pace, we are confident in completing enrollment on our accelerated timeline of early Q4. Reaching this point so quickly in a pivotal AFib study is extraordinary, and we attribute it partly to a straightforward dynamic. Physicians are thrilled by their personal nsPFA clinical experience when using this catheter and are highly enthusiastic to both expand their use and share their positive experiences with their peers. This response is universal across operators. Today I will focus most of my remarks on the catheter and then we'll provide updates on our two other nsPFA devices. We will then turn the call over to our Chief Financial Officer, Jon Skinner, to review the second quarter financial results in detail. We will then conclude with a question and answer session joined by Bob Duggan, Co-Chair of the Board. I will now discuss the nPulse Cardiac Catheter System for AF ablation. Earlier in July, we shared that the NANOPULSE-AF study crossed its enrollment midpoint with more than 82 evaluable patients, net of roll-ins, treated in the IDE since the study began enrolling in April. The pace exceeds all expectations and reflects investigational site enthusiasm for what nsPFA technology offers. Durable pulmonary vein isolation, familiar and rapid workflow, intuitive user experience, an efficient procedure, and consistently positive outcomes for patients in need of AFib resolution. We are proud of current results and, rest assured, we are persistent in striving to do even better. Given our enrollment cadence thus far and expectations for site performance in the second half of the study, we are confirming our target completion date of early October, 3 months earlier than our original timeline. This enrollment velocity reflects the quality of our investigational sites, along with their lab and clinical research staffs, and the compelling clinical attributes of our catheter and energy system. Physicians comment that the system is extremely intuitive, with a straightforward learning curve, as well as seamless workflow integration, translating directly to rapid, efficient procedure and ablation times. We have seen multiple sites perform 5 and up to 7 cases in a day, and multiple physicians have completed their initial cases with 7 to 8 minutes or faster ablation times. With other ablation catheters currently available, EP labs generally do not schedule more than 2 to 3 cases per day. This early on meaningful expansion of daily case capacity is the best evidence of the workflow and procedure speed advantages as well as potential hospital economies that will follow as they utilize the nPulse system. Catheters that change practice patterns for the better, and dramatically so in our view, will become a compelling and welcomed option for electrophysiologists and hospitals. Upon the basis of workflow efficiencies, patient outcomes, and more, our nsPFA console and catheters continue to demonstrate unprecedented potential to transform the treatment landscape for atrial fibrillation. We chose to amend our NANOPULSE-AF pivotal study protocol to increase the total enrollment target by 19 patients from a target of 145 to a new target of 164. This is being done in concert with reducing prior enrollment restrictions on the types of antiarrhythmic drugs, or AADs, a patient must fail in order to qualify for inclusion. Now, patients that have failed any 1 of the 4 classes of AADs may qualify for the study. We believe this protocol modification better reflects contemporary clinical practice and real-world patient management. This protocol change also expands the pool of qualifying patients. We are pleased to confirm that full study enrollment is still expected to be completed by our revised date of early October, even with the increase in study size. Site activation continues to proceed well, and the momentum across our investigational network is being maintained as we expanded the base of active study sites to 12, and this number is expanding in real time. While the study protocol allows for enrollment at up to 30 sites, we do not anticipate activating all 30 due to the physician enthusiasm and enrollment velocity we have already experienced in the current base as sites and investigators are activated. Diving further into our study protocol, our efficacy endpoint, freedom from treatment failure through 12 months, incorporates a mix of both 12-month and 6-month patient follow-up data. The blended endpoint optimizes overall follow-up time for the study while supporting statistical rigor. As a reminder of our data presented at Heart Rhythm Society, or HRS, Dr. Vivek Reddy, the National Principal Investigator for our pivotal study, shared expanded results from our European nPulse Cardiac Catheter feasibility study, including 6-month follow-up on 95 patients and 12-month follow-up on 53 patients within the 5-second ablation cohort. These data were outstanding. 100% freedom from AF measured by 24-hour Holter monitor at 6 months and 96% as measured by 24-hour Holter monitor at 1 year, along with 90% Kaplan-Meier estimated freedom from recurrent AF, flutter, or tachycardia at 1 year, alongside a serious adverse event rate of just 1.7% across 177 patients. Those numbers compare quite favorably to the meaningfully lower success rates typically seen with other ablation technologies and were achieved without antiarrhythmic drugs and with consistent performance across operators and sites. The EU feasibility data continue to support our path toward a CE Mark submission in the second half of this year, and we see a potential CE approval around the middle of 2027, roughly 6 months post-submission. Supporting our go-to-market strategy with the EP catheter, we are continuing to pursue a partnership strategy. Our dialogue with prospective partners is ongoing, centered around the established players in electrophysiology with available mapping technologies. Those conversations are underway and we'll provide details when appropriate. Let's now move to our surgical clamp program, where treatments in our pivotal IDE clinical study continue to perform well. Concomitant ablation for pre-existing AF is, in our view, significantly underpenetrated, and we believe nanosecond PFA can support increased surgeon adoption and drive meaningful market penetration over time. Currently available tools provide inconsistent results with involved and time-consuming procedure protocols. Our clamp was designed to address these needs efficiently and to deliver the speed and effectiveness of nsPFA technology, which is capable of delivering reproducible transmural lesions nearly instantaneously, producing a more reliable and trusted ablation procedure, all for the purpose of improved patient outcomes. In addition to our IDE enrollment, our EU feasibility study has now treated more than 70 patients across 6 sites. Three-month post-procedure electroanatomical mapping results were presented at the European Heart Rhythm Association 2026 meeting and demonstrated excellent lesion durability and procedural efficacy on 34 patients. Total ablation time averaged just 41 seconds per patient. And pulmonary vein isolation success held steady at an extremely high rate of 94% at the 3-month follow-up, unchanged from the initial readout we provided in October of 2025. Just as telling is the qualitative feedback. Surgeons consistently praised the speed, lesion quality, and ease of use provided by the Pulse nsPFA clamps. Given this encouraging progress, we remain on schedule to file for CE Mark before the end of 2026. In the U.S., our pivotal study, NANOCLAMP AF, continues to enroll. As a reminder, it remains the only trial of a PFA surgical device to have secured FDA IDE approval. The IDE is a prospective single-arm study spanning 20 centers, 3 of them international, with a target of 136 patients designed to establish the safety and effectiveness of the nPulse Cardiac Catheter System in treating AF during concomitant cardiac surgery. Enrollment and site activation is progressing, and we expect to complete enrollment by the end of the first half of 2027. Turning to our nPulse Vybrance Percutaneous Electrode System, the nPulse Vybrance System uses our nanosecond PFA technology to ablate soft tissue percutaneously. Vybrance can be used to ablate symptomatic benign thyroid nodules as an alternative to full thyroidectomy surgery. Rather than removing tissue unnecessarily, Vybrance treats the thyroid through a minimally invasive approach in the outpatient setting. The procedure shrinks the nodule and relieves symptoms while sparing the surrounding anatomy and preserving thyroid function, a highly desirable outcome that is not possible with traditional surgical excision of the thyroid. In the second quarter, Vybrance's disposable sales were $434,000, a sequential increase from $400,000 in the first quarter. We remain focused on core market development goals, including generating clinical data for both expanding reimbursement coverage and achieving specific regulatory label claims. We are proud to announce a new partnership with the Clayman Thyroid Center in Tampa, Florida, the largest thyroid surgery center in the United States. This unique partnership is focused on supporting our core strategy of demonstrating the viability of the Vybrance system therapy for patients with symptomatic benign thyroid nodules. Key elements of this partnership will include registry data generation and unique study protocols for interventional therapy in thyroid disease. Bringing on a center of this caliber is an important step toward our goal of establishing nsPFA as a minimally invasive standard of care for benign thyroid nodules. Over the past several weeks, the Clayman Center has onboarded the Vybrance system and performed its first cases, and we look forward to reporting on progress toward our partnership objectives in future quarters. Additionally, our PRECISE-BTN, benign thyroid nodule study, continues to proceed quickly, and we expect the study to be fully enrolled this month. We broadened the study from its original 50-patient design to 100 patients to deepen the data set in support of adoption and long-term market expansion. Scientific recognition of this work continues to grow. Data from Dr. Stefano Spiezia in Naples, Italy, was recently presented in a podium session at the North American Society of Interventional Thyroidology, or NASIT. The data showed durable results out to 15 to 22 months, a 74% reduction in treated nodule volume as per our expectations, alongside overwhelming patient satisfaction, featuring very rapid symptoms relief post-treatment. Volume reduction continued to improve from 1 month all the way through 22 months with no nodule regrowth observed in the 15 to 22-month time frame. Beyond PRECISE-BTN, we are also widening the clinical scope of our Vybrance platform. Through our research collaboration with the University of Texas MD Anderson Cancer Center, researchers at 2 study centers are conducting a multi-center, first-in-human feasibility study of nsPFA for papillary thyroid microcarcinoma, or PTMC. This study is designed to enroll up to 30 patients across 2 sites. I'm pleased to announce that this study is approximately half enrolled, and we expect to complete enrollment by year-end 2026. And looking ahead, we've begun planning additional clinical trials with the aim of extending the Vybrance platform into new thyroid indications as we support our plans to bring this revolutionary therapy to a broader patient population. With that, I'll turn the call over to Jon to walk through our second quarter financial results.

Thank you, Paul. Now, I will highlight our GAAP and non-GAAP financial results. 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, we generated revenue of $434,000 and cost of product revenue was $273,000 for the quarter. We remain in a disciplined launch focused on clinical and market development. Based on strong clinical results, we remain focused on growing procedural utilization within a limited customer base. Total GAAP costs and expenses for the quarter increased by $5.4 million to $25.7 million, compared to $20.3 million in the prior year period. The increase in GAAP costs and expenses was primarily driven by increased investment in our clinical programs and compensation and employee-related spend supporting our growth in clinical and product development. Compensation and employee-related expenses, including stock-based compensation, increased approximately $2.7 million versus the prior year period. To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation, and amortization, as well as non-recurring costs. Total non-GAAP costs and expenses in the second quarter of 2026 increased by $5.7 million to $20.5 million, compared to $14.8 million in the prior year period. The expected increase was driven by increasing clinical trial expenses and $2.9 million of compensation and employee-related expenses. Looking ahead, we expect quarterly operating expenses to remain in this range on a non-GAAP basis as we continue to invest in our clinical programs. GAAP net loss in the second quarter of 2026 was $24.7 million compared to $19.2 million in the prior year period. Non-GAAP net loss in the second quarter of 2026 was $19.4 million compared to $13.7 million in the prior year period. As of June 30, 2026, cash and cash equivalents totaled $101.6 million compared to $68.3 million as of March 31, 2026, representing an increase of $33.3 million versus the prior quarter. Cash used in operating activities during the second quarter of 2026 was $18.7 million compared to $12.8 million used in the prior year period and $14.6 million in Q1 of 2026. Through our ATM program, $57.5 million in net proceeds was raised since May. Bob Duggan and the Pulse team partnered with a sales agent to manage daily participation and run a successful program, raising approximately $44.5 million from outside investors. During Q2, insiders announced intent to purchase shares through the ATM program 3 trading days prior to the insider transaction, and management provided this update during our Q1 earnings call. This continued insider support contributed approximately $13 million through the ATM. Of the $57.5 million in net proceeds, $46.8 million was raised during the second quarter, with an additional $10.7 million raised subsequent to the close of Q2 and thus not included in our reported cash balances. As a result, we strengthened our balance sheet, ending with a stronger cash position than we began and extending our runway to the key clinical and regulatory milestones ahead. Additionally, we put a new $75 million ATM facility in place to preserve our financing flexibility going forward, along with our shelf that was put in place in February. We also received gross proceeds of $1.8 million related to exercises of the second tranche of 2024 rights offering warrants in July. Following this redemption, there are no remaining warrants outstanding. We remain disciplined on expense growth while continuing to fund our clinical programs, prioritizing financing through key milestones ahead. With that, I will now turn it back to Paul for closing remarks.

Thank you, Jon. Our strategic focus remains the treatment of atrial fibrillation, and with each new data readout, each new site activation, and each new investigator experience, the clinical strength and disruptive market potential of nsPFA becomes clearer to all. Enrollment in our pivotal IDE study is progressing ahead of our original timeline, driven by strong physician demand and site motivation. Looking ahead, our priorities remain clear. Continuing enrollment of our IDEs, progressing towards CE Mark approvals for our cardiology devices, advancing our catheter partnership discussions, and new this quarter, developing Vybrance market value through our partnership with Clayman Center, all while maintaining the operating discipline required to effectively execute and complete these critical milestones that will define Pulse Biosciences' future. nsPFA technology continues to demonstrate remarkable clinical differentiation, and our work going forward is to transform that platform potential into durable, scaled businesses capable of generating multiple billion dollars of recurring revenue. Thank you for your continued support, and we look forward to updating you again next quarter. Now, joining us for the question and answer session is Bob Duggan, Co-Chairman of the Board. Operator, please open the call for questions.

[Operator Instructions] Our first question comes from the line of Bill Plovanic with Canaccord Genuity.

Congratulations on successfully the enrollment rates. My first question pertains to that. You've talked about the combination of the 6 and 12-month data and the final module submission. Given that this enrollment is so fast, I don't think I've seen anything quite this fast, does it even benefit you to have it be a combination of 6 and 12-month data, or is this something where you might end up waiting till you have full 12-month data for the final module submission of the PMA for the NANOPULSE-AF?

Thank you, Bill. Good question, and you're right. So just to be, let's say, level-setting, the 6 and 12-month combination presumes that patients early in enrollment will be followed 12 months, and patients later in enrollment will be followed 6 months. Then the question becomes, what's the long pole, right? And if you enroll the second half of the study and follow those patients for 6 months, they might reach their 6-month endpoint before the earlier patients reach 12 months. So I think the real way to focus, that the -- I'll call it on the absolute timeline, is to think about 12-month follow-up on the patient cohort. And frankly, at that point, if enrollment continues to go so swiftly, whether you set that bar and say, "Let's do 12-month follow-up on the 80th patient or the 100th patient or the 130th patient, the absolute time differential between those is relatively short." So we're focused less on that than we are on quality and expedited enrollment. We're very pleased by how enrollment is going. I would say we're very pleased by the uptake of second and third wave sites, and the fact that there's really no distinction between how a new user establishes clinical comfort with our catheter today versus how that was established a few months ago when the IDE commenced or last year when our first in human experience was commenced. So, very good question. 12 months from the earlier patient group is the long pole in the tent. And despite that, we'll certainly, we're going to be using all tools available to us to manage timelines effectively, including enrollment, including follow-up, and then, of course, submitting very clean data to provide FDA the opportunity to minimize their review time once submitted.

Just a follow-up on that, Paul, is -- given that, I mean, 80 patients out of, you probably had only 6 or 7 accounts that did all of those, I would imagine it's gone so quickly. Do any of these accounts stop out just because they've had too many, you don't want them to get to be too many patients or too big a piece of the study? And so that's maybe why the pacing that you're providing kind of maintaining, even though you expand the number, but maintaining the timeline on this is because some of those earlier sites are going to cap out.

That also is a great observation. And the typical of all FDA-approved protocols, the FDA is worried about and focused on generating a representative patient pool of data. And in a multi-center study, they want to assure that there is not excessive skew toward 1 or 2 centers. And so we do have a cap that represents 15% of patient enrollment at a given site, no more. And I will say in response specifically to your observation, yes, several sites already have met their cap. Now, of course, the next sites being opened are equally interested in enrolling as many patients as they can. But as is always the case with clinical trial management, one, the sponsor, in this case, Pulse Biosciences, can't specifically predict which next site will be the next site to enroll very rapidly and to reach its cap. So, our job is to continue to activate sites, which we're doing. We have more in the queue, and we'll activate more sites over the next 1 and 2 months, and we'll continue to do that up to the point where we are nearing final enrollment. But, yes, some of the measured momentum throughout now and the next several months toward our expected completion date is regulated, if you will, by the turnover of high-performing sites as we cap out on some and as new ones emerge to become the next high-volume enrollers.

And then last one, I promise, is just, you expanded the study. So my question was any major learnings, you've enrolled 80 patients, but any major learnings from those 80 patients, and it sounds like one of them is just, hey, let's make sure we have all the AADs and get a real-world patient population, but I don't want to put words in your mouth.

Thank you, Bill. Well, I won't comment on any form of results, but as we've indicated in our message about both the rapidity of enrollment and all the way back to our first announcement of first patient in. This is a -- it's an exciting trial. Physicians are extremely enthusiastic about this technology. As you know, I've been doing clinical trials for 40 years, cardiovascular breakthrough clinical trials for probably 35 years. I've never seen trial enthusiasm any stronger than what we have here. And so we're just amazed by -- and I actually had this conversation with several members of our team, that as we focus on the extraordinary data, the outcomes, the data set that we announced at HRS, unprecedented data, it's important for us not to take for granted the acute experience in the lab. If we think about the AFib market, if we think about the dynamic change, the disruptive change that new technologies have brought in the last year, the shifts in market share, how those shifts in market share have translated to really fundamental shifts in market leadership positions, that has all been principally driven without outcomes data differences and mostly based on acute experience in the lab. And so the acute experience in the lab we have been clear about, we have been transparent about. That acute experience in the lab is unbelievable. Rapid learning curve. Almost no required time to become facile with our catheter. Extremely rapid procedure times based principally on a limited number of ablations required because of the clarity and power of our lesions, and extremely short lesion delivery times of 5 seconds. So when you piece those together, the physicians who are the crème de la crème are telling us that this is an experience they've never had before. And I think while it's not data, it's observation and it's anecdotal, but I think the biggest learning is the validation of the fact that the Pulse Biosciences catheter experience in the lab is something unlike they've ever experienced before. That is a telling marker for how this technology is likely to be adopted when it becomes available.

Paul, this is Bob. If I just might add something to Bill here.

Please, Bob.

Thank you. The faster enrollment is really a very positive product function feature as it's easy to use, as we found out. The quantity of patients treated is a very positive product economic feature for the OR. It is OR ROI that is significant. So we're really pleased about both of them, both the economics, which ultimately are the adjudicator of hospital take-up if in fact the product is giving you superior results on the patient side. So we look forward to the patient side, we're very confident, but we're very pleased about the quantity of patients being treated, and it wasn't something that we pushed or promoted. It was just the doctors went "Look, I've got more time here. I'm done with the 3 in a few hours, and I did stack up some patients, and we'll just bring them all through." So it's a double positive. We're really pleased with that.

Your next question comes from the line of Anthony Petrone with Mizuho Group.

And congrats here on the progress on the IDE study. Maybe, Paul and/or Bob, just one on just mapping integration. In the last, at HRS, we talked about nPulse magnet being compatible with Abbott's EnSite. I think the messaging there was that CARTO was going to be brought into the study. So in the IDE, are we still only using EnSite? Have you brought in CARTO at this point? And maybe can you recap, what do you think continuous mapping can do, you know, ultimately for results when you compare it just to the IDE or the EFS study where we just used fluoro? And I'll have one quick follow-up.

Thank you, Anthony. Yes, so the study has been enrolled to date with EnSite. We've been clear about that. You're commenting on physician commentary coming out of, I think, HRS where in some of those panel discussions, physicians, I would say, speculated about the potential for results to potentially even improve with higher quality integration of how our catheter is represented on the mapping system. And so I would say we expect to see that manifested. And I will say, if you think about more sites picking up the technology for the first time, treating patients, and you measure, I think, your question by the efficiency of the procedure. How many ablations were needed? And you can't compare specifically the IDE to feasibility because the feasibility study contained a little bit more patient heterogeneity, some additional ablation strategies were deployed. But if you look at the IDE, the number of ablations per case is quite limited, quite efficient. And that's a measure of physician confidence in their specific placement of the catheter in the anatomy. And of course, they deliver that limited lesion set, and then they do a post-anatomical map, and they can record specifically the effectiveness in the lab of that lesion set. And so the ability to have tight integration translates to limited lesion numbers while achieving acute isolation, and that's the goal. So I do think we see a clear result of tighter integration. And we won't comment further on any changes in the mapping systems being used, but I will confirm that through today, and while we have the ability to use other mapping systems, all of the cases have been done with the EnSite system.

No, it's helpful. And the follow-up here would be on capitalization. You brought some more capital in. The cost of the trials here is going higher. But we are getting to a point it is enrolling faster. You're looking into 2027. Almost presumably, you could be on a footing for a launch. Today as well, you announced on track for CE Mark submission. So does the capital also contemplate building up the infrastructure, you know, perhaps even on the direct sales side, where does the capital bring you? Is it just through clinical trial development, or will you actually start market development as well?

Thank you, Anthony. Go ahead, Bob.

Yes. Yes. I've had my finger on the pulse of that. Away from the pre-announcement that Paul and I made and gave other investors 3 days to jump in front of us if they desired to, the balance of the money was raised in the 27-28 area, which is about where we closed out the quarter. So we were pleased with our patience and how that went. The valuation has now gone up. So taking a measured pace on this was the right thing to do. We think it will continue to be the right thing to do. We will comfortably stay out there with at least 5 quarters of cash on hand relative to our forward spend. And as you get a label or close to a label, that spend will accelerate. I will say we already have calls from some of the best of sales and the best of marketing say, "As and if you get a label, don't lose my number, and here it is for the first time." That's the easiest area to add to and to complement what you have because you're getting calls from people that are competing with you now that well know how you stand. So that would be very difficult to go out and find a batch of engineers that could match or beat what we do. That's nigh near impossible. There's other administrative duties, regulatory, et cetera, that are difficult to come by. So we will be prepared for that. And whatever that case may be, we do recognize this is a business that has entrenched sales and marketing, but we do note that Boston Scientific from out of nowhere took market share like they were the Goliath, and until it was viewed as a commodity, I mean, they had like a $40 billion market cap jump when it looked like a monopoly. So valuation will not be a problem, if you look at that, and attracting the right people will not be a problem. Time is on our side. We look for the continuation of the trial and the very popular trial status will in a sense provide some early benchmark. You get physicians that are doing 7 a day, that's like 35 a week. There will be a classic number of EPs that go after this. And we have dealt with all the KOLs, so, to really get to the number, you can check in with them as to what they see, how competitive this will be. But we're pretty optimistic and we're very aware. In my former Pharmacyclics company, remember, we've not been in the drug business priorly, and my team, other people that are on board here, we did $1 billion of revenue in the second year from out of nowhere. So we're not unfamiliar with what it takes to do that. I hope that helps to respond to the question and our preparedness for it.

Thank you, Anthony. Your next question comes from Suraj Kalia with Oppenheimer.

Congrats on all the progress. So Paul, Bob, two questions. The first is a multi-part question, and just trying to get my arms around this. Paul, the fourth AAD added, I presume it's a calcium channel blocker. And maybe you could help us understand the average age of the patients now, is it going to end up being similar to the EFS? And maybe if you could just kind of help us on the math of 19 additional patients.

Sure. So, yes. So, let's just level set for everybody. There are 4 classes of AADs. Two of which are calcium channel blockers, 1 sodium and then 1 beta blocker. And the history of the field has generally driven patients to be non-responders at least in the class 1 and class 3. Current practice, though, if you think about what's going on in the marketplace today is that patients are in higher demand for earlier ablation. And that earlier ablation implies, yes, that patient still needs to be a non-responder to an AAD, but they don't want to go through the escalation of more severe drugs with greater toxicity and adverse effect profiles. So in order to keep the protocol contemporary with current clinical practice, we felt it was important to add the other 2 AAD classes so that they could fail any 1 of the classes. Now, first question on patient age. I don't believe this will alter patient age. What this will potentially do, and the way we thought about the stats, the change in the enrollment number was to basically accept a question from FDA regarding the possibility that if you skewed more patients to being non-responders to a lower efficacy drug, it's possible that their AF burden could be slightly lower. So that leads to a potential question about performance goals, statistical rigor, and in order to bring equilibrium to all of those moving parts, we added patients. I think the important part of our thought process there was that there's very little price for us to pay by adding 19 patients because our enrollment velocity is so high, that in order to keep all the stats balanced with the slight theoretical change in, call it, background risk of the phenotype of the enrollee, we'll add a few patients and it won't cost us anything because the time to enrollment would be essentially the same. So that's how we thought about it. I don't believe it will change the age. And when you consider that we're not implementing this change until midway through the study. You then have the first half already having gone through the class 1 and class 3 non-response. The second half potentially being a mix of 1 through 4, the larger patient population is going to be quite comparable. And we just bolstered our statistical assurance, if you will, by adding those 19 patients.

Perfect. Paul, 1 quick question, and I'll hop back in queue. The rest of the patients to be enrolled in Nano-Pulse. Maybe I missed your commentary. I know everything has been done on EnSite so far. Should we glean from that the rest of the patients also will be on EnSite just for statistical purity here, and maybe if you could also share -- give us an idea of the 80-plus patients enrolled, what percent would be on the AADs and what are now on four AADs?

Thank you, Suraj. You may have missed it. I did make the comment that all the patients so far have been enrolled using our system mapped with EnSite. We are not going to comment on any expected change in that. So I think staying the course, the safest assumption should be that the remaining patients also will be enrolled on EnSite. That would not, by the way, change anything in the statistics. To your question, our IDE actually allows us to use any available commercial mapping system. So there is no anticipated outcome difference. It really comes down to the -- really the quality of the feel and the representation of our catheter on those systems in the lab. So that's point number 1. And then point number 2, we are not going to comment on the specific AAD, I'd say, regimen of the first half of the population, the second half of the population. I would say physicians generally feel they can enroll with greater ease by using a more liberal definition of AAD class non-responder. But we don't expect it to translate through to any difference in the first half and second half of the study population. Given that, again, our principal goal here is to really make it easier for the clinical community to address patients who are now in the real world moving faster from diagnosis to ablation than they would have prior to the availability of PFA in the marketplace.

And your next question comes from the line of Josh Jennings with TD Cowen.

I wanted to just ask about the procedural efficiency you're seeing in the IDE study. The protocol, I think, is just general anesthesia for each patient. So it sounds like from your download, and I would imagine that physicians are having aha moments as they're doing 6, 7 cases in 1 day. And have any of them, kind of, forecast how many procedures using nPulse AFib ablation procedures they could do in an ASC, when, like, conscious sedation is used? I imagine some may be thinking about double-digit days, but I wanted to ask that, and I've got a follow-up.

Thanks, Josh. You're right. The protocol does call for general anesthesia. So one of the, I think, key observations that we have is that the relative time efficiency that we can deliver is technically impaired, right, by the protocol and by the way we're treating these patients. And that in the real world, that you would have higher throughput when a lab is thinking purely commercial cases, morning, midday and afternoon, multiple rooms, and patient throughput and efficiency. When you enter a patient in a protocol, you're more focused on great results, capturing data, and if it takes 10, 20 more minutes, you don't really think about that on a given day. Now, one of the dynamics we've emphasized, and this is key to Bob's point, and I'm sure he'd be interested in commenting as well, this is about the translation of efficiency through to hospital economics. And we are actually asking our sites to try, if it's within their management approach, to stack some cases. Let's try to do back-to-back cases. That does a couple of things. It's more efficient for the completion of the IDE, but it really forces them to experience what a day in the life would be like in the real world when this technology is available and when you can do 3 and 4 or 5 or 7 cases back-to-back and experience what that is like, you get both the acute benefit in that case, hey, my ablation time was only 6 or 8 minutes in total. But then you also get the sense when that patient has turned over to the next, to the next, to the next, and now you've done 4 or 5 cases and it's only 1 o'clock, this is what is creating such a positive enthusiasm and expectation for this technology going forward. You could then take that, yes, into the ASC. And we have done patients, of course, not in an ASC in the U.S., but we have done patients with sedation protocols in Europe. And so we believe that's going to be quite feasible. And of course, that is an unlock for ASC conversion in the future. So we do think multiple cases per day will be feasible. We do think labs will be thinking about how to make the downtime, right? It's less about now the time that Pulse consumes. It's about the non-ablative time in the case, and then it's about the movement of patients in and out of the lab and the turnover of that lab because the physician is not strained by these cases. And as a result, the physician can do multiple cases, and then it becomes more about, to use the analogy, the pit crew and the ability to turn over the room. And labs will be thinking about that because they know if they can do that low-value time more efficiently, they can bring higher throughput and do more cases, and that will translate directly to the ASC. And Bob, do you want to make any further comments about hospital economics?

Yes, just the number of procedures that I've been fortunate enough to be in that the doctors walk away at, and I've seen 2 of them at the 7 level just fresh, ready to do more. We're going to come back the next morning. This is huge for not only the doctor and their sanity, but for the hospital and its return. You really look at 7 cases exceeds the revenue, the cost of capital of the generator. So the economics are superb here. And we want a label, we want this done efficiently and we want smiles on everybody's faces, including the patient. Patients, by and large, if they have something less than full anesthesia, would rather do it if they knew for sure the outcome was the match and nothing less than full anesthesia. So I believe that is chapter 2. Some have been done. They look good, but we won't be doing that in the trial. Let's get through the trial, get the approval, and that's an uplift to be looked at as we get through regulatory approval and commercialization. But it's very practical and very doable. And yes, so I think, Josh, you're looking at it the right way. And it's really another differentiator. I think it's very, very difficult to pull that off with any pulse other than a pulse that stimulates regulated cell death, which other pulses have a very difficult time if they can do it at all; we do it consistently. Remember, the nsPulse is a 1,000-fold faster than the micropulse. You penetrate into the cell at a pace that the cell does not interbulate the inner cell working. So we're -- it's a powerful technology. We'll take it 1 step at a time, but it looks really, really good. Highly, highly differentiated. All in the direction of better for the physician, better for the OR owner, and better for the patient.

Thanks for sharing those answers and just one follow-up on them. I mean, just looking at the first in-human data and AFib symposium at the HRS, nPulse seems to have the potential to deliver a differentiated efficacy profile, maybe even a record kind of freedom from atrial arrhythmia rate in the IDE study, but in a scenario where, you know, it comes closer or even in line to the efficacy rates of competing AFib ablation technology or pulsed field ablation technologies and what you're talking about in terms of the economic value proposition that's coming into play. I mean, that would potentially still be a home run for Pulse Biosciences and the platform just in terms of the adoption trajectory. Have you had discussions like that with any investigators or any KOLs in terms of where they're thinking about the efficacy bar needs to be? And clearly, I'm not suggesting that it will be lower. Very strong preliminary signals in play already.

Thanks, Josh. I think...

Paul, you're the best one to answer that. But just on the top of this, Josh, an nsPulse delivered as we deliver it kills the cells. A dead cell, unless they are cousin of Lazarus, does not come back. A stunned cell, which can be otherwise the appearance of a dead cell, can come back. So I look at it that the reason that you report and you're on the OR table is AF tachycardia, bradycardia. There are many ways to accrue brady and tachycardia. But the way that you came into that OR, that means in that mechanism, you're not coming back when you're treated with nsPFA. Now, you may come up with -- you may marry someone else or lose money in the stock market or do whatever you do and have your heart go wild on it, and you could be back. We can't prevent other forms. But the reason that you reported in, that one's handled -- irreversibly handled. Dead cells don't come back, and we maintain that any other form of ablation can kill and can stun and have the appearance of dead cells, but somehow they seem to have recurrences. We're not going to be in that class. So that puts us in a good position, but it doesn't mean that you will never have another. You may have tachycardia today and 2 years later have bradycardia. That's just the human physiology.

And yes, I agree with Bob 100%. I think the way I would add further to that, Josh, is that let's assume that our data are exactly replicated from Europe and that we post a 90% Kaplan-Meier outcome across all atrial arrhythmias. That's going to be questioned, right? Competition in the marketplace will say, "Well, that was a single study, it's not head-to-head." And they will say, "That that was still a relatively small data set, we've done 100,000 cases." So I think the market will accept that if we post that feasibility data, and by the way the feasibility cohort will be double, right, in terms of 1-year follow-up by then. Then we have the IDE data followed a year. That will be compelling. You put those 2 data sets together. It's going to be, I think, very impressive. But I yield to the scientific community to say, "Until we've seen 10,000 patients, until we've seen this or that, we're not entirely convinced." But at that point they say, "You know, actually, the acute performance is so good, and I'm predisposed to believe in better outcomes, even if it's not definitive head-to-head across a 5,000-patient study." The market is going to switch. The market has switched heretofore, based on acute performance, where there's been 0 differentiation across outcomes. And so to add another leap in acute performance and complement that with a likely superior outcome still to be added to with more and more studies and more real-world evidence, I think that physicians are looking at that saying, "You know what, I don't need any more than that to switch."

And with no further questions in queue, I'll now return the call back to Paul for closing remarks.

Thank you, Operator, and thank you for those questions. Thank you all for your interest in Pulse Biosciences. We look forward to providing further updates on our progress, and I just want to wish everyone a good day, and thank you all for joining.

Thank you again for joining us today. This does conclude today's conference call. You may now disconnect.