Pulse Biosciences, Inc. (NASDAQ:PLSE) Q3 2025 Earnings Call Transcript

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q3 2025 Earnings Call Transcript November 5, 2025

Pulse Biosciences, Inc. beats earnings expectations. Reported EPS is $-0.29, expectations were $-0.31.

Operator: Hello, and thank you for standing by. My name is Mark, and I will be your conference operator today. At this time, I would like to welcome everyone to the Pulse Biosciences’ Q3 2025 Earnings Call. [Operator Instructions] Now I would like to turn the call over to Trip Taylor, Investor Relations. Please go ahead.

Philip Taylor: 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 5, 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 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.

Paul LaViolette: Thank you, Trip. Good afternoon, and thank you for joining. I’m very pleased by the progress Pulse Biosciences has made in Q3 towards advancing our goals in each of our 3 market development programs. I’m pleased to share these updates with you today. I will then turn the call over to our CFO, Jon Skinner, who will review the third quarter 2025 financial results. And we will conclude with a question-and-answer session, joined by Bob Duggan, Co-Chair of the Board. At our core, Pulse Biosciences creates, markets, and services a medical technology platform that delivers proprietary nanosecond pulse electric fields generated by our nPulse technology to ablate tissue in various parts of the anatomy. We are developing a portfolio of specialized devices for multiple clinical applications with the goal of creating great procedures.

Nanosecond PFA is clinically differentiated from thermal ablation energies and microsecond PFA as it delivers higher, shorter bursts and lower cumulative energy levels into tissue, preventing tissue temperature rise or the spread of thermal injury. Our extensive preclinical and clinical experiences suggest nanosecond PFA should advance the speed, safety, efficacy, and workflow efficiency of prior generation energy modalities in multiple clinical specialties and has already shown the potential to be a truly disruptive technology. As a next-generation leader in pulse field ablation, Pulse Biosciences is committed to advancing transformative therapies in large and growing markets with significant unmet clinical needs, consistently improving patient outcomes, procedural efficiency and patient access to minimally invasive therapies.

With this scientific foundation in place, we are now dedicated to executing our strategic priorities outlined at the start of the year. We are driving early targeted adoption of the nPulse Vybrance percutaneous electrode system for soft tissue ablation with benign thyroid nodule treatment as the first use case. This includes our pilot program, new commercialization accounts and the initiation of the PRECISE-BTN or PRECISE benign thyroid nodule clinical study, all of which contribute to growing procedural utilization. We have received FDA investigational device exemption approval to study the nPulse cardiac surgery system for atrial fibrillation, or AF, including the start of patient enrollment. We continue to advance our IDE submission with — for our nPulse 360 Catheter, for the treatment of atrial fibrillation.

Simultaneously, we are advancing our European feasibility studies for both of our cardiac devices with additional patients being treated with the surgical clamp and the electrophysiology catheter. Early therapy outcomes suggest market disrupting potential. And we will continue to share new data as available in the quarters ahead. We are proud of these recent accomplishments and pleased to see the excitement grow and a bright future emerge for Nanosecond PFA in the medical community. Our patient results speak volumes. Regulatory progress is essential. And we are pleased to be thoroughly engaged in that regulatory process. I will now provide more detailed updates on each of our individual market programs. Starting with our soft tissue ablation device, the nPulse Vybrance percutaneous electrode system.

We are excited to announce our new product and technology naming. Our proprietary nanosecond PFA platform is now called nPulse Technology. Our percutaneous electrode is now the Vybrance percutaneous electrode. This new naming was rolled out and well received by physicians at the recent American Thyroid Association Annual Meeting in Scottsdale, Arizona. Physicians are currently using the Vybrance device for the ablation of symptomatic benign thyroid nodules, along with toxic and cystic thyroid nodules. Through our pilot launch, we are proving very strong product market fit for the application of nsPFA to these conditions. Over 200 patients have now been treated across the pilot program, the PRECISE-BTN study and our first commercial procedures.

Procedure volumes in the quarter grew on a sequential basis as positive and consistent outcomes are being reported across a growing number of providers. We are pleased to observe growing utilization with one physician completing double-digit procedures in 1 month, indicating scale potential for this procedure. Our commercial team’s primary focus is on driving procedure count to the point of clear economic viability for our customers within a limited array of accounts and geographies. We are intensely focused during this early phase, ensuring we identify proper patients, develop and train physicians and staff on consistent techniques across multiple conditions, confirm market access for commercial reimbursement, and provide clinical support to generate consistently positive outcomes.

The nPulse Vybrance system is a first-in-class treatment and we are very pleased with early results. Given that physicians are already caring for many patients with symptomatic benign thyroid nodules, patient flow has been positive or accelerating at all pilot sites. Patients who do not want or are not candidates for surgery, the watchful waiters, including those patients under active surveillance and those who are newly diagnosed are all strong candidates for the Vybrance procedure. We continue to take steps to validate the potential of the nPulse Vybrance system to both convert current thyroidectomy volume and expand this overall interventional market by addressing the active surveillance pool of patients. Doctors have reported the procedure being straightforward to learn.

They are able to leverage the skill set used to perform other ultrasound-guided procedures, enabling them to gain proficiency after performing just a few cases. The perceived safety benefits of the inherently nonthermal energy delivery of the nPulse system are of high importance to physicians treating benign thyroid nodules with this minimally invasive alternative to thyroidectomy. Dr. Richard Harding of the Thyroid Nodule Treatment Center recently said, “I have treated 15 symptomatic thyroid nodule patients. And it is the safest intervention I perform for my patients on a weekly basis. We are seeing early and significant symptomatic relief in all patients. And they are very excited and satisfied to feel like themselves again without requiring an invasive surgical procedure.” We are hearing very similar feedback across our expanding group of new users.

We are encouraged to see a positive trend in insurance claims being processed and paid, which supports the clinical value of these procedures. There is a compelling economic reality to be presented for the minimally invasive organ-sparing Vybrance procedure versus the more expensive and invasive thyroidectomy that typically requires hormone replacement therapy and continual lifelong medical monitoring. We believe this economic argument will be a growing consideration for payers as we expand market access for patients and providers. We are early in our launch and focused on quality therapy development and are proud to recognize initial revenues this quarter as we initiated our limited market release during the third quarter. We have launched new accounts outside of our pilot program and completed initial commercial procedures during Q3, and expect to see procedures grow in Q4.

As we progress through the rest of the year, we will maintain consistent commercial headcount in Q4, as we concentrate on expanding accounts in the existing large metropolitan geographies covered by our current commercial team. Once these initial accounts achieve the desired utilization levels, we will expand headcount and launch into new geographies. As the pilot program continues to progress, we simultaneously initiated the PRECISE-BTN study with the first successful procedures of the study completed in multiple sites during the quarter. This prospective single-arm multicenter clinical study aims to generate robust clinical evidence to demonstrate the safety and effectiveness of this less invasive thyroid-preserving procedure. Benign thyroid nodule soft tissue ablation procedures will be performed on up to 50 patients at up to 4 sites.

Study endpoints evaluated during the follow-up time points will include safety, symptoms reduction, improvements in quality of life, targeted nodule volume reduction and cosmesis over various follow-up periods. The study is progressing according to plan with more than 40% enrollment to date, with multiple sites up and running. We expect to complete enrollment in Q1, and we will report on results at our next quarterly update. Positive data from our pilot program showcasing the safety, effectiveness and workflow efficiency of the nPulse Vybrance percutaneous electrode system was recently presented by Dr. Ralph Tufano at the prestigious American Thyroid Association Annual Meeting in September. And we look forward to sharing continued updates as patient follow-ups progress along and long-term follow-up data are published in the future.

Long-term follow-up evaluations of patients in our recently published Italian feasibility study are underway to further demonstrate the durability of Vybrance thyroid treatments. Additional data and publications will play an important role in driving adoption and utilization of this novel procedure as our commercial efforts scale. Let’s now discuss our surgical ablation clamp. We are pleased to announce that the FDA has granted approval of our IDE pivotal study, allowing us to proceed with the initiation of the nPulse surgical ablation clamp study, NANOCLAMP AF, for the treatment of atrial fibrillation. This is the first PFA study approved by FDA for a surgical cardiac ablation device in concomitant surgical procedures. The first patient has successfully been enrolled and treated in the IDE study, marking an important step in clinically validating the nPulse cardiac surgical system.

Based on active discussions and preparations, we intend to expand into additional sites by the end of the year, as well as into Q1. This prospective single-arm multicenter study is designed to assess the primary effectiveness of the nPulse cardiac surgical system in treating AF during concomitant cardiac surgeries. Up to 136 patients will be enrolled across approximately 20 sites, including 2 international locations. The nPulse cardiac clamp is engineered to deliver precise, continuous, and transmural linear lesions during concomitant cardiac surgeries. Due to its nonthermal mechanism, nsPFA significantly reduces the risk of unintentional damage to surrounding tissues. This bipolar system utilizes Pulse Biosciences’ proprietary nanosecond pulse field ablation, nsPFA energy to achieve full thickness, contiguous durable lesions with reduced ablation times compared to traditional thermal ablation methods like radio frequency.

The nPulse cardiac surgical system was granted FDA breakthrough device designation in July 2024, and is currently part of the FDA’s total Product Lifecycle Advisory or TAP program. The company’s feasibility study continues to enroll patients in the EU and aims to evaluate the initial safety and effectiveness of the nPulse cardiac surgical system for the treatment of atrial fibrillation. To date, 44 patients have been treated by investigators in Europe, including Dr. Bart Van Put at San Antonio Hospital in New Egan, Dr. Bart Mason at Maastricht Medical Center and Dr. Antoine Dresen at Amsterdam Medical Center. Within this initial cohort, 27 patients have undergone electro-anatomical mapping approximately 3 months after their ablation procedures to assess the effectiveness and durability of the treatment.

Initial data are incredibly promising with individual ablation times as low as 50 seconds total per patient. Late-breaking clinical results from the feasibility study were recently presented at the renowned Annual European Association for Cardiothoracic Surgery Meeting, or EAC, held October 8 to 11 in Copenhagen, Denmark. As the first clinical use of an nsPFA cardiac surgical technology, the study demonstrated that the nPulse cardiac surgical clamp enables a fast, safe and efficient workflow, highlighting its potential to significantly broaden the adoption of surgical ablation in the treatment of atrial fibrillation. We are excited to advance the IDE study while we continue to generate and publish positive patient outcomes with our feasibility study in Europe.

Now moving on to our nPulse 360 Catheter for AF ablation. The nPulse 360 Catheter is designed to deliver a complete circumferential lesion in a single brief energy application, eliminating the need to stop, rotate and reposition the catheter. We believe the system offers key advantages, including lower cumulative energy delivery, potentially reduced neuromuscular stimulation as well as the valuable ability to create deeper, more uniform lesions. The nPulse 360 Catheter system’s flexible design also enhances maneuverability within the left atrium, making it intuitive and user-friendly for physicians. Encouraging initial clinical outcomes from Europe confirm our belief that the benefits of Nanosecond PFA delivered by the 360 catheter will significantly advance the treatment of AF for patients worldwide.

Regarding current status with our IDE submission with this device, we are making positive progress. We are engaged with the FDA on our proposed IDE study protocol and expect to resolve several remaining open items over the next couple of months and we will be in a position to commence the study in Q1. In Europe, our ongoing feasibility study with the 360 catheter has now enrolled 150 patients by leading investigators and follow-up on early results continue to be collected. Importantly, in what we believe will be a significant development for the AF clinical community and positive catalyst for Pulse. We are anticipating sharing new safety and efficacy data, including 1-year follow-up data from the initial cohort of patients at an upcoming scientific meeting in Q1.

The EP ablation market presents a significant opportunity where a strategic partnership could accelerate Pulse’s growth and quickly achieve significant market penetration. We continue to explore potential collaborations with established leaders in electrophysiology. And we’ll share updates on any partnership progress as and when appropriate. With that, I will turn the call over to Jon to speak about our third quarter financial updates. Jon?

Jon Skinner: Thank you, Paul. Now I will highlight our GAAP and non-GAAP financial results before providing commentary on future cash use and revenue. 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 third quarter, we generated our initial revenues comprised of both nPulse capital and Vybrance disposable sales as we initiated our limited market release. Total revenue was $86,000. Total GAAP costs and expenses increased by $6.8 million to $20.5 million compared to $13.7 million in the prior year period. The increase in GAAP costs and expenses was primarily driven by an increase in expenses related to the expanding organization to support advancement of our nsPFA device clinical trials and commercialization, along with noncash stock-based compensation, which was $5.6 million in the third quarter of 2025 compared to $3 million in the prior year period.

Noncash stock-based compensation was 38% of the year-over-year increase in costs and expenses. To remind everyone, non-GAAP costs and expenses exclude stock-based compensation as well as depreciation and amortization. Total non-GAAP costs and expenses in the third quarter of 2025 increased by $4.2 million to $14.6 million compared to $10.4 million in the prior year period. GAAP net loss in the third quarter of 2025 was $19.4 million compared to $12.7 million in the prior year period. Non-GAAP net loss in the third quarter of 2025 was $13.5 million compared to $9.4 million in the prior year period. As of September 30, 2025, cash and cash equivalents totaled $95.2 million compared to $79 million as of September 30, 2024, and representing a decrease of $11.1 million versus Q2 of 2025.

Cash used in operating activities during the third quarter of 2025 was $13 million compared to $9 million used in the prior year period and $12.8 million in Q2 of 2025. Cash used this quarter was a result of continued expense management and deliberate resource expansion. Looking ahead, we expect disposables and in full system sales will grow along with overall procedure acceptance. At this time, a large portion of procedures are being completed under our pilot program or as part of the PRECISE study, which are not included in revenue totals. Our principal focus is to build a viable organization for the long term, supporting commercialization activity focused on key accounts in a few chosen geographies as we execute our strategy to train consistent technique, confirm significant market access as well as high-volume potential, generate consistent positive outcomes and ultimately, drive account utilization prior to expanding headcount within our sales force.

On the expense front, as previously stated, we expect quarterly cash use to increase as we’ve commenced enrollment in our cardiac surgery pivotal trial and expect to commence our EP study in the next couple of months. These essential pre-commercial investments are directly aligned with our 2025 priorities and will support development and commercial adoption of our nPulse technology. This is a very exciting and focused time for Pulse Biosciences, as we drive adoption of our transformational technology in soft tissue ablation and advance development of our cardiac devices for patients in need all around the world. Now joining us for the question-and-answer session is Bob Duggan, Co-Chairman of the Board. Operator, please open the line for questions.

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

Q&A Session

Suraj Kalia: Paul, Jon, Bob can you hear me all right?

Paul LaViolette: Yes, Suraj.

Suraj Kalia: Perfect. Gentlemen, congrats on all the progress. Paul, really three questions on the clinical trials, if I may. NANOCLAMP, congrats on the first enrollment. Paul, how should we think about the pre-op lesion work set done? Is it like one size fits all? Is that the approach? And also, if I read the trial design on clinicaltrials.gov, it isn’t obvious to me that left atrial appendage closure is also part of the trial, but measuring stroke is. So maybe if you could give us some clarification there.

Paul LaViolette: Right. Good question. So the lesion set does vary as a function of the severity of the Afib burden. And so the veins can be isolated, a full box maze can be performed. The surgeon really does have discretion in determining that lesion set. On left atrial appendage occlusion, you’re right. Now we don’t expect a large number of neurological events in this study. Left atrial appendage occlusion is occurring. And you see that now somewhat, I’ll call it, a dual concomitant procedure, right, concomitant surgery and sometimes LAA exclusion. That’s obviously not part of this protocol nor would it be expected to have essentially 2 therapies in 1. So we are only performing the ablation procedure. And we will adjudicate strokes per norm, and that’s very typical, right, within the established precedent of concomitant surgical protocols.

Suraj Kalia: Paul, in NS 360, the pivotal trial that is expected to begin in Q1. Is the thought process Pulse is going to fund this unilaterally? Or you still have expectations of bringing a strategic partner on?

Paul LaViolette: Well, those are not mutually exclusive, first of all. So yes, our base case is that we are funding. Our budget is that we are funding. We are the sponsor of the study. And the outcome is measuring the effectiveness of the 360 catheter in treating AF. So it is our study, number one. Number two, we remain committed over time to a partnership strategy. And that, of course, will manifest at commercialization and could become active before, including during the study. A study support a partner, let’s say, a mapping partner would provide mapping support in the procedure as would normally happen in any current ablation procedure. But that would not be, let’s say, core support of, let’s say, the strategy. The strategy for us is still we drive the study.

We get approval for our device and then our device would be supported by the mapping technology. So we would not necessarily expect funding of the study. Now we may or may not negotiate a fee structure in a partnership. That’s all speculative and to be determined. But funding specifically for the study would be expected to come off of the Pulse income statement.

Suraj Kalia: Paul, finally on my side, PRECISE-BTN, can you share some additional details on what the performance criteria? What is — how should we compare it after the results are posted? Gentlemen, congrats on all the progress.

Paul LaViolette: Thank you very much, Suraj. I think we have to back up and look at thyroid intervention and think about what we’re introducing here as a really a novel therapy. And today, of course, a patient can have his or her thyroid removed. That becomes an effective treatment in the sense that it eliminates, let’s say, the compressive symptoms for that patient. But at the same time, it also eliminates thyroid production. So measuring, let’s say, the elimination of compressive symptoms is one measure for the study, but cannot be the sole measure because if that were the case, it wouldn’t take into account the loss of the gland. The second would be — and this is more typical of, let’s say, RF ablation — a pure volume reduction.

What was the size of the thyroid nodule and what percent of that size was eliminated through a volume rate reduction measurement. That also, in our view, is an insufficient measurement, although it’s part of a base case, if you will, for intervention. It’s insufficient because size alone may or may not eliminate symptoms. And so — and I say that because if you ablate with RF, you can have a reduction in the raw size of the nodule. But you could introduce a fibrotic ball there, which itself would introduce symptoms. So what we’re looking at are patient outcomes in terms of the quality of life against an established thyroid patient scale. We’re looking at volume reduction, total symptoms burden and really trying to establish, I’ll call it, a composite endpoint for how these patients do so relatively well.

As an example, it’s our observation that patients treated with nsPFA have the bulk of their lesion reduced much faster than what we observed with RF. So speed of the elimination of symptoms burden would be a new measure. And as we said earlier, this whole notion of raw elimination of compressive symptoms in and of itself is no longer adequate because gland removal does that. But it also leaves the patient burdened without hormone production and all of the downstream consequences of that. So that’s how we’re thinking about this study to really establish a landmark of new data on that composite approach to treat these patients.

Operator: There’s no further questions at this time. I will now turn the call back over to Paul LaViolette for closing remarks. Paul?

Paul LaViolette: Thank you, operator. Well, on behalf of the entire team at Pulse Biosciences, thank you for joining. We look forward to having a very productive fourth quarter and to providing you with future updates on our progress. Thank you very much.

Operator: That concludes today’s call. You may now disconnect.