Earnings Labs

Pulse Biosciences, Inc. (PLSE)

Q3 2025 Earnings Call· Wed, Nov 5, 2025

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Transcript

Operator

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

Analyst

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

Analyst

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,…

Jon Skinner

Analyst

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…

Operator

Operator

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

Suraj Kalia

Analyst

Paul, Jon, Bob can you hear me all right?

Paul LaViolette

Analyst

Yes, Suraj.

Suraj Kalia

Analyst

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

Analyst

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

Analyst

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

Analyst

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

Analyst

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

Analyst

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

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

Analyst

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

Operator

That concludes today's call. You may now disconnect.