Pulse Biosciences, Inc

Hello and thank you for standing by. My name is Nell, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Pulse Biosciences Quarter 1, 2026 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press car, followed by the number 1 on the telephone keypad. If you would like to withdraw your questions, Thank you. I would now like to turn the call over to Tripp Taylor of 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, May 7, 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 on Monday 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.

Good afternoon and thank you for joining us. For those of you that are new to the Pulse Biosciences story, Let me start with a brief overview of the technology at the core of everything we do. Pulse Biosciences is the pioneer of nanosecond pulse field ablation, or NSPFA, a fundamentally new category of energy that we believe will change the way soft tissues in the human body are treated across multiple disease states. Conventional ablation modalities, whether radiofrequency, cryoablation, microwave, or even today's first generation microsecond pulse field systems share common limitations. They rely on relatively long duration energy delivery windows. They deliver current or temperature changes through tissue inefficiently. They cover small treatment areas, create shallow lesions, and often require repeated applications. Our NSPSA platform creates an entirely different and proprietary approach We deliver pulses measured in billionths of a second. At that time scale, with each pulse, the duration of a few billionths of a second, the energy interacts with cells through a non-thermal mechanism that initiates regulated cell death in target tissue while leaving collagen, blood vessels, nerves, and other non-cellular structures intact. The practical effect of NSPFA delivery is meaningful. NSPFA creates deeper and more durable lesions, delivered in dramatically less time, while providing a margin of safety that has been a core challenge for legacy energy sources. Surrounding this core technology, we have built a substantial and growing intellectual property estate that positions Pulse Biosciences as the clear first mover and the long-term leader We are developing this platform to treat atrial fibrillation, where the unmet need is enormous and where our differentiation seems to be pronounced. And we are advancing additional applications that leverage these remarkable underlying therapeutic advantages of NSPFA energy. Against this backslot, the first quarter of 2026 produced a true inflection point for PULSE. Three milestones defined the quarter and recent progress produced by our team. First, we presented landmark late-breaking data from our large European feasibility study at the AF Symposium, which set a new bar for what physicians and patients should expect from a pulse field ablation therapy. Second, leveraging this unprecedented clinical data set, We made the decision to strategically reshape Pulse Biosciences to focus on our highest value opportunity, our NPulse cardiac catheter for atrial fibrillation, and have rapidly reorganized our focus and operations to allocate an increased portion of our overall company resources to this program. And third, in just the past several weeks, we commenced enrollment in our IDE U.S. Pivotal Studies. Nanopulse AF, treating our first patients with the NSPFA catheter system in early April. We also released updated follow-up data from the European feasibility study, further validating strong, positive outcomes. Each one of these milestones represents a meaningful achievement. Together, they reflect a clinical development program of great importance moving at impressive speed. Today, I will provide updates on our NSPFA system in more detail and will then turn the call over to our Chief Financial Officer, Jon Skinner, to review the first quarter financial results. We will then conclude with a question and answer session joined by Bob Duggan, Co-Chair of the Board, and Leanne Toplisky, Chief Operating Officer. I will now begin with our impulse cardiac catheter system for AF ablation. Our impulse cardiac catheter system is purpose-built to address atrial fibrillation with a 360 degree circular design. The clinical goal of ablation in the treatment of parasympathetic AF is straightforward. Electrically isolate the pulmonary veins from the left atrium to prevent Abnormal electrical signals from triggering arrhythmias. Achieving that goal durably, efficiently, and safely has been the ongoing challenge in the field, and the ability to advance improvements in AF care will set our catheter apart from existing technology in this rapidly growing market. The NPulse NSPFA system represents what we believe is the world's first true single-shot pulmonary vein ablation treatment platform for AF. Early data suggests a physician can now rapidly position the circular catheter, deliver a single five-second application of nanosecond pulse energy per target location, and achieve a complete circumferential and transmural ablation without repositioning, without rotating, and without the need to stack multiple overlapping lesions. That workflow advantage stems directly from the underlying ultra-short duration and high energy pulse parameters unique to NSPFA energy and pulses unique catheter design, which is possible in part because of the unique properties of the energy. Because the energy is delivered in billionths of a second, The total cumulative energy transferred to tissue is dramatically lower, which means no measurable temperature rise and minimal neuromuscular stimulation. The result is a system designed for speed, reproducibility, and durability, qualities that make the procedure more streamlined and efficient for operators as we redefine the standard of care in electrophysiology. Since our last call, we announced a meaningful strategic alignment to prioritize and accelerate the development and future commercialization of our impulse cardiac catheter ablation system. The European feasibility study results from 177 patients send a powerful message. The impulse cardiac catheter system has the potential to improve clinical practice for millions of patients Living with Atrial Fibrillation. In response, we are increasingly prioritizing the program by allocating additional resources to our clinical and R&D teams to accelerate time to market for this catheter system. This investment in resources and focus will accelerate the pivotal IDE study, the introduction of additional clinical studies, and the development of our next generation catheters. As part of the strategic realignment, we continue to expand our EP leadership team. Most notably, Dr. David Kenigsberg has transitioned to a full-time chief medical officer. Dr. Kenigsberg will lead our clinical strategy, investigator engagement, medical affairs, and study execution as we enroll the pivotal IDE study and expand our clinical data set. In addition, We welcomed Leanne Toplitsky to the Pulse Biosciences executive team as chief operating officer, a newly created role on our executive leadership team. Leanne is a seasoned medtech executive with 20 years of experience and an exceptional track record of building and scaling innovative medtech businesses, particularly in electrophysiology. She held senior marketing and commercial leadership roles at Abbott Laboratories and St. Jude Medical, contributing to the development, clinical validation, and global commercialization of electrophysiology therapies. She will oversee our clinical, regulatory, quality, and commercial functions and will be focused on accelerating our strategic priorities with emphasis on the cardiac catheter development program. Collectively, the additions of David and Leanne strengthen our ability to execute a successful, pivotal IDE study and advance toward regulatory approvals. On the critical data front, we had a landmark war. At the Heart Rhythm 2026 meeting for HRS, Dr. Vivek Reddy, the national principal investigator of our pivotal study, presented late-breaking updated data from our NPulse cardiac catheter system first in human feasibility study. Building upon the very positive data presented at the AF Symposium in February, this newly expanded data set included six-month follow-up on 95 subjects and 12-month follow-up on 53 subjects within the five-second ablation cohort. The results were simply outstanding and reinforced the differentiated clinical profile we have observed since the earliest cases. Key findings included sustained 100% procedure success by 24-hour Holter of evaluable patients at six months, with 95 of 95 patients meeting the endpoint. Sustained 96% procedural success by 24-hour Holter of evaluable patients at one year, and sustained 90% Kaplan-Meier estimated freedom from recurrent AF atrial flutter or atrial tachycardia also at one year. Procedural performance data at HRS improved from the already impressive readout at AS Symposium with lower atrial dwell time, lower average number of applications, and lower procedure and fluoroscopy times. The safety profile also remained excellent with a primary safety endpoint, serious adverse event rate, of just 1.7% across 177 treated subjects. These outcomes are remarkable in a field where reported 20-25% AF recurrence rates are typical. It is particularly notable that our results were achieved without antiarrhythmic drugs and with a high degree of consistency across operators and sites, which is Typically difficult to achieve at an early stage of clinical development. As Dr. Reddy noted, the durability of pulmonary vein isolation plus the procedural efficiency we are observing is a positive combination not typically expected at this point in the clinical program. These results reflect the underlying advantages of nanosecond PSA and our innovative catheter design. Deeper lesion formation with fewer applications. Lower cumulative energy and durable pulmonary vein isolation in a fast, reproducible workflow. We believe our system directly addresses the limitations of current generation microsecond ablation catheters by enabling complete, durable isolation in a single energy delivery with the potential to reduce procedure time significantly. This time-saving advantage represents a meaningful potential capacity expansion for EP Procedures, and would likely drive rapid adoption of the NSPFA as the preferred next generation energy in the market, especially in light of the potential benefits of the efficacy improvements observed to date. As we look ahead toward the migration of AF ablation procedures to ambulatory surgery centers, or the AFC, we expect all the benefits of the impulse cardiac catheter to align directly with the needs of the ASC and the overall expansion of treating the growing population of patients with atrial fibrillation. The compelling body of clinical evidence from our European feasibility study provided a strong foundation for the most important operational milestone of the quarter, the commencement of our US IDE pivotal trial. In early April, we announced that the first patients had been enrolled in our Nanopulse AF study, a prospective multicenter IDE pivotal clinical investigation evaluating the end-pulse cardiac catheter system for the treatment of recurrent drug-resistant symptomatic paroxysmal atrial fibrillation. The first seven patients were treated at St. Bernard's Medical Center in Jonesboro, Arkansas, in just one day under the leadership of Dr. Debbie Nair, principal investigator of the arrhythmia research group. Dr. Nair has not previously used the impulse catheter, and the efficiency with which the procedures were completed speaks volumes about the short learning curve and usability benefits we can expect from our systems. Early feedback from physician investigators reinforces the user-friendly nature of the system and the efficient, reproducible, streamlined workflow it supports. This positive feedback has helped create significant enthusiasm for study participation. Site activation is accelerating, and we are encouraged by the current and planned enrollment momentum we are seeing. Based on the excitement and momentum coming out of HRS, along with the benefit of our strategic realignment, we are tightening our enrollment timeline to reflect the likely faster pace of our study execution. We now anticipate enrollment to be completed in early Q4 2026 compared to prior guidance that planned enrollment completion by the end of 2026. Regarding study follow-up, the final proportion of participants with primary effectiveness success or freedom from treatment failure through 12 months will be estimated using a Bayesian analysis that includes outcomes at 12 months for a subset of patients and at 6 months for the remainder. Using a blend of follow-up durations will shorten overall follow-up time for the study. This method allows determination of success earlier than traditional statistical methods used in other studies. Overall, we are accelerating both enrollment and follow-up timelines to optimize the planned filing date for the clinical P&A module. On the regulatory front in Europe, we expect to use the data from our European feasibility study to finalize our CE submission in the second half of 2026 with the potential for CE mark approval in mid-2027. We are also continuing discussions with potential strategic partner candidates. Potential partners include the world-class mapping providers and EP market leaders. A key advantage of the impulse cardiac catheter is its ability to be integrated with all mapping systems. This creates a compelling synergy in which our partner or partners may gain access to the most advanced nanosecond PSA energy solution available. These partnership conversations are active and we will share details of partnership prospects when the time is appropriate. Let's now discuss our surgical ablation clamp. Our impulse cardiac clamp pivotal study, NanoClampAS, is the first and only clinical study of a surgical device delivering PSA to receive FDA IDE approval. The impulse cardiac clamp applies nanosecond PFA energy to create durable transmural lesion sets during concomitant procedures where the surgeon has direct cardiac tissue access and atrial fibrillation is present. The clinical opportunity is substantial. However, despite strong guideline support for concomitant AF treatment during cardiac surgery, adoption of currently available devices remains low. We believe the primary adoption barriers have been procedural complexity, unreliable outcomes, and too much time added to the surgery. Concerns that nanosecond PSA may directly address through a combination of rapid energy delivery, reproducible lesion formation, and a straightforward surgical workflow. We continue to believe that concomitant ablation for preoperative AF is significantly underutilized and that the speed and effectiveness of NSPFA energy can transform this therapy and market. Enrollment in NanoClamp AF continued to progress during the first quarter. As a reminder, the trial is a prospective single-arm, multi-center study designed to assess the primary safety and effectiveness of the impulse cardiac surgical system in treating AF during concomitant cardiac surgeries. We plan to enroll a target of 136 patients at approximately 20 sites, including two international locations. Reflecting our strategic prioritization of the EP catheter ablation program, including some resource shifts, we now expect to complete enrollment of this IDE study by the end of the first half of 2027. We have moderated near-term development in cardiac surgery while maintaining trial execution and regulatory preparation, and clinical site activations continue to expand during Q1. In Europe, we continue to generate excellent results in our cardiac surgery feasibility study. To date, investigators have treated over 60 patients, and we have expanded the study to now include six clinical sites. Within this 60-patient cohort, 34 patients underwent electroanatomical mapping approximately three months after their ablation procedures to assess the effectiveness and durability of the treatment. These data were presented at the European Heart Rhythm Association 2026 meeting and are very promising, with individual ablation times averaging a very rapid 41 seconds total per patient. Notably, As patient numbers have increased, the PBI success rate of 94% at approximately three months has remained consistent with the clinical outcomes we reported in our initial data readout in October of 2025. Surgeons using the system have reported favorable procedural characteristics, rapid ablation delivery, consistent lesion quality, and smooth integration into existing surgical workflows without meaningful time or Complexity added to the underlying surgery. Feedback from the surgical community emphasizes that workflow efficiency and predictability matter as much as efficacy in the operating room. And the early signal is that nanosecond PSA delivers very favorably on both. We remain on track to submit for CE mark by the end of 2026 using the European clinical data set. Turning to our NPulse Vibrance Percutaneous Electro System. The NPulse Vibrance System applies nanosecond PFA technology to ablate soft tissue in surgical procedures through a percutaneous approach, offering, for example, an alternative to surgical removal for patients with symptomatic benign thyroid nodules. Vibrance is designed to address this patient population through a minimally invasive outpatient procedure that reduces nodule volume, alleviates symptoms, and preserves surrounding anatomy and normal thyroid function, outcomes that cannot be achieved with traditional surgical excision. In the first quarter, the team generated approximately $400,000 in revenue from impulse Vibrance systems and electrodes. Our approach continues to be extremely disciplined and remains focused on core market development objectives. We continue to operate at an intentionally limited scale to demonstrate how meaningful over the long term and how well we can service initial Vibrance customers in exploring along with them the potential of the NPulse Vibrance system. Our work is focused on ensuring we generate robust clinical data to support A treatment indication while formalizing patient reimbursement to expand patient access in partnership with key accounts at large hospital systems in select geographies. On the clinical front, the precise ETM, or benign thyroid nodule, study reached an important milestone with enrollment of the first 50 patients now completed. We have further expanded the study to 100 patients to broaden the data set, supporting adoption and long-term market expansion. It is also notable that scientific recognition of this work continues to build. Data from Dr. Stefanos Biasia of Maples, Italy, were presented in a podium session at the North American Society of Interventional Thyroidology, or NASF. In March, which demonstrated remarkable results. Data presented from durable 15 to 22-month results showed 74% volume reduction of treated benign thyroid nodules with overwhelming patient satisfaction reported. Continued volume reduction improvements were seen from 1 month to 22 months with no regrowth of nodules at 15 to 22 months. In parallel with the precise BGN study, we are continuing to expand the clinical scope of the Vibrance platform through our research collaboration with the University of Texas MD Anderson Cancer Center. Under this collaboration, we are conducting a first in human feasibility study evaluating NSPFA for the treatment of papillary thyroid microcarcinoma, PTNC, on up to 30 patients at two sites and we are happy to announce that first patient enrollments were completed in Q1. We continue to expect to complete enrollment by year end 2026. With that, I will turn the call over to Jon to speak about our first quarter financial results. Jon?