Pulse Biosciences, Inc Common Stock (DE) 2026 Q2 Earnings Call

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 sixth, 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 & 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, Tripp. 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 one. 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 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, three 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 five and up to seven cases in a day, and multiple physicians have completed their initial cases with seven to eight minutes or faster ablation times. With other ablation catheters currently available, EP labs generally do not schedule more than two to three 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.

Patients that have failed any one of the four 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. 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 six-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 six-month follow-up on 95 patients and 12-month follow-up on 53 patients within the five-second ablation cohort. These data were outstanding. 100% freedom from AF measured by 24-hour Holter monitor at six months, and 96% as measured by 24-hour Holter monitor at one year, along with 90% Kaplan-Meier estimated freedom from recurrent AF, flutter, or tachycardia at one 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 anti-arrhythmic 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 six 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.