PULSE BIOSCIENCES, INC. Q1 FY2026 earnings call

Product Segment Highlights - nPulse Cardiac Catheter System: Presented landmark late-breaking data from European feasibility study at AF Symposium. Strategically reshaped to focus on nPulse Cardiac Catheter for atrial fibrillation. Commenced enrollment in IDE U.S. pivotal study NANOPULSE-AF. Expanded EP leadership team with Dr. David Kenigsberg as Chief Medical Officer and Liane Teplitsky as Chief Operating Officer. - Surgical Ablation Clamp: NANOCLAMP-AF trial enrollment continued, with expectations to complete enrollment by end of first half of 2027. European cardiac surgery feasibility study had over 60 patients treated, with promising data. - nPulse Vybrance Percutaneous Electrode System: Generated revenue, PRECISE-BTN study completed first 50 patient enrollment and expanded to 100, data presented at NASIT, and collaboration with University of Texas MD Anderson Cancer Center for papillary thyroid microcarcinoma study with first patient enrollments in Q1. ### Financial: First quarter revenue $401,000, cost of product revenue $370,000. GAAP and non-GAAP costs and expenses increased, GAAP and non-GAAP net losses increased. Cash and cash equivalents decreased from end of 2025, cash used in operating activities increased, but company has shelf registration and ATM program with availability.

For the nPulse Cardiac Catheter System: In the first quarter, the company is prioritizing and allocating additional resources to accelerate its development. The European feasibility study showed promising results. For the nPulse Vybrance Percutaneous Electrode System: Generated approximately $400,000 in revenue. The PRECISE-BTN study completed enrollment of the first 50 patients and expanded to 100, and data from Dr. Stefano Spiezia was presented. For the surgical ablation clamp: Enrollment in NANOCLAMP-AF continued, with expectations to complete enrollment by the end of the first half of 2027. Total revenue for the first quarter was $401,000, cost of product revenue was $370,000. GAAP costs and expenses increased by $1.6 million to $19.6 million, non-GAAP costs and expenses increased by $4.7 million to $17.4 million. GAAP net loss was $18.6 million, non-GAAP net loss was $16.4 million.

Forward-Looking Statements - Enrollment in NANOPULSE-AF study now anticipated to be completed in early Q4 2026 instead of end of 2026. - Expect to submit for CE Mark by end of 2026 for surgical ablation clamp using European clinical data set. - Continue to advance clinical programs and partnerships while maintaining financial discipline to fund through milestones.

Risks - Actual results may differ materially from forward-looking statements due to certain risks and uncertainties described in press release and SEC filings. - Differences in patient populations between European feasibility study and U.S. pivotal study could potentially impact durability statistics, although steps are being taken to manage this risk. - Dependence on successful completion of clinical trials and regulatory approvals for market entry and commercialization.

Q: Did you highlight the number of sites that are as part of the clinical trial? The limits to each site because you don't want too much concentration. And finally, if these patients are consciously sedated or general anesthesia.

A: Regarding the number of sites, we have approval for up to 30 sites, but likely to involve active sites less than 30. Limits per site are typically around 15% to 20% of total enrollment. The protocol in the pivotal study calls for general anesthesia.

Q: Maybe taking it from HRS, the podium presentation, Dr. Reddy, maybe a little bit of noise that crept into the dialogue there at HRS relative to AF Symposium, sort of the idea that as we expand to more sites in the U.S., we potentially enroll a somewhat sicker patient population in the U.S., that we can see at least some degradation to the durability statistics that we saw out of the early feasibility study. So maybe just walk through the expectations for the capability to maintain durability, how continuous mapping can potentially help to improve that. And any risk that there may be just from the differences in patient populations. And then follow-ups on EnSite being the only mapper and soft tissue ablation, papillary thyroid microcarcinoma.

A: The data set so far has been strong. Patient populations in Europe and U.S. are principally paroxysmal, with minor differences like BMI. Mapping with EnSite provides high precision. EnSite is likely to be the main mapper in the IDE. For papillary thyroid microcarcinoma, it's the single most commonly diagnosed thyroid cancer, with significant TAM opportunity including benign nodules and papillary microcarcinoma patients.