Pulse Biosciences, Inc. (PLSE) Earnings

Management highlights

### Strategic Focus Update * Reaffirmed strategic alignment to prioritize the NPulse cardiac catheter AFib ablation program, while continuing disciplined advancement of the surgical clamp and thyroid programs * Added two key senior leaders: Liane Teplitsky as Chief Operating Officer and Dr. David Kenigsberg as full-time Chief Medical Officer to strengthen execution of the pivotal trial and regulatory path ### NPulse Cardiac Catheter Program Milestones * Enrolled the first patient in the U.S. pivotal IDE study in Q2 2026, and has already surpassed the 50% enrollment mark with 82 evaluable patients net of roll-ins as of mid-July 2026, well ahead of original schedule * Amended the study protocol to expand eligibility: reduced prior antiarrhythmic drug (AAD) failure requirements to allow patients who have failed any one of four AAD classes (better reflecting current clinical practice), and increased total enrollment from 145 to 164 patients, while still maintaining the accelerated enrollment timeline * Expanded active study sites to 12 (protocol allows up to 30, but full activation of all 30 is not needed given current enrollment velocity), with a 15% per-site enrollment cap to avoid excessive data skew to a small number of centers * Presented positive expanded 6-month feasibility data at the 2026 Heart Rhythm Society (HRS) meeting: 1-year estimated freedom from recurrent AF/flutter/tachycardia compared favorably to competing technologies, with a 1.7% serious adverse event rate across 177 European feasibility patients * All enrolled patients to date have used Abbott's Insight (NSITE) mapping system; the protocol allows use of any commercial mapping system, but no changes to mapping use for remaining enrollment have been announced * CE mark submission for the NPulse catheter is on track for H2 2026, with potential approval around mid-2027 * Ongoing partnership discussions with established electrophysiology players that have existing mapping technologies to support commercial go-to-market ### Surgical Clamp Program Milestones * The NanoClamp AF pivotal IDE study (the only FDA-approved IDE trial for a PFA surgical ablation device) continues to enroll, with a target of 136 patients across 20 centers * European feasibility study has treated over 70 patients across 6 sites; 3-month data presented at EHRA 2026 showed excellent lesion durability, 100% pulmonary vein isolation success, and an average total ablation time of just 41 seconds per patient ### Vibrance Thyroid Program Milestones * Announced a new strategic partnership with the Klayman Thyroid Center (the largest U.S. thyroid surgery center) to generate registry data and study protocols for NSPFA treatment of symptomatic benign thyroid nodules; the center has already onboarded the system and completed first cases * The company's Precision BTN benign thyroid nodule study was expanded from 50 to 100 patients to deepen the clinical dataset, and is expected to complete enrollment in August 2026 * Published 15-22 month data from an Italian study showing a 74% average reduction in treated nodule volume, no nodule regrowth, rapid symptom relief, and high patient satisfaction, presented at the 2026 NASIT meeting * First-in-human feasibility study for papillary thyroid microcarcinoma (PTMC) in collaboration with MD Anderson Cancer Center is approximately 50% enrolled, on track to complete enrollment by end-2026, with plans for additional trials expanding thyroid indications ### Balance Sheet Update * Strengthened cash position to over $100 million, extending operating runway through key upcoming clinical and regulatory milestones; completed a $57.5 million ATM offering (with $46.8 million raised in Q2) including $13 million in insider purchases, demonstrating management confidence * Put in place a new $75 million ATM facility to preserve future financing flexibility, and has no remaining outstanding warrants after July 2026 warrant redemptions

Guidance

• Full enrollment of the Nanopulse AF pivotal IDE study is expected to be completed in early Q4 2026 (early October 2026), three months ahead of the original timeline, even after the 19-patient enrollment increase • CE mark submission for the NPulse cardiac catheter is expected in H2 2026, with potential approval around mid-2027 • Quarterly non-GAAP operating expenses are expected to remain around the current Q2 2026 level of ~$20.5 million as the company continues to invest in clinical programs • The Precision BTN benign thyroid nodule study is expected to complete full enrollment in August 2026 • The PTMC thyroid feasibility study is expected to complete enrollment by the end of 2026 • Management confirmed the company now has at least five quarters of cash on hand relative to current forward spending, supporting progress through all key upcoming milestones

Segment performance

Pulse Biosciences is a clinical-stage medical device company focused on its proprietary nanosecond pulse field ablation (NSPFA) platform, with three primary development segments: 1) NPulse cardiac catheter ablation for atrial fibrillation (AFib): This is the company's top strategic priority, with no commercial revenue recognized from this segment in Q2 2026 as it remains in pivotal clinical testing. 2) NanoClamp surgical ablation clamp for concomitant AFib treatment during open heart surgery: Also in pivotal IDE testing, with no commercial revenue in Q2 2026. 3) Vibrance system for benign thyroid nodule treatment: Early clinical and market development, with minimal procedural revenue. Overall GAAP revenue for the entire company in Q2 2026 was $434,000, with cost of revenue of $273,000. Total GAAP operating costs and expenses were $25.7 million, up $5.4 million year-over-year, driven by increased clinical trial investment and employee compensation spend. Non-GAAP operating expenses were $20.5 million, up $5.7 million YoY, with a non-GAAP net loss of $19.4 million, compared to a $13.7 million non-GAAP net loss in Q2 2025. Cash and cash equivalents as of June 30, 2026 totaled $101.6 million after $46.8 million in net proceeds raised during the quarter via the company's ATM offering program.

Risks & headwinds

• Forward-looking statements around clinical enrollment timelines, regulatory approval timelines, product efficacy, and commercial adoption are subject to inherent risks and uncertainties, which are detailed in the company's SEC filings; actual results may differ materially from current expectations • Enrollment velocity could be impacted by the 15% per-site enrollment cap, as early high-performing sites hit their limits and new sites need to be activated to maintain current pacing • There is uncertainty around FDA review timelines and the acceptability of the blended 6- and 12-month follow-up endpoint for the pivotal study, even with the protocol adjustments made to maintain statistical rigor • The AFib ablation market is already competitive with established players, and there is no guarantee that NSPFA technology will achieve meaningful market penetration or that a favorable partnership or commercial launch outcome will be realized • Clinical trial results to date are early, and there is no guarantee that final pivotal study results will match the positive efficacy and safety signals seen in feasibility and early IDE enrollment

Analyst Q&A

• Q: Given faster-than-expected enrollment, will the company still use the blended 6- and 12-month follow-up endpoint, or wait for full 12-month data for all patients for PMA submission? /

  A: The 12-month follow-up for the earliest enrolled patients remains the longest lead-time item for the study. Even with rapid enrollment, the absolute time difference between different follow-up approaches is relatively small. Management is prioritizing enrollment speed and data quality over changing the endpoint structure, and will use all available tools to minimize overall timeline, including working to enable efficient FDA review once data is submitted. The main takeaway from rapid enrollment to date is strong physician adoption and a very low learning curve for the catheter.

• Q: Will the rapid enrollment pacing hold after early high-performing sites hit the 15% per-site enrollment cap? /

  A: FDA requires a 15% enrollment cap per site to avoid excessive skew to a small number of centers, and several early high-volume sites have already hit this cap. The company is continuing to activate new sites from its existing queue, and new sites are just as enthusiastic to enroll patients as early sites. While enrollment pacing will naturally adjust as sites turnover, management expects to maintain the current accelerated timeline to full enrollment in early October 2026.

• Q: With the new capital raised, does the cash position support pre-launch infrastructure buildout as well as clinical trial costs? /

  A: The current cash position gives the company at least five quarters of runway at current spending levels, and provides flexibility to prepare for commercial launch whether the company proceeds via partnership or builds its own direct sales and marketing infrastructure. Management is already receiving inquiries from experienced sales and marketing talent, and has experience scaling commercial operations from zero to $1 billion in annual revenue quickly, so it is prepared for launch regardless of the path it chooses.

• Q: Is the NPulse catheter's procedural efficiency advantage sufficient to drive strong adoption even if efficacy ends up in line with competing technologies? /

  A: The NSPFA mechanism kills target cells irreversibly, unlike competing ablation technologies that can stun cells leading to later recurrence, so management expects long-term efficacy to be superior to competitors. Even if efficacy were comparable, the major advantages in procedural speed, workflow, and hospital economics (allowing 5-7 cases per day versus 2-3 for existing technologies) are already driving massive physician enthusiasm, and the market has historically shifted to new technologies based on acute performance even without proven efficacy differences. This makes the current value proposition very strong regardless of near-term outcome data.