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Pulse Biosciences (PLSE) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 6, 2026

Source: earnings call transcript

Executive summary

Pulse Biosciences Q2 FY26 — Accelerated Clinical Enrollment and Strengthened Balance Sheet

Pulse Biosciences reported a quarter of significant clinical and financial progress, highlighted by accelerated enrollment in its pivotal AFib catheter study and a bolstered balance sheet. The company is leveraging strong physician enthusiasm for its nsPFA technology, which demonstrates rapid procedure times and high efficacy in early data, while strategically expanding its Vybrance thyroid nodule program through key partnerships. Management remains focused on advancing regulatory approvals and preparing for commercialization, supported by a strong cash position.

Highlights

5

  • Strengthened balance sheet with over $100 million cash on hand, including $57.5 million net proceeds raised through ATM program.

  • Accelerated enrollment in pivotal nPulse Cardiac Catheter IDE study, surpassing halfway point ahead of schedule and targeting early Q4 completion.

  • Presented outstanding European nPulse Cardiac Catheter feasibility data at HRS, showing 90% Kaplan-Meier estimated freedom from recurrent AF at 1 year and 1.7% serious adverse event rate.

  • Vybrance disposable sales increased sequentially to $434,000 in Q2 FY26 from $400,000 in Q1 FY26.

  • New partnership with Clayman Thyroid Center to generate registry data and study protocols for Vybrance system therapy.

Concerns

4

  • GAAP net loss increased to $24.7 million in Q2 FY26 from $19.2 million in prior year period.

  • Non-GAAP net loss increased to $19.4 million in Q2 FY26 from $13.7 million in prior year period.

  • Cash used in operating activities increased to $18.7 million in Q2 FY26 from $12.8 million in prior year period.

  • Total GAAP costs and expenses increased by $5.4 million to $25.7 million, primarily due to increased investment in clinical programs and compensation.

Guidance & targets

CategoryTargetConfidence
NANOPULSE-AF Study Enrollment Completion
Early October
high materiality
High
NANOPULSE-AF Study Enrollment Completion (Revised Target)
Early October
high materiality
High
nPulse Cardiac Catheter CE Approval
Around the middle of 2027
high materiality
Medium
Surgical Clamp CE Mark Filing
Before the end of 2026
medium materiality
High
NANOCLAMP AF Study Enrollment Completion
End of the first half of 2027
medium materiality
Medium
PTMC Feasibility Study Enrollment Completion
Year-end 2026
low materiality
High
Quarterly Operating Expenses (Non-GAAP)
Remain in this range
medium materiality
Medium

Segment performance

SegmentRevenueYoYQoQMargin
Vybrance Percutaneous Electrode System
Disposable sales for the nPulse Vybrance System, used for benign thyroid nodules, showed sequential growth.
$434,000—sequential increase from $400,000—

Deals & partnerships

Clayman Thyroid Center Partnership focused on supporting core strategy of demonstrating the viability of the Vybrance system therapy for patients with symptomatic benign thyroid nodules.

Key elements include registry data generation and unique study protocols for interventional therapy in thyroid disease. The center has onboarded the Vybrance system and performed its first cases.

Risks & headwinds

Complex environment for raising capital Current

Qualitative statement

Mitigation:Successfully raised $57.5 million in net proceeds through ATM program, bolstered balance sheet, and secured new $75 million ATM facility.

Increased operating expenses due to clinical investments Q2 FY26

Total GAAP costs and expenses increased by $5.4 million to $25.7 million. Non-GAAP costs and expenses increased by $5.7 million to $20.5 million.

Mitigation:Remain disciplined on expense growth while prioritizing financing through key milestones. Expect quarterly operating expenses to remain in this range on a non-GAAP basis.

Potential FDA scrutiny on expanded AAD criteria for NANOPULSE-AF study Current

Added 19 patients to the NANOPULSE-AF study enrollment target (from 145 to 164).

Mitigation:Increased study size to bolster statistical assurance and bring equilibrium to moving parts, without impacting enrollment timeline due to high velocity.

What to watch in Q3 FY26

NANOPULSE-AF study enrollment completion

Early October
Current Over 82 evaluable patients treated (midpoint surpassed)
Target Full enrollment completed

Why it matters

Completion of enrollment is a major de-risking event and moves the timeline closer to regulatory submission and potential approval.

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, 3 months earlier than our original timeline.

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Q&A highlights

Given rapid enrollment, will the company wait for full 12-month data for PMA submission, or use the 6/12-month blended endpoint?

Paul LaViolette explained that the 12-month follow-up on the earlier patient cohort is the 'long pole in the tent,' but rapid enrollment means the absolute time differential between 6 and 12-month data points is relatively short. They will use all tools to manage timelines effectively. Bob Duggan added that faster enrollment is a positive product feature due to ease of use and economic benefits for the OR.

“12 months from the earlier patient group is the long pole in the tent. And despite that, we'll certainly, we're going to be using all tools available to us to manage timelines effectively, including enrollment, including follow-up, and then, of course, submitting very clean data to provide FDA the opportunity to minimize their review time once submitted.”

asked by Bill Plovanic (Canaccord Genuity) · answered by Paul LaViolette

2 min read 5 chapters

Detailed narrative

nPulse Cardiac Catheter System Progress

The NANOPULSE-AF pivotal study for AF ablation has surpassed its enrollment midpoint with over 82 evaluable patients treated, significantly ahead of schedule. The company confirmed an accelerated target completion date of early October, three months earlier than originally planned, despite increasing the total enrollment target by 19 patients to 164 to better reflect contemporary clinical practice. Site activation is proceeding well, with 12 active study sites and more in the queue.

Strong Clinical Data and Physician Enthusiasm

European feasibility data for the nPulse Cardiac Catheter showed 100% freedom from AF at 6 months and 96% at 1 year, with 90% Kaplan-Meier estimated freedom from recurrent AF, flutter, or tachycardia at 1 year, and a low serious adverse event rate of 1.7%. Physicians report the system is intuitive, with a straightforward learning curve, enabling rapid procedure and ablation times, with some sites performing 5 to 7 cases per day compared to 2 to 3 cases with other technologies.

Surgical Clamp Program Updates

The surgical clamp program's EU feasibility study has treated over 70 patients across 6 sites, demonstrating excellent lesion durability and procedural efficacy with 94% pulmonary vein isolation success at 3-month follow-up, unchanged from October 2025. Total ablation time averaged 41 seconds per patient. The U.S. pivotal study, NANOCLAMP AF, continues enrollment across 20 centers (3 international) with a target of 136 patients and is expected to complete by the end of the first half of 2027.

Vybrance Percutaneous Electrode System Development

Vybrance disposable sales were $434,000 in Q2, a sequential increase from $400,000 in Q1. A new partnership with the Clayman Thyroid Center aims to generate registry data and study protocols for benign thyroid nodules. The PRECISE-BTN study was expanded from 50 to 100 patients and is expected to be fully enrolled this month, with data showing 74% nodule volume reduction at 15-22 months. A multi-center, first-in-human feasibility study for papillary thyroid microcarcinoma (PTMC) is half enrolled and expected to complete by year-end 2026.

Financial Position and Capital Strategy

Pulse Biosciences bolstered its balance sheet with over $100 million cash on hand as of June 30, 2026, including $57.5 million in net proceeds raised through an ATM program since May. This extends the company's runway to fund clinical and regulatory milestones. A new $75 million ATM facility has been put in place to preserve financing flexibility, and $1.8 million was received from warrant exercises in July.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.