Pulse Biosciences Inc ((PLSE)) has held its Q1 earnings call. Read on for the main highlights of the call.
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Pulse Biosciences Inc. recently held its earnings call, revealing a mixed sentiment. The company showcased significant advancements in clinical trials and FDA approvals, highlighting robust progress in technology and market penetration. However, challenges remain with increased operating expenses and cash usage, which require attention.
FDA Clearances and Breakthrough Device Designation
Pulse Biosciences has achieved a commendable milestone by obtaining seven FDA clearances and receiving a breakthrough device designation for their cardiac surgical clamp. This achievement underscores the strong validation and potential of their technology in the medical field.
Successful Clinical Trials
The company’s nsPFA 360 catheter has shown promising results in clinical trials, demonstrating excellent procedure efficiency and acute outcomes. In European clinical feasibility studies, 130 AF patients were successfully treated, marking a significant step forward in the product’s development.
Positive Outcomes for Thyroid Nodule Treatment
Pulse Biosciences reported impressive results for their nsPFA percutaneous electrode, achieving an average 83% volume reduction in thyroid nodules at one year. Additionally, patients experienced significant symptom reductions just one month post-treatment, indicating the treatment’s effectiveness.
Increased Cash Position
The company successfully raised $14 million through the exercise of warrants, boosting their cash and cash equivalents to $119.3 million as of March 31, 2025. This increase in cash position strengthens the company’s financial footing.
Encouraging Cardiac Catheter System Results
The 360 cardiac catheter system has delivered encouraging results, with a 94.2% success rate for pulmonary vein isolation and a 95.5% success rate for left atrial posterior wall isolation. These outcomes reflect the system’s potential efficacy in cardiac procedures.
Increased Operating Expenses
Despite the positive developments, Pulse Biosciences faced increased operating expenses, with total GAAP costs rising by $7.4 million to $18 million. This increase is primarily attributed to higher noncash stock-based compensation and other administrative expenses.
Higher Cash Usage
The company reported higher cash usage in operating activities during Q1 2025, amounting to $13.5 million, compared to $9.8 million in the same period the previous year. This rise in cash usage highlights the need for careful financial management.
Forward-Looking Guidance
Looking ahead, Pulse Biosciences is strategically focused on advancing its Nanosecond Pulsed Field Ablation (nsPFA) technology across various medical fields. The company aims to commercialize a percutaneous electrode for soft tissue ablation in benign thyroid disease and initiate IDE pivotal studies for their Cardiac 360 catheter and cardiac surgical clamp. Despite reporting a GAAP net loss of $16.8 million for Q1 2025, the company maintains a strong cash position, reflecting its commitment to innovative therapies and transforming patient care.
In summary, Pulse Biosciences Inc.’s earnings call highlighted significant technological advancements and FDA approvals, signaling robust progress. However, increased operating expenses and cash usage pose challenges that need addressing. The company’s strategic focus on advancing nsPFA technology and its applications holds promise for future growth and innovation.