10-Q: Pulse Biosciences Reports First Quarter 2025 Financial Results, Highlights Progress in Atrial Fibrillation and Soft Tissue Ablation

Pulse Biosciences reports a net loss of $16.8 million for Q1 2025, focusing on advancing its Nano-pulse Stimulation (NPS) technology in cardiology and soft tissue ablation.

Summary

• Pulse Biosciences reported a net loss of $16.8 million for the first quarter of 2025, compared to a net loss of $10.1 million for the same period in 2024.
• The company is focused on advancing its Nano-pulse Stimulation (NPS) technology, particularly in atrial fibrillation (AF) treatment and soft tissue ablation.
• Research and development expenses increased to $10.3 million, driven by higher stock-based compensation and compensation-related expenses.
• General and administrative expenses rose to $7.7 million, also due to increased stock-based compensation and compensation-related costs.
• The company had cash and cash equivalents of $119.3 million as of March 31, 2025.
• Pulse Biosciences believes its existing cash will fund operations for at least the next twelve months but plans to raise additional capital.
• The company is pursuing a PMA application for FDA approval of its cardiac clamp for AF treatment, with a pivotal clinical trial expected to begin in mid-2025.
• A U.S. IDE pivotal clinical study of the proprietary 360 Cardiac Catheter is expected to commence in mid-2025.
• The company has placed its CellFX System with eight sites in the United States and these sites have been performing initial patient treatments and evaluating the CellFX System under short-term evaluation agreements.
• To date, the clinicians in our pilot program have completed more than 90 patient procedures.

Sentiment

Score: 5

Explanation: The sentiment is neutral. While the company is making progress in its clinical programs, it is also experiencing increasing losses and needs to raise additional capital. The future success of the company is dependent on the successful development and commercialization of its technology.

Positives

• The company's cash position remains strong at $119.3 million.
• The company is advancing its cardiac surgical clamp for AF treatment towards a pivotal clinical trial.
• The company is planning a U.S. IDE pivotal clinical study of the proprietary 360 Cardiac Catheter.
• The company has placed its CellFX System with eight sites in the United States and these sites have been performing initial patient treatments and evaluating the CellFX System under short-term evaluation agreements.
• To date, the clinicians in our pilot program have completed more than 90 patient procedures.

Negatives

• The net loss increased to $16.8 million in Q1 2025 from $10.1 million in Q1 2024.
• The company has a history of operating losses and expects to continue incurring losses for the next several years.
• The company is dependent on raising additional capital to fund its operations.

Risks

• The company's future success depends on the successful development and commercialization of its NPS technology.
• The company faces intense competition in the medical device industry.
• The company is subject to stringent regulatory requirements and potential product liability claims.
• The company may not be able to obtain adequate reimbursement for its products from third-party payers.
• The company is dependent on raising additional capital to fund its operations.
• The company may find it difficult to enroll patients in our clinical trials.

Future Outlook

Pulse Biosciences expects its existing cash and cash equivalents will be sufficient to fund its projected operating requirements for at least the next twelve months but plans to raise additional capital in the future. The company plans to pursue a PMA application for FDA approval of its cardiac clamp for AF treatment, with a pivotal clinical trial expected to begin in mid-2025. A U.S. IDE pivotal clinical study of the proprietary 360 Cardiac Catheter is expected to commence in mid-2025.

Management Comments

• The company decided in 2022 to focus our primary efforts on the use of nsPFA energy and the CellFX platform in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers, such as surgical soft tissue ablation.
• We expect to pursue more clinical evidenced-based milestones throughout 2025 in connection with evaluating the early pilot commercialization of our percutaneous electrodes, and we expect to commence a clinical trial in mid-2025 to support the commercialization of the nsPFA Percutaneous Electrode System in the United States as a treatment for benign thyroid nodules.

Industry Context

Pulse Biosciences is operating in the competitive medical device industry, focusing on ablation technologies. The company is targeting the atrial fibrillation market, which is a growing area with significant unmet needs. The company is competing with larger, more established companies in the cardiac ablation market.

Comparison to Industry Standards

• Pulse Biosciences is competing with established companies like Abbott, AtriCure, Boston Scientific, Johnson & Johnson (Biosense Webster), and Medtronic in the cardiac ablation market.
• These companies have greater financial, technical, and marketing resources than Pulse Biosciences.
• The company's nsPFA technology is differentiated from standard thermal ablation modalities and micro-PFA, but it needs to demonstrate superior efficacy and safety in clinical trials to gain market share.
• The company's success depends on obtaining regulatory approvals, securing reimbursement, and educating physicians on the benefits of its technology compared to existing alternatives.

Legal Proceedings

• From time to time, we may be involved in various legal proceedings arising in the ordinary course of business.
• We are not presently a party to any legal proceedings that, in the opinion of management, could have a material adverse effect on our results of operations or financial condition.

Related Party Transactions

• Robert W. Duggan, the Company's majority stockholder and Co-Chairman, purchased approximately 88% of the units offered through the 2024 Rights Offering.

Stakeholder Impact

• Shareholders face the risk of dilution from future capital raises.
• Employees are subject to potential restructuring and headcount reductions.
• Customers (surgeons and physicians) may benefit from new and improved ablation technologies.
• Suppliers and creditors are subject to the company's ability to meet its financial obligations.

Next Steps

• The company expects to pursue more clinical evidenced-based milestones throughout 2025 in connection with evaluating the early pilot commercialization of our percutaneous electrodes.
• The company expects to commence a clinical trial in mid-2025 to support the commercialization of the nsPFA Percutaneous Electrode System in the United States as a treatment for benign thyroid nodules.
• The company expects to begin our pivotal clinical trial of the cardiac surgical clamp for AF in mid-2025.
• The company expect to commence a U.S. IDE pivotal clinical study of our proprietary 360 Cardiac Catheter sometime in mid-2025.

Key Dates

Keywords

Pulse Biosciences, Nano-pulse Stimulation, Atrial Fibrillation, Soft Tissue Ablation, CellFX System, nsPFA, Cardiac Clamp, Cardiac Catheter, Clinical Trial, FDA, Financial Results