8-K: Pulse Biosciences Announces Business Updates and Fourth Quarter 2024 Financial Results

Pulse Biosciences reports positive preliminary results from its first-in-human feasibility study using Nanosecond Pulsed Field Ablation technology for the treatment of benign thyroid nodules and announces financial results for the fourth quarter and full year ended December 31, 2024.

Summary

• Pulse Biosciences announced business updates and financial results for the fourth quarter and full year ended December 31, 2024.
• The company reported positive preliminary results from its first-in-human feasibility study for treating benign thyroid nodules using Nanosecond Pulsed Field Ablation (nsPFA) technology.
• They are advancing a pilot program with 8 centers in the U.S. expected to begin commercial use of the system in the coming months.
• A U.S. clinical trial is expected to commence in mid-2025 to evaluate the Percutaneous Electrode System for treating benign thyroid nodules.
• A preclinical study demonstrated the advantages of the nsPFA Cardiac Surgery System over radiofrequency technology for cardiac tissue ablation.
• The company treated 30 patients and opened a second study site in Europe for its atrial fibrillation (AF) feasibility study.
• Pulse Biosciences expects to submit an IDE in mid-2025 to commence a pivotal clinical trial for FDA approval of the nsPFA Cardiac Surgery System for AF treatment.
• Positive clinical data was released from the Nanosecond PFA 360 Cardiac Catheter System first-in-human feasibility study.
• Over 80 patients have been treated with the Nanosecond PFA 360 Cardiac Catheter System in Europe for AF treatment.
• David Kenigsberg, M.D., was appointed as Chief Medical Officer of Electrophysiology.
• The company expects to commence a U.S. IDE pivotal clinical study in mid-2025 for the 360 Cardiac Catheter System.
• Pulse Biosciences strengthened its balance sheet by raising $47.9 million in the fourth quarter through warrant exercises.
• Paul LaViolette was appointed Co-Chairman of the Board of Directors and remains Chief Executive Officer.
• Jon Skinner was appointed Chief Financial Officer.
• Total GAAP costs and expenses for the fourth quarter of 2024 were $20.3 million, compared to $12.5 million in the prior year period.
• Non-GAAP costs and expenses for the fourth quarter of 2024 were $11.3 million, compared to $8.9 million in the prior year period.
• GAAP net loss for the fourth quarter of 2024 was ($19.4) million, compared to ($11.9) million for the fourth quarter of 2023.
• Non-GAAP net loss for the fourth quarter of 2024 was ($10.4) million, compared to ($8.3) million for the fourth quarter of 2023.
• Cash and cash equivalents totaled $118.0 million as of December 31, 2024, compared to $44.4 million as of December 31, 2023.
• Cash used in the fourth quarter of 2024 totaled $9.3 million, compared to $6.9 million used in the same period in the prior year.
• Total GAAP costs and expenses for the full year of 2024 were $56.3 million, compared to $43.6 million in 2023.
• Non-GAAP costs and expenses for the full year of 2024 were $39.6 million, compared to $35.1 million in the prior year.
• GAAP net loss for the full year of 2024 was ($53.6) million, compared to ($42.2) million for 2023.
• Non-GAAP net loss for 2024 was ($36.9) million, compared to ($33.8) million for 2023.

Sentiment

Score: 6

Explanation: The sentiment is neutral to slightly positive. While the company is experiencing increased losses and expenses, they have also made significant progress in clinical trials, strengthened their balance sheet through warrant exercises, and appointed key personnel. The future outlook is focused on commercialization and further clinical development.

Positives

• Positive preliminary results from the first-in-human feasibility study for thyroid nodule treatment.
• Advancement of pilot program with 8 centers expected to begin commercial use.
• Preclinical study demonstrating advantages of nsPFA Cardiac Surgery System.
• Positive clinical data from the Nanosecond PFA 360 Cardiac Catheter System first-in-human feasibility study.
• Strengthened balance sheet with $47.9 million raised in Q4 through warrant exercises.
• Appointment of David Kenigsberg, M.D., as Chief Medical Officer of Electrophysiology.
• Appointment of Jon Skinner as Chief Financial Officer.
• Cash and cash equivalents increased significantly to $118.0 million as of December 31, 2024.

Negatives

• GAAP net loss for the fourth quarter of 2024 was ($19.4) million, compared to ($11.9) million for the fourth quarter of 2023.
• Non-GAAP net loss for the fourth quarter of 2024 was ($10.4) million, compared to ($8.3) million for the fourth quarter of 2023.
• GAAP net loss for the full year of 2024 was ($53.6) million, compared to ($42.2) million for 2023.
• Non-GAAP net loss for 2024 was ($36.9) million, compared to ($33.8) million for 2023.
• Total GAAP costs and expenses for the fourth quarter of 2024 were $20.3 million, compared to $12.5 million in the prior year period.
• Non-GAAP costs and expenses for the fourth quarter of 2024 were $11.3 million, compared to $8.9 million in the prior year period.
• Total GAAP costs and expenses for the full year of 2024 were $56.3 million, compared to $43.6 million in 2023.
• Non-GAAP costs and expenses for the full year of 2024 were $39.6 million, compared to $35.1 million in the prior year.

Risks

• The company's future success depends on the successful commercialization and product development efforts of its nsPFA technology.
• Early clinical successes may not be predictive of the safety and effectiveness of any medical device.
• The company's future clinical and regulatory initiatives are subject to risks and uncertainties.
• The company's actual results may differ materially from those in the forward-looking statements due to a number of factors, including those described in Pulse Biosciences' filings with the Securities and Exchange Commission.

Future Outlook

Pulse Biosciences is focused on advancing the commercialization of soft tissue ablation in the thyroid market and initiating IDE clinical trials for the 360 catheter and surgical clamp in 2025.

Management Comments

• Pulse Biosciences has incredible opportunities ahead.
• The differentiation of nanosecond PFA, strength of our team, preclinical and developing clinical data are laying the foundation for a transformative therapy with the potential to advance the standard of care for a variety of disease states, said Paul LaViolette, President and Chief Executive Officer of Pulse Biosciences.
• I am thrilled by the significant milestones we have made in the fourth quarter and recently with the introduction of our first direct commercial team to launch soft tissue ablation in the United States, and expansion of our leadership in the clinical department to prepare for upcoming trials.
• These advancements lay the groundwork for Pulses 2025 objectives, focusing on advancing the commercialization of soft tissue ablation in the thyroid market and initiating IDE clinical trials for the 360 catheter and surgical clamp.

Industry Context

Pulse Biosciences is leveraging its novel nsPFA technology to compete in the bioelectric medicine space, targeting atrial fibrillation and soft tissue ablation markets. The company's focus on non-thermal cell clearance differentiates it from traditional thermal ablation methods like radiofrequency ablation.

Comparison to Industry Standards

• The company's nsPFA technology is being compared to radiofrequency ablation in cardiac surgery, with preclinical studies suggesting advantages.
• Other companies in the atrial fibrillation ablation market include Medtronic, Abbott, and Boston Scientific, which offer catheter-based and surgical ablation systems.
• Pulse Biosciences is aiming to differentiate itself through its non-thermal approach and potential for sparing adjacent non-cellular tissue.

Management Changes

Stakeholder Impact

• Shareholders: Dilution from warrant exercises, potential for long-term value creation through successful commercialization.
• Employees: Expansion of the organization and new leadership appointments.
• Patients: Potential for new and improved treatments for thyroid nodules and atrial fibrillation.
• Healthcare Providers: Opportunity to utilize innovative nsPFA technology.

Next Steps

• Commence a U.S. clinical trial in mid-2025 to evaluate the Percutaneous Electrode System as a treatment for benign thyroid nodules.
• Submit an IDE in mid-2025 to commence a pivotal clinical trial for FDA approval of the nsPFA Cardiac Surgery System for AF treatment.
• Commence a U.S. IDE pivotal clinical study sometime in the middle of 2025 for the 360 Cardiac Catheter System.
• Advance the commercialization of soft tissue ablation in the thyroid market.

Key Dates

Keywords

Nanosecond Pulsed Field Ablation, nsPFA, Atrial Fibrillation, Thyroid Nodules, Cardiac Surgery, Electrophysiology, Clinical Trial, FDA Approval, Financial Results, Pulse Biosciences