Pulse Biosciences Announces Q3 2024 Financials and Business Updates

Pulse Biosciences, Inc. (Nasdaq: PLSE), based in Miami, recently disclosed their business updates and financial results for the third quarter ending September 30, 2024. The company, which specializes in the innovative Nanosecond Pulsed Field Ablation™ (nsPFA or nano-PFA) technology, highlighted significant progress in various clinical trials and preparations for future commercialization.

### Soft Tissue Ablation

During the third quarter, Pulse Biosciences placed its nsPFA Percutaneous Electrode Systems in seven U.S. sites as part of a pilot program aimed at clinical assessment, with commercial usage anticipated to start in the coming months. The company plans to begin a pivotal clinical trial by mid-2025 to support the labeling and commercialization of this system in the U.S. for treating benign thyroid nodules. Additionally, clinical data from a European feasibility study on using nano-PFA to treat benign thyroid nodules will be shared at the American Thyroid Association Conference on October 31, 2024.

### Surgical AF Ablation

In the realm of atrial fibrillation (AF) treatment, Pulse Biosciences treated nine patients and opened a second site for a multi-center, first-in-human AF feasibility study in Europe. The company aims to submit an Investigational Device Exemption (IDE) by mid-2025, which will allow them to commence a pivotal clinical trial to support a premarket approval (PMA) application for FDA approval of their nano-PFA Cardiac Surgical System in the U.S.

### Endocardial Catheter AF Ablation

Progress was also made in the treatment of AF using the nano-PFA 360° Cardiac Catheter. Over 50 patients have been treated, and two additional European sites have joined the first-in-human feasibility study. Dr. David Kenigsberg has been appointed as the Chief Medical Officer for Electrophysiology, and Dr. Andrea Natale has joined the electrophysiology medical advisory board, alongside Dr. Vivek Reddy and Dr. Jacob Koruth. The company expects to launch a U.S. IDE pivotal clinical study by mid-2025.

### Comments from Leadership

Burke T. Barrett, President and CEO of Pulse Biosciences, expressed optimism about the advancements made in the third quarter. He highlighted the ongoing clinical work with their three devices, suggesting that the differentiated nano-PFA technology could significantly improve treatments for various diseases by effectively eradicating cells. Barrett emphasized that the progress achieved positions Pulse Biosciences to initiate pivotal clinical trials in the U.S. for each device next year. The company is also preparing to share select European trial data at upcoming medical conferences. Efforts are being made to build the necessary team and infrastructure to support clinical and regulatory initiatives, starting with the commercial use of the nsPFA Percutaneous Electrode System in the near future.

### Financial Results

For the third quarter ending September 30, 2024, Pulse Biosciences reported total GAAP costs and expenses of $13.7 million, an increase from $11.3 million in the same period the previous year. This rise was primarily due to stock-based compensation and other administrative expenses supporting the expanding organization and the development of nano-PFA devices. Non-GAAP costs and expenses were $10.4 million, up from $9.2 million in the prior year.

The company reported a GAAP net loss of $12.7 million for the three months ending September 30, 2024, compared to a net loss of $10.6 million for the same period in 2023. Non-GAAP net loss for the same period was $9.4 million, compared to $8.5 million in the prior year.

As of September 30, 2024, Pulse Biosciences had cash and cash equivalents totaling $79.0 million. This includes $60 million in gross proceeds from a rights offering concluded in July 2024. The company may potentially raise an additional $66 million through the exercise of associated warrants. These warrants are exercisable at $11 per share, with half redeemable if the stock price exceeds $16.50 for twenty consecutive trading days, and the other half if it exceeds $22.00 for twenty consecutive trading days. Holders can exercise the warrants at any time before redemption or expiration.

Cash usage for the third quarter of 2024 was $8.5 million, excluding financing activity, compared to $8.7 million in both the second quarter of 2024 and the third quarter of 2023.

### Conclusion

Pulse Biosciences continues to make strides in developing and commercializing its innovative nano-PFA technology across various medical applications. The financial results and business updates reflect the company's commitment to advancing healthcare solutions and preparing for significant clinical trials and commercial launches in the near future.