Pulse Biosciences, Inc

Greetings and welcome to the Pulse Biosciences first quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tripp Taylor. Please go ahead.

Thank you, operator. Before we begin, I would like to inform you that comments and responses to your questions during today's call reflect management's views as of today, May 7, 2024 only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the US Securities and Exchange Commission. Our SEC filings can be found on our website or on the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures, can be found in the press release. Please note that this conference call will be available for audio replay on our website at PulseBiosciences.com in the News and Events section on our Investor Relations page. With that, I would now like to turn the call over to President and Chief Executive Officer Kevin Danahy.

Thank you, Tripp. Good afternoon, everyone, and thank you all for joining us. I am excited to provide today's condensed update, as our last call was just over five weeks ago. Mike Koffler, Vice President of Finance, will join me in the prepared remarks to review our first quarter 2024 financial results. Then Robert Duggan, Executive Chairman of the Board, Darren Uecker, Chief Technology Officer and Director, and Mitch Levinson, Chief Strategy Officer, will join me for a question and answer session. During today's call, we will give you an update about our proprietary designed and engineered CellFX NSPFA energy delivery system and three novel proprietary endofactor devices. Q1 was a very active and productive quarter for Pulse Biosciences. As you know, we are making a material and significant commitment to the field of nanosecond pulse build ablation, addressing soft tissue ablation for human beings in need. Pulse Biosciences is pleased to bring into existence a novel electrophysiology and surgical treatment modality that focuses in the nanosecond, up to billions of a second pulse duration range. This is up to two orders of magnitude faster than the millions of a second range currently deployed in the pulse field ablation area. This increase in pulse speed in conjunction with the capacity to increase pulse amplitude is believed by us to potentially bring out material improvements in safety and efficacy, as well as overall significant improvements in treatment times and thus treatment outcomes. Additionally, NSPFA is a very patient, physician, care provider-friendly treatment option. Going forward, we are planning to do multiple clinical trials across different indications. It is important to note that, inclusive of 6,000 human dermatological skin lesions treated, not a single serious adverse event has occurred. In March 2024, we received FDA 510K clearance for our non-cardiac cell effects NSPFA percutaneous system for soft tissue ablation indication. Soft tissue ablation is used by physicians in a wide range of procedures, including the thyroid, liver, breast, and other areas of the body. Currently, we have treated 30 patients in need of soft tissue ablation for thyroid disease. Dr. Stefano Spiazza, Chief of Endocrine Surgery Division at Napoli Hospital Damari in Naples, Italy, our key opinion leader in the field of thyroid, in collaboration with Dr. Ralph Trefano, medical director, head in endocrine surgery for Sarasota Memorial Healthcare System, have successfully performed soft tissue ablation procedures on 30 patients with the CellFX NSPFA percutaneous system in Italy. The first patient was treated in April 2023 and the last patient in January 2024. All procedures were thyroid. Her amended protocols, at our request, We have observed patients as early as one week and up to this point as late as 180 days. Patient follow-ups are weekly for the first four weeks, then 30, 60, 90, 180, and 360-day time points following the procedure. No evidence of scarring or injury to the surrounding tissue has been observed, and patients treated have been judged to be successful. Moving on to the updates of our cardiac indications, starting with our surgical clamp. In the past few weeks, we have communicated with the FDA regarding our CellFX NSPFA surgical clamp for cardiac procedures. The FDA has requested clinical data prior to rendering a final decision in pursuit of our request for FDA 510 clearance. As of today, only preclinical animal work has been performed. No patient has been treated as of yet with our CellFX NSPFA surgical clamp. In present time, however, we have submitted to the Ethics Committee in the Netherlands an application to start first in human feasibility study with the CellFX NSPFA surgical clamp. We anticipate their response within the next several weeks. The study is designed to treat up to 30 patients in several centers in the Netherlands. This study would provide information on first-in-human effectiveness and safety with our device. Our second device for cardiac indication is our CellFX NSPFA 360 degree cardiac catheter. We are pleased to announce that 24 of 30 patients have been successfully treated in Prague by Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Hospital, New York, and Dr. Peter Neutzel, Chief of Cardiology at Homoka Hospital, Prague, and his team in Prague. The remaining six patients are expected to be treated within the next 45 days. The primary endpoints for this study are acute effectiveness at the time of the procedure and add up to 30 days for safety. Discussions with the FDA are ongoing in present time and we will provide updates in a timely manner. Pulse Bioscience will have a strong presence at the upcoming Heart Rhythm Society HRS meeting May 16th to the 19th in Boston. Our CellFX NSPFA energy delivery system will be featured in a total of six poster presentation abstracts as well as a live case presentation. Before turning the call over to Mike, I will now provide additional details on our efforts to strengthen our balance sheet through the rights offering. This offer serves as a stockholder-friendly avenue for Pulse Biosciences to secure the necessary capital to advance our novel end-of-factors towards market entrance, while offering our existing stockholders a potential non-dilutive opportunity to continue to support the company's growth. The Board of Directors has approved a rights offering of up to $60 million worth of units that will be available to all holders of record of the company's common stock, as of the specified record date. This week, the company determined to initiate the rights offering in June or July, not in May, so that the early record date of May 16 will most likely be changed to a date in mid-June. The date will be selected by our board and announced once all the necessary filings have been completed. Subscriptions may begin immediately once the company commences the rights offering, most likely in June. It is important to note that the subscription rights will expire and have no value if they are not exercised prior to the expiration date of the offering, which date will also be announced by the company once the necessary filing have been completed. Assuming that the rights offering is fully subscribed at the initial price, the company will receive gross proceeds up to $60 million, less expenses related to the rights offering, and upon exercise of all the warrants, a potential to raise up to $126 million. A fully subscribed rights offering would fund the company's growth plans into the first quarter of 2026. Please refer to our release on the rights offering for more information. Now I will pass the call over to Mike Koffler for an update on our financial results.