Greetings, and welcome to the Pulse Biosciences First Quarter 2024 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Trip 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 U.S. 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, Trip. Good afternoon, everyone, and thank you all for joining us. I'm excited to provide today's condensed update as our last call was just over 5 weeks ago. Mike Koffler, Vice President of Finance, will join me in the prepared remarks to review our first quarter 2021 financial results. Then Robert Duggan, Executive Chairman of the Board; Darrin 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 3 novel proprietary end-effector 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 Pulsed Field 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 billionths of a second pulse duration range. This is up to 2 orders of magnitude faster than the millionths of a second range currently deployed in the pulsed 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 510(k) clearance for our noncardiac CellFX nsPFA percutaneous system with…

Thank you, Kevin. Today, I will highlight our GAAP and non-GAAP financial results. I encourage you to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the first quarter of 2024, total GAAP costs and expenses increased by $1 million to $10.6 million compared to $9.6 million in the prior year period. The increase in GAAP cost and expenses was primarily driven by an increase in noncash stock-based compensation expense, which was $1.8 million in the first quarter of 2024 compared to $0.9 million in the prior year period. Total non-GAAP cost and expenses in the first quarter of 2024 increased by $0.3 million to $8.6 million compared to $8.3 million in the prior year period. The increase in total non-GAAP costs and expenses was primarily driven by an increase in research and development expenses to support the advancement of our CellFX nsPFA devices. GAAP net loss in the first quarter of 2024 was $10.1 million compared to $9.8 million in the prior year period. Non-GAAP net loss in the first quarter of 2024 was $8.1 million compared to $8.6 million in the prior year period. Cash and cash equivalents totaled $34.9 million as of March 31, 2024, compared to $44.4 million as of December 31, 2023. Cash used in the first quarter of 2024 totaled $9.5 million compared to $7.2 million used in the same period in the prior year and $6.9 million used in the fourth quarter of 2023. The sequential quarterly increase was driven mainly by $2 million in 2023 annual cash bonus payouts. I will now turn the call back over to Kevin.

Thank you, Mike. It is an exciting year for Pulse Biosciences as we continue to advance our novel platform technology into the hands of more physicians for the benefit of more patients. In future earnings calls, we will provide real-time updates on events and interactions as they unfold. Joining me for the question-and-answer session today are Executive Chairman of the Board, Robert Duggan; Chief Technology Officer and Director, Darrin Uecker; and Chief Strategy Officer, Mitch Levinson. Operator, please open the call for questions.

Thank you, Kevin. Now we're going to address a few questions we've received over e-mail. Then we'll open up the line for questions from the audience. The first one is, how is the pilot launch going in the U.S. with the percutaneous electrode now that it's approved? What's the interest level? And when can we anticipate a full commercial launch?

Yes. Trip, this is Mitch. I can take that one. Since our 510(k) clearance we got a few weeks ago, we've reached out to the KOLs that we were targeting for our pilot program, and the interest has been just really high. We've got a lot of physicians at major institutions that want to evaluate our system for soft tissue ablation. As some of you may know, in institutions like this and hospitals, there's an approval process. It usually takes several weeks, sometimes longer, to approve bringing in new technologies. We've got multiple KOLs currently working through that approval process. We expect our CellFX percutaneous system is going to be used in a number of prominent hospitals and clinics by the end of this year. Right now, we are just really focused on building the appropriate training around the system, providing strong clinical support, and just ensuring that we are doing everything we can to help our physician customers get the best possible clinical outcomes that they can with our technology.

Great. Operator, can you please open the line for questions now?

[Operator Instructions] Your first question comes from Anthony Petrone with Mizuho Group.

Congratulations on the progress here. Maybe a little bit just on the FDA dialogue. It sounds like that's moving in the right direction. They've sort of given a little bit of guidance here, I think, on just kind of the clinical pathway going forward. And so maybe anything you could add there on how broad-based a pivotal program could look like? How many sites? How many patients? And I guess, your early views on timing of when this could be launched? And I have one follow-up.

Darrin, do you want to take that?

Yes, sure. Thanks, Anthony. This is on the clamp, right? I apologize.

Yes, that would be right, on the cardiac clamp. Yes.

Yes. So I think as we discussed on our last call, we received an additional information letter from the FDA. That led to a couple of meetings with FDA, one that we had very recently, and very collaborative, great discussion with FDA as we're moving this forward. As of today, as we mentioned, we remain in the 510(k) process. After receiving the AI letter, that goes on hold with regard to the review cycle, as you probably know. And I think we had good dialogue with FDA about the need or request for human clinical data. And so we're really in the process of discussing that with FDA and coming to some agreement on what that clinical program would look like and likewise, the regulatory path going forward. Right now, we really don't have much to report on that in terms of timing. One of the things on the clinical side that we have discussed is a first-in-human feasibility study for our clamp, which will happen in Europe in the Netherlands and that we've submitted to the Ethics Committee there. We expect to hear back from the Ethics Committee within the next several weeks and then commence that study soon thereafter. And so we've got a lot going on, on that side. FDA is aware of that study, and we'll just be working with FDA over the next period of time to finalize what's going to be required for the clamp in the United States.

That's helpful. And then a follow-up would be just on HRS. Looking ahead here, you have a live case with CellFX that's being presented post the presentations as well. The market here in the United States is now officially underway with PulseSelect and FARAPULSE out there. So what are you expecting out of HRS? And I guess, from the perspective of Pulse Biosciences, are you surprised at the rate of adoption by the early PFA catheters? And maybe just the expectations on physician feedback for CellFX out of HRS?

Go ahead, Darrin.

Yes. Thanks, Kevin. I would -- I guess, I would say we're really looking forward to HRS. We have 6 abstract presentations, as you mentioned, and those are both actually on the catheter and our clamp. So that is something that is very encouraging to get both of our products into HRS for this important meeting. And then as you mentioned, we have a live case in the PFA Summit at the beginning of the meeting. And as it relates to PFA, in general, I think we are not surprised by the progress of PFA and the progress that we're seeing in the United States by those other devices. I think it seems the data is pretty clear that PFA offers some pretty significant advantages over current modalities. What we're excited about and looking forward to at HRS is talking about nanosecond PFA and our view that it's sort of a next generation as it relates to PFA and what the differentiation is in terms of the lesions that we create, the integrity and durability of those lesions, the depth of those lesions, the speed with which GPs are able to create those lesions. So all those things, we think, are going to be really important to both physicians and patients. And we're looking forward to HRS to be able to talk about that and present our -- both our preclinical and clinical data that supports those different benefits. So we think it's going to be a really exciting meeting for PFA, in general, but also, of course, for nanosecond PFA and Pulse Biosciences.

Next question, Robert Lovgren with Medical Hope Production.

This question is for Bob. A little preliminary. The -- this ablation and catheters and so on is a real surgical coming. Basically, you, Bob's feel though that you have all the patents and the head of all the other people plus, of course, the machine itself? Or you think you're the tip of the spear?

Well, a head of Bob and a tip would be somewhat similar, right? But you really put your patent base together, evaluate it thoroughly, which we're constantly doing. At this point, we're very pleased with what we have and what we are generating. The asset test is when you bring it to market. It's not against the law to develop anything you want. You can copy, you can alter, and you can go de novo. But when you bring it to market, that's where the patents really swing in, so we will find out. But I am -- yes, I'm Bob Duggan. I'm confident that we're in a good position there, and I like the speed at which we continue to evolve our patent base. I hope that answers your question, Bob.

I would like to turn the floor over to Kevin Danahy for closing remarks.

Thank you, operator. In closing, I just want to thank you all for continuing to support and giving us the confidence that we have in our company. We are dedicated to delivering value and growth with nsPFA, and we look forward to the opportunities that lie ahead. Thank you for joining us today, and we remain committed to driving success for this company. Thank you.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.