Pulse Biosciences, Inc. ($PLSE)

All right. Thank you, everybody, for joining Day 2 here at the Bank of America Healthcare Conference. I'm Dan Lundquist, the health care specialist, very pleased today to have the team from Pulse Biosciences, where I'm joined on stage here by CEO, Paul LaViolette. CFO, Jon Skinner, is in the audience as well. They have a presentation which they'll run through. We have time. I have a couple of questions. But over to you, Paul. Thank you.

Thank you very much, and great to be joined by Jon and everyone interested in the Pulse Biosciences story. I'll be making forward-looking statements today, and this is our disclosure. And so let's get into the actual story of our mission. We are a company dedicated exclusively to the development and delivery of a novel energy form Nanosecond Pulsed Field Ablation, which also delivers a novel mechanism of action, which is the generation of the regulated cell death process. It's a very novel approach, and we'll address many ablation opportunities, which we'll talk about. As a company, we're very focused on the rigor of data generation. We have multiple clinical trials underway. We'll talk about those momentarily. And from an opportunity perspective, we're going after a number of significant markets, very large patient populations and the potential to be very disruptive as a next-generation energy opportunity. The team is extremely strong, anchored by Darrin Uecker. Darrin, our Chief Technology Officer and really a founder of the company, has led the vision for Nanosecond Pulsed Field Ablation since our inception. In the last quarter, we added both a Chief Operating Officer in Liane Teplitsky and a full-time Chief Medical Officer focused on the electrophysiology opportunity. So this is a group that is highly focused today on the development and execution of our clinical trial study and strategy. And we'll spend more time talking about that study plan in just a few minutes. We're led by an exceptionally experienced and successful Board of Directors anchored by Bob Duggan, of course, a legendary investor and entrepreneur. Bob is exceptionally involved in the company, and we're pleased to have his leadership and guidance. We most recently added Maria Sainz to that Board. Maria, most recently of the Board of Directors of Shockwave Medical, which she helped lead to its exit to Johnson & Johnson. So a great team leading a very strong story and strategy. From a financing and balance sheet perspective, we ended Q1 with $68.3 million of cash. That is in support of a quarterly burn of approximately $15 million. We've indicated that we expect our burn to increase slightly as a function of our increased strategic activity driven by those IDEs that I mentioned, principally the focus on rapid enrollment of our pivotal study for paroxysmal atrial fibrillation ablation, which is underway now. We have a second study also underway. And we announced, in response to fantastic clinical data at the AFib Symposium earlier this year, a slight shift in our focus and a concentration of our efforts on EP, and we'll spend a little bit of time describing that. We have described previously and remain committed to a market entry strategy that will depend upon a partnership strategy, and we won't go into that in more detail, but it's a central part of the Pulse differentiation and our plans to be capital-efficient as we access a substantial market value. From a description perspective on Nanosecond PFA, let me just spend a few minutes talking about how this energy functions and how it is differentiated. I think we're all aware of minimally invasive therapeutic markets based upon the delivery of energy to treat unwanted tissues. This is something that has been leading the conversion of surgical procedures over less-invasive alternatives for decades. It has resulted in procedural markets of millions and millions of procedures. And in the last several years, we've seen the emergence of pulse field ablation from a first generation perspective, which is really the microsecond PFA realm. That's what we see in Boston Scientific, Medtronic, Abbott, J&J, PFA Energies today. It is a -- in PFA terms, it is a relatively slow microsecond PFA delivery. It is operating relatively close to the thermal side of tissue temperature change. And because of its relative inefficiency requires significant manipulation, multiple overlapping lesions, it nevertheless has driven substantial market conversion in the very recent past year. nsPFA operates quite differently. It's a much shorter, dramatically shorter pulse duration measured in billions of a second. To offset that shorter duration, we add additional voltage and high amplitude. And so it's a more powerful shorter pulse that creates, as I mentioned, a unique mechanism of action of regulated cell death, operates entirely nonthermally. And as a result of the power of the ablation creation is much easier to deliver without the need for overlapping lesions and catheter manipulation. If we think about the novelty of that energy, it is protected by, I think, an unprecedented moat of an intellectual property for an early-stage company. We have IP on the generator. We have IP on systems of delivering that energy down through catheters out through electrodes into tissue and ultimately on methods of delivering energy. And so if you look at that in aggregate, 250 patents protecting Nanosecond PFA as a novel energy form and novel mechanism of action delivery system. We're extremely enthusiastic about our leadership in this field with IP today that will protect us in a leadership position for years to come. The first application of our focus is on the EP AFib opportunity. You know this today. Everyone in medtech knows this is one of the hottest markets. It's possessed of very rapid growth, double-digit compounded annually, a significant new population of diagnosed patients annually, close to 2 million, leading to hundreds of thousands of current ablation procedures and a multibillion dollar addressable U.S. market that is expected to double over the next 5 years and even grow more significantly outside the United States. Our catheter system will drop into the existing workflow of current systems and allows us the opportunity to convert this market quite rapidly to a superior energy form. The energy manifests itself in EP with significant advantages. Lesion quality is far superior based on transmural lesions delivered in a single 5-second application and creating transmural full-thickness lesion isolation of electrical signals. That produces a speed opportunity for us with very rapid lesion formation, 5-second energy delivery, shortened procedure times overall, and again, significantly less catheter manipulation for the operator. We have workflow advantages related to anesthesia that allow us over time to move this procedure to the ambulatory surgery center, and we are producing data now from our European feasibility study, which I'll highlight momentarily that are unprecedented based on current EP market performance. Just to give you a sense of how the catheter functions, a single lesion is formed. If you look at the animation in the middle of the fluoroscopic image on the right is -- replicates the same workflow. A single lesion is created for 5 seconds, then the catheter is pulled back and placed antrally on the roof of the vein and the second lesion is performed. Those steps, those 2 ablation steps are repeated at the 4 veins. And so really, the ability to produce a completed paroxysmal AF ablation with 2 lesions per vein and approximately 10 or 12 lesions for a full ablation sequence is what is so unique about this system and enables not only a very fast workflow, but the effectiveness of that lesion generation has produced this clinical data output, which, again, is significantly different than anything ever been produced. So here, you see a data set looking down the column in the middle, representing our 5-second dose. And with 95 patients followed out 6 months, we have 95 out 95 or 100% clinical efficacy at that mid-year point. We have 96% clinical efficacy, 51 out of 53 at the 12-month endpoint. That is a clinical data that reflects the primary endpoint that we'll be using in the pivotal study and is, again, a data set that is unmatched by any precedent data from competitive microsecond ablation systems. You also see on the right a Kaplan-Meier curve, reflecting an even broader endpoint of all atrial arrhythmias, a flutter atrial fibrillation, atrial tachycardia and measured more commonly, actually measured weekly with telemetry monitoring in addition to -- and Holter and you see 90% effectiveness over time. So these results have never been produced with an ablation system before. From a company perspective, we're focused on accelerating enrollment. We're focused on expanding the evidence development and also investing significantly in pipeline technology expansion, and I'll comment on those now. If you think about our acceleration of the pivotal study, we initiated enrollment in the United States just last month at St. Bernards in Jonesboro, Arkansas, 7 cases performed on the first day. That is extremely uncommon and really unprecedented for the AFib world and, I think, is exemplary of the ease and workflow benefits we have with our technology. And as we have now expanded to several additional sites and seeing comparable uptake and driven by the physician enthusiasm that we're hearing, we have shortened the time line for enrollment from our original forecast of the end of Q4 now to just the beginning of Q4 and October time frame. So we're extremely enthusiastic about how this trial is shaping up and the prospect for accelerated enrollment. On a technology basis, the catheter on the left reflects the current technology, which generates a regional footprint of ablation circumferentially around those bipolar electrodes. On our next generation, we intend to marry that with a second tool contained within the same device that would provide focal ablation. So focal or regional ablation in the same device that can do both ablation and mapping. We think this can produce a single catheter workflow for a comprehensive paroxysmal AFib ablation in not only the benefits -- with the benefits of our very rapid ablation time but without the demands for any form of catheter exchange to complete a case. In addition to AFib, we're also working on several additional markets, one of which is currently enrolling an IDE for concomitant ablation of patients undergoing cardiac surgery with prediagnosed AFib. This is a relatively small market today served by radio frequency ablation. We believe this market has the potential to be opened and expanded if PFA can demonstrate significant workflow and outcomes advantages. And so we're looking forward to the IDE to demonstrate those outcomes. We have a second developing market to treat thyroid nodules. This is a market of several hundred thousand thyroidectomies per year. We believe that has the potential to be developed into a less-invasive alternative using a percutaneous approach, ultrasound-guided using the unique benefits of Nanosecond Pulsed Field Ablation. So between cardiac surgery and thyroid intervention, we have 2 early-stage markets that we're developing data in and look forward to determining how those can be potential drivers of our business over time. And let me just flip over to the last slide and conclude by saying that we think we have an exceptionally novel story here. We have nanosecond pulse field energy delivery, which is a -- both has the benefits of PFA, but has the -- I'm sorry, has the -- let me just, there we go -- has the uniqueness of nanosecond pulse durations and extremely high voltage. That combination delivers regulated cell death, a unique outcome for PFA, and we think one that can revolutionize multiple fields of current clinical therapy. This technology is protected by 250 patents and that estate will continue to grow. We have mounting clinical evidence emanating from clinical studies in the U.S. and multiple IDEs. That first IDE is intending to replicate the durability data that we've seen from our European data set, which is a very large feasibility study producing unprecedented clinical outcomes. We have multiple markets of high interest. But without a doubt, the principal focus for our attention and investment is the EP ablation market for AFib, which, as you know, is a multibillion-dollar fast-growing, very hot space that has demonstrated significant switching potential for next-generation capabilities. We have multiple IDEs underway. We intend to execute flawlessly on those and a balance sheet to deliver the performance of those studies throughout the course of 2026 and into 2027. And with that, I'll end my comments and happily answer any questions.

Great. I think we're past on the 4:50 but appreciate the time. Thank you all for joining and thank you very much to Paul.

Thanks.