Pulse Biosciences Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 8, 2025

There are 4 speakers on the call.

Operator

Good afternoon, ladies and gentlemen, and welcome to the Pulse Biosciences First Quarter twenty twenty five Financial Results Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press 0 for the operator. This call is being recorded on Thursday, 05/08/2025.

Operator

I would like to hand over the conference to the first speaker today, Trip Taylor, Investor Relations. Please go ahead.

Speaker 1

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, 05/08/2025 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.

Speaker 1

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.

Speaker 1

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 Co Chair of the Board and Chief Executive Officer, Paul Le Violette.

Speaker 2

Good afternoon and thank you for joining. Pulse Biosciences has made strong progress through the first quarter and today. Since we held our last call just five weeks ago, I will keep our updates focused on new achievements and status while highlighting our progress within each of our market programs. I will then turn the call over to our CFO, John Skinner, who will review the first quarter twenty twenty five financial results. We will then be joined by Bob Duggan, Co Chair of the Board for a question and answer session.

Speaker 2

Pulse Biosciences at its core is an innovative medical device company focused on advancing human health by developing and commercializing its proprietary nanosecond pulse field ablation technology. Nanosecond pulse field ablation or nano or nspfa technology builds on the strength of microsecond PFA fast, safe and workflow efficient, while creating a fundamentally different mechanism of action to enable a deeper ablation in shorter delivery times, all while delivering lower energy levels, which further reduce the risk of thermal damage. Our early clinical studies in multiple applications and our initial launch efforts in soft tissue ablation indicate nanosecond PFA will be a truly disruptive technology. As a next generation leader in pulse field ablation and with unique and versatile platform, our focus reflects a commitment to advance therapies that can transform care across multiple large markets. Our company's seven FDA clearances treatment of over 6,000 patients and FDA breakthrough device designation for our cardiac surgical clamp have largely de risked the technology and serve as strong validation of its proprietary mechanism of action and therapeutic potential.

Speaker 2

Pulse Biosciences is focused on a few main objectives in 2025. Our top priorities are initiating commercialization of the percutaneous electrode for soft tissue ablation in benign thyroid disease and initiating IDE pivotal studies for our cardiac three sixty catheter and cardiac surgical clamp. In Q1 and in the first weeks of Q2, we have made important progress toward achieving those goals. Clinical data on the catheter based treatment of atrial fibrillation or AF with our NSPFA three sixty catheter were presented at the January AF symposium and in April at the heart rhythm society meeting, which featured a successful live case telecast using the Cardo mapping system from Johnson and Johnson med tech. The pulse three sixty catheter demonstrated excellent procedure efficiency and acute outcomes based on the treatment capacity of nanosecond PFA.

Speaker 2

We treated AF patients in the European clinical feasibility studies for our three sixty catheter and cardiac surgical clamp with one hundred and thirty patients treated to date respectively. We advance our preclinical and testing documentation in preparation for filings with FDA for approval to commence our two IDE studies. Clinical data were presented at the American Thyroid Association and the North American Society of Interventional Thyroidology on benign thyroid nodule ablation using nanosecond delivered with the percutaneous electrode. We continue to expand our direct commercial resources for the launch of our soft tissue ablation product in The United States. We raised $14,000,000 through the exercise of warrants during the first quarter to maintain our cash position at twenty twenty four year end levels.

Speaker 2

These milestones further validate the potential benefits of NSPFA and increase awareness of the technology among clinicians who may choose to support Pulse as clinical investigators or in the future as commercial customers. Now I'll provide updates on each of our individual products. Let's start with our soft tissue ablation device, the percutaneous electrode. We see broad market potential for this device, which has received FDA clearance for the ablation of soft tissues such as unwanted tumors and nodules in the thyroid, liver, and breast. Our first application target is benign thyroid nodules where the system offers a safe, non invasive, and gland preserving alternative to surgery.

Speaker 2

Its non thermal approach allows precise treatment within the delicate and busy anatomy of the neck without risk of thermal injury. We believe nanosecond PFA can emerge as a preferred treatment option for two compelling reasons. First, by converting a significant portion of annual thyroidectomy procedure volume. And second, by expanding the market as a very attractive treatment option for patients who have chosen not to undergo an intervention because of undesirable consequences of either surgery or current ablation modalities. These patients form a very large watchful waiters group, hoping for a safer, less invasive, as well as patient and physician friendly treatment for their disease.

Speaker 2

Thyroidectomy patients face permanent removal of a gland which controls core bodily functions, including blood pressure, body temperature, and heart rate. And in addition, it contributes to hormone production. The underproduction of hormones resulting from removing the thyroid can lead to required lifelong hormone replacement therapy, while the surgery also leaves behind a visible scar on the neck, which is not the case with our technology. Use of the percutaneous electrode for benign thyroid nodule treatment is proving to be quite compelling. Results from the thyroid preserving procedure demonstrate meaningful nodule size reduction, achieving on average 83% volume reduction at one year and significant reductions in patient symptoms just one month after treatment without evidence of residual fibrosis or scarring that would routinely accompany radiofrequency ablation.

Speaker 2

With increasing use of our NSPFA percutaneous electrode system to treat these nodules, we are building increasing evidence and patients and physician experiences that validate our positive earlier clinical findings. Our NS PFA percutaneous electrode system is currently being used at multiple centers in The United States. The small group of initial users are participating in a pilot program to generate data that will support workflow and procedure protocols for new users with the goal of generating consistent positive outcomes across providers who are adopting the therapy. Over ninety patients have been treated in the pilot program. Following completion of the program in Q2, we will collect and analyze the patient outcomes and follow-up data.

Speaker 2

We believe these clinical results will confirm our commercial use model as well as aid in the development of our next study protocol. We have identified five sites for this next study and plan to finish IRB approvals and commence enrollment in Q3. As these clinicians refine the procedural techniques and optimize workflows, we expect most of these clinical users will convert to using our nanosecond PFA percutaneous electrode on a commercial basis during the second half of twenty twenty five. In parallel, we are continuing to focus efforts on building our commercial infrastructure. Our team now consists of several capital equipment system sales professionals and supporting therapy development managers.

Speaker 2

They are developing a pipeline of target accounts based on fibroidectomy volumes and interventional ultrasound guided procedure capabilities. In the second quarter, we will be focused on finalizing site of care best practices and continuing to refine reimbursement guidance. We look forward to sharing updates on our commercial progress throughout the remainder of 2025. These factors will contribute to our plans to generate revenue, which we expect to materialize in the second half. Let's now discuss our surgical ablation plan.

Speaker 2

Our first in human feasibility study for the treatment of AF with pulses surgical cardiac clamp in Europe is progressing according to plan. In the past few weeks, we received EU approval by the IRB for clinical protocol expansion in our first in human feasibility study to enroll additional patients beyond the 30 we have treated to date. We now have approval to treat up to 60 patients and are continuing to enroll at multiple centers in Europe. Approximately three months post treatment, patients will undergo an electro anatomical mapping procedure by an electrophysiologist to validate the clinical outcomes. This level of rigor is atypical for surgical ablation protocols, but we believe this level of detail on patient outcomes reinforces the potential benefits of using NSPFA in cardiac surgery and will become an important consideration for future adoption.

Speaker 2

We are encouraged by the performance of the device and we expect to share preliminary results of this trial in late twenty twenty five. We believe the clamp will enable fast, full thickness ablations to execute a Cox maze procedure during open heart surgery. Despite clinical guidelines, this procedure is significantly underperformed today due in part to technology limitations and we believe the Pulse Biosciences NSPFA cardiac surgical clamp addresses this unmet need uniquely for surgeons. As a reminder, the FDA awarded breakthrough designation for our Cardiac Surgical Clamp Ablation Device in July 2024. And it was accepted for inclusion in the FDA's total product lifecycle advisory program, the TAP program, which provides additional benefits as we work through the regulatory process with the FDA.

Speaker 2

We are actively engaged with our FDA review team regarding the design of our IDE pivotal clinical study and are continuing to advance a formal IDE to the FDA for this study by mid year followed quickly by the commencement of pivotal clinical trial enrollment. Now, moving on to our three sixty catheter system for AF ablation. Our third product in development is the three sixty cardiac catheter system also designed to treat atrial fibrillation by delivering nanosecond technology for endocardial applications. Has been rapidly adopted by over the past year and has changed the treatment landscape. Our early data are demonstrating the potential for NSPFA to again evolve the space and advance the treatment of AF.

Speaker 2

We believe the three sixty catheter can provide improved efficacy and reduce the complexity of the procedure. The three sixty catheter delivers a full circumferential lesion in a single short energy application without the need for catheter rotations. We believe our system uses less energy, causes less neuromuscular stimulation, and enables deeper, more consistent lesions with a flexible catheter that physicians find easy to manipulate. We expect these features should enable more efficient, safer procedures with quicker recovery. While our early findings are promising, we recognize the importance that strong clinical evidence will have in supporting clinical adoption.

Speaker 2

We are accumulating a growing body of clinical evidence from our ongoing European first in human feasibility study. One hundred patients have now been treated in the study by multiple investigators at multiple sites. We will be expanding to additional sites in Europe throughout 2025 and are expecting one additional site to begin treating patients in Q2. Our initial clinical data set has now been shared at both the HRS twenty twenty five annual meeting two weeks ago, and the AF symposium in January and demonstrated the compelling potential for NSPFA to advance the treatment of AF. Highlights of the data to date include at HRS an oral abstract featured data highlighting the feasibility and durability of pulmonary vein isolation and posterior wall ablation in the left atrium using NSPFA technology in a twenty two patient cohort.

Speaker 2

Results from the study demonstrated one hundred percent acute successful electrical isolation in 86 of 86 pulmonary veins and twenty two of 22 left atrial posterior walls requiring an average of 12 pulmonary vein and 4.6 posterior wall ablations per patient. The three sixty catheter left atrial dwell time and fluoroscopy times were on average twenty six point two and six point five minutes respectively. Most importantly, invasive remapping at three months revealed durable pulmonary vein isolation in eighty one of eighty six pulmonary veins, a ninety four point two percent success rate, and left atrial posterior wall isolation in twenty one of twenty two patients, a ninety five point five percent success rate. We are highly encouraged by these early indicators of procedural efficiency and positive patient outcomes. At the AF symposium in January, late breaking data from the initial 30 patients were shared by Doctor.

Speaker 2

Vivek Reddy. The initial cohort of this first thirty patients treated have been evaluated by remapping completed at three months following the ablation procedure, the results demonstrated that ninety two point four percent of pulmonary veins treated were successfully in conduction block. Also presented at HRS was a preclinical assessment, which evaluated Pulse Biosciences newly developed focal catheter using various NSPFA delivery settings in swine myocardium. Results of this preclinical assessment further affirmed the novel endocardial focal NSPFA catheter systems capability of creating very deep lesions with a significantly streamlined workflow. And this represents the first data we have presented on this newly developed NSPFA focal catheter platform.

Speaker 2

With further development, the technology could be adapted for highly efficient procedures for the treatment of both atrial and ventricular arrhythmias. We are very appreciative of each of the leading clinicians who have supported our clinical programs and our mission of delivering patient as well as physician friendly procedures. Their skill and insights in the use of our devices is helping generate critical clinical data that both raises awareness of the unique features and benefits of NSPFA and supports our efforts in achieving regulatory clearance for the system. The positive data and clinician feedback continue to meet our high expectations and demonstrate how innovative the NSPFA three sixty cardiac catheter system and NSPFA truly are. This early clinical work has positioned us favorably to initiate our IDE pivotal trial to support FDA approval of the nanosecond PFA three sixty cardiac catheter system in the middle of the year.

Speaker 2

And as our platform expands, we're excited to see more physicians embracing our technology for endocardial applications. With that, I will turn the call over to John to speak about our first quarter financial updates. John?

Speaker 3

Thank you, Paul. Now I will highlight our GAAP and non GAAP financial results. I encourage listeners 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 twenty twenty five, total GAAP costs and expenses increased by $7,400,000 to $18,000,000 compared to $10,600,000 in the prior year period. The increase in GAAP costs and expenses was primarily driven by an increase in non cash stock based compensation, which was $5,700,000 in the first quarter of twenty twenty five, compared to $1,800,000 in the prior year period, along with other compensation and administrative expenses related to the expanding organization to support advancement of our NSPFA device clinical trials and commercialization.

Speaker 3

To remind everyone, non GAAP costs and expenses exclude stock based compensation, depreciation and amortization, and legal settlement expenses. Total non GAAP costs and expenses for the first quarter of twenty twenty five increased by $4,100,000 to $12,700,000 compared to $8,600,000 in the prior year period. GAAP net loss in the first quarter of twenty twenty five was $16,800,000 compared to $10,100,000 in the prior year period. Non GAAP net loss in the first quarter of twenty twenty five was $11,400,000 compared to $8,100,000 in the prior year period. As of 03/31/2025, cash and cash equivalents totaled $119,300,000 compared to $34,900,000 as of 03/31/2024, and representing an increase of $1,200,000 versus year end 2024.

Speaker 3

Cash used in operating activities during the first quarter of twenty twenty five was $13,500,000 compared to $9,800,000 used in the $1,000,000 in Q4 of twenty twenty four. This was more than offset by $14,100,000 in proceeds from the exercise of warrants. Now joining us for the question and answer session is Bob Duggan, Co Chairman of the Board. Operator, please open up the call for questions.

Operator

Thank you. There are no questions at this time. I'd like to turn the conference back to Paul LaViolet for closing remarks.

Speaker 2

Thank you, operator. Thanks to all participants on the call today for your interest in Pulse Biosciences. We look forward to providing additional updates on our progress in quarter three. Thank you.

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Powered by Quartr
Earnings Conference Call
Pulse Biosciences Q1 2025
00:00 / 00:00