Q1 2025 Pulse Biosciences Inc Earnings Call
The Doctor young, ladies and gentlemen, and welcome to the pulse Biosciences first quarter 2025 financial results Conference call.
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Following the presentation, we will conduct a question and answer session.
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This call is being recorded on Thursday may eight 2025.
Speaker Change: I would like hand over the conference to the first speaker today trip Taylor Investor Relations. Please go ahead.
Speaker Change: 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 eight 2025, only and will include forward looking statements and opinion statements, including predictions estimates plans expectations and other similar information.
Speaker Change: 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 or SEC filings can be found on our website or on the Sec's website investors are costs.
Speaker Change: 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.
Speaker Change: This conference call will be available for audio replay on our website at pulse Biosciences Dot com in the news and events section on our Investor Relations page with that I would now like to turn the call over co chair of the board and Chief Executive Officer, All of Ireland.
Speaker Change: Good afternoon, and thank you for joining pulse Biosciences has made strong progress through the first quarter and to date.
Speaker Change: Since we held our last call just five weeks ago I will keep all updates focused on new achievements in 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 2025 financial results.
Speaker Change: We will then be joined by Bob Duggan Co chair of the board for a question and answer session.
Speaker Change: <unk> Biosciences at its core is an innovative medical device company focused on advancing human health by developing and commercializing proprietary nanosecond pulsed field ablation technology.
Speaker Change: Nanosecond pulsed field ablation or nano or N S. PSA technology builds on the strength of microsecond, PFA fast pace and workflow efficient, while creating a fundamentally different mechanism of action to enable a deeper ablation in shorter delivery times.
Speaker Change: All while delivering lower energy levels, which further reduce the risk of thermal damage.
Speaker Change: Our early clinical studies in multiple applications and our initial launch efforts in soft tissue ablation indicate nanoseconds TSA will be a truly disruptive technology.
Speaker Change: As a next generation leader in pulse skilled ablation and with unique and versatile platform. Our focus reflects a commitment to advance therapies that can transform care across multiple large markets are companies seven FDA clearances treatment of over 6000 patients.
Speaker Change: U S D. A breakthrough device designation for a cardiac surgical quant have largely derisked the technology and serve as strong validation of its proprietary mechanism of action and therapeutic potential pulse Biosciences is focused on a few main objectives in 2025 our top.
Speaker Change: <unk> are initiating commercialization.
Percutaneous electrode for soft tissue ablation and benign thyroid disease.
Speaker Change: And initiating IGD pivotal.
Speaker Change: Pivotal studies for our cardiac 360 catheter and cardiac surgical plan.
Speaker Change: In Q1 and in the first weeks of Q2, we have made important progress towards achieving those goals clinic.
Speaker Change: Clinical data on the catheter based treatment of atrial fibrillation or <unk>.
Speaker Change: With our N S. P. A phase III 60 catheter were presented at the January AF Symposium in April at the Heart Rhythm Society meeting, which featured a successful live case telecast using the cargo mapping system from Johnson and Johnson Med Tech.
Speaker Change: The polls $3 60, catheter demonstrated excellent procedure efficiency and acute outcomes based on the treatment capacity of nanoseconds P. F E.
Speaker Change: We treated a S patients in the European clinical feasibility studies for our 360 catheter and cardiac surgical plan with 100.
Speaker Change: 30 patients treated to date, respectively.
Speaker Change: We advanced our preclinical and testing documentation in preparation for filings with FDA for approval to commence our two <unk> studies.
Speaker Change: Clinical data were presented at the American Thyroid Association and the North American Society of Interventional thyroid allergy and benign thyroid nodule ablation using nanosecond PSA delivered with the percutaneous electrodes.
Speaker Change: We continue to expand our direct commercial resources for the launch of our soft tissue ablation product.
Speaker Change: States.
Speaker Change: We raised $14 million through the exercise of warrants during the first quarter to maintain our cash position by 2024 year end levels.
Speaker Change: These milestones further validate the potential benefits of N S. PSA and increase awareness of the technology, among clinicians who may choose to support pulse as clinical investigators or in the future as commercial customers.
Speaker Change: Now I'll provide updates on each of our individual products.
Speaker Change: 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 knowledgeable in the thyroid liver and breast are first application target benign thyroid.
Speaker Change: Nodules were the system offers a safe noninvasive and Glenn preserving alternative to surgery. Its non thermal approach allows precise treatment within the delicate and busy anatomy of the neck without risk of thermal injury.
Speaker Change: We believe nanoseconds PFA can emerge as a preferred treatment option for two compelling reasons first by converting a significant portion of annual fibroid activate procedure volume and second by expanding the market as a very attractive treatment option for patients.
Speaker Change: Who have chosen not to undergo an intervention because of undesirable consequences of either surgery or current ablation modalities.
Speaker Change: These patients for a very large watchful waiters group, hoping for a safer less invasive as well as patient and physician friendly treatment for their disease.
Speaker Change: I worked at Tommy patients face permanent removal of a gland, which controls core bodily functions, including blood pressure body temperature and heart rate.
Speaker Change: 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.
Speaker Change: Use of the percutaneous electro benign thyroid nodule treatment is proving to be quite compelling results.
Speaker Change: Results from the thyroid preserving procedure demonstrate meaningful nodule size reduction achieving an 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.
Speaker Change: A company radiofrequency ablation.
Speaker Change: With increasing use of our NSP FAA percutaneous electric system to treat these nodules, we are building, increasing evidence and patient and physician experiences that validate our positive earlier clinical findings.
Speaker Change: Our endless PSA percutaneous electric system is currently being used.
Multiple centers in the United States.
Speaker Change: 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.
Speaker Change: Over 90 patients have been treated in the pilot program.
Speaker Change: Following completion of the program in Q2, we will collect and analyze the patient outcomes and follow up data.
Speaker Change: 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.
Speaker Change: 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 electrodes on a commercial basis during the second half of 2025.
Speaker Change: In parallel we are continuing to focus efforts on building our commercial infrastructure.
Speaker Change: Our team now consists of several capital equipment system sales professionals and supporting therapy development managers.
Speaker Change: They are developing a pipeline of target accounts based on thyroidectomy volumes and interventional ultrasound guided procedure capabilities.
Speaker Change: 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.
Speaker Change: These factors will contribute to our plans to generate revenue, which we expect to materialize in the second half.
Speaker Change: Let's now discuss our surgical ablation plant.
Speaker Change: Our first in human feasibility study for the treatment of <unk> with pulses surgical cardiac clearance in Europe is progressing according to plan.
Speaker Change: In the past few weeks, we received EU approval by the IRB preclinical protocol expansion in our first in human feasibility study to enroll additional patients beyond the 30, we have treated to date.
Speaker Change: We now have approval to treat up to 60 patients and are continuing to enroll at multiple centers in Europe.
Speaker Change: Approximately three months post treatment patients will undergo an electro anatomical mapping procedure by an electrophysiologist to validate the clinical outcomes.
Speaker Change: 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 N. S. P F <unk> and cardiac surgery and will become an important consideration for future adoption.
Speaker Change: We are encouraged by the performance of the device and we expect to share preliminary results of this trial in late 2025.
Speaker Change: We believe the clamp will enable fast full thickness ablation to execute a cox maze procedure during open heart surgery.
Speaker Change: Despite clinical guidelines. This procedure is significantly underperformed today due in part to technology limitations, and we believe the pulse Biosciences N S. P. S. A cardiac surgical clamp addresses this unmet need uniquely for surgeons.
Speaker Change: 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 bench.
Speaker Change: As we work through the regulatory process with the FDA.
Speaker Change: We are actively engaged with our FDA review team regarding the design of our.
Speaker Change: Pivotal clinical study and are continuing to advance a formal I E.
Speaker Change: For this study by mid year, followed quickly by the commencement of pivotal clinical trial enrollment.
Speaker Change: Now moving onto our 360 catheter system for AF ablation, our third product in development is the 360 <unk> cardiac catheter system also designed to treat atrial fibrillation by delivering nanoseconds PSA technology for endocardial applications.
Speaker Change: TSA has been rapidly adopted by EPS over the past year and has changed the treatment landscape.
Speaker Change: Our early data are demonstrating the potential for NSP MSA to again evolved this space and advance the treatment of a F.
Speaker Change: We believe the 360 catheter can provide improved efficacy and reduce the complexity of the procedure.
Speaker Change: The $3 60 catheter delivers a full circumferential lesion in a single short energy application without the need for catheter rotations we.
Speaker Change: 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.
Speaker Change: We expect these features should enable more efficient safer procedures with quicker recovery.
Speaker Change: While our early findings are promising.
Speaker Change: We recognize the importance that strong clinical evidence will have in supporting clinical adoption.
Speaker Change: We are accumulating a growing body of clinical evidence from our ongoing European first in human feasibility study.
Speaker Change: 100 patients have now been treated in the study by multiple investigators at multiple sites.
Speaker Change: We will be expanding to additional sites in Europe throughout 2025 and are expecting one additional site to begin treating patients in Q2.
Speaker Change: Our initial clinical dataset has now been shared at both the HRS 2025 annual meeting two weeks ago and the AF Symposium in January and demonstrated the compelling potential for <unk> to advance the treatment of a yeah hi.
Speaker Change: Highlights of the data to date include at HRS and oral abstract featured data highlighting the feasibility and durability of pulmonary vein isolation and post carrier wall ablation in the left atrium using N S. PFA technology in a 22 patient cohort.
Speaker Change: Results from this study demonstrated 100% of huge successful electrical isolation in 86 of 86 pulmonary veins in 'twenty, two or 'twenty, two left atrial post carrier wall, requiring an average of 12 pulmonary vein and four six close to <unk>.
Speaker Change: The wall oblations per patient.
Speaker Change: The $3 60 catheter.
Speaker Change: Atrial dwell time, and Fluoroscopy times were on average 26, 2% and six five minutes respectively.
Speaker Change: Most importantly, invasive reamer being at three months revealed durable pulmonary vein isolation in 81 of 86 pulmonary veins, a 94, 2% success rate.
Speaker Change: Left atrial poster wall isolation in 'twenty, one 'twenty two patients a 95, 5% success rate. We are highly encouraged by these early indicators of procedural efficiency and positive patient outcomes.
Speaker Change: At the <unk> Symposium in January late breaking data from the initial 30 patients were shared by Dr. Vivek Reddy.
Speaker Change: The initial cohort of this first 30 patients treated have been evaluated by re mapping completed at three months following the ablation procedure.
Speaker Change: The results demonstrated that 92, 4% of pulmonary veins treated were successfully in conduction blocks.
Speaker Change: Also presented at HRS was a preclinical assessment, which evaluated pulse biosciences newly developed vocal catheter using various S. PFA delivery settings in swine myocardium.
Speaker Change: Results of this preclinical assessment further affirmed the novel Endocardial focal N S. BFA catheter systems capability of creating very deep lesions with a significantly streamlined workflow and this represents the first data we had presented on this newly developed N S. PFA focal catheter.
Speaker Change: Platform.
Speaker Change: 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.
Speaker Change: <unk> raises awareness of the unique features and benefits of N S. TSA and supports our efforts in achieving regulatory clearance for the system.
Speaker Change: The positive data and clinician feedback continue to meet our high expectations and demonstrate how innovative the NSP <unk> hundred 60, <unk> cardiac catheter system and N S. Psa true.
Speaker Change: This early clinical work has positioned us favorably to initiate our IDE pivotal trial to support FDA approval of the nanoseconds PFA 360, cardiac catheter system in the middle of the year and as our platform expands we are excited to see more physicians embracing our technology for.
Speaker Change: <unk> cardio applications.
Speaker Change: With that I will turn the call over to John to speak about our first quarter financial update John.
John Skinner: Thank you Paul.
John Skinner: 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.
John Skinner: In the first quarter of 2025, total GAAP costs and expenses increased by $7 4 million to $18 million.
John Skinner: Compared to $10 6 million in the prior year period.
John Skinner: The increase in GAAP cost and expenses was primarily driven by an increase in noncash stock based compensation, which was $5 $7 million in the first quarter of 2025 compared to $1 8 million in the prior year period.
John Skinner: Along with other compensation and administrative expenses related to the expanding organization to support advancement of our NSP FAA device clinical trials and commercialization.
John Skinner: To remind everyone non-GAAP costs and expenses excludes stock based compensation depreciation and amortization and legal settlement expenses total non-GAAP costs and expenses for the first quarter of 2025 increased by $4 1 million to $12 7 million compared to $8 6 million.
John Skinner: The prior year period.
John Skinner: GAAP net loss in the first quarter of 2025 was $16 8 million compared to $10 1 million in the prior year period.
John Skinner: non-GAAP net loss in the first quarter of 2025 was $11 4 million compared to $8 1 million in the prior year period.
John Skinner: As of March 31, 2025, cash and cash equivalents totaled $119 3 million compared to $34 9 million as of March 31, 2024, and representing an increase of $1 2 million versus year end 2024.
John Skinner: Cash used in operating activities during the first quarter of 2025 was $13 5 million compared to $9 8 million used in the prior year period, and $9 1 million in Q4 of 2024.
John Skinner: This was more than offset by $14 1 million and proceeds from the exercise of warrants.
John Skinner: 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.
John Skinner: Thank you.
John Skinner: There are no questions at this time.
Paul: Like to turn the conference back to Paul <unk> for closing remarks.
Paul: 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.
Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
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