Clinical Development - The company initiated a first-in-human study for its nsPFA-enabled percutaneous electrode in June 2023, treating 30 subjects with no serious side effects reported[250]. - The company received FDA 510(k) clearance for the nsPFA Percutaneous Electrode System in March 2024, allowing commercialization for soft tissue ablation[251]. - The company has placed its CellFX System at eight sites in the U.S., with over 70 patient procedures completed to date[252]. - Atrial fibrillation (AF) affects an estimated 43 million people worldwide, and the company believes its nsPFA technology can provide significant advantages over current thermal modalities[254]. - The company plans to begin pivotal clinical trials for its cardiac surgical clamp and 360° cardiac catheter in mid-2025[258][262]. - The company received Breakthrough Device Designation from the FDA for its nsPFA Cardiac Surgery System for AF treatment in July 2024[259]. - The company has designed a proprietary catheter for circumferential ablation, which is expected to enable faster treatment times compared to thermal modalities[260]. - The company aims to explore additional applications for its nsPFA technology across various medical disciplines[264]. Financial Performance - The company reported no revenues for the years ended December 31, 2024 and 2023[278]. - Research and development expenses increased by $4.5 million to $32.3 million in 2024, primarily due to increases in stock-based compensation and employee-related expenses[279]. - General and administrative expenses rose by $8.1 million to $23.9 million in 2024, driven by increases in stock-based compensation and legal settlements[280]. - The net loss for the year ended December 31, 2024 was $53.6 million, compared to a net loss of $42.2 million in 2023, reflecting an increase of $11.4 million[277]. - Interest income increased by $0.2 million to $2.7 million in 2024, while interest expense decreased to zero from $1.1 million in 2023[281]. - The company completed the 2024 Rights Offering, raising $60 million by selling six million units at $10.00 per unit[285]. - As of December 31, 2024, the company had 253,246 warrants outstanding subject to a 150% redemption feature and 1,245,237 warrants subject to a 200% redemption feature[286]. - The company has incurred substantial operating losses and has relied on equity securities and debt for funding since inception[267]. - In 2024, the company used $36.3 million in operating activities, an increase from $33.0 million in 2023[289][290]. - Cash provided from financing activities in 2024 was $110.1 million, significantly higher than $16.3 million in 2023, primarily due to $59.6 million from the 2024 Rights Offering[294][295]. - As of December 31, 2024, the company had cash and cash equivalents of $118.0 million, with an additional $14.1 million received from the exercise of 2024 Rights Offering Warrants[287]. - The company incurred significant operating losses since inception and may continue to do so for several years[287]. - The total contractual obligations for operating leases as of December 31, 2024, amounted to $11.2 million, with $2.2 million due in less than one year[298]. - Cash used in investing activities was $0.1 million in both 2024 and 2023, primarily for the purchase of property and equipment[292][293]. - The company has no off-balance sheet arrangements as of December 31, 2024[299]. Market and Economic Conditions - Economic instability and high interest rates may adversely impact future financing sources for the company[266]. - The company expects to finance future cash needs through public or private equity offerings, debt financings, and potential collaborations, but there is no assurance that these funds will be available on acceptable terms[288]. - The company plans to raise additional capital in the future but may face challenges due to economic conditions and market uncertainties[288][303]. - The company is exposed to market risks, including interest rate and foreign exchange risks, but currently does not hedge interest rate exposure[306][307].

Financial Performance - GAAP net loss for Q4 2024 was ($19.4) million, compared to ($11.9) million for Q4 2023, representing a 63.9% increase in net loss[5] - GAAP net loss for the full year 2024 was ($53.6) million, compared to ($42.2) million for 2023, indicating a 26.5% increase in net loss[10] - Non-GAAP net loss for Q4 2024 was ($10.4) million, compared to ($8.3) million for Q4 2023, reflecting a 25.3% increase in net loss[5] - The net loss for the three-month period ended December 31, 2024, was $19,385,000, compared to a net loss of $11,933,000 in the same period of 2023, reflecting a 62% increase in losses[24] - Non-GAAP net loss for the three-month period ended December 31, 2024, was $10,410,000, compared to $8,285,000 in 2023, representing a 26% increase[28] Revenue and Expenses - Total GAAP costs and expenses for Q4 2024 were $20.3 million, an increase of 61.6% from $12.5 million in Q4 2023[4] - Total GAAP costs and expenses for the full year 2024 were $56.3 million, a 29.1% increase from $43.6 million in 2023[9] - Total cost and expenses for the three-month period ended December 31, 2024, were $20,261,000, compared to $12,533,000 in 2023, reflecting a 62% increase[24] - Research and development expenses increased to $10,662,000 for the three-month period ended December 31, 2024, up from $7,799,000 in 2023, representing a 36% increase[24] - General and administrative expenses rose to $9,599,000 for the three-month period ended December 31, 2024, compared to $4,734,000 in 2023, marking a 103% increase[24] - Total stock-based compensation expense for the three-month period ended December 31, 2024, was $6,793,000, up from $3,344,000 in 2023, indicating a 103% increase[24] Cash Position - Cash and cash equivalents increased to $118.0 million as of December 31, 2024, up from $44.4 million a year earlier, reflecting a 165.5% increase[6] Clinical Developments - The company plans to initiate U.S. clinical trials for the 360° catheter and surgical clamp in mid-2025[3] - Positive preliminary results were announced from a feasibility study using nanosecond PFA technology for treating benign thyroid nodules[7] - The company treated over 80 patients in a first-in-human feasibility study for the Nanosecond PFA 360° Cardiac Catheter System[7] Share Information - Basic and diluted net loss per share for the three-month period ended December 31, 2024, was $0.31, compared to $0.21 in 2023[24] - The weighted average shares used to compute net loss per share increased to 62,056 for the three-month period ended December 31, 2024, from 57,005 in 2023[24]

Financial Data and Key Metrics Changes - In Q4 2024, total GAAP costs and expenses increased by $7.7 million to $20.3 million compared to $12.5 million in the prior year period, primarily driven by an increase in non-cash stock-based compensation [55] - GAAP net loss in Q4 2024 was $19.4 million compared to $11.9 million in the prior year period, while non-GAAP net loss was $10.4 million compared to $8.3 million in the prior year period [56] - Cash and cash equivalents totaled $118 million as of December 31, 2024, compared to $44.4 million as of December 31, 2023 [57] Business Line Data and Key Metrics Changes - The company is advancing commercialization of its soft tissue ablation device, the Percutaneous Electrode, which has broad market clearance for the ablation of soft tissue, particularly for benign thyroid disease [23][27] - The surgical cardiac clamp for treating atrial fibrillation is undergoing a feasibility study in Europe, with 30 patients treated so far [36] - The 360 Catheter system for AF ablation is designed to deliver nanosecond PFA technology, targeting a $3 billion annual U.S. market for ablation catheters [40] Market Data and Key Metrics Changes - The U.S. sees approximately 250,000 patients diagnosed with benign thyroid nodules annually, with about 150,000 opting for thyroidectomy [25] - The market for atrial fibrillation treatment is significant, with over 1.9 million patients diagnosed annually in the U.S. [40] - The company expects nanosecond PFA to capture a significant share of the AF treatment market, expanding from 20% in 2024 to 40%-50% in 2025 [41] Company Strategy and Development Direction - The company aims to advance commercialization of its soft tissue ablation device and initiate pivotal studies for its cardiac catheter and surgical clamp [22] - A hybrid business model will be implemented to efficiently enter markets, either through direct sales or partnerships with established companies [48][49] - The focus is on leveraging its differentiated technology across multiple clinical programs while maintaining operational excellence [53][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unique nanosecond PFA technology's potential to disrupt multiple clinical applications and improve patient outcomes [11][12] - The company is optimistic about its growth trajectory, with a strong balance sheet and a commitment to advancing its clinical programs [10][21] - Management highlighted the importance of robust clinical evidence to drive adoption and validate the technology's effectiveness [45] Other Important Information - The company has received seven FDA clearances and has treated 6,000 patients, indicating a mature platform for future growth [17] - The company has a portfolio of over 180 issued patents covering various systems and methods for nanosecond pulse therapies [18] - The new CFO, Jon Skinner, has joined the company and is expected to contribute significantly to its growth and operational strategies [50][53] Q&A Session Summary Question: What are the company's expectations for the commercialization of its products? - The company is focused on advancing the commercialization of its soft tissue ablation device and initiating pivotal studies for its cardiac catheter and surgical clamp [22] Question: How does the company plan to address the competitive landscape? - The company will implement a hybrid business model to efficiently enter markets, either through direct sales or partnerships with established companies [48][49] Question: What is the outlook for the nanosecond PFA technology? - Management expressed confidence in the technology's potential to disrupt multiple clinical applications and improve patient outcomes [11][12]

Financial Data and Key Metrics Changes - In Q4 2024, total GAAP costs and expenses increased by $7.7 million to $20.3 million compared to $12.5 million in the prior year period, primarily driven by an increase in non-cash stock-based compensation [55] - GAAP net loss in Q4 2024 was $19.4 million compared to $11.9 million in the prior year period, while non-GAAP net loss was $10.4 million compared to $8.3 million in the prior year period [56] - Cash and cash equivalents totaled $118 million as of December 31, 2024, compared to $44.4 million as of December 31, 2023 [57] Business Line Data and Key Metrics Changes - The company is advancing commercialization of its soft tissue ablation device, the Percutaneous Electrode, which has broad market clearance for the ablation of soft tissue, particularly for benign thyroid disease [23][27] - The surgical cardiac clamp for treating atrial fibrillation is undergoing a feasibility study in Europe, with 30 patients treated so far [36] - The 360 Catheter system for atrial fibrillation ablation is designed to deliver nanosecond PFA technology, with an estimated $3 billion annual U.S. market for ablation catheters [40] Market Data and Key Metrics Changes - The U.S. market sees approximately 250,000 patients diagnosed with benign thyroid nodules annually, with about 150,000 opting for thyroidectomy [25] - The company estimates a prevalence of approximately 2 million patients in the watchful waiting category for benign thyroid disease, indicating a significant market opportunity [26] - The annual U.S. market for atrial fibrillation ablation is estimated at $3 billion, with PFA expected to be used in 20% of global AF cases in 2024, expanding to 40% to 50% in 2025 [40][41] Company Strategy and Development Direction - The company aims to advance commercialization of its soft tissue ablation device and initiate pivotal studies for its cardiac catheter and surgical clamp [22] - A hybrid business model will be implemented to efficiently enter markets, either through direct sales or partnerships with established companies [48][49] - The focus is on leveraging differentiated technologies backed by strong clinical evidence to disrupt existing treatment paradigms [47] Management's Comments on Operating Environment and Future Outlook - The CEO expressed confidence in the company's unique nanosecond PFA technology and its potential to improve patient outcomes across various medical conditions [11][15] - Management highlighted the importance of clinical data in validating the technology and driving adoption [45] - The company is optimistic about its growth prospects in 2025, with several important milestones set to be achieved [19][22] Other Important Information - The company has received seven FDA clearances and has treated 6,000 patients, indicating a mature platform for its technologies [17] - The company has a portfolio of over 180 issued patents covering various systems and methods for nanosecond pulse therapies [18] - The new CFO, Jon Skinner, has joined the company and is expected to contribute significantly to its growth and operational excellence [50][53] Q&A Session Summary - No questions were raised during the Q&A session, and the call concluded with closing remarks from the CEO [58][60]

Pulse Biosciences, Inc (PLSE) Q4 2024 Earnings Conference Call March 27, 2025 04:30 PM ET Company Participants Luella - Conference OperatorNot Provided - Conference Call Moderator (Operator Instructions)Tripp Taylor - Investor RelationsNot Provided - Legal/Compliance Disclaimer RepresentativePaul LaViolette - Co‐Chair of the Board and Chief Executive OfficerJohn Skinner - Chief Financial OfficerPaula Violet - Closing Remarks Luella Thank you for standing by. My name is Luella, and I will be your conference ...

Financial Data and Key Metrics Changes - In Q3 2024, total GAAP costs and expenses increased by $2.4 million to $13.7 million compared to $11.3 million in the prior year period [50] - GAAP net loss in Q3 2024 was $12.7 million compared to $10.6 million in the prior year period [52] - Cash and cash equivalents totaled $79 million as of September 30, 2024, compared to $44.4 million as of December 31, 2023 [53] Business Line Data and Key Metrics Changes - The company treated the first patients with Atrial Fibrillation (AF) using its nano-PFA Cardiac Surgical System in Europe [13] - The CellFX Percutaneous Electrode System received FDA 510(k) clearance for soft tissue ablation [21] - The initial clinical experiences with the nano-PFA needle ablation device in benign thyroid nodules have been positive, with patients experiencing symptomatic relief [31] Market Data and Key Metrics Changes - The incidence of palpable benign thyroid nodules in the U.S. is about 0.1% per year, with an estimated 250,000 patients diagnosed annually [24] - The treatment of benign thyroid nodules represents a potential market in excess of $1 billion per year for the company [30] Company Strategy and Development Direction - The company is focused on producing compelling clinical data to demonstrate the safety and effectiveness of its applications [19] - Plans to initiate pivotal clinical studies for its three products in mid-2025 [40][45] - The strategy includes seeking specific indications for the use of devices to drive faster clinician adoption and market penetration [20] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about continuing clinical experiences with three products throughout 2024 and into 2025 [55] - The company is building its team and infrastructure to support anticipated growth and conduct pivotal clinical studies [56] Other Important Information - The company completed a rights offering, raising $60 million in gross proceeds with the potential to raise an additional $66 million through the exercise of warrants [14] - The differentiated mechanism of action of nano-PFA technology has the potential to destroy cells more effectively than traditional methods [17] Q&A Session Summary Question: Are there any questions from participants? - There were no questions during the Q&A session [57]

Clinical Trials and Product Development - The company initiated a first-in-human study for its nsPFA-enabled percutaneous electrode in June 2023, treating thirty subjects with no serious side effects reported[102]. - The company received FDA 510(k) clearance for the CellFX nsPFA Percutaneous Electrode System in March 2024, allowing commercialization for soft tissue ablation[103]. - The company has placed the CellFX System in seven sites in the U.S., with over twenty-five patient procedures completed under short-term evaluation agreements[104]. - The company plans to begin pivotal clinical trials for its cardiac surgical clamp and catheter in mid-2025, with a multi-site study already initiated in the Netherlands[110][114]. - The company received Breakthrough Device Designation from the FDA for its CellFX nsPFA Cardiac Surgery System for AF treatment in July 2024[111]. - The company expects to complete the ongoing study of the nsPFA-enabled percutaneous electrode by 2025, with promising ultrasound results showing resorption of treated thyroid nodules[102]. - The company has expanded its clinical study for the CellFX nsPFA 360° Cardiac Catheter to enroll up to 60 patients due to encouraging preliminary results[114]. - The company aims to explore additional applications for nano-PFA technology across various medical disciplines through potential partnerships[116]. Financial Performance and Funding - The company raised $15 million through a common stock rights offering in June 2022, with Robert Duggan purchasing approximately 56% of the shares offered[117]. - In September 2022, the company entered into a loan agreement with Robert Duggan for $65 million to fund product development, which was later terminated in April 2023[117]. - A rights offering in June 2024 raised $60 million, with Robert Duggan purchasing approximately 88% of the shares offered[117]. - The company reported no revenues for the three-month periods ended September 30, 2024, and 2023[128]. - Research and development expenses increased by $0.2 million to $7.7 million for the three-month period ended September 30, 2024, compared to $7.5 million in 2023[129]. - General and administrative expenses rose by $2.2 million to $6.0 million for the three-month period ended September 30, 2024, compared to $3.8 million in 2023[131]. - For the nine-month period ended September 30, 2024, research and development expenses increased by $1.7 million to $21.7 million compared to $20.0 million in 2023[135]. - General and administrative expenses for the nine-month period ended September 30, 2024, increased by $3.3 million to $14.3 million compared to $11.0 million in 2023[137]. - Interest income, net, increased by $1.0 million to $1.8 million for the nine-month period ended September 30, 2024, compared to $0.8 million in 2023[138]. - The company has not generated significant revenues from product sales since inception and plans to invest in research and development for future products[139]. - The company completed a private placement on May 9, 2023, issuing 10,022,937 shares at $6.51 per share, which settled the $65.0 million loan and approximately $0.2 million in accrued interest[141]. - The 2024 Rights Offering resulted in the sale of six million units at $10.00 per unit, generating gross proceeds of $60 million, with potential additional proceeds of up to $66 million from warrant exercises[142]. - As of September 30, 2024, the company had cash and cash equivalents of $79.0 million, which is expected to fund projected operating requirements for at least the next twelve months[143]. - During the nine months ended September 30, 2024, the company used $27.2 million in operating activities, compared to $26.3 million for the same period in 2023[146][147]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $61.9 million, significantly higher than $15.6 million for the same period in 2023[149][150]. - The company has incurred significant operating losses since inception and may continue to do so for the next several years[143]. - The company plans to raise additional capital in the future, but there is no assurance that such financing will be available on acceptable terms[144]. - Research and development of new technologies are unpredictable, and the company may need to consider alternative financing options if sufficient funds are not available[155][156]. Market and Operational Risks - The company is exposed to market risks primarily due to fluctuations in interest rates, with no material changes in market risk reported since the last annual report[158].

Financial Performance - Total GAAP costs and expenses for Q3 2024 were $13.7 million, an increase of 21.2% from $11.3 million in Q3 2023[6]. - GAAP net loss for Q3 2024 was ($12.7) million, compared to ($10.6) million in Q3 2023, reflecting a 19.8% increase in losses[7]. - Total revenues for the quarter were $0, with no product revenues reported[18]. - The net loss for the quarter was $12,680,000, compared to a net loss of $10,566,000 in the prior year, indicating a 20% increase in losses[18]. - Basic and diluted net loss per share was $(0.21), compared to $(0.19) in the same quarter last year[18]. - Non-GAAP net loss for the quarter was $(9,405,000), compared to $(8,471,000) in the same quarter last year, reflecting an increase of 11%[21]. Cash and Assets - Cash and cash equivalents totaled $79.0 million as of September 30, 2024, including $60 million from a rights offering[8]. - Cash used in Q3 2024 was $8.5 million, a slight decrease from $8.7 million used in Q2 2024 and Q3 2023[9]. - Total assets increased to $93.0 million as of September 30, 2024, up from $59.2 million at the end of 2023[17]. - The company has the potential to raise an additional up to $66 million through the exercise of warrants from the rights offering[8]. Expenses - Research and development expenses increased to $7,703,000 from $7,472,000, representing a 3% increase year-over-year[18]. - General and administrative expenses rose significantly to $5,952,000, up from $3,780,000, marking a 57% increase compared to the previous year[18]. - Total cost and expenses for the quarter were $13,655,000, compared to $11,252,000 in the same quarter last year, reflecting a 21% increase[18]. - Stock-based compensation expense totaled $2,982,000, up from $1,798,000, representing a 66% increase year-over-year[19]. - Non-GAAP research and development expenses were $6,548,000, slightly up from $6,435,000, a 2% increase year-over-year[20]. - Non-GAAP general and administrative expenses increased to $3,832,000 from $2,722,000, a significant rise of 41% compared to the previous year[20]. Clinical Developments - The company placed nsPFA Percutaneous Electrode Systems with seven sites in the U.S. for clinical assessment, with commercial use expected to begin soon[2]. - The company expects to commence pivotal clinical trials in mid-2025 for the Percutaneous Electrode System and the nano-PFA Cardiac Surgical System[3][4]. - Over 50 patients have been treated with the nano-PFA 360° Cardiac Catheter in a feasibility study for AF[4]. - The company appointed Dr. David Kenigsberg as Chief Medical Officer for Electrophysiology, enhancing its leadership team[4].

Core Insights - Pulse Biosciences reported a loss of earnings per share amounting to -20 cents for the second quarter of 2024 [1] - The company did not generate any revenue during the quarter [1] Financial Performance - Earnings per share: -20 cents [1] - Revenue: $0 for the quarter [1]

Clinical Development - The company has initiated a first-in-human study for the CellFX nsPFA Percutaneous Electrode System, treating over 20 subjects with no serious side effects reported[82]. - In November 2023, the company filed a premarket notification 510(k) with the FDA for the CellFX nsPFA Percutaneous Electrode System, receiving clearance in March 2024 for soft tissue ablation[83]. - The company expects to commence a pivotal clinical trial in 2025 to support the commercialization of the Percutaneous Electrode System for benign thyroid nodules[84]. - Atrial fibrillation (AF) affects an estimated 43 million people worldwide, and the company believes its nsPFA technology is uniquely suited for safe and effective ablation of cardiac tissue[85]. - The nsPFA Cardiac Surgical System received Breakthrough Device Designation from the FDA in July 2024, expediting its development for AF treatment[89]. - The company has expanded its clinical study for the CellFX nsPFA 360° Cardiac Catheter from 30 to 60 patients due to promising early data[92]. - The company plans to pursue a PMA application for the cardiac ablation clamp, expecting to begin pivotal clinical trials in 2025[88]. - The CellFX Console is designed to accommodate various clinical applications and has been cleared for use in dermatology, now being repurposed for cardiology[93]. - The company continues to explore partnership opportunities to develop additional applications for nsPFA technology across various medical disciplines[94]. Financial Performance - The company reported no revenues for the three-month periods ended June 30, 2024, and 2023[105]. - Research and development expenses increased by $0.5 million to $7.2 million for the three-month period ended June 30, 2024, compared to $6.7 million in the same period in 2023[106]. - General and administrative expenses rose by $1.0 million to $4.5 million for the three-month period ended June 30, 2024, compared to $3.5 million in the same period in 2023[108]. - For the six-month period ended June 30, 2024, research and development expenses increased by $1.5 million to $14.0 million compared to $12.5 million in the same period in 2023[110]. - General and administrative expenses for the six-month period ended June 30, 2024, increased by $1.1 million to $8.4 million compared to $7.3 million in the same period in 2023[115]. - Interest income for the six-month period ended June 30, 2024, decreased by $0.4 million to $0.8 million compared to $1.2 million in the same period in 2023[116]. - The company has not generated significant revenues from product sales since inception and plans to invest in research and development for future products[117]. - The company used $18.2 million in operating activities during the six months ended June 30, 2024, compared to $15.8 million for the same period in 2023[123]. - Cash provided by financing activities was $40,000 for the six months ended June 30, 2024, a significant decrease from $13.4 million in the same period in 2023[125]. - As of June 30, 2024, the company had cash and cash equivalents of $26.2 million and raised approximately $60 million from a rights offering in July 2024[120]. Funding and Financing - The company raised $15 million through a common stock rights offering in June 2022, with Robert Duggan purchasing approximately 56% of the shares offered[95]. - In September 2022, the company entered into a loan agreement with Robert Duggan for $65 million to fund product development, which was later converted into equity[95]. - A rights offering in June 2024 raised $60 million, with Mr. Duggan purchasing approximately 88% of the shares offered[95]. - The company expects to finance future cash needs through public or private equity offerings, debt financings, and potential collaborations, but there is no assurance that such funds will be available[121]. - The company incurred significant operating losses since inception and may continue to do so for the next several years[120]. - The company may need to curtail operations or seek unattractive financing terms if adequate funds are not available[121]. - The company entered into a 2022 Loan Agreement with Robert W. Duggan for a principal sum of $65.0 million, with an interest rate of 5.0%[119]. Market and Risk Factors - Research and development of new technologies are unpredictable, and there is no assurance that the company will achieve sustainable revenues[129]. - The company has no off-balance sheet arrangements as of June 30, 2024[127]. - There have been no material changes in market risk, primarily related to fluctuations in interest rates, since the last annual report[131].