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]

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q4 2024 Earnings Conference Call March 27, 2025 4:30 PM ET Company Participants Philip Trip Taylor - Investor Relations Paul LaViolette - Chief Executive Officer and Co-Chairman of the Board of Directors Jon Skinner - Chief Financial Officer Conference Call Participants Operator Thank you for standing by. My name is Louella, and I will be your conference operator today. At this time, I would like to welcome everyone to the Pulse Biosciences’ Fourth Quarter 2024 Earnings ...

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].

Financial Data and Key Metrics Changes - Cash and cash equivalents totaled $26.2 million as of June 30, 2024, compared to $58.7 million as of June 30, 2023, not including the $60 million from the rights offering closed in July 2024 [24] - Cash used in Q2 2024 was $8.7 million, down from $10 million in the same period last year and $9.5 million in Q1 2024 [25] - Total GAAP costs and expenses increased by $1.5 million to $11.7 million compared to $10.2 million in the prior year period, primarily due to an increase in non-cash stock-based compensation [25] Business Line Data and Key Metrics Changes - The company is focused on three product lines: soft tissue ablation, epicardial surgical ablation, and endocardial catheter ablation, with significant progress reported in each area [11][22] - Initial clinical results for soft tissue ablation of benign thyroid nodules have been promising, with the first U.S. procedures completed following FDA clearance [13][14] - The cardiac surgical system for atrial fibrillation has received breakthrough device designation from the FDA, emphasizing its potential benefits [18] Market Data and Key Metrics Changes - The benign thyroid nodule market is estimated to have as many as 1.3 million people worldwide, representing a significant opportunity for the company's nano-PFA technology [33] - The company plans to expand its clinical studies in Europe, adding two prestigious clinical sites to gather additional user experiences and clinical outcomes [21] Company Strategy and Development Direction - The company aims to commercialize devices for soft tissue ablation, epicardial surgical ablation, and endocardial catheter ablation, focusing on compelling clinical data to support regulatory pathways [8][10] - The strategy includes pursuing specific labeled indications for regulatory approval, which will enhance marketing and clinician adoption [10][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of nano-PFA technology to transform treatment options across various medical applications, highlighting the importance of rigorous clinical and regulatory pathways [5][22] - The company anticipates that the cash on hand will support operations into 2026, even without exercising warrants from the rights offering [34] Other Important Information - The company completed a rights offering fundraising in July, which was oversubscribed and provided gross proceeds of $60 million [22] - Paul LaViolette has been appointed Co-Chairman of the Board, bringing extensive experience in scaling cardiology medtech franchises [23] Q&A Session Summary Question: Feedback on initial cardiac surgical cases and regulatory pathway - Management noted that initial procedures were efficient, and the device performed well, with excitement from clinicians involved [29] - The regulatory pathway will focus on a PMA application for atrial fibrillation treatment rather than a 510(k) submission [30][31] Question: Market opportunity for benign thyroid nodules - Management highlighted the significant number of patients with benign thyroid nodules and the advantages of nano-PFA in providing a non-invasive treatment option [32][33] Question: Capitalization for concurrent studies in 2025 - Management indicated that while cash burn will increase with the active phases of studies, current cash reserves are expected to last into 2026 without warrant exercises [34]

Financial Performance - Pulse Biosciences, Inc. reported financial results for the fiscal quarter ended June 30, 2024, with a focus on operational performance[4]. - The financial report and operational results are intended to provide insights into the company's performance and future outlook[4]. Board of Directors and Governance - The company appointed Paul A. LaViolette to its Board of Directors, who brings 40 years of experience in global medical technology[5]. - The Board established a new Strategic Advisory Committee to oversee corporate initiatives, including financing and licensing opportunities[5]. - Non-employee directors will receive an annual retainer of $55,000, with additional compensation for committee service, totaling up to $80,000 for the Lead Independent Director[8]. - The company amended its Non-Employee Director Compensation Policy to increase cash compensation for board service[8]. Stock Options and Compensation - Mr. LaViolette received an initial stock option grant to purchase 50,000 shares at a strike price of $15.65, vesting over three years[7]. - Newly appointed members of the Strategic Advisory Committee received 200,000 shares each, vesting over four years[10]. Strategic Initiatives - The company is focused on evaluating financing, partnering, and licensing opportunities as part of its strategic initiatives[5]. - The press release dated August 12, 2024, includes a business update and quarterly results[12].