Pulse Biosciences(PLSE)

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Pulse Biosciences(PLSE) - 2025 Q1 - Earnings Call Transcript
2025-05-08 21:32
Pulse Biosciences (PLSE) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Philip Taylor - Investor Relations, Gilmartin GroupPaul LaViolette - CEO & Co-Chairman of the Board of DirectorsJon Skinner - CFO 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 tim ...
Pulse Biosciences(PLSE) - 2025 Q1 - Earnings Call Transcript
2025-05-08 21:30
Pulse Biosciences (PLSE) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 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. I would like ...
Pulse Biosciences(PLSE) - 2025 Q1 - Quarterly Report
2025-05-08 21:24
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-34899 601 Brickell Key Drive, Suite 1080 Miami, FL 33131 (Address of principal executive offices) (Zip Code) ...
Pulse Biosciences(PLSE) - 2025 Q1 - Quarterly Results
2025-05-08 20:22
Exhibit 99.1 Pulse Biosciences Reports Business Updates and First Quarter 2025 Financial Results HAYWARD, California. [Business Wire] – May 8, 2025. Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) technology, today announced business updates and financial results for the first quarter ended March 31, 2025. Recent Business Highlights Soft Tissue Ablation Surgical AF Ablation Endocardial Catheter AF Ablation "W ...
Pulse Biosciences(PLSE) - 2024 Q4 - Annual Results
2025-03-28 13:09
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(PLSE) - 2024 Q4 - Earnings Call Transcript
2025-03-28 02:39
Pulse Biosciences (PLSE) Q4 2024 Earnings Call March 27, 2025 10:39 PM ET Company Participants Philip Taylor - PrincipalPaul LaViolette - CEO & Co-Chairman of the Board of DirectorsJon Skinner - CFO Operator Thank you for standing by. My name is Malala, and I will be your conference operator today. At this time, I would like to welcome everyone to the Pulse Biosciences Fourth Quarter twenty twenty four Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the sp ...
Pulse Biosciences(PLSE) - 2024 Q4 - Earnings Call Transcript
2025-03-27 23:46
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(PLSE) - 2024 4 - Earnings Call Transcript
2025-03-27 20:30
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 ...
Pulse Biosciences(PLSE) - 2024 Q3 - Earnings Call Transcript
2024-10-31 01:42
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]
Pulse Biosciences(PLSE) - 2024 Q3 - Quarterly Report
2024-10-30 20:07
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].