Pulse Biosciences(US:PLSE)2025-03-28 23:35Clinical 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].