Pulse Biosciences(US:PLSE)2024-10-30 20:07Clinical 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].