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Pulse Biosciences(PLSE) - 2024 Q2 - Quarterly Report
PLSEPulse Biosciences(PLSE)2024-08-19 20:25
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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 0.5millionto0.5 million to 7.2 million for the three-month period ended June 30, 2024, compared to 6.7millioninthesameperiodin2023[106].−Generalandadministrativeexpensesroseby6.7 million in the same period in 2023[106]. - General and administrative expenses rose by 1.0 million to 4.5millionforthethree−monthperiodendedJune30,2024,comparedto4.5 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 1.5millionto1.5 million to 14.0 million compared to 12.5millioninthesameperiodin2023[110].−Generalandadministrativeexpensesforthesix−monthperiodendedJune30,2024,increasedby12.5 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 8.4millioncomparedto8.4 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 0.4millionto0.4 million to 0.8 million compared to 1.2millioninthesameperiodin2023[116].−Thecompanyhasnotgeneratedsignificantrevenuesfromproductsalessinceinceptionandplanstoinvestinresearchanddevelopmentforfutureproducts[117].−Thecompanyused1.2 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 15.8millionforthesameperiodin2023[123].−Cashprovidedbyfinancingactivitieswas15.8 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 13.4millioninthesameperiodin2023[125].−AsofJune30,2024,thecompanyhadcashandcashequivalentsof13.4 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 60millionfromarightsofferinginJuly2024[120].FundingandFinancing−Thecompanyraised60 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 65milliontofundproductdevelopment,whichwaslaterconvertedintoequity[95].−ArightsofferinginJune2024raised65 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].