Pulse Biosciences(US:PLSE)2024-05-07 20:18Clinical Developments - The company has initiated a clinical study in December 2023 for its CellFX nsPFA 360° Cardiac Catheter in patients with atrial fibrillation (AF), with promising early acute data[93]. - The CellFX nsPFA Cardiac Clamp has achieved transmural ablations in 1.25 seconds during preclinical studies, independent of tissue type or thickness[96]. - The company filed a premarket notification 510(k) with the FDA in January 2024 for the CellFX nsPFA Cardiac Clamp, seeking clearance for commercialization in the U.S.[94]. - The CellFX nsPFA Percutaneous Electrode System received FDA 510(k) clearance in March 2024 for use in soft tissue ablation in percutaneous and intraoperative surgical procedures[103]. - The company has developed a cardiac ablation catheter and clamp specifically for the treatment of AF, differentiating from standard thermal modalities[93]. Strategic Focus - The company has shifted its focus from dermatology to cardiology, ceasing all commercial sales in dermatology to concentrate on AF treatment[105]. - The company is working with multiple hospitals and clinics in the U.S. to secure approvals for the installation of the CellFX System and initiate patient treatments[104]. - The company believes that nsPFA ablation technology can provide superior outcomes across various medical disciplines and may seek partnerships for additional applications[106]. - The company has expanded its thyroid study protocol to optimize treatment parameters, expecting to complete the study in 2025[102]. Financial Performance - The company reported no revenues for the three-month periods ended March 31, 2024, and 2023[120]. - Research and development expenses increased by $0.9 million to $6.7 million for the three-month period ended March 31, 2024, compared to $5.8 million in the same period in 2023[121]. - General and administrative expenses rose by $0.1 million to $3.9 million for the three-month period ended March 31, 2024, compared to $3.7 million in the same period in 2023[122]. - The company incurred a net loss of $10.1 million for the three-month period ended March 31, 2024, compared to a net loss of $9.8 million in the same period in 2023[119]. - As of March 31, 2024, the company had an accumulated deficit of $347.1 million and cash and cash equivalents of $34.9 million[127]. Capital 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[107]. - The company entered into a $65 million loan agreement with Robert Duggan in September 2022, which was terminated in April 2023 when the loan was converted into equity[107]. - The company plans to initiate a rights offering to existing stockholders in the second quarter of 2024 to raise additional capital[128]. - The company has substantial doubt about its ability to continue as a going concern without raising additional capital[110]. - Economic instability and high interest rates may adversely impact the company's future financing sources[129]. Cash Flow Analysis - Cash used in operating activities for Q1 2024 was $9.8 million, compared to $6.6 million in Q1 2023, reflecting an increase of approximately 48.5%[131][132]. - Cash used in investing activities was immaterial in Q1 2024, with only $0.04 million used for property and equipment purchases in Q1 2023[133]. - Cash provided from financing activities in Q1 2024 was $0.3 million, primarily from the issuance of common stock under the employee stock purchase plan[134]. - Cash used in financing activities in Q1 2023 was $0.4 million, which included $0.9 million in payments related to the 2022 Loan Agreement[135]. Risk Factors - The company acknowledges the unpredictability of research and development efforts and may seek additional financing options if current funds are insufficient[140]. - There are no assurances that the company's technology will achieve sustainable revenues or profitability, which may lead to operational cutbacks[141]. - No material changes in market risk have been reported since the last Annual Report, with exposure primarily due to interest rate fluctuations[144]. - There have been no material changes to contractual obligations since the Annual Report for the year ended December 31, 2023[136]. - As of March 31, 2024, there were no off-balance sheet arrangements[137].