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Pulse Biosciences(PLSE) - 2024 Q1 - Quarterly Report
2024-05-07 20:18
Clinical 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].
Pulse Biosciences(PLSE) - 2024 Q1 - Quarterly Results
2024-05-07 20:14
Pulse Biosciences Reports Business Updates and First Quarter 2024 Financial Results Exhibit 99.1 Recent Business Highlights HAYWARD, Calif. [Business Wire] – May 7, 2024. Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary CellFX® Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced business updates and financial results for the first quarter ended March 31, 2024. CellFX nsPFA Percutaneous Electrode ●March 2024, received FDA 510(k) clearance for use in th ...
Pulse Biosciences(PLSE) - 2023 Q4 - Earnings Call Transcript
2024-03-29 00:52
Pulse Biosciences Inc (NASDAQ:PLSE) Q4 2023 Results Conference Call March 28, 2024 4:30 PM ET Company Participants Philip Taylor - IR Kevin Danahy - President & CEO Darrin Uecker - CTO & Director Mitch Levinson - Chief Strategy Officer Mike Koffler - Vice President of Finance Bob Duggan - Executive Chairman Conference Call Participants Brad Bowers - Mizuho Securities Operator Greetings, and welcome to the Pulse Biosciences Fourth Quarter 2023 Earnings Conference Call. At this time, all participants are in a ...
Pulse Biosciences(PLSE) - 2023 Q4 - Annual Results
2024-03-28 20:18
Financial Performance - Total GAAP costs and expenses for Q4 2023 were $12.5 million, up from $8.7 million in Q4 2022, primarily due to a $3.3 million increase in non-cash stock-based compensation[5] - GAAP net loss for Q4 2023 was ($11.9) million compared to ($9.2) million in Q4 2022, while non-GAAP net loss was ($8.3) million compared to ($8.1) million in the prior year[6] - For the full year 2023, total GAAP costs and expenses were $43.6 million, a decrease from $58.8 million in 2022, with non-GAAP costs and expenses at $35.1 million compared to $51.3 million in 2022[7] - Full year GAAP net loss for 2023 was ($42.2) million, improved from ($58.5) million in 2022, while non-GAAP net loss was ($33.8) million compared to ($51.1) million in the previous year[9] - Total revenues for the three-month period ended December 31, 2023, were $0, a decrease of 9% compared to $700,000 in the same period of 2022[25] - The net loss for the three-month period ended December 31, 2023, was $11,933,000, compared to a net loss of $9,197,000 for the same period in 2022, reflecting a 30% increase in losses[25] - The company reported a comprehensive loss of $11,933,000 for the three-month period ended December 31, 2023, compared to a comprehensive loss of $9,197,000 in the same period of 2022[25] - Basic and diluted net loss per share for the three-month period ended December 31, 2023, was $0.22, compared to $0.25 for the same period in 2022[25] - Non-GAAP net loss for the three-month period ended December 31, 2023, was $8,285,000, compared to $8,113,000 for the same period in 2022[30] - Total cost and expenses for the three-month period ended December 31, 2023, were $12,533,000, compared to $8,736,000 in the same period of 2022, marking a 43% increase[25] Cash Position - Cash and cash equivalents as of December 31, 2023, totaled $44.4 million, down from $61.1 million a year earlier, with cash used in Q4 2023 at $6.9 million compared to $8.0 million in Q4 2022[10] Research and Development - Research and development expenses increased to $7,799,000 for the three-month period ended December 31, 2023, up from $4,095,000 in the same period of 2022, representing a 90% increase[25] - The company is actively developing its CellFX nsPFA technology for treating atrial fibrillation and other conditions, with positive early clinical results reported[19] Regulatory and Strategic Initiatives - The company received FDA 510(k) clearance for the CellFX nsPFA Percutaneous Electrode System and completed enrollment in a 30-patient clinical trial for benign thyroid nodules[8] - The company plans to initiate a rights offering pending SEC approval, allowing it to sell up to $50 million worth of securities over three years[8] - The company aims to optimize resources and streamline operations to advance the development of its product portfolio[7] Cost Structure Changes - Total stock-based compensation expense for the twelve-month period ended December 31, 2023, was $7,181,000, an increase from $5,191,000 in 2022[25] - The company reclassified certain expenses due to a shift in focus from dermatology to cardiology, impacting the cost structure[25] - Non-GAAP financial measures are used to provide a clearer view of ongoing operations, excluding stock-based compensation, depreciation, and restructuring charges[15]
Pulse Biosciences(PLSE) - 2023 Q4 - Annual Report
2024-03-28 20:05
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 Pulse Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 46-5696597 (State or ...
Pulse Biosciences(PLSE) - 2023 Q3 - Earnings Call Transcript
2023-11-13 23:16
Pulse Biosciences, Inc. (NASDAQ:PLSE) Q3 2023 Earnings Conference Call November 13, 2023 12:00 PM ET Company Participants Philip Taylor - IR Kevin Danahy - President and CEO Darrin Uecker - CTO and Director Mitchell Levinson - Chief Strategy Officer Michael Koffler - VP of Finance Bob Duggan - Chairman Conference Call Participants Operator Greetings, and welcome to the Pulse Biosciences Third Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It ...
Pulse Biosciences(PLSE) - 2023 Q3 - Quarterly Report
2023-11-13 22:18
(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q For the transition period from to Commission File Number: 001-34899 Pulse Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 46-5696597 ...
Pulse Biosciences(PLSE) - 2023 Q2 - Earnings Call Transcript
2023-08-11 01:04
Pulse Biosciences Inc. (NASDAQ:PLSE) Q2 2023 Results Conference Call August 10, 2023 4:30 PM ET Company Participants Philip Taylor - IR Kevin Danahy - Chief Executive Officer Darrin Uecker - CTO & Director Mitchell Levinson - Chief Strategy Officer Michael Koffler - Director of Finance Bob Duggan - Chariman of the Board of Pulse Biosciences Operator Greetings, and welcome to Pulse Biosciences' Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question ...
Pulse Biosciences(PLSE) - 2023 Q2 - Quarterly Report
2023-08-10 20:23
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 June 30, 2023 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 Pulse Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 46-5696597 (Stat ...
Pulse Biosciences(PLSE) - 2023 Q1 - Earnings Call Transcript
2023-05-12 01:59
Pulse Biosciences, Inc. (NASDAQ:PLSE) Q1 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants Trip Taylor - Investor Relations Kevin Danahy - President & Chief Executive Officer Darrin Uecker - Chief Technology Officer Mike Koffler - Vice President of Finance Robert Duggan – Executive Chairman Conference Call Participants Robert Lovgren – Medical Hope Productions Operator Good afternoon, ladies and gentlemen and thank you for standing by. Welcome to the Pulse Biosciences First Quarter ...