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Pulse Biosciences(PLSE) - 2024 Q1 - Earnings Call Transcript
2024-05-11 17:29
Financial Data and Key Metrics Changes - In Q1 2024, total GAAP costs and expenses increased by $1 million to $10.6 million compared to $9.6 million in the prior year period, primarily due to an increase in non-cash stock-based compensation expense, which rose to $1.8 million from $0.9 million [23][47] - Cash and cash equivalents totaled $34.9 million as of March 31, 2024, down from $44.4 million as of December 31, 2023, with cash used in Q1 2024 amounting to $9.5 million compared to $7.2 million in the same period last year [24] Business Line Data and Key Metrics Changes - The company has treated 30 patients for soft tissue ablation for thyroid disease using the CellFX nsPFA system, with no serious adverse events reported [16][17] - For cardiac indications, 24 out of 30 patients have been successfully treated with the CellFX nsPFA 360-degree Cardiac Catheter, with the remaining six expected to be treated within the next 45 days [19] Market Data and Key Metrics Changes - The company received FDA 510(k) clearance for its non-cardiac CellFX nsPFA percutaneous system in March 2024, which is used for soft tissue ablation across various procedures [40] - The company plans to have a strong presence at the upcoming Heart Rhythm Society meeting, featuring six poster presentations and a live case presentation [43][62] Company Strategy and Development Direction - The company is committed to advancing its proprietary CellFX nsPFA energy delivery system and plans to conduct multiple clinical trials across different indications [15] - A rights offering of up to $60 million is planned to secure necessary capital for advancing its devices towards market entrance [44][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth and the potential of its technology to improve treatment outcomes, emphasizing the importance of building strong clinical support for physicians [15][27] - Ongoing discussions with the FDA regarding the clinical pathway for the CellFX nsPFA Surgical Clamp indicate a collaborative approach to regulatory requirements [30][60] Other Important Information - The company has submitted an application to the Ethics Committee in the Netherlands for a first-in-human feasibility study with the CellFX nsPFA Surgical Clamp, expecting a response soon [42] - The rights offering is expected to provide funding for the company's growth plans into the first quarter of 2026 [45] Q&A Session Summary Question: How is the pilot launch going in the U.S. with the percutaneous electrode now that it's approved? - The interest level has been high among physicians at major institutions, and the company expects the CellFX percutaneous system to be used in several prominent hospitals by the end of the year [26][27] Question: Can you provide details on the FDA dialogue and the pivotal program? - The company has had productive discussions with the FDA and is working on the clinical program requirements for the 510(k) process [29][30] Question: What are the expectations for the upcoming Heart Rhythm Society meeting? - The company is looking forward to presenting both preclinical and clinical data at HRS, highlighting the advantages of nanosecond PFA technology [34][62]
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 ...