On March 30, 2023 Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary nanosecond pulsed field ablation (nsPFA) technology for electrophysiology and the treatment of atrial fibrillation, reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Pulse Biosciences, MAR 30, 2023, View Source [SID1234629610]).

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Company Updates

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Announced the progression of its corporate strategy elevating the focus on the development of nsPFA delivery devices, including a clamp and catheter, for cardiac ablation to treat atrial fibrillation (AF) in both the surgical and electrophysiology lab settings. Current company focus:
○ Develop and advance the cardiac clamp through the appropriate FDA regulatory path
○ Complete all catheter product and regulatory milestones required to treat patients

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Completed cardiac ablation clamp commercial design. Pre-submission meeting with FDA planned for 2Q23 to discuss the regulatory requirements.

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Advanced development of the nsPFA cardiac ablation catheter system intending to pursue a first-in-human safety feasibility study.

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AF Symposium poster presentation demonstrated the ability of the Company’s nsPFA catheter system to perform cardiac ablation and mapping with a single catheter in preclinical studies.

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Reduced fourth quarter 2022 cash usage to $8.0 million dollars, a reduction of $2.6 million compared to the third quarter of 2022 and in-line with prior guidance, and cash on hand is expected to be sufficient to fund planned operations into the third quarter of 2024.

● Extended the maturity date of the loan facility from Robert Duggan to September 2024.

"As a bioelectric medicine company committed to health innovation, shifting our focus to the treatment of atrial fibrillation is intended to maximize the benefit our technology can provide patients and the value we can create as a company. Based on our preclinical evidence, we believe the delivery of nsPFA utilizing the CellFX System with our clamp and catheter devices will offer a differentiated and improved safety and efficacy profile for cardiac ablation," said Kevin Danahy, Chief Executive Officer of Pulse Biosciences. "In 2023 we will remain laser focused on advancing the development and regulatory progress for both devices."

Fourth Quarter 2022 Results

As a result of the discontinuation of commercial dermatology activity there was no revenue recognized in the fourth quarter of 2022.

Total GAAP cost and expenses, representing cost of revenues, research and development, sales and marketing, and general and administrative expenses, for the three months ended December 31, 2022 were $8.7 million, compared to $16.3 million for the prior year period. Non-GAAP cost and expenses for the three months ended December 31, 2022 were $7.7 million compared to $12.3 million in the prior year period.

GAAP net loss for the three months ended December 31, 2022 was ($9.2) million compared to ($15.4) million for the three months ended December 31, 2021. Non-GAAP net loss for the three months ended December 31, 2022 was ($8.1) million compared to ($11.5) million for the three months ended December 31, 2021.

Full Year 2022 Results

Revenue for 2022 was $700 thousand driven mainly by commercial dermatology activity in the first half of the year.

Total GAAP costs and expenses, representing cost of revenues, research and development, sales and marketing and general and administrative expenses, for 2022 were $58.8 million, compared to $64.4 million in 2021. Non-GAAP cost and expenses for 2022 were $51.3 million compared to $48.7 million in the prior year.

GAAP net loss for the full year of 2022 was ($58.5) million compared to ($63.7) million for 2021. Non-GAAP net loss for 2022 was ($51.1) million compared to ($47.9) million in 2021.

Cash, cash equivalents and investments totaled $61.1 million as of December 31, 2022 compared to $28.6 million as of December 31, 2021 and $69.2 million as of September 30, 2022. Cash used in the fourth quarter of 2022 totaled $8.0 million compared to $13.4 million used in the same period in the prior year and $10.6 million used in the third quarter of 2022. Excluding net proceeds from financing, cash used in the full year of 2022 totaled $47.3 compared to $52.9 million used in 2021.

Reconciliations of GAAP to non-GAAP cost and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, March 30, 2022, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source