On May 7, 2024. Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology, reported business updates and financial results for the first quarter ended March 31, 2024 (Press release, Pulse Biosciences, MAY 7, 2024, View Source [SID1234642795]).

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Recent Business Highlights

CellFX nsPFA Percutaneous Electrode

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March 2024, received FDA 510(k) clearance for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures.

CellFX nsPFA Cardiac Clamp

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Remain in the 510(k) process while continuing productive dialogue with FDA regarding the go-forward regulatory path.

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FDA has requested clinical data in support of the regulatory filing and discussions regarding the required clinical data are underway.
● Submitted first-in-human feasibility study to take place at several centers in the Netherlands to the Ethics Committee and anticipate a response in the next several weeks.

CellFX nsPFA 360° Cardiac Catheter

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At the Heart Rhythm Society (HRS) meeting in Boston, May 16th to the 19th, CellFX nsPFA energy will be showcased across 6 poster presentations and abstracts in addition to a live case demonstrating pulmonary vein isolation at the PFA Live Case Summit.

Announcement of Rights Offering

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The Company’s Board of Directors has approved a planned rights offering of up to $60 million worth of units that will be available to all holders of record of the Company’s common stock.

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Company has decided to change the rights offering record date from May 16, 2024 to a date in mid-June. New record date will be announced by the Company once all necessary SEC filings have been completed.
● Assuming the rights offering is fully subscribed at the Initial Price, the Company will receive gross proceeds of up to $60 million, less expenses related to the rights offering, and upon exercise of all the warrants, would receive additional proceeds of up to $66 million. A fully subscribed rights offering would fund the growth plans of the Company into the first quarter of 2026.

"I am incredibly proud of the team’s accomplishments to start the year. Our proprietary CellFX nsPFA energy has demonstrated the potential to advance the standards of care for both soft tissue ablation and the treatment of atrial fibrillation. FDA clearance of the CellFX nsPFA Percutaneous Electrode System along with the posters, abstracts and a live case highlighting the CellFX nsPFA 360° Cardiac Catheter at HRS next week are early validations of our technology and its potential," said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences. "We remain focused on delivering the benefits of CellFX nsPFA to patients and providers following further clinical evaluations and regulatory clearances. For the remainder of the year, we are focused on executing our CellFX nsPFA percutaneous electrode pilot program to initiate the commercial launch and, all the while, continuing to advance the clinical and regulatory work with our CellFX nsPFA Surgical Clamp and 360° Cardiac Catheter."

First Quarter 2024 Financial Results

Total GAAP costs and expenses, representing research and development and general and administrative expenses, for the three months ended March 31, 2024, were $10.6 million compared to $9.6 million for the prior year period. The increase in GAAP costs and expenses was primarily driven by an increase in non-cash stock-based compensation expense, which was $1.8 million for the three months ended March 31, 2024, compared to $0.9 million for the prior year period. The remaining increase in costs and expenses compared to the prior year was driven by an increase in research and development expenses to support the development of the CellFX nsPFA product portfolio. Non-GAAP costs and expenses for the three months ended March 31, 2024, were $8.6 million, compared to $8.3 million for the prior year period.

GAAP net loss for the three months ended March 31, 2024 was ($10.1) million compared to ($9.8) million for the three months ended March 31, 2023. Non-GAAP net loss for the three months ended March 31, 2024 was ($8.1) million compared to ($8.6) million for the three months ended March 31, 2023.

Cash and cash equivalents totaled $34.9 million as of March 31, 2024, compared to $54.1 million as of March 31, 2023 and $44.4 million as of December 31, 2023. Cash used in the first quarter of 2024 was $9.5 million compared to $7.2 million in the same period in the prior year and $6.9 million used in the fourth quarter of 2023. The sequential quarterly increase was driven mainly by $2.0 million in 2023 annual cash bonus payouts.

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, May 7, 2024, 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