On March 16, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company, reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Pulse Biosciences, MAR 16, 2020, View Source [SID1234555610]).

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Recent Highlights

Nano-Pulse Stimulation (NPS) technology was highlighted in three clinical study presentations demonstrating its high clearance rates of benign skin lesions at the Annual Meeting of the American Society for Dermatologic Surgery.

Presented data from a study evaluating the clinical and histologic response of NPS technology in treating challenging cases of nodular Basal Cell Carcinoma at the International Master Course on Aging Skin World Congress.

Completed enrollment in the Company’s CellFX Warts Pivotal Study.

Obtained ISO-13485:2016 Quality System Management Certification to begin preparations for international commercialization of the CellFX System.

Appointed industry veteran Sandra Gardiner as Executive Vice President and Chief Financial Officer.

Announced Board approval to pursue a rights offering seeking to raise $30 million in net proceeds.

Following receipt of a Not Substantially Equivalent Letter from the U.S. Food and Drug Administration (FDA) on its previous 510(k) submission the Company remains engaged with the FDA to determine the regulatory path forward for the CellFX System. The Company recently requested a formal Q-submission meeting with FDA to discuss requirements for a new 510(k) submission and based on recent communication, expects the meeting to take place in May.

"I am proud of our continued work to develop NPS technology across multiple clinical applications. We’ve developed a novel and proprietary platform, the CellFX System, that implements a novel utilization-based business model to align incentives between physicians, patients and Pulse Biosciences. Our top priority remains FDA clearance for use of the CellFX System in aesthetic dermatology," said Darrin Uecker, President and CEO of Pulse Biosciences. "After recent developments and collaboration with FDA, we are refocused on generating and providing additional data that will support a new 510(k) submission for what we believe will be a general dermatologic indication. Our confidence in the technology continues to grow and we remain excited about the potential of our system."

Financial Update

Cash, cash equivalents and investments totaled $25.4 million as of December 31, 2019, compared to $34.5 million as of September 30, 2019. Cash used in the fourth quarter totaled $9.1 million. Cash use for the full year ended December 31, 2019 totaled $34.2 million.

Operating expenses for the three months ended December 31, 2019 were $13.9 million, compared to $9.1 million for the prior year period. Operating expenses for the full year ended December 31, 2019 were $48.0 million compared to $38.0 million for the full year ended December 31, 2018. The increase in operating expenses was driven by the expansion of operational infrastructure including marketing and sales functions as well as the expansion of the research and development teams and clinical trial costs.

Net loss for the fourth quarter ended December 31, 2019 was $13.8 million compared to $9.0 million for the fourth quarter ended December 31, 2018. Net loss for the full year ended December 31, 2019 was $47.0 million compared to $37.5 million for the full year ended December 31, 2018.