On November 9, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing its Nano-Pulse Stimulation (NPS) technology, reported financial results for the third quarter ended September 30, 2020 (Press release, Pulse Biosciences, NOV 9, 2020, View Source [SID1234570418]).
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Recent Highlights
Submitted a 510(k) Premarket Notification application to the U.S. Food and Drug Administration (FDA) for the CellFX System seeking to obtain initial clearance for a general dermatologic indication. Potential clearance remains on track to be received as early as the first quarter of 2021.
Received FDA Investigational Device Exemption (IDE) approval and completed enrollment ahead of schedule in a pivotal comparison study to evaluate the treatment of sebaceous hyperplasia (SH) lesions using the CellFX System, accelerating the planned 510(k) submission into the first quarter of 2021 versus the previous estimate of the second quarter of 2021.
Submitted a Medical Device License application to Health Canada for the CellFX System after receiving the Medical Device Single Audit Program certification, now on track for a potential Health Canada license as early as the first quarter of 2021.
Advanced the interactive review process with the notified body and on track for potential controlled launch in the European Union as early as the first quarter of 2021.
Clinical results from four studies of the CellFX System were presented at the American Society for Dermatologic Surgery virtual annual meeting on October 9-11, 2020.
"We made excellent progress over the last several months on our clinical and regulatory objectives. We remain on track to potentially receive marketing clearances for our CellFX System in our three top geographies, the United States, Canada, and the European Union by the end of the first quarter of 2021. Additionally, completing enrollment in our sebaceous hyperplasia pivotal study in just over five weeks, two months ahead of schedule, is a testament to the interest physicians and patients have regarding the CellFX procedure for this application," said Darrin Uecker, President and CEO of Pulse Biosciences. "Importantly, I would like to thank our team for their hard work and recognize their accomplishments during this last quarter."
Financial Update
Cash, cash equivalents and investments totaled $29.6 million as of September 30, 2020, compared to $37.8 million as of June 30, 2020. Cash used in the third quarter of 2020 totaled $8.2 million. This compares with $7.9 million used in the second quarter of 2020 net of the rights offering proceeds.
Operating expenses for the three months ended September 30, 2020 were $12.9 million, compared to $12.0 million for the prior year period. Third quarter 2020 operating expenses included stock-based compensation expense of $2.6 million, compared to $2.7 million in the third quarter of 2019. The increase in operating expenses was primarily driven by general and administrative increases for facilities expansion, and research and development increases for headcount growth.
Operating expenses for the nine months ended September 30, 2020 were $36.2 million, compared to $34.0 million for the prior year period. Stock-based compensation expense for the nine months ended September 30, 2020 was $7.7 million, consistent with the prior year period. The increase in operating expenses was primarily driven by the expansion of operational infrastructure and increased headcount to support commercial preparations.
Net loss for the three months ended September 30, 2020 was ($12.9) million compared to ($11.7) million for the three months ended September 30, 2019. Net loss for the nine months ended September 30, 2020 was ($36.1) million compared to ($33.2) million for the nine months ended September 30, 2019.
Impact of COVID-19
Operations in the third quarter of 2020 experienced minimal impacts as a result of the COVID-19 pandemic. Product development and regulatory timelines have not been materially affected at this time but due to the uncertain scope and duration of the pandemic, future impact to our operations and financial results cannot be reasonably estimated.
Webcast and Conference Call Information
Pulse Biosciences’ management will host a conference call today, November 9, 2020 beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-705-6003 for domestic callers or 1-201-493-6725 for international callers. A live and recorded webcast of the event will be available at View Source