Recent Highlights
- Completed Pre-Submission meeting with the U.S. Food and Drug Administration (FDA) to establish the criteria for the studies required for a 510(k) submission for the CellFX System for a general indication in aesthetic dermatology
- Obtained ISO-13485:2016 Quality System Management Certification to begin preparations for CE Mark filing and subsequent international commercialization of the CellFX System
- Initiated a rights offering seeking to raise gross proceeds of approximately $30 million through the sale of units consisting of common stock and warrants to existing stockholders, excluding proceeds of up to $4.5 million from the exercise of warrants issued in the rights offering
"Amid the difficult current circumstances created by the COVID-19 pandemic, Pulse Biosciences has prioritized mitigating infection risks to ensure the health of our team and community while continuing progress towards our goal of commercializing the CellFX System. We are thankful to all the members of the healthcare system and our thoughts are with those impacted by COVID-19," said Darrin Uecker, President and CEO of Pulse Biosciences. "We are very pleased to have recently completed our Pre-Submission meeting with FDA regarding our upcoming 510(k) submission for our CellFX System for a general indication in aesthetic dermatology. We now have greater clarity and confirmation around the requirements to achieve clearance for this indication. We remain extremely confident in the long-term value of our Nano-Pulse Stimulation technology and the value it can provide to patients and physicians in treating a broad range of dermatologic conditions and through additional clinical applications in the future."
Financial Update
Cash, cash equivalents and investments totaled $15.9 million as of March 31, 2020, compared to $25.4 million as of December 31, 2019. Cash used in the first quarter totaled $9.5 million.
Operating expenses for the three months ended March 31, 2020 were $12.0 million, compared to $10.4 million for the prior year period. 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 first quarter ended March 31, 2020 was $11.9 million compared to $10.1 million for the first quarter ended March 31, 2019.
Impact of COVID-19
Our operations in the first 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 point but due to the uncertain scope and duration of the pandemic, we cannot reasonably estimate the future impact to our operations and financial results.
Webcast and Conference Call Information
Pulse Biosciences' management will host a conference call today, May 11, 2020 beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 877-705-6003 for domestic callers or 201-493-6725 for international callers. A live and recorded webcast of the event will be available at http://investors.pulsebiosciences.com/.
About Pulse Biosciences
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. If cleared, the CellFX System will be the first commercial product to harness the distinctive advantages of the Company's proprietary Nano-Pulse Stimulation (NPS) technology to treat a variety of applications for which an optimal solution remains unfulfilled. Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. Subject to regulatory approval, the initial commercial use of the CellFX System is expected to address a broad range of dermatologic conditions that share high demand among patients and practitioners for improved and durable aesthetic outcomes. Designed as a multi-application platform, the CellFX System is intended to offer customer value with a utilization-based revenue model across an expanding spectrum of clinical applications.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation and NPS are trademarks of Pulse Biosciences, Inc.
Caution: Pulse Biosciences' CellFX System and Nano-Pulse Stimulation technology are for investigational use only.
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