Pulse Biosciences reports second quarter 2020 financial results

Pulse Biosciences, Inc., a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, today announced financial results for the second quarter ended June 30, 2020.

Recent Highlights

• Completed the CellFX System GLP (good laboratory practice) preclinical study treatments to generate the data required for the planned 510(k) submission to the U.S. Food and Drug Administration (FDA) for an initial FDA clearance with a general dermatologic indication. This puts the Company on track for a 510(k) submission in the next 60-90 days
• Conducted a formal Pre-Submission meeting with the FDA to establish the design for the comparative study required for a subsequent 510(k) submission to expand the indication for use of the CellFX System to include a specific indication for Sebaceous Hyperplasia. The meeting resulted in a general agreement on the study design which allows the Company to move forward with an IDE submission and a potential study start in early Q4, as planned
• Submitted the CellFX System technical file to its European notified body in pursuit of the CE mark, the regulatory approval that would authorize the Company to commercialize the CellFX System in the EU. Review is currently underway with expectations for receipt of a CE mark for the CellFX System in Q1 2021
• Three clinical studies demonstrating favorable results from the investigational use of NPS technology in Nodular Basal Cell Carcinoma, Sebaceous Hyperplasia and Common Warts, respectively, were presented at the virtual American Society for Laser Medicine and Surgery (ASLMS) annual conference
• Strengthened balance sheet with the successful completion of a substantially oversubscribed rights offering, incurring minimal offering costs compared to a traditional public offering, delivering greater net proceeds to the Company. The $30.0 million rights offering generated $29.5 million of net proceeds, not including additional potential gross proceeds of $4.5 million through the exercise of issued warrants
• Expanded its Board of Directors with the appointment of Richard van den Broek, serving as a member of the audit and the compensation committees of the Board

“We had a very productive second quarter despite the challenging circumstances persisting as a result of the COVID-19 pandemic. We have remained diligent in our efforts to create the safest work environment possible for our employees and the community and I would like to thank our entire team for their continued efforts and dedication. At the same time, we are pleased that we continue to drive progress towards our top priority of achieving regulatory approvals for the CellFX System,” said Darrin Uecker, President and CEO of Pulse Biosciences. “We believe our progress on the clinical and regulatory front combined with continued engagement from the scientific community has positioned us favorably for eventual commercialization in the US, Europe and Canada. Lastly, I would like to thank our shareholders for their participation in the rights offering. Proceeds from this offering will enable us to further progress our development, clinical and commercial objectives.”

Financial Update

Cash, cash equivalents and investments totaled $37.8 million as of June 30, 2020, compared to $15.9 million as of March 31, 2020. Excluding the net proceeds of the rights offering received in the three months ended June 30, cash used in the second quarter of 2020 totaled $7.9 million. This compares with $9.5 million used in the first quarter of 2020.

Operating expenses for the three months ended June 30, 2020 were $11.4 million, compared to $11.6 million for the prior year period. Second quarter 2020 operating expenses included stock-based compensation expense of $2.4 million, compared to $2.7 million in the second quarter of 2019. The decrease in operating expenses was primarily driven by reduced research and development costs which were partially offset by increases in general and administrative costs in preparation for commercialization.

Operating expenses for the six months ended June 30, 2020 were $23.3 million, compared to $22.1 million for the prior year period. Stock-based compensation expense for the six months ended June 30, 2020 was $5.0 million, compared to $5.1 million in the prior year period. The increase in operating expenses was primarily driven by the expansion of operational infrastructure including marketing and sales functions.

Net loss for the three months ended June 30, 2020 was ($11.3) million compared to ($11.4) million for the three months ended June 30, 2019. Net loss for the six months ended June 30, 2020 was ($23.2) million compared to ($21.4) million for the six months ended June 30, 2019.

Impact of COVID-19

Our operations in the second 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, we cannot reasonably estimate the future impact to our operations and financial results.

-BusinessWire