On May 10, 2021 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing its Nano-Pulse Stimulation (NPS) technology, reported financial results for the first quarter of 2021 (Press release, Pulse Biosciences, MAY 10, 2021, View Source [SID1234579582]).
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Recent Highlights
Commenced the CellFX System Controlled Launch program and onboarded the first 15 participating U.S. and European aesthetic specialty practices in the first quarter, representing significant progress toward the program goal of onboarding 75 Key Opinion Leader (KOL) sites by the end of the third quarter
Submitted anticipated final response to Health Canada regarding the CellFX System Medical Device License, expect completion of the review by the end of the second quarter
Received FDA IDE approval for a feasibility study to assess the treatment of basal cell carcinoma using the CellFX System, enrollment of 30 patients is planned to begin in the second quarter and to be completed by the end of the third quarter
Continued patient enrollment and treatments in an FDA IDE approved pivotal comparison study to assess the treatment of cutaneous non-genital warts using the CellFX System; 51 of 150 patients have been enrolled to date with completion expected as early as the end of the second quarter or early in the third quarter
U.S. consumer research presented at the American Academy of Dermatology (AAD) virtual annual meeting rated aesthetic patients’ willingness to pay premium out-of-pocket fees and prioritize clearance of skin lesions with the CellFX procedure profile ahead of other popular aesthetic procedures
Strengthened balance sheet through $41 million term loan with a maturity of June 2022 and announced an at-the-market (ATM) equity offering program which could raise up to $60 million in aggregate gross proceeds
"In the first quarter of 2021, we achieved two significant milestones in our business with regulatory clearances for our CellFX System in the U.S. and in Europe. With these regulatory clearances in hand, we immediately executed the rollout of our Controlled Launch program of the CellFX System integrated with CellFX CloudConnect services in both these important markets. We have already made meaningful progress onboarding the first group of KOL participants and over the next several months look forward to gaining insights and developing best practices on driving long term adoption and utilization as we move towards full commercial launch later this year," said Darrin Uecker, President and CEO of Pulse Biosciences. "As we continue to execute on our commercial strategy, we plan to build upon these clearances, selectively adding new markets and pursuing additional applications of our CellFX System outside of aesthetic dermatology."
First Quarter 2021 Results
Cash, cash equivalents and investments totaled $59.9 million as of March 31, 2021, compared to $20.5 million as of December 31, 2020. Cash used in the first quarter of 2021 totaled $10.7 million excluding net proceeds received under the Company’s term loan, ATM program and the exercise of warrants. This compares with $9.5 million used in the same period in the prior year and $9.2 million used in the fourth quarter of 2020, excluding net proceeds received from the exercise of warrants.
GAAP operating expenses for the three months ended March 31, 2021 were $18.5 million, compared to $12.0 million for the prior year period. Non-GAAP operating expenses for the first quarter were $11.3 million, compared to $9.1 million for the same period in the prior year. The year-over-year increase in operating expenses was primarily driven by the expansion of commercial and operational infrastructure, including increased headcount, to support commercialization activities.
GAAP net loss for the three months ended March 31, 2021 was ($18.6) million compared to ($11.9) million for the three months ended March 31, 2020. Non-GAAP net loss for the three months ended March 31, 2021 was ($11.4) million compared to ($9.0) million for the three months ended March 31, 2020.
Reconciliations of GAAP to non-GAAP operating 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."
Impact of COVID-19
The COVID-19 pandemic had minimal impact on the Company’s operations in the first quarter of 2021. Product development, execution of clinical trials, regulatory timelines and Controlled Launch have not been materially affected at this time but due to the uncertain scope and duration of the pandemic, future impact to the Company’s operations and financial results cannot be reasonably estimated.
Webcast and Conference Call Information
Pulse Biosciences’ management will host a conference call today, May 10, 2021 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