On August 9, 2021 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported financial results for the second quarter of 2021 (Press release, Pulse Biosciences, AUG 9, 2021, View Source [SID1234586134]).
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Recent Highlights
CellFX System Controlled Launch Program participants totaled 49 at the end of the second quarter, including 34 onboarded during the second quarter across the U.S., Europe and Canada, on track to complete program onboarding of the Key Opinion Leader (KOL) sites by the end of the third quarter
Initiated the transition of clinics from the Controlled Launch Program to commercial use as clinics opt to acquire the CellFX System
Achieved Health Canada Approval for the CellFX System and expanded the Controlled Launch into Canada with the onboarding of the first clinic and completion of the first procedures
Completed enrollment of 127 of the expected 150 patients in an FDA IDE approved pivotal comparison study to assess the treatment of cutaneous non-genital warts using the CellFX System, enrollment is on track to be completed by the end of the third quarter
Enrolled 18 of 30 patients as part of a study to assess the treatment of basal cell carcinoma using the CellFX System, enrollment is on track to be completed by the end of the third quarter
Four podium presentations of clinical studies highlighting NPS technology were delivered by leading dermatologic researchers at the American Society for Laser Medicine and Surgery (ASLMS) Virtual Annual Meeting in May
Completed $50 million common stock private placement with the Company’s Chairman Robert W. Duggan, including the extinguishment of the principal balance and accrued and unpaid interest of the March 11, 2021 term-loan and the investment of $8.4 million of new capital
"We are pleased with the progress across the business in the second quarter. We onboarded a significant number of controlled launch participant clinics, including in Canada following the achievement of Health Canada approval for the CellFX System and continued to make progress on our clinical initiatives intended to broaden the CellFX System’s applications in aesthetic dermatology and beyond," said Darrin Uecker, President and CEO of Pulse Biosciences. "With this progress and anticipated ongoing commercial conversions of controlled launch participants, we are well positioned to drive growth through increased adoption of CellFX procedures. We look forward to a broader commercial launch late in the year and toward delivering the benefits of NPS technology to more patients and clinicians."
Second Quarter 2021 Results
Cash, cash equivalents and investments totaled $47.4 million as of June 30, 2021 compared to $59.9 million as of March 31, 2021. The cash balance as of June 30, 2021 excludes approximately $8.4 million of private placement proceeds received in July 2021. Cash used in the second quarter of 2021 totaled $15.0 million excluding net proceeds received under the Company’s ATM program. Cash used in the second quarter of 2021 included the payment of $2.5 million to Mr. Duggan in accordance with the with terms of the May 2020 Letter Agreement whereby Mr. Duggan provided indemnity coverage on substantially the same terms as the Company’s prior director and officer liability insurance program. This compares with $7.9 million used in the same period in the prior year and $10.7 million used in the first quarter of 2021.
GAAP operating expenses for the three months ended June 30, 2021 were $14.8 million, compared to $11.4 million for the prior year period. Non-GAAP operating expenses for the second quarter were $12.1 million, compared to $8.7 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 June 30, 2021, was ($15.3) million compared to ($11.3) million for the three months ended June 30, 2020. Non-GAAP net loss for the three months ended June 30, 2021, was ($12.6) million compared to ($8.6) million for the three months ended June 30, 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 second quarter of 2021. Product development, execution of clinical trials, regulatory timelines and Controlled Launch have not been materially affected at this time. However, due to the uncertain scope and duration of the pandemic, future impact to the Company’s operations and financial results, if any, cannot be reasonably estimated.
Webcast and Conference Call Information
Pulse Biosciences’ management will host a conference call today, August 9, 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