On November 15, 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 third quarter of 2021 (Press release, Pulse Biosciences, NOV 15, 2021, View Source [SID1234595607]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Recent Highlights
Achieved third quarter 2021 revenue of $574 thousand, representing 12 Controlled Launch Program participants opting to acquire their CellFX Systems and transition to commercial use
Onboarded 68 CellFX System Controlled Launch Program participants to date and anticipate the remaining to be onboarded in Q4 to complete program enrollment across the U.S., Europe and Canada
Completed enrollment of 150 patients in an FDA IDE approved pivotal comparison study to assess the treatment of cutaneous non-genital warts using the CellFX System, the corresponding 510(k) submission is on track to be completed in the first half of 2022
Completed enrollment of 30 patients as part of a feasibility study to assess the treatment of basal cell carcinoma using the CellFX System, on track for tissue analysis to be completed in Q1 2022
Strengthened the executive leadership team with the appointment of Mitchell E. Levinson as Chief Strategy Officer, to spearhead the Company’s multi-specialty expansion efforts to leverage NPS technology, the CellFX platform and CellFX CloudConnect in applications outside of dermatology
Appointed healthcare industry executive Laureen DeBuono to its Board of Directors
"We made important progress across the business in the third quarter resulting in our first quarter of revenue as the initial Controlled Launch Program participants elected to purchase their CellFX Systems and Cycle Units for commercial use," said Darrin Uecker, President and CEO of Pulse Biosciences. "On the clinical front we continue to prioritize studies to support regulatory submissions to expand the CellFX System’s indications for use in dermatology. At the same time, we are pleased about the investigational preclinical work being done with NPS across other medical specialties. We are laying a foundation to drive value creation and maximize the full potential of the CellFX platform."
Third Quarter 2021 Results
Revenue for the three months ended September 30, 2021 was $574 thousand. System revenue for the three months ended September 30, 2021 was $490 thousand recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems. Cycle units revenue for the three months ended September 30, 2021 was $84 thousand resulting from the purchase of initial cycle units to be used with commercial systems.
Total GAAP gross loss* for the three months ended September 30, 2021 was ($0.2) million. Excluding non-cash expenses for stock-based compensation and depreciation and amortization, non-GAAP gross loss for the three months ended September 30, 2021 was ($0.1) million. As the business transitioned to commercial operations in the third quarter of 2021, all uncapitalized manufacturing operations costs are now recorded in cost of revenue. Prior to commercialization, these costs were recorded in research and development expenses.
Total GAAP operating expenses representing research and development, sales and marketing and general and administrative expenses for the three months ended September 30, 2021 were $14.1 million, compared to $12.9 million for the prior year period. Non-GAAP operating expenses for the three months ended September 30, 2021 were $12.3 million, compared to $10.0 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 September 30, 2021 was ($14.3) million compared to ($12.9) million for the three months ended September 30, 2020. Non-GAAP net loss for the three months ended September 30, 2021, was ($12.4) million compared to ($10.0) million for the three months ended September 30, 2020.
Cash, cash equivalents and investments totaled $42.0 million as of September 30, 2021 compared to $47.4 million as of June 30, 2021. Cash used in the third quarter of 2021 totaled $13.8 million excluding net proceeds received in the June 2021 private placement. This compares with $8.3 million used in the same period in the prior year and $15.0 million used in the second quarter of 2021.
* Gross loss is calculated as total revenues less cost of revenues.
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."
Webcast and Conference Call Information
Pulse Biosciences’ management will host a conference call today, November 15, 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