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Pulse Biosciences, Inc. (PLSE) SEC Filing 10-Q Quarterly Report for the period ending Wednesday, March 31, 2021

Pulse Biosciences, Inc.

CIK: 1625101 Ticker: PLSE

Pulse Biosciences Reports First Quarter 2021 Financial Results



HAYWARD, Calif. [Business Wire] – May 10, 2021

– Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing its Nano-Pulse Stimulation™ (NPS™) technology, today announced financial results for the first quarter of 2021.



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.

 

 

 


The following information was filed by Pulse Biosciences, Inc. (PLSE) on Monday, May 10, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Pulse Biosciences, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets (Parenthetical)
Condensed Consolidated Statements Of Cash Flows
Condensed Consolidated Statements Of Operations And Comprehensive Loss
Condensed Consolidated Statements Of Stockholders' Equity
Balance Sheet Components
Balance Sheet Components (Narrative) (Details)
Balance Sheet Components (Schedule Of Accrued Expenses) (Details)
Balance Sheet Components (Schedule Of Amortization Of Intangible Assets) (Details)
Balance Sheet Components (Schedule Of Intangible Assets, Net) (Details)
Balance Sheet Components (Schedule Of Property And Equipment, Net) (Details)
Balance Sheet Components (Tables)
Commitments And Contingencies
Commitments And Contingencies (Narrative) (Details)
Commitments And Contingencies (Schedule Of Information Related To Right-Of-Use Assets And Lease Liabilities) (Details)
Commitments And Contingencies (Schedule Of Maturity Lease Payments) (Details)
Commitments And Contingencies (Tables)
Controlled Launch
Controlled Launch (Narrative) (Details)
Description Of The Business
Fair Value Of Financial Instruments
Fair Value Of Financial Instruments (Fair Value Of Financial Assets Measured On A Recurring Basis) (Details)
Fair Value Of Financial Instruments (Narrative) (Details)
Fair Value Of Financial Instruments (Tables)
Goodwill
Goodwill (Narrative) (Details)
Related Party Transactions
Related Party Transactions (Narrative) (Details)
Research Grants And Agreements
Research Grants And Agreements (Narrative) (Details)
Stockholders' Equity And Stock-Based Compensation
Stockholders' Equity And Stock-Based Compensation (Narrative) (Details)
Stockholders' Equity And Stock-Based Compensation (Schedule Of Fair Value Of Employee Stock Options) (Details)
Stockholders' Equity And Stock-Based Compensation (Schedule Of Stock-Based Compensation Expense) (Details)
Stockholders' Equity And Stock-Based Compensation (Summary Of Exercise Price Of Stock Options Outstanding And Exercisable) (Details)
Stockholders' Equity And Stock-Based Compensation (Summary Of Stock Option Activity) (Details)
Stockholders' Equity And Stock-Based Compensation (Summary Of Stock Warrant Activity) (Details)
Stockholders' Equity And Stock-Based Compensation (Summary Of Stock-Based Compensation Expense) (Details)
Stockholders' Equity And Stock-Based Compensation (Tables)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Anti-Dilutive Shares Excluded From Computation Of Diluted Net Loss Per Share) (Details)
Summary Of Significant Accounting Policies (Narrative) (Details)
Summary Of Significant Accounting Policies (Policy)
Summary Of Significant Accounting Policies (Tables)

Material Contracts, Statements, Certifications & more

Pulse Biosciences, Inc. provided additional information to their SEC Filing as exhibits

Ticker: PLSE
CIK: 1625101
Form Type: 10-Q Quarterly Report
Accession Number: 0001625101-21-000023
Submitted to the SEC: Mon May 10 2021 4:38:09 PM EST
Accepted by the SEC: Mon May 10 2021
Period: Wednesday, March 31, 2021
Industry: Surgical And Medical Instruments And Apparatus

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