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Pulse Biosciences, Inc. (PLSE) SEC Filing 10-Q Quarterly report for the period ending Monday, September 30, 2019

Pulse Biosciences, Inc.

CIK: 1625101 Ticker: PLSE

Exhibit 99.1



PULSE BIOSCIENCES QUARTERLY INVESTOR CONFERENCE CALL



Conference call today at 1:30 p.m. PDT / 4:30 p.m. EDT





HAYWARD, Calif. - (BUSINESS WIRE) – – Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company”), a novel bioelectric medicine company bringing to market its proprietary CellFX™ System, today reported recent corporate developments and financial results for the three- and nine-month periods ended September 30, 2019.



Recent Corporate Developments

·

The Company continues to work with the Food and Drug Administration (“FDA”) on its 510(k) submission for the CellFX System in dermatology. On September 23, 2019 the Company submitted its formal response to the FDA’s April 30, 2019 Additional Information (“AI”) Letter request. Upon review of the AI Letter responses, the FDA requested responses to two additional questions and the Company has provided the FDA with draft responses to these questions. Following this, the Company and the FDA mutually agreed to temporarily put the 510(k) submission review on hold to allow sufficient time for the FDA to properly review these remaining responses. The Company continues to work collaboratively with the FDA and believes the review process will be completed during the fourth quarter of 2019 and is continuing to prepare for a potential 510(k) clearance.

·

In a separate press release today, the Company announced the appointment of Sandra Gardiner as Executive Vice President and Chief Financial Officer effective November 18, 2019. Ms. Gardiner succeeds Brian Dow who has served as our CFO since November 2015.

·

The Company’s Nano-Pulse Stimulation™ (NPS™) technology was featured prominently during the American Society for Dermatologic Surgery (“ASDS”) annual meeting held October 24-27, in Chicago. The following presentations all took place on Thursday October 24:

o

Investigator Dr. Girish Munavalli presented the latest clinical investigational study data on Sebaceous Hyperplasia (SH) and Warts in two separate oral abstract presentations. The Sebaceous Hyperplasia presentation provided new longer-term data on our original SH clinical study showing durability of efficacy out to at least 12-months with continued high patient satisfaction. The presentation also provided insights into our second SH clinical study including data demonstrating the ability of the CellFX System to clear SH lesions with minimal residual skin effects in a dose dependent manner.

o

In a second presentation Dr. Munavalli presented data on our wart program, including clinical data and experience from our NPS Wart Feasibility Study followed by early data from our current Warts Pivotal Study. This Pivotal Study allows for multiple NPS treatments to clear the warts so the findings discussed represent an early look at the data. 

o

Investigator Dr. Mark Nestor presented data on the first two patients enrolled in the feasibility acne study on severe back acne. Dr. Nestor reported reductions in acne lesion count of the NPS treated area when compared to control at 90-day follow-up in both patients with very good healing response.


The following information was filed by Pulse Biosciences, Inc. (PLSE) on Thursday, November 7, 2019 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
Accrued Expenses
Accrued Expenses (Schedule Of Accrued Expenses) (Details)
Accrued Expenses (Tables)
Commitments And Contingencies
Commitments And Contingencies (Narrative) (Details)
Commitments And Contingencies (Schedule Of Future Minimum Lease Payments) (Details)
Commitments And Contingencies (Schedule Of Information Related To Right-Of-Use Assets And Lease Liabilities) (Details)
Commitments And Contingencies (Tables)
Description Of The Business
Description Of The Business (Narrative) (Details)
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)
Intangible Assets, Net
Intangible Assets, Net (Narrative) (Details)
Intangible Assets, Net (Schedule Of Amortization Of Intangible Assets) (Details)
Intangible Assets, Net (Schedule Of Intangible Assets, Net) (Details)
Intangible Assets, Net (Tables)
Property And Equipment, Net
Property And Equipment, Net (Narrative) (Details)
Property And Equipment, Net (Schedule Of Property And Equipment, Net) (Details)
Property And Equipment, Net (Tables)
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 Stock Option Activity) (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: 0001625101-19-000039
Submitted to the SEC: Thu Nov 07 2019 11:46:12 AM EST
Accepted by the SEC: Thu Nov 07 2019
Period: Monday, September 30, 2019
Industry: Surgical And Medical Instruments And Apparatus

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