On August 8, 2019 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company"), a novel bioelectric medicine company bringing to market its proprietary CellFX System, reported recent corporate developments and financial results for the three- and six-month periods ended June 30, 2019 (Press release, Pulse Biosciences, AUG 8, 2019, View Source [SID1234538439]).

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Recent Corporate Developments

The Company is working with the FDA on its 510(k) submission for the CellFX System, continues to believe the 510(k) path is the appropriate path, and is looking forward to finalizing and submitting all responses to FDA during Q3 2019 for a potential clearance in Q4 2019.

The Company commenced enrollment and treated the first patient in its CellFX Warts Pivotal Study. The CellFX Warts Pivotal Study is a prospective, non-randomized, multicenter study evaluating the safety and effectiveness of the CellFX System in up to 60 patients with non-genital warts. The Company expects to complete enrollment by the end of 2019.

Nano-Pulse Stimulation (NPS) technology peer reviewed manuscripts featured by leading dermatology publications:

"A Dose Response Study of a Novel Method of Selective Tissue Modification of Cellular Structures in the Skin with Nanosecond Pulsed Electric Fields" with lead author David Kaufman, MD, FACS, published in the August 2019 edition of the journal of the American Society for Laser Medicine and Surgery and highlights the Company’s initial histologic skin studies that demonstrated the safety and unique mechanism of NPS to impact cellular structures while sparing surrounding non-cellular structures.

"Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia" with lead author Girish Munavalli, MD, MHS, FACMS, has been accepted for publication in an upcoming edition of the journal of Dermatologic Surgery and outlines the results, findings and observations from the Company’s clinical study evaluating the safety and efficacy of NPS for the treatment of Sebaceous Hyperplasia.

The Company’s Nano-Pulse Stimulation Technology is scheduled to be prominently featured during the "Hot Topics" session of the prestigious Controversies and Conversations in Lasers & Cosmetic Surgery symposium in San Francisco, CA on Friday August 9, 2019. Investigators Drs. Thomas Rohrer, Girish Munavalli, and Brian Zelickson will be presenting from the podium clinical study data and their experiences with NPS in Pulse Biosciences’ ongoing programs in Sebaceous Hyperplasia, Seborrheic Keratosis, Warts, BCC and tattoo removal.

Financial Highlights

Cash, cash equivalents, and investments totaled $42.6 million at June 30, 2019, compared to $59.6 million at December 31, 2018. Cash use totaled $10.2 million for the second quarter of 2019 compared to cash use of $6.8 million for the first quarter of 2019 and $6.4 million for the fourth quarter of 2018.

Operating expenses for the three-month period ended June 30, 2019 totaled $11.6 million, compared to $9.3 million for the three-month period ended June 30, 2018. Operating expenses for the three-month period ended June 30, 2019 included non-cash stock-based compensation of $2.7 million, compared to non-cash stock-based compensation of $3.2 million for the three-month period ended June 30, 2018.

Operating expenses for the six-month period ended June 30, 2019 totaled $22.1 million, compared to $18.0 million for the six-month period ended June 30, 2018. Operating expenses for the six-month period ended June 30, 2019 included non-cash stock-based compensation of $5.1 million, compared to non-cash stock-based compensation of $6.6 million for the six-month period ended June 30, 2018.

Net loss for the three-month period ended June 30, 2019 totaled $11.4 million compared to $9.2 million for the three-month period ended June 30, 2018. Net loss for the six-month period ended June 30, 2019 totaled $21.4 million compared to $17.8 million for the six-month period ended June 30, 2018.


Conference Call Details

Pulse Biosciences will host an investor call on August 8, 2019, at 1:30 p.m. PDT / 4:30 p.m. EDT. The telephone dial-in number for the call is (844) 494-0190 (U.S. toll-free) or (508) 637-5580 (international) using Conference ID 9229379. Listeners will also be able to access the call via webcast available on the Investors section of the Company’s website at www.PulseBiosciences.com.