On October 30, 2018 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel medical therapy company bringing to market its proprietary Nano-Pulse Stimulation (NPS) platform, reported recent corporate developments and financial results for the three- and nine-month periods ended September 30, 2018 (Press release, Pulse Biosciences, OCT 30, 2018, View Source [SID1234530396]).

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Recent Developments

Completion of enrollment and patient treatments in the Company’s NPS clinical study for the treatment of Sebaceous Hyperplasia (SH)

Study enrollment and patient treatments were completed in the Company’s multi-center study to evaluate the safety and efficacy of NPS for the treatment of Sebaceous Hyperplasia, a common but difficult-to-treat facial lesion.

Preliminary data on the first 79 of 226 (35%) treated lesions indicate excellent safety and efficacy results to date with no adverse events and over 95% of treated lesions rated as clear or mostly clear after 60-day follow-up.

Patient follow-up visits scheduled to be completed during the fourth quarter with study data available by the end of 2018.

Initiation of a clinical feasibility study using NPS to treat patients with cutaneous warts.

First patient enrollment and treatment in the Company’s feasibility study that includes up to 20 subjects at the prestigious Scripps Clinic in San Diego, CA. Patient enrollment commenced October 2018. Treatment and follow-up are expected to be completed during the first quarter of 2019.

Continued enrollment in NPS Basal Cell Carcinoma (BCC) Biomarker Study

First patient enrolled and treated in the Company’s multi-center "treat and resect" study evaluating local lesion effect and immune response changes to NPS. Study enrollment is progressing and is expected to be completed by the end of 2018 with data available during the first quarter of 2019.

Clinical introduction of the CellFX System, the Company’s next generation Nano-Pulse Stimulation system.

Designed with commercial intent for office, outpatient, or hospital setting;

Simple and intuitive system design suitable across multiple clinical applications;

Integrated networking capability for a per-click revenue model; and

Single-patient-use applicator available with a variety of tip sizes for different applications.

"We’re pleased with the continued and significant progress we’ve made and are making towards bringing our NPS platform closer to commercialization," said Darrin Uecker, Pulse Biosciences’ President and Chief Executive Officer. "Our data continues to demonstrate safety and efficacy allowing us the opportunity to move forward with our plans to target the cash paying aesthetic dermatology market while we continue to make progress in longer-term opportunities."

Financial Highlights

Cash, cash equivalents, and investments totaled $21.0 million at September 30, 2018, compared to $38.1 million at December 31, 2017. Cash use totaled $6.5 million for the third quarter of 2018 compared to cash use of $3.9 million for the fourth quarter of 2017. Cash use for 2018 is currently anticipated to total approximately $24 million.

Operating expenses for the three-month period ended September 30, 2018 totaled $10.9 million, compared to $7.5 million for the three-month period ended September 30, 2017. Operating expenses for the three-month period ended September 30, 2018 included non-cash stock-based compensation of $3.4 million, compared to non-cash stock-based compensation of $3.4 million for the three-month period ended September 30, 2017.

Operating expenses for the nine-month period ended September 30, 2018 totaled $28.9 million, compared to $17.0 million for the nine-month period ended September 30, 2017. Operating expenses for the nine-month period ended September 30, 2018 included non-cash stock-based compensation of $10.0 million, compared to non-cash stock-based compensation of $6.4 million for the nine-month period ended September 30, 2017.

Conference Call Details

Pulse Biosciences will host an investor call on October 30, 2018, 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 2098843. 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.