On November 7, 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 nine-month periods ended September 30, 2019 (Press release, Pulse Biosciences, NOV 7, 2019, View Source [SID1234550709]).
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 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:
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.
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.
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.
Dr. Tom Rohrer gave an invited presentation in the Emerging Therapies Plenary Session and presented an overview of NPS technology and the various NPS clinical programs to the ASDS audience.
"Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia" with lead author Girish Munavalli, MD, MHS, FACMS, has been published online by the Journal of Dermatologic Surgery. This peer reviewed paper 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 and can be found online at: View Source
"Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses" with lead author George J. Hruza, MD, MBA, FAAD, has been accepted for publication in an upcoming edition of the Journal of Dermatologic Surgery and outlines the results, findings and observations from our clinical study evaluating the safety and efficacy of NPS for the treatment of Seborrheic Keratosis.
The Company has enrolled a total of 35 patients 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 cutaneous warts. The Company expects to complete enrollment by the end of 2019.
Financial Highlights
Cash, cash equivalents, and investments totaled $34.5 million at September 30, 2019, compared to $59.6 million at December 31, 2018. Cash use totaled $8.1 million for the third quarter of 2019 compared to cash use of $10.2 million for the second quarter of 2019 and $6.8 million for the first quarter of 2019.
Operating expenses for the three-month period ended September 30, 2019 totaled $12.0 million, compared to $10.9 million for the three-month period ended September 30, 2018. Operating expenses for the three-month period ended September 30, 2019 included non-cash stock-based compensation of $2.7 million, compared to non-cash stock-based compensation of $3.4 million for the three-month period ended September 30, 2018.
Operating expenses for the nine-month period ended September 30, 2019 totaled $34.0 million, compared to $28.9 million for the nine-month period ended September 30, 2018. Operating expenses for the nine-month period ended September 30, 2019 included non-cash stock-based compensation of $7.7 million, compared to non-cash stock-based compensation of $10.0 million for the nine-month period ended September 30, 2018.
Net loss for the three-month period ended September 30, 2019 totaled $11.7 million compared to $10.8 million for the three-month period ended September 30, 2018. Net loss for the nine-month period ended September 30, 2019 totaled $33.2 million compared to $28.6 million for the nine-month period ended September 30, 2018.
Conference Call Details
Pulse Biosciences will host an investor call today 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 7381116. 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.