News
First patient treated in the CellFX™ back acne clinical feasibility study
Conference call today at
The Company also announced today treatment of the first of up to 20 patients in a clinical feasibility study to evaluate the CellFX System for acne on the back. This study leverages the unique mechanism of action of the CellFX System in order to target sebaceous glands deep in the dermis, as demonstrated in the previously announced clinical study evaluating NPS for the treatment of facial sebaceous hyperplasia (SH).
Recent Corporate Developments
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Demonstrated efficacy of over 99.5% of Sebaceous Hyperplasia (SH)
lesions treated with Nano-Pulse Stimulation™ (NPS™) in a clinical
feasibility study, the second successful study of a dermatologic
application of the Company’s NPS technology platform.
- 99.5% of the treated lesions were assessed as clear or mostly clear by investigators at the 60-day post-treatment follow-up evaluation.
- 92% (n=203) of treated lesions were assessed as clear or mostly clear after a single NPS treatment.
- Patients rated 78% of lesion outcomes as satisfied or mostly satisfied at study end.
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The study data has been accepted for presentation at the upcoming
American Academy of Dermatology Annual Meeting by Dr.Girish Munavalli , one of the study’s principal investigators.
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Successfully completed a
$45 million rights offering, an important financial milestone enablingPulse Biosciences to accelerate its progress towards commercialization of the CellFX System. -
Appointed key personnel focusing on CellFX commercialization:
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Promotion of
Edward Ebbers to Executive Vice President and General Manager,Dermatology. Mr. Ebbers brings over 35 years of leadership and management experience with major dermatology, pharmaceutical and medical device companies, including extensive experience introducing products with utilization-based revenue models in the private pay aesthetic dermatology market. -
Addition of
Robert Tyson as Vice President of Sales,North America . Mr. Tyson brings a proven track record as a sales leader with over 20 years of medical technology experience.
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Promotion of
“We are pleased with our accomplishments over the past year in advancing
our proprietary CellFX System and look forward to achieving key
commercialization milestones in 2019,” said
Acne Clinical Feasibility Study
The objective of the acne clinical feasibility study announced today is
to treat up to 20 patients between the ages of 18 and 80 to evaluate the
reduction in number and severity of back acne eruptions post CellFX
procedures through comparison of the treated to non-treated areas
90-days after the last procedure.
“We are very excited to enroll our first back acne patient as chronic
acne eruptions can be very difficult to control, and compliance with
ongoing use of oral or topical therapies can be problematic,” said
clinical investigator
Fourth Quarter and Full Year 2018 Financial Highlights
Cash, cash equivalents, and investments totaled
Operating expenses for the three-month period ended
Operating expenses for the fiscal year ended
Conference Call Details
About
Pulse Biosciences is a novel medical therapy company bringing to market its proprietary CellFX™ System utilizing the Company’s proprietary Nano-Pulse Stimulation™ (NPS™) platform technology. The Company’s CellFX System provides a novel, precise, non-thermal cellular treatment technology delivering nanosecond duration energy pulses that impact cells in treated tissue while sparing surrounding non-cellular tissue. This unique mechanism of action disrupts the functions of internal cell structures while maintaining the outer cell membrane, initiating a cascade of events within the cell resulting in regulated cell death. The novel characteristics of the Company’s CellFX System mechanism of action has the potential to significantly benefit patients across multiple medical applications, including dermatology, the Company’s first planned commercial application. Beyond dermatology applications, NPS has demonstrated an ability to induce immunogenic cell death in several cancer cell lines in pre-clinical studies. The Company believes its NPS platform technology may play a future role in immuno-oncology as a focal tumor treatment that can initiate an adaptive immune response. More information can be found at www.pulsebiosciences.com.
Forward-Looking Statements
All statements in this press release that are not historical are
forward-looking statements, including, among other things, statements
relating to Pulse Biosciences’ expectations regarding regulatory
clearance and the timing of
Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation (NPS) are investigational use only.
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PULSE BIOSCIENCES, INC. Condensed Consolidated Balance Sheets (Unaudited) |
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| December 31, | December 31, | |||||||
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(in thousands) |
2018 | 2017 | ||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and investments | $ | 59,583 | $ | 38,069 | ||||
| Prepaid expenses and other current assets | 779 | 412 | ||||||
| Total current assets | 60,362 | 38,481 | ||||||
| Property and equipment, net | 2,173 | 2,570 | ||||||
| Intangible assets, net | 5,213 | 5,878 | ||||||
| Goodwill | 2,791 | 2,791 | ||||||
| Other assets | 101 | 101 | ||||||
| Total assets | $ | 70,640 | $ | 49,821 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,272 | $ | 782 | ||||
| Accrued expenses | 1,421 | 1,034 | ||||||
| Deferred rent, current | 415 | 397 | ||||||
| Total current liabilities | 3,108 | 2,213 | ||||||
| Long term liabilities: | ||||||||
| Deferred rent, less current | 1,198 | 1,613 | ||||||
| Total liabilities | 4,306 | 3,826 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock and additional paid-in capital | 142,053 | 84,219 | ||||||
| Accumulated other comprehensive loss | (1 | ) | (51 | ) | ||||
| Accumulated deficit | (75,718 | ) | (38,173 | ) | ||||
| Total stockholders’ equity | 66,334 | 45,995 | ||||||
| Total liabilities and stockholders’ equity | $ | 70,640 | $ | 49,821 | ||||
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PULSE BIOSCIENCES, INC. Condensed Consolidated Statements of Operations (Unaudited) |
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| Three-Month Periods Ended | ||||||||
| December 31, | December 31, | |||||||
|
(in thousands, except per share amounts) |
2018 | 2017 | ||||||
| Revenue | $ | — | $ | — | ||||
| Operating expenses: | ||||||||
| General and administrative | 3,814 | 5,801 | ||||||
| Research and development | 5,080 | 2,864 | ||||||
| Amortization of intangible assets | 166 | 166 | ||||||
| Total operating expenses | 9,060 | 8,831 | ||||||
| Other income (expense): | ||||||||
| Interest income | 135 | 128 | ||||||
| Other expense | (28 | ) | - | |||||
| Total other income (expense) | 107 | 128 | ||||||
| Net loss | $ | (8,953 | ) | $ | (8,703 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted net loss per share | $ | (0.51 | ) | $ | (0.53 | ) | ||
| Weighted average shares used to compute net loss per common share — basic and diluted | 17,656 | 16,574 | ||||||
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PULSE BIOSCIENCES, INC. Condensed Consolidated Statements of Operations (Unaudited) |
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| Years Ended | ||||||||
| December 31, | December 31, | |||||||
|
(in thousands, except per share amounts) |
2018 | 2017 | ||||||
| Revenue | $ |
— |
$ | — | ||||
| Operating expenses: | ||||||||
| General and administrative | 20,045 | 15,503 | ||||||
| Research and development | 17,253 | 9,646 | ||||||
| Amortization of intangible assets | 665 | 665 | ||||||
| Total operating expenses | 37,963 | 25,814 | ||||||
| Other income (expense): | ||||||||
| Interest income | 446 | 247 | ||||||
| Other expense | (28 | ) |
— |
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| Total other income (expense) | 418 | 247 | ||||||
| Net loss | $ | (37,545 | ) | $ | (25,567 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted net loss per share | $ | (2.20 | ) | $ | (1.73 | ) | ||
| Weighted average shares used to compute net loss per common share — basic and diluted | 17,078 | 14,754 | ||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20190207005811/en/
Source:
Investor Relations:
Brian Dow
Sr. Vice President and
Chief Financial Officer
IR@pulsebiosciences.com
Gitanjali Jain Ogawa
Solebury Trout
gogawa@troutgroup.com
646-378-2949
or
Media:
Tosk Communications
Nadine D. Tosk, 504-453-8344
nadinepr@gmail.com