News
Conference call today at
Recent Developments
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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 commencedOctober 2018 . Treatment and follow-up are expected to be completed during the first quarter of 2019.
-
First patient enrollment and treatment in the Company’s
feasibility study that includes up to 20 subjects at the
prestigious
-
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
Financial Highlights
Cash, cash equivalents, and investments totaled
Operating expenses for the three-month period ended
Operating expenses for the nine-month period ended
Conference Call Details
About
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:
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PULSE BIOSCIENCES, INC. |
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Condensed Consolidated Balance Sheets |
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(Unaudited) |
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| September 30, | December 31, | |||||||
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(in thousands) |
2018 | 2017 | ||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash, cash equivalents and investments | $ | 21,021 | $ | 38,069 | ||||
| Prepaid expenses and other current assets | 1,095 | 412 | ||||||
| Total current assets | 22,116 | 38,481 | ||||||
| Property and equipment, net | 2,339 | 2,570 | ||||||
| Intangible assets, net | 5,379 | 5,878 | ||||||
| Goodwill | 2,791 | 2,791 | ||||||
| Other assets | 101 | 101 | ||||||
| Total assets | $ | 32,726 | $ | 49,821 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,281 | $ | 782 | ||||
| Accrued expenses | 1,657 | 1,034 | ||||||
| Deferred rent, current | 410 | 397 | ||||||
| Total current liabilities | 3,348 | 2,213 | ||||||
| Long term liabilities: | ||||||||
| Deferred rent, less current | 1,304 | 1,613 | ||||||
| Total liabilities | 4,652 | 3,826 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock and additional paid-in capital | 94,842 | 84,219 | ||||||
| Accumulated other comprehensive loss | (3 | ) | (51 | ) | ||||
| Accumulated deficit | (66,765 | ) | (38,173 | ) | ||||
| Total stockholders’ equity | 28,074 | 45,995 | ||||||
| Total liabilities and stockholders’ equity | $ | 32,726 | $ | 49,821 | ||||
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PULSE BIOSCIENCES, INC. |
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Condensed Consolidated Statements of Operations |
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(Unaudited) |
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| Three-Month Periods Ended | ||||||||
| September 30, | September 30, | |||||||
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(in thousands, except per share amounts) |
2018 | 2017 | ||||||
| Revenue | $ | — | $ | — | ||||
| Operating expenses: | ||||||||
| General and administrative | 5,675 | 4,434 | ||||||
| Research and development | 5,038 | 2,925 | ||||||
| Amortization of intangible assets | 166 | 166 | ||||||
| Total operating expenses | 10,879 | 7,525 | ||||||
| Other income: | ||||||||
| Interest income | 118 | 39 | ||||||
| Total other income | 118 | 39 | ||||||
| Net loss | $ | (10,761 | ) | $ | (7,486 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted net loss per share | $ | (0.64 | ) | $ | (0.52 | ) | ||
| Weighted average shares used to compute net loss per common share — basic and diluted | 16,927 | 14,381 | ||||||
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PULSE BIOSCIENCES, INC. |
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Condensed Consolidated Statements of Operations |
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(Unaudited) |
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| Nine-Month Periods Ended | ||||||||
| September 30, | September 30, | |||||||
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(in thousands, except per share amounts) |
2018 | 2017 | ||||||
| Revenue | $ | — | $ | — | ||||
| Operating expenses: | ||||||||
| General and administrative | 16,230 | 9,702 | ||||||
| Research and development | 12,174 | 6,782 | ||||||
| Amortization of intangible assets | 499 | 499 | ||||||
| Total operating expenses | 28,903 | 16,983 | ||||||
| Other income: | ||||||||
| Interest income | 311 | 119 | ||||||
| Total other income | 311 | 119 | ||||||
| Net loss | $ | (28,592 | ) | $ | (16,864 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted net loss per share | $ | (1.69 | ) | $ | (1.19 | ) | ||
| Weighted average shares used to compute net loss per common share — basic and diluted | 16,883 | 14,141 | ||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20181030006090/en/
Source:
Investor Relations:
Pulse Biosciences, Inc.
Brian Dow
Sr.
Vice President and Chief Financial Officer
IR@pulsebiosciences.com
or
Solebury
Trout
Gitanjali Jain Ogawa, 646-378-2949
gogawa@troutgroup.com
or
Media:
Tosk
Communications
Nadine D. Tosk, 504-453-8344
nadinepr@gmail.com