News
Investor conference call today at
Recent Developments
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First
FDA 510(k) submission for the PulseTx System. The PulseTx is an NPS platform comprised of a tunable nanosecond pulse generator and accompanying tissue applicators. TheFDA 510(k) submission is the Company’s first for the PulseTx System and intended to provide a foundation for future submissions for specific indications. - Treatments completed in first dermatologic human pilot study with the Company’s proprietary PulseTx platform. The Company successfully completed patient treatments and follow-up visits in the first PulseTx pilot dose response study with positive interim results. The objective of this first study is to establish safety and tissue response and recovery characteristics of skin to different NPS doses, enabling the Company to identify an initial application in dermatology.
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Progress towards entering the clinic with an initial NPS pilot study in immuno-oncology.Pulse Biosciences is pursuing multiple paths for its first pilot study in oncology and expects to initiate first pilot study trial during 2017.
“We are very pleased with our recent progress,” said
Financial Highlights
Cash, cash equivalents, and investments totaled
Operating expenses for fourth quarter ended
Conference Call Details
Pulse Biosciences’
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, the mechanism of action of NPS treatments, planned future
clinical trials, and other matters related to its pipeline of product
candidates and other future events. These statements are not historical
facts but rather are based on Pulse Biosciences’ current expectations,
estimates, and projections regarding Pulse Biosciences’ business,
operations and other similar or related factors. Words such as “may,”
“will,” “could,” “would,” “should,” “anticipate,” “predict,”
“potential,” “continue,” “expects,” “intends,” “plans,” “projects,”
“believes,” “estimates,” and other similar or related expressions are
used to identify these forward-looking statements, although not all
forward-looking statements contain these words. You should not place
undue reliance on forward-looking statements because they involve known
and unknown risks, uncertainties, and assumptions that are difficult or
impossible to predict and, in some cases, beyond Pulse Biosciences’
control. Actual results may differ materially from those in the
forward-looking statements as a result of a number of factors, including
those described in Pulse Biosciences’ filings with the
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PULSE BIOSCIENCES, INC. Condensed Consolidated Balance Sheets (Unaudited) |
||||||||
| December 31, | ||||||||
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(in thousands) |
2016 | 2015 | ||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,089 | $ | 3,606 | ||||
| Marketable Investments | 14,306 | — | ||||||
| Prepaid expenses and other current assets | 268 | 44 | ||||||
| Deferred offering costs | — | 347 | ||||||
| Total current assets | 16,663 | 3,997 | ||||||
| Equipment, net of accumulated depreciation | 317 | 329 | ||||||
| Intangible assets, net of accumulated amortization | 6,543 | 7,208 | ||||||
| Goodwill | 2,791 | 2,791 | ||||||
| Total assets | $ | 26,314 | $ | 14,325 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 265 | $ | 262 | ||||
| Accrued expenses | 751 | 398 | ||||||
| Total current liabilities | 1,016 | 660 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 13 | 8 | ||||||
| Additional paid-in capital | 37,898 | 16,745 | ||||||
| Accumulated other comprehensive loss | (7 | ) | — | |||||
| Accumulated deficit | (12,606 | ) | (3,088 | ) | ||||
| Total stockholders’ equity | 25,298 | 13,665 | ||||||
| Total liabilities and stockholders’ equity | $ | 26,314 | $ | 14,325 | ||||
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PULSE BIOSCIENCES, INC. Condensed Consolidated Statements of Operations (Unaudited) |
||||||||
| Three-Month Periods Ended | ||||||||
|
(in thousands, except per share amounts) |
December 31, 2016 | September 30, 2016 | ||||||
| Revenue | $ | — | $ | — | ||||
| Operating expenses: | ||||||||
| General and administrative | 870 | 893 | ||||||
| Research and development | 1,806 | 1,739 | ||||||
| Amortization of intangible assets | 167 | 166 | ||||||
| Total operating expenses | 2,843 | 2,798 | ||||||
| Other income: | ||||||||
| Interest income | 34 | 31 | ||||||
| Total other income | 34 | 31 | ||||||
| Loss from operations, before income taxes | (2,809 | ) | (2,767 | ) | ||||
| Income tax benefit | — | — | ||||||
| Net loss | $ | (2,809 | ) | $ | (2,767 | ) | ||
| Net loss per share – basic and diluted | $ | (0.21 | ) | $ | (0.21 | ) | ||
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Weighted average number of common shares outstanding – basic and diluted |
13,315 | 13,315 | ||||||
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PULSE BIOSCIENCES, INC. Condensed Consolidated Statements of Operations (Unaudited) |
||||||||
| Years Ended | ||||||||
| December 31, | ||||||||
|
(in thousands, except per share amounts) |
2016 | 2015 | ||||||
| Revenue | $ | — | $ | — | ||||
| Operating expenses: | ||||||||
| General and administrative | 2,933 | 1,224 | ||||||
| Research and development | 5,988 | 2,578 | ||||||
| Amortization of intangible assets | 665 | 666 | ||||||
| Total operating expenses | 9,586 | 4,468 | ||||||
| Other income: | ||||||||
| Interest income | 68 | — | ||||||
| Total other income | 68 | — | ||||||
| Loss from operations, before income taxes | (9,518 | ) | (4,468 | ) | ||||
| Income tax benefit | — | (1,657 | ) | |||||
| Net loss | $ | (9,518 | ) | $ | (2,811 | ) | ||
| Net loss per share – basic and diluted | $ | (0.86 | ) | $ | (0.37 | ) | ||
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Weighted average number of common shares outstanding – basic and diluted |
11,009 | 7,565 | ||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20170314006367/en/
Source:
Investors:
Pulse Biosciences, Inc.
Darrin Uecker, President
and Chief Executive Officer
IR@pulsebiosciences.com
or
Media:
Sam
Brown, Inc.
Hannah Hurdle, 805-601-5331
hannahhurdle@sambrown.com