Conference call today at 1:30 p.m. PDT / 4:30 p.m. EDT
HAYWARD, Calif.--(BUSINESS WIRE)--May 8, 2018--
Pulse Biosciences, Inc. (Nasdaq: PLSE), a medical technology company
developing a proprietary therapeutic tissue treatment based on its
Nano-Pulse Stimulation platform, today reported recent corporate
developments and financial results for the first quarter ended March 31,
2018.
Recent Developments
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Expanded management team with key executive hires:
- Jeff Kmetz, 30-year pharmaceutical executive, joined as Chief
Business Officer. Mr. Kmetz brings over 30 years of experience
within the pharmaceutical industry specializing in oncology at
companies including Pharmacyclics and Berlex/Bayer. Mr. Kmetz was
instrumental in the launch of IMBRUVICA, Pharmacyclics non-Hodgkin
lymphoma drug.
- William Knape, joined as Vice President, Clinical, Regulatory
and Quality.Mr. Knape brings 25 years of clinical and
regulatory affairs experience overseeing and managing worldwide
clinical trials and regulatory strategy. Mr. Knape has led
numerous successful regulatory filings with FDA, including
510(k)’s, PMA’s, and NDA’s.
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Presented favorable data from Pulse Biosciences’ first application
clinical study evaluating Nano-Pulse Stimulation (NPS) for the
treatment of seborrheic keratosis (SK) at the 38th American
Society for Laser Medicine and Surgery (ASLMS) Conference on
Energy-Based Medicine & Science in Dallas, Texas. At the 106-day
assessment mark, 82% of treated lesions were evaluated as clear or
mostly clear by study investigators, 71% during blinded independent
photographic review, and 78% of patients rated lesion outcomes as
satisfied or mostly satisfied. No adverse events were reported during
the study that included 472 NPS application cycles.
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Awarded “Best of Session for Basic Science and Translational Research”
by ASLMS for Pulse Biosciences’ clinical study presentation: “A
dose-response study of a novel non-thermal method of selectively
modifying cellular structure in skin with low energy nanosecond
electrical stimulation.”
“We continue to make progress towards our goal of introducing our
Nano-Pulse Stimulation technology into areas of unmet dermatological and
oncological clinical needs across multiple applications,” said Darrin
Uecker, Pulse Biosciences President and Chief Executive Officer.
“Leveraging the strong safety profile established to date, favorable
data from our recently completed SK study, input from clinical advisors,
and a portfolio of potential targets including sebaceous hyperplasia,
keloid scars, warts, actinic keratosis, and syringoma, we are now
preparing to proceed with multiple studies in parallel commencing in Q2
2018 and beyond to demonstrate the utility of our technology.”
Financial Highlights
Cash, cash equivalents, and investments totaled $33.4 million at
March 31, 2018, compared to $38.1 million at December 31, 2017. Cash use
totaled $4.7 million for the first quarter of 2018 compared to cash use
of $3.9 million for the fourth quarter of 2017. 2018 Cash use is
currently anticipated to total $22 million.
Operating expenses for the quarter ended March 31, 2018, totaled
$8.7 million, compared to $3.2 million for the quarter ended March 31,
2017. The operating expenses for the quarter ended March 31, 2018
included non-cash stock-based compensation of $3.4 million, compared to
non-cash stock-based compensation of $0.3 million for the quarter ended
March 31, 2017.
Conference Call Details
Pulse Biosciences will host an investor call on May 8, 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 4796365. 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.
About Pulse Biosciences
Pulse Biosciences is a clinical stage electroceutical, an electrical
energy based therapeutic, company pursuing commercial applications of
its proprietary Nano-Pulse Stimulation (NPS) technology. NPS is a
non-thermal, precise, focal, drug-free tissue treatment technology
utilizing nanosecond (billionth of a second) range pulsed electric
fields that directly affect the cell membrane and intracellular
structures and initiates programmed cell death in treated cells. The
unique ability of NPS to initiate cell death has the potential to
significantly benefit patients in a wide variety of medical applications
including applications in immuno-oncology and dermatology, and other
potential applications we may pursue in the future. The initiation of
programmed cell death by NPS results in a minimal inflammatory response,
which improves healing outcomes and supports the replacement of treated
tissue cells with healthy tissue cells. In cancerous lesions, NPS has
been shown in preclinical models to induce immunogenic cell death (ICD),
which exposes the unique antigens of the treated cells to the immune
system and enrolls immune system cells, such as cytotoxic T-cells to
mount an adaptive immune response. Pulse Biosciences is investigating a
variety of applications for its technology that exploits the
technology’s unique biologic effect, including immuno-oncology and
dermatology. More information is available 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 FDA filings or approvals, the mechanism of
action of NPS treatments, current and planned future clinical studies,
other matters related to its pipeline of product candidates, future
financial performance, anticipated cash use 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 Securities and Exchange Commission. Pulse Biosciences
undertakes no obligation to revise or update information in this release
to reflect events or circumstances in the future, even if new
information becomes available.
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PULSE BIOSCIENCES, INC.
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Consolidated Balance Sheets
(Unaudited)
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March 31, |
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December 31, |
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(in thousands)
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2018 |
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2017 |
| ASSETS |
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Current assets:
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Cash and investments
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$
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33,375
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$
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38,069
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Prepaid expenses and other current assets
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368
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412
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Total current assets
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33,743
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38,481
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Leasehold improvements and equipment, net of
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Accumulated depreciation
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2,451
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2,570
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Intangible assets, net of accumulated amortization
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5,712
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5,878
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Goodwill
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2,791
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2,791
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Other assets
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101
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101
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Total assets
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$
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44,798
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$
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49,821
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| LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities:
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Accounts payable
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$
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944
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$
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782
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Accrued expenses
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846
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1,034
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Deferred rent, current
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401
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397
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Total current liabilities
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2,191
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2,213
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Long term liabilities:
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Deferred rent
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1,512
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1,613
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Total liabilities
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3,703
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3,826
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Stockholders’ equity:
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Common stock
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87,939
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84,219
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Accumulated other comprehensive loss
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(3
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(51
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Accumulated deficit
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(46,841
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)
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(38,173
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Total stockholders’ equity
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41,095
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45,995
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Total liabilities and stockholders’ equity
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$
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44,798
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$
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49,821
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PULSE BIOSCIENCES, INC.
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Condensed Consolidated Statements of Operations
(Unaudited)
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Three-Month Periods Ended |
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March 31, |
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March 31, |
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(in thousands, except per share amounts)
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2018 |
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2017 |
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Revenue
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$
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—
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$
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—
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Operating expenses:
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General and administrative
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5,383
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1,344
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Research and development
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3,175
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1,727
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Amortization of intangible assets
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166
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166
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Total operating expenses
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8,724
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3,237
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Other income:
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Interest income
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56
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39
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Total other income
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56
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39
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Net loss
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$
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(8,668
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$
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(3,198
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Net loss per share:
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Basic and diluted net loss per share
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$
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(0.51
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$
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(0.23
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Weighted average shares used to compute net loss per common share —
basic and diluted
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16,842
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13,803
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View source version on businesswire.com: https://www.businesswire.com/news/home/20180508006706/en/
Source: Pulse Biosciences, Inc.
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:
Sam
Brown, Inc.
Christy Curran, 615-414-8668
christycurran@sambrown.com
