Conference call today at 1:30 p.m. PDT /
4:30 p.m. EDT
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
- 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.
- 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.
- 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.
PULSE BIOSCIENCES, INC.
Consolidated Balance Sheets
(Unaudited)
March 31, December 31,
(in
thousands)
2018 2017 ASSETS Current assets: Cash and
investments $ 33,375 $ 38,069 Prepaid expenses and other current
assets 368 412 Total current assets
33,743 38,481 Leasehold improvements and equipment, net of
Accumulated depreciation 2,451 2,570 Intangible assets, net of
accumulated amortization 5,712 5,878 Goodwill 2,791 2,791 Other
assets 101 101 Total assets $ 44,798
$ 49,821
LIABILITIES AND STOCKHOLDERS’
EQUITY Current liabilities: Accounts payable $ 944 $ 782
Accrued expenses 846 1,034 Deferred rent, current 401
397 Total current liabilities 2,191 2,213 Long term
liabilities: Deferred rent 1,512 1,613
Total liabilities 3,703 3,826
Stockholders’ equity: Common stock 87,939 84,219 Accumulated other
comprehensive loss (3 ) (51 ) Accumulated deficit (46,841 )
(38,173 ) Total stockholders’ equity 41,095
45,995 Total liabilities and stockholders’ equity $
44,798 $ 49,821
PULSE BIOSCIENCES, INC.
Condensed Consolidated Statements of
Operations
(Unaudited)
Three-Month Periods Ended March 31, March 31,
(in thousands,
except per share amounts)
2018 2017 Revenue $ — $ — Operating
expenses: General and administrative 5,383 1,344 Research and
development 3,175 1,727 Amortization of intangible assets
166 166 Total operating expenses 8,724
3,237 Other income: Interest income 56
39 Total other income 56
39 Net loss $ (8,668 ) $ (3,198 ) Net loss per share: Basic
and diluted net loss per share $ (0.51 ) $ (0.23 ) Weighted average
shares used to compute net loss per common share — basic and
diluted 16,842 13,803
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version on businesswire.com: https://www.businesswire.com/news/home/20180508006706/en/
Investor Relations:Pulse Biosciences, Inc.Brian DowSr.
Vice President and Chief Financial
OfficerIR@pulsebiosciences.comorSolebury TroutGitanjali Jain Ogawa,
646-378-2949gogawa@troutgroup.comorMedia:Sam Brown,
Inc.Christy Curran, 615-414-8668christycurran@sambrown.com
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