Conference call today at 1:30 p.m. PDT /
4:30 p.m. EDT
Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company”), a novel
bioelectric medicine company bringing to market its proprietary
CellFX™ System, today reported recent corporate developments and
financial results for the quarter ended March 31, 2019.
Recent Corporate Developments
- Pre-market Notification (510(k))
submitted to the U.S. Food and Drug Administration (FDA) for its
proprietary CellFX System seeking clearance for commercial use in
common dermatologic procedures to remove general benign lesions
including Sebaceous Hyperplasia, a common but difficult-to-treat
facial lesion and Seborrheic Keratosis, a common benign pigmented
lesion. This afternoon we received an additional information (“AI”)
letter request from FDA, and the FDA among other things is
questioning the adequacy of the predicate device provided in the
510(k). Responding to this request will add time and require
additional testing, inclusive of clinical trials. In consideration
of the above we are presently evaluating an alternative approach,
the De Novo process approach, which would also likely require
additional time, testing and clinical studies. At the end of the
day the De Novo approach may be in the best interest of Pulse
Biosciences. We will update on this important matter no later than
the upcoming Annual Meeting of Stockholders scheduled for May 16,
2019.
- Mitchell Levinson, a well-seasoned
entrepreneur and executive in the aesthetic procedure market,
appointed to the Board of Directors.
- Podium presentations by key opinion
leaders in aesthetic dermatology speaking to the novel mechanism of
action of the CellFX System and the positive results from our
clinical studies in Sebaceous Hyperplasia and Common Warts at the
American Academy of Dermatology Annual Meeting and the American
Society for Laser Medicine and Surgery Annual Conference.
- Continued progress in active
feasibility studies including Common Warts, Back Acne and Basal
Cell Carcinoma.
“At Pulse Biosciences we remain focused on commercializing our
CellFX System in aesthetic dermatology and we are pleased with our
progress towards this goal in Q1,” said Darrin Uecker, Pulse
Biosciences’ President and Chief Executive Officer.
Financial Highlights
Cash, cash equivalents, and investments totaled
$52.8 million at March 31, 2019, compared to
$59.6 million at December 31, 2018. Cash use totaled $6.8
million for the first quarter of 2019 compared to cash use of $6.4
million for the fourth quarter of 2018, and $4.7 million for the
first quarter of 2018.
Operating expenses for the three-month period ended March
31, 2019 was $10.4 million, compared to $8.7 million for the
three-month period ended March 31, 2018. The operating expenses for
the three-month period ended March 31, 2019 included non-cash
stock-based compensation of $2.4 million, compared to non-cash
stock-based compensation of $3.4 million for the three-month
period ended March 31, 2018.
Net Loss for the three-month period ended March 31, 2019
totaled $10.1 million, compared to $8.7 million for the
three-month period ended March 31, 2018.
Conference Call Details
Pulse Biosciences will host an investor call on April 30, 2019,
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 3466369. 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 novel bioelectric medicine company
committed to health innovation that improves and extends the lives
of patients. The Company utilizes its patented groundbreaking
Nano-Pulse Stimulation™ (NPS™) technology to treat a variety of
applications for which an optimal solution remains unfulfilled. NPS
is a proprietary technology that delivers nano-second pulses of
high amplitude electrical energy to non-thermally clear targeted
cells while sparing adjacent non-cellular tissue. The cell-specific
effects of NPS technology have been validated in a series of
ongoing clinical trials. In addition, early pre-clinical evidence
suggests that the NPS technology holds a promising future in
immuno-oncology by demonstrating an ability to induce immunogenic
cell death. The CellFX System, the first planned commercial product
to harness the distinctive advantages of NPS technology, is
preparing to launch in 2019 as a multi-application platform
designed to address a broad range of dermatologic conditions. As
part of the customer experience, the Company is offering an
utilization-based revenue model and easy-access customer portal
offering a suite of services. CellFX procedures offer customer
value across an expanding spectrum of clinical applications. The
initial commercial use will be the clearance of common skin
lesions, including sebaceous hyperplasia (SH) and seborrheic
keratosis (SK) – two prevalent and difficult-to-treat benign skin
conditions that share high demand among patients and practitioners
for improved and durable aesthetic outcomes that lead to greater
overall satisfaction. For more information about Pulse Biosciences,
proprietary NPS technology, or CellFX, please visit us at
PulseBiosciences.com
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding our CellFX System and the Company’s
commercialization of our CellFX System including the progress and
timing of such commercialization and the results of clinical study
plans. These forward-looking statements are based on current
expectations and estimates and involve a number of risks and
uncertainties that could cause actual results to differ materially
from those suggested or implied by the forward-looking statements.
These forward-looking statements should, therefore, be considered
in light of various important factors, including, but not limited
to, the following: the impact of governmental regulatory agencies,
including the U.S. FDA, and regulatory approvals, clearances and
restrictions or any dispute that may occur with any regulatory
body; risks inherent to the planning, design and execution of
clinical studies; domestic and regional economic conditions on
aesthetic healthcare spending; the timing and success of product
development and market acceptance of developed and approved
products, including, but not limited to, the CellFX System;
intellectual property positions and litigation; competition in the
medical device industry and in the specific markets of aesthetics
and dermatology in which the Company operates; unanticipated
manufacturing disruptions or the inability to meet demand for
products; the results of legal proceedings to which the Company is
or may become a party; product liability and other litigation
claims; adverse publicity regarding the company and the safety of
the Company’s products and adequacy of training; the impact of
changes to tax legislation, guidance, and interpretations; and
other risk factors under the heading “Risk Factors” in the
Company’s annual report on Form 10-K for the year
ended December 31, 2018, as periodically updated by the
Company’s subsequent filings with the Securities and Exchange
Commission. Statements using words such as “estimates,” “projects,”
“believes,” “anticipates,” “plans,” “expects,” “intends,” “may,”
“will,” “could,” “should,” “would,” “targeted” and similar words
and expressions are intended to identify forward-looking
statements. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
press release, April 30, 2019. Pulse Biosciences, Inc.
undertakes no obligation to publicly update or release any
revisions to these forward-looking statements, except as required
by law.
Caution: Pulse Biosciences’ CellFX System and Nano-Pulse
Stimulation (NPS) technology are for investigational use only.
PULSE BIOSCIENCES, INC. Condensed Consolidated
Balance Sheets (Unaudited) March
31, December 31,
(in
thousands)
2019 2018 ASSETS Current assets: Cash, cash
equivalents and investments $ 52,801 $ 59,583 Prepaid expenses and
other current assets 550 779 Total current assets
53,351 60,362 Property and equipment, net 2,056 2,173
Intangible assets, net 5,046 5,213 Goodwill 2,791 2,791 Other
assets 208 101 Total assets $ 63,452 $ 70,640
LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities:
Accounts payable $ 1,200 $ 1,272 Accrued expenses 1,519 1,421
Deferred rent, current — 415 Lease liability, current 396
— Total current liabilities 3,115 3,108 Long term
liabilities: Deferred rent, less current — 1,198 Lease liability,
less current 1,223 — Total liabilities 4,338
4,306 Stockholders’ equity: Common stock and additional
paid-in capital 144,908 142,053 Accumulated other comprehensive
loss 2 (1) Accumulated deficit (85,796) (75,718)
Total stockholders’ equity 59,114 66,334 Total
liabilities and stockholders’ equity $ 63,452 $ 70,640
PULSE BIOSCIENCES, INC. Condensed Consolidated
Statements of Operations (Unaudited)
Three-Month Periods Ended March 31,
March 31,
(in thousands,
except per share amounts)
2019 2018 Revenue $ — $ — Operating expenses: General
and administrative 4,401 5,383 Research and development 5,842 3,175
Amortization of intangible assets 167 166 Total
operating expenses 10,410 8,724 Other income:
Interest income 332 56 Total other income 332
56 Net loss $ (10,078) (8,668) Net loss per share:
Basic and diluted net loss per share $ (0.49) (0.51)
Weighted average shares used to compute net loss per common share —
basic and diluted 20,679 16,842
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190430006210/en/
Investor Relations:Brian DowSr. Vice President and Chief
Financial OfficerIR@pulsebiosciences.comGitanjali Jain
OgawaSolebury
Troutgogawa@troutgroup.com646-378-2949orMedia:Tosk
CommunicationsNadine D. Tosk, 504-453-8344nadinepr@gmail.com
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