Market Overview

Pulse Biosciences Quarterly Investor Conference Call

Share:

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 Comments and Join the Discussion!
 
Fastest Market News Application
You'll Hear It First On Pro
Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Trading Daily
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Daily Analyst Rating
A summary of each day’s top rating changes from sell-side analysts on the street.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com