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 three- and nine-month periods ended
September 30, 2019.
Recent Corporate Developments
- The Company continues to work with the Food and Drug
Administration (“FDA”) on its 510(k) submission for the CellFX
System in dermatology. On September 23, 2019, the Company submitted
its formal response to the FDA’s April 30, 2019 Additional
Information (“AI”) Letter request. Upon review of the AI Letter
responses, the FDA requested responses to two additional questions
and the Company has provided the FDA with draft responses to these
questions. Following this, the Company and the FDA mutually agreed
to temporarily put the 510(k) submission review on hold to allow
sufficient time for the FDA to properly review these remaining
responses. The Company continues to work collaboratively with the
FDA and believes the review process will be completed during the
fourth quarter of 2019 and is continuing to prepare for a potential
510(k) clearance.
- In a separate press release today, the Company announced the
appointment of Sandra Gardiner as Executive Vice President and
Chief Financial Officer effective November 18, 2019. Ms. Gardiner
succeeds Brian Dow who has served as our CFO since November
2015.
- The Company’s Nano-Pulse Stimulation™ (NPS™) technology was
featured prominently during the American Society for Dermatologic
Surgery (“ASDS”) annual meeting held October 24-27, in Chicago. The
following presentations all took place on Thursday October 24:
- Investigator Dr. Girish Munavalli presented the latest clinical
investigational study data on Sebaceous Hyperplasia (SH) and Warts
in two separate oral abstract presentations. The Sebaceous
Hyperplasia presentation provided new longer-term data on our
original SH clinical study showing durability of efficacy out to at
least 12-months with continued high patient satisfaction. The
presentation also provided insights into our second SH clinical
study including data demonstrating the ability of the CellFX System
to clear SH lesions with minimal residual skin effects in a dose
dependent manner.
- In a second presentation Dr. Munavalli presented data on our
wart program, including clinical data and experience from our NPS
Wart Feasibility Study followed by early data from our current
Warts Pivotal Study. This Pivotal Study allows for multiple NPS
treatments to clear the warts so the findings discussed represent
an early look at the data.
- Investigator Dr. Mark Nestor presented data on the first two
patients enrolled in the feasibility acne study on severe back
acne. Dr. Nestor reported reductions in acne lesion count of the
NPS treated area when compared to control at 90-day follow-up in
both patients with very good healing response.
- Dr. Tom Rohrer gave an invited presentation in the Emerging
Therapies Plenary Session and presented an overview of NPS
technology and the various NPS clinical programs to the ASDS
audience.
- “Safety and Efficacy of Nanosecond Pulsed Electric Field
Treatment of Sebaceous Gland Hyperplasia” with lead author Girish
Munavalli, MD, MHS, FACMS, has been published online by the Journal
of Dermatologic Surgery. This peer reviewed paper outlines the
results, findings and observations from the Company’s clinical
study evaluating the safety and efficacy of NPS for the treatment
of Sebaceous Hyperplasia and can be found online at:
https://journals.lww.com/dermatologicsurgery/Abstract/publishahead/Safety_and_Efficacy_of_Nanosecond_Pulsed_Electric.98114.aspx#pdf-link
- “Safety and Efficacy of Nanosecond Pulsed Electric Field
Treatment of Seborrheic Keratoses” with lead author George J.
Hruza, MD, MBA, FAAD, has been accepted for publication in an
upcoming edition of the Journal of Dermatologic Surgery and
outlines the results, findings and observations from our clinical
study evaluating the safety and efficacy of NPS for the treatment
of Seborrheic Keratosis.
- The Company has enrolled a total of 35 patients in its CellFX
Warts Pivotal Study. The CellFX Warts Pivotal Study is a
prospective, non-randomized, multicenter study evaluating the
safety and effectiveness of the CellFX System in up to 60 patients
with non-genital cutaneous warts. The Company expects to complete
enrollment by the end of 2019.
Financial Highlights
Cash, cash equivalents, and investments totaled $34.5
million at September 30, 2019, compared to $59.6 million at
December 31, 2018. Cash use totaled $8.1 million for the third
quarter of 2019 compared to cash use of $10.2 million for the
second quarter of 2019 and $6.8 million for the first quarter of
2019.
Operating expenses for the three-month period ended
September 30, 2019 totaled $12.0 million, compared to $10.9 million
for the three-month period ended September 30, 2018. Operating
expenses for the three-month period ended September 30, 2019
included non-cash stock-based compensation of $2.7 million,
compared to non-cash stock-based compensation of $3.4 million for
the three-month period ended September 30, 2018.
Operating expenses for the nine-month period ended
September 30, 2019 totaled $34.0 million, compared to $28.9 million
for the nine-month period ended September 30, 2018. Operating
expenses for the nine-month period ended September 30, 2019
included non-cash stock-based compensation of $7.7 million,
compared to non-cash stock-based compensation of $10.0 million for
the nine-month period ended September 30, 2018.
Net loss for the three-month period ended September 30,
2019 totaled $11.7 million compared to $10.8 million for the
three-month period ended September 30, 2018. Net loss for the
nine-month period ended September 30, 2019 totaled $33.2 million
compared to $28.6 million for the nine-month period ended September
30, 2018.
Conference Call Details
Pulse Biosciences will host an investor call today 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 7381116. 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 potentially
extends the lives of patients. The CellFX System is the first
planned commercial product to harness the distinctive advantages of
the Company’s proprietary Nano-Pulse Stimulation™ (NPS™) technology
to treat a variety of applications for which an optimal solution
remains unfulfilled. NPS technology delivers nano-second pulses of
electrical energy to non-thermally clear cells while sparing
adjacent non-cellular tissue. The cell-specific effects of NPS
technology have been validated in a series of ongoing clinical
trials. The CellFX System 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 a 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 in the
clearance of common and difficult-to-treat skin lesions that share
high demand among patients and practitioners for improved and
durable aesthetic outcomes that lead to greater overall
satisfaction.
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 when and whether
the Company will receive clearance from the FDA on its 510(k)
submission, progress towards commercialization, and the timing of
completion of enrollment in 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 ability of the Company to obtain sufficient
funding; the loss of key management personnel and the ability to
retain and recruit new personnel; the ability to adapt to rapidly
changing technology; competition in the medical device industry and
in the specific markets of aesthetics and dermatology in which the
Company plans to operate; reliance on third parties; the ability to
manage growth; 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, enrollment in 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;
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 most recently filed quarterly report on
Form 10-Q, 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. 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)
September 30,
December 31,
(in
thousands)
2019
2018
ASSETS
Current assets:
Cash and cash equivalents
$
9,570
$
51,103
Investments
24,928
8,480
Prepaid expenses and other current
assets
1,437
779
Total current assets
35,935
60,362
Property and equipment, net
2,428
2,173
Intangible assets, net
4,713
5,213
Goodwill
2,791
2,791
Right-of-use assets
1,190
—
Other assets
1,645
101
Total assets
$
48,702
$
70,640
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
1,816
$
1,272
Accrued expenses
2,054
1,421
Deferred rent, current
—
415
Lease liability, current
177
—
Total current liabilities
4,047
3,108
Deferred rent, net of current
—
1,198
Lease liability, net of current
3,674
—
Total liabilities
7,721
4,306
Stockholders’ equity:
Common stock and additional paid-in
capital
149,874
142,053
Accumulated other comprehensive loss
8
(1)
Accumulated deficit
(108,901)
(75,718)
Total stockholders’ equity
40,981
66,334
Total liabilities and stockholders’
equity
$
48,702
$
70,640
PULSE BIOSCIENCES,
INC.
Condensed Consolidated
Statements of Operations
(Unaudited)
Three-Month Periods
Ended
September 30,
(in thousands,
except per share amounts)
2019
2018
Revenue
$
—
$
—
Operating expenses:
General and administrative
5,606
5,675
Research and development
6,192
5,038
Amortization of intangible assets
166
166
Total operating expenses
11,964
10,879
Other income:
Interest income
218
118
Total other income
218
118
Net loss
(11,746)
(10,761)
Net loss per share:
Basic and diluted net loss per share
$
(0.57)
$
(0.64)
Weighted average shares used to compute
net loss per common share — basic and diluted
20,774
16,927
PULSE BIOSCIENCES,
INC.
Condensed Consolidated
Statements of Operations
(Unaudited)
Nine-Month Periods
Ended
September 30,
(in thousands,
except per share amounts)
2019
2018
Revenue
$
—
$
—
Operating expenses:
General and administrative
15,153
16,230
Research and development
18,371
12,174
Amortization of intangible assets
500
499
Total operating expenses
34,024
28,903
Other income:
Interest income
841
311
Total other income
841
311
Net loss
(33,183)
(28,592)
Net loss per share:
Basic and diluted net loss per share
$
(1.60)
$
(1.69)
Weighted average shares used to compute
net loss per common share — basic and diluted
20,728
16,883
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191107006033/en/
Investor Relations: Pulse Biosciences, Inc. Darrin Uecker
President and Chief Executive Officer IR@pulsebiosciences.com or
Solebury Trout Gitanjali Jain Ogawa, 646-378-2949
gogawa@troutgroup.com
Media: Tosk Communications Nadine D. Tosk, 504-453-8344
nadinepr@gmail.com
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