Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its
novel and proprietary CellFX® Nanosecond Pulsed Field Ablation™
(nsPFA™) technology, today announced business updates and financial
results for the first quarter ended March 31, 2024.
Recent Business Highlights
CellFX nsPFA Percutaneous Electrode
- March 2024, received FDA 510(k) clearance for use in the
ablation of soft tissue in percutaneous and intraoperative surgical
procedures.
CellFX nsPFA Cardiac Clamp
- Remain in the 510(k) process while continuing productive
dialogue with FDA regarding the go-forward regulatory path.
- FDA has requested clinical data in support of the regulatory
filing and discussions regarding the required clinical data are
underway.
- Submitted first-in-human feasibility study to take place at
several centers in the Netherlands to the Ethics Committee and
anticipate a response in the next several weeks.
CellFX nsPFA 360° Cardiac Catheter
- At the Heart Rhythm Society (HRS) meeting in Boston, May 16th
to the 19th, CellFX nsPFA energy will be showcased across 6 poster
presentations and abstracts in addition to a live case
demonstrating pulmonary vein isolation at the PFA Live Case
Summit.
Announcement of Rights Offering
- The Company’s Board of Directors has approved a planned rights
offering of up to $60 million worth of units that will be available
to all holders of record of the Company’s common stock.
- Company has decided to change the rights offering record date
from May 16, 2024 to a date in mid-June. New record date will be
announced by the Company once all necessary SEC filings have been
completed.
- Assuming the rights offering is fully subscribed at the Initial
Price, the Company will receive gross proceeds of up to $60
million, less expenses related to the rights offering, and upon
exercise of all the warrants, would receive additional proceeds of
up to $66 million. A fully subscribed rights offering would fund
the growth plans of the Company into the first quarter of
2026.
“I am incredibly proud of the team’s accomplishments to start
the year. Our proprietary CellFX nsPFA energy has demonstrated the
potential to advance the standards of care for both soft tissue
ablation and the treatment of atrial fibrillation. FDA clearance of
the CellFX nsPFA Percutaneous Electrode System along with the
posters, abstracts and a live case highlighting the CellFX nsPFA
360° Cardiac Catheter at HRS next week are early validations of our
technology and its potential,” said Kevin Danahy, President and
Chief Executive Officer of Pulse Biosciences. “We remain focused on
delivering the benefits of CellFX nsPFA to patients and providers
following further clinical evaluations and regulatory clearances.
For the remainder of the year, we are focused on executing our
CellFX nsPFA percutaneous electrode pilot program to initiate the
commercial launch and, all the while, continuing to advance the
clinical and regulatory work with our CellFX nsPFA Surgical Clamp
and 360° Cardiac Catheter.”
First Quarter 2024 Financial Results
Total GAAP costs and expenses, representing research and
development and general and administrative expenses, for the three
months ended March 31, 2024, were $10.6 million compared to $9.6
million for the prior year period. The increase in GAAP costs and
expenses was primarily driven by an increase in non-cash
stock-based compensation expense, which was $1.8 million for the
three months ended March 31, 2024, compared to $0.9 million for the
prior year period. The remaining increase in costs and expenses
compared to the prior year was driven by an increase in research
and development expenses to support the development of the CellFX
nsPFA product portfolio. Non-GAAP costs and expenses for the three
months ended March 31, 2024, were $8.6 million, compared to $8.3
million for the prior year period.
GAAP net loss for the three months ended March 31, 2024 was
($10.1) million compared to ($9.8) million for the three months
ended March 31, 2023. Non-GAAP net loss for the three months ended
March 31, 2024 was ($8.1) million compared to ($8.6) million for
the three months ended March 31, 2023.
Cash and cash equivalents totaled $34.9 million as of March 31,
2024, compared to $54.1 million as of March 31, 2023 and $44.4
million as of December 31, 2023. Cash used in the first quarter of
2024 was $9.5 million compared to $7.2 million in the same period
in the prior year and $6.9 million used in the fourth quarter of
2023. The sequential quarterly increase was driven mainly by $2.0
million in 2023 annual cash bonus payouts.
Reconciliations of GAAP to non-GAAP cost and expenses and net
loss have been provided in the tables following the financial
statements in this press release. An explanation of these measures
is also included below under the heading “Non-GAAP Financial
Measures.”
Webcast and Conference Call Information
Pulse Biosciences’ management will host a conference call today,
May 7, 2024, beginning at 1:30pm PT. Investors interested in
listening to the conference call may do so by dialing
1-877-704-4453 for domestic callers or 1-201-389-0920 for
international callers. A live and recorded webcast of the event
will be available at https://investors.pulsebiosciences.com/.
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company
committed to health innovation that has the potential to improve
the quality of life for patients. The Company’s proprietary CellFX®
nsPFA™ technology delivers nanosecond pulses of electrical energy
to non-thermally clear cells while sparing adjacent noncellular
tissue. The Company is actively pursuing the development of its
CellFX nsPFA technology for use in the treatment of atrial
fibrillation and in a select few other markets where it could have
a profound positive impact on healthcare for both patients and
providers.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS, nsPFA,
CellFX nsPFA and the stylized logos are among the trademarks and/or
registered trademarks of Pulse Biosciences, Inc. in the United
States and other countries.
Non-GAAP Financial Measures
In this press release, in order to supplement the Company’s
condensed consolidated financial statements presented in accordance
with Generally Accepted Accounting Principles, or GAAP, management
has disclosed certain non-GAAP financial measures for the statement
of operations. The Company believes that an evaluation of its
ongoing operations (and comparisons of its current operations with
historical and future operations) would be difficult if the
disclosure of its financial results were limited to financial
measures prepared in accordance with GAAP. As a result, the Company
is disclosing certain non-GAAP results in order to supplement
investors’ and other readers’ understanding and assessment of the
Company’s financial performance. Company management uses these
measurements as aids in monitoring the Company’s ongoing financial
performance from quarter to quarter, and year to year, on a regular
basis and for financial and operational decision-making. Non-GAAP
adjustments include stock-based compensation, depreciation and
amortization and restructuring charges. From time to time in the
future, there may be other items that the Company may exclude if
the Company believes that doing so is consistent with the goal of
providing useful information to management and investors. The
Company has provided a reconciliation of each non-GAAP financial
measure used in this earnings release to the most directly
comparable GAAP financial measure. Investors are cautioned that
there are a number of limitations associated with the use of
non-GAAP financial measures as analytical tools. Investors are
encouraged to review these reconciliations, and not to rely on any
single financial measure to evaluate the Company’s business.
Non-GAAP financial measures used by the Company may be
calculated differently from, and therefore may not be comparable
to, similarly titled measures used by other companies, which could
reduce the usefulness of the Company’s non-GAAP financial measures
as tools for comparison. Investors and other readers are encouraged
to review the related GAAP financial measures and the
reconciliation of non-GAAP measures to their most directly
comparable GAAP measures set forth below and should consider
non-GAAP measures only as a supplement to, not as a substitute for
or as a superior measure to, measures of financial performance
prepared in accordance with GAAP. Non-GAAP financial measures in
this earnings release exclude the following:
Non-cash expenses for stock-based compensation. The
Company has excluded the effect of stock-based compensation
expenses in calculating the Company’s non-GAAP cost and expenses
and net loss measures. Although stock-based compensation is a key
incentive offered to employees, the Company continues to evaluate
its business performance excluding stock-based compensation
expenses. The Company records stock-based compensation expense
related to grants of time-based and performance-based options, such
as options that vest as a result of the Company’s market
capitalization. Depending upon the size, timing and terms of the
grants, as well as the probability of achievement of
performance-based awards, this expense may vary significantly but
will recur in future periods. The Company believes that excluding
stock-based compensation better allows for comparisons from period
to period.
Depreciation and amortization. The Company has excluded
depreciation and amortization expense in calculating its non-GAAP
cost and expenses and net loss measures. Depreciation and
amortization are non-cash charges to current operations.
Restructuring charges. The Company has excluded
restructuring charges in calculating its non-GAAP cost and expenses
and net loss measures. Restructuring programs involve discrete
initiatives designed to improve operating efficiencies and include
employee termination, contract termination, and other exit costs
associated with the restructuring program. The Company believes
that excluding discrete restructuring charges allows for better
comparisons from period to period.
Forward-Looking Statements
All statements in this press release that are not historical are
forward-looking statements, including, among other things,
statements relating to the effectiveness of the Company’s CellFX
nsPFA technology and CellFX System to non-thermally clear cells
while sparing adjacent non-cellular tissue, statements concerning
the Company’s expected product development efforts and plans to
sell products commercially, such as its plans to demonstrate
advantages of its CellFX nsPFA Percutaneous Electrode over current
treatment options, statements concerning the Company’s future
fundraising efforts and whether those efforts will be successful
and allow the Company to continue current operations as planned,
statements concerning market opportunities, customer adoption and
future use of the CellFX System to address a range of conditions
such as atrial fibrillation, statements concerning early clinical
successes and whether they are predictive of the safety and
efficacy of any medical device such as the CellFX nsPFA 360°
Cardiac Catheter, Pulse Biosciences’ expectations, whether stated
or implied, regarding whether the Company’s CellFX nsPFA technology
will become a disruptive and durable treatment option for treating
atrial fibrillation or any other medical condition, 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.
Condensed Consolidated Balance
Sheets
(In thousands, except per
share amounts)
(Unaudited)
March 31,
December 31,
2024
2023
ASSETS
Current assets:
Cash and cash equivalents
$
34,885
$
44,365
Prepaid expenses and other current
assets
964
963
Total current assets
35,849
45,328
Property and equipment, net
1,400
1,528
Intangible assets, net
1,719
1,886
Goodwill
2,791
2,791
Right-of-use assets
7,040
7,256
Other assets
365
365
Total assets
$
49,164
$
59,154
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
1,712
$
1,836
Accrued expenses
2,268
3,814
Lease liability, current
1,101
1,058
Total current liabilities
5,081
6,708
Lease liability, less current
7,796
8,086
Total liabilities
12,877
14,794
Stockholders’ equity:
Preferred stock, $0.001 par value;
authorized – 50,000 shares; no shares issued and outstanding
—
—
Common stock, $0.001 par value: authorized
– 500,000 shares; issued and outstanding – 55,225 shares and 55,144
shares at March 31, 2024 and December 31, 2023, respectively
55
55
Additional paid-in capital
383,284
381,220
Accumulated other comprehensive income
(loss)
—
—
Accumulated deficit
(347,052
)
(336,915
)
Total stockholders’ equity
36,287
44,360
Total liabilities and stockholders’
equity
$
49,164
$
59,154
PULSE BIOSCIENCES,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except per
share amounts)
(Unaudited)
Three-Month Periods
Ended
March 31,
2024
2023
Revenues:
Product revenues
$
—
$
—
Total revenues
—
—
Cost and expenses:
Research and development
6,741
5,829
General and administrative
3,874
3,733
Total cost and expenses
10,615
9,562
Loss from operations
(10,615
)
(9,562
)
Other income (expense):
Interest income (expense), net
478
(239
)
Total other income (expense)
478
(239
)
Net loss
(10,137
)
(9,801
)
Comprehensive loss
$
(10,137
)
$
(9,801
)
Net loss per share:
Basic and diluted net loss per share
$
(0.18
)
$
(0.26
)
Weighted average shares used to compute
net loss per common share — basic and diluted
55,172
37,390
Three-Month Periods
Ended
March 31,
Stock Based Compensation
Expense:
2024
2023
Research and development
949
258
General and administrative
810
638
Total stock-based compensation expense
$
1,759
$
896
The following table presents the
reconciliation of non-GAAP financial measures to the most directly
comparable GAAP financial measures:
(In thousands)
(Unaudited)
Three-Month Periods
Ended
March 31,
2024
2023
Reconciliation of GAAP to non-GAAP
Research and development:
GAAP Research and development
$
6,741
$
5,829
Less: Stock-based compensation expense
(949
)
(258
)
Less: Depreciation and amortization
(53
)
(57
)
Less: Restructuring
—
(38
)
Non-GAAP Research and development
$
5,739
$
5,476
Reconciliation of GAAP to non-GAAP
General and administrative:
GAAP General and administrative
$
3,874
$
3,733
Less: Stock-based compensation expense
(810
)
(638
)
Less: Depreciation and amortization
(247
)
(244
)
Less: Restructuring
—
(12
)
Non-GAAP General and administrative
$
2,817
$
2,839
Reconciliation of GAAP to non-GAAP Cost
and expenses:
GAAP Cost and expenses
$
10,615
$
9,562
Less: Stock-based compensation expense
(1,759
)
(896
)
Less: Depreciation and amortization
(300
)
(301
)
Less: Restructuring
—
(50
)
Non-GAAP Cost and expenses
$
8,556
$
8,315
Reconciliation of GAAP to non-GAAP Net
loss:
GAAP Net loss
$
(10,137
)
$
(9,801
)
Add: Stock-based compensation expense
1,759
896
Add: Depreciation and amortization
300
301
Add: Restructuring
—
50
Non-GAAP Net loss
$
(8,078
)
$
(8,554
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240507618310/en/
Investor Contacts: Pulse Biosciences Kevin Danahy,
President and CEO 510.241.1077 IR@pulsebiosciences.com
or Gilmartin Group Philip Trip Taylor 415.937.5406
philip@gilmartinir.com
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