Pulse Biosciences Quarterly Investor Conference Call

First patient treated in the CellFX™ back acne clinical
feasibility study

Conference call today at 1:30 p.m. PDT / 4:30 p.m. EDT

HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel medical therapy company
bringing to market its proprietary CellFX™ System, today reported recent
corporate developments, and financial results for the quarter and
year-ended December 31, 2018.

The Company also announced today treatment of the first of up to 20
patients in a clinical feasibility study to evaluate the CellFX System
for acne on the back. This study leverages the unique mechanism of
action of the CellFX System in order to target sebaceous glands deep in
the dermis, as demonstrated in the previously announced clinical study
evaluating NPS for the treatment of facial sebaceous hyperplasia (SH).

Recent Corporate Developments

  • Demonstrated efficacy of over 99.5% of Sebaceous Hyperplasia (SH)
    lesions treated with Nano-Pulse Stimulation™ (NPS™) in a clinical
    feasibility study, the second successful study of a dermatologic
    application of the Company’s NPS technology platform.

    • 99.5% of the treated lesions were assessed as clear or mostly
      clear by investigators at the 60-day post-treatment follow-up
      evaluation.
    • 92% (n=203) of treated lesions were assessed as clear or mostly
      clear after a single NPS treatment.
    • Patients rated 78% of lesion outcomes as satisfied or mostly
      satisfied at study end.
    • The study data has been accepted for presentation at the upcoming
      American Academy of Dermatology Annual Meeting by Dr. Girish
      Munavalli, one of the study’s principal investigators.
  • Successfully completed a $45 million rights offering, an
    important financial milestone enabling Pulse Biosciences to accelerate
    its progress towards commercialization of the CellFX System.
  • Appointed key personnel focusing on CellFX commercialization:

    • Promotion of Edward Ebbers to Executive Vice President and
      General Manager,
      Dermatology. Mr. Ebbers brings over 35
      years of leadership and management experience with major
      dermatology, pharmaceutical and medical device companies,
      including extensive experience introducing products with
      utilization-based revenue models in the private pay aesthetic
      dermatology market.
    • Addition of Robert Tyson as Vice President of Sales, North
      America.
      Mr. Tyson brings a proven track record as a sales
      leader with over 20 years of medical technology experience.

We are pleased with our accomplishments over the past year in advancing
our proprietary CellFX System and look forward to achieving key
commercialization milestones in 2019,” said Darrin Uecker, Pulse
Biosciences’ President and Chief Executive Officer.

Acne Clinical Feasibility Study

The objective of the acne clinical feasibility study announced today is
to treat up to 20 patients between the ages of 18 and 80 to evaluate the
reduction in number and severity of back acne eruptions post CellFX
procedures through comparison of the treated to non-treated areas
90-days after the last procedure. Mark Nestor, MD, PhD, managing partner
of Skin and Cancer Associates, and Brian Berman, MD, PhD, director of
the Center for Clinical and Cosmetic Research in Miami and a past Vice
President of the American Academy of Dermatology, are the principal
investigators on the study.

We are very excited to enroll our first back acne patient as chronic
acne eruptions can be very difficult to control, and compliance with
ongoing use of oral or topical therapies can be problematic,” said
clinical investigator Brian Berman, MD. “Through this rigorous study, we
expect to achieve a meaningful reduction in the number and severity of
acne lesions treated with the CellFX System.”

Fourth Quarter and Full Year 2018 Financial Highlights

Cash, cash equivalents, and investments totaled $59.6 million at
December 31, 2018, compared to $38.1 million at December 31, 2017. Cash
use totaled $6.4 million for the fourth quarter of 2018 compared to cash
use of $3.9 million for the fourth quarter of 2017. Cash use for 2018
totaled $23.5 million.

Operating expenses for the three-month period ended December 31,
2018 totaled $9.1 million, compared to $8.8 million for the three-month
period ended December 31, 2017. Operating expenses for the three-month
period ended December, 2018 included non-cash stock-based compensation
of $2.4 million, compared to non-cash stock-based compensation of
$4.5 million for the three-month period ended December 31, 2017.

Operating expenses for the fiscal year ended December 31, 2018
totaled $38.0 million, compared to $25.8 million for the fiscal year
ended December 31, 2017. Operating expenses for the fiscal year ended
December 31, 2018 included non-cash stock-based compensation of
$12.3 million, compared to non-cash stock-based compensation of
$10.9 million for the fiscal year ended December 31, 2017.

Conference Call Details

Pulse Biosciences will host an investor call on February 7, 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 5196202. 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 medical therapy company bringing to market
its proprietary CellFX™ System utilizing the Company’s proprietary
Nano-Pulse Stimulation™ (NPS™) platform technology. The Company’s CellFX
System provides a novel, precise, non-thermal cellular treatment
technology delivering nanosecond duration energy pulses that impact
cells in treated tissue while sparing surrounding non-cellular tissue.
This unique mechanism of action disrupts the functions of internal cell
structures while maintaining the outer cell membrane, initiating a
cascade of events within the cell resulting in regulated cell death. The
novel characteristics of the Company’s CellFX System mechanism of action
has the potential to significantly benefit patients across multiple
medical applications, including dermatology, the Company’s first planned
commercial application. Beyond dermatology applications, NPS has
demonstrated an ability to induce immunogenic cell death in several
cancer cell lines in pre-clinical studies. The Company believes its NPS
platform technology may play a future role in immuno-oncology as a focal
tumor treatment that can initiate an adaptive immune response. More
information can be found 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.

Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation
(NPS) are investigational use only.

   

PULSE BIOSCIENCES, INC.

Condensed Consolidated Balance Sheets

(Unaudited)

 
December 31, December 31,

(in thousands)

2018 2017
ASSETS
Current assets:
Cash, cash equivalents and investments $ 59,583 $ 38,069
Prepaid expenses and other current assets   779     412  
Total current assets 60,362 38,481
 
Property and equipment, net 2,173 2,570
Intangible assets, net 5,213 5,878
Goodwill 2,791 2,791
Other assets   101     101  
Total assets $ 70,640   $ 49,821  
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 1,272 $ 782
Accrued expenses 1,421 1,034
Deferred rent, current   415     397  
Total current liabilities 3,108 2,213
Long term liabilities:
Deferred rent, less current   1,198     1,613  
Total liabilities   4,306     3,826  
Stockholders’ equity:
Common stock and additional paid-in capital 142,053 84,219
Accumulated other comprehensive loss (1 ) (51 )
Accumulated deficit   (75,718 )   (38,173 )
Total stockholders’ equity   66,334     45,995  
Total liabilities and stockholders’ equity $ 70,640   $ 49,821  
 

PULSE BIOSCIENCES, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

 

   
Three-Month Periods Ended
December 31, December 31,

(in thousands, except per share amounts)

2018 2017
Revenue $   $  
Operating expenses:
General and administrative 3,814 5,801
Research and development 5,080 2,864
Amortization of intangible assets   166     166  
Total operating expenses   9,060     8,831  
Other income (expense):
Interest income 135 128
Other expense   (28 )    
Total other income (expense)   107     128  
Net loss $ (8,953 ) $ (8,703 )
Net loss per share:
Basic and diluted net loss per share $ (0.51 ) $ (0.53 )
Weighted average shares used to compute net loss per common share —
basic and diluted
  17,656     16,574  
 

PULSE BIOSCIENCES, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

 

   
Years Ended
December 31, December 31,

(in thousands, except per share amounts)

2018 2017
Revenue $

  $  
Operating expenses:
General and administrative 20,045 15,503
Research and development 17,253 9,646
Amortization of intangible assets   665     665  
Total operating expenses   37,963     25,814  
Other income (expense):
Interest income 446 247
Other expense   (28 )  

 
Total other income (expense)   418     247  
Net loss $ (37,545 ) $ (25,567 )
Net loss per share:
Basic and diluted net loss per share $ (2.20 ) $ (1.73 )
Weighted average shares used to compute net loss per common share —
basic and diluted
  17,078     14,754  

Contacts

Investor Relations:
Brian Dow
Sr. Vice President and
Chief Financial Officer
[email protected]

Gitanjali Jain Ogawa
Solebury Trout
[email protected]
646-378-2949

or

Media:
Tosk Communications
Nadine D. Tosk, 504-453-8344
[email protected]

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