UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
____________________
FORM 8-K
____________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
July 31, 2018
____________________
Pulse Biosciences, Inc.
(Exact name of registrant as specified in its charter)
____________________
|
Delaware |
|
001-37744 |
|
46-5696597 |
|
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
3957 Point Eden Way
Hayward, California 94545
(Address of principal executive offices, including zip code)
(510) 906-4600
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
____________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2):
|
|
|
|
|
|
|
☐ |
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
ITEM 2.02. RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
On July 31, 2018, Pulse Biosciences, Inc. announced its financial results for the three- and six-month periods ended June 30, 2018. A copy of the press release containing the announcement is included as Exhibit 99.1 and is incorporated herein by reference.
This information, as well as Exhibit 99.1, is intended to be furnished under Item 2.02 of Form 8-K, “Results of Operations and Financial Condition” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS
|
(d) |
|
Exhibits. |
||
|
|
|
|
||
|
Exhibit No. |
|
Description |
||
|
99.1 |
|
Press Release issued by Pulse Biosciences, Inc. dated July 31, 2018 |
||
|
|
|
|
||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
Pulse Biosciences, Inc. |
|
|
|
|
|
|
|
By: |
/s/ Brian B. Dow |
|
|
|
Brian B. Dow Chief Financial Officer, Senior Vice President, Secretary and Treasurer (Principal Financial and Principal Accounting Officer) |
Date: July 31, 2018
Exhibit 99.1
PULSE BIOSCIENCES QUARTERLY INVESTOR CONFERENCE CALL
Conference call today at 1:30 p.m. PDT / 4:30 p.m. EDT
HAYWARD, Calif. - (BUSINESS WIRE) – July 31, 2018 – Pulse Biosciences, Inc. (Nasdaq: PLSE), a clinical stage electroceutical company developing a proprietary therapeutic tissue treatment based on its Nano-Pulse Stimulation (NPS) platform, today reported recent corporate developments and financial results for the three- and six-month periods ended June 30, 2018.
Recent Developments
|
· |
Announced treatment of first subjects in a study to evaluate the safety and efficacy of novel Nano-Pulse Stimulation for the treatment of Sebaceous Hyperplasia (SH), a common but difficult-to-treat facial lesion. |
|
o |
A multicenter study of NPS in the treatment of SH expected to enroll up to sixty patients at five leading medical centers across the U.S. The study’s primary success measurement is the degree of SH lesion clearance, as rated by the investigator at the final study visit. Study completion is expected by the end of 2018. |
|
· |
Announced the treatment of the first patient in a clinical study to evaluate NPS in Basal Cell Carcinoma (BCC). |
|
o |
A multi-center NPS & resect study evaluating immune and lesion response to NPS expected to enroll seventy-five patients with BCC at four leading skin cancer surgery centers in the U.S. The study will assess through histological and biomarker evaluation NPS’ impact on the primary BCC and changes elicited in the immune response to the BCC as a result of NPS. Study completion expected during the first quarter of 2019. |
|
· |
Abstract titled, Nanosecond Pulsed Stimulation study of intracellular organelle changes in liver tumor cells in vivo using electron microscopy, presented from the podium at The Joint Annual Meeting of the Bioelectromagnetics Society and the European Bioelectromagnetics Association. |
|
o |
Chief Science Officer Richard Nuccitelli, Ph.D., presented the results of a study of the intracellular effects of NPS on rat liver tumor cells as observed by electron microscopy. The study indicates that NPS treatment results in disruption of key intracellular organelles shortly after treatment and initiate cellular changes that present in the hours following treatment. |
“Our progress in developing clinical applications for Nano-Pulse Stimulation continues to accelerate through 2018 as we move additional projects into the clinic and further build the portfolio of scientific evidence of our mechanism of action,” stated Darrin Uecker, President and Chief Executive Officer. “We are mid-way through 2018 and are excited not only as to the progress made so far but the opportunity for additional advancements during the remainder of 2018.”
Financial Highlights
Cash, cash equivalents, and investments totaled $27.5 million at June 30, 2018, compared to $38.1 million at December 31, 2017. Cash use totaled $5.9 million for the second quarter of 2018 compared to cash use of $3.9 million for the fourth quarter of 2017. Cash use for 2018 is currently anticipated to total approximately $24 million.
Operating expenses for the three-month period ended June 30, 2018 totaled $9.3 million, compared to $6.2 million for the three-month period ended June 30, 2017. Operating expenses for the three-month period ended June 30, 2018 included non-cash stock-based compensation of $3.2 million, compared to non-cash stock-based compensation of $2.8 million for the three-month period ended June 30, 2017.
Operating expenses for the six-month period ended June 30, 2018 totaled $18.0 million, compared to $9.5 million for the six-month period ended June 30, 2017. Operating expenses for the six-month period ended June 30, 2018 included non-cash stock-based compensation of $6.6 million, compared to non-cash stock-based compensation of $3.1 million for the six-month period ended June 30, 2017.
Conference Call Details
Pulse Biosciences will host an investor call on July 31, 2018, 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 3295809. 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 publicly listed clinical stage electroceutical company pursuing multiple clinical applications of its proprietary Nano-Pulse Stimulation technology. Nano-Pulse Stimulation (NPS) is a non-thermal, precise, focal tissue treatment technology comprised of nanosecond (billionth of a second) range pulsed electric fields that directly affect the cell membrane and intracellular structures and initiates cell death in treated cells. The initiation of cell death by NPS results in a minimal inflammatory response, which improves healing outcomes and supports the replacement of treated tissue cells with healthy tissue cells. NPS’ unique mechanism of action to initiate cell death has the potential to significantly benefit patients for multiple medical applications in dermatology, immune-oncology, and in other unique tissue targets. In cancerous lesions, NPS has been shown in preclinical models to induce immunogenic cell death (ICD), which exposes the unique antigens of the treated cells to the immune system and enrolls immune system cells, such as cytotoxic T-cells to mount an adaptive immune response. More information is available 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.
Investor Relations:
Brian Dow
Sr. Vice President and Chief Financial Officer
IR@pulsebiosciences.com
Gitanjali Jain Ogawa
Solebury Trout
gogawa@troutgroup.com
(646) 378-2949
Condensed Consolidated Balance Sheets
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
||
|
(in thousands) |
|
2018 |
|
2017 |
||
|
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and investments |
|
$ |
27,499 |
|
$ |
38,069 |
|
Prepaid expenses and other current assets |
|
|
1,161 |
|
|
412 |
|
Total current assets |
|
|
28,660 |
|
|
38,481 |
|
Leasehold improvements and equipment, net of |
|
|
|
|
|
|
|
Accumulated depreciation |
|
|
2,432 |
|
|
2,570 |
|
Intangible assets, net of accumulated amortization |
|
|
5,545 |
|
|
5,878 |
|
Goodwill |
|
|
2,791 |
|
|
2,791 |
|
Other assets |
|
|
101 |
|
|
101 |
|
Total assets |
|
$ |
39,529 |
|
$ |
49,821 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,502 |
|
$ |
782 |
|
Accrued expenses |
|
|
1,164 |
|
|
1,034 |
|
Deferred rent, current |
|
|
406 |
|
|
397 |
|
Total current liabilities |
|
|
3,072 |
|
|
2,213 |
|
Long term liabilities: |
|
|
|
|
|
|
|
Deferred rent |
|
|
1,410 |
|
|
1,613 |
|
Total liabilities |
|
|
4,482 |
|
|
3,826 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Common stock |
|
|
91,051 |
|
|
84,219 |
|
Accumulated other comprehensive loss |
|
|
- |
|
|
(51) |
|
Accumulated deficit |
|
|
(56,004) |
|
|
(38,173) |
|
Total stockholders’ equity |
|
|
35,047 |
|
|
45,995 |
|
Total liabilities and stockholders’ equity |
|
$ |
39,529 |
|
$ |
49,821 |
PULSE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three-Month Periods Ended |
||||
|
|
|
June 30, |
|
June 30, |
||
|
(in thousands, except per share amounts) |
|
2018 |
|
2017 |
||
|
Revenue |
|
$ |
— |
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
General and administrative |
|
|
5,173 |
|
|
3,924 |
|
Research and development |
|
|
3,960 |
|
|
2,130 |
|
Amortization of intangible assets |
|
|
167 |
|
|
167 |
|
Total operating expenses |
|
|
9,300 |
|
|
6,221 |
|
Other income: |
|
|
|
|
|
|
|
Interest income |
|
|
137 |
|
|
41 |
|
Total other income |
|
|
137 |
|
|
41 |
|
Net loss |
|
$ |
(9,163) |
|
$ |
(6,180) |
|
Net loss per share: |
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.54) |
|
$ |
(0.43) |
|
Weighted average shares used to compute net loss per common share — basic and diluted |
|
|
16,881 |
|
|
14,233 |
PULSE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six-Month Periods Ended |
||||
|
|
|
June 30, |
|
June 30, |
||
|
(in thousands, except per share amounts) |
|
2018 |
|
2017 |
||
|
Revenue |
|
$ |
— |
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
General and administrative |
|
|
10,555 |
|
|
5,268 |
|
Research and development |
|
|
7,136 |
|
|
3,857 |
|
Amortization of intangible assets |
|
|
333 |
|
|
333 |
|
Total operating expenses |
|
|
18,024 |
|
|
9,458 |
|
Other income: |
|
|
|
|
|
|
|
Interest income |
|
|
193 |
|
|
80 |
|
Total other income |
|
|
193 |
|
|
80 |
|
Net loss |
|
$ |
(17,831) |
|
$ |
(9,378) |
|
Net loss per share: |
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(1.06) |
|
$ |
(0.67) |
|
Weighted average shares used to compute net loss per common share — basic and diluted |
|
|
16,861 |
|
|
14,019 |