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)
March 14, 2017
Pulse Biosciences, Inc.
(Exact name of registrant as specified in its charter)
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001-37744 |
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46-5696597 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
849 Mitten Road
Burlingame, California 94010
(Address of principal executive offices, including zip code)
(650) 697-3939
(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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
ITEM 2.02. RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
On March 14, 2017, Pulse Biosciences, Inc. announced its financial results for its fourth fiscal quarter and year ended December 31, 2016. 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.
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ITEM 9.01. |
FINANCIAL STATEMENTS AND EXHIBITS. |
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(d) |
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Exhibits. |
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99.1 |
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Press Release issued by Pulse Biosciences, Inc. dated March 14, 2017 titled “PULSE BIOSCIENCES QUARTERLY INVESTOR CONFERENCE CALL” (furnished and not filed herewith pursuant to Item 2.02). |
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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.
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Pulse Biosciences, Inc. |
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By: |
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/s/ Brian B. Dow |
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Brian B. Dows Chief Financial Officer, Senior Vice President, Secretary and Treasurer (Principal Financial and Principal Accounting Officer) |
Date: March 14, 2017
EXHIBIT INDEX
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Description |
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99.1 |
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Press Release issued by Pulse Biosciences, Inc. dated March 14, 2017 titled “PULSE BIOSCIENCES QUARTERY INVESTOR CONFERENCE CALL” (furnished and not filed herewith pursuant to Item 2.02) |
PULSE BIOSCIENCES QUARTERY INVESTOR CONFERENCE CALL
Investor conference call today at 1:30 p.m. PDT / 4:30 p.m. EDT
BURLINGAME, Calif.—(BUSINESS WIRE) – March 14, 2017 – Pulse Biosciences, Inc. (Nasdaq: PLSE), a medical technology company developing a proprietary therapeutic tissue treatment platform based on Nano-Pulse Stimulation (NPS), is hosting an investor conference call today to share information on recent developments and progress for its novel NPS platform in key markets. The Company will also provide financial results for the quarter and year ended December 31, 2016.
Recent Developments
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First FDA 510(k) submission for the PulseTx System. The PulseTx is an NPS platform comprised of a tunable nanosecond pulse generator and accompanying tissue applicators. The FDA 510(k) submission is the Company’s first for the PulseTx System and intended to provide a foundation for future submissions for specific indications. |
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Treatments completed in first dermatologic human pilot study with the Company’s proprietary PulseTx platform. The Company successfully completed patient treatments and follow-up visits in the first PulseTx pilot dose response study with positive interim results. The objective of this first study is to establish safety and tissue response and recovery characteristics of skin to different NPS doses, enabling the Company to identify an initial application in dermatology. |
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Progress towards entering the clinic with an initial NPS pilot study in immuno-oncology. Pulse Biosciences is pursuing multiple paths for its first pilot study in oncology and expects to initiate first pilot study trial during 2017. |
“We are very pleased with our recent progress,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. “The submission of our first FDA 510(k) for the PulseTx System and completion of patient treatments and follow-up visits in our dermatology dose response study are significant milestones for the Company.”
Financial Highlights
Cash, cash equivalents, and investments totaled $16.4 million at December 31, 2016 compared to $18.7 million and $3.6 million at September 30, 2016 and December 31, 2015, respectively. The December 2016 balance does not reflect $5.0 million of additional capital raised through the February 2017 private placement of approximately 820,000 shares of the Company’s Common Stock at $6.10 per share. Adjusting for $20.3 million of net proceeds raised in the Company’s second quarter, net cash used during the year totaled $7.5 million.
Operating expenses for fourth quarter ended December 31, 2016 totaled $2.8 million consistent with the $2.8 million reported for the third quarter ended September 30, 2016. Operating expenses for the year ended December 31, 2016 totaled $9.6 million compared to $4.5 million for the year ended December 31, 2015. The operating expenses reported included non-cash charges for stock-based compensation, intangible asset amortization and depreciation totaling $1.6 million for the year ended December 31, 2016 and $1.1 million for the year ended December 31, 2015.
Conference Call Details
Pulse Biosciences’ Darrin Uecker, President and Chief Executive Officer, and other senior executives will host the investor call on March 14, 2017, at 1:30 p.m. PDT / 4:30 p.m. EDT. For both “listen-only” participants and those who wish to take part in the question and answer portion of the call, the telephone dial-in number is (844) 494-0190 (U.S. toll-free) or (508) 637-5580 (international) using Conference ID 81225765. Listeners will also be able to access the call via webcast available on the Investor Section of the Company’s website at www.pulsebiosciences.com.
About Pulse Biosciences
Pulse Biosciences is a medical technology company developing a therapeutic tissue treatment platform based on Nano-Pulse Stimulation, a proprietary cell signaling technology. Nano-Pulse Stimulation is a non-thermal, precise, focal drug-free tissue treatment technology that directly affects the cell membrane and intracellular structures to stimulate unique behaviors in cells. NPS can initiate a cell death process that allows for the treatment of tissue cells with minimal inflammatory response which improves healing outcomes and supports the replacement of treated tissue cells with healthy tissue cells. In cancerous lesions, NPS has been shown in preclinical models to induce immunogenic cell death (ICD) exposing the unique antigens of the treated cells to the immune system, resulting in the generation of cytotoxic T-cells and the mounting of an adaptive immune response targeted against those cells. Pulse Biosciences is investigating a variety of applications for its technology that exploits the technology’s unique biologic effect, including immuno-oncology, dermatology, and veterinary medicine. 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, the mechanism of action of NPS treatments, planned future clinical trials, and other matters related to its pipeline of product candidates 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 press release to reflect events or circumstances in the future, even if new information becomes available.
Investors:
Darrin Uecker, President and Chief Executive Officer
IR@pulsebiosciences.com
or
Media:
Sam Brown, Inc.
Hannah Hurdle, 805-601-5331
hannahhurdle@sambrown.com
Condensed Consolidated Balance Sheets
(Unaudited)
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December 31, |
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(in thousands) |
2016 |
2015 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ |
2,089 |
$ |
3,606 | ||
Marketable Investments |
14,306 |
— |
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Prepaid expenses and other current assets |
268 | 44 | ||||
Deferred offering costs |
— |
347 | ||||
Total current assets |
16,663 | 3,997 | ||||
Equipment, net of accumulated depreciation |
317 | 329 | ||||
Intangible assets, net of accumulated amortization |
6,543 | 7,208 | ||||
Goodwill |
2,791 | 2,791 | ||||
Total assets |
$ |
26,314 |
$ |
14,325 | ||
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
$ |
265 |
$ |
262 | ||
Accrued expenses |
751 | 398 | ||||
Total current liabilities |
1,016 | 660 | ||||
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Stockholders’ equity: |
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Preferred stock |
— |
— |
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Common stock |
13 | 8 | ||||
Additional paid-in capital |
37,898 | 16,745 | ||||
Accumulated other comprehensive loss |
(7) |
— |
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Accumulated deficit |
(12,606) | (3,088) | ||||
Total stockholders’ equity |
25,298 | 13,665 | ||||
Total liabilities and stockholders’ equity |
$ |
26,314 |
$ |
14,325 |
PULSE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
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Three-Month Periods Ended |
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(in thousands, except per share amounts) |
December 31, 2016 |
September 30, 2016 |
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Revenue |
$ |
— |
$ |
— |
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Operating expenses: |
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General and administrative |
870 | 893 | |||||||
Research and development |
1,806 | 1,739 | |||||||
Amortization of intangible assets |
167 | 166 | |||||||
Total operating expenses |
2,843 | 2,798 | |||||||
Other income: |
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Interest income |
34 | 31 | |||||||
Total other income |
34 | 31 | |||||||
Loss from operations, before income taxes |
(2,809) | (2,767) | |||||||
Income tax benefit |
— |
— |
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Net loss |
$ |
(2,809) |
$ |
(2,767) | |||||
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Net loss per share – basic and diluted |
$ |
(0.21) |
$ |
(0.21) | |||||
Weighted average number of common shares |
13,315 | 13,315 |
Condensed Consolidated Statements of Operations
(Unaudited)
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Years Ended |
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December 31, |
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(in thousands, except per share amounts) |
2016 |
2015 |
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Revenue |
$ |
— |
$ |
— |
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Operating expenses: |
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General and administrative |
2,933 | 1,224 | ||||
Research and development |
5,988 | 2,578 | ||||
Amortization of intangible assets |
665 | 666 | ||||
Total operating expenses |
9,586 | 4,468 | ||||
Other income: |
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Interest income |
68 |
— |
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Total other income |
68 |
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Loss from operations, before income taxes |
(9,518) | (4,468) | ||||
Income tax benefit |
— |
(1,657) | ||||
Net loss |
$ |
(9,518) |
$ |
(2,811) | ||
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Net loss per share – basic and diluted |
$ |
(0.86) |
$ |
(0.37) | ||
Weighted average number of common shares outstanding – basic and diluted |
11,009 | 7,565 |