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 27, 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.) |
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):
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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)) |
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 27, 2017, Pulse Biosciences, Inc. announced its financial results for the fiscal quarter ended June 30, 2017. 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
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(d) |
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Exhibits. |
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Exhibit No. |
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Description |
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99.1 |
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Press Release issued by Pulse Biosciences, Inc. dated July 27, 2017 |
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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: July 27, 2017
EXHIBIT INDEX
PULSE BIOSCIENCES QUARTERLY INVESTOR AND ANALYST CONFERENCE CALL
Investor conference call today at 1:30 p.m. PDT / 4:30 p.m. EDT
HAYWARD, Calif.—(BUSINESS WIRE) – July 27, 2017 – Pulse Biosciences, Inc. (Nasdaq: PLSE), a medical technology company developing a proprietary therapeutic tissue treatment based on its Nano-Pulse Stimulation (NPS) platform today reports recent corporate developments and financial results for the quarter ended June 30, 2017.
Recent Developments
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Initiation of clinical study in patients with Seborrheic Keratosis. Patient enrollment and treatment is underway in the Company’s first clinical study investigating NPS for the treatment of Seborrheic Keratosis (SK), a benign skin lesion impacting over 80 million patients in the United States. |
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PulseTxTM System 510(k) under review. The PulseTx system is an NPS platform comprised of a tunable nanosecond pulse generator and accompanying tissue applicators. The FDA 510(k) submission made during the first quarter remains in the review process. |
“We continue to make meaningful and expedient progress toward our goal of delivering NPS as a novel therapeutic option that could represent a significant improvement over current treatments in a variety of indications,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. “Following the initiation of our first indication study applying the NPS technology for the treatment of SK lesions, we remain confident in NPS’ potential to deliver a treatment benefit to patients and clinicians across a variety of dermatologic conditions.”
Financial Highlights
Cash, cash equivalents, and investments totaled $15.4 million at June 30, 2017, compared to $16.4 million at December 31, 2016, including net cash use during 2017 totaling $6.0 million, and $3.5 million for the second quarter of 2017.
Operating expenses for the quarter ended June 30, 2017, totaled $6.2 million, compared to $3.2 million for the quarter ended March 31, 2017, and $2.3 million for the quarter ended June 30, 2016. The operating expenses for the quarter ended June 30, 2017, include non-cash stock-based compensation of
$2.8 million, compared to $0.3 million for the quarter ended March 31, 2017, and $0.2 million for the quarter ended June 30, 2016.
Conference Call Details
Pulse Biosciences’ Darrin Uecker, President and Chief Executive Officer, and other senior executives will host the investor and analyst call on July 27, 2017, 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 52323044. 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 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 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 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.
Investors:
Brian Dow
Sr. Vice President and Chief Financial Officer
IR@pulsebiosciences.com
or
The Trout Group
Mike Zanoni, 646-378-2924
mzanoni@troutgroup.com or
Media:
Sam Brown, Inc.
Hannah Hurdle, 805-601-5331
hannahhurdle@sambrown.com
Condensed Consolidated Balance Sheets
(Unaudited)
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June 30, |
December 31, |
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(in thousands) |
2017 |
2016 |
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ASSETS |
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Current assets: |
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Cash and investments |
$ |
15,399 |
$ |
16,395 | |||
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Prepaid expenses and other current assets |
717 | 268 | |||||
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Total current assets |
16,116 | 16,663 | |||||
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Leasehold improvements and equipment, net of |
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Accumulated depreciation |
2,730 | 317 | |||||
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Intangible assets, net of accumulated amortization |
6,210 | 6,543 | |||||
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Goodwill |
2,791 | 2,791 | |||||
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Other assets |
101 |
- |
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Total assets |
$ |
27,948 |
$ |
26,314 | |||
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
$ |
851 |
$ |
265 | |||
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Accrued expenses |
818 | 751 | |||||
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Deferred rent, current |
303 |
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Total current liabilities |
1,972 | 1,016 | |||||
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Long term liabilities: |
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Deferred rent |
1,816 |
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Total liabilities |
3,788 |
1,016 |
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Stockholders’ equity: |
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Common stock |
46,150 | 37,911 | |||||
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Accumulated other comprehensive loss |
(6) | (7) | |||||
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Accumulated deficit |
(21,984) | (12,606) | |||||
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Total stockholders’ equity |
24,160 | 25,298 | |||||
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Total liabilities and stockholders’ equity |
$ |
27,948 |
$ |
26,314 | |||
PULSE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
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Three-Month Periods Ended |
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June 30, |
March 31, |
June 30, |
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(in thousands, except per share amounts) |
2017 |
2017 |
2016 |
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Revenue |
$ |
— |
$ |
— |
$ |
— |
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Operating expenses: |
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General and administrative |
3,772 | 1,220 | 642 | ||||||
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Research and development |
2,282 | 1,851 | 1,453 | ||||||
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Amortization of intangible assets |
167 | 166 | 166 | ||||||
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Total operating expenses |
6,221 | 3,237 | 2,261 | ||||||
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Other income: |
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Interest income |
41 | 39 | 3 | ||||||
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Total other income |
41 | 39 | 3 | ||||||
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Net loss |
$ |
(6,180) |
$ |
(3,198) |
$ |
(2,258) | |||
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Net loss per share: |
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Basic and diluted net loss per share |
$ |
(0.43) |
$ |
(0.23) |
$ |
(0.23) | |||
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Weighted average shares used to compute net loss per common share — basic and diluted |
14,233 | 13,803 | 9,791 | ||||||
PULSE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
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Six-Month Periods Ended |
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June 30, |
June 30, |
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(in thousands, except per share amounts) |
2017 |
2016 |
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Revenue |
$ |
— |
$ |
— |
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Operating expenses: |
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General and administrative |
4,992 | 1,170 | |||||
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Research and development |
4,133 | 2,443 | |||||
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Amortization of intangible assets |
333 | 332 | |||||
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Total operating expenses |
9,458 | 3,945 | |||||
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Other income: |
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Interest income |
80 | 3 | |||||
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80 | 3 | |||||
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Net loss |
$ |
(9,378) |
$ |
(3,942) | |||
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Net loss per share: |
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Basic and diluted net loss per share |
$ |
(0.67) |
$ |
(0.45) | |||
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Weighted average shares used to compute net loss per common share — basic and diluted |
14,019 | 8,678 | |||||