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)
November 14, 2016
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 November 14, 2016, Pulse Biosciences, Inc. announced its financial results for its third fiscal quarter ended September 30, 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 November 14, 2016 titled “PULSE BIOSCIENCES QUARTERY NANO-PULSE STIMULATION (NPS) UPDATE” (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 Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer |
Date: November 14, 2016
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 November 14, 2016 titled “PULSE BIOSCIENCES QUARTERY NANO-PULSE STIMULATION (NPS) UPDATE” (furnished and not filed herewith pursuant to Item 2.02) |
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PULSE BIOSCIENCES QUARTERY NANO-PULSE STIMULATION (NPS) UPDATE
Investor conference call today at 1:30 p.m. PDT / 4:30 p.m. EDT
BURLINGAME, Calif.—(BUSINESS WIRE) – Nov. 14, 2016 – 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 new developments and significant advancements for its novel NPS platform in key markets. The company will also discuss its recent corporate progress and upcoming milestones, as well as provide financial results for the quarter ended September 30, 2016.
Recent Developments
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PulseTx System enters the clinic as company works towards 510(k) submission to FDA before year end. PulseTx is a first of its kind NPS platform comprised of a tunable nanosecond pulse generator accompanied by a suite of interchangeable tissue applicators to enable treatments across a wide variety of applications. |
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First dermatologic human pilot study with the company’s proprietary PulseTx platform. Successful first clinical procedure with the PulseTx System in the company’s initial pilot study evaluating a range of NPS doses in abdominal skin. The objective of this first study is to establish the response and recovery time of skin to different NPS doses, enabling the company to better design further clinical studies in dermatology. |
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Results from three preclinical studies presented at the Society for Immunotherapy of Cancer (SITC) 2016 annual meeting. Presented preclinical findings which demonstrate NPS’ potential to effectively trigger immunogenic cell death, stimulate anti-tumor immunity responses, and inhibit metastases in a variety of oncologic conditions. |
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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 have the pilot study trial design and strategy defined by year-end. |
“We are very pleased with our progress this quarter,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. “We have made great strides developing our novel and proprietary NPS platform, introducing the PulseTx System into the clinic in our first pilot study in dermatology and presented exciting preclinical data at the SITC Annual Meeting.”
Financial Highlights
Cash, cash equivalents, and investments totaled $18.7 million at September 30, 2016 compared to $20.7 million and $3.6 million at June 30, 2016 and December 31, 2015, respectively.
Operating expenses for third quarter ended September 30, 2016 totaled $2.8 million reflecting a 24% increase compared to $2.3 million for the quarter ended June 30, 2016 and a 127% increase compared to the third quarter of 2015. The operating expense increase noted in the current quarter as compared to the second quarter of 2016 reflects increased general and administrative expenses of $251,000, or 39%, due to the addition of personnel during the quarter and public company operating expenses stemming from the first full quarter as a public entity. In addition, research and development expenses increased $286,000, or 20%, reflecting design, development and testing services relating to preparing the PulseTx for entry in human pilot studies during early fourth quarter 2016.
Conference Call Details
Pulse Biosciences’ Darrin Uecker, President and CEO, and other senior executives will host the investor conference call on November 14, 2016, at 4:30 p.m. EST / 1:30 p.m. PST. 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 4064167. 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 bioelectronics cell signaling technology. Published pre-clinical studies have shown that a single, brief exposure of Nano-Pulse Stimulation to target tissue stimulates a cascade of events within cells and in the surrounding microenvironment that results in apoptosis (cell death) and the priming of a durable adaptive immune response. Pulse Biosciences is pursuing a variety of applications for its technology that exploits the technology’s unique biologic effect in immuno-oncology, dermatology, aesthetics, and veterinary medicine. Clinical studies are being planned using the first commercial system designed to support a broad array of applicators for use in superficial, minimally-invasive and open surgical procedures. 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, the development of Pulse Biosciences’ business, statements relating to future uses and markets for its NPES technology, and other future events. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, changes in circumstances and other factors that are, in some cases, beyond Pulse Biosciences’ control and could cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Factors that could materially affect actual results can be found in Pulse Biosciences’ most recent filings with the Securities and Exchange Commission, including Pulse Biosciences’ most recent registration statement on Form S-1, as amended, and quarterly report on Form 10-Q, and include those listed under the caption “Risk Factors.”
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.
Pulse Biosciences, Inc.
Investors:
Darrin Uecker, President and Chief Executive Officer
IR@pulsebiosciences.com
or
Media:
Sam Brown, Inc.
Hannah Hurdle, 818-456-4099
hannahhurdle@sambrown.com
Condensed Consolidated Balance Sheets
(Unaudited)
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September 30, |
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 |
$ |
4,628 |
$ |
3,606 | ||
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Investments |
14,085 |
— |
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Prepaid expenses and other current assets |
294 | 44 | ||||
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Deferred offering costs |
— |
347 | ||||
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Total current assets |
19,007 | 3,997 | ||||
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Equipment, net of accumulated depreciation |
323 | 329 | ||||
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Intangible assets, net of accumulated amortization |
6,709 | 7,208 | ||||
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Goodwill |
2,791 | 2,791 | ||||
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Total assets |
$ |
28,830 |
$ |
14,325 | ||
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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446 |
$ |
262 | ||
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Accrued expenses |
521 | 398 | ||||
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Total current liabilities |
967 | 660 | ||||
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Stockholders’ equity: |
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Common stock |
13 | 8 | ||||
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Additional paid-in capital |
37,655 | 16,745 | ||||
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Accumulated comprehensive loss |
(8) |
— |
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Accumulated deficit |
(9,797) | (3,088) | ||||
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Total stockholders’ equity |
27,863 | 13,665 | ||||
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Total liabilities and stockholders’ equity |
$ |
28,830 |
$ |
14,325 | ||
Condensed Consolidated Statements of Operations
(Unaudited)
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Three-Month Periods Ended |
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(in thousands, except per share amounts) |
September 30, 2016 |
June 30, 2016 |
September 30, 2015 |
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Revenue |
$ |
— |
$ |
— |
$ |
— |
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Operating expenses: |
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General and administrative |
893 | 642 | 408 | ||||||
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Research and development |
1,739 | 1,453 | 659 | ||||||
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Amortization of intangible assets |
166 | 166 | 167 | ||||||
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Total operating expenses |
2,798 | 2,261 | 1,234 | ||||||
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Other income: |
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Interest income |
31 | 3 |
— |
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Total other income |
31 | 3 |
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Loss from operations, before income taxes |
(2,767) | (2,258) | (1,234) | ||||||
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Income tax benefit |
— |
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483 | ||||||
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Net loss |
$ |
(2,767) |
$ |
(2,258) |
$ |
(751) | |||
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Net loss per share |
$ |
(0.21) |
$ |
(0.23) |
$ |
(0.10) | |||
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Weighted average number of shares |
13,315 | 9,791 | 7,565 | ||||||