UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
October 30, 2018
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Pulse Biosciences, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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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)
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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 October 30, 2018, Pulse Biosciences, Inc. announced its financial results for the three- and nine-month periods ended September 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
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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 October 30, 2018 |
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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: |
/s/ Brian B. Dow |
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Brian B. Dow Chief Financial Officer, Senior Vice President, Secretary and Treasurer (Principal Financial and Principal Accounting Officer) |
Date: October 30, 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) – October 30, 2018 – Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel medical therapy company bringing to market its proprietary Nano-Pulse Stimulation™ (NPS™) platform, today reported recent corporate developments and financial results for the three- and nine-month periods ended September 30, 2018.
Recent Developments
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Completion of enrollment and patient treatments in the Company’s NPS clinical study for the treatment of Sebaceous Hyperplasia (SH) |
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Study enrollment and patient treatments were completed in the Company’s multi-center study to evaluate the safety and efficacy of NPS for the treatment of Sebaceous Hyperplasia, a common but difficult-to-treat facial lesion. |
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Preliminary data on the first 79 of 226 (35%) treated lesions indicate excellent safety and efficacy results to date with no adverse events and over 95% of treated lesions rated as clear or mostly clear after 60-day follow-up. |
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Patient follow-up visits scheduled to be completed during the fourth quarter with study data available by the end of 2018. |
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Initiation of a clinical feasibility study using NPS to treat patients with cutaneous warts. |
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First patient enrollment and treatment in the Company’s feasibility study that includes up to 20 subjects at the prestigious Scripps Clinic in San Diego, CA. Patient enrollment commenced October 2018. Treatment and follow-up are expected to be completed during the first quarter of 2019. |
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Continued enrollment in NPS Basal Cell Carcinoma (BCC) Biomarker Study |
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First patient enrolled and treated in the Company’s multi-center “treat and resect” study evaluating local lesion effect and immune response changes to NPS. Study enrollment is progressing and is expected to be completed by the end of 2018 with data available during the first quarter of 2019. |
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Clinical introduction of the CellFX™ System, the Company’s next generation Nano-Pulse Stimulation system. |
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Designed with commercial intent for office, outpatient, or hospital setting; |
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Simple and intuitive system design suitable across multiple clinical applications; |
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Integrated networking capability for a per-click revenue model; and |
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Single-patient-use applicator available with a variety of tip sizes for different applications. |
“We’re pleased with the continued and significant progress we’ve made and are making towards bringing our NPS platform closer to commercialization,” said Darrin Uecker, Pulse Biosciences’ President and Chief Executive Officer. “Our data continues to demonstrate safety and efficacy allowing us the opportunity to move forward with our plans to target the cash paying aesthetic dermatology market while we continue to make progress in longer-term opportunities.”
Financial Highlights
Cash, cash equivalents, and investments totaled $21.0 million at September 30, 2018, compared to $38.1 million at December 31, 2017. Cash use totaled $6.5 million for the third 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 September 30, 2018 totaled $10.9 million, compared to $7.5 million for the three-month period ended September 30, 2017. Operating expenses for the three-month period ended September 30, 2018 included non-cash stock-based compensation of $3.4 million, compared to non-cash stock-based compensation of $3.4 million for the three-month period ended September 30, 2017.
Operating expenses for the nine-month period ended September 30, 2018 totaled $28.9 million, compared to $17.0 million for the nine-month period ended September 30, 2017. Operating expenses for the nine-month period ended September 30, 2018 included non-cash stock-based compensation of $10.0 million, compared to non-cash stock-based compensation of $6.4 million for the nine-month period ended September 30, 2017.
Conference Call Details
Pulse Biosciences will host an investor call on October 30, 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 2098843. 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 Nano-Pulse Stimulation™ (NPS™) platform. NPS is a novel, precise, non-thermal, treatment technology delivering nanosecond duration energy pulses that impact cells in treated tissue while sparing acellular tissue. NPS’s 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 that results in regulated cell death. The novel characteristics of NPS’s mechanism of action has the potential to significantly benefit patients across multiple medical applications, including dermatology, the Company’s first planned commercial application. In pre-clinical studies, NPS has demonstrated an ability to induce immunogenic cell death in several cancer cell lines. The Company believes NPS may play a role in immuno-oncology as a focal tumor treatment that can initiate 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.
Caution: Pulse Biosciences’ Nano-Pulse Stimulation (NPS) is an investigational use therapy.
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
or
Media:
Tosk Communications
Nadine D. Tosk, 504-453-8344
nadinepr@gmail.com
Condensed Consolidated Balance Sheets
(Unaudited)
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September 30, |
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December 31, |
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(in thousands) |
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2018 |
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2017 |
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ASSETS |
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Current assets: |
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Cash, cash equivalents and investments |
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$ |
21,021 |
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$ |
38,069 |
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Prepaid expenses and other current assets |
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1,095 |
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412 |
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Total current assets |
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22,116 |
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38,481 |
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Property and equipment, net |
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2,339 |
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2,570 |
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Intangible assets, net |
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5,379 |
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5,878 |
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Goodwill |
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2,791 |
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2,791 |
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Other assets |
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101 |
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101 |
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Total assets |
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$ |
32,726 |
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$ |
49,821 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,281 |
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$ |
782 |
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Accrued expenses |
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1,657 |
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1,034 |
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Deferred rent, current |
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410 |
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397 |
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Total current liabilities |
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3,348 |
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2,213 |
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Long term liabilities: |
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Deferred rent, less current |
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1,304 |
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1,613 |
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Total liabilities |
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4,652 |
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3,826 |
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Stockholders’ equity: |
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Common stock and additional paid-in capital |
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94,842 |
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84,219 |
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Accumulated other comprehensive loss |
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(3) |
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(51) |
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Accumulated deficit |
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(66,765) |
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(38,173) |
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Total stockholders’ equity |
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28,074 |
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45,995 |
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Total liabilities and stockholders’ equity |
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$ |
32,726 |
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$ |
49,821 |
PULSE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
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Three-Month Periods Ended |
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September 30, |
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September 30, |
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(in thousands, except per share amounts) |
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2018 |
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2017 |
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Revenue |
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$ |
— |
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$ |
— |
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Operating expenses: |
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General and administrative |
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5,675 |
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4,434 |
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Research and development |
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5,038 |
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2,925 |
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Amortization of intangible assets |
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166 |
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166 |
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Total operating expenses |
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10,879 |
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7,525 |
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Other income: |
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Interest income |
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118 |
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39 |
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Total other income |
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118 |
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39 |
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Net loss |
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$ |
(10,761) |
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$ |
(7,486) |
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Net loss per share: |
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Basic and diluted net loss per share |
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$ |
(0.64) |
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$ |
(0.52) |
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Weighted average shares used to compute net loss per common share — basic and diluted |
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16,927 |
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14,381 |
PULSE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
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Nine-Month Periods Ended |
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September 30, |
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September 30, |
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(in thousands, except per share amounts) |
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2018 |
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2017 |
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Revenue |
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$ |
— |
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$ |
— |
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Operating expenses: |
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General and administrative |
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16,230 |
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9,702 |
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Research and development |
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12,174 |
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6,782 |
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Amortization of intangible assets |
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499 |
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499 |
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Total operating expenses |
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28,903 |
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16,983 |
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Other income: |
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Interest income |
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311 |
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119 |
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Total other income |
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311 |
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119 |
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Net loss |
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$ |
(28,592) |
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$ |
(16,864) |
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Net loss per share: |
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Basic and diluted net loss per share |
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$ |
(1.69) |
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$ |
(1.19) |
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Weighted average shares used to compute net loss per common share — basic and diluted |
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16,883 |
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14,141 |