8K 2017-05-04





 

 

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)

May 4, 2017

 

 

Pulse Biosciences, Inc.

(Exact name of registrant as specified in its charter)

 

 

 



 

 

 

 



 

 

 

 



 

 

 

 

Nevada

 

001-37744

 

46-5696597

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(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):





 

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 May 4, 2017,  Pulse Biosciences, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2017 and confirming, as previously announced, that it would be holding a conference call on May 4, 2017. A copy of the press release containing the announcement is attached 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.



 



 

 

Exhibit No.

 

Description

99.1

 

Press Release issued by Pulse Biosciences, Inc. dated May 4, 2017 titled “PULSE BIOSCIENCES QUARTERLY INVESTOR CONFERENCE CALL (furnished and not filed herewith pursuant to Item 2.02).



 

 







 


 





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: May 4, 2017

 






 

EXHIBIT INDEX



ch

 

 



 

 

Exhibit   No.

 

Description

99.1

 

Press Release issued by Pulse Biosciences, Inc. dated May 4, 2017 titled “PULSE BIOSCIENCES QUARTERY INVESTOR CONFERENCE CALL” (furnished and not filed herewith pursuant to Item 2.02)






Ex 99.1 2017-05-04

Exhibit 99.1



PULSE BIOSCIENCES QUARTERLY  INVESTOR CONFERENCE CALL 

Investor conference call today at 1:30 p.m. PDT / 4:30 p.m. EDT

BURLINGAME, Calif.—(BUSINESS WIRE) – May 4, 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. The Company will also provide financial results for the three-month period ended March 31, 2017.

Recent Developments

"

First FDA 510(k) submission for the PulseTx System.  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 is now under substantive review by the FDA.



"

Treatment of first patient in canine oral melanoma study.  The first patient was treated in the Company’s NPS veterinary medicine pilot study treating solid malignant tumors in canines.



"

Publication of preclinical research in the Journal for ImmunoTherapy of Cancer.  Data demonstrating NPS’ ability to trigger immunogenic cell death (ICD) was recently published in the paper “Nano-Pulse Stimulation is a physical modality that can trigger immunogenic tumor cell death, in the peer-reviewed Journal for ImmunoTherapy of Cancer. This paper highlighted the expression of key DAMPS indicative of immunogenic cell death.



We are very pleased with our ongoing progress over the weeks since our last update,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences.  “We continue to make meaningful progress in developing our technology and pursuing clinical applications for the benefit of patients and clinicians.

Financial Highlights

Cash, cash equivalents and investments totaled $18.9 million at March 31, 2017, compared to $16.4 million at December 31, 2016.  The March 2017 balance reflects $5.0 million of additional capital raised in February 2017 through a private placement of approximately 820,000 shares of the Company’s

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common stock.  Adjusting for such $5.0 million financing, net cash used during the first quarter totaled $2.5 million.

Operating expenses for the quarter ended March 31, 2017 totaled $3.2 million, compared to $2.8 million for the quarter ended December 31, 2016 and $1.7 million for the quarter ended March 31, 2016.

Conference Call Details

Pulse Biosciences’ Darrin Uecker, President and Chief Executive Officer, and other senior executives will host the investor call on May 4, 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 8287733.  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 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:

Darrin Uecker, President and Chief Executive Officer

IR@pulsebiosciences.com



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or



Media:

Sam Brown, Inc.

Hannah Hurdle, 805-601-5331

hannahhurdle@sambrown.com

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PULSE BIOSCIENCES, INC.

Condensed Consolidated Balance Sheets

(Unaudited)





 

 

 

 

 

 



 

 

 

 

 

 



 

March 31,

 

December 31,

(in thousands)

 

2017

 

2016

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash, cash equivalents and investments

 

$

18,860 

 

$

16,395 

Prepaid expenses and other current assets

 

 

253 

 

 

268 

Total current assets

 

 

19,113 

 

 

16,663 

Equipment, net of accumulated depreciation

 

 

293 

 

 

317 

Intangible assets, net of accumulated amortization

 

 

6,377 

 

 

6,543 

Goodwill

 

 

2,791 

 

 

2,791 

Total assets

 

$

28,574 

 

$

26,314 



 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

782 

 

$

265 

Accrued expenses

 

 

460 

 

 

751 

Total current liabilities

 

 

1,242 

 

 

1,016 



 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock and additional paid-in capital

 

 

43,145 

 

 

37,911 

Accumulated other comprehensive loss

 

 

(9)

 

 

(7)

Accumulated deficit

 

 

(15,804)

 

 

(12,606)

Total stockholders’ equity

 

 

27,332 

 

 

25,298 

Total liabilities and stockholders’ equity

 

$

28,574 

 

$

26,314 



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PULSE BIOSCIENCES, INC.

Condensed Consolidated Statements of Operations

(Unaudited)





 

 

 

 

 

 

 

 

 



 

Three-Month Periods Ended



 

March 31,

 

December 31,

 

March 31,

(in thousands, except per share amounts)

 

2017

 

2016

 

2016

Revenue

 

$

 

$

 

$

Operating expenses:

 

 

 

 

 

 

 

 

 

General and administrative

 

 

1,220 

 

 

870 

 

 

528 

Research and development

 

 

1,851 

 

 

1,806 

 

 

990 

Amortization of intangible assets

 

 

166 

 

 

167 

 

 

166 

Total operating expenses

 

 

3,237 

 

 

2,843 

 

 

1,684 

Other income:

 

 

 

 

 

 

 

 

 

Interest income

 

 

39 

 

 

34 

 

 

Total other income

 

 

39 

 

 

34 

 

 

Net loss

 

$

(3,198)

 

$

(2,809)

 

$

(1,684)

Net loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.23)

 

$

(0.21)

 

$

(0.22)

Weighted average shares used to compute net loss per common share basic and diluted

 

 

13,803 

 

 

13,315 

 

 

7,565 



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