UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

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FORM SD

Specialized Disclosure Report

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Pulse Biosciences, Inc.

(Exact name of registrant as specified in its charter)

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3957 Point Eden Way

Hayward, California 94545

(Address of principal executive offices, including zip code)

Brian B. Dow

Senior Vice President and Chief Financial Officer

(510) 906-4600

(Name and telephone number, including area code, of the person to contact in connection with this report)



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Check the appropriate box to indicate the rule pursuant to which this form is being filed, and provide the period to which the information in this form applies:







 

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Section 1.    Conflict minerals disclsosure 



Item 1.01 Conflict Minerals Disclosure and Report 

A copy of Pulse Biosciences, Inc.’s (the “Company’s”) Conflict Minerals Report for the reporting period January 1, 2018 to December 31, 2018 is provided as Exhibit 1.01 hereto and is publicly available at www.pulsebiosciences.com. The Company’s determination and related disclosures relating to materials that may come from the Democratic Republic of Congo, the Republic of Congo, the Central African Republic, South Sudan, Uganda, Rwanda, Burundi, Tanzania, Zambia or Angola or from recycled and scrap sources that are included in the Company’s Conflict Minerals Report and incorporated by reference herein.



Item 1.02 Exhibit 

In accordance with Rule 13p-1, and this Form SD, the Company is hereby filing its Conflict Minerals Report for the calendar year ended December 31, 2018 as Exhibit 1.01 to this report.



Section 2.    Exhibits 

The following exhibits are filed as part of this report:



Item 2.01 Exhibits 

Exhibit 1.01 — 2018 Conflict Minerals Report of Pulse Biosciences, Inc. as required by Items 1.01 and 1.02 of this Form SD.











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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.





Date: May 24, 2019

 

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EXHIBIT INDEX









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Conflict Minerals Report of Pulse Biosciences, Inc.

in Accordance with Rule 13p-1 under the Securities Exchange Act of 1934

 

This is the Conflict Minerals Report (“CMR”) of Pulse Biosciences, Inc. (“Pulse Biosciences” or the “Company”) for the reporting period January 1, 2018 to December 31, 2018 in accordance with Rule 13p-1 (“Rule 13p-1”) under the Securities Exchange Act of 1934, as amended (the “1934 Act”). Rule 13p-1 requires disclosure of certain information when a company manufactures or contracts to manufacture products and the minerals specified in Rule 13p-1 are necessary to the functionality or production of those products. The specified minerals referred to as “Conflict Minerals” are gold, columbite-tantalite (coltan), cassiterite and wolframite, including their derivatives which include tantalum, tin and tungsten (collectively, the “3TG Minerals”). The “Covered Countries” for purposes of Rule 13p-1 and this CMR are the Democratic Republic of Congo (“DRC”), the Republic of Congo, the Central African Republic, South Sudan, Uganda, Rwanda, Burundi, Tanzania, Zambia and Angola. Please refer to Rule 13p-1, Form SD and the 1934 Act Release No. 34-67716 for definitions to the terms used in this CMR, unless otherwise defined herein.

 

Company Overview



Pulse Biosciences is a bioelectric medicine company pursuing commercial introduction of our proprietary CellFX™ System utilizing our patented Nano-Pulse Stimulation™ (NPS™) platform technology. With our proprietary NPS technology, we can deliver nanosecond pulses of high amplitude electrical energy to non-thermally clear targeted cells while sparing adjacent non-cellular tissue. The cell-specific effect of our NPS technology has been demonstrated through a series of clinical trials. In addition, early preclinical evidence suggests that the NPS technology may have future applications in immuno-oncology by demonstrating an ability to induce immunogenic cell death. We are currently conducting research and development activities in pursuit of commercial applications for our NPS technology, but we have not yet commercialized or recognized revenue from our technology.

 

Pulse Biosciences supports the goal of avoiding the use of “conflict minerals” mined from troubled regions in the Covered Countries, the exploitation and trade of which may help finance armed conflict or benefit armed groups. Pulse Biosciences conducted an analysis of its products and determined that certain 3TG Minerals are necessary to the functionality or production of its CellFX System.    

 

Reasonable Country of Origin Inquiry

 

Pulse Biosciences has conducted a reasonable country of origin inquiry (“RCOI”) reasonably designed to determine if 3TG Minerals used in its products originated in the Covered Countries. The Company’s RCOI process began with an evaluation of its suppliers that provided materials, components or products that became part of products Pulse Biosciences contracted to manufacture in 2018, which the Company knew contained or were likely to contain 3TG Minerals. This evaluation consisted of examining internal records such as product specifications and performing a qualitative review of purchasing records and/or information provided by the suppliers. Based on its evaluation, the Company then surveyed the suppliers of those materials, components or products which it concluded contained or were likely to contain 3TG Minerals. The suppliers were asked to report on the presence of any 3TG Minerals in the goods sold to Pulse Biosciences. In cases where the Company confirmed that 3TG Minerals were present, it asked the applicable supplier to submit information to the Company about the country of origin of the 3TG Minerals.

 

Due Diligence

 

Pulse Biosciences performed due diligence procedures to determine the Conflict Minerals status of the 3TG Minerals used in its products. In conducting its due diligence, Pulse Biosciences implemented the Organization for Economic Co-operation and Development (“OECD”) Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas (the “OECD Guidance”), an internationally recognized due diligence framework. The Company designed its due diligence process, management and measures within the OECD Guidance for a company downstream in the supply chain. 

 

The following is a summary of the due diligence actions that Pulse Biosciences has taken with regards to the reporting period for which this CMR is submitted:

 







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Findings and Conclusion

 

The Company sent out surveys to the 17 suppliers identified in its due diligence efforts and received responses from 13 suppliers, providing a 76% response rate. One of the suppliers did not respond to all the questions. Suppliers and manufacturers generally provided facility information at the “Company Level,” which represents the suppliers’ and manufacturers’ entire product lines, and generally did not limit their responses to facility information for covered minerals in products they specifically supply to Pulse Biosciences. 11 suppliers provided responses specific to Pulse Biosciences’ product (“Product Level”). 

 

Out of the 13 responses received, 1 stated that their products do not contain 3TG Minerals, 3 stated that the 3TG Minerals were not sourced from the Covered Countries, 5 stated that at least some of their 3TG Minerals were sourced from Covered Countries and 4 stated that they were uncertain as to the origin of the 3TG Minerals in their products or did not provide sufficient information to adequately determine the source. Of the 5 suppliers that stated that at least some of their 3TG Minerals were sourced from Covered

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Countries, all of them noted that all their products were from sources certified as being conflict-free, actively obtaining conflict-free certification, or had complete control from mine to production. However, 2 stated that all their products are from sources certified as being conflict-free. The remaining sources were uncertified or had an unknown certification status. However, Pulse Biosciences has not identified any known instances in which any 3TG Minerals were sourced directly or indirectly from armed groups of the conflict regions of the Covered Countries.

 

Of the 5 suppliers whose responses indicated that their products may contain 3TG Minerals sourced from the Covered Countries, all 5 of those suppliers responded at the Company Level. As a result, some of those smelters identified by Pulse Biosciences’ suppliers in Company Level declarations may not actually be involved in the products supplied to Pulse Biosciences. For the 5 suppliers that indicated that their products may contain 3TG sourced from the Covered Countries that responded at the Product Level, all of them noted that 3TG Minerals sourced from Covered Countries were from sources certified as being conflict-free, actively obtaining conflict-free certification, or had complete control from mine to production.    

 

Based on the representations made by its suppliers, Pulse Biosciences does not have sufficient information to determine whether its supply chain is “DRC conflict-free” for the calendar year 2018. Pulse Biosciences has been unable to determine the origin of all 3TG Minerals used in certain integrated circuits and other components used in the manufacturing of its instruments and related consumables. This was due to a lack of information from its suppliers to conclude whether the 3TG Minerals originated in the Covered Countries and, if so, whether the 3TG Minerals were from recycle or scrap sources, were DRC conflict-free, or have not been found to be DRC conflict-free. 

 

Future Steps

 

Pulse Biosciences is continuing to develop methods, implement tools and adopt procedures that are designed to be both auditable and in accordance with the OECD Guidance. In the next compliance period, Pulse Biosciences intends to continue to develop its processes in working with its suppliers to provide accurate and complete information regarding conflict mineral sourcing.

 



Additional Risk Factors and Considerations

 

This CMR contains forward looking statements relating to actions that Pulse Biosciences may take in the future. Such statements are based on the current expectations of Pulse Biosciences management and are neither promises nor guarantees of future performance of the actions. Subsequent events and developments may cause management’s views to change. While Pulse Biosciences may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this report.

 

The statements above are based on the due diligence performed in good faith by Pulse Biosciences. The statements are all based on information available at the time, and many factors can introduce errors impacting or otherwise affect Pulse Biosciences’ Conflict Minerals status. Some factors could include but are not limited to unavailable supplier data, incomplete supplier data, incomplete smelter data, errors or omissions in supplier or smelter responses, all instances of Conflict Minerals necessary to the functionality or manufacturing of Pulse Biosciences’ products possibly not yet having been identified, public information not discovered during a reasonable search, errors in public data, language barriers and translation, Covered Countries sourced materials being declared secondary materials, companies going out of business, smuggling of Conflict Minerals from the Covered Countries to countries beyond the Covered Countries, and suppliers or smelter operators who are unfamiliar with the Conflict Minerals rules and protocols for responding to requests for information about Conflict Minerals. 

 

Suppliers and manufacturers generally provided facility information at the Company Level, representing the suppliers’ and manufacturers’ entire product lines, and generally did not limit their responses to facility information for covered minerals in products they specifically supply to Pulse Biosciences. 

 

Independent Private Sector Audit



Based on guidance from the SEC’s staff, an independent private sector audit is not required to be conducted under Rule 13p-1 and therefore, has not been conducted.



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