8-K

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):  October 12, 2020

Commission File Number:  001-32420

Charlie's Holdings, Inc.

(Exact name of registrant as specified in its charter.)

1007 Brioso Drive, Costa Mesa, California 92627

(Address of principal executive offices)

949-203-3500

(Registrant's Telephone number)

Not Applicable

(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:

[ ] 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 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2)

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. [ ]

Securities registered pursuant to Section 12(b) of the Act:

Item 7.01 Regulation FD Disclosure.

On October 12, 2020, Charlie’s Holdings, Inc. (the “Company”) issued an open letter to customers discussing current operations and announcing that the Food and Drug Administration has issued its determination that the Company’s Premarket Tobacco Application (“PMTA”) is sufficiently complete and the Company’s PMTA can enter the substantive review phase. A copy of the letter is attached to this Current Report on Form 8-K as Exhibit 99.1.

The information in this Current Report on Form 8-K, including the information set forth in Exhibit 99.1, are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall Exhibit 99.1 filed herewith be deemed 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.

Forward Looking Statements

This document contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this communication, the words “will,” “may,” “would,” “approximate,” “expect,” “intend,” and similar expressions and their variants, as they relate to the Company, or the management of the Company, or the submission of the Company’s PMTA, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements relating to the timing and completion of the PMTA process; the adequacy of the PMTA; whether the PMTA will be approved; and any impact on operations based upon the potential approval of the PMTA. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation, uncertainties as to the timing of the approval of the PMTA, and the whether the Company will receive approval for its PMTA. This review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s Annual Report on Form 10-K filed with the SEC on April 14, 2020. Forward looking statements are based on information available and assumptions as of the date of this report. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Item 9.01 Financial Statements and Exhibits.

See Exhibit Index.

SIGNATURES

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.

Exhibit Index

ex99-1

Exhibit 99.1

Charlie’s is no stranger to adversity. As we have all experienced, the vapor industry has had its share of ups and downs during the past few years. From unfavorable news late last year and the ensuing regulatory uncertainty, to the advent of a global pandemic during 2020, we as an industry have collectively overcome many challenges. At Charlie’s, we have always been at the forefront of change creating innovative products, helping to shape regulation, and acting as industry stewards.

Our first test was in 2016 when the European Union announced the revision of its Tobacco Products Directive (TPD) to include vapor products. As a result of our clean flavor formulations and propensity to fully adhere to regulations, Charlie’s became one of the first American brands to become fully compliant in the EU.

Fast forward to Q4 of 2019 when the media sensationally reported on people dying from lung injuries related to usage of black-market THC products. Undoubtedly the victim of opportunism, our industry was forced to fight a battle it should have never been a participant in. Charlie’s was able to utilize CNBC and FOX News as platforms to inform the public about the truth regarding our industry’s involvement, or lack thereof, in these illnesses.

Now, as the global economy has been adversely affected due to disruptions from COVID-19, Charlie’s has been able to find creative ways to work with our customers and help them to find continued success during these trying times. We believe it is incumbent upon us as an industry leader to work with our customers to help shoulder the burden of economic uncertainty.

All the while, the team at Charlie’s has been diligently working to ensure its customers will have access to high quality, safe products for decades to come. To continue legally selling products in the domestic market, a Premarket Tobacco Application is required and was to be submitted to the FDA by September 9th, 2020. We utilized the knowledge gathered from our TPD experience to appropriately plan and execute a long-term, fully developed strategy for submitting a PMTA with the FDA. We took the premium, rather than the discounted approach, having already invested $5 million on the highest quality application available to us. An outsourced team of over 200 professionals, including doctors, scientists, biostatisticians and industry-specific consultants, worked in collaboration to perform clinical and behavioral tests in the creation of a comprehensive submission.

It is with great pleasure that we can announce to our customers that the FDA’s Center for Tobacco Products has informed us that our PMTA is sufficiently complete to enter the Substantive Review phase of the process. This news is worthy of celebration as it highlights our progress towards achieving full regulatory compliance and providing our customers with a trusted product portfolio. It is a reflection of our relentless hard work and meticulousness in the pursuit of precision. We are confident that during the Substantive Review process the FDA will recognize that our submission is both distinguished and suitable for approval.

Charlie’s is optimistic we will find a path toward full compliance and will have the ability to provide a safer alternative to combustible tobacco products for years to come. Without our loyal customers we are nothing. Thank you for your continued support.

Sincerely,

Brandon Stump, CEO