UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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) | March 8, 2019 |
AquaBounty Technologies, Inc. |
(Exact name of registrant as specified in its charter) |
Delaware | 001-36426 | 04-3156167 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
2 Mill & Main Place, Suite 395, Maynard, Massachusetts | 01754 |
(Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code | 978-648-6000 |
(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 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company x
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 8.01 Other Events.
On March 8, 2019, AquaBounty Technologies, Inc. (the “Company”) issued a press release regarding a decision by the U.S. Food and Drug Administration to lift the 2016 Import Alert that has prevented the Company’s AquAdvantage Salmon and egg
s from entering the United States. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
The information included in this Current Report on Form 8-K pursuant to Item 8.01, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description | |
99.1 | Press release issued by AquaBounty Technologies, Inc. on March 8, 2019, furnished herewith. | |
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.
AquaBounty Technologies, Inc. | ||
(Registrant) | ||
March 8, 2019 | /s/ David A. Frank | |
David A. Frank | ||
Chief Financial Officer | ||
EXHIBIT INDEX
AquaBounty Technologies, Inc.
FDA Lifts Import Alert on AquAdvantage Salmon
MAYNARD, Massachusetts, March 8, 2019 - AquaBounty Technologies, Inc. (NASDAQ: AQB) (“AquaBounty” or the “Company”), a biotechnology company focused on enhancing productivity in the aquaculture market and a majority-owned subsidiary of Intrexon Corporation (NASDAQ: XON), announces the U.S. Food and Drug Administration (FDA) lifting of the Import Alert, allowing the Company to start farming AquAdvantage Salmon in Indiana.
Sylvia Wulf, Chief Executive Officer of AquaBounty, stated: “We are delighted that FDA has lifted the import alert, which will allow AquaBounty to begin producing and marketing AquAdvantage Salmon in the United States. As FDA notes in this announcement, our salmon was approved by the agency over three years ago based upon a very comprehensive science-based review process, which established that our salmon was safe, nutritious, and environmentally sound and met all other regulatory requirements. We will immediately start the process to import AquAdvantage eggs from our hatchery in Canada to begin grow out at our Indiana facility.”
Approximately 350,000 tons of Atlantic salmon are consumed in the United States with more than 95% of it imported. FDA’s actions will allow for production and sale to begin here in the U.S., bringing opportunity for investment in rural America, creating American jobs, while also reducing dependence on seafood imports.
The United States has been a world leader in biotechnology and food innovation, and today’s decision helps to advance the Company’s leadership in this critical space. This decision is an important achievement not just for AquaBounty, but for biotechnology and agricultural innovation in general. As both FDA and USDA have recognized, animal and plant biotechnology enable the development of innovative and transformational products that have the potential to increase sustainable production of food, enhance human nutrition, and help feed a rapidly growing global population.
Inquiries:
AquaBounty Technologies, Inc.
Dave Conley, Corporate Communications +1 613 294 3078
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding the importation of AquAdvantage Salmon eggs into the United States, the commencement of production and marketing of AquAdvantage Salmon in the United States, the potential for benefits to the United States economy, and the anticipated benefits of biotechnology products, including AquAdvantage Salmon. Forward-looking statements may be identified with words such as “will,” “may,” “expect,” “plan,” “anticipate,” “upcoming,” “believe,” “estimate,” or similar terminology, and the negative of these terms. Forward-looking statements are not promises or guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. For additional information regarding these and other risks faced by us, please refer to our public filings with the Securities and Exchange Commission (“SEC”), available on the Investors section of our website at www.aquabounty.com and on the SEC’s website at www.sec.gov.