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CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
Arcturus Therapeutics Holdings Inc. commenced the submission of regulatory documents to the Ministry of Health in Vietnam in December 2021 with respect to an Emergency Use Authorization application for ARCT-154 (its next generation, self-amplifying mRNA vaccine candidate against COVID-19), and plans to complete an Emergency Use Authorization application in the first quarter of 2022, assuming positive data.
The information in this Item 7.01 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contain 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. Any statements, other than statements of historical fact included in this Current Report on Form 8-K, are forward-looking statements, including those regarding plans to complete an Emergency Use Authorization application in Vietnam for ARCT-154 in the first quarter of 2022. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the heading "Risk Factors" in Arcturus’ most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in subsequent filings with, or submissions to, the SEC, which are available on the SEC’s website at www.sec.gov. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements made in this Current Report on Form 8-K, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
The statements made in this Current Report on Form 8-K speak only as of the date stated herein, and subsequent events and developments may cause the Company’s expectations and beliefs to change. While the Company may elect to update these forward-looking statements publicly at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date after the date stated herein.
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.
| Arcturus Therapeutics Holdings Inc. | ||
| Date: January 11, 2022 | ||
| By: |
/s/ Joseph E. Payne | |
| Name: | Joseph E. Payne | |
| Title: | Chief Executive Officer | |