For the fiscal year ended December 31, 2019
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO |
Commission File Number 001-38942
ARCTURUS THERAPEUTICS HOLDINGS INC.
(Exact name of Registrant as specified in its Charter)
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Delaware |
32-0595345 |
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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10628 Science Center Drive, Suite 250 San Diego, California |
92121 |
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(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (858) 900-2660
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Common Stock, par value $0.001 per share |
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ARCT |
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The Nasdaq Stock Market LLC |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☐ NO ☒
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ☐ NO ☒
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). YES ☒ NO ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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. ☐
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
The aggregate market value of the common equity held by non-affiliates of the Registrant, based on the closing price of the common stock on The Nasdaq Stock Market on June 28, 2019 was $76.4 million.
As of March 1, 2020, the registrant had 15,137,964 shares of voting common stock outstanding.
Table of Contents
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Page |
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PART I |
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Item 1. |
3 |
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Item 1A. |
39 |
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Item 1B. |
68 |
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Item 2. |
68 |
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Item 3. |
68 |
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Item 4. |
69 |
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PART II |
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Item 5. |
70 |
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Item 6. |
71 |
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Item 7. |
72 |
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Item 7A. |
79 |
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Item 8. |
79 |
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Item 9. |
79 |
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Item 9A. |
79 |
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Item 9B. |
82 |
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PART III |
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Item 10. |
83 |
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Item 11. |
83 |
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Item 12. |
83 |
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Item 13. |
83 |
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Item 14. |
83 |
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PART IV |
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Item 15. |
84 |
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Item 16 |
84 |
Special Note Regarding Forward-Looking Statements
This Annual Report on Form 10-K, or this annual report, and the documents incorporated by reference herein may contain “forward-looking statements” within the meaning of the federal securities laws made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below under Part I, Item 3.D, “Risk Factors” in this annual report. Except as required by law, we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise. These statements, which represent our current expectations or beliefs concerning various future events, may contain words such as “may,” “will,” “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate” or other words indicating future results, though not all forward-looking statements necessarily contain these identifying words. Such statements may include, but are not limited to, statements concerning the following:
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the initiation, cost, timing, progress and results of, and our expected ability to undertake certain activities and accomplish certain goals with respect to, our research and development activities, preclinical studies and clinical trials; |
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our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate; |
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our ability to obtain and deploy funding for our operations; |
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our ability to continue as a going concern; |
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our plans to research, develop and commercialize our product candidates; |
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our strategic alliance partners’ election to pursue development and commercialization of any programs or product candidates that are subject to our collaboration and license agreements with such partners; |
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our ability to attract collaborators with relevant development, regulatory and commercialization expertise; |
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future activities to be undertaken by our strategic alliance partners, collaborators and other third parties; |
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our ability to obtain and maintain intellectual property protection for our product candidates; |
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the size and growth potential of the markets for our product candidates, and our ability to serve those markets; |
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our ability to successfully commercialize, and our expectations regarding future therapeutic and commercial potential with respect to, our product candidates; |
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the rate and degree of market acceptance of our product candidates; |
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our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; |
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regulatory developments in the United States and foreign countries; |
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our ability to attract and retain experienced and seasoned scientific and management professionals to lead the Company; |
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the performance of our third-party suppliers and manufacturers; |
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the success of competing therapies that are or may become available; and |
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the accuracy of our estimates regarding future expenses, future revenues, capital requirements and need for additional financing. |
Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those projected. These statements are only current predictions 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. In addition, historic results of scientific research, preclinical and clinical trials do not guarantee that future research or trials will suggest the same conclusions, nor that historic results referred to herein will be interpreted the same in light of additional research, preclinical and clinical trial results. The forward-looking statements contained in this annual report are subject to risks and uncertainties, including those discussed in our other filings with the United States Securities and Exchange Commission, or the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.