UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 7, 2024
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(Exact name of registrant as specified in its charter)
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Registrant’s telephone number, including area code: (203 ) 535-1456
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Securities registered pursuant to Section 12(b) of the Act:
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The | ||||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
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. o
Item 8.01. Other Events.
The investigational new drug application submitted by Arvinas, Inc. (the “Company”) for ARV-393, a PROTAC® degrader designed to target the BCL6 protein, and the clinical trial application submitted by the Company for ARV-102, the Company’s PROTAC® degrader designed to target the LRRK2 protein, have been authorized by the U.S. Food and Drug Administration and European Medicines Agency, respectively. The Company plans to initiate first-in-human Phase 1 clinical trials for both ARV-393 and ARV-102 in the first half of 2024.
Forward-Looking Statements.
This Current Report on Form 8-K contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the potential plans related to and timing of clinical trials for ARV-393 and ARV-102. All statements, other than statements of historical facts, contained in this Current Report on Form 8-K, including statements regarding the Company’s strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The word “plan,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements the Company makes as a result of various risks and uncertainties, including the important factors discussed the important factors discussed in the “Risk Factors” sections contained in the Company’s quarterly and annual reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this Current Report on Form 8-K reflect the Company’s current views with respect to future events, and the Company assumes no obligation to update any forward-looking statements except as required by applicable law. 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 Current Report on Form 8-K.
Item 9.01 | Financial Statements and Exhibits. | ||||
| (d) | Exhibits | ||||
| Exhibit Number | Description of Exhibit | ||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) | ||||
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.
| ARVINAS, INC. | ||||||||
| Date: January 8, 2024 | By: | /s/ Sean Cassidy | ||||||
Sean Cassidy Chief Financial Officer | ||||||||