SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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Item 7.01 Regulation FD Disclosure.
On September 28, 2021, Arvinas, Inc. (the “Company”) posted an updated corporate presentation on the “Investors + Media” section of the Company’s website (www.arvinas.com). The information contained in, or that can be accessed through, the Company’s website is not a part of this filing. The updated portion of the presentation regarding the timing of clinical data for the Company’s ARV-110 clinical program is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “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 it 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.
Item 8.01 Other Events.
On September 28, 2021, the Company announced updated timing for the anticipated presentation of clinical data for the Company’s ARV-110 clinical program. The Company anticipates presenting data from the dose escalation portion and interim data from the ARDENT expansion portion of its Phase 1/2 clinical trial of ARV-110 at the ASCO Genitourinary Cancers Symposium in February 2022.
Item 9.01 Financial Statements and Exhibits.
|99.1||Excerpt from Company Presentation, dated September 28, 2021|
|104||Cover Page Interactive Data File (formatted as Inline XBRL)|
This Current Report on Form 8-K, including the document furnished as Exhibit 99.1 hereto, contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of the Company’s product candidates, such as statements with respect to the Company’s lead product candidates, ARV-110, ARV-471 and ARV-766 and other candidates in the Company’s pipeline, and the timing of clinical trials and data from those trials and plans for registration for the Company’s product candidates, and the Company’s development programs that may lead to the Company’s development of additional product candidates, the potential utility of the Company’s technology and therapeutic potential of the Company’s product candidates and the potential commercialization of any of the Company’s product candidates. 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 words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” 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 but not limited to: whether the Company will be able to successfully conduct Phase 1/2 clinical trials for ARV-110, ARV-471 and ARV-766, complete its clinical trials for its product candidates, and receive results from its clinical trials on the Company’s expected timelines, or at all, whether the Company’s cash resources will be sufficient to fund its foreseeable and
unforeseeable operating expenses and capital expenditure requirements, the Company’s expected timeline and other important factors discussed in the “Risk Factors” sections contained in the Company’s quarterly and annual reports on file with the 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.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: September 28, 2021||ARVINAS, INC.|
|Chief Financial Officer|
Rapid pace of anticipated milestones ARV-110 (AR PROTAC®) Initiate abiraterone combination study Share complete Phase 1 dose escalation and interim ARDENT Phase 2 data (anticipated at ASCO GU) Share completed ARDENT Phase 2 data Share interim abiraterone combination data ARV-766 (AR PROTAC®) Initiate Phase 1 Share Phase 1 data Initiate Phase 2 INDs ARV-766 BCL6 Tau Undisclosed oncology ARV-471 (ER PROTAC®) Share completed Phase 1 data (anticipated at SABCS) Initiate Phase 1b combination study with everolimus Begin early breast cancer study (neoadjuvant setting) Initiate Phase 3 studies in metastatic breast cancer (as monotherapy and in combination) VERITAC Phase 2 data Safety data from Phase 1b IBRANCE® (palbociclib) combination study data 2021 2022 INDs Four additional INDs through 2023 Exhibit 99.1