SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 13, 2020
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
5 Science Park
395 Winchester Ave.
New Haven, Connecticut
|(Address of principal executive offices)||(Zip Code)|
Registrants telephone number, including area code: (203) 535-1456
(Former Name or Former Address, if Changed Since Last Report)
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Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange on
|Common stock, par value $0.001 per share||ARVN||The Nasdaq Stock Market LLC|
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 ☒
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|Item 8.01|| |
On May 13, 2020, Arvinas, Inc. (the Company) announced updated safety and initial efficacy data contained in an abstract scheduled as an oral presentation at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program, to be held May 2931, 2020. The presentation will share updated data from the dose escalation portion of the Companys Phase 1/2 clinical trial of ARV-110 in men with metastatic castration-resistant prostate cancer. The abstract describes two patients with ongoing confirmed prostate-specific antigen responses, including one with an unconfirmed partial tumor response.
The presentation will include data collected since the abstract submission date. Dose escalation for the Phase 1/2 clinical trial continues, supported by the safety profile to date, with enrollment initiated above the previously disclosed daily dose of 280 milligrams.
Abstract details are as follows:
Presentation Title: First-in-human phase I study of ARV-110, an androgen receptor PROTAC degrader in patients with metastatic castrate-resistant prostate cancer following enzalutamide and/or abiraterone.
Abstract Number: 3500
Session Type: Oral Abstract Session
Session Track: Development Therapeutics Molecularly Targeted Agents and Tumor Biology
This Current Report on Form 8-K contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of the Companys product candidates, the conduct of and plans for the Companys ongoing Phase 1/2 clinical trial for ARV-110, the plans for presentation of data from the Companys clinical trial for ARV-110 and the potential advantages and therapeutic potential of the Companys product candidates. All statements, other than statements of historical facts, contained in this Current Report on Form 8-K, including statements regarding the Companys 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 and ARV-471, complete its clinical trials for its product candidates, and receive results from its clinical trials on the Companys expected timelines, or at all, whether the Companys cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Companys expected timeline and other important factors discussed in the Risk Factors sections contained in the Companys 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 Companys 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 Companys 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, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: May 13, 2020
/s/ Sean Cassidy
Chief Financial Officer